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Sample records for identify randomized controlled

  1. Identifying reports of randomized controlled trials (RCTs) via a hybrid machine learning and crowdsourcing approach.

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    Wallace, Byron C; Noel-Storr, Anna; Marshall, Iain J; Cohen, Aaron M; Smalheiser, Neil R; Thomas, James

    2017-11-01

    Identifying all published reports of randomized controlled trials (RCTs) is an important aim, but it requires extensive manual effort to separate RCTs from non-RCTs, even using current machine learning (ML) approaches. We aimed to make this process more efficient via a hybrid approach using both crowdsourcing and ML. We trained a classifier to discriminate between citations that describe RCTs and those that do not. We then adopted a simple strategy of automatically excluding citations deemed very unlikely to be RCTs by the classifier and deferring to crowdworkers otherwise. Combining ML and crowdsourcing provides a highly sensitive RCT identification strategy (our estimates suggest 95%-99% recall) with substantially less effort (we observed a reduction of around 60%-80%) than relying on manual screening alone. Hybrid crowd-ML strategies warrant further exploration for biomedical curation/annotation tasks. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  2. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

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    Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

    2018-02-27

    Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question

  3. Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature

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    Sinha, Shashank S.; Sukul, Devraj; Lazarus, John J.; Polavarapu, Vivek; Chan, Paul S.; Neumar, Robert W.; Nallamothu, Brahmajee K.

    2016-01-01

    Background Cardiac arrests are a major public health concern worldwide. The extent and types of randomized controlled trials (RCTs) – our most reliable source of clinical evidence – conducted in these high-risk patients over recent years are largely unknown. Methods and Results We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on acute treatment of non-traumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported and how these factors have changed over time. Over this twenty-year period, 92 RCTs were published containing 64,309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the U.S., 68 (73.9%) were performed outside the U.S., and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post-cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of risk of bias was limited. The most common outcome reported was ROSC: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes whereas 15 (16.3%) reported quality-of-life. RCTs in the last 5 years were more likely to be focused on protocol improvement and post-cardiac arrest care. Conclusions Important gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, post-cardiac arrest care, and long-term or quality-of-life outcomes. PMID:27756794

  4. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    Directory of Open Access Journals (Sweden)

    Mayer JM

    2013-03-01

    Full Text Available John M Mayer,1 James L Nuzzo,1 Simon Dagenais2 1School of Physical Therapy and Rehabilitation Sciences, College of Medicine, University of South Florida, Tampa, FL, 2Palladian Health, West Seneca, NY, USA Background: Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective: To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs. Methods: Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results: A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion: Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on

  5. An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial.

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    Watson, Judith; Tober, Gillian; Raistrick, Duncan; Mdege, Noreen; Dale, Veronica; Crosby, Helen; Godfrey, Christine; Lloyd, Charlie; Toner, Paul; Parrott, Steve

    2013-04-30

    Alcohol misuse is a major cause of premature mortality and ill health. Although there is a high prevalence of alcohol problems among patients presenting to general hospital, many of these people are not help seekers and do not engage in specialist treatment. Hospital admission is an opportunity to steer people towards specialist treatment, which can reduce health-care utilization and costs to the public sector and produce substantial individual health and social benefits. Alcohol misuse is associated with other lifestyle problems, which are amenable to intervention. It has been suggested that the development of a healthy or balanced lifestyle is potentially beneficial for reducing or abstaining from alcohol use, and relapse prevention. The aim of the study is to test whether or not the offer of a choice of health-related lifestyle interventions is more acceptable, and therefore able to engage more problem drinkers in treatment, than an alcohol-focused intervention. This is a pragmatic, randomized, controlled, open pilot study in a UK general hospital setting with concurrent economic evaluation and a qualitative component. Potential participants are those admitted to hospital with a diagnosis likely to be responsive to addiction interventions who score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT). The main purpose of this pilot study is to evaluate the acceptability of two sorts of interventions (healthy living related versus alcohol focused) to the participants and to assess the components and processes of the design. Qualitative research will be undertaken to explore acceptability and the impact of the approach, assessment, recruitment and intervention on trial participants and non-participants. The effectiveness of the two treatments will be compared at 6 months using AUDIT scores as the primary outcome measure. There will be additional economic, qualitative and secondary outcome measurements. Development of the study was a

  6. Brief Alcohol Intervention by Newly Trained Workers Versus Leaflets: Comparison of Effect in Older Heavy Drinkers Identified in a Population Health Examination Survey: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hansen, Anders Blædel Gottlieb; Becker, Ulrik; Nielsen, Anette Søgaard

    2011-01-01

    Aims: To test if a brief motivational intervention (BMI) in a non-treatment seeking population of heavy drinkers results in a reduced alcohol intake. Methods: Screening of 12,364 participants in a Danish health examination survey led to 1026 heavy drinkers of whom 772 were included and randomized...

  7. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  8. a randomized, placebo- controlled study

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    Hall, Franziska van

    2012-01-01

    Introduction: Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated non-invasive method, which has also been proved to have mild antidepressant effects and is used as “add-on“-therapy in treating pharmaco-resistant major depression. Objective: The efficacy of an escitalopram plus rTMS-combination-treatment was evaluated and compared to escitalopram plus sham rTMS. Methods: We designed a four week-, randomized, rater-blinded, and controlled add-on study with two trea...

  9. Sequential Treatment of Severe Postmenopausal Osteoporosis Following Teriparatide: Final Results of the Randomized, Controlled European Study of Forsteo (EUROFORS): Trial registration: clinicaltrials.gov identifier NCT00191425 (Trial registration date: 12 September 2005)

    DEFF Research Database (Denmark)

    Eastell, Richard; Nickelsen, Thomas; Marin, Fernando

    2009-01-01

    Abstract It is unclear which treatment should be given after stopping teriparatide therapy for severe osteoporosis. In a prospective, randomized, controlled, 2-yr study, we compared bone mineral density (BMD) effects and clinical safety of 3 follow-up treatments (anabolic with teriparatide, antir...

  10. Identifying randomized clinical trials in Spanish-language dermatology journals.

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    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  11. Identifying diseases-related metabolites using random walk.

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    Hu, Yang; Zhao, Tianyi; Zhang, Ningyi; Zang, Tianyi; Zhang, Jun; Cheng, Liang

    2018-04-11

    Metabolites disrupted by abnormal state of human body are deemed as the effect of diseases. In comparison with the cause of diseases like genes, these markers are easier to be captured for the prevention and diagnosis of metabolic diseases. Currently, a large number of metabolic markers of diseases need to be explored, which drive us to do this work. The existing metabolite-disease associations were extracted from Human Metabolome Database (HMDB) using a text mining tool NCBO annotator as priori knowledge. Next we calculated the similarity of a pair-wise metabolites based on the similarity of disease sets of them. Then, all the similarities of metabolite pairs were utilized for constructing a weighted metabolite association network (WMAN). Subsequently, the network was utilized for predicting novel metabolic markers of diseases using random walk. Totally, 604 metabolites and 228 diseases were extracted from HMDB. From 604 metabolites, 453 metabolites are selected to construct the WMAN, where each metabolite is deemed as a node, and the similarity of two metabolites as the weight of the edge linking them. The performance of the network is validated using the leave one out method. As a result, the high area under the receiver operating characteristic curve (AUC) (0.7048) is achieved. The further case studies for identifying novel metabolites of diabetes mellitus were validated in the recent studies. In this paper, we presented a novel method for prioritizing metabolite-disease pairs. The superior performance validates its reliability for exploring novel metabolic markers of diseases.

  12. Dynamic Output Feedback Control for Nonlinear Networked Control Systems with Random Packet Dropout and Random Delay

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    Shuiqing Yu

    2013-01-01

    Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.

  13. ASSISTments Dataset from Multiple Randomized Controlled Experiments

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    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

    In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

  14. PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial.

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    Hammond, Simon P; Cross, Jane L; Shepstone, Lee; Backhouse, Tamara; Henderson, Catherine; Poland, Fiona; Sims, Erika; MacLullich, Alasdair; Penhale, Bridget; Howard, Robert; Lambert, Nigel; Varley, Anna; Smith, Toby O; Sahota, Opinder; Donell, Simon; Patel, Martyn; Ballard, Clive; Young, John; Knapp, Martin; Jackson, Stephen; Waring, Justin; Leavey, Nick; Howard, Gregory; Fox, Chris

    2017-12-04

    Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit "suitable informants" (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and

  15. Plasma biomarker analysis in pediatric ARDS: generating future framework from a pilot randomized control trial of methylprednisoloneA framework for identifying plasma biomarkers related to clinical outcomes in pediatric ARDS

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    Dai eKimura

    2016-03-01

    Full Text Available Objective: Lung injury activates multiple pro-inflammatory pathways, including neutrophils, epithelial and endothelial injury, and coagulation factors leading to acute respiratory distress syndrome (ARDS. Low-dose methylprednisolone therapy (MPT improved oxygenation and ventilation in early pediatric ARDS without altering duration of mechanical ventilation or mortality. We evaluated the effects of MPT on biomarkers of endothelial (Ang-2, sICAM-1 or epithelial (sRAGE injury, neutrophil activation (MMP-8, and coagulation (PAI-1. Design: Double-blind, placebo-controlled randomized trialSetting: Tertiary-care Pediatric Intensive Care Unit Patients: Mechanically ventilated children (0-18 years with early ARDS.Interventions: Blood samples were collected on Days 0 (before MPT, 7, and 14 during low-dose MPT (n=17 vs. placebo (n=18 therapy. The MPT group received a 2mg/kg loading dose followed by 1mg/kg/day continuous infusions from days 1-7, tapered off over 7 days; placebo group received equivalent amounts of 0.9% saline. We analyzed plasma samples using a multiplex assay for 5 biomarkers of ARDS. Multiple regression models were constructed to predict associations between changes in biomarkers and the clinical outcomes reported earlier including: P/F ratio on days 8&9, plateau pressure on days 1&2, PaCO2 on days 2&3, racemic epinephrine following extubation, and supplemental oxygen at ICU discharge.Results: No differences occurred in biomarker concentrations between the groups on Day 0. On Day 7, reduction in MMP-8 levels (p=0.0016 occurred in the MPT group, whereas increases in sICAM-1 levels (p=0.0005 occurred in the placebo group (no increases in sICAM-1 in the MPT group. sRAGE levels decreased in both MPT and placebo groups (p<0.0001 from Day 0 to Day 7. On Day 7, sRAGE levels were positively correlated with MPT group PaO2/FiO2 ratios on Day 8 (r=0.93, p=0.024. O2 requirements at ICU transfer positively correlated with Day 7 MMP-8 (r=0.85, p=0

  16. Recent randomized controlled trials in otolaryngology.

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    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  17. Objective Model Selection for Identifying the Human Feedforward Response in Manual Control

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    Drop, F.M.; Pool, D.M.; van Paassen, M.M.; Mulder, M.; Bülthoff, Heinrich H.

    2017-01-01

    Realistic manual control tasks typically involve predictable target signals and random disturbances. The human controller (HC) is hypothesized to use a feedforward control strategy for target-following, in addition to feedback control for disturbance-rejection. Little is known about human feedforward control, partly because common system identification methods have difficulty in identifying whether, and (if so) how, the HC applies a feedforward strategy. In this paper, an identification proce...

  18. The Randomised Controlled Trial in Medical Research: Using Bibliometric Methods to Identify Core Journals. A review of: Tsay, Migh-yueh, and Yen-hsu Yang. “Bibliometric Analysis of the Literature of Randomized Controlled Trials.” Journal of the Medical Library Association 93.4 (October 2005: 450-58.

    Directory of Open Access Journals (Sweden)

    John Loy

    2006-03-01

    Full Text Available Objective – To explore the characteristics and distribution of randomized controlled trials (RCTs in the medical literature. The study aims to identify the growth patterns of the RCT, key subject matter, country and language of publication, and determine a list of core journals which contain a substantial proportion of the RCT literature. Design – Retrospective analysis of RCTs. Setting – Medical journal literature. Subjects – A total of 160,213 articles published between 1965‐2001. Detailed analysis of a subset numbering 114,850 articles published from 1990‐2001. Methods – The study seeks to identify all RCTs in MEDLINE from 1965‐2001, and examines the growth rate of the RCT. The authors then do a more detailed analysis on a subset of data from 1990‐2001, using Access database and Excel spreadsheet software, and PERL programming language. The references were analyzed by five fields within MEDLINE; publication type, source, language, country of publication, and descriptor (subject index. Main results – An exponential growth rate for the RCT is demonstrated, suggesting that in the medical literature development has not yet matured and that research using this method continues to grow. A growth rate for the RCT of 11.2% per annum is identified. The most common form of publication is the journal article, making up approximately 98% of the RCT literature. Approximately 75% of the RCTs are multicentre trials indicating that this is the design of choice adopted by researchers. The United States proves to be the greatest source of RCT literature, with 39.9% of journals and 50.6% of articles originating there. After the USA, the most productive countries are England (15.8% of journals and 21.7% articles and Germany (6.5% journals and 6.1% articles. As might be expected, English is the predominant language providing 92.9% of the total publications. Of the remaining 7%, German is the most common language accounting for 2.2%. The top

  19. Celiac Patients: A Randomized, Controlled Clinical Study

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    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  20. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

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    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  1. Do randomized controlled trials discuss healthcare costs?

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    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  2. Do randomized controlled trials discuss healthcare costs?

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    Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna

    2010-08-23

    Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  3. Preference towards Control in Risk Taking: Control, No Control, or Randomize?

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    Li, King King

    2010-01-01

    This paper experimentally investigates preference towards different methods of control in risk taking. Participants are asked to choose between different ways for choosing which numbers to bet on for a gamble. They can choose the numbers themselves (control), let the experimenter choose (no control), or randomize. It is found that in addition to the more conventional preference for control, some participants prefer not to control, or randomization. These preferences are robust as participants...

  4. Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program.

    NARCIS (Netherlands)

    Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

    2006-01-01

    OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

  5. Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program

    NARCIS (Netherlands)

    Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

    2006-01-01

    Objective: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. Method: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

  6. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  7. Digital servo control of random sound fields

    Science.gov (United States)

    Nakich, R. B.

    1973-01-01

    It is necessary to place number of sensors at different positions in sound field to determine actual sound intensities to which test object is subjected. It is possible to determine whether specification is being met adequately or exceeded. Since excitation is of random nature, signals are essentially coherent and it is impossible to obtain true average.

  8. A randomized, controlled trial of oral propranolol in infantile hemangioma.

    Science.gov (United States)

    Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

    2015-02-19

    Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

  9. Autoshaping, random control, and omission training in the rat.

    Science.gov (United States)

    Locurto, C; Terrace, H S; Gibbon, J

    1976-11-01

    The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

  10. Autoshaping, random control, and omission training in the rat1

    Science.gov (United States)

    Locurto, Charles; Terrace, H. S.; Gibbon, John

    1976-01-01

    The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

  11. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

  12. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial.

    Science.gov (United States)

    Winker, Robert; Barth, Alfred; Bidmon, Daniela; Ponocny, Ivo; Weber, Michael; Mayr, Otmar; Robertson, David; Diedrich, André; Maier, Richard; Pilger, Alex; Haber, Paul; Rüdiger, Hugo W

    2005-03-01

    Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.

  13. Randomized Controlled Trials: The Most Powerful Tool In Modern ...

    African Journals Online (AJOL)

    Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

  14. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  15. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  16. Prospective Randomized Controlled Comparison of Caudal ...

    African Journals Online (AJOL)

    including 50 consecutive patients in the age group of 1‑10 years, who underwent urogenital surgeries ... The duration of absolute analgesia was defined as the time from caudal injection until the pain score was >2. Motor block was assessed by modified Bromage scale. .... double-blind, phase III, controlled trial comparing.

  17. Identifying and Analyzing Novel Epilepsy-Related Genes Using Random Walk with Restart Algorithm

    Directory of Open Access Journals (Sweden)

    Wei Guo

    2017-01-01

    Full Text Available As a pathological condition, epilepsy is caused by abnormal neuronal discharge in brain which will temporarily disrupt the cerebral functions. Epilepsy is a chronic disease which occurs in all ages and would seriously affect patients’ personal lives. Thus, it is highly required to develop effective medicines or instruments to treat the disease. Identifying epilepsy-related genes is essential in order to understand and treat the disease because the corresponding proteins encoded by the epilepsy-related genes are candidates of the potential drug targets. In this study, a pioneering computational workflow was proposed to predict novel epilepsy-related genes using the random walk with restart (RWR algorithm. As reported in the literature RWR algorithm often produces a number of false positive genes, and in this study a permutation test and functional association tests were implemented to filter the genes identified by RWR algorithm, which greatly reduce the number of suspected genes and result in only thirty-three novel epilepsy genes. Finally, these novel genes were analyzed based upon some recently published literatures. Our findings implicate that all novel genes were closely related to epilepsy. It is believed that the proposed workflow can also be applied to identify genes related to other diseases and deepen our understanding of the mechanisms of these diseases.

  18. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    Directory of Open Access Journals (Sweden)

    SOFIA VON HUMBOLDT

    2013-01-01

    Full Text Available El objetivo del estudio que se informa fue ex- plorar si una intervención individual de terapia centrada en la persona (TCP en personas adul- tas mayores puede promover su sentido de cohe- rencia, en comparación con un grupo control (lista de espera. Se plantea que los participantes asignados al azar a TCP informarían mejoras en SDC de pre y post-intervención en comparación con el grupo control. Un grupo de 87 participantes de 65 a 86 años (M = 72.4; DE = 5.15 fue evaluado con la Escala de Sentido de Coherencia (ESDC y el cuestio- nario sociodemográfico en tres momentos dife- rentes: al inicio del estudio (t1, post-tratamiento (t2 y a los 12 meses de seguimiento (t3. Los resultados indicaron que los participan- tes en TCP evidenciaron un aumento significa- tivo en cuanto a su SDC (16.7%, mientras que en el grupo control se encontró una disminu- ción significativa (-2.7%, entre el inicio del es- tudio y el momento de seguimiento. El tamaño del efecto en el grupo TCP fue alto (η2p = .776. En concreto, tanto en la post-intervención como en el momento del seguimiento, los participan- tes que se sometieron a TCP tenían un SDC sig- nificativamente mayor (M = 3.84, DE = .219 Se encontraron diferencias significativas entre el grupo de intervención y el grupo control en la post-intervención y en el seguimiento. Se concluye que los cambios en SDC fueron positivos y mantenidos, por lo tanto, los resul- tados sugieren que la TCP es favorable a la me- jora de SDC. Por otra parte, ya que la SDC se asocia con el bienestar relacionado con la salud de las poblaciones de mayor edad, hay que en- fatizar el desarrollo de SDC en la vejez.

  19. Performance Analysis: Work Control Events Identified January - August 2010

    Energy Technology Data Exchange (ETDEWEB)

    De Grange, C E; Freeman, J W; Kerr, C E; Holman, G; Marsh, K; Beach, R

    2011-01-14

    This performance analysis evaluated 24 events that occurred at LLNL from January through August 2010. The analysis identified areas of potential work control process and/or implementation weaknesses and several common underlying causes. Human performance improvement and safety culture factors were part of the causal analysis of each event and were analyzed. The collective significance of all events in 2010, as measured by the occurrence reporting significance category and by the proportion of events that have been reported to the DOE ORPS under the ''management concerns'' reporting criteria, does not appear to have increased in 2010. The frequency of reporting in each of the significance categories has not changed in 2010 compared to the previous four years. There is no change indicating a trend in the significance category and there has been no increase in the proportion of occurrences reported in the higher significance category. Also, the frequency of events, 42 events reported through August 2010, is not greater than in previous years and is below the average of 63 occurrences per year at LLNL since 2006. Over the previous four years, an average of 43% of the LLNL's reported occurrences have been reported as either ''management concerns'' or ''near misses.'' In 2010, 29% of the occurrences have been reported as ''management concerns'' or ''near misses.'' This rate indicates that LLNL is now reporting fewer ''management concern'' and ''near miss'' occurrences compared to the previous four years. From 2008 to the present, LLNL senior management has undertaken a series of initiatives to strengthen the work planning and control system with the primary objective to improve worker safety. In 2008, the LLNL Deputy Director established the Work Control Integrated Project Team to develop the core requirements and graded

  20. Objective Model Selection for Identifying the Human Feedforward Response in Manual Control.

    Science.gov (United States)

    Drop, Frank M; Pool, Daan M; van Paassen, Marinus Rene M; Mulder, Max; Bulthoff, Heinrich H

    2018-01-01

    Realistic manual control tasks typically involve predictable target signals and random disturbances. The human controller (HC) is hypothesized to use a feedforward control strategy for target-following, in addition to feedback control for disturbance-rejection. Little is known about human feedforward control, partly because common system identification methods have difficulty in identifying whether, and (if so) how, the HC applies a feedforward strategy. In this paper, an identification procedure is presented that aims at an objective model selection for identifying the human feedforward response, using linear time-invariant autoregressive with exogenous input models. A new model selection criterion is proposed to decide on the model order (number of parameters) and the presence of feedforward in addition to feedback. For a range of typical control tasks, it is shown by means of Monte Carlo computer simulations that the classical Bayesian information criterion (BIC) leads to selecting models that contain a feedforward path from data generated by a pure feedback model: "false-positive" feedforward detection. To eliminate these false-positives, the modified BIC includes an additional penalty on model complexity. The appropriate weighting is found through computer simulations with a hypothesized HC model prior to performing a tracking experiment. Experimental human-in-the-loop data will be considered in future work. With appropriate weighting, the method correctly identifies the HC dynamics in a wide range of control tasks, without false-positive results.

  1. Randomized algorithms in automatic control and data mining

    CERN Document Server

    Granichin, Oleg; Toledano-Kitai, Dvora

    2015-01-01

    In the fields of data mining and control, the huge amount of unstructured data and the presence of uncertainty in system descriptions have always been critical issues. The book Randomized Algorithms in Automatic Control and Data Mining introduces the readers to the fundamentals of randomized algorithm applications in data mining (especially clustering) and in automatic control synthesis. The methods proposed in this book guarantee that the computational complexity of classical algorithms and the conservativeness of standard robust control techniques will be reduced. It is shown that when a problem requires "brute force" in selecting among options, algorithms based on random selection of alternatives offer good results with certain probability for a restricted time and significantly reduce the volume of operations.

  2. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  3. Human strongyloidiasis: identifying knowledge gaps, with emphasis on environmental control

    Directory of Open Access Journals (Sweden)

    Taylor MJ

    2014-08-01

    Full Text Available Michael J Taylor, Tara A Garrard, Francis J O'Donahoo, Kirstin E Ross Health and Environment, School of the Environment, Flinders University, Adelaide, SA, Australia Abstract: Strongyloides is a human parasitic nematode that is poorly understood outside a clinical context. This article identifies gaps within the literature, with particular emphasis on gaps that are hindering environmental control of Strongyloides. The prevalence and distribution of Strongyloides is unclear. An estimate of 100–370 million people infected worldwide has been proposed; however, inaccuracy of diagnosis, unreliability of prevalence mapping, and the fact that strongyloidiasis remains a neglected disease suggest that the higher figure of more than 300 million cases is likely to be a more accurate estimate. The complexity of Strongyloides life cycle means that laboratory cultures cannot be maintained outside of a host. This currently limits the range of laboratory-based research, which is vital to controlling Strongyloides through environmental alteration or treatment. Successful clinical treatment with antihelminthic drugs has meant that controlling Strongyloides through environmental control, rather than clinical intervention, has been largely overlooked. These control measures may encompass alteration of the soil environment through physical means, such as desiccation or removal of nutrients, or through chemical or biological agents. Repeated antihelminthic treatment of individuals with recurrent strongyloidiasis has not been observed to result in the selection of resistant strains; however, this has not been explicitly demonstrated, and relying on such assumptions in the long-term may prove to be shortsighted. It is ultimately naive to assume that continued administration of antihelminthics will be without any negative long-term effects. In Australia, strongyloidiasis primarily affects Indigenous communities, including communities from arid central Australia. This

  4. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  5. A Combined Control Chart for Identifying Out–Of–Control Points in Multivariate Processes

    Directory of Open Access Journals (Sweden)

    Marroquín–Prado E.

    2010-10-01

    Full Text Available The Hotelling's T2 control chart is widely used to identify out–of–control signals in multivariate processes. However, this chart is not sensitive to small shifts in the process mean vec tor. In this work we propose a control chart to identify out–of–control signals. The proposed chart is a combination of Hotelling's T2 chart, M chart proposed by Hayter et al. (1994 and a new chart based on Principal Components. The combination of these charts identifies any type and size of change in the process mean vector. Us ing simulation and the Average Run Length (ARL, the performance of the proposed control chart is evaluated. The ARL means the average points within control before an out–of–control point is detected, The results of the simulation show that the proposed chart is more sensitive that each one of the three charts individually

  6. Quality control methods in accelerometer data processing: identifying extreme counts.

    Directory of Open Access Journals (Sweden)

    Carly Rich

    Full Text Available Accelerometers are designed to measure plausible human activity, however extremely high count values (EHCV have been recorded in large-scale studies. Using population data, we develop methodological principles for establishing an EHCV threshold, propose a threshold to define EHCV in the ActiGraph GT1M, determine occurrences of EHCV in a large-scale study, identify device-specific error values, and investigate the influence of varying EHCV thresholds on daily vigorous PA (VPA.We estimated quantiles to analyse the distribution of all accelerometer positive count values obtained from 9005 seven-year old children participating in the UK Millennium Cohort Study. A threshold to identify EHCV was derived by differentiating the quantile function. Data were screened for device-specific error count values and EHCV, and a sensitivity analysis conducted to compare daily VPA estimates using three approaches to accounting for EHCV.Using our proposed threshold of ≥ 11,715 counts/minute to identify EHCV, we found that only 0.7% of all non-zero counts measured in MCS children were EHCV; in 99.7% of these children, EHCV comprised < 1% of total non-zero counts. Only 11 MCS children (0.12% of sample returned accelerometers that contained negative counts; out of 237 such values, 211 counts were equal to -32,768 in one child. The medians of daily minutes spent in VPA obtained without excluding EHCV, and when using a higher threshold (≥19,442 counts/minute were, respectively, 6.2% and 4.6% higher than when using our threshold (6.5 minutes; p<0.0001.Quality control processes should be undertaken during accelerometer fieldwork and prior to analysing data to identify monitors recording error values and EHCV. The proposed threshold will improve the validity of VPA estimates in children's studies using the ActiGraph GT1M by ensuring only plausible data are analysed. These methods can be applied to define appropriate EHCV thresholds for different accelerometer models.

  7. Identifying co-targets to fight drug resistance based on a random walk model

    Directory of Open Access Journals (Sweden)

    Chen Liang-Chun

    2012-01-01

    Full Text Available Abstract Background Drug resistance has now posed more severe and emergent threats to human health and infectious disease treatment. However, wet-lab approaches alone to counter drug resistance have so far still achieved limited success due to less knowledge about the underlying mechanisms of drug resistance. Our approach apply a heuristic search algorithm in order to extract active network under drug treatment and use a random walk model to identify potential co-targets for effective antibacterial drugs. Results We use interactome network of Mycobacterium tuberculosis and gene expression data which are treated with two kinds of antibiotic, Isoniazid and Ethionamide as our test data. Our analysis shows that the active drug-treated networks are associated with the trigger of fatty acid metabolism and synthesis and nicotinamide adenine dinucleotide (NADH-related processes and those results are consistent with the recent experimental findings. Efflux pumps processes appear to be the major mechanisms of resistance but SOS response is significantly up-regulation under Isoniazid treatment. We also successfully identify the potential co-targets with literature confirmed evidences which are related to the glycine-rich membrane, adenosine triphosphate energy and cell wall processes. Conclusions With gene expression and interactome data supported, our study points out possible pathways leading to the emergence of drug resistance under drug treatment. We develop a computational workflow for giving new insights to bacterial drug resistance which can be gained by a systematic and global analysis of the bacterial regulation network. Our study also discovers the potential co-targets with good properties in biological and graph theory aspects to overcome the problem of drug resistance.

  8. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (Pperiodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

  9. LigandRFs: random forest ensemble to identify ligand-binding residues from sequence information alone

    KAUST Repository

    Chen, Peng

    2014-12-03

    Background Protein-ligand binding is important for some proteins to perform their functions. Protein-ligand binding sites are the residues of proteins that physically bind to ligands. Despite of the recent advances in computational prediction for protein-ligand binding sites, the state-of-the-art methods search for similar, known structures of the query and predict the binding sites based on the solved structures. However, such structural information is not commonly available. Results In this paper, we propose a sequence-based approach to identify protein-ligand binding residues. We propose a combination technique to reduce the effects of different sliding residue windows in the process of encoding input feature vectors. Moreover, due to the highly imbalanced samples between the ligand-binding sites and non ligand-binding sites, we construct several balanced data sets, for each of which a random forest (RF)-based classifier is trained. The ensemble of these RF classifiers forms a sequence-based protein-ligand binding site predictor. Conclusions Experimental results on CASP9 and CASP8 data sets demonstrate that our method compares favorably with the state-of-the-art protein-ligand binding site prediction methods.

  10. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  11. Randomized, Controlled Study of Adderall XR in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-08-01

    Full Text Available The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA.

  12. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

  13. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  14. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  15. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

    Science.gov (United States)

    Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

    2012-01-25

    Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

  16. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  17. Filtering, control and fault detection with randomly occurring incomplete information

    CERN Document Server

    Dong, Hongli; Gao, Huijun

    2013-01-01

    This book investigates the filtering, control and fault detection problems for several classes of nonlinear systems with randomly occurring incomplete information. It proposes new concepts, including RVNs, ROMDs, ROMTCDs, and ROQEs. The incomplete information under consideration primarily includes missing measurements, time-delays, sensor and actuator saturations, quantization effects and time-varying nonlinearities. The first part of this book focuses on the filtering, control and fault detection problems for several classes of nonlinear stochastic discrete-time systems and

  18. Random small interfering RNA library screen identifies siRNAs that induce human erythroleukemia cell differentiation.

    Science.gov (United States)

    Fan, Cuiqing; Xiong, Yuan; Zhu, Ning; Lu, Yabin; Zhang, Jiewen; Wang, Song; Liang, Zicai; Shen, Yan; Chen, Meihong

    2011-03-01

    Cancers are characterized by poor differentiation. Differentiation therapy is a strategy to alleviate malignant phenotypes by inducing cancer cell differentiation. Here we carried out a combinatorial high-throughput screen with a random siRNA library on human erythroleukemia K-562 cell differentiation. Two siRNAs screened from the library were validated to be able to induce erythroid differentiation to varying degrees, determined by CD235 and globin up-regulation, GATA-2 down-regulation, and cell growth inhibition. The screen we performed here is the first trial of screening cancer differentiation-inducing agents from a random siRNA library, demonstrating that a random siRNA library can be considered as a new resource in efforts to seek new therapeutic agents for cancers. As a random siRNA library has a broad coverage for the entire genome, including known/unknown genes and protein coding/non-coding sequences, screening using a random siRNA library can be expected to greatly augment the repertoire of therapeutic siRNAs for cancers.

  19. How to Identify and Control Water Weeds and Algae.

    Science.gov (United States)

    Applied Biochemists, Inc., Mequon, WI.

    Included in this guide to water management are general descriptions of algae, toxic algae, weed problems in lakes, ponds, and canals, and general discussions of mechanical, biological and chemical control methods. In addition, pictures, descriptions, and recommended control methods are given for algae, 6 types of floating weeds, 18 types of…

  20. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

  1. Identifying Controlling Nodes in Neuronal Networks in Different Scales

    Science.gov (United States)

    Tang, Yang; Gao, Huijun; Zou, Wei; Kurths, Jürgen

    2012-01-01

    Recent studies have detected hubs in neuronal networks using degree, betweenness centrality, motif and synchronization and revealed the importance of hubs in their structural and functional roles. In addition, the analysis of complex networks in different scales are widely used in physics community. This can provide detailed insights into the intrinsic properties of networks. In this study, we focus on the identification of controlling regions in cortical networks of cats’ brain in microscopic, mesoscopic and macroscopic scales, based on single-objective evolutionary computation methods. The problem is investigated by considering two measures of controllability separately. The impact of the number of driver nodes on controllability is revealed and the properties of controlling nodes are shown in a statistical way. Our results show that the statistical properties of the controlling nodes display a concave or convex shape with an increase of the allowed number of controlling nodes, revealing a transition in choosing driver nodes from the areas with a large degree to the areas with a low degree. Interestingly, the community Auditory in cats’ brain, which has sparse connections with other communities, plays an important role in controlling the neuronal networks. PMID:22848475

  2. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

    Science.gov (United States)

    De Pascale, Gennaro; Pennisi, Mariano Alberto; Vallecoccia, Maria Sole; Bello, Giuseppe; Maviglia, Riccardo; Montini, Luca; Di Gravio, Valentina; Cutuli, Salvatore Lucio; Conti, Giorgio; Antonelli, Massimo

    2017-01-01

    To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS). This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually. No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; paspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality. The use AG 100 system and AG tube in critically ill intubated patients is safe and

  3. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Gennaro De Pascale

    Full Text Available To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system that continuously monitors and controls the cuff pressure (Pcuff, while facilitating the aspiration of subglottic secretions (SS.This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE and serious AE (SAE as a result of using AnapnoGuard (AG 100 during mechanical ventilation. Secondary endpoints were: (1 mechanical complications rate (2 ICU staff satisfaction; (3 VAP occurrence; (4 length of mechanical ventilation; (5 length of Intensive Care Unit stay and mortality; (6 volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually.No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01 and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total; (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily. No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7, hoarseness (42.9% vs. 75%; p = 0.55 and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65. Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP (14.8% vs. 40%; p = 0.06, which were more frequently monomicrobial (25% vs. 70%; p = 0.03. No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality.The use AG 100 system and AG tube in critically ill

  4. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2016-10-29

    clinician applicants occurred. b. SP baseline interviews with eligible clinicians occurred. c. Automated random assignment of participants with Completed SP...intervention without web-centered supervision and a wait-list control with regard to improvements in two CBT-based skill areas (behavioral task...Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based training with or without web-centered supervision and

  5. Random Forest Application for NEXRAD Radar Data Quality Control

    Science.gov (United States)

    Keem, M.; Seo, B. C.; Krajewski, W. F.

    2017-12-01

    Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e

  6. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    OpenAIRE

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

  7. HOW to Identify and Control Sapsucker Injury on Trees

    Science.gov (United States)

    Michael E. Ostry; Thomas H. Nicholls

    1976-01-01

    The yellow-bellied sapsucker (Sphyrapicus varius), a member of the woodpecker family, is a migratory bird whose summer breeding range includes the Lakes States region. The identifying field markings of adult birds are a black crescent on the breast, pale yellow belly, white wing stripe, and a crimson crown. The male also has a crimson chin and throat, distinguishing...

  8. From control system security indices to attack identifiability

    NARCIS (Netherlands)

    Herdeiro Teixeira, A.M.; Sandberg, H

    2016-01-01

    In this paper, we investigate detectability and identifiability of attacks on linear dynamical systems that are subjected to external disturbances. We generalize a concept for a security index, which was previously introduced for static systems. The index exactly quantifies the resources

  9. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

    Science.gov (United States)

    Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

    Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

  10. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

    Science.gov (United States)

    Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

    2013-01-01

    Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  11. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

    Science.gov (United States)

    Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

    2013-03-01

    To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

  12. Controlled searching in reversibly de-identified medical imaging archives.

    Science.gov (United States)

    Silva, Jorge Miguel; Pinho, Eduardo; Monteiro, Eriksson; Silva, João Figueira; Costa, Carlos

    2018-01-01

    Nowadays, digital medical imaging in healthcare has become a fundamental tool for medical diagnosis. This growth has been accompanied by the development of technologies and standards, such as the DICOM standard and PACS. This environment led to the creation of collaborative projects where there is a need to share medical data between different institutions for research and educational purposes. In this context, it is necessary to maintain patient data privacy and provide an easy and secure mechanism for authorized personnel access. This paper presents a solution that fully de-identifies standard medical imaging objects, including metadata and pixel data, providing at the same time a reversible de-identifier mechanism that retains search capabilities from the original data. The last feature is important in some scenarios, for instance, in collaborative platforms where data is anonymized when shared with the community but searchable for data custodians or authorized entities. The solution was integrated into an open source PACS archive and validated in a multidisciplinary collaborative scenario. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  14. Identifying the social capital influencing diabetes control in Japan

    OpenAIRE

    Yamada, Yohei; Suematsu, Mina; Takahashi, Noriyuki; Okazaki, Kentaro; Yasui, Hiroki; Hida, Takeshi; Uemura, Kazumasa; Murotani, Kenta; Kuzuya, Masafumi

    2018-01-01

    The number of patients with diabetes is increasing in Japan. Recently, Social capital (SC) has received increasing attention as a factor influencing health conditions. In the US, the relation between SC and diabetes control has been reported, but little attention has been paid to this connection in Japan. Three SC questionnaires, entitled “trust in people in a community,” “social support,” and “social relationships,” were constructed. The subjects were adult patients with type 2 diabetes. Inf...

  15. Yoga in Correctional Settings: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Nóra Kerekes

    2017-10-01

    Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

  16. Biomimetic propulsion under random heaving conditions, using active pitch control

    Science.gov (United States)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  17. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  18. Building Kindergartners' Number Sense: A Randomized Controlled Study.

    Science.gov (United States)

    Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-08-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

  19. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    Science.gov (United States)

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  20. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  1. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  2. Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches.

    Science.gov (United States)

    Vroland-Nordstrand, Kristina; Eliasson, Ann-Christin; Jacobsson, Helén; Johansson, Ulla; Krumlinde-Sundholm, Lena

    2016-06-01

    The efficacy of two different goal-setting approaches (children's self-identified goals and goals identified by parents) were compared on a goal-directed, task-oriented intervention. In this assessor-blinded parallel randomized trial, 34 children with disabilities (13 males, 21 females; mean age 9y, SD 1y 4mo) were randomized using concealed allocation to one of two 8-week, goal-directed, task-oriented intervention groups with different goal-setting approaches: (1) children's self-identified goals (n=18) using the Perceived Efficacy and Goal-Setting System, or (2) goals identified by parents (n=16) using the Canadian Occupational Performance Measure (COPM). Participants were recruited through eight paediatric rehabilitation centres and randomized between October 2011 and May 2013. The primary outcome measure was the Goal Attainment Scaling and the secondary measure, the COPM performance scale (COPM-P). Data were collected pre- and post-intervention and at the 5-month follow-up. There was no evidence of a difference in mean characteristics at baseline between groups. There was evidence of an increase in mean goal attainment (mean T score) in both groups after intervention (child-goal group: estimated mean difference [EMD] 27.84, 95% CI 22.93-32.76; parent-goal group: EMD 21.42, 95% CI 16.16-26.67). There was no evidence of a difference in the mean T scores post-intervention between the two groups (EMD 6.42, 95% CI -0.80 to 13.65). These results were sustained at the 5-month follow-up. Children's self-identified goals are achievable to the same extent as parent-identified goals and remain stable over time. Thus children can be trusted to identify their own goals for intervention, thereby influencing their involvement in their intervention programmes. © 2015 Mac Keith Press.

  3. Standards for reporting randomized controlled trials in neurosurgery.

    Science.gov (United States)

    Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

    2011-02-01

    The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

  4. Time-delayed feedback control of diffusion in random walkers

    Science.gov (United States)

    Ando, Hiroyasu; Takehara, Kohta; Kobayashi, Miki U.

    2017-07-01

    Time delay in general leads to instability in some systems, while specific feedback with delay can control fluctuated motion in nonlinear deterministic systems to a stable state. In this paper, we consider a stochastic process, i.e., a random walk, and observe its diffusion phenomenon with time-delayed feedback. As a result, the diffusion coefficient decreases with increasing delay time. We analytically illustrate this suppression of diffusion by using stochastic delay differential equations and justify the feasibility of this suppression by applying time-delayed feedback to a molecular dynamics model.

  5. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...

  6. Medication reconciliation at patient admission: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mendes AE

    2016-03-01

    Full Text Available Objective: To measure length of hospital stay (LHS in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620. The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.

  7. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

  8. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  9. Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

    Science.gov (United States)

    Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

    2018-02-01

    The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

  10. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

  11. Random fiber lasers based on artificially controlled backscattering fibers

    Science.gov (United States)

    Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

    2017-10-01

    The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

  12. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

  13. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  14. Random fiber laser based on artificially controlled backscattering fibers.

    Science.gov (United States)

    Wang, Xiaoliang; Chen, Daru; Li, Haitao; She, Lijuan; Wu, Qiong

    2018-01-10

    The random fiber laser (RFL), which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previously reported RFLs are based on distributed feedback of Rayleigh scattering amplified through the stimulated Raman-Brillouin scattering effect in single-mode fibers, which require long-distance (tens of kilometers) single-mode fibers and high threshold, up to watt level, due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open-cavity RFL based on a segment of an artificially controlled backscattering single-mode fiber with a length of 210 m, 310 m, or 390 m. A fiber Bragg grating with a central wavelength of 1530 nm and a segment of artificially controlled backscattering single-mode fiber fabricated by using a femtosecond laser form the half-open cavity. The proposed RFL achieves thresholds of 25 mW, 30 mW, and 30 mW, respectively. Random lasing at a wavelength of 1530 nm and extinction ratio of 50 dB is achieved when a segment of 5 m erbium-doped fiber is pumped by a 980 nm laser diode in the RFL. A novel RFL with many short cavities has been achieved with low threshold.

  15. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  16. Random Forests Are Able to Identify Differences in Clotting Dynamics from Kinetic Models of Thrombin Generation.

    Science.gov (United States)

    Arumugam, Jayavel; Bukkapatnam, Satish T S; Narayanan, Krishna R; Srinivasa, Arun R

    2016-01-01

    Current methods for distinguishing acute coronary syndromes such as heart attack from stable coronary artery disease, based on the kinetics of thrombin formation, have been limited to evaluating sensitivity of well-established chemical species (e.g., thrombin) using simple quantifiers of their concentration profiles (e.g., maximum level of thrombin concentration, area under the thrombin concentration versus time curve). In order to get an improved classifier, we use a 34-protein factor clotting cascade model and convert the simulation data into a high-dimensional representation (about 19000 features) using a piecewise cubic polynomial fit. Then, we systematically find plausible assays to effectively gauge changes in acute coronary syndrome/coronary artery disease populations by introducing a statistical learning technique called Random Forests. We find that differences associated with acute coronary syndromes emerge in combinations of a handful of features. For instance, concentrations of 3 chemical species, namely, active alpha-thrombin, tissue factor-factor VIIa-factor Xa ternary complex, and intrinsic tenase complex with factor X, at specific time windows, could be used to classify acute coronary syndromes to an accuracy of about 87.2%. Such a combination could be used to efficiently assay the coagulation system.

  17. Random Forests Are Able to Identify Differences in Clotting Dynamics from Kinetic Models of Thrombin Generation.

    Directory of Open Access Journals (Sweden)

    Jayavel Arumugam

    Full Text Available Current methods for distinguishing acute coronary syndromes such as heart attack from stable coronary artery disease, based on the kinetics of thrombin formation, have been limited to evaluating sensitivity of well-established chemical species (e.g., thrombin using simple quantifiers of their concentration profiles (e.g., maximum level of thrombin concentration, area under the thrombin concentration versus time curve. In order to get an improved classifier, we use a 34-protein factor clotting cascade model and convert the simulation data into a high-dimensional representation (about 19000 features using a piecewise cubic polynomial fit. Then, we systematically find plausible assays to effectively gauge changes in acute coronary syndrome/coronary artery disease populations by introducing a statistical learning technique called Random Forests. We find that differences associated with acute coronary syndromes emerge in combinations of a handful of features. For instance, concentrations of 3 chemical species, namely, active alpha-thrombin, tissue factor-factor VIIa-factor Xa ternary complex, and intrinsic tenase complex with factor X, at specific time windows, could be used to classify acute coronary syndromes to an accuracy of about 87.2%. Such a combination could be used to efficiently assay the coagulation system.

  18. Moxibustion for breech version: a randomized controlled trial.

    Science.gov (United States)

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  19. Identifying a system of predominant negative symptoms: Network analysis of three randomized clinical trials.

    Science.gov (United States)

    Levine, Stephen Z; Leucht, Stefan

    2016-12-01

    Reasons for the recent mixed success of research into negative symptoms may be informed by conceptualizing negative symptoms as a system that is identifiable from network analysis. We aimed to identify: (I) negative symptom systems; (I) central negative symptoms within each system; and (III) differences between the systems, based on network analysis of negative symptoms for baseline, endpoint and change. Patients with chronic schizophrenia and predominant negative symptoms participated in three clinical trials that compared placebo and amisulpride to 60days (n=487). Networks analyses were computed from the Scale for the Assessment of Negative Symptoms (SANS) scores for baseline and endpoint for severity, and estimated change based on mixed models. Central symptoms to each network were identified. The networks were contrasted for connectivity with permutation tests. Network analysis showed that the baseline and endpoint symptom severity systems formed symptom groups of Affect, Poor responsiveness, Lack of interest, and Apathy-inattentiveness. The baseline and endpoint networks did not significantly differ in terms of connectivity, but both significantly (Psymptom group split into three other groups. The most central symptoms were Decreased Spontaneous Movements at baseline and endpoint, and Poverty of Speech for estimated change. Results provide preliminary evidence for: (I) a replicable negative symptom severity system; and (II) symptoms with high centrality (e.g., Decreased Spontaneous Movement), that may be future treatment targets following replication to ensure the curent results generalize to other samples. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Identifying pathogenicity genes in the rubber tree anthracnose fungus Colletotrichum gloeosporioides through random insertional mutagenesis.

    Science.gov (United States)

    Cai, Zhiying; Li, Guohua; Lin, Chunhua; Shi, Tao; Zhai, Ligang; Chen, Yipeng; Huang, Guixiu

    2013-07-19

    To gain more insight into the molecular mechanisms of Colletotrichum gloeosporioides pathogenesis, Agrobacterium tumefaciens-mediated transformation (ATMT) was used to identify mutants of C. gloeosporioides impaired in pathogenicity. An ATMT library of 4128 C. gloeosporioides transformants was generated. Transformants were screened for defects in pathogenicity with a detached copper brown leaf assay. 32 mutants showing reproducible pathogenicity defects were obtained. Southern blot analysis showed 60.4% of the transformants had single-site T-DNA integrations. 16 Genomic sequences flanking T-DNA were recovered from mutants by thermal asymmetric interlaced PCR, and were used to isolate the tagged genes from the genome sequence of wild-type C. gloeosporioides by Basic Local Alignment Search Tool searches against the local genome database of the wild-type C. gloeosporioides. One potential pathogenicity genes encoded calcium-translocating P-type ATPase. Six potential pathogenicity genes had no known homologs in filamentous fungi and were likely to be novel fungal virulence factors. Two putative genes encoded Glycosyltransferase family 28 domain-containing protein and Mov34/MPN/PAD-1 family protein, respectively. Five potential pathogenicity genes had putative function matched with putative protein of other Colletotrichum species. Two known C. gloeosporioides pathogenicity genes were also identified, the encoding Glomerella cingulata hard-surface induced protein and C. gloeosporioides regulatory subunit of protein kinase A gene involved in cAMP-dependent PKA signal transduction pathway. Copyright © 2013 Elsevier GmbH. All rights reserved.

  1. A randomized controlled trial of interim methadone maintenance.

    Science.gov (United States)

    Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J

    2006-01-01

    Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (Pmethadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.

  2. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

    2017-12-01

    There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

  3. A randomized controlled trial to promote volunteering in older adults.

    Science.gov (United States)

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  4. Random and externally controlled occurrences of Dansgaard–Oeschger events

    Directory of Open Access Journals (Sweden)

    J. Lohmann

    2018-05-01

    Full Text Available Dansgaard–Oeschger (DO events constitute the most pronounced mode of centennial to millennial climate variability of the last glacial period. Since their discovery, many decades of research have been devoted to understand the origin and nature of these rapid climate shifts. In recent years, a number of studies have appeared that report emergence of DO-type variability in fully coupled general circulation models via different mechanisms. These mechanisms result in the occurrence of DO events at varying degrees of regularity, ranging from periodic to random. When examining the full sequence of DO events as captured in the North Greenland Ice Core Project (NGRIP ice core record, one can observe high irregularity in the timing of individual events at any stage within the last glacial period. In addition to the prevailing irregularity, certain properties of the DO event sequence, such as the average event frequency or the relative distribution of cold versus warm periods, appear to be changing throughout the glacial. By using statistical hypothesis tests on simple event models, we investigate whether the observed event sequence may have been generated by stationary random processes or rather was strongly modulated by external factors. We find that the sequence of DO warming events is consistent with a stationary random process, whereas dividing the event sequence into warming and cooling events leads to inconsistency with two independent event processes. As we include external forcing, we find a particularly good fit to the observed DO sequence in a model where the average residence time in warm periods are controlled by global ice volume and cold periods by boreal summer insolation.

  5. Random and externally controlled occurrences of Dansgaard-Oeschger events

    Science.gov (United States)

    Lohmann, Johannes; Ditlevsen, Peter D.

    2018-05-01

    Dansgaard-Oeschger (DO) events constitute the most pronounced mode of centennial to millennial climate variability of the last glacial period. Since their discovery, many decades of research have been devoted to understand the origin and nature of these rapid climate shifts. In recent years, a number of studies have appeared that report emergence of DO-type variability in fully coupled general circulation models via different mechanisms. These mechanisms result in the occurrence of DO events at varying degrees of regularity, ranging from periodic to random. When examining the full sequence of DO events as captured in the North Greenland Ice Core Project (NGRIP) ice core record, one can observe high irregularity in the timing of individual events at any stage within the last glacial period. In addition to the prevailing irregularity, certain properties of the DO event sequence, such as the average event frequency or the relative distribution of cold versus warm periods, appear to be changing throughout the glacial. By using statistical hypothesis tests on simple event models, we investigate whether the observed event sequence may have been generated by stationary random processes or rather was strongly modulated by external factors. We find that the sequence of DO warming events is consistent with a stationary random process, whereas dividing the event sequence into warming and cooling events leads to inconsistency with two independent event processes. As we include external forcing, we find a particularly good fit to the observed DO sequence in a model where the average residence time in warm periods are controlled by global ice volume and cold periods by boreal summer insolation.

  6. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  7. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  8. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  9. A randomized controlled trial of nasolaryngoscopy training techniques.

    Science.gov (United States)

    Smith, Matthew E; Leung, Billy C; Sharma, Rishi; Nazeer, Sammar; McFerran, Don J

    2014-09-01

    Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop, but there is a lack of standardized training for this procedure. The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees' performance at flexible nasolaryngoscopy. Three-armed, single-blinded, randomized controlled study. Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups. All received a lecture and video presentation on flexible nasolaryngoscopy. One group received additional tuition using a training mannequin. The last group received mannequin training and feedback on their performance using a video recording. The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded. Blinded observers scored the trainees on a range of objective and subjective measures. The volunteers who were also blinded to the candidates' training scored the comfort of the procedure. Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance. Mannequin training together with video feedback produced significant performance improvement in patient comfort (P = .0065), time to reach the vocal folds (P = .017), and global ability (P = .0006). Inter-rater reliability was excellent with P training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  10. Cognitive training in Alzheimer's disease: a controlled randomized study.

    Science.gov (United States)

    Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

    2017-08-01

    This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

  11. NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research.

    Science.gov (United States)

    Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D; Cui, Licong

    2015-11-10

    A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f1, f2, ..., fk. The input for each function fi has 3 components: a random number r, an integer n, and input data m. The result, fi(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f1(r1, n1, m1), f2(r2, n2, m2), ..., fk(rk, nk, mk). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result

  12. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  13. Prenatal emotion management improves obstetric outcomes: a randomized control study.

    Science.gov (United States)

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

  14. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  15. Neighborhood effects in a behavioral randomized controlled trial.

    Science.gov (United States)

    Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-11-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Synthesis of results of randomized controlled trials of contrast media

    International Nuclear Information System (INIS)

    Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

    1988-01-01

    The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

  17. Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

    Science.gov (United States)

    Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

    2017-06-01

    Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

  18. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  19. Random number generation as an index of controlled processing.

    Science.gov (United States)

    Jahanshahi, Marjan; Saleem, T; Ho, Aileen K; Dirnberger, Georg; Fuller, R

    2006-07-01

    Random number generation (RNG) is a functionally complex process that is highly controlled and therefore dependent on Baddeley's central executive. This study addresses this issue by investigating whether key predictions from this framework are compatible with empirical data. In Experiment 1, the effect of increasing task demands by increasing the rate of the paced generation was comprehensively examined. As expected, faster rates affected performance negatively because central resources were increasingly depleted. Next, the effects of participants' exposure were manipulated in Experiment 2 by providing increasing amounts of practice on the task. There was no improvement over 10 practice trials, suggesting that the high level of strategic control required by the task was constant and not amenable to any automatization gain with repeated exposure. Together, the results demonstrate that RNG performance is a highly controlled and demanding process sensitive to additional demands on central resources (Experiment 1) and is unaffected by repeated performance or practice (Experiment 2). These features render the easily administered RNG task an ideal and robust index of executive function that is highly suitable for repeated clinical use. ((c) 2006 APA, all rights reserved).

  20. Wellness program for anesthesiology residents: a randomized, controlled trial.

    Science.gov (United States)

    Saadat, H; Snow, D L; Ottenheimer, S; Dai, F; Kain, Z N

    2012-10-01

    Multiple reports illustrate the deleterious effects of stress on physicians' mental and physical health, as well as on patient care. This study evaluates the effects of a wellness program on anesthesiology residents' well-being. Sixty residents were randomly assigned to one of three groups: (1) wellness intervention group, (2) no-treatment control with release time, and (3) no-treatment control with routine duties. Coping, stressors, social support, psychological symptoms, and alcohol and tobacco use were measured using a pre-test-post-test design. Residents in the wellness program reported significantly fewer stressors in their role as parent, increased social support at work, greater problem-solving coping, and less anxiety as compared with one or both of the control groups. Findings related to reducing avoidance coping and alcohol consumption also were suggestive of positive intervention effects. An intervention to increase the use of active coping and social support, to reduce reliance on avoidance coping, and to decrease work and family stressors had an overall pattern of beneficial effects on residents' well-being. The importance of offering such programs during residency training, ways to strengthen intervention effectiveness, and areas for future research are discussed. © 2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.

  1. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    Science.gov (United States)

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  2. Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

    Science.gov (United States)

    Gay, Caryl L.; Lynch, Mary; Lee, Kathryn A.

    2011-01-01

    OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration. PMID:22123869

  3. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  4. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  5. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

  6. A systematic mapping review of Randomized Controlled Trials (RCTs in care homes

    Directory of Open Access Journals (Sweden)

    Gordon Adam L

    2012-06-01

    Full Text Available Abstract Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated.

  7. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  8. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  9. Garlic for hypertension: A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xiong, X J; Wang, P Q; Li, S J; Li, X K; Zhang, Y Q; Wang, J

    2015-03-15

    In the past decade, garlic has become one of the most popular complementary therapies for blood pressure (BP) control used by hypertensive patients. Numerous clinical studies have focused on the BP-lowering effect of garlic, but results have been inconsistent. Overall, there is a dearth of information available to guide the clinical community on the efficacy of garlic in hypertensive patients. To systematically review the medical literature to investigate the current evidence of garlic for the treatment of hypertension. PubMed, the Cochrane Library and EMBASE were searched for appropriate articles from their respective inceptions until August 2014. Randomized, placebo-controlled trials comparing garlic vs. a placebo in patients with hypertension were considered. Papers were independently reviewed by two reviewers and were analyzed using Cochrane software Revman 5.2. A total of seven randomized, placebo-controlled trials were identified. Compared with the placebo, this meta-analysis revealed a significant lowering effect of garlic on both systolic BP (WMD: -6.71 mmHg; 95% CI: -12.44 to -0.99; P = 0.02) and diastolic BP (WMD: -4.79 mmHg; 95% CI: -6.60 to -2.99; P garlic is an effective and safe approach for hypertension. However, more rigorously designed randomized controlled trials focusing on primary endpoints with long-term follow-up are still warranted before garlic can be recommended to treat hypertensive patients. Copyright © 2015 Elsevier GmbH. All rights reserved.

  10. Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

    Science.gov (United States)

    Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-09-01

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  12. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  13. A Randomized Controlled Trial of an Eczema Care Plan.

    Science.gov (United States)

    Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L

    2018-03-02

    To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  14. Improving aerobic capacity through active videogames: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jorge Luiz de Brito-Gomes

    2015-09-01

    Full Text Available AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6, unstructured AVG (n= 7 and a control group (n= 7. Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-session. The control group maintained normal activities. Both structured and unstructured AVG improved peak workload after four weeks but only the structured group maintained this improvement through week five and six. Aerobic capacity improved in the unstructured (Pre: 36.0 ± 5.2ml.kg.min-¹,Post: 39.7 ± 4.9ml.kg.min-¹, p = .038 and structured AVG (Pre: 39.0 ± 5.9ml.kg.min-¹,Post: 47.8 ± 4.3ml.kg.min-¹, p = .006 groups. Structured AVG provide greater health benefits to aerobic capacity and peak workload in young sedentary but otherwise healthy males relative to unstructured AVG.

  15. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  16. Rural providers’ access to online resources: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jonathan D. Eldredge

    2016-01-01

    Full Text Available Objective: The research determined the usage and satisfaction levels with one of two point-of-care (PoC resources among health care providers in a rural state. Methods: In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants’ attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA, paired t tests, and Cohen’s d statistic to compare pre- and post-study effects sizes. Results: Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to ‘‘about right amounts of information’’ at the completion of the study. DynaMed users reported a Cohen’s d increase of þ1.50 compared to AccessMedicine users’ reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen’s d. Conclusion: Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine.

  17. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    Science.gov (United States)

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  18. Rural providers' access to online resources: a randomized controlled trial

    Science.gov (United States)

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  19. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  20. The handsearching of 2 medical journals of Bahrain for reports of randomized controlled trials.

    Science.gov (United States)

    Al-Hajeri, Amani A; Fedorowicz, Zbigniew; Amin, Fawzi A; Eisinga, Anne

    2006-04-01

    To identify reports of randomized trials by handsearching 2 Bahrain medical journals, which are indexed in the biomedical database EMBASE and to determine any added value of the handsearching by comparing the reports found by handsearching with what would have been found by searching EMBASE to examine (i) the precision and sensitivity of the EMBASE index term Randomized Controlled Trial (RCT) and (ii) The Cochrane Collaboration's systematic electronic search of EMBASE (which uses 4 index terms and 9 free-text terms). All issues of the Bahrain Medical Bulletin (BMB) (1979-2004) and the Journal of the Bahrain Medical Society (JBMS) (1989-2004) were handsearched in February 2005 for reports of RCTs or Controlled Clinical Trials (CCTs), according to Cochrane eligibility criteria. Out of 395 articles in BMB we found reports of 12 RCTs and 4 CCTs. Distribution by country of corresponding author: Jordan (4 RCTs, one CCT), Bahrain (one RCT, one CCT), India (3 RCTs, one CCT), Kuwait (one CCT), Saudi Arabia (2 RCTs), USA/Bahrain (one RCT), and Oman (one RCT); and by specialty: Anesthesia (8), Surgery (1) Pediatrics (1), Radiotherapy (1), Community Medicine (1), Sports Medicine (1), Obstetrics/Gynecology (3). The Journal of the Bahrain Medical Society included reports of 14 RCTs and 3 CCTs, out of 97 articles. Distribution by country of corresponding author: Jordan (9 RCTs, 2 CCTs), Bahrain (3 RCTs), Egypt (one RCT), Kuwait (one RCT), and Saudi Arabia (one RCT); and by specialty: Anesthesia (7), General Surgery (3), Obstetrics/Gynecology (1), Radiotherapy (1), Pediatrics (1), Orthopaedic Surgery (1), Education (1) Ear Nose and Throat (1) Ophthalmology (1). Overall, of the 33 reports of trials found by handsearching both journals, only 23 were included in EMBASE of which only 6 had been indexed with the term RCT. Of the 23 reports of trials included in EMBASE, 16 had been identified in the Collaboration s systematic search of EMBASE. Two reports of trials could have been

  1. Job maintenance through Supported Employment PLUS: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nils-Torge Telle

    2016-09-01

    Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  2. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    Science.gov (United States)

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N  = 99 employees who reported mental distress due to work-related problems. The intervention group ( n  = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n  = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  3. Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

    Science.gov (United States)

    Matteson, Michelle L; Russell, Cynthia

    2010-10-01

    Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

  4. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    William F. Clark

    2017-08-01

    linear regression. Supplementary analyses will examine alternative definitions of eGFR change, including annual percentage change, rate of decline, and rapid decline (a P value <0.05 will be interpreted as statistically significant if there is concordance with the primary outcome. Trial Registration: This randomized controlled trial has been registered at www.clinicaltrials.gov ; government identifier: NCT01766687.

  5. Quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorders: a systematic review.

    Science.gov (United States)

    Strech, Daniel; Soltmann, Bettina; Weikert, Beate; Bauer, Michael; Pfennig, Andrea

    2011-09-01

    This study aimed to assess (1) the quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorder, (2) the potential improvement in quality of reporting over time, and (3) differences in quality of reporting between journals that endorse or do not endorse the Uniform Requirements for Manuscripts Submitted to Biomedical Journals developed by the International Committee of Medical Journal Editors. A systematic literature search was done to identify all randomized controlled trials published between 2000 and 2008 relevant to the pharmacologic treatment of bipolar disorder. The search strategy of the published National Institute for Health and Clinical Excellence guideline for management of bipolar disorders was used and adapted. All included and excluded clinical trials mentioned in the guideline and published from 2000 onward were reviewed for eligibility. For an update search from July 2004 through December 2008, an adapted search strategy was used in MEDLINE, EMBASE, PsycINFO, CINAHL, Ovid, and Cochrane Central Register of Controlled Trials. Titles and abstracts were scanned for relevance, and full texts were ordered in case of uncertainty to maximize sensitivity. Reference lists of retrieved systematic reviews were checked. All full texts were checked for eligibility. Only relevant randomized controlled trials published between 2000 and 2008 were included. Abstracts, randomized controlled trials published before 2000, nonrandomized clinical studies, pooled analyses, editorials, reviews, case reports, observational studies, and unpublished reports were excluded. A checklist based on the Consolidated Standards of Reporting Trials (CONSORT) statement was used to assess quality of reporting of all included studies. A total of 105 randomized controlled trials were included in the analysis. Of the 72 applicable checklist items, 42% were generally reported adequately and 25% inadequately. Reporting was especially poor for

  6. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  7. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  8. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial

    DEFF Research Database (Denmark)

    Hedayati-Hajikand, Trifa; Lundberg, Ulrika; Eldh, Catarina

    2015-01-01

    BACKGROUND: To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area. METHODS: The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138...... healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic...... childhood caries development could be reduced through administration of these probiotic chewing tablets as adjunct to daily use of fluoride toothpaste in preschool children. Further studies on a possible dose-response relationship seem justified TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01720771...

  9. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  10. Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

    International Nuclear Information System (INIS)

    Tariq, N.; Basharat, A.; Fahim, A.

    2017-01-01

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

  11. Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial.

    Science.gov (United States)

    Imhoff-Kunsch, Beth; Stein, Aryeh D; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle; Ramakrishnan, Usha

    2011-09-01

    Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58-1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and "other illness," respectively, but 74% longer duration of vomiting (all P DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.

  12. Measurement model choice influenced randomized controlled trial results.

    Science.gov (United States)

    Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

    2016-11-01

    In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Electrical stimulation enhances sensory recovery: a randomized controlled trial.

    Science.gov (United States)

    Wong, Joshua N; Olson, Jaret L; Morhart, Michael J; Chan, K Ming

    2015-06-01

    Brief postsurgical electrical stimulation (ES) has been shown to enhance peripheral nerve regeneration in animal models following axotomy and crush injury. However, whether this treatment is beneficial in humans with sensory nerve injury has not been tested. The goal of this study was to test the hypothesis that ES would enhance sensory nerve regeneration following digital nerve transection compared to surgery alone. Patients with complete digital nerve transection underwent epineurial nerve repair. After coaptation of the severed nerve ends, fine wire electrodes were implanted before skin closure. Postoperatively, patients were randomized to receiving either 1 hour of 20Hz continuous ES or sham stimulation in a double-blinded manner. Patients were followed monthly for 6 months by a blinded evaluator to monitor physiological recovery of spatial discrimination, pressure threshold, and quantitative small fiber sensory testing. Functional disability was measured using the Disability of Arm, Shoulder, and Hand questionnaire. A total of 36 patients were recruited, with 18 in each group. Those in the ES group showed consistently greater improvements in all sensory modalities by 5 to 6 months postoperatively compared to the controls. Although there was a trend of greater functional improvements in the ES group, it was not statistically significant (p > 0.01). Postsurgical ES enhanced sensory reinnervation in patients who sustained complete digital nerve transection. The conferred benefits apply to a wide range of sensory functions. © 2015 American Neurological Association.

  14. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    Science.gov (United States)

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  15. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    Science.gov (United States)

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  16. Effectiveness of a Web-Based Intervention to Reduce Alcohol Consumption among French Hazardous Drinkers: A Randomized Controlled Trial

    Science.gov (United States)

    Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre

    2017-01-01

    This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…

  17. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  18. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  19. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  20. Synthesis for robust synchronization of chaotic systems under output feedback control with multiple random delays

    International Nuclear Information System (INIS)

    Wen Guilin; Wang Qingguo; Lin Chong; Han Xu; Li Guangyao

    2006-01-01

    Synchronization under output feedback control with multiple random time delays is studied, using the paradigm in nonlinear physics-Chua's circuit. Compared with other synchronization control methods, output feedback control with multiple random delay is superior for a realistic synchronization application to secure communications. Sufficient condition for global stability of delay-dependent synchronization is established based on the LMI technique. Numerical simulations fully support the analytical approach, in spite of the random delays

  1. Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

    Science.gov (United States)

    Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

    2015-11-01

    Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

  2. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial.

    Science.gov (United States)

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V; Dhananjaya, Kiran Murthy

    2014-12-01

    Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70-80% of prisoners have been identified as current smokers. To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. A randomized controlled trial was planned among male prisoners in Central Jail, Bangalore city. There were 1600 convicted prisoners. A self-administered questionnaire was given to the prisoners to assess their smoking behavior by which prevalence of tobacco smoking was found. Exactly 1352 tobacco users were studied. Among them, there were 1252 smokers. Based on inclusion criteria and informed consent given by the prisoners, a sample of 600 was chosen for the study by systematic random sampling. Among the 600 prisoners, 300 were randomly selected for the study group and 300 for the control group. Prevalence of tobacco smoking among the prisoners was 92.60%. In the present study, after smoking cessation intervention, 17% showed no change in smoking, 21.66% reduced smoking, 16% stopped smoking, and 45.33% relapsed (P prison even if the living conditions are not favorable. Relatively high rate of relapse in our study indicates that some policies should be adopted to improve smokers' information on consequences of tobacco on health and motivational intervention should be added to prisoners.

  3. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  4. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    Science.gov (United States)

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  5. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  6. Non-identifier based adaptive control in mechatronics theory and application

    CERN Document Server

    Hackl, Christoph M

    2017-01-01

    This book introduces non-identifier-based adaptive control (with and without internal model) and its application to the current, speed and position control of mechatronic systems such as electrical synchronous machines, wind turbine systems, industrial servo systems, and rigid-link, revolute-joint robots. In mechatronics, there is often only rough knowledge of the system. Due to parameter uncertainties, nonlinearities and unknown disturbances, model-based control strategies can reach their performance or stability limits without iterative controller design and performance evaluation, or system identification and parameter estimation. The non-identifier-based adaptive control presented is an alternative that neither identifies the system nor estimates its parameters but ensures stability. The adaptive controllers are easy to implement, compensate for disturbances and are inherently robust to parameter uncertainties and nonlinearities. For controller implementation only structural system knowledge (like relativ...

  7. Topical diclofenac therapy for osteoarthritis: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Deng, Zhen-Han; Zeng, Chao; Yang, Ye; Li, Yu-Sheng; Wei, Jie; Yang, Tuo; Li, Hui; Lei, Guang-Hua

    2016-05-01

    The objective of this study was to evaluate the efficacy and safety of topical diclofenac therapy for osteoarthritis (OA). A meta-analysis of randomized controlled trials was conducted. A comprehensive literature search, covering the databases of Medline, the Cochrane Central Register of Controlled Trials, and EMBASE, was conducted in September 2014 to identify the randomized controlled trials which adopted the topical diclofenac therapy for OA. A total of nine papers were included in this meta-analysis. Topical diclofenac appears to be effective in both pain relief (standard mean differences (SMD) = 0.40; 95 % confidence interval (CI) 0.19 to 0.62; P = 0.0003) and function improvement (SMD = 0.23; 95 % CI 0.03 to 0.43; P = 0.03) when compared with the control group. The sensitivity analysis and subgroup analysis showed that the result of pain intensity was stable and reliable, while the result of physical function improvement was vague. With respect to safety, topical diclofenac demonstrated a higher incidence of adverse events such as dry skin, rash, dermatitis, neck pain, and withdrawal. Topical diclofenac is effective in pain relief as a treatment of OA. It may also have a potential effect in function improvement, which needs further studies to be explored. Although, some adverse effects were observed in the application of topical diclofenac, none of them was serious.

  8. On the necessity of identifying the true parameter in adaptive LQ control

    NARCIS (Netherlands)

    Polderman, Jan W.

    1986-01-01

    In adaptive control problems one may drop the requirement of identifying the true system in order to simplify the problem of control. It will be shown that in the adaptive LQ control problem this does not at all lead to an easier problem.

  9. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  10. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  11. A randomized controlled trial of storytelling as a communication tool.

    Directory of Open Access Journals (Sweden)

    Lisa Hartling

    Full Text Available INTRODUCTION: Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED with a child with croup. METHODS: Parents were randomized to receive story booklets (n=208 or standard information sheets (n=205 during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms, and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. RESULTS: There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78. The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001: 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement "I would go for the same choice if I had to do it over again". The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04. No other outcomes were different between study groups. CONCLUSIONS: Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. TRIAL REGISTRATION

  12. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics. This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.

  13. Minimal stimulation IVF vs conventional IVF: a randomized controlled trial

    NARCIS (Netherlands)

    Zhang, John J.; Merhi, Zaher; Yang, Mingxue; Bodri, Daniel; Chavez-Badiola, Alejandro; Repping, Sjoerd; van Wely, Madelon

    2016-01-01

    Minimal stimulation in vitro fertilization (mini-in vitro fertilization) is an alternative in vitro fertilization treatment protocol that may reduce ovarian hyperstimulation syndrome, multiple pregnancy rates, and cost while retaining high live birth rates. We performed a randomized noninferiority

  14. A randomized controlled trial comparing haemodynamic stability in ...

    African Journals Online (AJOL)

    Methods: Thirty two elderly patients scheduled for lower limb or pelvic surgery under spinal anaesthesia were randomized .... conducted and that their personal information would be kept .... file which was stored in a lockable filing drawer.

  15. Identifying novel fruit-related genes in Arabidopsis thaliana based on the random walk with restart algorithm.

    Science.gov (United States)

    Zhang, Yunhua; Dai, Li; Liu, Ying; Zhang, YuHang; Wang, ShaoPeng

    2017-01-01

    Fruit is essential for plant reproduction and is responsible for protection and dispersal of seeds. The development and maturation of fruit is tightly regulated by numerous genetic factors that respond to environmental and internal stimulation. In this study, we attempted to identify novel fruit-related genes in a model organism, Arabidopsis thaliana, using a computational method. Based on validated fruit-related genes, the random walk with restart (RWR) algorithm was applied on a protein-protein interaction (PPI) network using these genes as seeds. The identified genes with high probabilities were filtered by the permutation test and linkage tests. In the permutation test, the genes that were selected due to the structure of the PPI network were discarded. In the linkage tests, the importance of each candidate gene was measured from two aspects: (1) its functional associations with validated genes and (2) its similarity with validated genes on gene ontology (GO) terms and KEGG pathways. Finally, 255 inferred genes were obtained, subsequent extensive analysis of important genes revealed that they mainly contribute to ubiquitination (UBQ9, UBQ8, UBQ11, UBQ10), serine hydroxymethyl transfer (SHM7, SHM5, SHM6) or glycol-metabolism (HXKL2_ARATH, CSY5, GAPCP1), suggesting essential roles during the development and maturation of fruit in Arabidopsis thaliana.

  16. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  17. A Novel Screen for Suppressors of Breast Tumor Cell Growth Using an Oriented Random Peptide Library Method to Identify Inhibitors of the ErbB2 Tyrosine Kinase

    National Research Council Canada - National Science Library

    Carraway, Kermit

    1998-01-01

    .... To identify potential antagonists, the extracellular ligand binding domain of the ErbB2 is immobilized on a column support, and used to affinity purify cyclic peptides from oriented random peptide libraries...

  18. A Novel Screen for Suppressors of Breast Tumor Cell Growth Using an Oriented Random Peptide Library Method to Identify Inhibitors of the ErbB2 Tyrosine Kinase

    National Research Council Canada - National Science Library

    Carraway, Kermit

    1999-01-01

    .... To identify potential antagonists, the extracellular ligand binding domain of the ErbB2 is immobilized on a column support, and used to affinity purify cyclic peptides from oriented random peptide libraries...

  19. EEG Neurofeedback treatments in children with ADHD: An updated meta-analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jean-Arthur eMicoulaud Franchi

    2014-11-01

    Full Text Available Objective We undertook a meta-analysis of published Randomized Controlled Trials (RCT with semi-active control and sham-NF groups to determine whether EEG-NF significantly improves the overall symptoms, inattention and hyperactivity/impulsivity dimensions for probably unblinded assessment (parent assessment and probably blinded assessment (teacher assessment in children with Attention Deficit Hyperactivity Disorder (ADHD.Data Sources A systematic review identified independent studies that were eligible for inclusion in a random effects meta-analysis.Data Extraction Effect sizes for ADHD symptoms were expressed as standardized mean differences (SMD with 95% confidence intervals.ResultsFive identified studies met eligibility criteria, 263 patients with ADHD were included, 146 patients were trained with EEG-NF. On parent assessment (probably unblinded assessment, the overall ADHD score (SMD=-0.49 [-0.74, -0.24], the inattention score (SMD=-0.46 [-0.76, -0.15] and the hyperactivity/impulsivity score (SMD=-0.34 [-0.59, -0.09] were significantly improved in patients receiving EEG-NF compared to controls. On teacher assessment (probably blinded assessment, only the inattention score was significantly improved in patients receiving EEG-NF compared to controls (SMD=-0.30 [-0.58, -0.03]. ConclusionsThis meta-analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms. Future investigations should pay greater attention to adequately blinded studies and EEG-NF protocols that carefully control the implementation and embedding of training.

  20. Recruitment of black and Latina women to a randomized controlled trial.

    Science.gov (United States)

    Martin, Anika; Negron, Rennie; Balbierz, Amy; Bickell, Nina; Howell, Elizabeth A

    2013-08-01

    Minority women are often not adequately represented in randomized controlled trials, limiting the generalizability of research trial results. We implemented a recruitment strategy for a postpartum depression prevention trial that utilized patient feedback to identify and understand the recruitment barriers of black and Latina postpartum women. Feedback on patients' reasons for trial refusal informed adaptations to the recruitment process. We calculated weekly recruitment rates and analyzed qualitative and quantitative data from patient refusals. Of the 668 women who were approached and completed the consent process, 540 enrolled in the trial and 128 declined participation. Over 52-weeks of recruitment, refusal rates decreased from 40% to 19%. A taxonomy of eight reasons for refusal derived from patient responses identified barriers to recruitment and generated targeted revisions to the recruitment message. A recruitment strategy designed to incorporate and respond to patient feedback improved recruitment of Black and Latina women to a clinical trial.

  1. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  2. Identifying Genes Controlling Ferulate Cross-Linking Formation in Grass Cell Walls

    Energy Technology Data Exchange (ETDEWEB)

    de O. Buanafina, Marcia Maria [Pennsylvania State Univ., University Park, PA (United States)

    2013-10-16

    This proposal focuses on cell wall feruloylation and our long term goal is to identify and isolate novel genes controlling feruloylation and to characterize the phenotype of mutants in this pathway, with a spotlight on cell wall properties.

  3. Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

    Science.gov (United States)

    Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

    2017-10-01

    Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, η p 2 =0.04), peak power output (F(2150)=8.16, pmobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial

    Science.gov (United States)

    Deepeshwar, Singh; Tanwar, Monika; Kavuri, Vijaya; Budhi, Rana B.

    2018-01-01

    Objective: To investigate the effect of integrated approach of yoga therapy (IAYT) intervention in individual with knee Osteoarthritis. Design: Randomized controlled clincial trail. Participants: Sixty-six individual prediagnosed with knee osteoarthritis aged between 30 and 75 years were randomized into two groups, i.e., Yoga (n = 31) and Control (n = 35). Yoga group received IAYT intervention for 1 week at yoga center of S-VYASA whereas Control group maintained their normal lifestyle. Outcome measures: The Falls Efficacy Scale (FES), Handgrip Strength test (left hand LHGS and right hand RHGS), Timed Up and Go Test (TUG), Sit-to-Stand (STS), and right & left extension and flexion were measured on day 1 and day 7. Results: There were a significant reduction in TUG (p Yoga group. Conclusion: IAYT practice showed an improvement in TUG, STS, HGS, and Goniometer test, which suggest improved muscular strength, flexibility, and functional mobility. CTRI Registration Number: http://ctri.nic.in/Clinicaltrials, identifier CTRI/2017/10/010141. PMID:29867604

  5. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magura Stephen

    2012-11-01

    Full Text Available Abstract Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two did not have a significant effect

  6. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR) certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two) did not have a significant effect on any outcomes

  7. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  8. Garlic intake lowers fasting blood glucose: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Hou, Li-qiong; Liu, Yun-hui; Zhang, Yi-yi

    2015-01-01

    Garlic is a common spicy flavouring agent also used for certain therapeutic purposes. Garlic's effects on blood glucose have been the subject of many clinical and animal studies, however, studies reporting hypoglycemic effects of garlic in humans are conflicting. A comprehensive literature search was conducted to identify relevant trials of garlic or garlic extracts on markers of glycemic control [fasting blood glucose (FBG), postprandial glucose (PPG), glycosylated haemoglobin (HbA1c)]. A meta-analysis of the effect of garlic intake on human was done to assess garlic's effectiveness in lowering glucose levels. Two reviewers extracted data from each of the identified studies. Seven eligible randomized controlled trials with 513 subjects were identified. Pooled analyses showed that garlic intake results in a statistically significant lowering in FBG [SMD=-1.67; 95% CI (-2.80, -0.55), p=0.004]. Our pooled analyses did not include PPG control and HbA1c outcomes. Because only 1 study included in the meta-analysis reported PPG variables and only 2 studies reported HbA1c variables. In conclusion, the current meta-analysis showed that the administration of garlic resulted in a significant reduction in FBG concentrations. More trials are needed to investigate the effectiveness of garlic on HbA1c and PPG.

  9. A systematic review of randomized controlled trials using music therapy for children.

    Science.gov (United States)

    Mrázová, Marcela; Celec, Peter

    2010-10-01

    Music therapy is a promising approach widening the potential applications of psychotherapy. Music influences both, psychologic and physiologic parameters, and children are especially responsive to this form of therapy. Many aspects of its action mechanisms remain to be elucidated, underscoring the need for evidence-based medicine (EBM) for clinical use of music therapy. This review seeks to highlight some of the issues of music therapy research and to initiate a discussion about the need for international multicenter cooperation to bring scientifically sound evidence of the benefits of music therapy in pediatric patients. Scientific bibliographic databases were searched for randomized controlled trials on use of music therapy for children. Identified articles were evaluated according to criteria for scientific quality. Twenty-eight studies were identified. Most of the trials were biased by the number of participants, and some trials showed the need to improve design of control groups. Indeed, the novelty of this area of study has produced a large number of different studies (with variability in diagnoses, interventions, control groups, duration, and/or outcome parameters), and there is a need for a more homogeneous and systematic approach. Available studies highlight the need to address reproducibility issues. This analysis identifies the need for a subsequent series of clinical studies on the efficacy of music in the pediatric population, with more focus on eligibility criteria with respect to EBM and reproducibility.

  10. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

    Science.gov (United States)

    Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

    2018-04-01

    Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

  11. Heterogenic control groups in randomized, controlled, analgesic trials of total hip and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2018-03-01

    Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  12. No Randomization? No Problem: Experimental Control and Random Assignment in Single Case Research

    Science.gov (United States)

    Ledford, Jennifer R.

    2018-01-01

    Randomization of large number of participants to different treatment groups is often not a feasible or preferable way to answer questions of immediate interest to professional practice. Single case designs (SCDs) are a class of research designs that are experimental in nature but require only a few participants, all of whom receive the…

  13. A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

    Science.gov (United States)

    Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

    2017-04-01

    The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.

  14. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial. 

  15. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  16. Randomized controlled study of CBT in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Grover Naveen

    2007-01-01

    Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

  17. Procedures for identifying reasonably available control technology for stationary sources of PM-10. Final report

    International Nuclear Information System (INIS)

    Fitzpatrick, M.J.; Ellefson, R.

    1992-09-01

    The guidance document sets forth procedures and identifies sources of information that will assist State and local air pollution control agencies in determining Reasonably Available Control Technology (RACT) for PM-10 (particulate matter having a nominal aerometric diameter of 10 microns or less) emission from existing stationary sources on a case-by-case basis. It provides an annotated bibliography of documents to aid in identifying the activities that cause PM-10 emissions as well as applicable air pollution control measures and their effectiveness in reducing emissions. The most stringent state total particulate matter (PM) emission limits are identified for several categories of PM-10 sources and compared to available emission test data. Finally, guidance is provided on procedures for estimating total capital investment and total annual cost of the control measures which are generally used to control PM-10 emissions

  18. Oral Medication for Agitation of Psychiatric Origin: A Scoping Review of Randomized Controlled Trials.

    Science.gov (United States)

    Mullinax, Samuel; Shokraneh, Farhad; Wilson, Michael P; Adams, Clive E

    2017-10-01

    Understanding more about the efficacy and safety of oral second-generation antipsychotic medications in reducing the symptoms of acute agitation could improve the treatment of psychiatric emergencies. The objective of this scoping review was to examine the evidence base underlying expert consensus panel recommendations for the use of oral second-generation antipsychotics to treat acute agitation in mentally ill patients. The Cochrane Schizophrenia Group's Study-Based Register was searched for randomized controlled trials comparing oral second-generation antipsychotics, benzodiazepines, or first-generation antipsychotics with or without adjunctive benzodiazepines, irrespective of route of administration of the drug being compared. Six articles were included in the final review. Two oral second-generation antipsychotic medications were studied across the six included trials. While the studies had relatively small sample sizes, oral second-generation antipsychotics were similarly effective to intramuscular first-generation antipsychotics in treating symptoms of acute agitation and had similar side-effect profiles. This scoping review identified six randomized trials investigating the use of oral second-generation antipsychotic medications in the reduction of acute agitation among patients experiencing psychiatric emergencies. Further research will be necessary to make clinical recommendations due to the overall dearth of randomized trials, as well as the small sample sizes of the included studies. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Neurocognitive effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    Science.gov (United States)

    Bink, Marleen; van Nieuwenhuizen, Chijs; Popma, Arne; Bongers, Ilja L; van Boxtel, Geert J M

    2014-05-01

    Neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder (ADHD), mainly attention problems. However, the additional influence of neurofeedback over treatment as usual (TAU) on neurocognitive functioning for adolescents with ADHD remains unclear. By using a multicenter parallel randomized controlled trial (RCT) design, male adolescents with a DSM-IV-TR diagnosis of ADHD (mean age = 16.1 years; range, 12-24) were randomized to receive either a combination of TAU and neurofeedback (n = 45) or TAU (n = 26). Randomization was computer generated and stratified by age group (ages 12 through 15, 16 through 20, and 21 through 24 years). The neurofeedback intervention consisted of approximately 37 sessions over a period of 25 weeks of theta/sensorimotor rhythm training on the vertex (Cz). Primary neurocognitive outcomes included performance parameters derived from the D2 Test of Attention, the Digit Span backward, the Stroop Color-Word Test and the Tower of London, all assessed preintervention and postintervention. Data were collected between December 2009 and July 2012. At postintervention, outcomes of attention and/or motor speed were improved, with faster processing times for both intervention conditions and with medium to large effect sizes (range, ηp2 = .08-.54; P values neurofeedback over TAU was observed. Hence, this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to TAU for adolescents with ADHD symptoms. Trialregister.nl identifier: 1759. © Copyright 2014 Physicians Postgraduate Press, Inc.

  20. Out of control: Identifying the role of self-control strength in family violence

    NARCIS (Netherlands)

    Finkenauer, C.; Buyukcan-Tetik, A.; Baumeister, R. F.; Schoemaker, K.; Bartels, M.; Vohs, K. D.

    2015-01-01

    Family violence is common and brings tremendous costs to individuals, relationships, and society. Victims are vulnerable to negative outcomes across a host of dimensions, including cognitive performance, impulse control, emotion regulation, and physical health. Links between family violence and

  1. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  2. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

    Full Text Available Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. Methods/design First-year university students (n = 800 will be randomized to receive either 1 their personal genetic test result for a gene (FTO related to weight gain susceptibility in addition to a leaflet with simple weight control advice (‘Feedback + Advice’ group, FA, or 2 only the leaflet containing simple weight control advice (‘Advice Only’ group, AO. Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. Discussion We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Trial registration Current controlled trials ISRCTN91178663

  3. Nonlinear Methodologies for Identifying Seismic Event and Nuclear Explosion Using Random Forest, Support Vector Machine, and Naive Bayes Classification

    Directory of Open Access Journals (Sweden)

    Longjun Dong

    2014-01-01

    Full Text Available The discrimination of seismic event and nuclear explosion is a complex and nonlinear system. The nonlinear methodologies including Random Forests (RF, Support Vector Machines (SVM, and Naïve Bayes Classifier (NBC were applied to discriminant seismic events. Twenty earthquakes and twenty-seven explosions with nine ratios of the energies contained within predetermined “velocity windows” and calculated distance are used in discriminators. Based on the one out cross-validation, ROC curve, calculated accuracy of training and test samples, and discriminating performances of RF, SVM, and NBC were discussed and compared. The result of RF method clearly shows the best predictive power with a maximum area of 0.975 under the ROC among RF, SVM, and NBC. The discriminant accuracies of RF, SVM, and NBC for test samples are 92.86%, 85.71%, and 92.86%, respectively. It has been demonstrated that the presented RF model can not only identify seismic event automatically with high accuracy, but also can sort the discriminant indicators according to calculated values of weights.

  4. Methods for identifying SNP interactions: a review on variations of Logic Regression, Random Forest and Bayesian logistic regression.

    Science.gov (United States)

    Chen, Carla Chia-Ming; Schwender, Holger; Keith, Jonathan; Nunkesser, Robin; Mengersen, Kerrie; Macrossan, Paula

    2011-01-01

    Due to advancements in computational ability, enhanced technology and a reduction in the price of genotyping, more data are being generated for understanding genetic associations with diseases and disorders. However, with the availability of large data sets comes the inherent challenges of new methods of statistical analysis and modeling. Considering a complex phenotype may be the effect of a combination of multiple loci, various statistical methods have been developed for identifying genetic epistasis effects. Among these methods, logic regression (LR) is an intriguing approach incorporating tree-like structures. Various methods have built on the original LR to improve different aspects of the model. In this study, we review four variations of LR, namely Logic Feature Selection, Monte Carlo Logic Regression, Genetic Programming for Association Studies, and Modified Logic Regression-Gene Expression Programming, and investigate the performance of each method using simulated and real genotype data. We contrast these with another tree-like approach, namely Random Forests, and a Bayesian logistic regression with stochastic search variable selection.

  5. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

    2016-11-16

    The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

  6. Promoting gross motor skills and physical activity in childcare: A translational randomized controlled trial.

    Science.gov (United States)

    Jones, Rachel A; Okely, Anthony D; Hinkley, Trina; Batterham, Marijka; Burke, Claire

    2016-09-01

    Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  7. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2015-10-01

    PI, program manager, and two research assistants will guide the mixed-method coding, analysis, and synthesis of the three consultation data sources...A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine , and pill placebo in the treatment of

  8. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  9. On-line method to identify control rod drops in Pressurized Water Reactors

    International Nuclear Information System (INIS)

    Souza, T.J.; Martinez, A.S.; Medeiros, J.A.C.C.; Palma, D.A.P.; Gonçalves, A.C.

    2014-01-01

    Highlights: • On-line method to identify control rod drops in PWR reactors. • Identification method based on the readings of the ex-core detector. • Recognition of the patterns in the ex-core detector responses. - Abstract: A control rod drop event in PWR reactors leads to an unsafe operating condition. It is important to quickly identify the rod to minimise undesirable effects in such a scenario. The goal of this work is to develop an online method to identify control rod drops in PWR reactors. The method entails the construction of a tool based on ex-core detector responses. It proposes to recognize patterns in the neutron ex-core detectors responses and thus to make an online identification of a control rod drop in the core during the reactor operation. The results of the study, as well as the behaviour of the detector responses demonstrated the feasibility of this method

  10. An Ontology for Identifying Cyber Intrusion Induced Faults in Process Control Systems

    Science.gov (United States)

    Hieb, Jeffrey; Graham, James; Guan, Jian

    This paper presents an ontological framework that permits formal representations of process control systems, including elements of the process being controlled and the control system itself. A fault diagnosis algorithm based on the ontological model is also presented. The algorithm can identify traditional process elements as well as control system elements (e.g., IP network and SCADA protocol) as fault sources. When these elements are identified as a likely fault source, the possibility exists that the process fault is induced by a cyber intrusion. A laboratory-scale distillation column is used to illustrate the model and the algorithm. Coupled with a well-defined statistical process model, this fault diagnosis approach provides cyber security enhanced fault diagnosis information to plant operators and can help identify that a cyber attack is underway before a major process failure is experienced.

  11. Improving the outcomes of children affected by parental substance abuse: a review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Calhoun S

    2015-01-01

    Full Text Available Stacy Calhoun,1,2 Emma Conner,2 Melodi Miller,3 Nena Messina1 1UCLA Integrated Substance Abuse Programs, Los Angeles, CA, USA; 2Department of Criminology, Law and Society, University of California, Irvine, CA, USA; 3Social Solutions International, Inc., Silver Spring, MD, USA Abstract: Substance abuse is a major public health concern that impacts not just the user but also the user's family. The effect that parental substance abuse has on children has been given substantial attention over the years. Findings from the literature suggest that children of substance-abusing parents have a high risk of developing physical and mental health and behavioral problems. A number of intervention programs have been developed for parents who have a substance abuse problem. There have also been a number of interventions that have been developed for children who have at least one parent with a substance abuse problem. However, it remains unclear how we can best mitigate the negative effects that parental substance abuse has on children due to the scarcity of evaluations that utilize rigorous methodologies such as experimental designs. The purpose of this study is to review randomized controlled trials of intervention programs targeting parents with substance abuse problems and/or children with at least one parent with a substance abuse problem in order to identify programs that show some promise in improving the behavioral and mental health outcomes of children affected by parental substance abuse. Four randomized controlled trials that met our eligibility criteria were identified using major literature search engines. The findings from this review suggest that interventions that focus on improving parenting practices and family functioning may be effective in reducing problems in children affected by parental substance abuse. However, further research utilizing rigorous methodologies are needed in order to identify other successful interventions that can

  12. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

    Science.gov (United States)

    Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

    2012-03-01

    A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

  13. Sternotomy or drainage for a hemopericardium after penetrating trauma: a randomized controlled trial.

    Science.gov (United States)

    Nicol, Andrew J; Navsaria, Pradeep H; Hommes, Martijn; Ball, Chad G; Edu, Sorin; Kahn, Delawir

    2014-03-01

    To determine if stable patients with a hemopericardium detected after penetrating chest trauma can be safely managed with pericardial drainage alone. The current international practice is to perform a sternotomy and cardiac repair if a hemopericardium is detected after penetrating chest trauma. The experience in Cape Town, South Africa, on performing a mandatory sternotomy in hemodynamically stable patients was that a sternotomy was unnecessary and the cardiac injury, if present, had sealed. A single-center parallel-group randomized controlled study was completed. All hemodynamically stable patients with a hemopericardium confirmed at subxiphoid pericardial window (SPW), and no active bleeding, were randomized. The primary outcome measure was survival to discharge from hospital. Secondary outcomes were complications and postoperative hospital stay. Fifty-five patients were randomized to sternotomy and 56 to pericardial drainage and wash-out only. Fifty-one of the 55 patients (93%) randomized to sternotomy had either no cardiac injury or a tangential injury. There were only 4 patients with penetrating wounds to the endocardium and all had sealed. There was 1 death postoperatively among the 111 patients (0.9%) and this was in the sternotomy group. The mean intensive care unit (ICU) stay for a sternotomy was 2.04 days (range, 0-25 days) compared with 0.25 days (range, 0-2) for the drainage (P drainage group (95% CI: 0.8-2.7). Total hospital stay was significantly shorter in the SPW group (P drainage is effective and safe in the stable patient with a hemopericardium after penetrating chest trauma, with no increase in mortality and a shorter ICU and hospital stay. (ClinicalTrials.gov Identifier: NCT00823160).

  14. Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

    Science.gov (United States)

    Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

    2015-01-01

    To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

  15. Tai Chi for treating knee osteoarthritis: Designing a long-term follow up randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rones Ramel

    2008-07-01

    Full Text Available Abstract Background Knee Osteoarthritis (KOA is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. Methods/Design Forty eligible patients, age > 55 yr, BMI ≤ 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi or attention control (wellness education and stretching. The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks. Discussion In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence

  16. Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement.

    Science.gov (United States)

    Austin, Peter C; Fine, Jason P

    2017-04-15

    In studies with survival or time-to-event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high-impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan-Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

  17. Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease.

    Science.gov (United States)

    Chang, Matthew S; Minaya, Maria T; Cheng, Jianfeng; Connor, Bradley A; Lewis, Suzanne K; Green, Peter H R

    2011-10-01

    Small intestinal bacterial overgrowth (SIBO) is one cause of a poor response to a gluten-free diet (GFD) and persistent symptoms in celiac disease. Rifaximin has been reported to improve symptoms in non-controlled trials. To determine the effect of rifaximin on gastrointestinal symptoms and lactulose-hydrogen breath tests in patients with poorly responsive celiac disease. A single-center, double-blind, randomized, controlled trial of patients with biopsy-proven celiac disease and persistent gastrointestinal symptoms despite a GFD was conducted. Patients were randomized to placebo (n = 25) or rifaximin (n = 25) 1,200 mg daily for 10 days. They completed the Gastrointestinal Symptom Rating Scale (GSRS) and underwent lactulose-hydrogen breath tests at weeks 0, 2, and 12. An abnormal breath test was defined as: (1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 min, or (2) two peaks ≥20 ppm over baseline. GSRS scores were unaffected by treatment with rifaximin, regardless of baseline breath tests. In a multivariable regression model, the duration of patients' gastrointestinal symptoms significantly predicted their overall GSRS scores (estimate 0.029, p symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy.

  18. Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Pajaree Sriuttha

    2018-01-01

    Full Text Available Background. Nonsteroidal anti-inflammatory drugs (NSAIDs are the most widely used medication in several countries, including Thailand. NSAIDs have been associated with hepatic side effects; however, the frequency of these side effects is uncertain. Aim of the Review. To systematically review published literature on randomized, controlled trials that assessed the risk of clinically significant hepatotoxicity associated with NSAIDs. Methods. Searches of bibliographic databases EMBASE, PubMed, and the Cochrane Library were conducted up to July 30, 2016, to identify randomized controlled trials of ibuprofen, naproxen, diclofenac, piroxicam, meloxicam, mefenamic acid, indomethacin, celecoxib, and etoricoxib in adults with any disease that provide information on hepatotoxicity outcomes. Results. Among the 698 studies, 18 studies met the selection criteria. However, only 8 studies regarding three NSAIDs (celecoxib, etoricoxib, and diclofenac demonstrated clinically significant hepatotoxic evidence based on hepatotoxicity justification criteria. Of all the hepatotoxicity events found from the above-mentioned three NSAIDs, diclofenac had the highest proportion, which ranged from 0.015 to 4.3 (×10−2, followed by celecoxib, which ranged from 0.13 to 0.38 (×10−2, and etoricoxib, which ranged from 0.005 to 0.930 (×10−2. Conclusion. Diclofenac had higher rates of hepatotoxic evidence compared to other NSAIDs. Hepatotoxic evidence is mostly demonstrated as aminotransferase elevation, while liver-related hospitalization or discontinuation was very low.

  19. Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Tao Wang

    2016-01-01

    Full Text Available This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depression than using standard methods of treatment/care. Four studies compared true acupoints stimulation with sham methods, and no significant differences can be found between groups for either depression or anxiety, although the pooled effects still favored true intervention. For the five studies that evaluated sleep quality, the results were conflicting, with three supporting the superiority of acupoints stimulation in improving sleep quality and two demonstrating no differences across groups. Acupoints stimulation seems to be an effective approach in relieving depression and anxiety in cancer patients, and placebo effects may partially contribute to the benefits. However, the evidence is not conclusive due to the limited number of included studies and the clinical heterogeneity identified among trials. More rigorous designed randomized, sham-controlled studies are necessary in future research.

  20. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    Science.gov (United States)

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  1. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

    2014-06-21

    Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

  2. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2013-10-01

    behavioral therapy (CBT) interventions have been shown to be effective in alleviating symptoms of Post - Traumatic Stress Disorder ( PTSD ) and related... traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study. Implement Sci, 7, 43. doi: 10.1186...Friedman, M. J., Young-Xu, Y., & Stevens, S. P. (2006). Cognitive processing therapy for veterans with military-related posttraumatic stress disorder

  3. Acupuncture for alcohol withdrawal: a randomized controlled trial.

    Science.gov (United States)

    Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter

    2003-01-01

    Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.

  4. Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized controlled trials.

    Science.gov (United States)

    Bressler, Neil M; Boyer, David S; Williams, David F; Butler, Steven; Francom, Steven F; Brown, Benton; Di Nucci, Flavia; Cramm, Timothy; Tuomi, Lisa L; Ianchulev, Tsontcho; Rubio, Roman G

    2012-10-01

    To analyze cerebrovascular accidents (CVAs) pooled from large, randomized, controlled clinical trials of ranibizumab treatment for neovascular age-related macular degeneration. Events in five trials (FOCUS, MARINA, ANCHOR, PIER, and SAILOR) were analyzed using a standard safety monitoring process. Exact methods, stratified by study, were used to test for treatment differences based on odds ratios. A stepwise logistic regression model was fit to classify subjects' risk for CVA based on medical history. Treatment differences in CVA rates at 1 year or 2 years were evaluated within risk groups using stratified exact methods. Pooled 2-year CVA rates were <3%; odds ratios (95% confidence intervals) for CVA risk were 1.2 (0.4-4.4) for ranibizumab 0.3-mg versus control, 2.2 (0.8-7.1) for 0.5 mg versus control, and 1.5 (0.8-3.0) for 0.5-mg versus 0.3-mg ranibizumab. No substantial increased risk of CVA for 0.5 mg versus 0.3 mg was identified in pooled analyses or any of the individual trials. In pooled analyses, the difference between 0.5-mg ranibizumab and control was larger (7.7 [1.2-177]) among high-risk CVA patients. This analysis provided some evidence, although not definitive, of a potential increased risk of CVA with ranibizumab versus control or with 0.5-mg versus 0.3-mg ranibizumab. Continued monitoring for CVA within clinical trials seems warrented.

  5. De-identifying Swedish clinical text - refinement of a gold standard and experiments with Conditional random fields

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    Dalianis Hercules

    2010-04-01

    Full Text Available Abstract Background In order to perform research on the information contained in Electronic Patient Records (EPRs, access to the data itself is needed. This is often very difficult due to confidentiality regulations. The data sets need to be fully de-identified before they can be distributed to researchers. De-identification is a difficult task where the definitions of annotation classes are not self-evident. Results We present work on the creation of two refined variants of a manually annotated Gold standard for de-identification, one created automatically, and one created through discussions among the annotators. The data is a subset from the Stockholm EPR Corpus, a data set available within our research group. These are used for the training and evaluation of an automatic system based on the Conditional Random Fields algorithm. Evaluating with four-fold cross-validation on sets of around 4-6 000 annotation instances, we obtained very promising results for both Gold Standards: F-score around 0.80 for a number of experiments, with higher results for certain annotation classes. Moreover, 49 false positives that were verified true positives were found by the system but missed by the annotators. Conclusions Our intention is to make this Gold standard, The Stockholm EPR PHI Corpus, available to other research groups in the future. Despite being slightly more time-consuming we believe the manual consensus gold standard is the most valuable for further research. We also propose a set of annotation classes to be used for similar de-identification tasks.

  6. Identifying Ant-Mirid Spatial Interactions to Improve Biological Control in Cacao-Based Agroforestry System.

    Science.gov (United States)

    Bagny Beilhe, Leïla; Piou, Cyril; Tadu, Zéphirin; Babin, Régis

    2018-06-06

    The use of ants for biological control of insect pests was the first reported case of conservation biological control. Direct and indirect community interactions between ants and pests lead to differential spatial pattern. We investigated spatial interactions between mirids, the major cocoa pest in West Africa and numerically dominant ant species, using bivariate point pattern analysis to identify potential biological control agents. We assume that potential biological control agents should display negative spatial interactions with mirids considering their niche overlap. The mirid/ant data were collected in complex cacao-based agroforestry systems sampled in three agroecological areas over a forest-savannah gradient in Cameroon. Three species, Crematogaster striatula Emery (Hymenoptera: Formicidae), Crematogaster clariventris Mayr (Hymenoptera: Formicidae), and Oecophylla longinoda Latreille (Hymenoptera: Formicidae) with high predator and aggressive behaviors were identified as dominant and showed negative spatial relationships with mirids. The weaver ant, O. longinoda was identified as the only potential biological control agent, considering its ubiquity in the plots, the similarity in niche requirements, and the spatial segregation with mirids resulting probably from exclusion mechanisms. Combining bivariate point pattern analysis to good knowledge of insect ecology was an effective method to identify a potentially good biological control agent.

  7. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

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    Winstein Carolee J

    2013-01-01

    Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

  8. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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    Callahan Christopher M

    2012-06-01

    to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011

  9. Prophylactic amnioinfusion for intrapartum oligohydramnios: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Pitt, C; Sanchez-Ramos, L; Kaunitz, A M; Gaudier, F

    2000-11-01

    To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by oligohydramnios. Randomized controlled trials of prophylactic amnioinfusion in women with oligohydramnios were identified using computerized databases, index reviews, and references cited in original studies and review articles. We evaluated, abstracted data from, and analyzed randomized studies of prophylactic intrapartum amnioinfusion in women with oligohydramnios. In every study the group allocation was based exclusively on presence of oligohydramnios. Only published studies with clearly documented outcome data were included. The quality of each trial was evaluated for methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. The trials were evaluated concerning cesarean deliveries for fetal heart rate (FHR) abnormalities, overall cesarean rates, acidemia at birth, intrapartum fetal heart rate abnormalities, Apgar scores under 7 at 5 minutes, and postpartum endometritis. Thirty-five studies were identified, of which 14 met the inclusion criteria for this systematic review. They included 1533 patients, 793 in the amnioinfusion group, and 740 controls. Odds ratios (OR) with their 95% confidence intervals (CI) for each outcome were calculated. We calculated an estimate of the OR and risk difference for dichotomous outcomes using random and fixed-effects models. A test of homogeneity was done across studies. Women with oligohydramnios who received intrapartum amnioinfusion had lower incidence of cesarean for FHR abnormalities (OR 0.23; 95% CI 0.15, 0.35). Intrapartum amnioinfusion also was associated with lower overall rates of cesarean deliveries (OR 0.52; 95% CI 0.40, 0. 68), acidemia at birth (OR 0.40; 95% CI 0.30, 0.55), FHR abnormalities during labor (OR 0.24; 95% CI 0.17, 0.34), and Apgar scores under 7 at 5 minutes (OR 0.52; 95% CI 0.29, 0.91). Postpartum endometritis

  10. A Novel Algorithm of Quantum Random Walk in Server Traffic Control and Task Scheduling

    Directory of Open Access Journals (Sweden)

    Dong Yumin

    2014-01-01

    Full Text Available A quantum random walk optimization model and algorithm in network cluster server traffic control and task scheduling is proposed. In order to solve the problem of server load balancing, we research and discuss the distribution theory of energy field in quantum mechanics and apply it to data clustering. We introduce the method of random walk and illuminate what the quantum random walk is. Here, we mainly research the standard model of one-dimensional quantum random walk. For the data clustering problem of high dimensional space, we can decompose one m-dimensional quantum random walk into m one-dimensional quantum random walk. In the end of the paper, we compare the quantum random walk optimization method with GA (genetic algorithm, ACO (ant colony optimization, and SAA (simulated annealing algorithm. In the same time, we prove its validity and rationality by the experiment of analog and simulation.

  11. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

  12. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

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    Yan-hui Li

    Full Text Available BACKGROUND: Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM, the role of massage therapy in the management of FM remained controversial. OBJECTIVE: The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. METHODS: Electronic databases (up to June 2013 were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD and 95% confidence intervals (CI were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2 statistic. RESULTS: Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03, anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01, and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005 in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52. CONCLUSION: Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  13. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua

    2014-01-01

    Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2) statistic. Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52). Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  14. A behavioral intervention for war-affected youth in Sierra Leone: a randomized controlled trial.

    Science.gov (United States)

    Betancourt, Theresa S; McBain, Ryan; Newnham, Elizabeth A; Akinsulure-Smith, Adeyinka M; Brennan, Robert T; Weisz, John R; Hansen, Nathan B

    2014-12-01

    Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)-based group mental health intervention for multisymptomatic war-affected youth (aged 15-24 years) in Sierra Leone. War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI); http://clinicaltrials.gov; NCT

  15. Identifying the gaps in infection prevention and control resources for long-term care facilities in British Columbia.

    Science.gov (United States)

    Gamage, Bruce; Schall, Valerie; Grant, Jennifer

    2012-03-01

    Infection prevention and control (IPC) is a critical, although often neglected, part of long-term care (LTC) management. Little is known about what IPC resources are available for LTC and how that impacts patient care and safety. One hundred eighty-eight LTC facilities were randomly selected out of all British Columbia facilities and surveyed using a validated survey tool. The tool was used to collect data regarding IPC resources grouped within 6 indices: (1) leadership, (2) infection control professionals (ICP) coverage, (3) policies and procedures, (4) support through partnerships, (5) surveillance, and (6) control activities. All components measured have been identified as key for an effective IPC program. Survey responses were used to calculate scores for IPC programs as a whole and for each of the 6 indices. Of 188 randomly selected facilities, 86 institutions participated. Facilities were compared by region, funding source, and ICP coverage. Overall, LTC facilities lacked IPC leadership, especially physician support. Having no dedicated ICP was associated with poorer scores on all indices. Only 41% of practicing ICPs had more than 2 years experience, and only 14% were professionally certified. Twenty-two percent of ICPs had additional roles within the institution, and 44% had additional roles outside of the institution. Thirty-five percent of institutions had no IPC dedicated budget. LTC institutions-with bed numbers exceeding those in acute care-represent an important aspect of health services. These data show that many LTC facilities lack the necessary resources to provide quality infection control programs. Copyright © 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  16. Randomized controlled trial of a patient decision-making aid for orthodontics.

    Science.gov (United States)

    Parker, Kate; Cunningham, Susan J; Petrie, Aviva; Ryan, Fiona S

    2017-08-01

    Patient decision-making aids (PDAs) are instruments that facilitate shared decision making and enable patients to reach informed, individual decisions regarding health care. The objective of this study was to assess the efficacy of a PDA compared with traditional information provision for adolescent patients considering fixed appliance orthodontic treatment. Before treatment, orthodontic patients were randomly allocated into 2 groups: the intervention group received the PDA and standard information regarding fixed appliances, and the control group received the standard information only. Decisional conflict was measured using the Decisional Conflict Scale, and the levels of decisional conflict were compared between the 2 groups. Seventy-two patients were recruited and randomized in a ratio of 1:1 to the PDA and control groups. Seventy-one patients completed the trial (control group, 36; PDA group, 35); this satisfied the sample size calculation. The median total Decisional Conflict Scale score in the PDA group was lower than in the control group (15.63 and 19.53, respectively). However, this difference was not statistically significant (difference between groups, 3.90; 95% confidence interval of the difference, -4.30 to 12.11). Sex, ethnicity, age, and the time point at which patients were recruited did not have significant effects on Decisional Conflict Scale scores. No harm was observed or reported for any participant in the study. The results of this study showed that the provision of a PDA to adolescents before they consented for fixed appliances did not significantly reduce decisional conflict. There may be a benefit in providing a PDA for some patients, but it is not yet possible to say how these patients could be identified. This trial was registered with the Harrow National Research Ethics Committee (reference 12/LO/0279). The protocol was not published before trial commencement. Copyright © 2017. Published by Elsevier Inc.

  17. Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial.

    Science.gov (United States)

    Krewer, Carmen; Luther, Marianne; Koenig, Eberhard; Müller, Friedemann

    2015-01-01

    One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC) is to enhance patients' arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R) showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo). The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com), identifier number ISRCTN72853718.

  18. Tilt Table Therapies for Patients with Severe Disorders of Consciousness: A Randomized, Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Carmen Krewer

    Full Text Available One major aim of the neurological rehabilitation of patients with severe disorders of consciousness (DOC is to enhance patients' arousal and ability to communicate. Mobilization into a standing position by means of a tilt table has been shown to improve their arousal and awareness. However, due to the frequent occurrence of syncopes on a tilt table, it is easier to accomplish verticalization using a tilt table with an integrated stepping device. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of a tilt table therapy with or without an integrated stepping device on the level of consciousness. A total of 50 participants in vegetative or minimally conscious states 4 weeks to 6 month after injury were treated with verticalization during this randomized controlled trial. Interventions involved ten 1-hour sessions of the specific treatment over a 3-week period. Blinded assessors made measurements before and after the intervention period, as well as after a 3-week follow-up period. The coma recovery scale-revised (CRS-R showed an improvement by a median of 2 points for the group receiving tilt table with integrated stepping (Erigo. The rate of recovery of the group receiving the conventional tilt table therapy significantly increased by 5 points during treatment and by an additional 2 points during the 3-week follow-up period. Changes in spasticity did not significantly differ between the two intervention groups. Compared to the conventional tilt table, the tilt table with integrated stepping device failed to have any additional benefit for DOC patients. Verticalization itself seems to be beneficial though and should be administered to patients in DOC in early rehabilitation. Trial Registration: Current Controlled Trials Ltd (www.controlled-trials.com, identifier number ISRCTN72853718.

  19. Behavior therapy for children with Tourette disorder: a randomized controlled trial.

    Science.gov (United States)

    Piacentini, John; Woods, Douglas W; Scahill, Lawrence; Wilhelm, Sabine; Peterson, Alan L; Chang, Susanna; Ginsburg, Golda S; Deckersbach, Thilo; Dziura, James; Levi-Pearl, Sue; Walkup, John T

    2010-05-19

    Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition. Antipsychotic medications, the first-line treatments for moderate to severe tics, are often associated with adverse effects. Behavioral interventions, although promising, have not been evaluated in large-scale controlled trials. To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents. Randomized, observer-blind, controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years, with impairing Tourette or chronic tic disorder as a primary diagnosis, randomly assigned to 8 sessions during 10 weeks of behavior therapy (n = 61) or a control treatment consisting of supportive therapy and education (n = 65). Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment. Comprehensive behavioral intervention. Yale Global Tic Severity Scale (range 0-50, score >15 indicating clinically significant tics) and Clinical Global Impressions-Improvement Scale (range 1 [very much improved] to 8 [very much worse]). Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale (24.7 [95% confidence interval {CI}, 23.1-26.3] to 17.1 [95% CI, 15.1-19.1]) from baseline to end point compared with the control treatment (24.6 [95% CI, 23.2-26.0] to 21.1 [95% CI, 19.2-23.0]) (P tic worsening was reported by 4% of children (5/126). Treatment gains were durable, with 87% of available responders to behavior therapy exhibiting continued benefit 6 months following treatment. A comprehensive behavioral intervention, compared with supportive therapy and education, resulted in greater improvement in symptom severity among children with Tourette and chronic tic disorder. clinicaltrials.gov Identifier: NCT00218777.

  20. School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial.

    Science.gov (United States)

    Szilagyi, Peter G; Schaffer, Stanley; Rand, Cynthia M; Goldstein, Nicolas P N; Vincelli, Phyllis; Hightower, A Dirk; Younge, Mary; Eagan, Ashley; Blumkin, Aaron; Albertin, Christina S; DiBitetto, Kristine; Yoo, Byung-Kwang; Humiston, Sharon G

    2018-02-01

    We aimed to evaluate the effect of school-located influenza vaccination (SLIV) on adolescents' influenza vaccination rates. In 2015-2016, we performed a cluster-randomized trial of adolescent SLIV in middle/high schools. We selected 10 pairs of schools (identical grades within pairs) and randomly allocated schools within pairs to SLIV or usual care control. At eight suburban SLIV schools, we sent parents e-mail notifications about upcoming SLIV clinics and promoted online immunization consent. At two urban SLIV schools, we sent parents (via student backpack fliers) paper immunization consent forms and information about SLIV. E-mails were unavailable at these schools. Local health department nurses administered nasal or injectable influenza vaccine at dedicated SLIV clinics and billed insurers. We compared influenza vaccination rates at SLIV versus control schools using school directories to identify the student sample in each school. We used the state immunization registry to determine receipt of influenza vaccination. The final sample comprised 17,650 students enrolled in the 20 schools. Adolescents at suburban SLIV schools had higher overall influenza vaccination rates than did adolescents at control schools (51% vs. 46%, p < .001; adjusted odds ratio = 1.27, 95% confidence interval 1.18-1.38, controlling for vaccination during the prior two seasons). No effect of SLIV was noted among urbanschools on multivariate analysis. SLIV did not substitute for vaccinations in primary care or other settings; in suburban settings, SLIV was associated with increased vaccinations in primary care or other settings (adjusted odds ratio = 1.10, 95% confidence interval 1.02-1.19). SLIV in this community increased influenza vaccination rates among adolescents attending suburban schools. Copyright © 2018. Published by Elsevier Inc.

  1. Cluster randomized controlled trial of a peer support program for people with diabetes

    DEFF Research Database (Denmark)

    Riddell, Michaela A; Renwick, Carla; Wolfe, Rory

    2012-01-01

    ABSTRACT: BACKGROUND: Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional...... and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self......-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support...

  2. Adding randomness controlling parameters in GRASP method applied in school timetabling problem

    Directory of Open Access Journals (Sweden)

    Renato Santos Pereira

    2017-09-01

    Full Text Available This paper studies the influence of randomness controlling parameters (RCP in first stage GRASP method applied in graph coloring problem, specifically school timetabling problems in a public high school. The algorithm (with the inclusion of RCP was based on critical variables identified through focus groups, whose weights can be adjusted by the user in order to meet the institutional needs. The results of the computational experiment, with 11-year-old data (66 observations processed at the same high school show that the inclusion of RCP leads to significantly lowering the distance between initial solutions and local minima. The acceptance and the use of the solutions found allow us to conclude that the modified GRASP, as has been constructed, can make a positive contribution to this timetabling problem of the school in question.

  3. The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails.

    Science.gov (United States)

    Lan, Lihuan; Zhang, Xiaoni; Li, Xiangpen; Rong, Xiaoming; Peng, Ying

    2017-08-22

    As a non-invasive therapy, whether transcranial magnetic stimulation (TMS) is effective on migraine. This article was aimed to assess the efficacy of TMS on migraine based on randomized controlled trails (RCTs). We searched PubMed, Embase and Cochrane Library electronic databases for published studies which compared TMS group with sham group, conducted a meta-analysis of all RCTs. Five studies, consisting of 313 migraine patients, were identified. Single-pulse transcranial magnetic stimulation is effective for the acute treatment of migraine with aura after the first attack (p = 0.02). And, the efficacy of TMS on chronic migraine was not significant (OR 2.93; 95% CI 0.71-12.15; p = 0.14). TMS is effective for migraine based on the studies included in the article.

  4. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Transforming local government by project portfolio management: Identifying and overcoming control problems

    DEFF Research Database (Denmark)

    Hansen, Lars Kristian

    2013-01-01

    Purpose – As public organizations strive for higher e-government maturity, information technology (IT) Project Portfolio Management (IT PPM) has become a high priority issue. Assuming control is central in IT PPM, the purpose of this paper is to investigate how a Danish local government conducts...... workshop, and analyses of documents. Findings – It is found that the local government relies vastly on informal control mechanisms and five control problems are identified: weak accountability processes between the political and administrative level; weak accountability between the director level...... the identified control problems. Research limitations/implications – As a single qualitative case study, the results are limited to one organization and subject. Practical implications – The paper has implications for IT PPM in Danish local governments and similar organizations in other countries. The paper...

  6. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial.

    NARCIS (Netherlands)

    Scheltens, P.; Kamphuis, P.J.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.

    2010-01-01

    OBJECTIVE: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). METHODS: A total of 225 drug-naive AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

  7. Efficacy of a medical food in mild Alzheimer's disease: a randomized, controlled trial

    NARCIS (Netherlands)

    Scheltens, P.; Kamphuis, P.J.G.H.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.

    2010-01-01

    Objective: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). Methods: A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

  8. Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

    2017-01-01

    Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

  9. After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

    Science.gov (United States)

    McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

    2006-01-01

    This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

  10. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    Science.gov (United States)

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  11. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  12. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    Science.gov (United States)

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  13. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study

    NARCIS (Netherlands)

    Witvliet, M.; van Lier, P.A.C.; Cuijpers, P.; Koot, H.M.

    2009-01-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal

  14. Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

    Science.gov (United States)

    Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

    2016-01-01

    This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

  15. Effects of wet-cupping on blood pressure in hypertensive patients: a randomized controlled trial.

    Science.gov (United States)

    Aleyeidi, Nouran A; Aseri, Khaled S; Matbouli, Shadia M; Sulaiamani, Albaraa A; Kobeisy, Sumayyah A

    2015-11-01

    Although cupping remains a popular treatment modality worldwide, its efficacy for most diseases, including hypertension, has not been scientifically evaluated. We aimed to determine the efficacy of wet-cupping for high blood pressure, and the incidence of the procedure's side effects in the intervention group. This is a randomized controlled trial conducted in the General Practice Department at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, between May 2013 and February 2014. There were two groups (40 participants each): intervention group undergoing wet-cupping (hijama) in addition to conventional hypertension treatment, and a control group undergoing only conventional hypertension treatment. Three wet-cupping sessions were performed every other day. The mean systolic and diastolic blood pressures were measured using a validated automatic sphygmomanometer. The follow-up period was 8 weeks. Wet-cupping provided an immediate reduction of systolic blood pressure. After 4 weeks of follow-up, the mean systolic blood pressure in the intervention group was 8.4 mmHg less than in the control group (P=0.046). After 8 weeks, there were no significant differences in blood pressures between the intervention and control groups. In this study, wet-cupping did not result in any serious side effects. Wet-cupping therapy is effective for reducing systolic blood pressure in hypertensive patients for up to 4 weeks, without serious side effects. Wet-cupping should be considered as a complementary hypertension treatment, and further studies are needed. ClinicalTrials.gov Identifier NCT01987583.

  16. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial.

    Science.gov (United States)

    Bickel, Amitai; Gurevits, Michael; Vamos, Ronny; Ivry, Simon; Eitan, Arieh

    2011-04-01

    To assess the influence of hyperoxygenation on surgical site infection by using the most homogeneous study population. A randomized, prospective, controlled trial. Department of surgery in a government hospital. A total of 210 patients who underwent open surgery for acute appendicitis. In the study group, patients received 80% oxygen during anesthesia, followed by high-flow oxygen for 2 hours in the recovery room. The control group received 30% oxygen, as usual. Open appendectomy via incision in the right lower quadrant of the abdomen. Surgical site infection, mainly assessed by the ASEPSIS (additional treatment, serous discharge, erythema, purulent discharge, separation of deep tissues, isolation of bacteria, and stay in hospital prolonged >14 days) system score. Surgical site infections were recorded in 6 of 107 patients (5.6%) in the study group vs 14 of 103 patients (13.6%) in the control group (P = .04). Significant differences in the ASEPSIS score were also found. The mean hospital stay was longer in the control group (2.92 days) compared with the study group (2.51 days) (P = .01). The use of supplemental oxygen is advantageous in operations for acute appendicitis by reducing surgical site infection rate and hospital stay. clinicaltrials.gov Identifier: NCT01002365.

  17. Snack purchasing is healthier when the cognitive demands of choice are reduced: A randomized controlled trial.

    Science.gov (United States)

    Allan, Julia L; Johnston, Marie; Campbell, Neil

    2015-07-01

    Individuals with inefficient executive (higher level cognitive) function have a reduced ability to resist dietary temptation. The present study aimed to design and test a theory-based point-of-purchase intervention for coffee shops that reduced the calorie content of customers' purchases by reducing the need for executive function (EF) at the moment of choice. Key facets of EF were identified by a multidisciplinary group and used to develop a point-of-purchase intervention (signage). This intervention was evaluated in a randomized controlled trial (RCT) in a public coffee shop on consumer purchases of >20,000 snacks and drinks over 12 weeks. A sample of customers (n = 128) was recruited to complete an embedded cross-sectional study measuring EF strength, dietary intentions, typical purchases, and purchases made after exposure to the intervention. The proportion of snack purchases that were high in calorie reduced significantly (t(10) = 2.34, p = .04) in intervention weeks relative to control. High calorie drink purchases were also lower in intervention than control weeks, however, this difference was not significant (t(10) = 1.56, p = .15). On average, customers purchased items containing 66 calories customer behavior increased as EF strength decreased (β = .24, p = .03). The calorie content of cafe purchases can be lowered by reducing the cognitive demands of healthy food choice at the moment of purchase, especially in those with poor EF. Environmental changes like these have the potential to help achieve population weight control. (c) 2015 APA, all rights reserved.

  18. Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial.

    Science.gov (United States)

    Teut, M; Ullmann, A; Ortiz, M; Rotter, G; Binting, S; Cree, M; Lotz, F; Roll, S; Brinkhaus, B

    2018-04-02

    We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial. 110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n = 37), minimal cupping with 8 treatments plus paracetamol on demand (n = 36) or the control group with paracetamol on demand only (n = 37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks. The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p back function after 4 weeks, but not after 12 weeks (- 5.4 (- 11.7;0.8); p = 0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (- 5.6 (- 9.3;-2.0); p = 0.003; - 6.1 (- 9.9;-2.4); p = 0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (- 0.4;15.0); p = 0.063); minimal cupping vs. control (6.3 (- 2.0;14.5); p = 0.133). Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks. The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).

  19. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  20. WeChat Public Account Use Improves Clinical Control of Cough-Variant Asthma: A Randomized Controlled Trial.

    Science.gov (United States)

    Cao, Yuan; Lin, Shi-Hua; Zhu, Ding; Xu, Feng; Chen, Zhi-Hua; Shen, Hua-Hao; Li, Wen

    2018-03-14

    BACKGROUND WeChat is a convenient and popular social medium, and it seems to be an appropriate platform for education and management of patients. This study sought to identify usefulness in clinical control of cough-variant asthma (CVA). MATERIAL AND METHODS A randomized controlled trial was conducted among 80 CVA patients. After being assigned to either the traditional group (TG) or the WeChat group (WG), they received the same inhalation therapy, but patients in WG received additional education and instruction via our public account on the WeChat application. Questionnaires on asthma and chronic cough, data on pulmonary function, blood-related items, follow-up adherence, and Emergency Department (ED) visits were collected at the initial visit and at 3 months. RESULTS A total of 67 participants completed the trial for analysis. FEV1/predicted and FEV1/FVC were significantly increased in WG (pWeChat as part of treatment and management of CVA can help patients learn about their disease and medications, as well as improve disease control and therapy outcomes.

  1. Improving preschoolers' mathematics achievement with tablets: a randomized controlled trial

    Science.gov (United States)

    Schacter, John; Jo, Booil

    2017-09-01

    With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered by their classroom teachers. After 22 weeks, there was a large and statistically significant effect on mathematics achievement for Math Shelf students (Cohen's d = .94). Moderator analyses demonstrated an even larger effect for low achieving children (Cohen's d = 1.27). These results suggest that early education teachers can improve their students' mathematics outcomes by integrating experimentally proven tablet software into their daily routines.

  2. Design and rationale of the HITTS randomized controlled trial

    DEFF Research Database (Denmark)

    Nytrøen, Kari; Yardley, Marianne; Rolid, Katrine

    2016-01-01

    There is no consensus on how, when, and at what intensity exercise should be performed and organized after heart transplantation (HTx). Most rehabilitation programs are conducted in HTx centers, which might be impractical and costly. We have recently shown that high-intensity interval training (HIT...... Scandinavian HTx centers. Participants are randomized to HIT or moderate training, shortly after surgery. All exercises are supervised in the patients' local communities. Testing at baseline and follow-up includes the following: VO2peak (primary end point), muscle strength, body composition, quality of life......) is safe, well tolerated, and efficacious in maintenance HTx recipients, but there are no studies among de novo patients, and whether HIT is feasible and superior to moderate training in HTx recipients is unclear. A total of 120 clinically stable HTx recipients older than 18 years will be recruited from 3...

  3. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  4. Efficacy of auriculotherapy for constipation in adults: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yang, Li-Hua; Duan, Pei-Bei; Du, Shi-Zheng; Sun, Jin-Fang; Mei, Si-Juan; Wang, Xiao-Qing; Zhang, Yuan-Yuan

    2014-08-01

    To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; pcultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

  5. Effect of Providing Ankle-Foot Orthoses in Patients with Acute and Subacute Stroke: a Randomized Controlled Trial : A randomized controlled trial

    NARCIS (Netherlands)

    Nikamp-Simons, Corien D.M.; Buurke, Jaap H.; Van Der Palen, Job; Hermens, Hermie J.; Rietman, Johan S.; Ibánez, Jaime; Azorín, José María; Akay, Metin; Pons, José Luis

    2017-01-01

    Despite frequent application of ankle-foot orthoses (AFOs), little scientific evidence is available to guide AFO-provision early after stroke. A randomized controlled trial was conducted to study the effects of AFO-provision in (sub-) acute stroke patients. Primary aim: to study effects of the

  6. Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials.

    Science.gov (United States)

    Tan, Shanjun; Wu, Guohao; Zhuang, Qiulin; Xi, Qiulei; Meng, Qingyang; Jiang, Yi; Han, Yusong; Yu, Chao; Yu, Zhen; Li, Ning

    2016-09-01

    The role of laparoscopic surgery in the repair for peptic ulcer disease is unclear. The present study aimed to compare the safety and efficacy of laparoscopic versus open repair for peptic ulcer disease. Randomized controlled trials (RCTs) comparing laparoscopic versus open repair for peptic ulcer disease were identified from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and references of identified articles and relevant reviews. Primary outcomes were postoperative complications, mortality, and reoperation. Secondary outcomes were operative time, postoperative pain, postoperative hospital stay, nasogastric tube duration, and time to resume diet. Statistical analysis was carried out by Review Manage software. Five RCTs investigating a total of 549 patients, of whom, 279 received laparoscopic repair and 270 received open repair, were included in the final analysis. There were no significant differences between these two procedures in some primary outcomes including overal postoperative complication rate, mortality, and reoperation rate. Subcategory analysis of postoperative complications showed that laparoscopic repair had also similar rates of repair site leakage, intra-abdominal abscess, postoperative ileus, pneumonia, and urinary tract infection as open surgery, except of the lower surgical site infection rate (P peptic ulcer. The obvious advantages of laparoscopic surgery are the lower surgical site infection rate, shorter nasogastric tube duration and less postoperative pain. However, more higher quality studies should be undertaken to further assess the safety and efficacy of laparoscopic repair for peptic ulcer disease. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  7. Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials.

    Science.gov (United States)

    Dascal, Julieta; Reid, Mark; IsHak, Waguih William; Spiegel, Brennan; Recacho, Jennifer; Rosen, Bradley; Danovitch, Itai

    2017-01-01

    Objective: We evaluated the evidence supporting the use of virtual reality among patients in acute inpatient medical settings. Method: We conducted a systematic review of randomized controlled trials conducted that examined virtual reality applications in inpatient medical settings between 2005 and 2015. We used PsycINFO, PubMed, and Medline databases to identify studies using the keywords virtual reality , VR therapy , treatment , and inpatient. Results: We identified 2,024 citations, among which 11 met criteria for inclusion. Studies addressed three general areas: pain management, eating disorders, and cognitive and motor rehabilitation. Studies were small and heterogeneous and utilized different designs and measures. Virtual reality was generally well tolerated by patients, and a majority of studies demonstrated clinical efficacy. Studies varied in quality, as measured by an evaluation metric developed by Reisch, Tyson, and Mize (average quality score=0.87; range=0.78-0.96). Conclusion: Virtual reality is a promising intervention with several potential applications in the inpatient medical setting. Studies to date demonstrate some efficacy, but there is a need for larger, well-controlled studies to show clinical and cost-effectiveness.

  8. Optimal strategy analysis based on robust predictive control for inventory system with random demand

    Science.gov (United States)

    Saputra, Aditya; Widowati, Sutrisno

    2017-12-01

    In this paper, the optimal strategy for a single product single supplier inventory system with random demand is analyzed by using robust predictive control with additive random parameter. We formulate the dynamical system of this system as a linear state space with additive random parameter. To determine and analyze the optimal strategy for the given inventory system, we use robust predictive control approach which gives the optimal strategy i.e. the optimal product volume that should be purchased from the supplier for each time period so that the expected cost is minimal. A numerical simulation is performed with some generated random inventory data. We simulate in MATLAB software where the inventory level must be controlled as close as possible to a set point decided by us. From the results, robust predictive control model provides the optimal strategy i.e. the optimal product volume that should be purchased and the inventory level was followed the given set point.

  9. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified

  10. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  11. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, N.J.; Wildt, S.N. de; Verlaat, C.W.; Knibbe, C.A.; Mooij, M.G.; Woensel, J.B. van; Rosmalen, J. van; Tibboel, D.; Hoog, M. de

    2016-01-01

    PURPOSE: To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. METHODS: In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically

  12. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, Nienke J.; de Wildt, Saskia N.; Verlaat, Carin W. M.; Knibbe, Catherijne A. J.; Mooij, Miriam G.; van Woensel, Job B. M.; van Rosmalen, Joost; Tibboel, Dick; de Hoog, Matthijs

    2016-01-01

    To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically ill children with

  13. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    NARCIS (Netherlands)

    Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.

    2017-01-01

    Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in

  14. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  15. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  16. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: Randomized controlled trial

    NARCIS (Netherlands)

    W.A. Moojen (Wouter); M.P. Arts (Mark); W.C.H. Jacobs (Wilco); E.W. van Zwet (Erik); M.E. van den Akker-van Marle (Elske); B.W. Koes (Bart); C.L.A.M. Vleggeert-Lankamp (Carmen); W.C. Peul (Wilco)

    2013-01-01

    markdownabstractAbstract Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled

  17. Melodic intonation therapy in chronic aphasia: Evidence from a pilot randomized controlled trial

    NARCIS (Netherlands)

    I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)

    2016-01-01

    textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining

  18. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  19. Tool for identifying critical control points in embedded purchasing activities in SMEs

    NARCIS (Netherlands)

    Hagelaar, Geoffrey; Staal, Anne; Holman, Richard; Walhof, Gert

    2015-01-01

    This paper discusses risk and uncertainty aspects and proposes an assessment tool leading to identification of critical control points (CCPs) within purchasing-oriented activities of small and medium enterprises (SMEs). Identifying such CCPs is the basis for developing SME purchasing instruments to

  20. Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Feng; Li, Wen-Xiong; Liu, Zhu; Liu, Li

    2016-10-22

    Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved. We propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial. If BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated. Clinical Trials.gov Identifier: NCT02705131 . Registered on 9

  1. Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

    Science.gov (United States)

    McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

    2014-06-01

    Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

  2. Support or competition? How online social networks increase physical activity: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jingwen Zhang, PhD

    2016-12-01

    Full Text Available To identify what features of online social networks can increase physical activity, we conducted a 4-arm randomized controlled trial in 2014 in Philadelphia, PA. Students (n = 790, mean age = 25.2 at an university were randomly assigned to one of four conditions composed of either supportive or competitive relationships and either with individual or team incentives for attending exercise classes. The social comparison condition placed participants into 6-person competitive networks with individual incentives. The social support condition placed participants into 6-person teams with team incentives. The combined condition with both supportive and competitive relationships placed participants into 6-person teams, where participants could compare their team's performance to 5 other teams' performances. The control condition only allowed participants to attend classes with individual incentives. Rewards were based on the total number of classes attended by an individual, or the average number of classes attended by the members of a team. The outcome was the number of classes that participants attended. Data were analyzed using multilevel models in 2014. The mean attendance numbers per week were 35.7, 38.5, 20.3, and 16.8 in the social comparison, the combined, the control, and the social support conditions. Attendance numbers were 90% higher in the social comparison and the combined conditions (mean = 1.9, SE = 0.2 in contrast to the two conditions without comparison (mean = 1.0, SE = 0.2 (p = 0.003. Social comparison was more effective for increasing physical activity than social support and its effects did not depend on individual or team incentives.

  3. Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

    Science.gov (United States)

    Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

    2017-05-01

    This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

  4. Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study.

    Science.gov (United States)

    2008-12-01

    To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an omega-3 fatty acid, improves the motor features of Huntington disease. Six-month multicenter, randomized, double-blind, placebo-controlled trial followed by a 6-month open-label phase without disclosing initial treatment assignments. Forty-one research sites in the United States and Canada. Three hundred sixteen adults with Huntington disease, enriched for a population with shorter trinucleotide (cytosine-adenine-guanine) repeat length expansions. Random assignment to placebo or ethyl-EPA, 1 g twice a day, followed by open-label treatment with ethyl-EPA. Six-month change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale analyzed for all research participants and those with shorter cytosine-adenine-guanine repeat length expansions (<45). At 6 months, the Total Motor Score 4 point change for patients receiving ethyl-EPA did not differ from that for those receiving placebo. No differences were found in measures of function, cognition, or global impression. Before public disclosure of the 6-month placebo-controlled results, 192 individuals completed the open-label phase. The Total Motor Score 4 change did not worsen for those who received active treatment for 12 continuous months compared with those who received active treatment for only 6 months (2.0-point worsening; P=.02). Ethyl-EPA was not beneficial in patients with Huntington disease during 6 months of placebo-controlled evaluation. Clinical Trial Registry clinicaltrials.gov Identifier: NCT00146211.

  5. A systematic review of the quality of randomized controlled trials in head and neck oncology surgery.

    Science.gov (United States)

    Carlton, Daniel A; Kocherginsky, Masha; Langerman, Alexander J

    2015-01-01

    To determine the quality of randomized controlled trials (RCTs) in head and neck surgery in which surgery was a primary intervention. Potential articles were identified in PubMed without publication date restrictions. Articles were scored using the CONSORT checklist and the relationship between the checklist score and whether the first and/or last authors were surgeons was investigated. Differences in the checklist score based on how many surgeons were among the first and last authors of the study were analyzed using the Kruskal-Wallis test. Fisher's exact test was used to examine if there was a significant difference of the reporting of individual items from the checklist between surgeons and nonsurgeons. A nonparametric trend test was used to determine whether there was a difference in the reporting of individual items based on whether there were none, one, or two surgeons among first and last authors. A total of 38 publications satisfied the inclusion criteria. There was a trend toward lower quality for studies in which surgeons were either first, last, or both first and last authors compared to studies that were first-authored and last-authored by nonsurgeons (P = 0.068). Nonsurgeons were more likely to report on critical elements regarding hypothesis, sample size determination, randomization, and eligibility of centers (P = 0.023-0.058). The quality of RCTs in head and neck surgery is poor. Improved training in conducting and reporting clinical research is needed in otolaryngology residencies. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  6. Virtual reality exposure therapy for social anxiety disorder: a randomized controlled trial.

    Science.gov (United States)

    Anderson, Page L; Price, Matthew; Edwards, Shannan M; Obasaju, Mayowa A; Schmertz, Stefan K; Zimand, Elana; Calamaras, Martha R

    2013-10-01

    This is the first randomized trial comparing virtual reality exposure therapy to in vivo exposure for social anxiety disorder. Participants with a principal diagnosis of social anxiety disorder who identified public speaking as their primary fear (N = 97) were recruited from the community, resulting in an ethnically diverse sample (M age = 39 years) of mostly women (62%). Participants were randomly assigned to and completed 8 sessions of manualized virtual reality exposure therapy, exposure group therapy, or wait list. Standardized self-report measures were collected at pretreatment, posttreatment, and 12-month follow-up, and process measures were collected during treatment. A standardized speech task was delivered at pre- and posttreatment, and diagnostic status was reassessed at 3-month follow-up. Analysis of covariance showed that, relative to wait list, people completing either active treatment significantly improved on all but one measure (length of speech for exposure group therapy and self-reported fear of negative evaluation for virtual reality exposure therapy). At 12-month follow-up, people showed significant improvement from pretreatment on all measures. There were no differences between the active treatments on any process or outcome measure at any time, nor differences on achieving partial or full remission. Virtual reality exposure therapy is effective for treating social fears, and improvement is maintained for 1 year. Virtual reality exposure therapy is equally effective as exposure group therapy; further research with a larger sample is needed, however, to better control and statistically test differences between the treatments.

  7. A human immunodeficiency virus risk reduction intervention for incarcerated youth: a randomized controlled trial.

    Science.gov (United States)

    Goldberg, Eudice; Millson, Peggy; Rivers, Stephen; Manning, Stephanie Jeanneret; Leslie, Karen; Read, Stanley; Shipley, Caitlin; Victor, J Charles

    2009-02-01

    To evaluate, by gender, the impact of a structured, comprehensive risk reduction intervention with and without boosters on human immunodeficiency virus (HIV) knowledge, attitudes and behaviors in incarcerated youth; and to determine predictors of increasing HIV knowledge and reducing high-risk attitudes and behaviors. This randomized controlled trial involved participants completing structured interviews at 1, 3, and 6 months. Repeated measures analysis of variance was used to analyze changes over time. The study was conducted in secure custody facilities and in the community. The study sample comprising 391 incarcerated youth, 102 female and 289 male aged 12-18, formed the voluntary sample. Participants were randomly assigned to one of three conditions: education intervention; education intervention with booster; or no systematic intervention. The outcome and predictor measures included the Rosenberg Self-Esteem Scale, Youth Self Report, Drug Use Inventory, and HIV Knowledge, Attitudes and Behavior Scale. The 6-month retention rate was 59.6%. At 6 months, males in the education and booster groups sustained increases in knowledge scores (p variations by gender underline the importance of gender issues in prevention interventions. Predictors of success were identified to inform future HIV education interventions.

  8. Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

    Science.gov (United States)

    Birken, Sarah A; Urquhart, Robin; Munoz-Plaza, Corrine; Zizzi, Alexandra R; Haines, Emily; Stover, Angela; Mayer, Deborah K; Hahn, Erin E

    2018-03-23

    The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes. We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes. RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives. RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders. SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.

  9. Hydrotherapy for the Treatment of Pain in People with Multiple Sclerosis: A Randomized Controlled Trial

    OpenAIRE

    Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A.; Lara-Palomo, Inmaculada; Saavedra-Hernández, Manuel; Arroyo-Morales, Manuel; Moreno-Lorenzo, Carmen

    2011-01-01

    Background. Multiple sclerosis (MS) is a chronic demyelinating neurological disease. Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients. Objective. The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients. Methods. In this randomized controlled trial, 73 MS patients were randomly assigned to an experimental or control group for a 20-we...

  10. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial

    OpenAIRE

    Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.

    2015-01-01

    Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...

  11. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials

    OpenAIRE

    de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Mill?n-Calenti, Jos? C.

    2015-01-01

    Background Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. Methods The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for random...

  12. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    OpenAIRE

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

  13. Hydrotherapy improves pain and function in older women with knee osteoarthritis: a randomized controlled trial

    OpenAIRE

    Dias, João Marcos; Cisneros, Lígia; Dias, Rosângela; Fritsch, Carolina; Gomes, Wellington; Pereira, Leani; Santos, Mary Luci; Ferreira, Paulo Henrique

    2017-01-01

    Background Currently, there is poor evidence of the effect of hydrotherapy alone on patients with hip or knee osteoarthritis. Objectives The study aimed to assess the impact of hydrotherapy on pain, function, and muscle function in older women with knee osteoarthritis. Methods A randomized controlled trial was conducted to evaluate the efficacy of hydrotherapy in women with knee osteoarthritis. Seventy-three women aged 65 and older were randomized to hydrotherapy (n = 36) or a control group (...

  14. Transforming local government by project portfolio management: Identifying and overcoming control problems

    DEFF Research Database (Denmark)

    Hansen, Lars Kristian

    2013-01-01

    Purpose – As public organizations strive for higher e-government maturity, information technology (IT) Project Portfolio Management (IT PPM) has become a high priority issue. Assuming control is central in IT PPM, the purpose of this paper is to investigate how a Danish local government conducts...... to understand how local governments can improve IT PPM. Keywords IT project portfolio management, E-government, Control theory, Control problems, Formal mechanisms, Informal mechanisms, Local government, Denmark...... control in IT PPM. The authors identify control problems and formulate recommendations to address these. Design/methodology/approach – Adopting principles from Engaged Scholarship, the authors have conducted a case study using a wide variety of data collection methods, including 29 interviews, one...

  15. Do Motion Controllers Make Action Video Games Less Sedentary? A Randomized Experiment

    OpenAIRE

    Lyons, Elizabeth J.; Tate, Deborah F.; Ward, Dianne S.; Ribisl, Kurt M.; Bowling, J. Michael; Kalyanaraman, Sriram

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0....

  16. Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.

    Science.gov (United States)

    Ibinda, Fredrick; Mbuba, Caroline K; Kariuki, Symon M; Chengo, Eddie; Ngugi, Anthony K; Odhiambo, Rachael; Lowe, Brett; Fegan, Greg; Carter, Julie A; Newton, Charles R

    2014-02-01

    The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74-2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71-1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no

  17. An online spaced-education game among clinicians improves their patients' time to blood pressure control: a randomized controlled trial.

    Science.gov (United States)

    Kerfoot, B Price; Turchin, Alexander; Breydo, Eugene; Gagnon, David; Conlin, Paul R

    2014-05-01

    Many patients with high blood pressure (BP) do not have antihypertensive medications appropriately intensified at clinician visits. We investigated whether an online spaced-education (SE) game among primary care clinicians can decrease time to BP target among their hypertensive patients. A 2-arm randomized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals. Educational content consisted of 32 validated multiple-choice questions with explanations on hypertension management. Providers were randomized into 2 groups: SE clinicians were enrolled in the game, whereas control clinicians received identical educational content in an online posting. SE game clinicians were e-mailed 1 question every 3 days. Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition. Primary outcome measure was time to BP target (game was completed by 87% of clinicians (48/55), whereas 84% of control clinicians (47/56) read the online posting. In multivariable analysis of 17 866 hypertensive periods among 14 336 patients, the hazard ratio for time to BP target in the SE game cohort was 1.043 (95% confidence interval, 1.007-1.081; P=0.018). The number of hypertensive episodes needed to treat to normalize one additional patient's BP was 67.8. The number of clinicians needed to teach to achieve this was 0.43. An online SE game among clinicians generated a modest but significant reduction in the time to BP target among their hypertensive patients. http://www.clinicaltrials.gov. Unique identifier: NCT00904007. © 2014 American Heart Association, Inc.

  18. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena

    2016-03-01

    Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

  19. Balneotherapy for chronic low back pain: a randomized, controlled study.

    Science.gov (United States)

    Kesiktas, Nur; Karakas, Sinem; Gun, Kerem; Gun, Nuran; Murat, Sadiye; Uludag, Murat

    2012-10-01

    A large number of treatments were used for patients with chronic low back pain. Frequent episodes have been reported very high. Although balneotherapy was found effective in this disease, there are not well-designed studies. We aimed to determine the effectiveness of balneotherapy versus physical therapy in patients with chronic low back pain. Exercise was added to both treatment programs. Sixty patients with chronic low back pain were randomly divided into two groups. Physical modalities plus exercise were applied to group 1, and group 2 was received balneotherapy plus exercise for ten sessions. The following parameters were measured: visual analogue scale at rest and movement for pain, paracetamol dose, manual muscle test for lumber muscles, modified Schoeber' test, Oswestry disability index, and Short-Form 36 at the beginning and end of the therapies and at the 3 months follow-up. The statistical analyses were performed using the SPSS 10.0 program. Both groups achieved significant improvements within themselves. But balneotherapy groups were improved at back extensor muscle test (P Balneotherapy combined with exercise therapy had advantages than therapy with physical modalities plus exercise in improving quality of life and flexibility of patients with chronic low back pain.

  20. Randomized Controlled Trial Comparing Daycare and Overnight Stay Laparoscopic Cholecystectomy.

    Science.gov (United States)

    Salleh, A A M; Affirul, C A; Hairol, O; Zamri, Z; Azlanudin, A; Hilmi, M A; Razman, J

    2015-01-01

    This present study sought to review the feasibility and patients' satisfaction of laparoscopic cholecystectomy to be perform as daycare procedure. Sixty-two patients with symptomatic gallstones were recruited within a year. They were randomized into overnight stay and daycare groups. The outcomes and post-operative complications were analyzed. Fifty-eight patients were eligible for analysis and four patients were excluded because of conversion to open cholecystectomy. All patients in daycare group reported no fever but two patients in the overnight stay group complaint of post-operative fever (p=0.150). The mean pain score using Visual Analogue Score (VAS) in daycare group was 2.93 but in the overnight stay was recorded as 3.59 (p=0.98). Five patients had post-operative nausea and vomiting (PONV) in daycare group compared to 2 patients in the overnight stay group (p=0.227). Patient's satisfaction were higher in the daycare group (p=0.160). All patients in daycare group were back at work within a week but in overnight stay, 11 patients had to stay off work for more than one week (p=0.01). Daycare laparoscopic cholecystectomy is safe and feasible. The satisfaction of daycare surgery is higher than overnight stay group. Patients' selection is an important aspect of its success.

  1. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  2. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  3. Can tamsulosin facilitate expulsion of ureteral stones? A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Fan, Bo; Yang, Deyong; Wang, Jianbo; Che, Xiangyu; Li, Xiancheng; Wang, Lina; Chen, Feng; Wang, Tiezheng; Song, Xishuang

    2013-08-01

    To determine the efficacy and safety of the adrenergic alpha-antagonist tamsulosin in facilitating ureteral stones expulsion. A literature search was carried out using the PubMed database, Medline via Ovid, Embase and the Cochrane Library database to identify randomized controlled trials evaluating the efficiency of tamsulosin in the treatment of ureteral stones. Meta-analysis and forest plots were carried out by use of Review Manager version 5.1 software (Cochrane Collaboration). Compared with the control group, the tamsulosin group had an increase in expulsion rate of 51% and a decrease in expulsion time of 2.63 days. Furthermore, tamsulosin was found to reduce the risk of ureteral colic during treatment by 40% and also the risk of requirement of auxiliary procedures during follow up by 60%. In terms of safety, the tamsulosin group had a 117% increase in the incidence of side-effects compared with the control group, especially for incidence of dizziness. Tamsulosin facilitates the expulsion of ureteral calculi by providing a higher expulsion rate, a shorter expulsion time, a lower incidence of ureteral colic during treatment and a lower requirement of auxiliary procedures. However, the incidence of dizziness occurring during tamsulosin treatment is significantly higher in this setting. © 2012 The Japanese Urological Association.

  4. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

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    Krishna Dalal

    2014-01-01

    Full Text Available Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N=58 with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

  5. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  6. Pelvic Static Magnetic Stimulation to Control Urinary Incontinence in Older Women: A Randomized Controlled Trial

    Science.gov (United States)

    Wallis, Marianne C.; Davies, Elizabeth A.; Thalib, Lukman; Griffiths, Susan

    2012-01-01

    Objectives To determine the efficacy of non-invasive static magnetic stimulation (SMS) of the pelvic floor compared to placebo in the treatment of women aged 60 years and over with urinary incontinence for 6 months or more. Subjects and Methods A single-blinded randomized, placebo-controlled, parallel-group trial. Subjects were excluded if they had an implanted electronic device, had experienced a symptomatic urinary tract infection, or had commenced pharmacotherapy for the same in the previous 4 weeks, or if they were booked for pelvic floor or gynecological surgery within the next 3 months. Once written consent was obtained, subjects were randomly assigned to the active SMS group (n=50) or the placebo group (n=51). Treatment was an undergarment incorporating 15 static magnets of 800–1200 Gauss anterior, posterior, and inferior to the pelvis for at least 12 hours a day for 3 months. Placebo was the same protocol with inert metal disks replacing the magnets. Primary outcome measure was cessation of incontinence as measured by a 24-hour pad test. Secondary outcomes were frequency and severity of symptoms as measured by the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF), the Incontinence Severity Index, a Bothersomeness Visual Analog scale, and a 24-hour bladder diary. Data were collected at baseline and 12 weeks later. Results There were no statistically significant differences between groups in any of the outcome measures from baseline to 12 weeks. Initial evidence of subjective improvement in the treatment group compared to the placebo group was not sustained with sensitivity analysis. Conclusion This study found no evidence that static magnets cure or decrease the symptoms of urinary incontinence. Additional work into the basic physics of the product and garment design is recommended prior to further clinical trials research. PMID:21817123

  7. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  8. Unique genetic loci identified for emotional behavior in control and chronic stress conditions.

    Directory of Open Access Journals (Sweden)

    Kimberly AK Carhuatanta

    2014-10-01

    Full Text Available An individual’s genetic background affects their emotional behavior and response to stress. Although studies have been conducted to identify genetic predictors for emotional behavior or stress response, it remains unknown how prior stress history alters the interaction between an individual’s genome and their emotional behavior. Therefore, the purpose of this study is to identify chromosomal regions that affect emotional behavior and are sensitive to stress exposure. We utilized the BXD behavioral genetics mouse model to identify chromosomal regions that predict fear learning and emotional behavior following exposure to a control or chronic stress environment. 62 BXD recombinant inbred strains and C57BL/6 and DBA/2 parental strains underwent behavioral testing including a classical fear conditioning paradigm and the elevated plus maze. Distinct quantitative trait loci (QTLs were identified for emotional learning, anxiety and locomotion in control and chronic stress populations. Candidate genes, including those with already known functions in learning and stress were found to reside within the identified QTLs. Our data suggest that chronic stress history reveals novel genetic predictors of emotional behavior.

  9. Random T-DNA mutagenesis identifies a Cu-Zn-superoxide dismutase gene as a virulence factor of Sclerotinia sclerotiorum

    Science.gov (United States)

    Agrobacterium-mediated transformation (AMT) was used to identify potential virulence factors in Sclerotinia sclerotiorum. Screening AMT transformants identified two mutants showing significantly reduced virulence. The mutants showed similar growth rate, colony morphology, and sclerotial and oxalate ...

  10. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial.

    Science.gov (United States)

    Hilton, Jennifer; Allan, Bruce; Swaby, Cheryl; Wahba, Raouf; Wah, Raouf; Jarrell, John; Wood, Stephen; Ross, Sue; Tran, Quynh

    2009-09-01

    To estimate whether treatment with intravenous nitroglycerin for uterine relaxation increases the chance of successful external cephalic version. Two double-blind, randomized clinical trials were undertaken: one in nulliparous women and a second in multiparous women. Women presenting for external cephalic version at term were eligible to participate. The primary outcome was immediate success of external cephalic version. Other outcomes were presentation at delivery, cesarean delivery rate, and side effects and complications. Sample size calculations were based on a 100% increase in success of external cephalic version with a one-sided analysis and alpha=0.05 (80% power). In total, 126 women were recruited-82 in the nulliparous trial and 44 in the multiparous trial. Seven patients did not have external cephalic version before delivery but were included in the analysis of success of external cephalic version. One patient was lost to follow-up. The external cephalic version success rate for nulliparous patients was 24% (10 of 42) in patients who received nitroglycerin compared with 8% (3 of 40) in those who receive placebo (P=.04, one-sided Fisher exact test, odds ratio 3.85, lower bound 1.22). In multiparous patients, the external cephalic version success rate did not differ significantly between groups: 44% (10 of 23) in the nitroglycerin group compared with 43% (9 of 21) in the placebo group (P=.60). Treatment with intravenous nitroglycerin increased the rate of successful external cephalic version in nulliparous, but not in multiparous, women. Treatment with intravenous nitroglycerin appeared to be safe, but our numbers were too small to rule out rare serious adverse effects. I.

  11. A pilot randomized controlled trial of EKG for neonatal resuscitation.

    Directory of Open Access Journals (Sweden)

    Anup Katheria

    Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

  12. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

    Science.gov (United States)

    Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan

    2007-07-26

    Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

  13. Pilates in heart failure patients: a randomized controlled pilot trial.

    Science.gov (United States)

    Guimarães, Guilherme Veiga; Carvalho, Vitor Oliveira; Bocchi, Edimar Alcides; d'Avila, Veridiana Moraes

    2012-12-01

    Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Investigate the effects of Pilates on exercise capacity variables in HF. Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P = 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P = 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P = 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P = 0.02). The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy. © 2011 Blackwell Publishing Ltd.

  14. Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals.

    Science.gov (United States)

    Hua, Fang; Deng, Lijia; Kau, Chung How; Jiang, Han; He, Hong; Walsh, Tanya

    2015-09-01

    The authors conducted a study to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading general dental journals, investigate any improvement after the release of the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts guidelines, and identify factors associated with better reporting quality. The authors searched PubMed for RCTs published in 10 leading general dental journals during the periods from 2005 to 2007 (pre-CONSORT period) and 2010 to 2012 (post-CONSORT period). The authors evaluated and scored the reporting quality of included abstracts by using the original 16-item CONSORT for Abstracts checklist. The authors used risk ratios and the t test to compare the adequate reporting rate of each item and the overall quality in the 2 periods. The authors used univariate and multivariate regressions to identify predictors of better reporting quality. The authors included and evaluated 276 RCT abstracts. Investigators reported significantly more checklist items during the post-CONSORT period (mean [standard deviation {SD}], 4.53 [1.69]) than during the pre-CONSORT period (mean [SD], 3.87 [1.10]; mean difference, -0.66 [95% confidence interval, -0.99 to -0.33]; P 80%). In contrast, the authors saw sufficient reporting of randomization, recruitment, outcome in the results section, and funding in none of the pre-CONSORT abstracts and less than 2% of the post-CONSORT abstracts. On the basis of the multivariate analysis, a higher impact factor (P general dental journals has improved significantly, but there is still room for improvement. Joint efforts by authors, reviewers, journal editors, and other stakeholders to improve the reporting of dental RCT abstracts are needed. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

  15. Randomized controlled trials and neuro-oncology: should alternative designs be considered?

    Science.gov (United States)

    Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

    2015-09-01

    Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

  16. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Kira Geoffrey

    2011-05-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of death worldwide. Cardiac rehabilitation (CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention. The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ, cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio, health related quality of life (SF-36, and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed

  17. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    Science.gov (United States)

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  18. Control of Phlebotomus argentipes (Diptera: Psychodidae sand fly in Bangladesh: A cluster randomized controlled trial.

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    Rajib Chowdhury

    2017-09-01

    Full Text Available A number of studies on visceral leishmaniasis (VL vector control have been conducted during the past decade, sometimes came to very different conclusion. The present study on a large sample investigated different options which are partially unexplored including: (1 indoor residual spraying (IRS with alpha cypermethrin 5WP; (2 long lasting insecticide impregnated bed-net (LLIN; (3 impregnation of local bed-nets with slow release insecticide K-O TAB 1-2-3 (KOTAB; (4 insecticide spraying in potential breeding sites outside of house using chlorpyrifos 20EC (OUT and different combinations of the above.The study was a cluster randomized controlled trial where 3089 houses from 11 villages were divided into 10 sections, each section with 6 clusters and each cluster having approximately 50 houses. Based on vector density (males plus females during baseline survey, the 60 clusters were categorized into 3 groups: (1 high, (2 medium and (3 low. Each group had 20 clusters. From these three groups, 6 clusters (about 300 households were randomly selected for each type of intervention and control arms. Vector density was measured before and 2, 4, 5, 7, 11, 14, 15, 18 and 22 months after intervention using CDC light traps. The impact of interventions was measured by using the difference-in-differences regression model.A total of 17,434 sand flies were collected at baseline and during the surveys conducted over 9 months following the baseline measurements. At baseline, the average P. argentipes density per household was 10.6 (SD = 11.5 in the control arm and 7.3 (SD = 8.46 to 11.5 (SD = 20.2 in intervention arms. The intervention results presented as the range of percent reductions of sand flies (males plus females and rate ratios in 9 measurements over 22 months. Among single type interventions, the effect of IRS with 2 rounds of spraying (applied by the research team ranged from 13% to 75% reduction of P. argentipes density compared to the control arm (rate

  19. Stroke rehabilitation evidence and comorbidity: a systematic scoping review of randomized controlled trials.

    Science.gov (United States)

    Nelson, Michelle L A; McKellar, Kaileah A; Yi, Juliana; Kelloway, Linda; Munce, Sarah; Cott, Cheryl; Hall, Ruth; Fortin, Martin; Teasell, Robert; Lyons, Renee

    2017-07-01

    Most strokes occur in the context of other medical diagnoses. Currently, stroke rehabilitation evidence reviews have not synthesized or presented evidence with a focus on comorbidities and correspondingly may not align with current patient population. The purpose of this review was to determine the extent and nature of randomized controlled trial stroke rehabilitation evidence that included patients with multimorbidity. A systematic scoping review was conducted. Electronic databases were searched using a combination of terms related to "stroke" and "rehabilitation." Selection criteria captured inpatient rehabilitation studies. Methods were modified to account for the amount of literature, classified by study design, and randomized controlled trials (RCTs) were abstracted. The database search yielded 10771 unique articles. Screening resulted in 428 included RCTs. Three studies explicitly included patients with a comorbid condition. Fifteen percent of articles did not specify additional conditions that were excluded. Impaired cognition was the most commonly excluded condition. Approximately 37% of articles excluded patients who had experienced a previous stroke. Twenty-four percent excluded patients one or more Charlson Index condition, and 83% excluded patients with at least one other medical condition. This review represents a first attempt to map literature on stroke rehabilitation related to co/multimorbidity and identify gaps in existing research. Existing evidence on stroke rehabilitation often excluded individuals with comorbidities. This is problematic as the evidence that is used to generate clinical guidelines may not match the patient typically seen in practice. The use of alternate research methods are therefore needed for studying the care of individuals with stroke and multimorbidity.

  20. Effect of Maintenance Therapy with Isoxsuprine in the Prevention of Preterm Labor: Randomized controlled trial

    Science.gov (United States)

    Alavi, Azin; Rajaee, Minoo; Amirian, Malihe; Mahboobi, Hamidreza; Jahanshahi, Keramat Allah; Faghihi, Armaghan

    2015-01-01

    Background: Isoxsuprine (Vasodilan) is a beta-adrenergic that directly affects the vascular smooth muscle and results in peripheral vascular dilation. Isoxsuprine relaxes the uterine smooth muscles and is used for treatment of pre-term labor and dysmenorrhea. Isoxsuprine is used extensively in hospitals and private clinics in Iran; however, few studies have reported its safety and efficacy in the prevention of pre-term labor. Objective: The aim of this study was to assess the effect of maintenance therapy with oral isoxsuprine for the prevention of pre-term labor. Methods: We undertook a blinded prospective randomized trial of 70 women with singleton pregnancies who presented in pre-term labor between 26 to 34 weeks of gestation. After arresting the contractions with intravenous magnesium sulfate, the patients were randomized into two groups, with the treatment group receiving oral isoxsuprine until 34 weeks of gestation. Response to treatment was assessed by the progression of the pregnancies in both groups. The data were analyzed using SPSS software. Results: Our results showed that 14 (40%) of the patients in the case group and 12 (34.29%) of patients in the control group had pre-term births, and there was no significant difference between the two groups (P=0.621). Also four women (11.43%) in the case group and five women (14.29%) in the control group delivered before 34 weeks (P=0.721). Conclusion: Oral isoxsuprine was not effective as a maintenance treatment in preventing pre-term births or in delaying delivery until after 34 weeks. Larger studies are needed to identify the best treatment for pre-term labor. PMID:26396726

  1. Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

    Science.gov (United States)

    Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

    2017-01-01

    Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient

  2. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2006-10-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or

  3. Radiation therapy for Graves' ophthalmopathy: a systematic review and meta-analysis of randomized controlled trials

    International Nuclear Information System (INIS)

    Viani, Gustavo Arruda; Stefano, Eduardo Jose; De Fendi, Ligia Issa; Fonseca, Ellen Carrara; Paula, Jayter Silva de

    2012-01-01

    Purpose: To evaluate the efficacy of radiotherapy (RT) with total dose of 20 Gy (RT 20 Gy) in the treatment of Graves' ophthalmopathy. Methods: A systematic review and meta-analysis of randomized controlled trials was performed comparing RT 20 Gy with or without glucocorticoid to clinical treatments for Graves' ophthalmopathy. The Medline, Embase, Cochrane Library databases and recent relevant journals were searched. Relevant reports were reviewed by two reviewers. Response to radiotherapy was defined as clinical success according to each trial. We also evaluated the quality of life and whether RT to produce fewer side effects than other treatments. Results: A total of 8 randomized controlled trials (439 patients) were identified. In the subgroup analysis, the overall response to treatment rates was better for: RT 20 Gy plus glucocorticoid vs glucocorticoids alone, OR=17.5 (CI95% 1.85-250, p=0.04), RT 20 Gy vs sham RT, OR= 3.15 (CI95% 1.59-6.23, p=0.003) and RT 20Gy plus intravenous glucocorticoid vs RT 20Gy plus oral glucocorticoid, OR=4.15(CI95% 1.34-12.87, p=0.01). There were no differences between RT 20 Gy versus other fractionations and RT 20 Gy versus glucocorticoid alone. RT 20 Gy with or without glucocorticoids showed an improvement in diplopia grade, visual acuity, optic neuropathy, lid width, proptosis and ocular motility. No difference was seen for costs, intraocular pressure and quality of life. Conclusion: Our data have shown that RT 20 Gy should be offered as a valid therapeutic option to patients with moderate to severe ophthalmopathy. The effectiveness of orbital radiotherapy can be increased by the synergistic interaction with glucocorticoids. Moreover, RT 20 Gy is useful to improve a lot of ocular symptoms, excluding intraocular pressure, without any difference in quality of life and costs. (author)

  4. Omega-3 Supplementation and Loneliness-Related Memory Problems: Secondary Analyses Of A Randomized Controlled Trial

    Science.gov (United States)

    Jaremka, Lisa M.; Derry, Heather M.; Bornstein, Robert; Prakash, Ruchika Shaurya; Peng, Juan; Belury, Martha A.; Andridge, Rebecca R.; Malarkey, William B.; Kiecolt-Glaser, Janice K.

    2014-01-01

    Objective Loneliness enhances risk for episodic memory declines over time. Omega-3 supplementation can improve cognitive function for people experiencing mild cognitive difficulties. Accordingly, we explored whether omega-3 supplementation would attenuate loneliness-related episodic memory problems. Methods Participants (N=138) from a parent randomized controlled trial (RCT) were randomized to the placebo, 1.25 grams/day of omega-3, or 2.50 grams/day of omega-3 conditions for a 4-month period. They completed a baseline loneliness questionnaire and a battery of cognitive tests both at baseline and at the end of the RCT. Results Controlling for baseline verbal episodic memory scores, lonelier people within the placebo condition had poorer verbal episodic memory post-supplementation, as measured by immediate (b = −0.28, t(117) = −2.62, p = .010) and long-delay (b = −.06, t(116) = −2.07, p = .040) free recall, than their less lonely counterparts. This effect was not observed in the 1.25 grams/day and 2.50 grams/day supplementation groups, all p values > .10. The plasma omega-6:omega-3 ratio data mirrored these results. There were no loneliness-related effects of omega-3 supplementation on short-delay recall or the other cognitive tests, all p values > .32. Conclusion These results suggest that omega-3 supplementation attenuates loneliness-related verbal episodic memory declines over time and support the utility of exploring novel interventions for treating episodic memory problems among lonely people. ClinicalTrials.gov identifier: NCT00385723 PMID:25264972

  5. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  6. Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zwerenz, Rüdiger; Becker, Jan; Knickenberg, Rudolf J; Hagen, Karin; Dreier, Michael; Wölfling, Klaus; Beutel, Manfred E

    2015-03-17

    Depression is one of the most debilitating and costly mental disorders. There is increasing evidence for the efficacy of online self-help in alleviating depression. Knowledge regarding the options of combining online self-help with inpatient psychotherapy is still limited. Therefore, we plan to evaluate an evidence-based self-help program (deprexis®; Gaia AG, Hamburg, Germany) to improve the efficacy of inpatient psychotherapy and to maintain treatment effects in the aftercare period. Depressed patients (n = 240) with private internet access aged between 18 and 65 are recruited during psychosomatic inpatient treatment. Participants are randomized to an intervention or control group at the beginning of inpatient treatment. The intervention group (n = 120) is offered an online self-help program with 12 weekly tasks, beginning during the inpatient treatment. The control group (n = 120) obtains access to an online platform with weekly updated information on depression for the same duration. Assessments are conducted at the beginning (T0) and the end of inpatient treatment (T1), at the end of intervention (T2) and 6 months after randomization (T3). The primary outcome is the depression score measured by the Beck Depression Inventory-II at T2. Secondary outcome measures include anxiety, self-esteem, quality of life, dysfunctional cognitions and work ability. We expect the intervention group to benefit from additional online self-help during inpatient psychotherapy and to maintain the benefits during follow-up. This could be an important approach to develop future concepts of inpatient psychotherapy. ClinicalTrials.gov Identifier: NCT02196896 (registered on 16 July 2014).

  7. Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry

    Directory of Open Access Journals (Sweden)

    Christiane Alves Ferreira

    2011-01-01

    Full Text Available OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.

  8. Brief telephone interventions for problem gambling: a randomized controlled trial.

    Science.gov (United States)

    Abbott, Max; Hodgins, David C; Bellringer, Maria; Vandal, Alain C; Palmer Du Preez, Katie; Landon, Jason; Sullivan, Sean; Rodda, Simone; Feigin, Valery

    2018-05-01

    Problem gambling is a significant public health issue world-wide. There is substantial investment in publicly funded intervention services, but limited evaluation of effectiveness. This study investigated three brief telephone interventions to determine whether they were more effective than standard helpline treatment in helping people to reduce gambling. Randomized clinical trial. National gambling helpline in New Zealand. A total of 462 adults with problem gambling. INTERVENTIONS AND COMPARATOR: (1) Single motivational interview (MI), (2) single motivational interview plus cognitive-behavioural self-help workbook (MI + W) and (3) single motivational interview plus workbook plus four booster follow-up telephone interviews (MI + W + B). Comparator was helpline standard care [treatment as usual (TAU)]. Blinded follow-up was at 3, 6 and 12 months. Primary outcomes were days gambled, dollars lost per day and treatment goal success. There were no differences across treatment arms, although participants showed large reductions in gambling during the 12-month follow-up period [mean reduction of 5.5 days, confidence interval (CI) = 4.8, 6.2; NZ$38 lost ($32, $44; 80.6%), improved (77.2%, 84.0%)]. Subgroup analysis revealed improved days gambled and dollars lost for MI + W + B over MI or MI + W for a goal of reduction of gambling (versus quitting) and improvement in dollars lost by ethnicity, gambling severity and psychological distress (all P gambling severity than TAU or MI at 12 months and also better for those with higher psychological distress and lower self-efficacy to MI (all P gambling in New Zealand, brief telephone interventions are associated with changes in days gambling and dollars lost similar to more intensive interventions, suggesting that more treatment is not necessarily better than less. Some client subgroups, in particular those with greater problem severity and greater distress, achieve better outcomes when they receive more

  9. Unipedal standing exercise and hip bone mineral density in postmenopausal women: a randomized controlled trial.

    Science.gov (United States)

    Sakai, Akinori; Oshige, Toshihisa; Zenke, Yukichi; Yamanaka, Yoshiaki; Nagaishi, Hitoshi; Nakamura, Toshitaka

    2010-01-01

    The aim of this study was to test the effect of unipedal standing exercise on bone mineral density (BMD) of the hip in postmenopausal women. Japanese postmenopausal women (n = 94) were assigned at random to an exercise or control group (no exercise). The 6-month exercise program consisted of standing on a single foot for 1 min per leg 3 times per day. BMD of the hip was measured by dual-energy X-ray absorptiometry. There was no significant difference in age and baseline hip BMD between the exercise group (n = 49) and control group (n = 45). Exercise did not improve hip BMD compared with the control group. Stepwise regression analysis identified old age as a significant determinant (p = 0.034) of increased hip total BMD at 6 months after exercise. In 31 participants aged >/=70 years, the exercise group (n = 20) showed significant increase in the values of hip BMD at the areas of total (p = 0.008), intertrochanteric (p = 0.023), and Ward's triangle (p = 0.032). The same parameters were decreased in the control group (n = 11). The percent changes in hip BMD of the exercise group were not significantly different from those of the control group either in the participants with low baseline hip total BMD ( or =80% of the young adult mean). In conclusion, unipedal standing exercise for 6 months did not improve hip BMD in Japanese postmenopausal women. Effect of exercise on hip total BMD was age dependent. In participants aged > or =70 years, the exercise significantly increased hip total BMD.

  10. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Chmiel C

    2014-10-01

    Full Text Available Corinne Chmiel, Oliver Senn, Thomas Rosemann, Valerio Del Prete, Claudia Steurer-Stey Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland Background: Inadequate blood pressure (BP control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP improves BP control and adherence with home BP measurement.Methods: In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg, and adherence with home BP measurement after 6 months.Results: One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7. BP control (treatment target <140/90 mmHg was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5. Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1Conclusion: Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months, but no significant between-group difference was

  11. Marketing depression care management to employers: design of a randomized controlled trial.

    Science.gov (United States)

    Rost, Kathryn M; Marshall, Donna

    2010-03-16

    Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. By addressing the 'value to whom?' question, the study advances

  12. Marketing depression care management to employers: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marshall Donna

    2010-03-01

    Full Text Available Abstract Background Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. Methods In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. Discussion By

  13. Meta-Analysis: Risk of Tics Associated With Psychostimulant Use in Randomized, Placebo-Controlled Trials.

    Science.gov (United States)

    Cohen, Stephanie C; Mulqueen, Jilian M; Ferracioli-Oda, Eduardo; Stuckelman, Zachary D; Coughlin, Catherine G; Leckman, James F; Bloch, Michael H

    2015-09-01

    Clinical practice currently restricts the use of psychostimulant medications in children with tics or a family history of tics for fear that tics will develop or worsen as a side effect of treatment. Our goal was to conduct a meta-analysis to examine the risk of new onset or worsening of tics as an adverse event of psychostimulants in randomized, placebo-controlled trials. We conducted a PubMed search to identify all double-blind, randomized, placebo-controlled trials examining the efficacy of psychostimulant medications in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). We used a fixed effects meta-analysis with risk ratio of new onset or worsening tics in children treated with psychostimulants compared to placebo. We used stratified subgroup analysis and meta-regression to examine the effects of stimulant type, dose, duration of treatment, recorder of side effect data, trial design, and mean age of participants on the measured risk of tics. We identified 22 studies involving 2,385 children with ADHD for inclusion in our meta-analysis. New onset tics or worsening of tic symptoms were commonly reported in the psychostimulant (event rate = 5.7%, 95% CI = 3.7%-8.6%) and placebo groups (event rate = 6.5%, 95% CI = 4.4%-9.5%). The risk of new onset or worsening of tics associated with psychostimulant treatment was similar to that observed with placebo (risk ratio = 0.99, 95% CI = 0.78-1.27, z = -0.05, p = .962). Type of psychostimulant, dose, duration of treatment, recorder, and participant age did not affect risk of new onset or worsening of tics. Crossover studies were associated with a significantly greater measured risk of tics with psychostimulant use compared to parallel group trials. Meta-analysis of controlled trials does not support an association between new onset or worsening of tics and psychostimulant use. Clinicians may want to consider rechallenging children who report new onset or worsening of tics with psychostimulant

  14. TransDetect Identifies a New Regulatory Module Controlling Phosphate Accumulation.

    Science.gov (United States)

    Pal, Sikander; Kisko, Mushtak; Dubos, Christian; Lacombe, Benoit; Berthomieu, Pierre; Krouk, Gabriel; Rouached, Hatem

    2017-10-01

    Identifying transcription factor (TFs) cooperation controlling target gene expression is still an arduous challenge. The accuracy of current methods at genome scale significantly drops with the increase in number of genes, which limits their applicability to more complex genomes, like animals and plants. Here, we developed an algorithm, TransDetect, able to predict TF combinations controlling the expression level of a given gene. TransDetect was used to identify novel TF modules regulating the expression of Arabidopsis ( Arabidopsis thaliana ) phosphate transporter PHO1;H3 comprising MYB15, MYB84, bHLH35, and ICE1. These TFs were confirmed to interact between themselves and with the PHO1;H3 promoter. Phenotypic and genetic analyses of TF mutants enable the organization of these four TFs and PHO1;H3 in a new gene regulatory network controlling phosphate accumulation in zinc-dependent manner. This demonstrates the potential of TransDetect to extract directionality in nondynamic transcriptomes and to provide a blueprint to identify gene regulatory network involved in a given biological process. © 2017 American Society of Plant Biologists. All Rights Reserved.

  15. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study.

    Science.gov (United States)

    Optale, Gabriele; Urgesi, Cosimo; Busato, Valentina; Marin, Silvia; Piron, Lamberto; Priftis, Konstantinos; Gamberini, Luciano; Capodieci, Salvatore; Bordin, Adalberto

    2010-05-01

    Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology. Virtual reality (VR) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals. The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions. The authors randomly assigned 36 elderly residents of a rest care facility (median age 80 years) who were impaired on the Verbal Story Recall Test either to the experimental group (EG) or the control group (CG). The EG underwent 6 months of VR memory training (VRMT) that involved auditory stimulation and VR experiences in path finding. The initial training phase lasted 3 months (3 auditory and 3 VR sessions every 2 weeks), and there was a booster training phase during the following 3 months (1 auditory and 1 VR session per week). The CG underwent equivalent face-to-face training sessions using music therapy. Both groups participated in social and creative and assisted-mobility activities. Neuropsychological and functional evaluations were performed at baseline, after the initial training phase, and after the booster training phase. The EG showed significant improvements in memory tests, especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition. In contrast, the CG showed progressive decline. The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention.

  16. Fetal response to abbreviated relaxation techniques. A randomized controlled study.

    Science.gov (United States)

    Fink, Nadine S; Urech, Corinne; Isabel, Fornaro; Meyer, Andrea; Hoesli, Irène; Bitzer, Johannes; Alder, Judith

    2011-02-01

    stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome. this study aims (1) to obtain fetal behavioral states (quiet/active sleep, quiet/active wakefulness), (2) to investigate the effects of maternal relaxation on fetal behavior as well as on uterine activity, and (3) to investigate maternal physiological and endocrine parameters as potential underlying mechanisms for maternal-fetal relaxation-transferral. the behavior of 33 fetuses was analyzed during laboratory relaxation/quiet rest (control group, CG) and controlled for baseline fetal behavior. Potential associations between relaxation/quiet rest and fetal behavior (fetal heart rate (FHR), FHR variation, FHR acceleration, and body movements) and uterine activity were studied, using a computerized cardiotocogram (CTG) system. Maternal heart rate, blood pressure, cortisol, and norepinephrine were measured. intervention (progressive muscle relaxation, PMR, and guided imagery, GI) showed changes in fetal behavior. The intervention groups had higher long-term variation during and after relaxation compared to the CG (p=.039). CG fetuses had more FHR acceleration, especially during and after quiet rest (p=.027). Women in the PMR group had significantly more uterine activity than women in the GI group (p=.011) and than CG women. Maternal heart rate, blood pressure, and stress hormones were not associated with fetal behavior. this study indicates that the fetus might participate in maternal relaxation and suggests that GI is superior to PMR. This could especially be true for women who tend to direct their attention to body sensations such as abdominal activity. 2010 Elsevier Ltd. All rights reserved.

  17. Identifying mechanisms in the control of quantum dynamics through Hamiltonian encoding

    International Nuclear Information System (INIS)

    Mitra, Abhra; Rabitz, Herschel

    2003-01-01

    A variety of means are now available to design control fields for manipulating the evolution of quantum systems. However, the underlying physical mechanisms often remain obscure, especially in the cases of strong fields and high quantum state congestion. This paper proposes a method to quantitatively determine the various pathways taken by a quantum system in going from the initial state to the final target. The mechanism is revealed by encoding a signal in the system Hamiltonian and decoding the resultant nonlinear distortion of the signal in the system time-evolution operator. The relevant interfering pathways determined by this analysis give insight into the physical mechanisms operative during the evolution of the quantum system. A hierarchy of mechanism identification algorithms with increasing ability to extract more detailed pathway information is presented. The mechanism identification concept is presented in the context of analyzing computer simulations of controlled dynamics. As illustrations of the concept, mechanisms are identified in the control of several simple, discrete-state quantum systems. The mechanism analysis tools reveal the roles of multiple interacting quantum pathways to maximally take advantage of constructive and destructive interference. Similar procedures may be applied directly in the laboratory to identify control mechanisms without resort to computer modeling, although this extension is not addressed in this paper

  18. Structured triglyceride for parenteral nutrition: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, Yong; Wu, Xiao-Ting; Li, Ni; Zhuang, Wen; Liu, Guanjian; Wu, Taixiang; Wei, Mao-Ling

    2006-01-01

    This study assessed the safety and efficacy of structured triglyceride (ST) for parenteral nutrition. A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Clinical trials were identified from the following electronic databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database. The search was undertaken in March 2005. Language was restricted to Chinese and English. Literature references were checked at the same time. Only RCTs were extracted and evaluated by two reviewers independently of each other. The statistical analysis was performed by RevMan4.2 software which was provided by the Cochrane Collaboration. A P value of triglyceride (LCT), and the combined results showed that the ST had significant effect on resting energy expenditure (weighted mean difference [WMD] =1.54, 95%CI [ 1.26, 1.82], ptriglycerides (WMD = -0.10, 95%CI [-0.30, 0.10], P=0.32). Only two RCTs compared ST with the physical mixture of medium- and long-chain triglyceride (MCT/LCT), data from trials were not combined due to clinical differences between trials, and conclusions can not be drew from the present data. ST appeared to be safe and well tolerated. Further trials are required, especially compared with the MCT/LCT, with sufficient size and rigorous design.

  19. Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

    Science.gov (United States)

    Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

    2016-07-01

    To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

  20. A Randomized, Controlled Trial of Behavioral Voice Therapy for Dysphonia Related to Prematurity of Birth.

    Science.gov (United States)

    Reynolds, Victoria; Meldrum, Suzanne; Simmer, Karen; Vijayasekaran, Shyan; French, Noel

    2017-03-01

    Dysphonia is a potential complication of prematurity. Preterm children may sustain iatrogenic laryngeal damage from medical intervention in the neonatal period, and further, adopt compensatory, maladaptive voicing behaviors. This pilot study aimed to evaluate the effects of a voice therapy protocol on voice quality in school-aged, very preterm (VP) children. Twenty-seven VP children with dysphonia were randomized to an immediate intervention group (n = 7) or a delayed-intervention, waiting list control group (n = 14). Following analysis of these data, a secondary analysis was conducted on the pooled intervention data (n = 21). Six participants did not complete the trial. Change to voice quality was measured via pre- and posttreatment assessments using the Consensus Auditory Perceptual Evaluation of Voice. The intervention group did not demonstrate statistically significant improvements in voice quality, whereas this was observed in the control group (P = 0.026). However, when intervention data were pooled including both the immediate and delayed groups following intervention, dysphonia severity was significantly lower (P = 0.026) in the treatment group. Dysphonia in most VP children in this cohort was persistent. These pilot data indicate that some participants experienced acceptable voice outcomes on spontaneous recovery, whereas others demonstrated a response to behavioral intervention. Further research is needed to identify the facilitators of and barriers to intervention success, and to predict those who may experience spontaneous recovery. Copyright © 2017 The Voice Foundation. All rights reserved.

  1. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  2. Perioperative Dextromethorphan as an Adjunct for Postoperative Pain: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    King, Michael R; Ladha, Karim S; Gelineau, Amanda M; Anderson, T Anthony

    2016-03-01

    N-methyl-D-aspartate receptor antagonists have been shown to reduce perioperative pain and opioid use. The authors performed a meta-analysis to determine whether the use of perioperative dextromethorphan lowers opioid consumption or pain scores. PubMed, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Pubget, and EMBASE were searched. Studies were included if they were randomized, double-blinded, placebo-controlled trials written in English, and performed on patients 12 yr or older. For comparison of opioid use, included studies tracked total consumption of IV or intramuscular opioids over 24 to 48 h. Pain score comparisons were performed at 1, 4 to 6, and 24 h postoperatively. Difference in means (MD) was used for effect size. Forty studies were identified and 21 were eligible for one or more comparisons. In 848 patients from 14 trials, opioid consumption favored dextromethorphan (MD, -10.51 mg IV morphine equivalents; 95% CI, -16.48 to -4.53 mg; P = 0.0006). In 884 patients from 13 trials, pain at 1 h favored dextromethorphan (MD, -1.60; 95% CI, -1.89 to -1.31; P dextromethorphan (MD, -0.89; 95% CI, -1.11 to -0.66; P dextromethorphan (MD, -0.92; 95% CI, -1.24 to -0.60; P dextromethorphan use perioperatively reduces the postoperative opioid consumption at 24 to 48 h and pain scores at 1, 4 to 6, and 24 h.

  3. Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial.

    Science.gov (United States)

    Osman, Hibah; Saliba, Matilda; Chaaya, Monique; Naasan, Georges

    2014-10-15

    The postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers. Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10). Of the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers. The trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.

  4. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    Tavecchio, L.

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings

  5. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  6. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    Science.gov (United States)

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  7. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    Science.gov (United States)

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  8. Detection of Botnet Command and Control Traffic by the Multistage Trust Evaluation of Destination Identifiers

    Directory of Open Access Journals (Sweden)

    Pieter Burghouwt

    2015-10-01

    Full Text Available Network-based detection of botnet Command and Control communication is a difficult task if the traffic has a relatively low volume and if popular protocols, such as HTTP, are used to resemble normal traffic. We present a new network-based detection approach that is capable of detecting this type of Command and Control traffic in an enterprise network by estimating the trustworthiness of the traffic destinations. If the destination identifier of a traffic flow origins directly from: human input, prior traffic from a trusted destination, or a defined set of legitimate applications, the destination is trusted and its associated traffic is classified as normal. Advantages of this approach are: the ability of zero day malicious traffic detection, low exposure to malware by passive host-external traffic monitoring, and the applicability for real-time filtering. Experimental evaluation demonstrates successful detection of diverse types of Command and Control Traffic.

  9. Control-based method to identify underlying delays of a nonlinear dynamical system.

    Science.gov (United States)

    Yu, Dongchuan; Frasca, Mattia; Liu, Fang

    2008-10-01

    We suggest several stationary state control-based delay identification methods which do not require any structural information about the controlled systems and are applicable to systems described by delayed ordinary differential equations. This proposed technique includes three steps: (i) driving a system to a steady state; (ii) perturbing the control signal for shifting the steady state; and (iii) identifying all delays by detecting the time that the system is abruptly drawn out of stationarity. Some aspects especially important for applications are discussed as well, including interaction delay identification, stationary state convergence speed, performance comparison, and the influence of noise on delay identification. Several examples are presented to illustrate the reliability and robustness of all delay identification methods suggested.

  10. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fischer Mary

    2010-03-01

    Full Text Available Abstract Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen, bone formation (osteocalcin, and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry. Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16 to explore the feasibility of modeling skeletal

  11. Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial.

    Science.gov (United States)

    Webster, Louise M; Myers, Jenny E; Nelson-Piercy, Catherine; Harding, Kate; Cruickshank, J Kennedy; Watt-Coote, Ingrid; Khalil, Asma; Wiesender, Cornelia; Seed, Paul T; Chappell, Lucy C

    2017-11-01

    Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12 +0 -27 +6 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; P =0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment. URL: https://www.isrctn.com. Unique identifier: ISRCTN40973936. © 2017 American Heart Association, Inc.

  12. Controlled Assembly of Fibronectin Nanofibrils Triggered by Random Copolymer Chemistry.

    Science.gov (United States)

    Mnatsakanyan, Hayk; Rico, Patricia; Grigoriou, Eleni; Candelas, Aarón Maturana; Rodrigo-Navarro, Aleixandre; Salmeron-Sanchez, Manuel; Sabater i Serra, Roser

    2015-08-19

    Fibronectin fibrillogenesis is the physiological process by which cells elaborate a fibrous FN matrix. Poly(ethyl acrylate), PEA, has been described to induce a similar process upon simple adsorption of fibronectin (FN) from a protein solution-in the absence of cells-leading to the so-called material-driven fibronectin fibrillogenesis. Poly(methyl acrylate), PMA, is a polymer with very similar chemistry to PEA, on which FN is adsorbed, keeping the globular conformation of the protein in solution. We have used radical polymerization to synthesize copolymers with controlled EA/MA ratio, seeking to modulate the degree of FN fibrillogenesis. The physicochemical properties of the system were studied using dynamic-mechanical analysis, differential scanning calorimetry, and water contact angle. Both the degree of FN fibrillogenesis and the availability of the integrin binding region of FN directly depend on the percentage of EA in the copolymer, whereas the same total amount of FN was adsorbed regardless the EA/MA ratio. Cell morphology adhesion and differentiation of murine C2C12 were shown to depend on the degree of FN fibrillogenesis previously attained on the material surface. Myogenic differentiation was enhanced on the copolymers with higher EA content, i.e. more interconnected FN fibrils.

  13. Identifying Core Competencies of Infection Control Nurse Specialists in Hong Kong.

    Science.gov (United States)

    Chan, Wai Fong; Bond, Trevor G; Adamson, Bob; Chow, Meyrick

    2016-01-01

    To confirm a core competency scale for Hong Kong infection control nurses at the advanced nursing practice level from the core competency items proposed in a previous phase of this study. This would serve as the foundation of competency assurance in Hong Kong hospitals. A cross-sectional survey design was used. All public and private hospitals in Hong Kong. All infection control nurses in hospitals of Hong Kong. The 83-item proposed core competency list established in an earlier study was transformed into a questionnaire and sent to 112 infection control nurses in 48 hospitals in Hong Kong. They were asked to rate the importance of each infection prevention and control item using Likert-style response categories. Data were analyzed using the Rasch model. The response rate of 81.25% was achieved. Seven items were removed from the proposed core competency list, leaving a scale of 76 items that fit the measurement requirements of the unidimensional Rasch model. Essential core competency items of advanced practice for infection control nurses in Hong Kong were identified based on the measurement criteria of the Rasch model. Several items of the scale that reflect local Hong Kong contextual characteristics are distinguished from the overseas standards. This local-specific competency list could serve as the foundation for education and for certification of infection control nurse specialists in Hong Kong. Rasch measurement is an appropriate analytical tool for identifying core competencies of advanced practice nurses in other specialties and in other locations in a manner that incorporates practitioner judgment and expertise.

  14. Optimal input shaping for Fisher identifiability of control-oriented lithium-ion battery models

    Science.gov (United States)

    Rothenberger, Michael J.

    This dissertation examines the fundamental challenge of optimally shaping input trajectories to maximize parameter identifiability of control-oriented lithium-ion battery models. Identifiability is a property from information theory that determines the solvability of parameter estimation for mathematical models using input-output measurements. This dissertation creates a framework that exploits the Fisher information metric to quantify the level of battery parameter identifiability, optimizes this metric through input shaping, and facilitates faster and more accurate estimation. The popularity of lithium-ion batteries is growing significantly in the energy storage domain, especially for stationary and transportation applications. While these cells have excellent power and energy densities, they are plagued with safety and lifespan concerns. These concerns are often resolved in the industry through conservative current and voltage operating limits, which reduce the overall performance and still lack robustness in detecting catastrophic failure modes. New advances in automotive battery management systems mitigate these challenges through the incorporation of model-based control to increase performance, safety, and lifespan. To achieve these goals, model-based control requires accurate parameterization of the battery model. While many groups in the literature study a variety of methods to perform battery parameter estimation, a fundamental issue of poor parameter identifiability remains apparent for lithium-ion battery models. This fundamental challenge of battery identifiability is studied extensively in the literature, and some groups are even approaching the problem of improving the ability to estimate the model parameters. The first approach is to add additional sensors to the battery to gain more information that is used for estimation. The other main approach is to shape the input trajectories to increase the amount of information that can be gained from input

  15. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial

    OpenAIRE

    McGraw, Thomas

    2016-01-01

    Thomas McGraw Global Medical Affairs, Merck & Co., Inc., Kenilworth, NJ, USA Purpose: To evaluate the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation.Patients and methods: The patients who met Rome III diagnostic criteria for functional constipation were randomized in this multicenter, randomized, placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 g) ASC or ...

  16. Transient Oscilliations in Mechanical Systems of Automatic Control with Random Parameters

    Science.gov (United States)

    Royev, B.; Vinokur, A.; Kulikov, G.

    2018-04-01

    Transient oscillations in mechanical systems of automatic control with random parameters is a relevant but insufficiently studied issue. In this paper, a modified spectral method was applied to investigate the problem. The nature of dynamic processes and the phase portraits are analyzed depending on the amplitude and frequency of external influence. It is evident from the obtained results, that the dynamic phenomena occurring in the systems with random parameters under external influence are complex, and their study requires further investigation.

  17. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study

    OpenAIRE

    Ayça Utkan Karasu; Elif Balevi Batur; Gülçin Kaymak Karataş

    2018-01-01

    Objective: To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. Methods: During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Asses...

  18. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    OpenAIRE

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-01-01

    Abstract Objective To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs...

  19. Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Thornton, J Daryl; Sullivan, Catherine; Albert, Jeffrey M; Cedeño, Maria; Patrick, Bridget; Pencak, Julie; Wong, Kristine A; Allen, Margaret D; Kimble, Linda; Mekesa, Heather; Bowen, Gordon; Sehgal, Ashwini R

    2016-08-01

    Low organ donation rates remain a major barrier to organ transplantation. We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider. This was a randomized controlled trial between February 2013 and May 2014. The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio. The study included 915 patients over 15.5 years of age who had not previously consented to organ donation. Just prior to their clinical encounter, intervention patients (n = 456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n = 459) visited their provider per usual routine. The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter. Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10-2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1-20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61-1.25). How the observed increases in organ donation consent might translate into a greater organ supply is unclear. Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected. clinicaltrials.gov Identifier: NCT01697137.

  20. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

    Science.gov (United States)

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2018-01-01

    To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

  1. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

    Science.gov (United States)

    Steinberg, Dori M; Levine, Erica L; Askew, Sandy; Foley, Perry; Bennett, Gary G

    2013-11-18

    Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

  2. Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Li, Xinger; Liu, Haiyan; Feng, Huiping; Xian, Zhongren; Chen, Yanhong; Chen, Jianping; Tang, Chunzhi; Lai, Xinsheng; Lan, Xiaoling; Huang, Huanzhen; Yu, Dongdong

    2017-06-28

    Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic. An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA 1c ) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth

  3. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial.

    Science.gov (United States)

    Lazarov, Amit; Pine, Daniel S; Bar-Haim, Yair

    2017-07-01

    Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats. Forty patients with social anxiety disorder were randomly assigned to eight sessions of either gaze-contingent music reward therapy, designed to divert patients' gaze toward neutral stimuli rather than threat stimuli, or to a control condition. Clinician and self-report measures of social anxiety were acquired pretreatment, posttreatment, and at 3-month follow-up. Dwell time on socially threatening faces was assessed during the training sessions and at pre- and posttreatment. Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition on both clinician-rated and self-reported measures. Therapeutic effects were maintained at follow-up. Gaze-contingent music reward therapy, but not the control condition, also reduced dwell time on threat, which partially mediated clinical effects. Finally, gaze-contingent music reward therapy, but not the control condition, also altered dwell time on socially threatening faces not used in training, reflecting near-transfer training generalization. This is the first randomized controlled trial to examine a gaze-contingent intervention in social anxiety disorder. The results demonstrate target engagement and clinical effects. This study sets the stage for larger randomized controlled trials and testing in other emotional disorders.

  4. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Voils Corrine I

    2012-08-01

    Full Text Available Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540

  5. Field-based random sampling without a sampling frame: control selection for a case-control study in rural Africa.

    Science.gov (United States)

    Crampin, A C; Mwinuka, V; Malema, S S; Glynn, J R; Fine, P E

    2001-01-01

    Selection bias, particularly of controls, is common in case-control studies and may materially affect the results. Methods of control selection should be tailored both for the risk factors and disease under investigation and for the population being studied. We present here a control selection method devised for a case-control study of tuberculosis in rural Africa (Karonga, northern Malawi) that selects an age/sex frequency-matched random sample of the population, with a geographical distribution in proportion to the population density. We also present an audit of the selection process, and discuss the potential of this method in other settings.

  6. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials.

    Science.gov (United States)

    Levkovitz, Yeciel; Tedeschini, Enrico; Papakostas, George I

    2011-04-01

    The authors sought to determine the efficacy of antidepressants in dysthymic disorder and to compare antidepressant and placebo response rates between major depressive disorder (MDD) and dysthymic disorder. PubMed/MEDLINE databases were searched for double-blind, randomized, placebo-controlled trials of antidepressants used as monotherapy for treatment of MDD or dysthymic disorder. We defined antidepressants as those with a letter of approval by the US, Canadian, or European Union drug regulatory agencies for treatment of MDD or dysthymic disorder, which included the following: amitriptyline, nortriptyline, imipramine, desipramine, clomipramine, trimipramine, protriptyline, dothiepin, doxepin, lofepramine, amoxapine, maprotiline, amineptine, nomifensine, bupropion, phenelzine, tranylcypromine, isocarboxazid, moclobemide, brofaromine, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine, zimelidine, tianeptine, ritanserin, trazodone, nefazodone, agomelatine, venlafaxine, desvenlafaxine, duloxetine, milnacipran, reboxetine, mirtazapine, and mianserin. Eligible studies were identified by cross-referencing the search term placebo with each of the above-mentioned agents. The search was limited to articles published between January 1, 1980, and November 20, 2009 (inclusive). To expand our database, we also reviewed the reference lists of the identified studies. We selected randomized, double-blind, placebo-controlled trials of antidepressants for either MDD or dysthymic disorder according to preset criteria relating to comorbidities, patient age, drug formulation, study duration, diagnostic criteria, choice of assessment scales, and whether or not the study reported original data. Final selection of articles was determined by consensus among the authors. A total of 194 studies were found that were eligible for inclusion in our analysis. Of these, 177 focused on the treatment of MDD and 17 on the treatment of dysthymic disorder. We found that

  7. Randomized Controlled Trial of Family Therapy in Advanced Cancer Continued Into Bereavement.

    Science.gov (United States)

    Kissane, David W; Zaider, Talia I; Li, Yuelin; Hichenberg, Shira; Schuler, Tammy; Lederberg, Marguerite; Lavelle, Lisa; Loeb, Rebecca; Del Gaudio, Francesca

    2016-06-01

    Systematic family-centered cancer care is needed. We conducted a randomized controlled trial of family therapy, delivered to families identified by screening to be at risk from dysfunctional relationships when one of their relatives has advanced cancer. Eligible patients with advanced cancer and their family members screened above the cut-off on the Family Relationships Index. After screening 1,488 patients or relatives at Memorial Sloan Kettering Cancer Center or three related community hospice programs, 620 patients (42%) were recruited, which represented 170 families. Families were stratified by three levels of family dysfunction (low communicating, low involvement, and high conflict) and randomly assigned to one of three arms: standard care or 6 or 10 sessions of a manualized family intervention. Primary outcomes were the Complicated Grief Inventory-Abbreviated (CGI) and Beck Depression Inventory-II (BDI-II). Generalized estimating equations allowed for clustered data in an intention-to-treat analysis. On the CGI, a significant treatment effect (Wald χ(2) = 6.88; df = 2; P = .032) and treatment by family-type interaction was found (Wald χ(2) = 20.64; df = 4; P families. Low-communicating families improved by 6 months of bereavement. In the standard care arm, 15.5% of the bereaved developed a prolonged grief disorder at 13 months of bereavement compared with 3.3% of those who received 10 sessions of intervention (Wald χ(2) = 8.31; df = 2; P =.048). No significant treatment effects were found on the BDI-II. Family-focused therapy delivered to high-risk families during palliative care and continued into bereavement reduced the severity of complicated grief and the development of prolonged grief disorder. © 2016 by American Society of Clinical Oncology.

  8. Randomized, controlled trial of Interpersonal and Social Rhythm Therapy for young people with bipolar disorder.

    Science.gov (United States)

    Inder, Maree L; Crowe, Marie T; Luty, Suzanne E; Carter, Janet D; Moor, Stephanie; Frampton, Christopher M; Joyce, Peter R

    2015-03-01

    This randomized, controlled clinical trial compared the effect of interpersonal and social rhythm therapy (IPSRT) to that of specialist supportive care (SSC) on depressive outcomes (primary), social functioning, and mania outcomes over 26-78 weeks in young people with bipolar disorder receiving psychopharmacological treatment. Subjects were aged 15-36 years, recruited from a range of sources, and the patient groups included bipolar I disorder, bipolar II disorder, and bipolar disorder not otherwise specified. Exclusion criteria were minimal. Outcome measures were the Longitudinal Interval Follow-up Evaluation and the Social Adjustment Scale. Paired-sample t-tests were used to determine the significance of change from baseline to outcome period. Analyses of covariance were used to determine the impact of therapy, impact of lifetime and current comorbidity, interaction between comorbidity and therapy, and impact of age at study entry on depression. A group of 100 participants were randomized to IPSRT (n = 49) or SSC (n = 51). The majority had bipolar I disorder (78%) and were female (76%), with high levels of comorbidity. After treatment, both groups had improved depressive symptoms, social functioning, and manic symptoms. Contrary to our hypothesis, there was no significant difference between therapies. There was no impact of lifetime or current Axis I comorbidity or age at study entry. There was a relative impact of SSC for patients with current substance use disorder. IPSRT and SSC used as an adjunct to pharmacotherapy appear to be effective in reducing depressive and manic symptoms and improving social functioning in adolescents and young adults with bipolar disorder and high rates of comorbidity. Identifying effective treatments that particularly address depressive symptoms is important in reducing the burden of bipolar disorder. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Peers versus professional training of basic life support in Syria: a randomized controlled trial.

    Science.gov (United States)

    Abbas, Fatima; Sawaf, Bisher; Hanafi, Ibrahem; Hajeer, Mohammad Younis; Zakaria, Mhd Ismael; Abbas, Wafaa; Alabdeh, Fadi; Ibrahim, Nazir

    2018-06-18

    Peer training has been identified as a useful tool for delivering undergraduate training in basic life support (BLS) which is fundamental as an initial response in cases of emergency. This study aimed to (1) Evaluate the efficacy of peer-led model in basic life support training among medical students in their first three years of study, compared to professional-led training and (2) To assess the efficacy of the course program and students' satisfaction of peer-led training. A randomized controlled trial with blinded assessors was conducted on 72 medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students were randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills. Sixty-four students who underwent checklist based assessment using objective structured clinical examination design (OSCE) (practical assessment of BLS skills) and answered BLS knowledge checkpoint-questionnaire were included in the analysis. There was no statistically significant difference between the two groups in delivering BLS skills to medical students in practical (P = 0.850) and BLS knowledge questionnaire outcomes (P = 0.900). Both groups showed statistically significant improvement from pre- to post-course assessment with significant statistical difference in both practical skills and theoretical knowledge (P-Value life support for medical students was beneficial and it provided a quality of education which was as effective as training conducted by professionals. This method is applicable and desirable especially in poor-resource countries and in crisis situation.

  10. Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence.

    Science.gov (United States)

    Manzardo, Ann M; He, Jianghua; Poje, Albert; Penick, Elizabeth C; Campbell, Jan; Butler, Merlin G

    2013-12-01

    Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analog, benfotiamine (BF), and BF's effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria for current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, -611 ± 380 standard drinks; PL: N=11, -159 ± 562 standard drinks, p-value=0.02). BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  11. Effects of sapropterin on endothelium-dependent vasodilation in patients with CADASIL: a randomized controlled trial.

    Science.gov (United States)

    De Maria, Renata; Campolo, Jonica; Frontali, Marina; Taroni, Franco; Federico, Antonio; Inzitari, Domenico; Tavani, Alessandra; Romano, Silvia; Puca, Emanuele; Orzi, Francesco; Francia, Ada; Mariotti, Caterina; Tomasello, Chiara; Dotti, Maria Teresa; Stromillo, Maria Laura; Pantoni, Leonardo; Pescini, Francesca; Valenti, Raffaella; Pelucchi, Claudio; Parolini, Marina; Parodi, Oberdan

    2014-10-01

    Cerebral autosomal-dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), a rare autosomal dominant disorder caused by NOTCH3 mutations, is characterized by vascular smooth muscle and endothelial cells abnormalities, altered vasoreactivity, and recurrent lacunar infarcts. Vasomotor function may represent a key factor for disease progression. Tetrahydrobiopterin, essential cofactor for nitric oxide synthesis in endothelial cells, ameliorates endothelial function. We assessed whether supplementation with sapropterin, a synthetic tetrahydrobiopterin analog, improves endothelium-dependent vasodilation in CADASIL patients. In a 24-month, multicenter randomized, double-blind, placebo-controlled trial, CADASIL patients aged 30 to 65 years were randomly assigned to receive placebo or sapropterin 200 to 400 mg BID. The primary end point was change in the reactive hyperemia index by peripheral arterial tonometry at 24 months. We also assessed the safety and tolerability of sapropterin. Analysis was done by intention-to-treat. The intention-to-treat population included 61 patients. We found no significant difference between sapropterin (n=32) and placebo (n=29) in the primary end point (mean difference in reactive hyperemia index by peripheral arterial tonometry changes 0.19 [95% confidence interval, -0.18, 0.56]). Reactive hyperemia index by peripheral arterial tonometry increased after 24 months in 37% of patients on sapropterin and in 28% on placebo; however, after adjustment for age, sex, and clinical characteristics, improvement was not associated with treatment arm. The proportion of patients with adverse events was similar on sapropterin and on placebo (50% versus 48.3%); serious adverse events occurred in 6.3% versus 13.8%, respectively. Sapropterin was safe and well-tolerated at the average dose of 5 mg/kg/day, but did not affect endothelium-dependent vasodilation in CADASIL patients. https://www.clinicaltrialsregister.eu. Unique

  12. A randomized controlled trial evaluating a brief parenting program with children with autism spectrum disorders.

    Science.gov (United States)

    Tellegen, Cassandra L; Sanders, Matthew R

    2014-12-01

    This randomized controlled trial evaluated the efficacy of Primary Care Stepping Stones Triple P, a brief individualized parenting program, in a sample of parents of children with autism spectrum disorder (ASD). Sixty-four parents of children aged 2-9 years (M = 5.67, SD = 2.14) with an ASD diagnosis participated in the study. Eighty-six percent of children were male, and 89% of parents identified their child's ethnicity as Australian/White. Families were randomly assigned to 1 of 2 conditions (intervention or care-as-usual) and were assessed at 3 time points (preintervention, postintervention, and 6-month follow-up). Parents completed a range of questionnaires to assess changes in child behavior (Eyberg Child Behavior Inventory) and parent outcomes (Parenting Scale, Depression Anxiety Stress Scale-21, Parent Problem Checklist, Relationship Quality Inventory, Parental Stress Scale) and 30-min home observations of parent-child interactions. Relative to the care-as-usual group, significant short-term improvements were found in the intervention group on parent-reported child behavior problems, dysfunctional parenting styles, parenting confidence, and parental stress, parental conflict, and relationship happiness. No significant intervention effects were found on levels of parental depression or anxiety, or on observed child disruptive and parent aversive behavior. The effect sizes for significant variables ranged from medium to large. Short-term effects were predominantly maintained at 6-month follow-up, and parents reported high levels of goal achievement and satisfaction with the program. The results indicate that a brief low intensity version of Stepping Stones Triple P is an efficacious intervention for parents of children with ASD.

  13. Argatroban versus Lepirudin in critically ill patients (ALicia): a randomized controlled trial.

    Science.gov (United States)

    Treschan, Tanja A; Schaefer, Maximilian S; Geib, Johann; Bahlmann, Astrid; Brezina, Tobias; Werner, Patrick; Golla, Elisabeth; Greinacher, Andreas; Pannen, Benedikt; Kindgen-Milles, Detlef; Kienbaum, Peter; Beiderlinden, Martin

    2014-10-25

    Critically ill patients often require renal replacement therapy accompanied by thrombocytopenia. Thrombocytopenia during heparin anticoagulation may be due to heparin-induced thrombocytopenia with need for alternative anticoagulation. Therefore, we compared argatroban and lepirudin in critically ill surgical patients. Following institutional review board approval and written informed consent, critically ill surgical patients more than or equal to 18 years with suspected heparin-induced thrombocytopenia, were randomly assigned to receive double-blind argatroban or lepirudin anticoagulation targeting an activated Partial Thromboplastin Time (aPTT) of 1.5 to 2 times baseline. In patients requiring continuous renal replacement therapy we compared the life-time of hemodialysis filters. We evaluated in all patients the incidence of bleeding and thrombembolic events. We identified 66 patients with suspected heparin-induced thrombocytopenia, including 28 requiring renal replacement therapy. Mean filter lifetimes did not differ between groups (argatroban 32 ± 25 hours (n = 12) versus lepirudin 27 ± 21 hours (n = 16), mean difference 5 hours, 95% CI -13 to 23, P = 0.227). Among all 66 patients, relevant bleeding occurred in four argatroban- versus eleven lepirudin-patients (OR 3.9, 95% CI 1.1 to 14.0, P = 0.040). In the argatroban-group, three thromboembolic events occurred compared to two in the lepirudin group (OR 0.7, 95% CI 0.1 to 4.4, P = 0.639). The incidence of confirmed heparin-induced thrombocytopenia was 23% (n = 15) in our study population. This first randomized controlled double-blind trial comparing two direct thrombin inhibitors showed comparable effectiveness for renal replacement therapy, but suggests fewer bleeds in surgical patients with argatroban anticoagulation. Clinical Trials.gov NCT00798525. Registered 25 November 2008.

  14. Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

    2018-04-01

    To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

  15. Identifying Patient Attitudinal Clusters Associated with Asthma Control: The European REALISE Survey.

    Science.gov (United States)

    van der Molen, Thys; Fletcher, Monica; Price, David

    Asthma is a highly heterogeneous disease that can be classified into different clinical phenotypes, and treatment may be tailored accordingly. However, factors beyond purely clinical traits, such as patient attitudes and behaviors, can also have a marked impact on treatment outcomes. The objective of this study was to further analyze data from the REcognise Asthma and LInk to Symptoms and Experience (REALISE) Europe survey, to identify distinct patient groups sharing common attitudes toward asthma and its management. Factor analysis of respondent data (N = 7,930) from the REALISE Europe survey consolidated the 34 attitudinal variables provided by the study population into a set of 8 summary factors. Cluster analyses were used to identify patient clusters that showed similar attitudes and behaviors toward each of the 8 summary factors. Five distinct patient clusters were identified and named according to the key characteristics comprising that cluster: "Confident and self-managing," "Confident and accepting of their asthma," "Confident but dependent on others," "Concerned but confident in their health care professional (HCP)," and "Not confident in themselves or their HCP." Clusters showed clear variability in attributes such as degree of confidence in managing their asthma, use of reliever and preventer medication, and level of asthma control. The 5 patient clusters identified in this analysis displayed distinctly different personal attitudes that would require different approaches in the consultation room certainly for asthma but probably also for other chronic diseases. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  16. Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

    Science.gov (United States)

    Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

    2013-04-01

    To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

  17. A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

    Science.gov (United States)

    Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

    2016-02-01

    The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

  18. Identifying knowledge gaps for gene drive research to control invasive animal species: The next CRISPR step

    Directory of Open Access Journals (Sweden)

    Dorian Moro

    2018-01-01

    Full Text Available Invasive animals have been linked to the extinctions of native wildlife, and to significant agricultural financial losses or impacts. Current approaches to control invasive species require ongoing resources and management over large geographic scales, and often result in the short-term suppression of populations. New and innovative approaches are warranted. Recently, the RNA guided gene drive system based on CRISPR/Cas9 is being proposed as a potential gene editing tool that could be used by wildlife managers as a non-lethal addition or alternative to help reduce pest animal populations. While regulatory control and social acceptance are crucial issues that must be addressed, there is an opportunity now to identify the knowledge and research gaps that exist for some important invasive species. Here we systematically determine the knowledge gaps for pest species for which gene drives could potentially be applied. We apply a conceptual ecological risk framework within the gene drive context within an Australian environment to identify key requirements for undertaking work on seven exemplar invasive species in Australia. This framework allows an evaluation of the potential research on an invasive species of interest and within a gene drive and risk context. We consider the currently available biological, genetic and ecological information for the house mouse, European red fox, feral cat, European rabbit, cane toad, black rat and European starling to evaluate knowledge gaps and identify candidate species for future research. We discuss these findings in the context of future thematic areas of research worth pursuing in preparation for a more formal assessment of the use of gene drives as a novel strategy for the control of these and other invasive species. Keywords: Invasive species, Gene drive, CRISPR, Pest management, Islands

  19. Randomized Controlled Study of a Remote Flipped Classroom Neuro-otology Curriculum.

    Science.gov (United States)

    Carrick, Frederick Robert; Abdulrahman, Mahera; Hankir, Ahmed; Zayaruzny, Maksim; Najem, Kinda; Lungchukiet, Palita; Edwards, Roger A

    2017-01-01

    Medical Education can be delivered in the traditional classroom or via novel technology including an online classroom. To test the hypothesis that learning in an online classroom would result in similar outcomes as learning in the traditional classroom when using a flipped classroom pedagogy. Randomized controlled trial. A total of 274 subjects enrolled in a Neuro-otology training program for non-Neuro-otologists of 25 h held over a 3-day period. Subjects were randomized into a "control" group attending a traditional classroom and a "trial" group of equal numbers participating in an online synchronous Internet streaming classroom using the Adobe Connect e-learning platform. Subjects were randomized into a "control" group attending a traditional classroom and a "treatment" group of equal numbers participating in an online synchronous Internet streaming classroom. Pre- and post-multiple choice examinations of VOR, Movement, Head Turns, Head Tremor, Neurodegeneration, Inferior Olivary Complex, Collateral Projections, Eye Movement Training, Visual Saccades, Head Saccades, Visual Impairment, Walking Speed, Neuroprotection, Autophagy, Hyperkinetic Movement, Eye and Head Stability, Oscilllatory Head Movements, Gaze Stability, Leaky Neural Integrator, Cervical Dystonia, INC and Head Tilts, Visual Pursuits, Optokinetic Stimulation, and Vestibular Rehabilitation. All candidates took a pretest examination of the subject material. The 2-9 h and 1-8 h sessions over three consecutive days were given live in the classroom and synchronously in the online classroom using the Adobe Connect e-learning platform. Subjects randomized to the online classroom attended the lectures in a location of their choice and viewed the sessions live on the Internet. A posttest examination was given to all candidates after completion of the course. Two sample unpaired t tests with equal variances were calculated for all pretests and posttests for all groups including gender differences. All 274

  20. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

  1. Pulse versus daily oral Alfacalcidol treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sawalmeh O

    2018-01-01

    Full Text Available Osama Sawalmeh,1 Shaheed Moala,1 Zakaria Hamdan,2 Huda Masri,3 Khubaib Ayoub,4 Emad Khazneh,2 Mujahed Shraim5 1Medicine Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; 2Nephrology Department, 3Pharmacy Department, 4Internal Medicine Department, An-Najah National University Hospital, Nablus, Palestine; 5Public Health Department, College of Health Sciences, Qatar University, Doha, Qatar Background: Secondary hyperparathyroidism is a common complication of chronic kidney disease and is managed using vitamin D replacement therapy. Very few studies have examined the effectiveness of pulse alfacalcidol therapy in comparison to daily oral alfacalcidol therapy in suppressing serum parathyroid hormone (PTH levels in hemodialysis patients. The aim of this randomized controlled trial was to replicate the findings of prior studies comparing effectiveness of pulse oral alfacalcidol therapy versus daily oral alfacalcidol therapy in suppressing PTH after 13 weeks of therapy using a Palestinian sample of hemodialysis patients, and to identify demographic and biomedical characteristics of patients that are independently associated with PTH levels.Methods: One hundred and sixty-seven patients completed the study, 88 in the daily group and 79 in the pulse group. The pulse group had more clinically significant reduction in mean PTH level by 75 pg/dL at 13 weeks than the daily group, but this was not statistically significant.Results: The effect of alfacalcidol therapy on metabolism of phosphate and corrected calcium levels was comparable in both groups, and pulse therapy was not associated with increased risk of hypercalcemia and hyperphosphatemia. Serum PTH levels were independently and inversely associated with older age and diabetes.Conclusion: Switching daily alfacalcidol therapy to thrice-weekly alfacalcidol pulse therapy seems safe and convenient, especially for hemodialysis patients with poor compliance

  2. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

    International Nuclear Information System (INIS)

    Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

    2016-01-01

    Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

  3. Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

    Science.gov (United States)

    Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

    2017-08-01

    This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Myo-inositol effects in women with PCOS: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Vittorio Unfer1,

    2017-10-01

    Full Text Available Myo-inositol (MI supplementation in women with polycystic ovary syndrome (PCOS has been evaluated over the last years. Many hormonal and reproductive impairments associated with this disorder seem relieved by the supplement. The objective of the meta-analysis was to assess the effects of MI alone or combined with d-chiro-inositol (DCI on the endocrine and metabolic abnormalities of women with PCOS. Literature was retrieved from selected databases, MEDLINE, EMBASE, PubMed and Research Gate (up to November 2016. Only randomized controlled trials (RCTs investigating the effects of MI alone or combined with DdCI were reviewed. Nine RCTs involving 247 cases and 249 controls were included. Significant decreases in fasting insulin (SMD = −1.021 μU/mL, 95% CI: −1.791 to −0.251, P = 0.009 and homeostasis model assessment (HOMA index (SMD = −0.585, 95% CI: −1.145 to −0.025, P = 0.041 were identified after MI supplementation. The trial sequential analysis of insulin meta-analysis illustrates that the cumulative z-curve crossed the monitoring boundary, providing firm evidence of the intervention effect. A slight trend toward a reduction of testosterone concentration by MI with respect to controls was found (SMD = −0.49, 95% CI: −1.072 to 0.092, P = 0.099, whereas androstenedione levels remained unaffected. Throughout a subgroup’s meta-analysis, a significant increase in serum SHBG was observed only in those studies where MI was administered for at least 24 weeks (SMD = 0.425 nmol/L, 95% CI: 0.050–0.801, P = 0.026. These results highlight the beneficial effect of MI in improving the metabolic profile of women with PCOS, concomitantly reducing their hyperandrogenism.

  5. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial.

    Science.gov (United States)

    Bunketorp-Käll, Lina; Lundgren-Nilsson, Åsa; Samuelsson, Hans; Pekny, Tulen; Blomvé, Karin; Pekna, Marcela; Pekny, Milos; Blomstrand, Christian; Nilsson, Michael

    2017-07-01

    Treatments that improve function in late phase after stroke are urgently needed. We assessed whether multimodal interventions based on rhythm-and-music therapy or horse-riding therapy could lead to increased perceived recovery and functional improvement in a mixed population of individuals in late phase after stroke. Participants were assigned to rhythm-and-music therapy, horse-riding therapy, or control using concealed randomization, stratified with respect to sex and stroke laterality. Therapy was given twice a week for 12 weeks. The primary outcome was change in participants' perception of stroke recovery as assessed by the Stroke Impact Scale with an intention-to-treat analysis. Secondary objective outcome measures were changes in balance, gait, grip strength, and cognition. Blinded assessments were performed at baseline, postintervention, and at 3- and 6-month follow-up. One hundred twenty-three participants were assigned to rhythm-and-music therapy (n=41), horse-riding therapy (n=41), or control (n=41). Post-intervention, the perception of stroke recovery (mean change from baseline on a scale ranging from 1 to 100) was higher among rhythm-and-music therapy (5.2 [95% confidence interval, 0.79-9.61]) and horse-riding therapy participants (9.8 [95% confidence interval, 6.00-13.66]), compared with controls (-0.5 [-3.20 to 2.28]); P =0.001 (1-way ANOVA). The improvements were sustained in both intervention groups 6 months later, and corresponding gains were observed for the secondary outcomes. Multimodal interventions can improve long-term perception of recovery, as well as balance, gait, grip strength, and working memory in a mixed population of individuals in late phase after stroke. URL: http//www.ClinicalTrials.gov. Unique identifier: NCT01372059. © 2017 American Heart Association, Inc.

  6. A randomized controlled trial testing a social network intervention to promote physical activity among adolescents.

    Science.gov (United States)

    van Woudenberg, Thabo J; Bevelander, Kirsten E; Burk, William J; Smit, Crystal R; Buijs, Laura; Buijzen, Moniek

    2018-04-23

    The current study examined the effectiveness of a social network intervention to promote physical activity among adolescents. Social network interventions utilize peer influence to change behavior by identifying the most influential individuals within social networks (i.e., influence agents), and training them to promote the target behavior. A total of 190 adolescents (46.32% boys; M age = 12.17, age range: 11-14 years) were randomly allocated to either the intervention or control condition. In the intervention condition, the most influential adolescents (based on peer nominations of classmates) in each classroom were trained to promote physical activity among their classmates. Participants received a research smartphone to complete questionnaires and an accelerometer to measure physical activity (steps per day) at baseline, and during the intervention one month later. A multilevel model tested the effectiveness of the intervention, controlling for clustering of data within participants and days. No intervention effect was observed, b = .04, SE = .10, p = .66. This was one of the first studies to test whether physical activity in adolescents could be promoted via influence agents, and the first social network intervention to use smartphones to do so. Important lessons and implications are discussed concerning the selection criterion of the influence agents, the use of smartphones in social network intervention, and the rigorous analyses used to control for confounding factors. Dutch Trial Registry (NTR): NTR6173 . Registered 5 October 2016 Study procedures were approved by the Ethics Committee of the Radboud University (ECSW2014-100614-222).

  7. Evaluation of a transdiagnostic psychodynamic online intervention to support return to work: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rüdiger Zwerenz

    Full Text Available Given their flexibility, online interventions may be useful as an outpatient treatment option to support vocational reintegration after inpatient rehabilitation. To that purpose we devised a transdiagnostic psychodynamic online intervention to facilitate return to work, focusing on interpersonal conflicts at the workplace often responsible for work-related stress.In a randomized controlled trial, we included employed patients from cardiologic, psychosomatic and orthopedic rehabilitation with work-related stress or need for support at intake to inpatient rehabilitation after they had given written consent to take part in the study. Following discharge, maladaptive interpersonal interactions at the workplace were identified via weekly blogs and processed by written therapeutic comments over 12 weeks in the intervention group (IG. The control group (CG received an augmented treatment as usual condition. The main outcome, subjective prognosis of gainful employment (SPE, and secondary outcomes (psychological complaints were assessed by means of online questionnaires before, at the end of aftercare (3 months and at follow-up (12 months. We used ITT analyses controlling for baseline scores and medical group.N = 319 patients were enrolled into IG and N = 345 into CG. 77% of the IG logged in to the webpage (CG 74% and 65% of the IG wrote blogs. Compared to the CG, the IG reported a significantly more positive SPE at follow-up. Measures of depression, anxiety and psychosocial stressors decreased from baseline to follow-up, whereas the corresponding scores increased in the CG. Correspondingly, somatization and psychological quality of life improved in the IG.Psychodynamic online aftercare was effective to enhance subjective prognosis of future employment and improved psychological complaints across a variety of chronic physical and psychological conditions, albeit with small effect sizes.

  8. Robust Fuzzy Control for Fractional-Order Uncertain Hydroturbine Regulating System with Random Disturbances

    Directory of Open Access Journals (Sweden)

    Fengjiao Wu

    2016-01-01

    Full Text Available The robust fuzzy control for fractional-order hydroturbine regulating system is studied in this paper. First, the more practical fractional-order hydroturbine regulating system with uncertain parameters and random disturbances is presented. Then, on the basis of interval matrix theory and fractional-order stability theorem, a fuzzy control method is proposed for fractional-order hydroturbine regulating system, and the stability condition is expressed as a group of linear matrix inequalities. Furthermore, the proposed method has good robustness which can process external random disturbances and uncertain parameters. Finally, the validity and superiority are proved by the numerical simulations.

  9. Digital servo control of random sound test excitation. [in reverberant acoustic chamber

    Science.gov (United States)

    Nakich, R. B. (Inventor)

    1974-01-01

    A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

  10. Communication and Low Mood (CALM): a randomized controlled trial of behavioural therapy for stroke patients with aphasia.

    Science.gov (United States)

    Thomas, Shirley A; Walker, Marion F; Macniven, Jamie A; Haworth, Helen; Lincoln, Nadina B

    2013-05-01

    The aim was to evaluate behavioural therapy as a treatment for low mood in people with aphasia. A randomized controlled trial comparing behavioural therapy plus usual care with a usual care control. Potential participants with aphasia after stroke were screened for the presence of low mood. Those who met the criteria and gave consent were randomly allocated. Participants were recruited from hospital wards, community rehabilitation, speech and language therapy services and stroke groups. Of 511 people with aphasia identified, 105 had low mood and were recruited. Behavioural therapy was offered for up to three months. Outcomes were assessed three and six months after random allocation. Stroke Aphasic Depression Questionnaire, Visual Analog Mood Scales 'sad' item, and Visual Analogue Self-Esteem Scale. Participants were aged 29 to 94 years (mean 67.0, SD 13.5) and 66 (63%) were men. Regression analysis showed that at three months, when baseline values and communication impairment were controlled for, group allocation was a significant predictor of the Stroke Aphasic Depression Questionnaire (P aphasia.

  11. What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

    Science.gov (United States)

    Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

    2015-02-01

    This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

  12. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis.

    Directory of Open Access Journals (Sweden)

    Sara Llufriu

    Full Text Available Uncontrolled studies of mesenchymal stem cells (MSCs in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL on magnetic resonance imaging (MRI at 6 months and at the end of the study.Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS 3.0-6.5 were randomized to receive IV 1-2×10(6 bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite, and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects.At baseline 9 patients were randomized to receive MSCs (n = 5 or placebo (n = 4. One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI = 1.1-8.8 vs 12.3, 95% CI = 4.4-34.5, p = 0.064, and at the end of study to reduced mean GEL (-2.8±5.9 vs 3±5.4, p = 0.075. No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-γ+ cells in blood of MSCs treated patients.Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266.

  13. Green tea polyphenols and Tai Chi for bone health: Designing a placebo-controlled randomized trial

    Directory of Open Access Journals (Sweden)

    Chyu Ming-Chien

    2009-09-01

    model of repeated measurements with random effect error terms was applied. Traditional procedures such as ANCOVA, chi-squared analysis, and regression were used for comparisons. Discussion We present the rationale, design, and methodology of a placebo-controlled randomized trial to investigate a new complementary and alternative medicine strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in osteopenic postmenopausal women. Trial registration ClinicalTrials.gov identifier: NCT00625391

  14. Effects of exercise and diet in nonobese asthma patients - a randomized controlled trial

    DEFF Research Database (Denmark)

    Tønnesen, Louise Lindhardt; Meteran, Howraman; Hostrup, Morten

    2018-01-01

    BACKGROUND: Behavioral interventions focusing on exercise and healthy diet improve asthma control in obese patients with asthma, but whether these interventions can lead to improvements in nonobese patients remains unclear. OBJECTIVES: In a randomized, controlled parallel-group design, we studied...... the effects of an 8-week intervention of either exercise (high-intensity interval training), diet (high protein/low glycemic index), or a combination of the 2, on asthma control and clinical outcomes in nonobese patients with asthma. METHODS: Nonobese adult patients with asthma (n = 149) were randomized to 1...... of 4 groups: an exercise group, a diet group, an exercise + diet group, or a control group. Outcomes included Asthma Control Questionnaire (ACQ) score, asthma-related quality-of-life (Asthma-Related Quality-of-Life Questionnaire [AQLQ]) score, inflammatory cell counts in induced sputum, FEV1...

  15. Randomized Algorithms for Analysis and Control of Uncertain Systems With Applications

    CERN Document Server

    Tempo, Roberto; Dabbene, Fabrizio

    2013-01-01

    The presence of uncertainty in a system description has always been a critical issue in control. The main objective of Randomized Algorithms for Analysis and Control of Uncertain Systems, with Applications (Second Edition) is to introduce the reader to the fundamentals of probabilistic methods in the analysis and design of systems subject to deterministic and stochastic uncertainty. The approach propounded by this text guarantees a reduction in the computational complexity of classical  control algorithms and in the conservativeness of standard robust control techniques. The second edition has been thoroughly updated to reflect recent research and new applications with chapters on statistical learning theory, sequential methods for control and the scenario approach being completely rewritten.   Features: ·         self-contained treatment explaining Monte Carlo and Las Vegas randomized algorithms from their genesis in the principles of probability theory to their use for system analysis; ·    ...

  16. Identifying controlling variables for math computation fluency through experimental analysis: the interaction of stimulus control and reinforcing consequences.

    Science.gov (United States)

    Hofstadter-Duke, Kristi L; Daly, Edward J

    2015-03-01

    This study investigated a method for conducting experimental analyses of academic responding. In the experimental analyses, academic responding (math computation), rather than problem behavior, was reinforced across conditions. Two separate experimental analyses (one with fluent math computation problems and one with non-fluent math computation problems) were conducted with three elementary school children using identical contingencies while math computation rate was measured. Results indicate that the experimental analysis with non-fluent problems produced undifferentiated responding across participants; however, differentiated responding was achieved for all participants in the experimental analysis with fluent problems. A subsequent comparison of the single-most effective condition from the experimental analyses replicated the findings with novel computation problems. Results are discussed in terms of the critical role of stimulus control in identifying controlling consequences for academic deficits, and recommendations for future research refining and extending experimental analysis to academic responding are made. © The Author(s) 2014.

  17. Tuning of an optimal fuzzy PID controller with stochastic algorithms for networked control systems with random time delay.

    Science.gov (United States)

    Pan, Indranil; Das, Saptarshi; Gupta, Amitava

    2011-01-01

    An optimal PID and an optimal fuzzy PID have been tuned by minimizing the Integral of Time multiplied Absolute Error (ITAE) and squared controller output for a networked control system (NCS). The tuning is attempted for a higher order and a time delay system using two stochastic algorithms viz. the Genetic Algorithm (GA) and two variants of Particle Swarm Optimization (PSO) and the closed loop performances are compared. The paper shows that random variation in network delay can be handled efficiently with fuzzy logic based PID controllers over conventional PID controllers. Copyright © 2010 ISA. Published by Elsevier Ltd. All rights reserved.

  18. Intrinsic, identified, and controlled types of motivation for school subjects in young elementary school children.

    Science.gov (United States)

    Guay, Frédéric; Chanal, Julien; Ratelle, Catherine F; Marsh, Herbert W; Larose, Simon; Boivin, Michel

    2010-12-01

    There are two approaches to the differential examination of school motivation. The first is to examine motivation towards specific school subjects (between school subject differentiation). The second is to examine school motivation as a multidimensional concept that varies in terms of not only intensity but also quality (within school subject differentiation). These two differential approaches have led to important discoveries and provided a better understanding of student motivational dynamics. However, little research has combined these two approaches. This study examines young elementary students' motivations across school subjects (writing, reading, and maths) from the stance of self-determination theory. First, we tested whether children self-report different levels of intrinsic, identified, and controlled motivation towards specific school subjects. Second, we verified whether children self-report differentiated types of motivation across school subjects. Participants were 425 French-Canadian children (225 girls, 200 boys) from three elementary schools. Children were in Grades 1 (N=121), 2 (N=126), and 3 (N=178). Results show that, for a given school subject, young elementary students self-report different levels of intrinsic, identified, and controlled motivation. Results also indicate that children self-report different levels of motivation types across school subjects. Our findings also show that most differentiation effects increase across grades. Some gender effects were also observed. These results highlight the importance of distinguishing among types of school motivation towards specific school subjects in the early elementary years.

  19. Transcriptional patterns identify resource controls on the diazotroph Trichodesmium in the Atlantic and Pacific oceans.

    Science.gov (United States)

    Rouco, Mónica; Frischkorn, Kyle R; Haley, Sheean T; Alexander, Harriet; Dyhrman, Sonya T

    2018-02-28

    The N 2 -fixing cyanobacterium Trichodesmium is intensely studied because of the control this organism exerts over the cycling of carbon and nitrogen in the low nutrient ocean gyres. Although iron (Fe) and phosphorus (P) bioavailability are thought to be major drivers of Trichodesmium distributions and activities, identifying resource controls on Trichodesmium is challenging, as Fe and P are often organically complexed and their bioavailability to a single species in a mixed community is difficult to constrain. Further, Fe and P geochemistries are linked through the activities of metalloenzymes, such as the alkaline phosphatases (APs) PhoX and PhoA, which are used by microbes to access dissolved organic P (DOP). Here we identified significant correlations between Trichodesmium-specific transcriptional patterns in the North Atlantic (NASG) and North Pacific Subtropical Gyres (NPSG) and patterns in Fe and P biogeochemistry, with the relative enrichment of Fe stress markers in the NPSG, and P stress markers in the NASG. We also observed the differential enrichment of Fe-requiring PhoX transcripts in the NASG and Fe-insensitive PhoA transcripts in the NPSG, suggesting that metalloenzyme switching may be used to mitigate Fe limitation of DOP metabolism in Trichodesmium. This trait may underpin Trichodesmium success across disparate ecosystems.

  20. Moderator Roles of Optimism and Weight Control on the Impact of Playing Exergames on Happiness: The Perspective of Social Cognitive Theory Using A Randomized Controlled Trial.

    Science.gov (United States)

    Nguyen, Huynh Van; Huang, Han-Chung; Wong, May-Kuen; Yang, Ya-Hui; Huang, Tzu-Ling; Teng, Ching-I

    2018-04-30

    The literature on exergames has examined their impact on user-perceived psychological health (i.e., user-perceived happiness), but little is known about whether such an impact depends on user characteristics. Therefore, this study used the perspective of social cognitive theory (SCT) to identify potential moderators (i.e., whether the user is optimistic or attempting to control his or her weight) of the impact of playing exergames on user-perceived happiness. This large-scale randomized controlled trial recruited 337 college students (of whom 57.3% were female and all were aged 20-40 years) as participants. The participants were randomly assigned to the intervention group or the control group. Participants in the intervention group were asked to use an Xbox 360 to play 1 of 10 exergame programs for 30 minutes once a week for 2 weeks. Participants in the control group were not required to do so. Repeated-measures ANOVA was used for the analyses. The analytical results indicate that playing exergames helped to maintain happiness levels and prevented them from decreasing. The maintained happiness was more prominent among participants who were trying to control their weight, but did not differ between participants who were highly optimistic and those who were less optimistic. This study is the first using SCT to explain the contingent effect of playing exergames on user happiness. Exergames can maintain happiness among users, and such maintenance can be the strongest among users who are trying to control their weight.

  1. Perception of young adults with sickle cell disease or sickle cell trait about participation in the CHOICES randomized controlled trial.

    Science.gov (United States)

    Hershberger, Patricia E; Gallo, Agatha M; Molokie, Robert; Thompson, Alexis A; Suarez, Marie L; Yao, Yingwei; Wilkie, Diana J

    2016-06-01

    To gain an in-depth understanding of the perceptions of young adults with sickle cell disease and sickle cell trait about parenthood and participating in the CHOICES randomized controlled trial that used computer-based, educational programmes. In the USA, there is insufficient education to assure that all young adults with sickle cell disease or sickle cell trait understand genetic inheritance risks and reproductive options to make informed reproductive decisions. To address this educational need, we developed a computer-based, multimedia program (CHOICES) and reformatted usual care into a computer-based (e-Book) program. We then conducted a two-year randomized controlled trial that included a qualitative component that would deepen understanding of young adults' perceptions of parenthood and use of computer-based, educational programmes. A qualitative descriptive approach completed after a randomized controlled trial. Sixty-eight men and women of childbearing age participated in semi-structured interviews at the completion of the randomized controlled trial from 2012-2013. Thematic content analysis guided the qualitative description. Three main themes were identified: (1) increasing knowledge and new ways of thinking and behaving; (2) rethinking parenting plans; and (3) appraising the program design and delivery. Most participants reported increased knowledge and rethinking of their parenting plans and were supportive of computer-based learning. Some participants expressed difficulty in determining individual transmission risks. Participants perceived the computer programs as beneficial to their learning. Future development of an Internet-based educational programme is warranted, with emphasis on providing tailored education or memory boosters about individual transmission risks. © 2015 John Wiley & Sons Ltd.

  2. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    Science.gov (United States)

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  3. RANDOMIZED CONTROLLED TRIALS IN ORTHOPEDICS AND TRAUMATOLOGY: SYSTEMATIC ANALYSIS ON THE NATIONAL EVIDENCE

    Science.gov (United States)

    de Moraes, Vinícius Ynoe; Moreira, Cesar Domingues; Tamaoki, Marcel Jun Sugawara; Faloppa, Flávio; Belloti, Joao Carlos

    2015-01-01

    Objective: To assess whether there has been any improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through the application of standardized and validated scores. Methods: We electronically selected all RCTs published in the two indexed Brazilian journals that focus on orthopedics, over the period 2000-2009: Acta Ortopédica Brasileira (AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers in accordance with the Jadad scale and the Cochrane Bone, Joint and Muscle Trauma Group score. The studies selected were grouped as follows: 1) publication period (2000-2004 or 2004-2009); 2) journal of publication (AOB or RBO). Results: Twenty-two papers were selected: 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportions (nRCT/nTotal of published papers) of RCTs published in the two journals (p = 0.458), or in the Jadad score (p = 0.722) and Cochrane score (p = 0.630). Conclusion: The relative quality and quantity of RCTs in the journals analyzed were similar. There was a trend towards improvement of quality, but there was no increase in the number of RCTs between the two periods analyzed. PMID:27026971

  4. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  5. Geographic analysis of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam.

    Science.gov (United States)

    Ali, Mohammad; Thiem, Vu Dinh; Park, Jin-Kyung; Ochiai, Rion Leon; Canh, Do Gia; Danovaro-Holliday, M Carolina; Kaljee, Linda M; Clemens, John D; Acosta, Camilo J

    2007-09-01

    This paper identifies spatial patterns and predictors of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam. Data for this study result from the integration of demographic surveillance, vaccine record, and geographic data of the study area. A multi-level cross-classified (non-hierarchical) model was used for analyzing the non-nested nature of individual's ecological data. Vaccine uptake was unevenly distributed in space and there was spatial variability among predictors of vaccine uptake. Vaccine uptake was higher among students with younger, male, or not literate family heads. Students from households with higher per-capita income were less likely to participate in the trial. Residency south of the river or further from a hospital/polyclinic was associated with higher vaccine uptake. Younger students were more likely to be vaccinated than older students in high- or low-risk areas, but not in the entire study area. The findings are important for the management of vaccine campaigns during a trial and for interpretation of disease patterns during vaccine-efficacy evaluation.

  6. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

    2017-05-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  7. Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol

    Directory of Open Access Journals (Sweden)

    Tarnanen Sami

    2012-07-01

    Full Text Available Abstract Background Lumbar spine fusion (LSF effectively decreases pain and disability in specific spinal disorders; however, the disability rate following surgery remains high. This, combined with the fact that in Western countries the number of LSF surgeries is increasing rapidly it is important to develop rehabilitation interventions that improve outcomes. Methods/design In the present RCT-study we aim to assess the effectiveness of a combined back-specific and aerobic exercise intervention for patients after LSF surgery. One hundred patients will be randomly allocated to a 12-month exercise intervention arm or a usual care arm. The exercise intervention will start three months after surgery and consist of six individual guidance sessions with a physiotherapist and a home-based exercise program. The primary outcome measures are low back pain, lower extremity pain, disability and quality of life. Secondary outcomes are back function and kinesiophobia. Exercise adherence will also be evaluated. The outcome measurements will be assessed at baseline (3 months postoperatively, at the end of the exercise intervention period (15 months postoperatively, and after a 1-year follow-up. Discussion The present RCT will evaluate the effectiveness of a long-term rehabilitation program after LSF. To our knowledge this will be the first study to evaluate a combination of strength training, control of the neutral lumbar spine position and aerobic training principles in rehabilitation after LSF. Trial registration ClinicalTrials.gov Identifier NCT00834015

  8. Enhancing condom use among Black male youths: a randomized controlled trial.

    Science.gov (United States)

    Crosby, Richard A; Charnigo, Richard J; Salazar, Laura F; Pasternak, Ryan; Terrell, Ivy W; Ricks, JaNelle; Smith, Rachel V; Taylor, Stephanie N

    2014-11-01

    We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection (STI) clinics in 3 southern US cities. In 2010 to 2012, we screened (n = 1102) and enrolled (n = 702) youths aged 15 to 23 years who identified as Black and reported recent (past 2 months) sexual activity and randomized them to a private, brief, interactive intervention (n = 349) or an attention-equivalent control condition (n = 353). Assessments occurred at baseline and 2 and 6 months after the intervention. At 6 months, with adjustment for age and pretest nonequivalence of the outcome variable, an estimated odds ratio (EOR) of 1.63 (95% confidence interval [CI] = 1.07, 2.49; P = .02) indicated efficacy for correct condom use. An adjusted generalized estimating equations model with both 2- and 6-month condom use variables produced an EOR of 1.49 (95% CI = 1.06, 2.08; P = .02). We did not observe significant effects on chlamydia and gonorrhea incidence. This brief intervention, delivered as part of STI clinical care, could help alleviate the disproportionate STI-HIV burden among young Black men.

  9. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    International Nuclear Information System (INIS)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

    2017-01-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  10. How are palliative care cancer populations characterized in randomized controlled trials? A literature review.

    Science.gov (United States)

    Sigurdardottir, Katrin Ruth; Oldervoll, Line; Hjermstad, Marianne Jensen; Kaasa, Stein; Knudsen, Anne Kari; Løhre, Erik Torbjørn; Loge, Jon Håvard; Haugen, Dagny Faksvåg

    2014-05-01

    The difficulties in defining a palliative care patient accentuate the need to provide stringent descriptions of the patient population in palliative care research. To conduct a systematic literature review with the aim of identifying which key variables have been used to describe adult palliative care cancer populations in randomized controlled trials (RCTs). The data sources used were MEDLINE (1950 to January 25, 2010) and Embase (1980 to January 25, 2010), limited to RCTs in adult cancer patients with incurable disease. Forty-three variables were systematically extracted from the eligible articles. The review includes 336 articles reporting RCTs in palliative care cancer patients. Age (98%), gender (90%), cancer diagnosis (89%), performance status (45%), and survival (45%) were the most frequently reported variables. A large number of other variables were much less frequently reported. A substantial variation exists in how palliative care cancer populations are described in RCTs. Few variables are consistently registered and reported. There is a clear need to standardize the reporting. The results from this work will serve as the basis for an international Delphi process with the aim of reaching consensus on a minimum set of descriptors to characterize a palliative care cancer population. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  11. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Kamioka, Hiroharu; Okada, Shinpei; Tsutani, Kiichiro; Park, Hyuntae; Okuizumi, Hiroyasu; Handa, Shuichi; Oshio, Takuya; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Honda, Takuya; Mutoh, Yoshiteru

    2014-04-01

    The objectives of this review were to summarize the evidence from randomized controlled trials (RCTs) on the effects of animal-assisted therapy (AAT). Studies were eligible if they were RCTs. Studies included one treatment group in which AAT was applied. We searched the following databases from 1990 up to October 31, 2012: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, GHL, WPRIM, and PsycINFO. We also searched all Cochrane Database up to October 31, 2012. Eleven RCTs were identified, and seven studies were about "Mental and behavioral disorders". Types of animal intervention were dog, cat, dolphin, bird, cow, rabbit, ferret, and guinea pig. The RCTs conducted have been of relatively low quality. We could not perform meta-analysis because of heterogeneity. In a study environment limited to the people who like animals, AAT may be an effective treatment for mental and behavioral disorders such as depression, schizophrenia, and alcohol/drug addictions, and is based on a holistic approach through interaction with animals in nature. To most effectively assess the potential benefits for AAT, it will be important for further research to utilize and describe (1) RCT methodology when appropriate, (2) reasons for non-participation, (3) intervention dose, (4) adverse effects and withdrawals, and (5) cost. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials.

    Science.gov (United States)

    Wang, Kang-Feng; Zhang, Li-Juan; Lu, Feng; Lu, Yong-Hui; Yang, Chuan-Hua

    2016-06-01

    To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. A comprehensive search [PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. RevMan 5.0 was used for data synthesis. Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio (OR): 5.89, 95% confidence interval (CI): 2.97 to 11.67, Pfirm conclusion could not be reached until further studies of high quality are available.

  13. Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial.

    Science.gov (United States)

    Fujimaki, Yoko; Tsunoda, Koichi; Kobayashi, Rika; Tonghyo, Chong; Tanaka, Fujinobu; Kuroda, Hiroyuki; Numata, Tsutomu; Ishii, Toyota; Kuroda, Reiko; Masuda, Sawako; Hashimoto, Sho; Misawa, Hayato; Shindo, Naoko; Mori, Takahiro; Mori, Hiroko; Uchiyama, Naoki; Kamei, Yuichirou; Tanaka, Masashi; Hamaya, Hironobu; Funatsuki, Shingo; Usui, Satoko; Ito, Ikuno; Hamada, Kohei; Shindo, Akihito; Tokumaru, Yutaka; Morita, Yoko; Ueha, Rumi; Nito, Takaharu; Kikuta, Shu; Sekimoto, Sotaro; Kondo, Kenji; Sakamoto, Takashi; Itoh, Kenji; Yamasoba, Tatsuya; Matsumoto, Sumio

    2017-08-01

    To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Parallel-arm, individual randomized controlled trial. Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. gov Identifier-UMIN000015567.

  14. Searches for Randomized Controlled Trials of Drugs in MEDLINE and EMBASE Using Only Generic Drug Names Compared with Searches Applied in Current Practice in Systematic Reviews

    Science.gov (United States)

    Waffenschmidt, Siw; Guddat, Charlotte

    2015-01-01

    Background: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bibliographic search using only the generic drug name produces sufficient results for the generation…

  15. Timely and complete publication of economic evaluations alongside randomized controlled trials.

    Science.gov (United States)

    Thorn, Joanna C; Noble, Sian M; Hollingworth, William

    2013-01-01

    Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

  16. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

    2013-01-05

    Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among

  17. Use of a twin dataset to identify AMD-related visual patterns controlled by genetic factors

    Science.gov (United States)

    Quellec, Gwénolé; Abràmoff, Michael D.; Russell, Stephen R.

    2010-03-01

    The mapping of genotype to the phenotype of age-related macular degeneration (AMD) is expected to improve the diagnosis and treatment of the disease in a near future. In this study, we focused on the first step to discover this mapping: we identified visual patterns related to AMD which seem to be controlled by genetic factors, without explicitly relating them to the genes. For this purpose, we used a dataset of eye fundus photographs from 74 twin pairs, either monozygotic twins, who have the same genotype, or dizygotic twins, whose genes responsible for AMD are less likely to be identical. If we are able to differentiate monozygotic twins from dizygotic twins, based on a given visual pattern, then this pattern is likely to be controlled by genetic factors. The main visible consequence of AMD is the apparition of drusen between the retinal pigment epithelium and Bruch's membrane. We developed two automated drusen detectors based on the wavelet transform: a shape-based detector for hard drusen, and a texture- and color- based detector for soft drusen. Forty visual features were evaluated at the location of the automatically detected drusen. These features characterize the texture, the shape, the color, the spatial distribution, or the amount of drusen. A distance measure between twin pairs was defined for each visual feature; a smaller distance should be measured between monozygotic twins for visual features controlled by genetic factors. The predictions of several visual features (75.7% accuracy) are comparable or better than the predictions of human experts.

  18. Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

    Science.gov (United States)

    Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

    2017-01-01

    Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

  19. Postpartum depression peer support: maternal perceptions from a randomized controlled trial.

    Science.gov (United States)

    Dennis, Cindy-Lee

    2010-05-01

    Peer support in the early postpartum period is effective in the prevention of postpartum depression among women identified as high-risk. To describe maternal perceptions of peer support received while participating in a trial. Cross-sectional survey of women participating in a randomized controlled trial to evaluate the effect of peer support in the prevention of postpartum depression. Seven health regions across Ontario Canada. 701 women were recruited between November 2004 and September 2006. Women eligible for the study were all mothers with an Edinburgh Postnatal Depression Scale score >9 who were within 2 weeks postpartum, at least 18 years of age, able to speak English, had a live birth, and had been discharged home from the hospital. Exclusion criteria included an infant not discharged home with the mother and current use of antidepressant or antipsychotic medication. Two hundred and twenty-one mothers completed the mailed questionnaire. Women were randomly allocated to receive usual postpartum care (control group) or usual postpartum care plus telephone-based peer support (intervention group). Maternal perceptions of peer support were evaluated at 12 weeks postpartum using the validated Peer Support Evaluation Inventory. Interactions provided by the peer volunteer included the provision of emotional (92.7%), informational (72.4%), and appraisal (72.0%) support. Mothers reported high levels of positive relationship qualities such as trust (83.6%) and perceived acceptance (79.1%). Most (80.5%) mothers indicated they were very satisfied with their peer support experience. Maternal satisfaction was associated with the number and duration of peer volunteer contacts. The majority of mothers perceived their peer volunteer experience positively lending further support to telephone-based peer support as a preventative strategy for postpartum depression. The following program modifications were suggested: (a) adapt training to enhance the provision of appraisal

  20. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients.

    Science.gov (United States)

    Denault, André Y; Bussières, Jean S; Arellano, Ramiro; Finegan, Barry; Gavra, Paul; Haddad, François; Nguyen, Anne Q N; Varin, France; Fortier, Annik; Levesque, Sylvie; Shi, Yanfen; Elmi-Sarabi, Mahsa; Tardif, Jean-Claude; Perrault, Louis P; Lambert, Jean

    2016-10-01

    Inhaled milrinone (iMil) has been used for the treatment of pulmonary hypertension (PH) but its efficacy, safety, and prophylactic effects in facilitating separation from cardiopulmonary bypass (CPB) and preventing right ventricular (RV) dysfunction have not yet been evaluated in a clinical trial. The purpose of this study was to investigate if iMil administered before CPB would be superior to placebo in facilitating separation from CPB. High-risk cardiac surgical patients with PH were randomized to receive iMil or placebo after the induction of anesthesia and before CPB. Hemodynamic parameters and RV function were evaluated by means of pulmonary artery catheterization and transesophageal echocardiography. The groups were compared for the primary outcome of the level of difficulty in weaning from CPB. Among the secondary outcomes examined were the reduction in the severity of PH, the incidence of RV failure, and mortality. Of the 124 patients randomized, the mean (standard deviation [SD]) EuroSCORE II was 8.0 (2.6), and the baseline mean (SD) systolic pulmonary artery pressure (SPAP) was 53 (9) mmHg. The use of iMil was associated with increases in cardiac output (P = 0.03) and a reduction in SPAP (P = 0.04) with no systemic hypotension. Nevertheless, there was no difference in the combined incidence of difficult or complex separation from CPB between the iMil and control groups (30% vs 28%, respectively; absolute difference, 2%; 95% confidence interval [CI], -14 to 18; P = 0.78). There was also no difference in RV failure between the iMil and control groups (15% vs 14%, respectively; difference, 1%; 95% CI, -13 to 12; P = 0.94). Mortality was increased in patients with RV failure vs those without (22% vs 2%, respectively; P < 0.001). In high-risk cardiac surgery patients with PH, the prophylactic use of iMil was associated with favourable hemodynamic effects that did not translate into improvement of clinically relevant endpoints. This trial was registered at

  1. A systematic review of randomized controlled trials on curative and health enhancement effects of forest therapy

    Directory of Open Access Journals (Sweden)

    Kamioka H

    2012-07-01

    problem of heterogeneity, thus a meta-analysis was unable to be performed.Conclusion: Because there was insufficient evidence on forest therapy due to poor methodological and reporting quality and heterogeneity of RCTs, it was not possible to offer any conclusions about the effects of this intervention. However, it was possible to identify problems with current RCTs of forest therapy, and to propose a strategy for strengthening study quality and stressing the importance of study feasibility and original check items based on characteristics of forest therapy as a future research agenda.Keywords: forest therapy, randomized controlled trial, curative effect, health enhancement

  2. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

    Science.gov (United States)

    Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

    2017-01-17

     To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

  3. A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline

    Directory of Open Access Journals (Sweden)

    Walton Sumner

    2016-07-01

    Full Text Available Abstract Background Telephone quitlines can help employees quit smoking. Quitlines typically use directive coaching, but nondirective, flexible coaching is an alternative. Call-2-Quit used a worksite-sponsored quitline to compare directive and nondirective coaching modes, and evaluated employee race and income as potential moderators. Methods An unblinded randomized controlled trial compared directive and nondirective telephone coaching by trained laypersons. Participants were smoking employees and spouses recruited through workplace smoking cessation campaigns in a hospital system and affiliated medical school. Coaches were four non-medical women trained to use both coaching modes. Participants were randomized by family to coaching mode. Participants received up to 7 calls from coaches who used computer assisted telephone interview software to track topics and time. Outcomes were reported smoking abstinence for 7 days at last contact, 6 or 12 months after coaching began. Both worksites implemented new tobacco control policies during the study. Results Most participants responded to an insurance incentive introduced at the hospital. Call-2-Quit coached 518 participants: 22 % were African-American; 45 % had incomes below $30,000. Income, race, and intervention did not affect coaching completion rates. Cessation rates were comparable with directive and nondirective coaching (26 % versus 30 % quit, NS. A full factorial logistic regression model identified above median income (odds ratio = 1.8, p = 0.02, especially among African Americans (p = 0.04, and recent quit attempts (OR = 1.6, p = 0.03 as predictors of cessation. Nondirective coaching was associated with high cessation rates among subgroups of smokers reporting income above the median, recent quit attempts, or use of alternative therapies. Waiting up to 4 weeks to start coaching did not affect cessation. Of 41 highly addicted or depressed smokers who had never quit

  4. A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline.

    Science.gov (United States)

    Sumner, Walton; Walker, Mark S; Highstein, Gabrielle R; Fischer, Irene; Yan, Yan; McQueen, Amy; Fisher, Edwin B

    2016-07-11

    Telephone quitlines can help employees quit smoking. Quitlines typically use directive coaching, but nondirective, flexible coaching is an alternative. Call-2-Quit used a worksite-sponsored quitline to compare directive and nondirective coaching modes, and evaluated employee race and income as potential moderators. An unblinded randomized controlled trial compared directive and nondirective telephone coaching by trained laypersons. Participants were smoking employees and spouses recruited through workplace smoking cessation campaigns in a hospital system and affiliated medical school. Coaches were four non-medical women trained to use both coaching modes. Participants were randomized by family to coaching mode. Participants received up to 7 calls from coaches who used computer assisted telephone interview software to track topics and time. Outcomes were reported smoking abstinence for 7 days at last contact, 6 or 12 months after coaching began. Both worksites implemented new tobacco control policies during the study. Most participants responded to an insurance incentive introduced at the hospital. Call-2-Quit coached 518 participants: 22 % were African-American; 45 % had incomes below $30,000. Income, race, and intervention did not affect coaching completion rates. Cessation rates were comparable with directive and nondirective coaching (26 % versus 30 % quit, NS). A full factorial logistic regression model identified above median income (odds ratio = 1.8, p = 0.02), especially among African Americans (p = 0.04), and recent quit attempts (OR = 1.6, p = 0.03) as predictors of cessation. Nondirective coaching was associated with high cessation rates among subgroups of smokers reporting income above the median, recent quit attempts, or use of alternative therapies. Waiting up to 4 weeks to start coaching did not affect cessation. Of 41 highly addicted or depressed smokers who had never quit more than 30 days, none quit. Nondirective

  5. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Xuelong Zhou

    Full Text Available Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard.Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL were searched to identify all randomized controlled trials (RCTs that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies.Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08 and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84 and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26 were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2-6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46 and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49 and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92 satisfaction. While, the number of patients with at least 50% pain relief within 0-1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77. There was no difference in the incidence of postoperative nausea and vomiting (PONV following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68 or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93.Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety.

  6. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison.

    Science.gov (United States)

    Duncan, Larissa G; Cohn, Michael A; Chao, Maria T; Cook, Joseph G; Riccobono, Jane; Bardacke, Nancy

    2017-05-12

    Childbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education. This study, the Prenatal Education About Reducing Labor Stress (PEARLS) study, is a randomized controlled trial (RCT; n = 30) of a short, time-intensive, 2.5-day mindfulness-based childbirth preparation course offered as a weekend workshop, the Mind in Labor (MIL): Working with Pain in Childbirth, based on Mindfulness-Based Childbirth and Parenting (MBCP) education. First-time mothers in the late 3rd trimester of pregnancy were randomized to attend either the MIL course or a standard childbirth preparation course with no mind-body focus. Participants completed self-report assessments pre-intervention, post-intervention, and post-birth, and medical record data were collected. In a demographically diverse sample, this small RCT demonstrated mindfulness-based childbirth education improved women's childbirth-related appraisals and psychological functioning in comparison to standard childbirth education. MIL program participants showed greater childbirth self-efficacy and mindful body awareness (but no changes in dispositional mindfulness), lower post-course depression symptoms that were maintained through postpartum follow-up, and a trend toward a lower rate of opioid analgesia use in labor. They did not, however, retrospectively report lower perceived labor pain or use epidural less frequently than controls. This study suggests mindfulness training carefully tailored to address fear and pain of childbirth may lead to important maternal mental health benefits, including improvements in childbirth-related appraisals and the prevention of postpartum

  7. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

  8. Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review.

    Science.gov (United States)

    Gerbens, L A A; Chalmers, J R; Rogers, N K; Nankervis, H; Spuls, P I

    2016-10-01

    'Symptoms' is a core outcome domain for atopic eczema (AE) trials, agreed by consensus as part of the Harmonising Outcome Measures for Eczema (HOME) initiative. To standardize and validate the core domain symptoms and symptom instruments for AE trials the HOME roadmap is followed. Its first step is to establish if and how symptoms have been measured in published AE treatment trials. Therefore the Global Resource for Eczema Trials database was used to collect all randomized controlled trials (RCTs) of treatments for AE between January 2000 and April 2014. Study selection and data extraction were performed by three reviewers independently. We identified the use of symptoms in 295 of 378 trials (78%). Symptoms as a primary end point were applied by 147 RCTs (50%). Seventeen different symptoms were measured, but mostly itch and sleep loss. Symptoms were assessed by only 37% of trials by a stand-alone symptom measurement. Overall 63% of RCTs used a composite instrument, and 30 different instruments were identified. The Scoring Atopic Dermatitis (SCORAD) index was the most commonly applied, but only 23% of RCTs reported the SCORAD symptom score separately. This systematic review demonstrates that symptoms, most frequently itch and sleep loss, are commonly reported in AE treatment trials, but are measured using many different instruments. Often symptoms are evaluated as part of a composite instrument, and currently it is not possible to extract symptoms-only data from most published studies. Future trials should report symptom scores to permit meta-analysis of the core outcomes. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  9. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Utility of the Conners' Adult ADHD Rating Scale validity scales in identifying simulated attention-deficit hyperactivity disorder and random responding.

    Science.gov (United States)

    Walls, Brittany D; Wallace, Elizabeth R; Brothers, Stacey L; Berry, David T R

    2017-12-01

    Recent concern about malingered self-report of symptoms of attention-deficit hyperactivity disorder (ADHD) in college students has resulted in an urgent need for scales that can detect feigning of this disorder. The present study provided further validation data for a recently developed validity scale for the Conners' Adult ADHD Rating Scale (CAARS), the CAARS Infrequency Index (CII), as well as for the Inconsistency Index (INC). The sample included 139 undergraduate students: 21 individuals with diagnoses of ADHD, 29 individuals responding honestly, 54 individuals responding randomly (full or half), and 35 individuals instructed to feign. Overall, the INC showed moderate sensitivity to random responding (.44-.63) and fairly high specificity to ADHD (.86-.91). The CII demonstrated modest sensitivity to feigning (.31-.46) and excellent specificity to ADHD (.91-.95). Sequential application of validity scales had correct classification rates of honest (93.1%), ADHD (81.0%), feigning (57.1%), half random (42.3%), and full random (92.9%). The present study suggests that the CII is modestly sensitive (true positive rate) to feigned ADHD symptoms, and highly specific (true negative rate) to ADHD. Additionally, this study highlights the utility of applying the CAARS validity scales in a sequential manner for identifying feigning. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  11. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2013-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…

  12. Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial

    NARCIS (Netherlands)

    Kok, Marjolein; Bais, Joke M.; van Lith, Jan M.; Papatsonis, Dimitri M.; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P.; Mol, Ben W.; van der Post, Joris A.

    2008-01-01

    OBJECTIVE: To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. METHODS: In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or

  13. Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

    2013-01-01

    Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

  14. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins

    NARCIS (Netherlands)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J.

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions).

  15. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis

    NARCIS (Netherlands)

    Sheffler, L.R.; Taylor, P.N.; Gunzler, D.D.; Buurke, Jaap; IJzerman, Maarten Joost; Chae, J.

    2013-01-01

    Objective: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. Design: Single-blinded randomized controlled trial. Setting: Teaching hospital of

  16. Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled Trial

    Science.gov (United States)

    Amir, Nader; Beard, Courtney; Taylor, Charles T.; Klumpp, Heide; Elias, Jason; Burns, Michelle; Chen, Xi

    2009-01-01

    The authors conducted a randomized, double-blind placebo-controlled trial to examine the efficacy of an attention training procedure in reducing symptoms of social anxiety in 44 individuals diagnosed with generalized social phobia (GSP). Attention training comprised a probe detection task in which pictures of faces with either a threatening or…

  17. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial

    NARCIS (Netherlands)

    Scheltens, P.; Twisk, J.W.; Blesa, R.; Scarpini, E.; von Arnim, C.A.F.; Bongers, A.; Harrison, J.; Swinkels, S.H.N.; Stam, C.J.; de Waal, H.; Wurtman, R.J.; Wieggers, R.L.; Vellas, B.; Kamphuis, P.J.G.H.

    2012-01-01

    Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind,

  18. Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Bartels, Rosalie H.; Bourdon, Celine; Potani, Isabel; Mhango, Brian; van den Brink, Deborah A.; Mponda, John S.; Kobold, Anneke C. Muller; Bandsma, Robert H.; van Hensbroek, Michael Boele; Voskuijl, Wieger P.

    Objective: To assess the benefits of pancreatic enzyme replacement therapy (PERT) in children with complicated severe acute malnutrition. Study design: We conducted a randomized, controlled trial in 90 children aged 6-60 months with complicated severe acute malnutrition at the Queen Elizabeth

  19. Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Bartels, Rosalie H.; Bourdon, Céline; Potani, Isabel; Mhango, Brian; van den Brink, Deborah A.; Mponda, John S.; Muller Kobold, Anneke C.; Bandsma, Robert H.; Boele van Hensbroek, Michael; Voskuijl, Wieger P.

    2017-01-01

    Objective To assess the benefits of pancreatic enzyme replacement therapy (PERT) in children with complicated severe acute malnutrition. Study design We conducted a randomized, controlled trial in 90 children aged 6-60 months with complicated severe acute malnutrition at the Queen Elizabeth Central

  20. A worksite prevention program for construction workers: Design of a randomized controlled trial

    NARCIS (Netherlands)

    Oude Hengel, K.M.; Joling, C.I.; Proper, K.I.; Blatter, B.M.; Bongers, P.M.

    2010-01-01

    Background. A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program

  1. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  2. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    Science.gov (United States)

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  3. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

    DEFF Research Database (Denmark)

    Bosch, Jaime; Thabut, Dominique; Albillos, Agustín

    2008-01-01

    A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal...

  4. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM)

    NARCIS (Netherlands)

    Kemp, Samuel V.; Slebos, Dirk-Jan; Kirk, Alan; Kornaszewska, Malgorzata; Carron, Kris; Ek, Lars; Broman, Gustav; Hillerdal, Gunnar; Mal, Herve; Pison, Christophe; Briault, Amandine; Downer, Nicola; Darwiche, Kaid; Rao, Jagan; Huebner, Ralf-Harto; Ruwwe-Glosenkamp, Christof; Trosini-Desert, Valery; Eberhardt, Ralf; Herth, Felix J.; Derom, Eric; Malfait, Thomas; Shah, Pallav L.; Garner, Justin L.; ten Hacken, Nick H.; Fallouh, Hazem; Leroy, Sylvie; Marquette, Charles H.

    2017-01-01

    Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. Objectives: To evaluate the efficacy and safety of Zephyr EBVs

  5. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  6. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials

    OpenAIRE

    Wu, Y; Robinson, N; Hardiman, PJ; Taw, MB; Zhou, J; Wang, FF; Qu, F

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  7. Effects of PMTO in foster families with children with behavior problems : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Maaskant, A.M.; van Rooij, F.B.; Overbeek, G.J.; Oort, F.J.; Arntz, M.; Hermanns, J.M.A.

    The present randomized controlled trial examined the effectiveness of Parent Management Training Oregon for foster parents with foster children (aged 4–12) with severe externalizing behavior problems in long-term foster care arrangements. Foster children’s behavior problems are challenging for

  8. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial

    NARCIS (Netherlands)

    van der Zwan, J.E.; de Vente, W.; Huizink, A.C.; Bögels, S.M.; de Bruin, E.I.

    2015-01-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing

  9. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    Science.gov (United States)

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  10. Self-tracking of physical activity in people with type 2 diabetes : a randomized controlled trial

    NARCIS (Netherlands)

    Kooiman, Thea; de Groot, Martijn; Hoogenberg, Klaas; Krijnen, Wim P; van der Schans, Cees P; Kooy, Adriaan

    2018-01-01

    The purpose of this study was to determine the efficacy of an online self-tracking program on physical activity, glycated hemoglobin, and other health measures in patients with type 2 diabetes. Seventy-two patients with type 2 diabetes were randomly assigned to an intervention or control group. All

  11. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2008-01-01

    The transversus abdominis plane (TAP) block is an effective method of providing postoperative analgesia in patients undergoing midline abdominal wall incisions. We evaluated its analgesic efficacy over the first 48 postoperative hours after cesarean delivery performed through a Pfannensteil incision, in a randomized controlled, double-blind, clinical trial.

  12. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    Science.gov (United States)

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  13. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    Science.gov (United States)

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  14. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    N.J. Vet (Nienke); S.N. de Wildt (Saskia); C.W.M. Verlaat (Carin); C.A.J. Knibbe (Catherijne); M.G. Mooij (Miriam); J.B. van Woensel (Job); J.M. van Rosmalen (Joost); D. Tibboel (Dick); M. de Hoog (Matthijs)

    2016-01-01

    textabstractPurpose: To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. Methods: In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically

  15. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia : A Randomized Waitlist Controlled Trial

    NARCIS (Netherlands)

    Horsch, C.H.G.; Lancee, J.; Griffioen-Both, F.; Spruit, S.; Fitrianie, S.; Neerincx, M.A.; Beun, R.J.; Brinkman, W.-P.

    Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have

  16. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia : A Randomized Waitlist Controlled Trial

    NARCIS (Netherlands)

    Horsch, C.H.G.; Lancee, J; Griffioen-Both, Fiemke; Spruit, Sandor; Fitrianie, S.; Neerincx, M.A.; Beun, RJ; Brinkman, W.P.

    2017-01-01

    Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have

  17. Theory of Mind training in children with autism: a randomized controlled trial

    NARCIS (Netherlands)

    Begeer, S.M.; Gevers, C.; Clifford, P.; Verhoeve, M.; Kat, K.; Hoddenbach, E.; Boer, F.

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13

  18. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    Science.gov (United States)

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  19. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  20. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  1. A neurofeedback video game (MindLight) to prevent anxiety in children: A randomized controlled trial

    NARCIS (Netherlands)

    Schoneveld, E.A.; Malmberg, M.; Lichtwarck-Aschoff, A.; Verheijen, G.P.; Engels, R.C.M.E.; Granic, I.

    2016-01-01

    Background Childhood anxiety is a global mental health concern. Interventions are needed that are effective, but also cost less, are more accessible and engage children long enough to build emotional resilience skills through practice. Methods The present randomized controlled study aimed to examine

  2. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  3. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    Science.gov (United States)

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  4. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    Science.gov (United States)

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  5. A Randomized Control Study of Responsive Teaching with Young Turkish Children and Their Mothers

    Science.gov (United States)

    Karaaslan, Ozcan; Diken, Ibrahim H.; Mahoney, Gerald

    2013-01-01

    A randomized control study was conducted to evaluate the effectiveness of responsive teaching (RT) with a sample of 19 Turkish preschool-age children with disabilities and their mothers over a 6-months period. RT is an early intervention curriculum that attempts to promote children's development by encouraging parents to engage in highly…

  6. Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.

    2016-01-01

    Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma

  7. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  8. Mindfulness-based stress reduction for residents: A randomized controlled trial

    NARCIS (Netherlands)

    Verweij, H.; Ravesteijn, H.J. van; Hooff, M.L.M. van; Lagro-Janssen, A.L.M.; Speckens, A.E.M.

    2018-01-01

    Background: Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents. Objective: To determine the effectiveness of MBSR in reducing burnout in residents. Design: A

  9. Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede

    2015-01-01

    . Methods  A randomized, double-blind, placebo-controlled parallel multicenter study. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric...

  10. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Lerchbaum, Elisabeth; Pilz, Stefan; Trummer, Christian; Schwetz, Verena; Pachernegg, Oliver; Heijboer, Annemieke C.; Obermayer-Pietsch, Barbara

    2017-01-01

    Available evidence shows an association of vitamin D with androgen levels in men. However, results from preliminary randomized controlled trials (RCTs) are conflicting. To evaluate whether vitamin D supplementation increases total testosterone (TT) levels in healthy men. The Graz Vitamin D&TT-RCT is

  11. Potassium supplementation and heart rate : A meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Gijsbers, L.; Moelenberg, F. J. M.; Bakker, S. J. L.; Geleijnse, J. M.

    Background and aims: Increasing the intake of potassium has been shown to lower blood pressure, but whether it also affects heart rate (HR) is largely unknown. We therefore assessed the effect of potassium supplementation on HR in a meta-analysis of randomized controlled trials. Methods and results:

  12. Establishing the experimenting society : The historical origin of social experimentation according to the randomized controlled design

    NARCIS (Netherlands)

    Dehue, T

    2001-01-01

    This article tl aces the historical origin of social experimentation. It highlights the central role of psychology in establishing the randomized controlled design and its quasi-experimental derivatives. The author investigates the differences in the 19th- and 20th-century meaning of the expression

  13. Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

    Science.gov (United States)

    Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

    2010-07-01

    To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

  14. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to

  15. The impact of life review on depression in older adults: a randomized controlled trial

    NARCIS (Netherlands)

    Pot, A.M.; Bohlmeijer, E.T.; Onrust, S.; Melenhorst, A.S.; Veerbeek, M.A.; de Vries, W.

    2010-01-01

    Background: We developed an indicated preventive life-review course, Looking for Meaning, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion criteria

  16. The impact of life review on depression in older adults: a randomized controlled trial

    NARCIS (Netherlands)

    Pot, Anne Margriet; Bohlmeijer, Ernst Thomas; Onrust, Simone; Melenhorst, Anne-Sophie; Veerbeek, Marjolein; de Vries, Wilma

    2010-01-01

    Background: We developed an indicated preventive life-review course, “Looking for Meaning”, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion

  17. A randomized controlled trial of the ketogenic diet in refractory childhood epilepsy

    NARCIS (Netherlands)

    Lambrechts, D.A.J.E.; de Kinderen, R.J.A.; Vles, J.S.H.; de Louw, A.J.A.; Aldenkamp, A.P.; Majoie, H.J.M.

    2017-01-01

    Objective: To evaluate the efficacy and tolerability of the ketogenic diet (KD) during the first 4 months of a randomized controlled trial (RCT) in refractory epilepsy patients aged 1–18 years. Methods: Children and adolescents with refractory epilepsy, not eligible for epilepsy surgery, were

  18. Cognitive behavior therapy for pediatric functional abdominal pain: a randomized controlled trial

    NARCIS (Netherlands)

    van der Veek, Shelley M. C.; Derkx, Bert H. F.; Benninga, Marc A.; Boer, Frits; de Haan, Else

    2013-01-01

    This randomized controlled trial investigated the effectiveness of a 6-session protocolized cognitive behavior therapy (CBT) compared with 6 visits to a pediatrician (intensive medical care; IMC) for the treatment of pediatric functional abdominal pain (FAP). One hundred four children aged 7 to 18

  19. QUINT : A tool to detect qualitative treatment-subgroup interactions in randomized controlled trials

    NARCIS (Netherlands)

    Doove, L.L.; Va