Reconfigurable Antenna Aperture with Optically Controlled GeTe-Based RF Switches

DTIC Science & Technology

2015-03-31

duration (~100ns) but high amplitude raises the material’s temperature above the melting point . As a liquid, the atoms are randomly distributed...100ns, there is sufficient optical energy to heat and melt a 100nm thick GeTe PCM area of approximately 3µm 2 . Figure 3. Optimum PCM area...which tracks well with previously published thin film heater model [9]. Figure 4. Validation of Melt /Quench Thermal Model Optical Control: The

Erasure and reestablishment of random allelic expression imbalance after epigenetic reprogramming.

PubMed

Jeffries, Aaron Richard; Uwanogho, Dafe Aghogho; Cocks, Graham; Perfect, Leo William; Dempster, Emma; Mill, Jonathan; Price, Jack

2016-10-01

Clonal level random allelic expression imbalance and random monoallelic expression provides cellular heterogeneity within tissues by modulating allelic dosage. Although such expression patterns have been observed in multiple cell types, little is known about when in development these stochastic allelic choices are made. We examine allelic expression patterns in human neural progenitor cells before and after epigenetic reprogramming to induced pluripotency, observing that loci previously characterized by random allelic expression imbalance (0.63% of expressed genes) are generally reset to a biallelic state in induced pluripotent stem cells (iPSCs). We subsequently neuralized the iPSCs and profiled isolated clonal neural stem cells, observing that significant random allelic expression imbalance is reestablished at 0.65% of expressed genes, including novel loci not found to show allelic expression imbalance in the original parental neural progenitor cells. Allelic expression imbalance was associated with altered DNA methylation across promoter regulatory regions, with clones characterized by skewed allelic expression being hypermethylated compared to their biallelic sister clones. Our results suggest that random allelic expression imbalance is established during lineage commitment and is associated with increased DNA methylation at the gene promoter. © 2016 Jeffries et al.; Published by Cold Spring Harbor Laboratory Press for the RNA Society.

Scattering from randomly oriented circular discs with application to vegetation

NASA Technical Reports Server (NTRS)

Karam, M. A.; Fung, A. K.

1984-01-01

A vegetation layer is modeled by a collection of randomly oriented circular discs over a half space. The backscattering coefficient from such a half space is computed using the radiative transfer theory. It is shown that significantly different results are obtained from this theory as compared with some earlier investigations using the same modeling approach but with restricted disc orientations. In particular, the backscattered cross polarized returns cannot have a fast increasing angular trend which is inconsistent with measurements. By setting the appropriate angle of orientation to zero the theory reduces to previously published results. Comparisons are shown with measurements taken from milo, corn and wheat and good agreements are obtained for both polarized and cross polarized returns.

Scattering from randomly oriented circular discs with application to vegetation

NASA Technical Reports Server (NTRS)

Karam, M. A.; Fung, A. K.

1983-01-01

A vegetation layer is modeled by a collection of randomly oriented circular discs over a half space. The backscattering coefficient from such a half space is computed using the radiative transfer theory. It is shown that significantly different results are obtained from this theory as compared with some earlier investigations using the same modeling approach but with restricted disc orientations. In particular, the backscattered cross-polarized returns cannot have a fast increasing angular trend which is inconsistent with measurements. By setting the appropriate angle of orientation to zero the theory reduces to previously published results. Comparisons are shown with measurements taken from milo, corn and wheat and good agreements are obtained for both polarized and cross-polarized returns.

Stepping Stones Triple P: the importance of putting the findings into context.

PubMed

Tellegen, Cassandra L; Sofronoff, Kate

2015-02-04

The Stepping Stones Triple P (SSTP) parenting program is an evidence-based program for parents of children with a disability. A trial of SSTP was recently published in BMC Medicine, which reported results of a randomized controlled trial comparing SSTP to care-as-usual. Although the paper described what should be an important replication trial of SSTP, there are significant shortcomings to the scientific approach of the reporting that need to be addressed. The paper initially cites only a few published SSTP studies and describes evidence for the efficacy of the program as "very scarce". A meta-analysis of studies evaluating SSTP published prior to submission of this paper was not cited. The results are inconsistent with previous evidence for SSTP, yet the authors provide scant interpretation for this inconsistency. Similarly, the unusually high dropout rate of 49% was not adequately explained. The claims that previous research has only been conducted by the developers, has not included children with intellectual disability, and has not used care-as-usual comparison groups, are inaccurate. This commentary explores these issues further in order to place the findings from the recent trial into context.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis.

PubMed

Messier, S P; Callahan, L F; Golightly, Y M; Keefe, F J

2015-05-01

The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

PubMed

Roy, S; Azen, C

1994-06-01

We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

And, not or: Quality, quantity in scientific publishing

PubMed Central

Allesina, Stefano

2017-01-01

Scientists often perceive a trade-off between quantity and quality in scientific publishing: finite amounts of time and effort can be spent to produce few high-quality papers or subdivided to produce many papers of lower quality. Despite this perception, previous studies have indicated the opposite relationship, in which productivity (publishing more papers) is associated with increased paper quality (usually measured by citation accumulation). We examine this question in a novel way, comparing members of the National Academy of Sciences with themselves across years, and using a much larger dataset than previously analyzed. We find that a member’s most highly cited paper in a given year has more citations in more productive years than in in less productive years. Their lowest cited paper each year, on the other hand, has fewer citations in more productive years. To disentangle the effect of the underlying distributions of citations and productivities, we repeat the analysis for hypothetical publication records generated by scrambling each author’s citation counts among their publications. Surprisingly, these artificial histories re-create the above trends almost exactly. Put another way, the observed positive relationship between quantity and quality can be interpreted as a consequence of randomly drawing citation counts for each publication: more productive years yield higher-cited papers because they have more chances to draw a large value. This suggests that citation counts, and the rewards that have come to be associated with them, may be more stochastic than previously appreciated. PMID:28570567

Interventions Designed to Promote Exclusive Breastfeeding in High-Income Countries: A Systematic Review Update.

PubMed

Skouteris, Helen; Bailey, Cate; Nagle, Cate; Hauck, Yvonne; Bruce, Lauren; Morris, Heather

2017-12-01

Worldwide, women seldom reach the recommended target of exclusive breastfeeding up to 6 months postpartum. The aim of the current study was to update a previously published review that presented a conceptual and methodological synthesis of interventions designed to promote exclusive breastfeeding up to 6 months in high-income countries. A systematic search of leading databases was conducted for scholarly, peer-reviewed, randomized controlled trials published from June 2013 to December 2016. Twelve new articles were identified as relevant; all were published in English and assessed exclusive breastfeeding with a follow-up period extending beyond 4 months postpartum. Articles were analyzed for overall quality of evidence in regard to duration of exclusive breastfeeding, using the Grading and Recommendations Assessment, Development, and Evaluation approach. A significant increase in the duration of exclusive breastfeeding was found in 4 of the 12 studies. All four successful interventions had long-duration postpartum programs, implemented by telephone, text message, or through a website. Some of the successful interventions also included prenatal education or in-hospital breastfeeding support. Results from this review update correspond closely with previous findings, in that all of the successful interventions had lengthy postnatal support or an education component. More studies assessed intervention fidelity than in the previous review; however, there was little discussion of maternal body-mass index. While a pattern of successful interventions is beginning to emerge, further research is needed to provide a robust evidence base to inform future interventions, particularly with overweight and obese women.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Equations based on anthropometry to predict body fat measured by absorptiometry in schoolchildren and adolescents.

PubMed

Ortiz-Hernández, Luis; Vega López, A Valeria; Ramos-Ibáñez, Norma; Cázares Lara, L Joana; Medina Gómez, R Joab; Pérez-Salgado, Diana

To develop and validate equations to estimate the percentage of body fat of children and adolescents from Mexico using anthropometric measurements. A cross-sectional study was carried out with 601 children and adolescents from Mexico aged 5-19 years. The participants were randomly divided into the following two groups: the development sample (n=398) and the validation sample (n=203). The validity of previously published equations (e.g., Slaughter) was also assessed. The percentage of body fat was estimated by dual-energy X-ray absorptiometry. The anthropometric measurements included height, sitting height, weight, waist and arm circumferences, skinfolds (triceps, biceps, subscapular, supra-iliac, and calf), and elbow and bitrochanteric breadth. Linear regression models were estimated with the percentage of body fat as the dependent variable and the anthropometric measurements as the independent variables. Equations were created based on combinations of six to nine anthropometric variables and had coefficients of determination (r 2 ) equal to or higher than 92.4% for boys and 85.8% for girls. In the validation sample, the developed equations had high r 2 values (≥85.6% in boys and ≥78.1% in girls) in all age groups, low standard errors (SE≤3.05% in boys and ≤3.52% in girls), and the intercepts were not different from the origin (p>0.050). Using the previously published equations, the coefficients of determination were lower, and/or the intercepts were different from the origin. The equations developed in this study can be used to assess the percentage of body fat of Mexican schoolchildren and adolescents, as they demonstrate greater validity and lower error compared with previously published equations. Copyright © 2017 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

PubMed Central

King, Summer; Green, Heather Joy

2015-01-01

Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

Percutaneous Creation of a Central Iliac Arteriovenous Anastomosis for the Treatment of Arterial Hypertension.

PubMed

Bertog, Stefan C; Sobotka, Nathan A; Sobotka, Paul A; Lobo, Melvin D; Sievert, Kolja; Vaskelyte, Laura; Sievert, Horst; Schmieder, Roland E

2018-03-19

Provision of a summary on the physiologic effects of arteriovenous fistula creation and description of previously published human data on the efficacy of a percutaneously implanted device creating an arteriovenous fistula. Though antihypertensive therapy is effective, some patient's blood pressure remains poorly controlled despite adherence to optimal medical therapy. Moreover, some patients are not compliant with recommended medical therapy due to side effects or personal decision. This has prompted exploration of alternative, device-based antihypertensive therapies including, among others, the percutaneous creation of an arteriovenous fistula. An arteriovenous fistula is accompanied by a number of favorable physiologic changes that may lower blood pressure. These physiologic changes, conduction of the procedure, and previously published human experience are summarized in this review article. The results of a recently published trial comparing arteriovenous fistula creation and standard antihypertensive therapy versus standard antihypertensive therapy alone are summarized. Creation of an arteriovenous fistula is accompanied by a significant blood pressure reduction likely related to a reduction in total arterial resistance, perhaps blood volume reduction, inhibition of the baroreceptor reflex, and release of natriuretic peptides. These findings foster further interest in studying the impact of an arteriovenous fistula and arterial blood pressure. The design of a large randomized trial comparing arteriovenous fistula creation to sham control is outlined.

Total curvature and total torsion of knotted random polygons in confinement

NASA Astrophysics Data System (ADS)

Diao, Yuanan; Ernst, Claus; Rawdon, Eric J.; Ziegler, Uta

2018-04-01

Knots in nature are typically confined spatially. The confinement affects the possible configurations, which in turn affects the spectrum of possible knot types as well as the geometry of the configurations within each knot type. The goal of this paper is to determine how confinement, length, and knotting affect the total curvature and total torsion of random polygons. Previously published papers have investigated these effects in the unconstrained case. In particular, we analyze how the total curvature and total torsion are affected by (1) varying the length of polygons within a fixed confinement radius and (2) varying the confinement radius of polygons with a fixed length. We also compare the total curvature and total torsion of groups of knots with similar complexity (measured as crossing number). While some of our results fall in line with what has been observed in the studies of the unconfined random polygons, a few surprising results emerge from our study, showing some properties that are unique due to the effect of knotting in confinement.

Follow-up report of potential linkage for schizophrenia on chromosome 22q: Part 3

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-04-24

The previously published results of a random search of the genome for susceptibility loci for schizophrenia showed a {open_quotes}hot spot{close_quotes} region on chromosome 22 (22q12-q13.1). We now have a sample of 57 families being genotyped and have completed analysis of 495 markers throughout the genome. From the results, no region of 22q can be excluded in our families, and the most likely region may be 22q11-q12. 4 refs., 1 tab.

Stroke Caused by Atherosclerosis of the Major Intracranial Arteries

PubMed Central

Banerjee, Chirantan; Chimowitz, Marc I.

2017-01-01

Our goal in this review is to discuss the pathophysiology, diagnosis and treatment of stroke caused by atherosclerosis of the major intracranial arteries. References for the review were identified by searching PubMed for related studies published from 1955 to June 2016 using search terms “intracranial stenosis” and “intracranial atherosclerosis”. Reference sections of published randomized clinical trials and previously published reviews were searched for additional references. Intracranial atherosclerotic disease (ICAD) is a highly prevalent cause of stroke that is associated with a high risk of recurrent stroke. It is more prevalent among blacks, Hispanics and Asians compared with whites. Diabetes, hypertension, metabolic syndrome, smoking, hyperlipidemia and a sedentary lifestyle are the major modifiable risk factors associated with ICAD. Randomized clinical trials comparing aggressive management (dual antiplatelet treatment for 90 days followed by aspirin monotherapy and intensive management of vascular risk factors) with intracranial stenting plus aggressive medical management have shown medical management alone to be safer and more effective for preventing stroke. As such, aggressive medical management has become the standard of care for symptomatic patients with ICAD. Nevertheless, there are subgroups of patients who are still at high risk of stroke despite being treated with aggressive medical management. Future research should aim to establish clinical, serologic, and imaging biomarkers to identify high-risk patients, and clinical trials evaluating novel therapies should be focused on these patients. PMID:28154100

No evidential value in samples of transcranial direct current stimulation (tDCS) studies of cognition and working memory in healthy populations.

PubMed

Medina, Jared; Cason, Samuel

2017-09-01

A substantial number of studies have been published over the last decade, claiming that transcranial direct current stimulation (tDCS) can influence performance on cognitive tasks. However, there is some skepticism regarding the efficacy of tDCS, and evidence from meta-analyses are mixed. One major weakness of these meta-analyses is that they only examine outcomes in published studies. Given biases towards publishing positive results in the scientific literature, there may be a substantial "file-drawer" of unpublished negative results in the tDCS literature. Furthermore, multiple researcher degrees of freedom can also inflate published p-values. Recently, Simonsohn, Nelson and Simmons (2014) created a novel meta-analytic tool that examines the distribution of significant p-values in a literature, and compares it to expected distributions with different effect sizes. Using this tool, one can assess whether the selected studies have evidential value. Therefore, we examined a random selection of studies that used tDCS to alter performance on cognitive tasks, and tDCS studies on working memory in a recently published meta-analysis (Mancuso et al., 2016). Using a p-curve analysis, we found no evidence that the tDCS studies had evidential value (33% power or greater), with the estimate of statistical power of these studies being approximately 14% for the cognitive studies, and 5% (what would be expected from randomly generated data) for the working memory studies. It is likely that previous tDCS studies are substantially underpowered, and we provide suggestions for future research to increase the evidential value of future tDCS studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Rates of attrition, non-compliance and missingness in randomized controlled trials of child physical activity interventions using accelerometers: A brief methodological review.

PubMed

Howie, Erin K; Straker, Leon M

2016-10-01

The purpose of this brief review was to describe the missingness, from both attrition and non-compliance, during physical activity randomized controlled trials among children which have used accelerometers to measure physical activity. Systematic review. Using a previously published search strategy, an updated search of the literature was performed in the MEDLINE database for articles published from 1996 to February 2015 identifying physical activity RCTs in children (ages 2-18) measuring physical activity using accelerometers. Rates of attrition and non-compliance were extracted from identified articles. Twenty-three independent studies provided complete attrition and non-compliance data and were included. The mean attrition rate was 11.5% (SD 10.1%, range 0-30.9%). The mean accelerometer non-compliance rate at baseline was 22.7% (SD 16.4%, range 1.7-67.8%) and 29.6% (SD 19.4%, range 3.3-70.1%) at follow-up. The mean total study missingness was 37.4% (SD 20.2%, range 3.3-75.4%) and ranged from 3.3% to 75.4%. There was large variation in how missingness was accounted for between studies. There were no statistically significant differences in missingness between study characteristics including sample size, participant age, intervention setting, duration of follow-up, whether physical activity was the primary outcome, and weartime compliance criteria. Missingness is common among randomized controlled trials using accelerometry in children and is currently handled inconsistently. Researchers must plan for high levels of missingness in study design and account for missingness in reporting and analyses of trial outcomes. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Randomized trials published in Chinese or Western journals: comparative empirical analysis.

PubMed

Purgato, Marianna; Cipriani, Andrea; Barbui, Corrado

2012-06-01

A major concern to the inclusion in systematic reviews of studies originating in China and published in Chinese journals refers to the quality of study reporting. In this systematic survey of randomized trials, we compared the characteristics of studies published in Chinese journals with those of studies published in Western journals. We included 69 studies comparing citalopram with other antidepressant drugs in the treatment of major depression. Of these, 37 (54%) were published in Chinese journals. The standard of reporting was generally poor in both Western and Chinese studies. In some Chinese studies, the generation of the randomization sequence raised concern about their experimental nature, and in almost all included studies, the concealment of allocation was not properly described. Blinding was seldom adopted in Chinese studies, and the risk of sponsorship bias was uncertain because Chinese studies did not report any financial support. In most Western studies, outcome data were selectively and incompletely reported. Pooling together all trials revealed that citalopram was similarly effective in comparison with all other antidepressant drugs both in Western studies (standardized mean difference, -0.04; 95% confidence interval, -0.15 to 0.06) and in Chinese studies (standardized mean difference, -0.08, 95% confidence interval, -0.18 to 0.02). Randomized controlled trials published in Chinese journals represent most of the studies included in this review. This suggests that omitting to search biomedical databases originating from China would systematically exclude a relevant proportion of randomized trials published in Chinese journals, with a risk of random error or bias. The increasing inclusion of Chinese studies in systematic reviews reinforces the need to check the quality of randomized trials that are meta-analyzed.

Participant comprehension of research for which they volunteer: a systematic review.

PubMed

Montalvo, Wanda; Larson, Elaine

2014-11-01

Evidence indicates that research participants often do not fully understand the studies for which they have volunteered. The aim of this systematic review was to examine the relationship between the process of obtaining informed consent for research and participant comprehension and satisfaction with the research. Systematic review of published research on informed consent and participant comprehension of research for which they volunteer using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement as a guide. PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trails, and Cochrane Database of Systematic Reviews were used to search the literature for studies meeting the following inclusion criteria: (a) published between January 1, 2006, and December 31, 2013, (b) interventional or descriptive quantitative design, (c) published in a peer-reviewed journal, (d) written in English, and (e) assessed participant comprehension or satisfaction with the research process. Studies were assessed for quality using seven indicators: sampling method, use of controls or comparison groups, response rate, description of intervention, description of outcome, statistical method, and health literacy assessment. Of 176 studies identified, 27 met inclusion criteria: 13 (48%) were randomized interventional designs and 14 (52%) were descriptive. Three categories of studies included projects assessing (a) enhanced consent process or form, (b) multimedia methods, and (c) education to improve participant understanding. Most (78%) used investigator-developed tools to assess participant comprehension, did not assess participant health literacy (74%), or did not assess the readability level of the consent form (89%). Researchers found participants lacked basic understanding of research elements: randomization, placebo, risks, and therapeutic misconception. Findings indicate (a) inconsistent assessment of participant reading or health literacy level, (b) measurement variation associated with use of nonstandardized tools, and (c) continued therapeutic misconception and lack of understanding among research participants of randomization, placebo, benefit, and risk. While the Agency for Healthcare and Quality and National Quality Forum have published informed consent and authorization toolkits, previously published validated tools are underutilized. Informed consent requires the assessment of health literacy, reading level, and comprehension of research participants using validated assessment tools and methods. © 2014 Sigma Theta Tau International.

Effects of date palm pollen on fertility: research proposal for a systematic review.

PubMed

Abdi, Fatemeh; Roozbeh, Nasibeh; Mortazavian, Amir Mohammad

2017-08-01

Over 10-15% of couples in different countries are infertile. Male infertility is a contributing factor and the only cause of infertility in respectively 50% and 20-30% of all cases of infertility. According to previous research, micro-elements isolated from date palm pollen (DPP), e.g. estrogen and sterols, may enhance male and female fertility. DPP has also been reported to improve sperm parameters including sperm motility and viability, acrosome reaction, and lipid peroxidation. This article may justify the need for a future systematic review and meta-analysis about the effects of DPP on the reproductive system and DPP's ability to enhance fertility. It will then describe the methodology of such a study. A comprehensive search of relevant randomized and quasi-randomized controlled trials will be performed in MEDLINE, EMBASE, Web of Science, Cochrane Central, ProQuest, and Google Scholar databases. Two authors will independently assess the eligibility of the studies and consult the third author in cases of disagreement. The risk of bias of the randomized controlled trials and animal studies will be evaluated using the Cochrane risk of bias tool and the Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool, respectively. This study will raise no ethical issues as it will review the findings of previous research. The results are intended to be published in a peer-reviewed medical journal.

Non-Fickian dispersion of groundwater age

PubMed Central

Engdahl, Nicholas B.; Ginn, Timothy R.; Fogg, Graham E.

2014-01-01

We expand the governing equation of groundwater age to account for non-Fickian dispersive fluxes using continuous random walks. Groundwater age is included as an additional (fifth) dimension on which the volumetric mass density of water is distributed and we follow the classical random walk derivation now in five dimensions. The general solution of the random walk recovers the previous conventional model of age when the low order moments of the transition density functions remain finite at their limits and describes non-Fickian age distributions when the transition densities diverge. Previously published transition densities are then used to show how the added dimension in age affects the governing differential equations. Depending on which transition densities diverge, the resulting models may be nonlocal in time, space, or age and can describe asymptotic or pre-asymptotic dispersion. A joint distribution function of time and age transitions is developed as a conditional probability and a natural result of this is that time and age must always have identical transition rate functions. This implies that a transition density defined for age can substitute for a density in time and this has implications for transport model parameter estimation. We present examples of simulated age distributions from a geologically based, heterogeneous domain that exhibit non-Fickian behavior and show that the non-Fickian model provides better descriptions of the distributions than the Fickian model. PMID:24976651

Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial.

PubMed

Fong, Youyi; Halloran, M Elizabeth; Park, Jin Kyung; Marks, Florian; Clemens, John D; Chao, Dennis L

2018-02-20

Oral cholera vaccine (OCV) is a feasible tool to prevent or mitigate cholera outbreaks. A better understanding of the vaccine's efficacy among different age groups and how rapidly its protection wanes could help guide vaccination policy. To estimate the level and duration of OCV efficacy, we re-analyzed data from a previously published cluster-randomized, double-blind, placebo controlled trial with five years of follow-up. We used a Cox proportional hazards model and modeled the potentially time-dependent effect of age categories on both vaccine efficacy and risk of infection in the placebo group. In addition, we investigated the impact of an outbreak period on model estimation. Vaccine efficacy was 38% (95% CI: -2%,62%) for those vaccinated from ages 1 to under 5 years old, 85% (95% CI: 67%,93%) for those 5 to under 15 years, and 69% (95% CI: 49%,81%) for those vaccinated at ages 15 years and older. Among adult vaccinees, efficacy did not appear to wane during the trial, but there was insufficient data to assess the waning of efficacy among child vaccinees. Through this re-analysis we were able to detect a statistically significant difference in OCV efficacy when the vaccine was administered to children under 5 years old vs. children 5 years and older. The estimated efficacies are more similar to the previously published analysis based on the first two years of follow-up than the analysis based on all five years. ClinicalTrials.gov identifier NCT00289224.

A random utility model of delay discounting and its application to people with externalizing psychopathology.

PubMed

Dai, Junyi; Gunn, Rachel L; Gerst, Kyle R; Busemeyer, Jerome R; Finn, Peter R

2016-10-01

Previous studies have demonstrated that working memory capacity plays a central role in delay discounting in people with externalizing psychopathology. These studies used a hyperbolic discounting model, and its single parameter-a measure of delay discounting-was estimated using the standard method of searching for indifference points between intertemporal options. However, there are several problems with this approach. First, the deterministic perspective on delay discounting underlying the indifference point method might be inappropriate. Second, the estimation procedure using the R2 measure often leads to poor model fit. Third, when parameters are estimated using indifference points only, much of the information collected in a delay discounting decision task is wasted. To overcome these problems, this article proposes a random utility model of delay discounting. The proposed model has 2 parameters, 1 for delay discounting and 1 for choice variability. It was fit to choice data obtained from a recently published data set using both maximum-likelihood and Bayesian parameter estimation. As in previous studies, the delay discounting parameter was significantly associated with both externalizing problems and working memory capacity. Furthermore, choice variability was also found to be significantly associated with both variables. This finding suggests that randomness in decisions may be a mechanism by which externalizing problems and low working memory capacity are associated with poor decision making. The random utility model thus has the advantage of disclosing the role of choice variability, which had been masked by the traditional deterministic model. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Toxoplasma gondii and schizophrenia: a review of published RCTs.

PubMed

Chorlton, Sam D

2017-07-01

Over the last 60 years, accumulating evidence has suggested that acute, chronic, and maternal Toxoplasma gondii infections predispose to schizophrenia. More recent evidence suggests that chronically infected patients with schizophrenia present with more severe disease. After acute infection, parasites form walled cysts in the brain, leading to lifelong chronic infection and drug resistance to commonly used antiparasitics. Chronic infection is the most studied and closely linked with development and severity of schizophrenia. There are currently four published randomized controlled trials evaluating antiparasitic drugs, specifically azithromycin, trimethoprim, artemisinin, and artemether, in patients with schizophrenia. No trials have demonstrated a change in psychopathology with adjunctive treatment. Published trials have either selected drugs without evidence against chronic infection or used them at doses too low to reduce brain cyst burden. Furthermore, trials have failed to achieve sufficient power or account for confounders such as previous antipsychotic treatment, sex, age, or rhesus status on antiparasitic effect. There are currently no ongoing trials of anti-Toxoplasma therapy in schizophrenia despite ample evidence to justify further testing.

Reporting of participant flow diagrams in published reports of randomized trials.

PubMed

Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G

2011-12-05

Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

Impact of a social franchising program on uptake of oral rehydration solution plus zinc for childhood diarrhea in myanmar: a community-level randomized controlled trial.

PubMed

Aung, Tin; Montagu, Dominic; Su Su Khin, Hnin; Win, Zaw; San, Ang Kyaw; McFarland, Willi

2014-06-01

Diarrhea's impact on childhood morbidity can be reduced by administering oral rehydration solution (ORS) with zinc; challenges to wider use are changing health-seeking behavior and ensuring access. We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar. Village tracts, matched in 52 pairs, were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc. Intervention and control communities were comparable on demographics, prevalence of diarrhea and previous use of ORS. One year after randomization, ORS plus zinc use was 13.7% in the most recent case of diarrhea in intervention households compared with 1.8% in control households (p < 0.001) (N = 3605). A significant increase in ORS plus zinc use was noted in the intervention (p = 0.044) but not in the control (p = 0.315) group. Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar. Scale-up stands to reduce morbidity among children in similar settings. Current Controlled Trials ISRCTN73606238. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Genetic structure of Mexican Mestizos with type 2 diabetes mellitus based on three STR loci.

PubMed

Cerda-Flores, Ricardo M; Rivera-Prieto, Roxana A; Pereyra-Alférez, Benito; Calderón-Garcidueñas, Ana L; Barrera-Saldaña, Hugo A; Gallardo-Blanco, Hugo L; Ortiz-López, Rocío; Flores-Peña, Yolanda; Cárdenas-Villarreal, Velia M; Rivas, Fernando; Figueroa, Andrés; Kshatriya, Gautam

2013-08-01

The aims of this population genetics study were: 1) to ascertain whether Mexicans with type 2 diabetes mellitus (DM) were genetically homogeneous and 2) to compare the genetic structure of this selected population with the previously reported data of four random populations (Nuevo León, Hispanics, Chihuahua, and Central Region of Mexico). A sample of 103 unrelated individuals with DM and whose 4 grandparents were born in five zones of Mexico was interviewed in 32 Medical Units in the Mexican Institute of Social Security (IMSS). The non-coding STRs D16S539, D7S820, and D13S317 were analyzed. Genotype distribution was in agreement with Hardy-Weinberg expectations for all three markers. Allele frequencies were found to be similar between the selected population and the four random populations. Gene diversity analysis suggested that more than 99.57% of the total gene diversity could be attributed to variation between individuals within the population and 0.43% between the populations. According to the present and previous studies using molecular and non-molecular nuclear DNA markers not associated with any disease, the Mexican Mestizo population is found to be genetically homogeneous and therefore the genetic causes of DM are less heterogeneous, thereby simplifying genetic epidemiological studies as has been found in a previous study with the same design in Mexican women with breast cancer. Published by Elsevier B.V.

[Tele-medicine system for high-risk asthmatic patients].

PubMed

Kokubu, F; Suzuki, H; Sano, Y; Kihara, N; Adachi, M

1999-07-01

We have developed a tele-medicine system to monitor the airway status at home for patients with poorly controlled asthma, whereby a nurse provides instructions to individuals via the telephone to help them manage exacerbation under the supervision of their physicians. We examined the effectiveness of this system with a randomized control study. Patients with high hospitalization risk were enrolled in the study by screening patients for those with multiple previous emergency room visits and randomly assigned to either the tele-medicine or control group. After six months of participation in the program, the number of emergency room visits decreased significantly and the activities of daily living were improved in the tele-medicine group. Most of the patients in the tele-medicine group were able to continue measuring and transmitting peak expiratory flow (PEF) value successfully, and at six months had noticed an improvement in PEF. We therefore conclude that the system effectively contributes to the management of poorly controlled asthma. In addition, further consideration suggests that the reduction of emergency room visits may lead to reduction in hospitalization since we found a good correlation between number of emergency room visits and hospitalization from the studies published previously.

Tamoxifen with ovarian function suppression versus tamoxifen alone as an adjuvant treatment for premenopausal breast cancer: a meta-analysis of published randomized controlled trials

PubMed Central

Yan, Shunchao; Li, Kai; Jiao, Xin; Zou, Huawei

2015-01-01

Background Ovarian function suppression (OFS) significantly downregulates the concentration of plasma estrogens. However, it is unclear whether it offers any survival benefits if combined with adjuvant tamoxifen treatment in premenopausal women. This meta-analysis was designed to assess data from previous studies involving adjuvant tamoxifen treatment plus OFS in premenopausal breast cancer. Methods Electronic literature databases (PubMed, Embase, the Web of Science, and the Cochrane Library) were searched for relevant randomized controlled trials published prior to February 1, 2015. Only randomized controlled trials that compared tamoxifen alone with tamoxifen plus OFS for premenopausal women with breast cancer were selected. The evaluated endpoints were disease-free survival and overall survival. Results Four randomized controlled trials comprising 6,279 patients (OFS combination, n=3,133; tamoxifen alone, n=3,146) were included in the meta-analysis. There was no significant improvement in disease-free survival or overall survival with addition of OFS in either the whole population or the hormone receptor-positive subgroup. The risk of distant recurrence was not reduced with the addition of OFS in the whole population. A subgroup analysis showed that addition of OFS significantly improved overall survival in patients who were administered chemotherapy. Conclusion Based on the available studies, concurrent administration of OFS and adjuvant tamoxifen treatment for premenopausal women with breast cancer has no effect on prolonging disease-free survival and overall survival, excluding patients who were administered chemotherapy. It should not be widely recommended, except perhaps for women who were hormone-receptor positive and who were also administered adjuvant chemotherapy. PMID:26109867

Laterality in coiling behaviour of snakes: another interpretation.

PubMed

Heatwole, Harold; King, Peter; Levine, Samuel G

2007-11-01

The direction of coiling was periodically recorded for two species of viperid snakes--copperheads (Agkistrodon contortrix) and cottonmouths (Agkistrodon piscivorus). Overall, neither species showed a significant preference for coiling in a particular direction. Only 1 of 22 snakes exhibited an individual preference, a result within expectation for random direction of coiling when using a 5% rejection level for statistical testing. A previously published claim for laterality in coiling direction by cottonmouths presented similar results but came to the opposite conclusion. The data from the combined studies suggest that if laterality in coiling direction does occur, it is extremely weak and inconsistent.

Extracorporeal shock waves in the treatment of nonunions.

PubMed

Biedermann, Rainer; Martin, Arho; Handle, Gerhart; Auckenthaler, Thomas; Bach, Christian; Krismer, Martin

2003-05-01

Nonunion remains a major complication after skeletal trauma. In the last decade, extracorporeal shock wave therapy has become a common tool for the treatment of nonunions. To date, no prospective, randomized trial has been conducted to show the efficacy of this form of treatment. This study was performed to determine the value of extracorporeal shock wave therapy for nonunions. Previous published results in the literature and our own clinical results were analyzed and related to the natural history of bony union. No study has proven that extracorporeal shock wave therapy improves bone healing. Clinical studies reporting the acceleration of union after application of shock waves instead seem to misinterpret the natural history of bony union. No evidence supports the treatment of pseudarthroses with extracorporeal shock waves. A randomized, prospective, clinical trial with a control group has to be performed before a final decision can be made regarding this indication for extracorporeal shock wave therapy.

The trajectory of scientific discovery: concept co-occurrence and converging semantic distance.

PubMed

Cohen, Trevor; Schvaneveldt, Roger W

2010-01-01

The paradigm of literature-based knowledge discovery originated by Swanson involves finding meaningful associations between terms or concepts that have not occurred together in any previously published document. While several automated approaches have been applied to this problem, these generally evaluate the literature at a point in time, and do not evaluate the role of change over time in distributional statistics as an indicator of meaningful implicit associations. To address this issue, we develop and evaluate Symmetric Random Indexing (SRI), a novel variant of the Random Indexing (RI) approach that is able to measure implicit association over time. SRI is found to compare favorably to existing RI variants in the prediction of future direct co-occurrence. Summary statistics over several experiments suggest a trend of converging semantic distance prior to the co-occurrence of key terms for two seminal historical literature-based discoveries.

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2011-08-01

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

Which surgery should be offered for carpal tunnel syndrome in a patient who was previously treated for recurrence on the contralateral side? Preliminary study of 13 patients with the Canaletto® implant.

PubMed

Illuminati, I; Seigle-Murandi, F; Gouzou, S; Fabacher, T; Facca, S; Hidalgo Diaz, J J; Liverneaux, P

2017-12-01

There are no published studies on the management of carpal tunnel syndrome (CTS) patients who have already been operated for recurrent CTS on the contralateral side. The aim of this study was to evaluate 13 patients with CTS who underwent primary release using a Canaletto ® implant. The 13 patients had all been operated for recurrent CTS previously. On the contralateral side, they all had subjective signs, and two of them already had complications. All were operated with the Canaletto ® implant according to Duché's technique, in a mean of 20minutes. After a mean 19.3-month follow-up, paresthesia, pain, and QuickDASH scores were significantly improved, even in one patient who underwent revision at another facility. This preliminary study suggests that use of a Canaletto ® implant as first-line treatment for CTS in patients who already underwent revision surgery on the other side is a simple and safe technique, without worsening of symptoms. These findings should be assessed with a prospective randomized controlled trial. Copyright © 2017 SFCM. Published by Elsevier Masson SAS. All rights reserved.

Reporting of participant flow diagrams in published reports of randomized trials

PubMed Central

2011-01-01

Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. PMID:22141446

Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

PubMed

Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

2015-07-01

Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

The effects of steroids during sepsis depend on dose and severity of illness: an updated meta-analysis

PubMed Central

Minneci, P. C.; Deans, K. J.; Eichacker, P. Q.; Natanson, C.

2012-01-01

A previous meta-analysis determined that the effects of steroids during sepsis were dose-dependent; since then, additional trials have been published. The current analysis updates our previous analysis examining the effects of steroids during sepsis. A literature search from 2004 to 2008 identified seven randomized controlled trials in adult patients; these were added to 14 previously identified trials. The effects of steroids on mortality were highly variable among the 21 trials (p <0.001, I2 = 60%). In trials published before 1989, which involved short courses of high-dose steroids, steroids increased mortality (n = 8, I2 = 14%, OR of death 1.39 (95% CI 1.04–1.86), p 0.03). In trials published after 1997, which involved longer courses of lower-dose steroids, steroids consistently improved shock reversal (n = 7, I2 = 0%, OR of shock reversal 1.66 [95% CI 1.25–2.20), p <0.001), but demonstrated a more heterogeneous beneficial effect on mortality (n = 12, I2 = 25%, OR of death 0.64 (95% CI 0.45–0.93), p 0.02). An inverse linear relationship between severity of illness and the effects of steroids on mortality was identified across all trials (p 0.03) and within the subgroup of trials published after 1997 (p 0.03); steroids were harmful in less severely ill patient populations and beneficial in more severely ill patient populations. There was no effect of response to adrenocorticotrophic hormone (ACTH) stimulation testing concerning the effects of steroids and no increase in steroid-associated adverse events. Low-dose steroids appear to improve mortality rates in patients with septic shock who are at high risk of death; however, additional trials in this subpopulation are necessary to definitively determine the role of low-dose steroids during sepsis. PMID:19416302

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

PubMed

Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

2014-04-01

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

A systematic review of financial incentives for dietary behavior change.

PubMed

Purnell, Jason Q; Gernes, Rebecca; Stein, Rick; Sherraden, Margaret S; Knoblock-Hahn, Amy

2014-07-01

In light of the obesity epidemic, there is growing interest in the use of financial incentives for dietary behavior change. Previous reviews of the literature have focused on randomized controlled trials and found mixed results. The purpose of this systematic review is to update and expand on previous reviews by considering a broader range of study designs, including randomized controlled trials, quasi-experimental, observational, and simulation studies testing the use of financial incentives to change dietary behavior and to inform both dietetic practice and research. The review was guided by theoretical consideration of the type of incentive used based on the principles of operant conditioning. There was further examination of whether studies were carried out with an institutional focus. Studies published between 2006 and 2012 were selected for review, and data were extracted regarding study population, intervention design, outcome measures, study duration and follow-up, and key findings. Twelve studies meeting selection criteria were reviewed, with 11 finding a positive association between incentives and dietary behavior change in the short term. All studies pointed to more specific information on the type, timing, and magnitude of incentives needed to motivate individuals to change behavior, the types of incentives and disincentives most likely to affect the behavior of various socioeconomic groups, and promising approaches for potential policy and practice innovations. Limitations of the studies are noted, including the lack of theoretical guidance in the selection of incentive structures and the absence of basic experimental data. Future research should consider these factors, even as policy makers and practitioners continue to experiment with this potentially useful approach to addressing obesity. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

A Multi-Start Evolutionary Local Search for the Two-Echelon Location Routing Problem

NASA Astrophysics Data System (ADS)

Nguyen, Viet-Phuong; Prins, Christian; Prodhon, Caroline

This paper presents a new hybrid metaheuristic between a greedy randomized adaptive search procedure (GRASP) and an evolutionary/iterated local search (ELS/ILS), using Tabu list to solve the two-echelon location routing problem (LRP-2E). The GRASP uses in turn three constructive heuristics followed by local search to generate the initial solutions. From a solution of GRASP, an intensification strategy is carried out by a dynamic alternation between ELS and ILS. In this phase, each child is obtained by mutation and evaluated through a splitting procedure of giant tour followed by a local search. The tabu list, defined by two characteristics of solution (total cost and number of trips), is used to avoid searching a space already explored. The results show that our metaheuristic clearly outperforms all previously published methods on LRP-2E benchmark instances. Furthermore, it is competitive with the best meta-heuristic published for the single-echelon LRP.

A Review of Propensity-Score Methods and Their Use in Cardiovascular Research.

PubMed

Deb, Saswata; Austin, Peter C; Tu, Jack V; Ko, Dennis T; Mazer, C David; Kiss, Alex; Fremes, Stephen E

2016-02-01

Observational studies using propensity-score methods have been increasing in the cardiovascular literature because randomized controlled trials are not always feasible or ethical. However, propensity-score methods can be confusing, and the general audience may not fully understand the importance of this technique. The objectives of this review are to describe (1) the fundamentals of propensity score methods, (2) the techniques to assess for propensity-score model adequacy, (3) the 4 major methods for using the propensity score (matching, stratification, covariate adjustment, and inverse probability of treatment weighting [IPTW]) using examples from previously published cardiovascular studies, and (4) the strengths and weaknesses of these 4 techniques. Our review suggests that matching or IPTW using the propensity score have shown to be most effective in reducing bias of the treatment effect. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Analysis of the relationship between the number of citations and the quality evaluated by experts in psychology journals.

PubMed

Buela-Casal, Gualberto; Zych, Izabela

2010-05-01

The study analyzes the relationship between the number of citations as calculated by the IN-RECS database and the quality evaluated by experts. The articles published in journals of the Spanish Psychological Association between 1996 and 2008 and selected by the Editorial Board of Psychology in Spain were the subject of the study. Psychology in Spain is a journal that includes the best papers published throughout the previous year, chosen by the Editorial Board made up of fifty specialists of acknowledged prestige within Spanish psychology and translated into English. The number of the citations of the 140 original articles republished in Psychology in Spain was compared to the number of the citations of the 140 randomly selected articles. Additionally, the study searched for a relationship between the number of the articles selected from each journal and their mean number of citations. The number of citations received by the best articles as evaluated by experts is significantly higher than the number of citations of the randomly selected articles. Also, the number of citations is higher in the articles from the most frequently selected journals. A statistically significant relation between the quality evaluated by experts and the number of the citations was found.

Clinical outcomes of gamma knife radiosurgery in the salvage treatment of patients with recurrent high-grade glioma.

PubMed

Elaimy, Ameer L; Mackay, Alexander R; Lamoreaux, Wayne T; Demakas, John J; Fairbanks, Robert K; Cooke, Barton S; Lamm, Andrew F; Lee, Christopher M

2013-12-01

Previously published randomized evidence did not report a survival advantage for patients diagnosed with grade IV glioma who were treated with stereotactic radiosurgery followed by external beam radiation therapy and chemotherapy when compared to patients treated with external beam radiation therapy and chemotherapy alone. In recent years, gamma knife radiosurgery has become increasingly popular as a salvage treatment modality for patients diagnosed with recurrent high-grade glioma. The purpose of this article is to review the efficacy of gamma knife radiosurgery for patients who suffer from this malignancy. Retrospective, prospective, and randomized clinical studies published between the years 2000 and 2012 analyzing gamma knife radiosurgery for patients with high-grade glioma were reviewed. After assessing patient age, Karnofsky performance status, tumor histology, and extent of resection, gamma knife radiosurgery is a viable, minimally invasive treatment option for patients diagnosed with recurrent high-grade glioma. The available prospective and retrospective evidence suggests that gamma knife radiosurgery provides patients with a high local tumor control rate and a median survival after tumor recurrence ranging from 13 to 26 months. Gamma knife radiosurgery followed by chemotherapy for recurrent high-grade glioma may provide select patients with increased levels of survival. However, further investigation into this matter is needed due to the limited number of published reports. Additional clinical research is also needed to analyze the efficacy and radiation-related toxicities of fractionated gamma knife radiosurgery due to its potential to limit treatment-associated morbidity. Gamma knife radiosurgery is a safe and effective treatment option for select patients diagnosed with recurrent high-grade glioma. Although treatment outcomes have improved, further evidence in the form of phase III randomized trials is needed to assess the durability of treating patients in specific clinical situations. Copyright © 2013 Elsevier Inc. All rights reserved.

A hands-on practical tutorial on performing meta-analysis with Stata.

PubMed

Chaimani, Anna; Mavridis, Dimitris; Salanti, Georgia

2014-11-01

Statistical synthesis of research findings via meta-analysis is widely used to assess the relative effectiveness of competing interventions. A series of three papers aimed at familiarising mental health scientists with the key statistical concepts and problems in meta-analysis was recently published in this journal. One paper focused on the selection and interpretation of the appropriate model to synthesise results (fixed effect or random effects model) whereas the other two papers focused on two major threats that compromise the validity of meta-analysis results, namely publication bias and missing outcome data. In this paper we provide guidance on how to undertake meta-analysis using Stata, one of the most commonly used software packages for meta-analysis. We address the three topics covered in the previous issues of the journal, focusing on their implementation in Stata using a working example from mental health research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Bayesian estimation of the discrete coefficient of determination.

PubMed

Chen, Ting; Braga-Neto, Ulisses M

2016-12-01

The discrete coefficient of determination (CoD) measures the nonlinear interaction between discrete predictor and target variables and has had far-reaching applications in Genomic Signal Processing. Previous work has addressed the inference of the discrete CoD using classical parametric and nonparametric approaches. In this paper, we introduce a Bayesian framework for the inference of the discrete CoD. We derive analytically the optimal minimum mean-square error (MMSE) CoD estimator, as well as a CoD estimator based on the Optimal Bayesian Predictor (OBP). For the latter estimator, exact expressions for its bias, variance, and root-mean-square (RMS) are given. The accuracy of both Bayesian CoD estimators with non-informative and informative priors, under fixed or random parameters, is studied via analytical and numerical approaches. We also demonstrate the application of the proposed Bayesian approach in the inference of gene regulatory networks, using gene-expression data from a previously published study on metastatic melanoma.

Lactobacillus rhamnosus GG probiotic enteric regimen does not appreciably alter the gut microbiome or provide protection against GVHD after allogeneic hematopoietic stem cell transplantation.

PubMed

Gorshein, Elan; Wei, Catherine; Ambrosy, Susan; Budney, Shanna; Vivas, Juliana; Shenkerman, Angelika; Manago, Jacqueline; McGrath, Mary Kate; Tyno, Anne; Lin, Yong; Patel, Vimal; Gharibo, Mecide; Schaar, Dale; Jenq, Robert R; Khiabanian, Hossein; Strair, Roger

2017-05-01

Graft-versus-host disease (GVHD) is a major adverse effect associated with allogeneic stem cell transplant. Previous studies in mice indicated that administration of the probiotic Lactobacillus rhamnosus GG can reduce the incidence of GVHD after hematopoietic stem cell transplant. Here we report results from the first randomized probiotic enteric regimen trial in which allogenic hematopoietic stem cell patients were supplemented with Lactobacillus rhamnosus GG. Gut microbiome analysis confirmed a previously reported gut microbiome association with GVHD. However, the clinical trial was terminated when interim analysis did not detect an appreciable probiotic-related change in the gut microbiome or incidence of GVHD. Additional studies are necessary to determine whether probiotics can alter the incidence of GVHD after allogeneic stem cell transplant. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Numerical comparison of grid pattern diffraction effects through measurement and modeling with OptiScan software

NASA Astrophysics Data System (ADS)

Murray, Ian B.; Densmore, Victor; Bora, Vaibhav; Pieratt, Matthew W.; Hibbard, Douglas L.; Milster, Tom D.

2011-06-01

Coatings of various metalized patterns are used for heating and electromagnetic interference (EMI) shielding applications. Previous work has focused on macro differences between different types of grids, and has shown good correlation between measurements and analyses of grid diffraction. To advance this work, we have utilized the University of Arizona's OptiScan software, which has been optimized for this application by using the Babinet Principle. When operating on an appropriate computer system, this algorithm produces results hundreds of times faster than standard Fourier-based methods, and allows realistic cases to be modeled for the first time. By using previously published derivations by Exotic Electro-Optics, we compare diffraction performance of repeating and randomized grid patterns with equivalent sheet resistance using numerical performance metrics. Grid patterns of each type are printed on optical substrates and measured energy is compared against modeled energy.

Methodological exemplar of integrating quantitative and qualitative evidence - supportive care for men with prostate cancer: what are the most important components?

PubMed

Huntley, Alyson L; King, Anna J L; Moore, Theresa H M; Paterson, Charlotte; Persad, Raj; Sharp, Debbie; Evans, Maggie

2017-01-01

To present a methodological exemplar of integrating findings from a quantitative and qualitative review on the same topic to provide insight into components of care that contribute to supportive care that is acceptable to men with prostate cancer. Men with prostate cancer are likely to live a long time with the disease, experience side effects from treatment and therefore have ongoing supportive care needs. Quantitative and qualitative reviews have been published but the findings have yet to be integrated. Integration of quantitative and qualitative synthesized evidence. Two previously published systematic reviews. Synthesized evidence on supportive care for men with prostate cancer was integrated from two previously published systematic reviews: a narrative quantitative review and a qualitative review with thematic synthesis. These two streams of synthesized evidence were synthesized using concurrent narrative summary. Data from both reviews were used to develop a set of propositions from which a summary of components of care that likely to contribute to supportive care acceptable to men with prostate cancer were identified. Nine propositions were developed which covered men's supportive care focusing on the role of health professionals. These propositions were used to compose nine components of care likely to lead to supportive care that is acceptable to men with prostate cancer. Some of these components are no/low cost such as developing a more empathic personalized approach, but more specific approaches need further investigation in randomized controlled trials, for example, online support. This methodological exemplar demonstrates the integration of quantitative and qualitative synthesized data to determine components of care likely to lead to provision of supportive care acceptable to men with prostate cancer. © 2016 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Subjective randomness as statistical inference.

PubMed

Griffiths, Thomas L; Daniels, Dylan; Austerweil, Joseph L; Tenenbaum, Joshua B

2018-06-01

Some events seem more random than others. For example, when tossing a coin, a sequence of eight heads in a row does not seem very random. Where do these intuitions about randomness come from? We argue that subjective randomness can be understood as the result of a statistical inference assessing the evidence that an event provides for having been produced by a random generating process. We show how this account provides a link to previous work relating randomness to algorithmic complexity, in which random events are those that cannot be described by short computer programs. Algorithmic complexity is both incomputable and too general to capture the regularities that people can recognize, but viewing randomness as statistical inference provides two paths to addressing these problems: considering regularities generated by simpler computing machines, and restricting the set of probability distributions that characterize regularity. Building on previous work exploring these different routes to a more restricted notion of randomness, we define strong quantitative models of human randomness judgments that apply not just to binary sequences - which have been the focus of much of the previous work on subjective randomness - but also to binary matrices and spatial clustering. Copyright © 2018 Elsevier Inc. All rights reserved.

Changes in work affect in response to lunchtime walking in previously physically inactive employees: A randomized trial.

PubMed

Thøgersen-Ntoumani, C; Loughren, E A; Kinnafick, F-E; Taylor, I M; Duda, J L; Fox, K R

2015-12-01

Physical activity may regulate affective experiences at work, but controlled studies are needed and there has been a reliance on retrospective accounts of experience. The purpose of the present study was to examine the effect of lunchtime walks on momentary work affect at the individual and group levels. Physically inactive employees (N = 56; M age = 47.68; 92.86% female) from a large university in the UK were randomized to immediate treatment or delayed treatment (DT). The DT participants completed both a control and intervention period. During the intervention period, participants partook in three weekly 30-min lunchtime group-led walks for 10 weeks. They completed twice daily affective reports at work (morning and afternoon) using mobile phones on two randomly chosen days per week. Multilevel modeling was used to analyze the data. Lunchtime walks improved enthusiasm, relaxation, and nervousness at work, although the pattern of results differed depending on whether between-group or within-person analyses were conducted. The intervention was effective in changing some affective states and may have broader implications for public health and workplace performance. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The (not so) immortal strand hypothesis.

PubMed

Tomasetti, Cristian; Bozic, Ivana

2015-03-01

Non-random segregation of DNA strands during stem cell replication has been proposed as a mechanism to minimize accumulated genetic errors in stem cells of rapidly dividing tissues. According to this hypothesis, an "immortal" DNA strand is passed to the stem cell daughter and not the more differentiated cell, keeping the stem cell lineage replication error-free. After it was introduced, experimental evidence both in favor and against the hypothesis has been presented. Using a novel methodology that utilizes cancer sequencing data we are able to estimate the rate of accumulation of mutations in healthy stem cells of the colon, blood and head and neck tissues. We find that in these tissues mutations in stem cells accumulate at rates strikingly similar to those expected without the protection from the immortal strand mechanism. Utilizing an approach that is fundamentally different from previous efforts to confirm or refute the immortal strand hypothesis, we provide evidence against non-random segregation of DNA during stem cell replication. Our results strongly suggest that parental DNA is passed randomly to stem cell daughters and provides new insight into the mechanism of DNA replication in stem cells. Copyright © 2015. Published by Elsevier B.V.

A Permutation-Randomization Approach to Test the Spatial Distribution of Plant Diseases.

PubMed

Lione, G; Gonthier, P

2016-01-01

The analysis of the spatial distribution of plant diseases requires the availability of trustworthy geostatistical methods. The mean distance tests (MDT) are here proposed as a series of permutation and randomization tests to assess the spatial distribution of plant diseases when the variable of phytopathological interest is categorical. A user-friendly software to perform the tests is provided. Estimates of power and type I error, obtained with Monte Carlo simulations, showed the reliability of the MDT (power > 0.80; type I error < 0.05). A biological validation on the spatial distribution of spores of two fungal pathogens causing root rot on conifers was successfully performed by verifying the consistency between the MDT responses and previously published data. An application of the MDT was carried out to analyze the relation between the plantation density and the distribution of the infection of Gnomoniopsis castanea, an emerging fungal pathogen causing nut rot on sweet chestnut. Trees carrying nuts infected by the pathogen were randomly distributed in areas with different plantation densities, suggesting that the distribution of G. castanea was not related to the plantation density. The MDT could be used to analyze the spatial distribution of plant diseases both in agricultural and natural ecosystems.

Replication of a Prospective Randomized Controlled Trial of Resource Facilitation to Improve Return to Work and School After Brain Injury.

PubMed

Trexler, Lance E; Parrott, Devan R; Malec, James F

2016-02-01

To determine the extent to which previous findings on the effectiveness of resource facilitation to impact return to work and school could be replicated. Randomized controlled trial. Outpatient rehabilitation clinic. Outpatients with acquired brain injury (N=44). Fifteen months of resource facilitation services. A revised version of the Vocational Independence Scale and the Mayo-Portland Adaptability Inventory-4 Participation Index. Participants randomized to the resource facilitation group demonstrated a significant advantage in terms of rate and timing of return to productive community-based work relative to control participants. When examining only return to competitive work (and not return to school), 69% of the resource facilitation group was able to return compared with 50% of the control participants. Analyses of measures of participation in household and community activities revealed that both groups improved significantly over the 15-month study period, but no significant advantage for either group was demonstrated. This study replicates the positive impact of resource facilitation in improving productive community-based activity, including competitive employment and volunteering in the community. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Laboratory animal research published in plastic surgery journals in 2014 has extensive waste: A systematic review.

PubMed

Freshwater, M Felix

2015-11-01

Laboratory animal research must be designed in a manner that minimizes bias if it is to yield valid and reproducible results. In 2009, a survey that examined 271 animal studies found that 87% did not use randomization and 86% did not use blinding. This has been called "research waste" because it wasted time and resources. This systematic review measured the quantity of research waste in plastic surgery journals in 2014. The PRISMA-P protocol was used. SCOPUS and PubMed searches were done for all animal studies published in 2014 in Aesthetic Plast Surg, Aesthet Surg J, Ann Plast Surg, JPRAS, J Plast Surg Hand Surg and Plast Reconstr Surg. These were supplemented by manual searches of the 2014 issues not indexed. Articles were analyzed for descriptions of randomization, randomization methodology, allocation concealment, and blinding of the primary outcome assessment. Corresponding authors who mentioned randomization without elaborating were emailed for details. 112 of 154 articles met the inclusion criteria. Only 24/112 (21.4%) had blinding of the primary outcome measure, 28/110 (25.5%) of articles that required randomization mentioned it. While 12/28 articles clearly described randomizing the intervention, only 4/28 described the method of randomization, and 2/28 mentioned allocation concealment. Only two authors responded and described the randomization methodology. The quality of plastic surgery laboratory animal research published in 2014 was poor. Use of the National Centre for the Replacement Refinement & Reduction of Animals in Research's "Animal Research: Reporting In Vivo Experiments" (ARRIVE) Guidelines by authors, and enforcement of them by editors and reviewers could improve research quality and reduce waste. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Municipal water consumption forecast accuracy

NASA Astrophysics Data System (ADS)

Fullerton, Thomas M.; Molina, Angel L.

2010-06-01

Municipal water consumption planning is an active area of research because of infrastructure construction and maintenance costs, supply constraints, and water quality assurance. In spite of that, relatively few water forecast accuracy assessments have been completed to date, although some internal documentation may exist as part of the proprietary "grey literature." This study utilizes a data set of previously published municipal consumption forecasts to partially fill that gap in the empirical water economics literature. Previously published municipal water econometric forecasts for three public utilities are examined for predictive accuracy against two random walk benchmarks commonly used in regional analyses. Descriptive metrics used to quantify forecast accuracy include root-mean-square error and Theil inequality statistics. Formal statistical assessments are completed using four-pronged error differential regression F tests. Similar to studies for other metropolitan econometric forecasts in areas with similar demographic and labor market characteristics, model predictive performances for the municipal water aggregates in this effort are mixed for each of the municipalities included in the sample. Given the competitiveness of the benchmarks, analysts should employ care when utilizing econometric forecasts of municipal water consumption for planning purposes, comparing them to recent historical observations and trends to insure reliability. Comparative results using data from other markets, including regions facing differing labor and demographic conditions, would also be helpful.

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

PubMed

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement.

PubMed

Totton, Sarah C; Cullen, Jonah N; Sargeant, Jan M; O'Connor, Annette M

2018-02-01

The goal of the REFLECT Statement (Reporting guidElines For randomized controLled trials in livEstoCk and food safeTy) (published in 2010) was to provide the veterinary research community with reporting guidelines tailored for randomized controlled trials for livestock and food safety. Our objective was to determine the prevalence of REFLECT Statement reporting of items 1-19 in controlled trials published in journals between 1970 and 2017 examining the comparative efficacy of FDA-registered antimicrobials against naturally acquired BRD (bovine respiratory disease) in weaned beef calves in Canada or the USA, and to compare the prevalence of reporting before and after 2010, when REFLECT was published. We divided REFLECT Statement, items 3, 5, 10, and 11 into subitems, because each dealt with multiple elements requiring separate assessment. As a result, 28 different items or subitems were evaluated independently. We searched MEDLINE ® and CABI (CAB Abstracts ® and Global Health ® ) (Web of Science™) in April 2017 and screened 2327 references. Two reviewers independently assessed the reporting of each item and subitem. Ninety-five references were eligible for the study. The reporting of the REFLECT items showed a point estimate for the prevalence ratio >1 (i.e. a higher proportion of studies published post-2010 reported this item compared to studies published pre-2010), apart from items 10.3, i.e., item 10, subitem 3 (who assigned study units to the interventions), 13 (the flow of study units through the study), 16 (number of study units in analysis), 18 (multiplicity), and 19 (adverse effects). Fifty-three (79%) of 67 studies published before 2010 and all 28 (100%) papers published after 2010 reported using a random allocation method in either the title, abstract, or methods (Prevalence ratio = 1.25; 95% CI (1.09,1.43)). However, 8 studies published prior to 2010 and 7 studies published post-2010 reported the term "systematic randomization" or variations of this term (which is not true randomization) to describe the allocation procedure. Fifty-five percent (37/67) of studies published pre-2010 reported blinding status (blinded/not blinded) of outcome assessors, compared to 24/28 (86%) of studies published post-2010 (Prevalence ratio = 1.5, 95% CI (1.19, 2.02)). The reporting of recommended items in journal articles in this body of work is generally improving; however, there is also evidence of confusion about what constitutes a random allocation procedure, and this suggests an educational need. As this study is observational, this precludes concluding that the publication of the REFLECT Statement was the cause of this trend. Copyright © 2017 Elsevier B.V. All rights reserved.

A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

PubMed

Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

2018-06-01

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

PubMed

Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all

PubMed Central

Antonoglou, Georgios N.; Sándor, George K.; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date. PMID:28777820

Competing risk bias was common in Kaplan-Meier risk estimates published in prominent medical journals.

PubMed

van Walraven, Carl; McAlister, Finlay A

2016-01-01

Risk estimates from Kaplan-Meier curves are well known to medical researchers, reviewers, and editors. In this study, we determined the proportion of Kaplan-Meier analyses published in prominent medical journals that are potentially biased because of competing events ("competing risk bias"). We randomly selected 100 studies that had at least one Kaplan-Meier analysis and were recently published in prominent medical journals. Susceptibility to competing risk bias was determined by examining the outcome and potential competing events. In susceptible studies, bias was quantified using a previously validated prediction model when the number of outcomes and competing events were given. Forty-six studies (46%) contained Kaplan-Meier analyses susceptible to competing risk bias. Sixteen studies (34.8%) susceptible to competing risk cited the number of outcomes and competing events; in six of these studies (6/16, 37.5%), the outcome risk from the Kaplan-Meier estimate (relative to the true risk) was biased upward by 10% or more. Almost half of Kaplan-Meier analyses published in medical journals are susceptible to competing risk bias and may overestimate event risk. This bias was found to be quantitatively important in a third of such studies. Copyright © 2016 Elsevier Inc. All rights reserved.

A four-kallikrein panel for the prediction of repeat prostate biopsy: data from the European Randomized Study of Prostate Cancer screening in Rotterdam, Netherlands.

PubMed

Gupta, A; Roobol, M J; Savage, C J; Peltola, M; Pettersson, K; Scardino, P T; Vickers, A J; Schröder, F H; Lilja, H

2010-08-24

Most men with elevated levels of prostate-specific antigen (PSA) do not have prostate cancer, leading to a large number of unnecessary biopsies. A statistical model based on a panel of four kallikreins has been shown to predict the outcome of a first prostate biopsy. In this study, we apply the model to an independent data set of men with previous negative biopsy but persistently elevated PSA. The study cohort consisted of 925 men with a previous negative prostate biopsy and elevated PSA (>or=3 ng ml(-1)), with 110 prostate cancers detected (12%). A previously published statistical model was applied, with recalibration to reflect the lower positive biopsy rates on rebiopsy. The full-kallikrein panel had higher discriminative accuracy than PSA and DRE alone, with area under the curve (AUC) improving from 0.58 (95% confidence interval (CI): 0.52, 0.64) to 0.68 (95% CI: 0.62, 0.74), P<0.001, and high-grade cancer (Gleason >or=7) at biopsy with AUC improving from 0.76 (95% CI: 0.64, 0.89) to 0.87 (95% CI: 0.81, 0.94), P=0.003). Application of the panel to 1000 men with persistently elevated PSA after initial negative biopsy, at a 15% risk threshold would reduce the number of biopsies by 712; would miss (or delay) the diagnosis of 53 cancers, of which only 3 would be Gleason 7 and the rest Gleason 6 or less. Our data constitute an external validation of a previously published model. The four-kallikrein panel predicts the result of repeat prostate biopsy in men with elevated PSA while dramatically decreasing unnecessary biopsies.

10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002–2011

PubMed Central

2013-01-01

Background Quality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period. Methods We individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol. Results Of 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000). Conclusions In mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years. PMID:23914882

Overlapping meta-analyses on the same topic: survey of published studies.

PubMed

Siontis, Konstantinos C; Hernandez-Boussard, Tina; Ioannidis, John P A

2013-07-19

To assess how common it is to have multiple overlapping meta-analyses of randomized trials published on the same topic. Survey of published meta-analyses. PubMed. Meta-analyses published in 2010 were identified, and 5% of them were randomly selected. We further selected those that included randomized trials and examined effectiveness of any medical intervention. For eligible meta-analyses, we searched for other meta-analyses on the same topic (covering the same comparisons, indications/settings, and outcomes or overlapping subsets of them) published until February 2013. Of 73 eligible meta-analyses published in 2010, 49 (67%) had at least one other overlapping meta-analysis (median two meta-analyses per topic, interquartile range 1-4, maximum 13). In 17 topics at least one author was involved in at least two of the overlapping meta-analyses. No characteristics of the index meta-analyses were associated with the potential for overlapping meta-analyses. Among pairs of overlapping meta-analyses in 20 randomly selected topics, 13 of the more recent meta-analyses did not include any additional outcomes. In three of the four topics with eight or more published meta-analyses, many meta-analyses examined only a subset of the eligible interventions or indications/settings covered by the index meta-analysis. Conversely, for statins in the prevention of atrial fibrillation after cardiac surgery, 11 meta-analyses were published with similar eligibility criteria for interventions and setting: there was still variability on which studies were included, but the results were always similar or even identical across meta-analyses. While some independent replication of meta-analyses by different teams is possibly useful, the overall picture suggests that there is a waste of efforts with many topics covered by multiple overlapping meta-analyses.

Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

PubMed

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.

Bias and inference from misspecified mixed-effect models in stepped wedge trial analysis.

PubMed

Thompson, Jennifer A; Fielding, Katherine L; Davey, Calum; Aiken, Alexander M; Hargreaves, James R; Hayes, Richard J

2017-10-15

Many stepped wedge trials (SWTs) are analysed by using a mixed-effect model with a random intercept and fixed effects for the intervention and time periods (referred to here as the standard model). However, it is not known whether this model is robust to misspecification. We simulated SWTs with three groups of clusters and two time periods; one group received the intervention during the first period and two groups in the second period. We simulated period and intervention effects that were either common-to-all or varied-between clusters. Data were analysed with the standard model or with additional random effects for period effect or intervention effect. In a second simulation study, we explored the weight given to within-cluster comparisons by simulating a larger intervention effect in the group of the trial that experienced both the control and intervention conditions and applying the three analysis models described previously. Across 500 simulations, we computed bias and confidence interval coverage of the estimated intervention effect. We found up to 50% bias in intervention effect estimates when period or intervention effects varied between clusters and were treated as fixed effects in the analysis. All misspecified models showed undercoverage of 95% confidence intervals, particularly the standard model. A large weight was given to within-cluster comparisons in the standard model. In the SWTs simulated here, mixed-effect models were highly sensitive to departures from the model assumptions, which can be explained by the high dependence on within-cluster comparisons. Trialists should consider including a random effect for time period in their SWT analysis model. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Preschool-based social communication treatment for children with autism: 12-month follow-up of a randomized trial.

PubMed

Kaale, Anett; Fagerland, Morten W; Martinsen, Egil W; Smith, Lars

2014-02-01

This study reports 12-month follow-up data from a randomized controlled trial of preschool-based social communication treatment for young children with autism. A total of 61 children (48 males) with autism, 29 to 60 months of age, had earlier been randomized either to 8 weeks of preschool-based social communication treatment in addition to standard preschool program (n = 34) or to standard preschool program only (n = 27). Significant short-term effects on targeted social communication skills have previously been published. Long-term gains in social communication, language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions, Early Social Communication Scales, Reynell Developmental Language Scale, and Social Communication Questionnaire. Compared with those in the control group, the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up. However, no effects were detected on language and global ratings of social functioning and communication. The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline, whereas nonverbal IQ and expressive language had no moderating effect. This study is the first to show that, similar to specialist-delivered treatment, preschool-based treatment may produce small but possibly clinically important long-term changes in social communication in young children with autism. The treatment did not affect language and global ratings of social functioning and communication. More studies are needed to better understand whether treatment effects may be improved by increasing the intensity and duration of the treatment. Clinical trial registration information--Joint Attention Intervention and Young Children With Autism; http://clinicaltrials.gov/; NCT00378157. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Efficacy of killed whole-parasite vaccines in the prevention of leishmaniasis: a meta-analysis.

PubMed

Noazin, Sassan; Khamesipour, Ali; Moulton, Lawrence H; Tanner, Marcel; Nasseri, Kiumarss; Modabber, Farrokh; Sharifi, Iraj; Khalil, E A G; Bernal, Ivan Dario Velez; Antunes, Carlos M F; Smith, Peter G

2009-07-30

Despite decades of investigation in countries on three continents, an efficacious vaccine against Leishmania infections has not been developed. Although some indication of protection was observed in some of the controlled trials conducted with "first-generation" whole, inactivated Leishmania parasite vaccines, convincing evidence of protection was lacking. After reviewing all previously published or unpublished randomized, controlled field efficacy clinical trials of prophylactic candidate vaccines, a meta-analysis of qualified trials was conducted to evaluate whether there was some evidence of protection revealed by considering the results of all trials together. The findings indicate that the whole-parasite vaccine candidates tested do not confer significant protection against human leishmaniasis.

Doing better by getting worse: posthypnotic amnesia improves random number generation.

PubMed

Terhune, Devin Blair; Brugger, Peter

2011-01-01

Although forgetting is often regarded as a deficit that we need to control to optimize cognitive functioning, it can have beneficial effects in a number of contexts. We examined whether disrupting memory for previous numerical responses would attenuate repetition avoidance (the tendency to avoid repeating the same number) during random number generation and thereby improve the randomness of responses. Low suggestible and low dissociative and high dissociative highly suggestible individuals completed a random number generation task in a control condition, following a posthypnotic amnesia suggestion to forget previous numerical responses, and in a second control condition following the cancellation of the suggestion. High dissociative highly suggestible participants displayed a selective increase in repetitions during posthypnotic amnesia, with equivalent repetition frequency to a random system, whereas the other two groups exhibited repetition avoidance across conditions. Our results demonstrate that temporarily disrupting memory for previous numerical responses improves random number generation.

Doing Better by Getting Worse: Posthypnotic Amnesia Improves Random Number Generation

PubMed Central

Terhune, Devin Blair; Brugger, Peter

2011-01-01

Although forgetting is often regarded as a deficit that we need to control to optimize cognitive functioning, it can have beneficial effects in a number of contexts. We examined whether disrupting memory for previous numerical responses would attenuate repetition avoidance (the tendency to avoid repeating the same number) during random number generation and thereby improve the randomness of responses. Low suggestible and low dissociative and high dissociative highly suggestible individuals completed a random number generation task in a control condition, following a posthypnotic amnesia suggestion to forget previous numerical responses, and in a second control condition following the cancellation of the suggestion. High dissociative highly suggestible participants displayed a selective increase in repetitions during posthypnotic amnesia, with equivalent repetition frequency to a random system, whereas the other two groups exhibited repetition avoidance across conditions. Our results demonstrate that temporarily disrupting memory for previous numerical responses improves random number generation. PMID:22195022

Strand-seq: a unifying tool for studies of chromosome segregation.

PubMed

Falconer, Ester; Lansdorp, Peter M

2013-01-01

Non random segregation of sister chromatids has been implicated to help specify daughter cell fate (the Silent Sister Hypothesis [1]) or to protect the genome of long-lived stem cells (the Immortal Strand Hypothesis [2]). The idea that sister chromatids are non-randomly segregated into specific daughter cells is only marginally supported by data in sporadic and often contradictory studies. As a result, the field has moved forward rather slowly. The advent of being able to directly label and differentiate sister chromatids in vivo using fluorescence in situ hybridization [3] was a significant advance for such studies. However, this approach is limited by the need for large tracks of unidirectional repeats on chromosomes and the reliance on quantitative imaging of fluorescent probes and rigorous statistical analysis to discern between the two competing hypotheses. A novel method called Strand-seq which uses next-generation sequencing to assay sister chromatid inheritance patterns independently for each chromosome [4] offers a comprehensive approach to test for non-random segregation. In addition Strand-seq enables studies on the deposition of chromatin marks in relation to DNA replication. This method is expected to help unify the field by testing previous claims of non-random segregation in an unbiased way in many model systems in vitro and in vivo. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial.

PubMed

Michopoulos, Vasiliki; Mancini, Fulvia; Loucks, Tammy L; Berga, Sarah L

2013-06-01

To determine whether cognitive behavior therapy (CBT), which we had shown in a previous study to restore ovarian function in women with functional hypothalamic amenorrhea (FHA), could also ameliorate hypercortisolemia and improve other neuroendocrine and metabolic concomitants of in FHA. Randomized controlled trial. Clinical research center at an academic medical university. Seventeen women with FHA were randomized either to CBT or observation. CBT versus observation. Circulatory concentrations of cortisol, leptin, thyroid-stimulating hormone (TSH), total and free thyronine (T(3)), and total and free thyroxine (T(4)) before and immediately after completion of CBT or observation. (Each woman served as her own control.) Cognitive behavior therapy but not observation reduced cortisol levels in women with FHA. There were no changes in cortisol, leptin, TSH, T(3), or T(4) levels in women randomized to observation. Women treated with CBT showed increased levels of leptin and TSH, but their levels of T(3) and T(4) remained unchanged. In women with FHA, CBT ameliorated hypercortisolism and improved the neuroendocrine and metabolic concomitants of FHA while observation did not. We conclude that a cognitive, nonpharmacologic approach aimed at alleviating problematic attitudes not only can restore ovarian activity but also improve neuroendocrine and metabolic function in women with FHA. NCT01674426. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Meta-analysis of randomized controlled trials comparing 17α-hydroxyprogesterone caproate and vaginal progesterone for the prevention of recurrent spontaneous preterm delivery.

PubMed

Oler, Elizabeth; Eke, Ahizechukwu C; Hesson, Ashley

2017-07-01

Vaginal progesterone and 17α-hydroxyprogesterone (17α-OHP) are both used to prevent preterm delivery in women who have experienced spontaneous preterm delivery (SPTD) previously. Randomized trial data of the comparative effectiveness of these interventions have been mixed. To compare the efficacy of intramuscular 17α-OHP and vaginal progesterone in the prevention of recurrent SPTD. Cochrane Central Register of Controlled Trials, African Journals Online, Embase, Google Scholar, ISI Web of Science, LILACS, CINAHL, PubMed, and registers of ongoing trials were searched using keywords related to 17α-OHP, vaginal progesterone, and preterm delivery. Randomized controlled trials published between January 1, 1966, and November 30, 2016, comparing 17α-OHP and vaginal progesterone for the prevention of recurrent SPTD during singleton pregnancies were included. Study data were extracted and meta-analyses were performed when outcomes were comparable. The meta-analyses included data from three randomized trials. Lower rates of SPTD before 34 weeks (relative risk 0.71, 95% confidence interval 0.53-0.95) and before 32 weeks (relative risk 0.62, 95% confidence interval 0.40-0.94) of pregnancy were observed among patients treated with vaginal progesterone. Vaginal progesterone and 17α-OHP were comparable for the prevention of recurrent SPTD in singleton pregnancies; vaginal progesterone could be superior. © 2017 International Federation of Gynecology and Obstetrics.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Lemaster, Chelsey M; Elwy, A Rani; Paris, Ruth; Herman, Patricia M; Plumb, Dorothy N; Sherman, Karen J; Groessl, Erik J; Lynch, Susan; Wang, Shihwe; Weinberg, Janice

2016-04-29

Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. ClinicalTrials.gov: NCT02224183.

Fabrication of scalable tissue engineering scaffolds with dual-pore microarchitecture by combining 3D printing and particle leaching.

PubMed

Mohanty, Soumyaranjan; Sanger, Kuldeep; Heiskanen, Arto; Trifol, Jon; Szabo, Peter; Dufva, Marin; Emnéus, Jenny; Wolff, Anders

2016-04-01

Limitations in controlling scaffold architecture using traditional fabrication techniques are a problem when constructing engineered tissues/organs. Recently, integration of two pore architectures to generate dual-pore scaffolds with tailored physical properties has attracted wide attention in tissue engineering community. Such scaffolds features primary structured pores which can efficiently enhance nutrient/oxygen supply to the surrounding, in combination with secondary random pores, which give high surface area for cell adhesion and proliferation. Here, we present a new technique to fabricate dual-pore scaffolds for various tissue engineering applications where 3D printing of poly(vinyl alcohol) (PVA) mould is combined with salt leaching process. In this technique the sacrificial PVA mould, determining the structured pore architecture, was filled with salt crystals to define the random pore regions of the scaffold. After crosslinking the casted polymer the combined PVA-salt mould was dissolved in water. The technique has advantages over previously reported ones, such as automated assembly of the sacrificial mould, and precise control over pore architecture/dimensions by 3D printing parameters. In this study, polydimethylsiloxane and biodegradable poly(ϵ-caprolactone) were used for fabrication. However, we show that this technique is also suitable for other biocompatible/biodegradable polymers. Various physical and mechanical properties of the dual-pore scaffolds were compared with control scaffolds with either only structured or only random pores, fabricated using previously reported methods. The fabricated dual-pore scaffolds supported high cell density, due to the random pores, in combination with uniform cell distribution throughout the scaffold, and higher cell proliferation and viability due to efficient nutrient/oxygen transport through the structured pores. In conclusion, the described fabrication technique is rapid, inexpensive, scalable, and compatible with different polymers, making it suitable for engineering various large scale organs/tissues. Copyright © 2015. Published by Elsevier B.V.

Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study.

PubMed

Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

2017-02-07

Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. A cross-sectional study. Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their 'Instruction for Authors'. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6-92.3%) and 73.0% (IQR: 59.5-94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively. Nonetheless, the adherence level of nursing journals to the PRISMA statement does not significantly vary whether they endorse or recommend such a guideline. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Evidence-based emergency medicine. Update: do ophthalmic nonsteroidal anti-inflammatory drugs reduce the pain associated with simple corneal abrasion without delaying healing?

PubMed

Weaver, Christopher S; Terrell, Kevin M

2003-01-01

Some studies have suggested that ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) decrease the pain associated with corneal abrasions without impairing healing. This evidence-based emergency medicine (EBEM) critical appraisal reviews the literature, including additional studies appearing since the publication of an earlier EBEM review in 1999. The updated search for randomized controlled trials from 1999 to 2002 complemented the previous 1966 to 1999 search. The methodologic quality of the studies was assessed. Qualitative methods were used to summarize the study results. The search identified 3 studies not included in the previously published review of ophthalmic NSAIDs, yielding a total of 5 blinded, randomized, placebo-controlled trials involving NSAIDs for corneal abrasions. The methodologic quality of the new studies was somewhat higher than that of the 2 original studies and was rated as "good" to "strong." The qualitative summary indicates that NSAIDs provide greater pain relief and improvement of other subjective symptoms when compared with placebo. However, whether the reduction of pain, as measured by visual analog pain scales, exceeds the minimal clinically significant difference is equivocal. The use of ophthalmic NSAIDs may decrease the need for sedating analgesics. Ophthalmic NSAIDs appear to be useful for decreasing pain in patients with corneal abrasions who can afford the medication and who must return to work immediately, particularly where potential opioid-induced sedation is intolerable.

Endorsement of PRISMA statement and quality of systematic reviews and meta-analyses published in nursing journals: a cross-sectional study

PubMed Central

Tam, Wilson W S; Lo, Kenneth K H; Khalechelvam, Parames

2017-01-01

Objective Systematic reviews (SRs) often poorly report key information, thereby diminishing their usefulness. Previous studies evaluated published SRs and determined that they failed to meet explicit criteria or characteristics. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was recommended as a reporting guideline for SR and meta-analysis (MA), but previous studies showed that adherence to the statement was not high for SRs published in different medical fields. Thus, the aims of this study are twofold: (1) to investigate the number of nursing journals that have required or recommended the use of the PRISMA statement for reporting SR, and (2) to examine the adherence of SRs and/or meta-analyses to the PRISMA statement published in nursing journals. Design A cross-sectional study. Methods Nursing journals listed in the ISI journal citation report were divided into 2 groups based on the recommendation of PRISMA statement in their ‘Instruction for Authors’. SRs and meta-analyses published in 2014 were searched in 3 databases. 37 SRs and meta-analyses were randomly selected in each group. The adherence of each item to the PRISMA was examined and summarised using descriptive statistics. The quality of the SRs was assessed by Assessing the Methodological Quality of Systematic Reviews. The differences between the 2 groups were compared using the Mann-Whitney U test. Results Out of 107 nursing journals, 30 (28.0%) recommended or required authors to follow the PRISMA statement when they submit SRs or meta-analyses. The median rates of adherence to the PRISMA statement for reviews published in journals with and without PRISMA endorsement were 64.9% (IQR: 17.6–92.3%) and 73.0% (IQR: 59.5–94.6%), respectively. No significant difference was observed in any of the items between the 2 groups. Conclusions The median adherence of SRs and meta-analyses in nursing journals to PRISMA is low at 64.9% and 73.0%, respectively. Nonetheless, the adherence level of nursing journals to the PRISMA statement does not significantly vary whether they endorse or recommend such a guideline. PMID:28174224

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Predicting the chance of vaginal delivery after one cesarean section: validation and elaboration of a published prediction model.

PubMed

Fagerberg, Marie C; Maršál, Karel; Källén, Karin

2015-05-01

We aimed to validate a widely used US prediction model for vaginal birth after cesarean (Grobman et al. [8]) and modify it to suit Swedish conditions. Women having experienced one cesarean section and at least one subsequent delivery (n=49,472) in the Swedish Medical Birth Registry 1992-2011 were randomly divided into two data sets. In the development data set, variables associated with successful trial of labor were identified using multiple logistic regression. The predictive ability of the estimates previously published by Grobman et al., and of our modified and new estimates, respectively, was then evaluated using the validation data set. The accuracy of the models for prediction of vaginal birth after cesarean was measured by area under the receiver operating characteristics curve. For maternal age, body mass index, prior vaginal delivery, and prior labor arrest, the odds ratio estimates for vaginal birth after cesarean were similar to those previously published. The prediction accuracy increased when information on indication for the previous cesarean section was added (from area under the receiver operating characteristics curve=0.69-0.71), and increased further when maternal height and delivery unit cesarean section rates were included (area under the receiver operating characteristics curve=0.74). The correlation between the individual predicted vaginal birth after cesarean probability and the observed trial of labor success rate was high in all the respective predicted probability decentiles. Customization of prediction models for vaginal birth after cesarean is of considerable value. Choosing relevant indicators for a Swedish setting made it possible to achieve excellent prediction accuracy for success in trial of labor after cesarean. During the delicate process of counseling about preferred delivery mode after one cesarean section, considering the results of our study may facilitate the choice between a trial of labor or an elective repeat cesarean section. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The natural history of conducting and reporting clinical trials: interviews with trialists.

PubMed

Smyth, Rebecca M D; Jacoby, Ann; Altman, Douglas G; Gamble, Carrol; Williamson, Paula R

2015-01-26

To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.

Self-Published Books: An Empirical "Snapshot"

ERIC Educational Resources Information Center

Bradley, Jana; Fulton, Bruce; Helm, Marlene

2012-01-01

The number of books published by authors using fee-based publication services, such as Lulu and AuthorHouse, is overtaking the number of books published by mainstream publishers, according to Bowker's 2009 annual data. Little empirical research exists on self-published books. This article presents the results of an investigation of a random sample…

Do pressures to publish increase scientists' bias? An empirical support from US States Data.

PubMed

Fanelli, Daniele

2010-04-21

The growing competition and "publish or perish" culture in academia might conflict with the objectivity and integrity of research, because it forces scientists to produce "publishable" results at all costs. Papers are less likely to be published and to be cited if they report "negative" results (results that fail to support the tested hypothesis). Therefore, if publication pressures increase scientific bias, the frequency of "positive" results in the literature should be higher in the more competitive and "productive" academic environments. This study verified this hypothesis by measuring the frequency of positive results in a large random sample of papers with a corresponding author based in the US. Across all disciplines, papers were more likely to support a tested hypothesis if their corresponding authors were working in states that, according to NSF data, produced more academic papers per capita. The size of this effect increased when controlling for state's per capita R&D expenditure and for study characteristics that previous research showed to correlate with the frequency of positive results, including discipline and methodology. Although the confounding effect of institutions' prestige could not be excluded (researchers in the more productive universities could be the most clever and successful in their experiments), these results support the hypothesis that competitive academic environments increase not only scientists' productivity but also their bias. The same phenomenon might be observed in other countries where academic competition and pressures to publish are high.

A Monte Carlo analysis of breast screening randomized trials.

PubMed

Zamora, Luis I; Forastero, Cristina; Guirado, Damián; Lallena, Antonio M

2016-12-01

To analyze breast screening randomized trials with a Monte Carlo simulation tool. A simulation tool previously developed to simulate breast screening programmes was adapted for that purpose. The history of women participating in the trials was simulated, including a model for survival after local treatment of invasive cancers. Distributions of time gained due to screening detection against symptomatic detection and the overall screening sensitivity were used as inputs. Several randomized controlled trials were simulated. Except for the age range of women involved, all simulations used the same population characteristics and this permitted to analyze their external validity. The relative risks obtained were compared to those quoted for the trials, whose internal validity was addressed by further investigating the reasons of the disagreements observed. The Monte Carlo simulations produce results that are in good agreement with most of the randomized trials analyzed, thus indicating their methodological quality and external validity. A reduction of the breast cancer mortality around 20% appears to be a reasonable value according to the results of the trials that are methodologically correct. Discrepancies observed with Canada I and II trials may be attributed to a low mammography quality and some methodological problems. Kopparberg trial appears to show a low methodological quality. Monte Carlo simulations are a powerful tool to investigate breast screening controlled randomized trials, helping to establish those whose results are reliable enough to be extrapolated to other populations and to design the trial strategies and, eventually, adapting them during their development. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Will reducing sugar-sweetened beverage consumption reduce obesity? Evidence supporting conjecture is strong, but evidence when testing effect is weak

PubMed Central

Kaiser, Kathryn A.; Shikany, James M.; Keating, Karen D.; Allison, David B.

2014-01-01

We provide arguments to the debate question and update a previous meta-analysis with recently published studies on effects of sugar-sweetened beverages (SSBs) on body weight/composition indices (BWIs). We abstracted data from randomized controlled trials examining effects of consumption of SSBs on BWIs. Six new studies met these criteria: 1) human trials, 2) 3 weeks duration, 3) random assignment to conditions differing only in consumption of SSBs, and 4) including a BWI outcome. Updated meta-analysis of a total of seven studies that added SSBs to persons’ diets showed dose-dependent increases in weight. Updated meta-analysis of eight studies attempting to reduce SSB consumption showed an equivocal effect on BWIs in all randomized subjects. When limited to subjects overweight at baseline, meta-analysis showed a significant effect of roughly 0.25 standard deviations (more weight loss/less weight gain) relative to controls. Evidence to date is equivocal in showing that decreasing SSB consumption will reduce the prevalence of obesity. Although new evidence suggests that an effect may yet be demonstrable in some populations, the integrated effect size estimate remains very small and of equivocal statistical significance. Problems in this research area and suggestions for future research are highlighted. PMID:23742715

Anatomy of open access publishing: a study of longitudinal development and internal structure

PubMed Central

2012-01-01

Background Open access (OA) is a revolutionary way of providing access to the scholarly journal literature made possible by the Internet. The primary aim of this study was to measure the volume of scientific articles published in full immediate OA journals from 2000 to 2011, while observing longitudinal internal shifts in the structure of OA publishing concerning revenue models, publisher types and relative distribution among scientific disciplines. The secondary aim was to measure the share of OA articles of all journal articles, including articles made OA by publishers with a delay and individual author-paid OA articles in subscription journals (hybrid OA), as these subsets of OA publishing have mostly been ignored in previous studies. Methods Stratified random sampling of journals in the Directory of Open Access Journals (n = 787) was performed. The annual publication volumes spanning 2000 to 2011 were retrieved from major publication indexes and through manual data collection. Results An estimated 340,000 articles were published by 6,713 full immediate OA journals during 2011. OA journals requiring article-processing charges have become increasingly common, publishing 166,700 articles in 2011 (49% of all OA articles). This growth is related to the growth of commercial publishers, who, despite only a marginal presence a decade ago, have grown to become key actors on the OA scene, responsible for 120,000 of the articles published in 2011. Publication volume has grown within all major scientific disciplines, however, biomedicine has seen a particularly rapid 16-fold growth between 2000 (7,400 articles) and 2011 (120,900 articles). Over the past decade, OA journal publishing has steadily increased its relative share of all scholarly journal articles by about 1% annually. Approximately 17% of the 1.66 million articles published during 2011 and indexed in the most comprehensive article-level index of scholarly articles (Scopus) are available OA through journal publishers, most articles immediately (12%) but some within 12 months of publication (5%). Conclusions OA journal publishing is disrupting the dominant subscription-based model of scientific publishing, having rapidly grown in relative annual share of published journal articles during the last decade. PMID:23088823

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications.

PubMed

Tharyan, Prathap; George, Aneesh Thomas; Kirubakaran, Richard; Barnabas, Jabez Paul

2013-01-01

We sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI). An observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys. Journal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials. The CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results. Copyright © 2013 Elsevier Inc. All rights reserved.

Ozone measurement system for NASA global air sampling program

NASA Technical Reports Server (NTRS)

Tiefermann, M. W.

1979-01-01

The ozone measurement system used in the NASA Global Air Sampling Program is described. The system uses a commercially available ozone concentration monitor that was modified and repackaged so as to operate unattended in an aircraft environment. The modifications required for aircraft use are described along with the calibration techniques, the measurement of ozone loss in the sample lines, and the operating procedures that were developed for use in the program. Based on calibrations with JPL's 5-meter ultraviolet photometer, all previously published GASP ozone data are biased high by 9 percent. A system error analysis showed that the total system measurement random error is from 3 to 8 percent of reading (depending on the pump diaphragm material) or 3 ppbv, whichever are greater.

Averages of ratios of the Riemann zeta-function and correlations of divisor sums

NASA Astrophysics Data System (ADS)

Conrey, Brian; Keating, Jonathan P.

2017-10-01

Nonlinearity has published articles containing a significant number-theoretic component since the journal was first established. We examine one thread, concerning the statistics of the zeros of the Riemann zeta function. We extend this by establishing a connection between the ratios conjecture for the Riemann zeta-function and a conjecture concerning correlations of convolutions of Möbius and divisor functions. Specifically, we prove that the ratios conjecture and an arithmetic correlations conjecture imply the same result. This provides new support for the ratios conjecture, which previously had been motivated by analogy with formulae in random matrix theory and by a heuristic recipe. Our main theorem generalises a recent calculation pertaining to the special case of two-over-two ratios.

The linear trend of headache prevalence and some headache features in school children.

PubMed

Ozge, Aynur; Buğdayci, Resul; Saşmaz, Tayyar; Kaleağasi, Hakan; Kurt, Oner; Karakelle, Ali; Siva, Aksel

2007-04-01

The objectives of this study were to determine the age and sex dependent linear trend of recurrent headache prevalence in schoolchildren in Mersin. A stratified sample composed of 5562 children; detailed characteristics were previously published. In this study the prevalence distribution of headache by age and sex showed a peak in the female population at the age of 11 (27.2%) with a plateau in the following years. The great stratified random sample results suggested that, in addition to socio-demographic features, detailed linear trend analysis showed headache features of children with headache have some specific characteristics dependent on age, gender and headache type. This study results can constitute a basis for the future epidemiological based studies.

Early behavioral intervention is associated with normalized brain activity in young children with autism.

PubMed

Dawson, Geraldine; Jones, Emily J H; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J; Webb, Sara J

2012-11-01

A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Forty-eight 18- to 30-month-old children with autism spectrum disorder were randomized to receive the ESDM or referral to community intervention for 2 years. After the intervention (age 48 to 77 months), EEG activity (event-related potentials and spectral power) was measured during the presentation of faces versus objects. Age-matched typical children were also assessed. The ESDM group exhibited greater improvements in autism symptoms, IQ, language, and adaptive and social behaviors than the community intervention group. The ESDM group and typical children showed a shorter Nc latency and increased cortical activation (decreased α power and increased θ power) when viewing faces, whereas the community intervention group showed the opposite pattern (shorter latency event-related potential [ERP] and greater cortical activation when viewing objects). Greater cortical activation while viewing faces was associated with improved social behavior. This was the first trial to demonstrate that early behavioral intervention is associated with normalized patterns of brain activity, which is associated with improvements in social behavior, in young children with autism spectrum disorder. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Compensated Row-Column Ultrasound Imaging System Using Fisher Tippett Multilayered Conditional Random Field Model

PubMed Central

Ben Daya, Ibrahim; Chen, Albert I. H.; Shafiee, Mohammad Javad; Wong, Alexander; Yeow, John T. W.

2015-01-01

3-D ultrasound imaging offers unique opportunities in the field of non destructive testing that cannot be easily found in A-mode and B-mode images. To acquire a 3-D ultrasound image without a mechanically moving transducer, a 2-D array can be used. The row column technique is preferred over a fully addressed 2-D array as it requires a significantly lower number of interconnections. Recent advances in 3-D row-column ultrasound imaging systems were largely focused on sensor design. However, these imaging systems face three intrinsic challenges that cannot be addressed by improving sensor design alone: speckle noise, sparsity of data in the imaged volume, and the spatially dependent point spread function of the imaging system. In this paper, we propose a compensated row-column ultrasound image reconstruction system using Fisher-Tippett multilayered conditional random field model. Tests carried out on both simulated and real row-column ultrasound images show the effectiveness of our proposed system as opposed to other published systems. Visual assessment of the results show our proposed system’s potential at preserving detail and reducing speckle. Quantitative analysis shows that our proposed system outperforms previously published systems when evaluated with metrics such as Peak Signal to Noise Ratio, Coefficient of Correlation, and Effective Number of Looks. These results show the potential of our proposed system as an effective tool for enhancing 3-D row-column imaging. PMID:26658577

Monostatic lidar in weak-to-strong turbulence

NASA Astrophysics Data System (ADS)

Andrews, L. C.; Phillips, R. L.

2001-07-01

A heuristic scintillation model previously developed for weak-to-strong irradiance fluctuations of a spherical wave is extended in this paper to the case of a monostatic lidar configuration. As in the previous model, we account for the loss of spatial coherence as the optical wave propagates through atmospheric turbulence by eliminating the effects of certain turbulent scale sizes that exist between the scale size of the spatial coherence radius of the beam and that of the scattering disc. These mid-range scale-size effects are eliminated through the formal introduction of spatial scale frequency filters that continually adjust spatial cut-off frequencies as the optical wave propagates. In addition, we also account for correlations that exist in the incident wave to the target and the echo wave from the target arising from double-pass propagation through the same random inhomogeneities of the atmosphere. We separately consider the case of a point target and a diffuse target, concentrating on both the enhanced backscatter effect in the mean irradiance and the increase in scintillation in a monostatic channel. Under weak and strong irradiance fluctuations our asymptotic expressions are in agreement with previously published asymptotic results.

Mechanical properties of electrospun bilayer fibrous membranes as potential scaffolds for tissue engineering.

PubMed

Pu, Juan; Komvopoulos, Kyriakos

2014-06-01

Bilayer fibrous membranes of poly(l-lactic acid) (PLLA) were fabricated by electrospinning, using a parallel-disk mandrel configuration that resulted in the sequential deposition of a layer with fibers aligned across the two parallel disks and a layer with randomly oriented fibers, both layers deposited in a single process step. Membrane structure and fiber alignment were characterized by scanning electron microscopy and two-dimensional fast Fourier transform. Because of the intricacies of the generated electric field, bilayer membranes exhibited higher porosity than single-layer membranes consisting of randomly oriented fibers fabricated with a solid-drum collector. However, despite their higher porosity, bilayer membranes demonstrated generally higher elastic modulus, yield strength and toughness than single-layer membranes with random fibers. Bilayer membrane deformation at relatively high strain rates comprised multiple abrupt microfracture events characterized by discontinuous fiber breakage. Bilayer membrane elongation yielded excessive necking of the layer with random fibers and remarkable fiber stretching (on the order of 400%) in the layer with fibers aligned in the stress direction. In addition, fibers in both layers exhibited multiple localized necking, attributed to the nonuniform distribution of crystalline phases in the fibrillar structure. The high membrane porosity, good mechanical properties, and good biocompatibility and biodegradability of PLLA (demonstrated in previous studies) make the present bilayer membranes good scaffold candidates for a wide range of tissue engineering applications. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial.

PubMed

Konstam, Varda; Gregory, Douglas; Chen, Jie; Weintraub, Andrew; Patel, Ayan; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

2011-02-01

Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure (HF), the incremental impact of an automated home monitoring (AHM) system on health-related quality of life (HRQL) is unknown. We performed a prospective randomized investigation, examining the additive value of AHM to a previously described nurse-directed HF disease management program (SPAN-CHF), with attention to HRQL, in patients with a recent history of decompensated HF. A total of 188 patients were randomized to receive the SPAN-CHF intervention for 90 days, either with (AHM group) or without (NAHM, standard-care group) AHM, with a 1:1 randomization ratio after HF-related hospitalization. HRQL, measured by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) (Physical, Emotional, and Total scores on MLHFQ) was assessed at 3 time points: baseline, 45 days, and 90 days. Although both treatments (AHM and NAHM) improved HRQL at 45 and 90 days compared with baseline with respect to Physical, Emotional, and Total domain scales, no significant difference emerged between AHM and NAHM groups. AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment. When comparing 2 state-of the-art disease management programs regarding HRQL outcomes, our results did not support the added value of AHM. Copyright © 2011. Published by Elsevier Inc.

The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent.

PubMed

Farsi, Marco; Bernini, Marco; Bencini, Lapo; Miranda, Egidio; Manetti, Roberto; de Manzoni, Giovanni; Verlato, Giuseppe; Marrelli, Daniele; Pedrazzani, Corrado; Roviello, Francesco; Marchet, Alberto; Cristadoro, Luigi; Gerard, Leonardo; Moretti, Renato

2009-05-15

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to each surgeon preference. The study is a randomized controlled investigation. The study will be performed in the General and Oncologic Surgery, Department of Oncology-Azienda Ospedaliero-Universitaria Careggi-Florence-Italy, a large teaching institution, with the participation of all surgeons who accept to be involved in, together with other Italian Surgical Centers, on behalf of the GIRCG (Italian Research Group for Gastric Cancer).The patients will be randomized into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group he/she will be submitted to standard gastric surgery only. ClinicalTrials.gov ID. NCT00757640.

Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial.

PubMed

Williams, Hywel C; Bath-Hextall, Fiona; Ozolins, Mara; Armstrong, Sarah J; Colver, Graham B; Perkins, William; Miller, Paul S J

2017-03-01

We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma at low-risk sites in our noninferiority randomized controlled SINS trial. Here we report 5-year data. Participants were randomized to imiquimod 5% cream once daily (superficial basal cell carcinoma, 6 weeks; nodular basal cell carcinoma, 12 weeks) or excisional surgery (4-mm margin). The primary outcome was clinical absence of initial failure or signs of recurrence at the 3-year dermatology review. Five-year success was defined as 3-year success plus absence of recurrences identified through hospital, histopathology, and general practitioner records. Of 501 participants randomized, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five-year success rates for imiquimod were 82.5% (170/206) compared with 97.7% (173/177) for surgery (relative risk of imiquimod success = 0.84, 95% confidence interval = 0.77-0.91, P < 0.001). These were comparable to year 3 success rates of 83.6% (178/213) and 98.4% (185/188) for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year 1. Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

PubMed

Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

2016-08-02

Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

Three-Dimensional Modeling of the Brain's ECS by Minimum Configurational Energy Packing of Fluid Vesicles

PubMed Central

Nandigam, Ravi K.; Kroll, Daniel M.

2007-01-01

The extracellular space of the brain is the heterogeneous porous medium formed by the spaces between the brain cells. Diffusion in this interstitial space is the mechanism by which glucose and oxygen are delivered to the brain cells from the vascular system. It is also a medium for the transport of certain informational substances between the cells (called volume transmission), and for drug delivery. This work involves three-dimensional modeling of the extracellular space as void space in close-packed arrays of fluid membrane vesicles. These packings are generated by minimizing the configurational energy using a Monte Carlo procedure. Both regular and random packs of vesicles are considered. A random walk algorithm is then used to compute the geometric tortuosities, and the results are compared with published experimental data. For the random packings, it is found that although the absolute values for the tortuosities differ, the dependence of the tortuosity on pore volume fraction is very similar to that observed in experiment. The tortuosities we measure are larger than those computed in previous studies of packings of convex polytopes, and modeling improvements, which require higher resolution studies and an improved modeling of brain cell shapes and mechanical properties, could help resolve remaining discrepancies between model simulations and experiment. It is also shown that the specular reflection scheme is the appropriate technique for implementing zero-flux boundary conditions in random walk simulations commonly encountered in diffusion problems. PMID:17307830

Three-dimensional modeling of the brain's ECS by minimum configurational energy packing of fluid vesicles.

PubMed

Nandigam, Ravi K; Kroll, Daniel M

2007-05-15

The extracellular space of the brain is the heterogeneous porous medium formed by the spaces between the brain cells. Diffusion in this interstitial space is the mechanism by which glucose and oxygen are delivered to the brain cells from the vascular system. It is also a medium for the transport of certain informational substances between the cells (called volume transmission), and for drug delivery. This work involves three-dimensional modeling of the extracellular space as void space in close-packed arrays of fluid membrane vesicles. These packings are generated by minimizing the configurational energy using a Monte Carlo procedure. Both regular and random packs of vesicles are considered. A random walk algorithm is then used to compute the geometric tortuosities, and the results are compared with published experimental data. For the random packings, it is found that although the absolute values for the tortuosities differ, the dependence of the tortuosity on pore volume fraction is very similar to that observed in experiment. The tortuosities we measure are larger than those computed in previous studies of packings of convex polytopes, and modeling improvements, which require higher resolution studies and an improved modeling of brain cell shapes and mechanical properties, could help resolve remaining discrepancies between model simulations and experiment. It is also shown that the specular reflection scheme is the appropriate technique for implementing zero-flux boundary conditions in random walk simulations commonly encountered in diffusion problems.

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

PubMed Central

Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

2016-01-01

Background. Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Materials and Methods. Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. Results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532). Conclusion. This is the largest reported study examining why oncology trials are not published. The data show that 4−6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. Implications for Practice: The Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects notes the ethical obligation to report clinical trial data, whether positive or negative. This obligation is listed alongside requirements for risk minimization, access, confidentiality, and informed consent, all bedrocks of the clinical trial system, yet clinical trials are often not published, particularly if negative or difficult to complete. This study found that among American Society for Clinical Oncology (ASCO) Annual Meeting abstracts, 2009–2011, only 61% were published 4–6 years later: 75% of randomized trials and 54% of nonrandomized trials. Clinicians need to insist that every study in which they participate is published. PMID:26888691

Neonatal Seizure Detection Using Deep Convolutional Neural Networks.

PubMed

Ansari, Amir H; Cherian, Perumpillichira J; Caicedo, Alexander; Naulaers, Gunnar; De Vos, Maarten; Van Huffel, Sabine

2018-04-02

Identifying a core set of features is one of the most important steps in the development of an automated seizure detector. In most of the published studies describing features and seizure classifiers, the features were hand-engineered, which may not be optimal. The main goal of the present paper is using deep convolutional neural networks (CNNs) and random forest to automatically optimize feature selection and classification. The input of the proposed classifier is raw multi-channel EEG and the output is the class label: seizure/nonseizure. By training this network, the required features are optimized, while fitting a nonlinear classifier on the features. After training the network with EEG recordings of 26 neonates, five end layers performing the classification were replaced with a random forest classifier in order to improve the performance. This resulted in a false alarm rate of 0.9 per hour and seizure detection rate of 77% using a test set of EEG recordings of 22 neonates that also included dubious seizures. The newly proposed CNN classifier outperformed three data-driven feature-based approaches and performed similar to a previously developed heuristic method.

Randomized controlled trial of 'teens and toddlers': a teenage pregnancy prevention intervention combining youth development and voluntary service in a nursery.

PubMed

Bonell, Chris; Maisey, Ruth; Speight, Svetlana; Purdon, Susan; Keogh, Peter; Wollny, Ivonne; Sorhaindo, Annik; Wellings, Kaye

2013-10-01

We conducted an independent evaluation of the "Teens and Toddlers" intervention. Our randomized trial examined effects on self-reported last sex without contraception, >1 episode of sex without contraception in previous 3 months, expectation of teenage parenthood and youth development score, plus secondary outcomes among 449 at-risk girls age 13/14 in England. The intervention involves 18-20 weekly sessions in pre-school nurseries. Response rates were 95% post-intervention and 91% one year later. At follow-up two, there was no evidence of intervention benefits for primary outcomes and a positive impact for our secondary outcome, low self-esteem. At follow-up one, there was no evidence of benefits for our primary outcomes but evidence of benefits for our secondary outcomes: low self-esteem; low sexual health knowledge; and difficulty discussing the contraceptive pill. The intervention should be refined, with a clearer logic model and more emphasis on sex education, and re-evaluated. Copyright © 2013 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update.

PubMed

Sammour, Tarik; Barazanchi, Ahmed W H; Hill, Andrew G

2017-02-01

The aim of this systematic review was to update previous PROSPECT ( http://www.postoppain.org ) review recommendations for the management of pain after excisional haemorrhoidectomy. Randomized studies and reviews published in the English language from July 2006 (end date of last review) to March 2016, assessing analgesic, anaesthetic, and operative interventions pertaining to excisional haemorrhoidectomy in adults, and reporting pain scores, were retrieved from the EMBASE and MEDLINE databases. An additional 464 studies were identified of which 74 met the inclusion criteria. There were 48 randomized controlled trials and 26 reviews. Quantitative analyses were not performed, as there were limited numbers of trials with a sufficiently homogeneous design. Pudendal nerve block, with or without general anaesthesia, is recommended for all patients undergoing haemorrhoidal surgery. Either closed haemorrhoidectomy, or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure. Combinations of analgesics (paracetamol, non-steroidal anti-inflammatory drugs, and opioids), topical lignocaine and glyceryl trinitrate, laxatives, and oral metronidazole are recommended post-operatively. The recommendations are largely based on single intervention, not multimodal intervention, studies.

Tubal anastomosis after previous sterilization: a systematic review.

PubMed

van Seeters, Jacoba A H; Chua, Su Jen; Mol, Ben W J; Koks, Carolien A M

2017-05-01

Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location. We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success. Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness. We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated. In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

What works best for whom? An exploratory, subgroup analysis in a randomized, controlled trial on the effectiveness of a workplace intervention in low back pain patients on return to work.

PubMed

Steenstra, Ivan A; Knol, Dirk L; Bongers, Paulien M; Anema, Johannes R; van Mechelen, Willem; de Vet, Henrica C W

2009-05-20

Exploratory subgroup analysis in a randomized controlled trial (RCT). To detect possible moderators in the effectiveness of a workplace intervention in a population of workers with sick leave due to sub acute nonspecific low back pain. In a recently published RCT, a workplace intervention was effective on return to work, compared to usual care. Examining the heterogeneity of effect sizes within the population in this RCT (n = 196) can lead to information on the effectiveness of the intervention in subgroups of patients. A subgroup analysis was performed by adding interaction terms to the statistical model. Before analysis the following possible moderators for treatment were identified: age, gender, pain, functional status, heavy work, and sick leave in the previous 12 months. Cox regression analyses were performed and survival curves were plotted. The interaction (P = 0.02) between age (dichotomized at the median value) and the workplace intervention indicates a modifying effect. The workplace intervention is more effective for workers > or =44 years (HR, 95% CI = 2.5, [1.6, 4.1] vs. 1.2 [0.8, 1.8] for workers <44 years old). The interaction between sick leave in the previous 12 months and the workplace intervention is significant (P = 0.02). The intervention is more effective for workers with previous sick leave (HR, 95% CI = 2.8 [1.7, 4.9] vs. 1.3 [0.8, 2.0]). A modifying effect of gender, heavy work, and pain score and functional status on the effectiveness of this intervention was not found. The findings from these exploratory analyses should be tested in future RCTs. This workplace intervention seems very suitable for return to work of older workers and workers with previous sick leave. Gender, perceived heavy work, and baseline scores in pain and functional status should not be a basis for assignment to this intervention.

Improving influenza vaccination rates in the workplace: a randomized trial.

PubMed

Nowalk, Mary Patricia; Lin, Chyongchiou J; Toback, Seth L; Rousculp, Matthew D; Eby, Charles; Raymund, Mahlon; Zimmerman, Richard K

2010-03-01

To minimize absenteeism resulting from influenza, employers frequently offer on-site influenza vaccination to employees. Yet the level of uptake of vaccine is low among working adults. This study was designed to increase workplace influenza vaccination rates by offering both a choice of intranasal (LAIV) and injectable (TIV) influenza vaccines to eligible employees, and an incentive for being vaccinated, and by increasing awareness of the vaccine clinic. This study used a stratified randomized cluster trial. A total of 12,222 employees in 53 U.S. companies with previous influenza vaccine clinics were examined. Control sites advertised and offered vaccine clinics as previously done. Choice sites offered LAIV or TIV and maintained their previous advertising level but promoted the choice of vaccines. Choice Plus sites increased advertising and promoted and offered a choice of vaccines and a nominal incentive. These included vaccination rates among eligible employees. Hierarchic linear modeling (HLM) was used to determine factors associated with vaccination. The overall vaccination rate increased from 39% in 2007-2008 to 46% in 2008-2009 (p<0.001). The difference in vaccination rates for LAIV was 6.5% for Choice versus Control and 9.9% for Choice Plus versus Control (both p<0.001). Rates of TIV increased by 15.9 percentage points in the Choice Plus arm versus Control for workers aged > or =50 years (p=0.024). Rates of TIV did not change in workers aged 18-49 years in either intervention arm or in workers aged > or =50 years in the Choice arm. In HLM analyses, factors significantly associated with increased vaccination were older age, female gender, previous company vaccination rate, and the Choice Plus intervention. An incentive for vaccination, an intensified advertising campaign, and offering a choice of influenza vaccines improved vaccination rates in the workplace. Copyright (c) 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Total hip arthroplasty after a previous pelvic osteotomy: A systematic review and meta-analysis.

PubMed

Shigemura, T; Yamamoto, Y; Murata, Y; Sato, T; Tsuchiya, R; Wada, Y

2018-06-01

There are several reports regarding total hip arthroplasty (THA) after a previous pelvic osteotomy (PO). However, to our knowledge, until now there has been no formal systematic review and meta-analysis published to summarize the clinical results of THA after a previous PO. Therefore, we conducted a systematic review and meta-analysis of results of THA after a previous PO. We focus on these questions as follows: does a previous PO affect the results of subsequent THA, such as clinical outcomes, operative time, operative blood loss, and radiological parameters. Using PubMed, Web of Science, and Cochrane Library, we searched for relevant original papers. The pooling of data was performed using RevMan software (version 5.3, Cochrane Collaboration, Oxford, UK). A p-value<0.05 was judged as significant. Standardized mean differences (SMD) were calculated for continuous data with a 95% confidence interval (CI) was reported. Statistical heterogeneity was assessed based on I 2 using standard χ 2 test. When I 2 >50%, significant heterogeneity was assumed and a random-effects model was applied for the meta-analysis. A fixed-effects model was applied in the absence of significant heterogeneity. Eleven studies were included in this meta-analysis. The pooled results indicated that there was no significant difference in postoperative Merle D'Aubigne-Postel score (I 2 =0%, SMD=-0.15, 95% CI: -0.36 to 0.06, p=0.17), postoperative Harris hip score (I 2 =60%, SMD=-0.23, 95% CI: -0.50 to 0.05, p=0.10), operative time (I 2 =86%, SMD=0.37, 95% CI: -0.09 to 0.82, p=0.11), operative blood loss (I 2 =82%, SMD=0.23, 95% CI: -0.17 to 0.63, p=0.25), and cup abduction angle (I 2 =43%, SMD=-0.08, 95% CI: -0.25 to 0.09, p=0.38) between THA with and without a previous PO. However, cup anteversion angle of THA with a previous PO was significantly smaller than that of without a previous PO (I 2 =77%, SMD=-0.63, 95% CI: -1.13 to -0.13, p=0.01). Systematic review and meta-analysis of results of THA after a previous PO was performed. A previous PO did not affect the results of subsequent THA, except for cup anteversion. Because of the low quality evidence currently available, high-quality randomized controlled trials are required. Level III, meta-analysis of case-control studies. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Assessment of reporting quality of conference abstracts in sports injury prevention according to CONSORT and STROBE criteria and their subsequent publication rate as full papers.

PubMed

Yoon, Uzung; Knobloch, Karsten

2012-04-11

The preliminary results of a study are usually presented as an abstract in conference meetings. The reporting quality of those abstracts and the relationship between their study designs and full paper publication rate is unknown. We hypothesized that randomized controlled trials are more likely to be published as full papers than observational studies. 154 oral abstracts presented at the World Congress of Sports Injury Prevention 2005 Oslo and the corresponding full paper publication were identified and analysed. The main outcome measures were frequency of publication, time to publication, impact factor, CONSORT (for Consolidated Standards of Reporting Trials) score, STROBE (for Strengthening the Reporting of Observational Studies in Epidemiology) score, and minor and major inconsistencies between the abstract and the full paper publication. Overall, 76 of the 154 (49%) presented abstracts were published as full papers in a peer-reviewed journal with an impact factor of 1.946 ± 0.812. No significant difference existed between the impact factor for randomized controlled trials (2.122 ± 1.015) and observational studies (1.913 ± 0.765, p = 0.469). The full papers for the randomized controlled trials were published after an average (SD) of 17 months (± 13 months); for observational studies, the average (SD) was 12 months (± 14 months) (p = 0.323). A trend was observed in this study that a higher percentage of randomized controlled trial abstracts were published as full papers (71% vs. 47%, p = 0.078) than observational trials. The reporting quality of abstracts, published as full papers, significantly increased compared to conference abstracts both in randomized control studies ( 5.7 ± 0.7 to 7.2 ± 1.3; p = 0.018, CI -2.7 to -0.32) and in observational studies (STROBE: 8.2 ± 1.3 to 8.6 ± 1.4; p = 0.007, CI -0.63 to -0.10). All of the published abstracts had at least one minor inconsistency (title, authors, research center, outcome presentation, conclusion), while 65% had at least major inconsistencies (study objective, hypothesis, study design, primary outcome measures, sample size, statistical analysis, results, SD/CI). Comparing the results of conference and full paper; results changed in 90% vs. 68% (randomized, controlled studies versus observational studies); data were added (full paper reported more result data) in 60% vs. 30%, and deleted (full paper reported fewer result data) in 40% vs. 30%. No significant differences with respect to type of study (randomized controlled versus observational), impact factor, and time to publication existed for the likelihood that a World Congress of Sports Injury conference abstract could be published as a full paper.

Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

PubMed

Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

2013-12-01

The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration-approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose). From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0.02), adverse events (73% versus 45%, p<0.001), and serious adverse events (99% versus 63%, p<0.001). The main study limitation was that we considered only the publication describing the results for the primary outcomes. Our results highlight the need to search ClinicalTrials.gov for both unpublished and published trials. Trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article.

Computer simulated modeling of healthy and diseased right ventricular and pulmonary circulation.

PubMed

Chou, Jody; Rinehart, Joseph B

2018-01-12

We have previously developed a simulated cardiovascular physiology model for in-silico testing and validation of novel closed-loop controllers. To date, a detailed model of the right heart and pulmonary circulation was not needed, as previous controllers were not intended for use in patients with cardiac or pulmonary pathology. With new development of controllers for vasopressors, and looking forward, for combined vasopressor-fluid controllers, modeling of right-sided and pulmonary pathology is now relevant to further in-silico validation, so we aimed to expand our existing simulation platform to include these elements. Our hypothesis was that the completed platform could be tuned and stabilized such that the distributions of a randomized sample of simulated patients' baseline characteristics would be similar to reported population values. Our secondary outcomes were to further test the system in representing acute right heart failure and pulmonary artery hypertension. After development and tuning of the right-sided circulation, the model was validated against clinical data from multiple previously published articles. The model was considered 'tuned' when 100% of generated randomized patients converged to stability (steady, physiologically-plausible compartmental volumes, flows, and pressures) and 'valid' when the means for the model data in each health condition were contained within the standard deviations for the published data for the condition. A fully described right heart and pulmonary circulation model including non-linear pressure/volume relationships and pressure dependent flows was created over a 6-month span. The model was successfully tuned such that 100% of simulated patients converged into a steady state within 30 s. Simulation results in the healthy state for central venous volume (3350 ± 132 ml) pulmonary blood volume (405 ± 39 ml), pulmonary artery pressures (systolic 20.8 ± 4.1 mmHg and diastolic 9.4 ± 1.8 mmHg), left atrial pressure (4.6 ± 0.8 mmHg), PVR (1.0 ± 0.2 wood units), and CI (3.8 ± 0.5 l/min/m 2 ) all met criteria for acceptance of the model, though the standard deviations of LAP and CI were somewhat narrower than published comparators. The simulation results for right ventricular infarction also fell within the published ranges: pulmonary blood volume (727 ± 102 ml), pulmonary arterial pressures (30 ± 4 mmHg systolic, 12 ± 2 mmHg diastolic), left atrial pressure (13 ± 2 mmHg), PVR (1.6 ± 0.3 wood units), and CI (2.0 ± 0.4 l/min/m 2 ) all fell within one standard deviation of the reported population values and vice-versa. In the pulmonary hypertension model, pulmonary blood volume of 615 ± 90 ml, pulmonary arterial pressures of 80 ± 14 mmHg systolic, 36 ± 7 mmHg diastolic, and the left atrial pressure of 11 ± 2 mmHg all met criteria for acceptance. For CI, the simulated value of 2.8 ± 0.4 l/min/m 2 once again had a narrower spread than most of the published data, but fell inside of the SD of all published data, and the PVR value of 7.5 ± 1.6 wood units fell in the middle of the four published studies. The right-ventricular and pulmonary circulation simulation appears to be a reasonable approximation of the right-sided circulation for healthy physiology as well as the pathologic conditions tested.

Endophthalmitis Prophylaxis in Cataract Surgery: Overview of Current Practice Patterns Around the World.

PubMed

Grzybowski, Andrzej; Schwartz, Stephen G; Matsuura, Kazuki; Ong Tone, Stephan; Arshinoff, Steve; Ng, Jonathon Q; Meyer, Jay J; Liu, Wu; Jacob, Soosan; Packer, Mark; Lutfiamida, Rifna; Tahija, Sjakon; Roux, Paul; Malyugin, Boris; Urrets-Zavalia, Julio A; Crim, Nicolas; Esposito, Evangelina; Daponte, Pablo; Pellegrino, Fernando; Graue-Hernandez, Enrique O; Jimenez-Corona, Aida; Valdez-Garcia, Jorge E; Hernandez-Camarena, Julio C; Relhan, Nidhi; Flynn, Harry W; Ravindran, Ravilla D; Behnding, Anders

2017-01-01

Acute-onset postoperative endophthalmitis after cataract surgery remains a rare but important cause of visual loss. There is no global consensus regarding the optimal strategies for prophylaxis of endophthalmitis and practices vary substantially around the world, especially with respect to the use of intracameral antibiotics. The European Society of Cataract & Refractive Surgeons in a randomized clinical trial (2007) reported an approximately 5-fold reduction in endophthalmitis rates associated with the use of intracameral cefuroxime. Despite this report, the use of intracameral antibiotics has not been universally adopted. Various endophthalmitis prophylaxis patterns around the world (including the United States, Canada, Australia/New Zealand, Japan, China, India, Indonesia, South Africa, Argentina, Russia, Sweden and Mexico) are compared. Each contributing author was asked to provide similar information, including endophthalmitis rates based on published studies, current practice patterns, and in some cases original survey data. Various methods were used to obtain this information, including literature reviews, expert commentary, and some new survey data not previously published. Many different practice patterns were reported from around the world, specifically with respect to the use of intracameral antibiotics. There is no worldwide consensus regarding endophthalmitis prophylaxis with cataract surgery. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Can Functional Movement Assessment Predict Football Head Impact Biomechanics?

PubMed

Ford, Julia M; Campbell, Kody R; Ford, Cassie B; Boyd, Kenneth E; Padua, Darin A; Mihalik, Jason P

2018-06-01

The purposes of this study was to determine functional movement assessments' ability to predict head impact biomechanics in college football players and to determine whether head impact biomechanics could explain preseason to postseason changes in functional movement performance. Participants (N = 44; mass, 109.0 ± 20.8 kg; age, 20.0 ± 1.3 yr) underwent two preseason and postseason functional movement assessment screenings: 1) Fusionetics Movement Efficiency Test and 2) Landing Error Scoring System (LESS). Fusionetics is scored 0 to 100, and participants were categorized into the following movement quality groups as previously published: good (≥75), moderate (50-75), and poor (<50). The LESS is scored 0 to 17, and participants were categorized into the following previously published movement quality groups: good (≤5 errors), moderate (6-7 errors), and poor (>7 errors). The Head Impact Telemetry (HIT) System measured head impact frequency and magnitude (linear acceleration and rotational acceleration). An encoder with six single-axis accelerometers was inserted between the padding of a commercially available Riddell football helmet. We used random intercepts general linear-mixed models to analyze our data. There were no effects of preseason movement assessment group on the two Head Impact Telemetry System impact outcomes: linear acceleration and rotational acceleration. Head impact frequency did not significantly predict preseason to postseason score changes obtained from the Fusionetics (F1,36 = 0.22, P = 0.643, R = 0.006) or the LESS (F1,36 < 0.01, P = 0.988, R < 0.001) assessments. Previous research has demonstrated an association between concussion and musculoskeletal injury, as well as functional movement assessment performance and musculoskeletal injury. The functional movement assessments chosen may not be sensitive enough to detect neurological and neuromuscular differences within the sample and subtle changes after sustaining head impacts.

Cognitive Behaviour Therapy for Bulimia Nervosa and Eating Disorders Not Otherwise Specified: Translation from Randomized Controlled Trial to a Clinical Setting.

PubMed

Knott, Sarah; Woodward, Debbie; Hoefkens, Antonia; Limbert, Caroline

2015-11-01

Enhanced Cognitive Behaviour Therapy (CBT-E) (Fairburn, Cooper and Shafran, 2003) was developed as a treatment approach for eating disorders focusing on both core psychopathology and additional maintenance mechanisms. To evaluate treatment outcomes associated with CBT-E in a NHS Eating Disorders Service for adults with bulimia and atypical eating disorders and to make comparisons with a previously published randomized controlled trial (Fairburn et al., 2009) and "real world" evaluation (Byrne, Fursland, Allen and Watson, 2011). Participants were referred to the eating disorder service between 2002 and 2011. They were aged between 18-65 years, registered with a General Practitioner within the catchment area, and had experienced symptoms fulfilling criteria for BN or EDNOS for a minimum of 6 months. CBT-E was commenced by 272 patients, with 135 completing treatment. Overall, treatment was associated with significant improvements in eating disorder and associated psychopathology, for both treatment completers and the intention to treat sample. Findings support dissemination of CBT-E in this context, with significant improvements in eating disorder psychopathology. Improvements to global EDE-Q scores were higher for treatment completers and lower for the intention to treat sample, compared to previous studies (Fairburn et al., 2009; Byrne et al., 2011). Level of attrition was found at 40.8% and non-completion of treatment was associated with higher levels of anxiety. Potential explanations for these findings are discussed.

A randomized breast-feeding promotion intervention did not reduce child obesity in Belarus.

PubMed

Kramer, Michael S; Matush, Lidia; Vanilovich, Irina; Platt, Robert W; Bogdanovich, Natalia; Sevkovskaya, Zinaida; Dzikovich, Irina; Shishko, Gyorgy; Collet, Jean-Paul; Martin, Richard M; Smith, George Davey; Gillman, Matthew W; Chalmers, Beverley; Hodnett, Ellen; Shapiro, Stanley

2009-02-01

The evidence that breast-feeding protects against obesity is based on observational studies, with potential for confounding and selection bias. This article summarizes a previously published study in which we assessed whether an intervention designed to promote exclusive and prolonged breast-feeding affects children's height, weight, adiposity, and blood pressure (BP) at age 6.5 y. The Promotion of Breastfeeding Intervention Trial (PROBIT) is a cluster-randomized trial of a breast-feeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative. A total of 17,046 healthy breast-fed infants were enrolled from 31 Belarussian maternity hospitals and affiliated clinics, of whom 13,889 (81.5%) were followed up at 6.5 y with duplicate measurements of height, weight, waist circumference, triceps and subscapular skinfold thicknesses, systolic and diastolic BP. Analysis was based on intention to treat, with statistical adjustment for clustering within hospitals/clinics to permit inferences at the individual level. The experimental intervention led to a large increase in exclusive breast-feeding at 3 mo (43.3% vs. 6.4%, P < 0.001) and a significantly higher prevalence of any breast-feeding throughout infancy. No significant intervention effects were observed on height, BMI, adiposity measures, or BP. The breast-feeding promotion intervention resulted in substantial increases in the duration and exclusivity of breast-feeding yet did not reduce measures of adiposity at age 6.5 y. Previous reports of protective effects against obesity may reflect uncontrolled bias caused by confounding and selection.

A systematic review of randomized clinical trials published in Malaria Journal between 2008 and 2013.

PubMed

Martínez-Alonso, E; Ramos, J M

2016-06-01

Randomized controlled trials (RCT) are a key component in clinical research and they provide the highest quality clinical results. The objective of this study was to describe the main characteristics of RCTs published in Malaria Journal, including research topics, study population and design, funding sources and collaboration between institutions. This may help researchers and funders define future research priorities in this field. A retrospective analysis was performed on the RCTs published in Malaria Journal between January 1, 2008 and December 31, 2013. A key-word search by "Randomized controlled trial" or "Random*" was carried out in PubMed. RCT indexed to MEDLINE were selected for the analysis. A total of 108 published articles containing RCTs were analysed. Treatment of uncomplicated Plasmodium falciparum malaria (n=45, 41.6%), especially the efficacy and safety of antimalarial drugs, and malaria prevention (n=34, 31.5%) were the two main research topics. The majority of trials were conducted in Africa (62.2%) and Asia (27%) and received external funding (private, 42.3% and/or public, 38.6%). Paediatric population was the primary study group (n=63, 58.3%), followed by adults (n=29, 26.9%). Pregnant women (n=7) and geriatric population (n=1) remain underrepresented. Nearly 75% of trials were conducted in individual subjects and 25% in groups of subjects (cluster RCTs). A considerable collaboration between researchers and institutions is noteworthy. RCTs published in Malaria Journal address a wide range of research topics. Paediatric trials conducted in Africa and Asia are frequently performed, and a significant worldwide collaboration to fight against malaria has been identified.

Pancreatic surgery.

PubMed

Donahue, Timothy R; Reber, Howard A

2013-09-01

To summarize published research on pancreatic surgery over the past year. A number of studies aiming to reduce the costs associated with pancreatic surgery were reported. Retrospective analyses confirmed previous findings that neither the routine use of pancreatic duct stents decreases the rate of fistula formation nor does placement of a drain at the time of surgery change the morbidity in patients who develop one. Minimally invasive approaches, both laparoscopic and robot-assisted, are being performed more frequently to remove pancreatic cancers. A randomized trial confirmed that reinforcement of stapled closure during distal pancreatectomy reduces the rate of fistula formation. Controversy remains over whether small pancreatic neuroendocrine tumors need to be surgically resected or can be treated nonoperatively. Patients with chronic pancreatitis should be screened thoroughly before being offered surgical treatment; two studies reported preoperative factors that can be used to identify those most likely to experience pain relief. Studies published on pancreatic surgery last year focused on a wide-range of topics. The morbidity and mortality of patients undergoing pancreatic surgery continues to improve, and we anticipate that incorporation of these new findings will lead to even better outcomes.

Prefilled certolizumab pegol (Cimzia®) syringes for self-use in the treatment of rheumatoid arthritis

PubMed Central

Rosa, J; Sabelli, M; Soriano, Enrique R

2010-01-01

A new anti-tumor necrosis factor alpha (TNF-α) inhibitor with a novel mechanism of action has entered phase 3 trials in rheumatoid arthritis (RA). Certolizumab pegol (Cimzia®) is a humanized Fab′ antibody fragment against TNF-α with a polyethylene glycol tail that prevents complement-dependent and antibody-dependent cell-mediated cytotoxicity or apoptosis. Four randomized clinical trials have been published so far. Reported results are similar to those published in previous studies with other TNF-α inhibitors, with ACR20, ACR50, and ACR70 responses of around 60%, 40%, and 20%, respectively, when combined with methotrexate and slightly lower when used as monotherapy. Safety was shown to be similar to that seen with TNF-α blockers and some cases of tuberculosis were seen in the trials, stressing the importance of a complete screening in these patients. Although we still need effectiveness and safety data in larger numbers of patients and longer follow-up, this new TNF inhibitor is a welcome addition to our current armamentarium for the treatment of RA. PMID:22915918

Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis.

PubMed

Bala, Malgorzata M; Akl, Elie A; Sun, Xin; Bassler, Dirk; Mertz, Dominik; Mejza, Filip; Vandvik, Per Olav; Malaga, German; Johnston, Bradley C; Dahm, Philipp; Alonso-Coello, Pablo; Diaz-Granados, Natalia; Srinathan, Sadeesh K; Hassouneh, Basil; Briel, Matthias; Busse, Jason W; You, John J; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

2013-03-01

To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals. We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals. Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P < 0.05 for all differences. RCTs published in higher impact journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias. Copyright © 2013 Elsevier Inc. All rights reserved.

Association between expression of random gene sets and survival is evident in multiple cancer types and may be explained by sub-classification.

PubMed

Shimoni, Yishai

2018-02-01

One of the goals of cancer research is to identify a set of genes that cause or control disease progression. However, although multiple such gene sets were published, these are usually in very poor agreement with each other, and very few of the genes proved to be functional therapeutic targets. Furthermore, recent findings from a breast cancer gene-expression cohort showed that sets of genes selected randomly can be used to predict survival with a much higher probability than expected. These results imply that many of the genes identified in breast cancer gene expression analysis may not be causal of cancer progression, even though they can still be highly predictive of prognosis. We performed a similar analysis on all the cancer types available in the cancer genome atlas (TCGA), namely, estimating the predictive power of random gene sets for survival. Our work shows that most cancer types exhibit the property that random selections of genes are more predictive of survival than expected. In contrast to previous work, this property is not removed by using a proliferation signature, which implies that proliferation may not always be the confounder that drives this property. We suggest one possible solution in the form of data-driven sub-classification to reduce this property significantly. Our results suggest that the predictive power of random gene sets may be used to identify the existence of sub-classes in the data, and thus may allow better understanding of patient stratification. Furthermore, by reducing the observed bias this may allow more direct identification of biologically relevant, and potentially causal, genes.

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

PubMed

Vierhout, Bastiaan P; Saleem, Ben R; Ott, Alewijn; van Dijl, Jan Maarten; de Kempenaer, Ties D van Andringa; Pierie, Maurice E N; Bottema, Jan T; Zeebregts, Clark J

2015-09-14

Access for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. Percutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections. NTR4257 10 November 2013, NL44578.042.13.

Association between expression of random gene sets and survival is evident in multiple cancer types and may be explained by sub-classification

PubMed Central

2018-01-01

One of the goals of cancer research is to identify a set of genes that cause or control disease progression. However, although multiple such gene sets were published, these are usually in very poor agreement with each other, and very few of the genes proved to be functional therapeutic targets. Furthermore, recent findings from a breast cancer gene-expression cohort showed that sets of genes selected randomly can be used to predict survival with a much higher probability than expected. These results imply that many of the genes identified in breast cancer gene expression analysis may not be causal of cancer progression, even though they can still be highly predictive of prognosis. We performed a similar analysis on all the cancer types available in the cancer genome atlas (TCGA), namely, estimating the predictive power of random gene sets for survival. Our work shows that most cancer types exhibit the property that random selections of genes are more predictive of survival than expected. In contrast to previous work, this property is not removed by using a proliferation signature, which implies that proliferation may not always be the confounder that drives this property. We suggest one possible solution in the form of data-driven sub-classification to reduce this property significantly. Our results suggest that the predictive power of random gene sets may be used to identify the existence of sub-classes in the data, and thus may allow better understanding of patient stratification. Furthermore, by reducing the observed bias this may allow more direct identification of biologically relevant, and potentially causal, genes. PMID:29470520

Patients' ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial.

PubMed

Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

2015-07-01

Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful - RR 1.00 (95% CI 0.68-1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. © 2015 The Authors Allergy Published by John Wiley & Sons Ltd.

Diabetes, plasma glucose and incidence of pancreatic cancer: A prospective study of 0.5 million Chinese adults and a meta-analysis of 22 cohort studies.

PubMed

Pang, Yuanjie; Kartsonaki, Christiana; Guo, Yu; Bragg, Fiona; Yang, Ling; Bian, Zheng; Chen, Yiping; Iona, Andri; Millwood, Iona Y; Lv, Jun; Yu, Canqing; Chen, Junshi; Li, Liming; Holmes, Michael V; Chen, Zhengming

2017-04-15

Diabetes is associated with an increased risk of pancreatic cancer (PC) in Western populations. Uncertainty remains, however, about the relevance of plasma glucose for PC among people without diabetes and about the associations of diabetes and high blood glucose with PC in China where the increase in diabetes prevalence has been very recent. The prospective China Kadoorie Biobank (CKB) study recruited 512,000 adults aged 30-79 years from 10 diverse areas of China during 2004-2008, recording 595 PC cases during 8 years of follow-up. Cox regression yielded adjusted hazard ratios (HRs) for PC associated with diabetes (previously diagnosed or screen-detected) and, among those without previously diagnosed diabetes, with levels of random plasma glucose (RPG). These were further meta-analysed with 22 published prospective studies. Overall 5.8% of CKB participants had diabetes at baseline. Diabetes was associated with almost twofold increased risk of PC (adjusted HR = 1.87, 95% CI 1.48-2.37), with excess risk higher in those with longer duration since diagnosis (p for trend = 0.01). Among those without previously diagnosed diabetes, each 1 mmol/L higher usual RPG was associated with a HR of 1.12 (1.04-1.21). In meta-analysis of CKB and 22 other studies, previously diagnosed diabetes was associated with a 52% excess risk (1.52, 1.43-1.63). Among those without diabetes, each 1 mmol/L higher blood glucose was associated with a 15% (1.15, 1.09-1.21) excess risk. In Chinese and non-Chinese populations, diabetes and higher blood glucose levels among those without diabetes are associated with an increased risk of PC. © 2017 The Authors International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

Is the concomitant use of clopidogrel and Proton Pump Inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty?: a systematic review and meta-analysis of recently published studies (2012 - 2016).

PubMed

Bundhun, Pravesh Kumar; Teeluck, Abhishek Rishikesh; Bhurtu, Akash; Huang, Wei-Qiang

2017-01-05

Controversies were previously observed with the concomitant use of clopidogrel and Proton Pump Inhibitors (PPIs), especially omeprazole, following coronary angioplasty. Even though several studies showed no interaction between clopidogrel and PPIs, questions have been raised about the decrease in antiplatelet effects of clopidogrel with PPIs. A previously published meta-analysis showed concomitant use of clopidogrel and PPIs to be associated with higher adverse cardiovascular outcomes. However, data which were used were extracted from studies published before the year 2012. Whether these controversies still exist in this new era is not clear. Therefore, we aim to show if the concomitant use of clopidogrel and PPIs is still associated with higher adverse outcomes following Percutaneous Coronary Intervention (PCI) using data obtained from recently published studies (2012 to 2016). Electronic databases were searched for recent publications (2012-2016) comparing (clopidogrel plus PPIs) versus clopidogrel alone following PCI. Adverse cardiovascular outcomes were considered as the clinical endpoints. Odds Ratios (OR) with 95% Confidence Intervals (CI) were used as the statistical parameters and the pooled analyses were performed with RevMan 5.3 software. Eleven studies with a total number of 84,729 patients (29,235 patients from the PPIs group versus 55,494 patients from the non-PPIs group) were included. Results of this analysis showed that short term mortality and Target Vessel Revascularization (TVR) significantly favored the non-PPIs group with OR: 1.55; 95% CI: 1.43-1.68, P < 0.00001 and OR: 1.26; 95% CI: 1.06-1.49, P = 0.009 respectively. Long-term Major Adverse Cardiac Events (MACEs), Myocardial Infarction (MI), Stent Thrombosis (ST) and TVR significantly favored patients who did not use PPIs with OR: 1.37; 95% CI: 1.23-1.53, P < 0.00001, OR: 1.41; 95% CI: 1.26-1.57, P < 0.00001 and OR: 1.38; 95% CI: 1.13-1.70, P = 0.002 and OR: 1.28; 95% CI: 1.01-1.61, P = 0.04 respectively. However, the result for long term mortality was not statistically significant. The combined use of clopidogrel with PPIs is still associated with significantly higher adverse cardiovascular events such as MACEs, ST and MI following PCI supporting results of the previously published meta-analysis. However, long-term mortality is not statistically significant warranting further analysis with randomized patients.

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting.

PubMed

Massey, Paul R; Wang, Ruibin; Prasad, Vinay; Bates, Susan E; Fojo, Tito

2016-03-01

Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4-6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11-1.36], p < .001; and 1.64 [1.15-2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38-1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61-1.29]; p = .532). This is the largest reported study examining why oncology trials are not published. The data show that 4-6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. ©AlphaMed Press.

Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access.

PubMed

Squara, Fabien; Tomi, Julien; Scarlatti, Didier; Theodore, Guillaume; Moceri, Pamela; Ferrari, Emile

2017-12-01

Axillary vein access for pacemaker implantation is uncommon in many centres because of the lack of training in this technique. We assessed whether the introduction of the axillary vein technique was safe and efficient as compared with cephalic vein access, in a centre where no operators had any previous experience in axillary vein puncture. Patients undergoing pacemaker implantation were randomized to axillary or cephalic vein access. All three operators had no experience nor training in axillary vein puncture, and self-learned the technique by reading a published review. Axillary vein puncture was fluoroscopy-guided without contrast venography. Cephalic access was performed by dissection of delto-pectoral groove. Venous access success, venous access duration (from skin incision to guidewire or lead in superior vena cava), procedure duration, X-ray exposure, and peri-procedural (1 month) complications were recorded. results We randomized 74 consecutive patients to axillary (n = 37) or cephalic vein access (n = 37). Axillary vein was successfully accessed in 30/37 (81.1%) patients vs. 28/37 (75.7%) of cephalic veins (P = 0.57). Venous access time was shorter in axillary group than in cephalic group [5.7 (4.4-8.3) vs. 12.2 (10.5-14.8) min, P < 0.001], as well as procedure duration [34.8 (30.6-38.4) vs. 42.0 (39.1-46.6) min, P = 0.043]. X-ray exposure and peri-procedural overall complications were comparable in both groups. Axillary puncture was safe and faster than cephalic access even for the five first procedures performed by each operator. Self-taught axillary vein puncture for pacemaker implantation seems immediately safe and faster than cephalic vein access, when performed by electrophysiologists trained to pacemaker implantation but not to axillary vein puncture. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

Randomly auditing research labs could be an affordable way to improve research quality: A simulation study

PubMed Central

Zardo, Pauline; Graves, Nicholas

2018-01-01

The “publish or perish” incentive drives many researchers to increase the quantity of their papers at the cost of quality. Lowering quality increases the number of false positive errors which is a key cause of the reproducibility crisis. We adapted a previously published simulation of the research world where labs that produce many papers are more likely to have “child” labs that inherit their characteristics. This selection creates a competitive spiral that favours quantity over quality. To try to halt the competitive spiral we added random audits that could detect and remove labs with a high proportion of false positives, and also improved the behaviour of “child” and “parent” labs who increased their effort and so lowered their probability of making a false positive error. Without auditing, only 0.2% of simulations did not experience the competitive spiral, defined by a convergence to the highest possible false positive probability. Auditing 1.35% of papers avoided the competitive spiral in 71% of simulations, and auditing 1.94% of papers in 95% of simulations. Audits worked best when they were only applied to established labs with 50 or more papers compared with labs with 25 or more papers. Adding a ±20% random error to the number of false positives to simulate peer reviewer error did not reduce the audits’ efficacy. The main benefit of the audits was via the increase in effort in “child” and “parent” labs. Audits improved the literature by reducing the number of false positives from 30.2 per 100 papers to 12.3 per 100 papers. Auditing 1.94% of papers would cost an estimated $15.9 million per year if applied to papers produced by National Institutes of Health funding. Our simulation greatly simplifies the research world and there are many unanswered questions about if and how audits would work that can only be addressed by a trial of an audit. PMID:29649314

Randomly auditing research labs could be an affordable way to improve research quality: A simulation study.

PubMed

Barnett, Adrian G; Zardo, Pauline; Graves, Nicholas

2018-01-01

The "publish or perish" incentive drives many researchers to increase the quantity of their papers at the cost of quality. Lowering quality increases the number of false positive errors which is a key cause of the reproducibility crisis. We adapted a previously published simulation of the research world where labs that produce many papers are more likely to have "child" labs that inherit their characteristics. This selection creates a competitive spiral that favours quantity over quality. To try to halt the competitive spiral we added random audits that could detect and remove labs with a high proportion of false positives, and also improved the behaviour of "child" and "parent" labs who increased their effort and so lowered their probability of making a false positive error. Without auditing, only 0.2% of simulations did not experience the competitive spiral, defined by a convergence to the highest possible false positive probability. Auditing 1.35% of papers avoided the competitive spiral in 71% of simulations, and auditing 1.94% of papers in 95% of simulations. Audits worked best when they were only applied to established labs with 50 or more papers compared with labs with 25 or more papers. Adding a ±20% random error to the number of false positives to simulate peer reviewer error did not reduce the audits' efficacy. The main benefit of the audits was via the increase in effort in "child" and "parent" labs. Audits improved the literature by reducing the number of false positives from 30.2 per 100 papers to 12.3 per 100 papers. Auditing 1.94% of papers would cost an estimated $15.9 million per year if applied to papers produced by National Institutes of Health funding. Our simulation greatly simplifies the research world and there are many unanswered questions about if and how audits would work that can only be addressed by a trial of an audit.

Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

PubMed

Luciano, Juan V; D'Amico, Francesco; Feliu-Soler, Albert; McCracken, Lance M; Aguado, Jaume; Peñarrubia-María, María T; Knapp, Martin; Serrano-Blanco, Antoni; García-Campayo, Javier

2017-07-01

The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

True photographs and false memories.

PubMed

Lindsay, D Stephen; Hagen, Lisa; Read, J Don; Wade, Kimberley A; Garry, Maryanne

2004-03-01

Some trauma-memory-oriented psychotherapists advise clients to review old family photo albums to cue suspected "repressed" memories of childhood sexual abuse. Old photos might cue long-forgotten memories, but when combined with other suggestive influences they might also contribute to false memories. We asked 45 undergraduates to work at remembering three school-related childhood events (two true events provided by parents and one pseudoevent). By random assignment, 23 subjects were also given their school classes' group photos from the years of the to-be-recalled events as memory cues. As predicted, the rate of false-memory reports was dramatically higher in the photo condition than in the no-photo condition. Indeed, the rate of false-memory reports in the photo condition was substantially higher than the rate in any previously published study.

Generalized Effective Medium Theory for Particulate Nanocomposite Materials

PubMed Central

Siddiqui, Muhammad Usama; Arif, Abul Fazal M.

2016-01-01

The thermal conductivity of particulate nanocomposites is strongly dependent on the size, shape, orientation and dispersion uniformity of the inclusions. To correctly estimate the effective thermal conductivity of the nanocomposite, all these factors should be included in the prediction model. In this paper, the formulation of a generalized effective medium theory for the determination of the effective thermal conductivity of particulate nanocomposites with multiple inclusions is presented. The formulated methodology takes into account all the factors mentioned above and can be used to model nanocomposites with multiple inclusions that are randomly oriented or aligned in a particular direction. The effect of inclusion dispersion non-uniformity is modeled using a two-scale approach. The applications of the formulated effective medium theory are demonstrated using previously published experimental and numerical results for several particulate nanocomposites. PMID:28773817

Cleanroom certification model

NASA Technical Reports Server (NTRS)

Currit, P. A.

1983-01-01

The Cleanroom software development methodology is designed to take the gamble out of product releases for both suppliers and receivers of the software. The ingredients of this procedure are a life cycle of executable product increments, representative statistical testing, and a standard estimate of the MTTF (Mean Time To Failure) of the product at the time of its release. A statistical approach to software product testing using randomly selected samples of test cases is considered. A statistical model is defined for the certification process which uses the timing data recorded during test. A reasonableness argument for this model is provided that uses previously published data on software product execution. Also included is a derivation of the certification model estimators and a comparison of the proposed least squares technique with the more commonly used maximum likelihood estimators.

The secret life of pronouns: flexibility in writing style and physical health.

PubMed

Campbell, R Sherlock; Pennebaker, James W

2003-01-01

Numerous disclosure studies have demonstrated that individuals randomly assigned to write about emotional topics evidence improved physical health compared with those who write about superficial topics. The writing samples from three previously published studies of 74 first-year students, 50 upper-division students, and 59 maximum-security prisoners were reanalyzed using Latent Semantic Analysis (LSA) to explore possible relationships of writing content and style to changes in frequency of physician visits following the disclosure intervention. LSA revealed that flexibility in the use of common words-particularly personal pronouns--when writing about traumatic memories was related to positive health outcomes. The findings point to the importance of the role of discussing the self and social relationships in writing and, at the same time, to the remarkable potential of techniques such as LSA.

Use of Platelet-Rich Plasma in Intra-Articular Knee Injections for Osteoarthritis: A Systematic Review.

PubMed

Lai, Lawrence P; Stitik, Todd P; Foye, Patrick M; Georgy, John S; Patibanda, Varun; Chen, Boqing

2015-06-01

To systematically analyze the literature on the use of platelet-rich plasma (PRP) for intra-articular injections of the knee and its efficacy in the treatment of knee osteoarthritis (OA). Systematic literature reviews were conducted in PubMed, Embase, and CINAHL (ie, Cumulative Index to Nursing and Allied Health Literature) on October 30, 2013, using the keywords "platelet-rich plasma" and "knee" and "osteoarthritis." Inclusion criteria included (1) studies with human subjects, (2) prospective clinical studies (including either clinical trials or observational studies), and (3) full-text articles published in English. Exclusion criteria were: (1) animal studies; (2) retrospective studies; (3) patients with previous surgical intervention with total knee arthroplasty or reconstruction of the anterior cruciate ligaments; and (4) articles not published in English A total of 319 abstracts and titles were reviewed (60 from PubMed, 250 from Embase, and 9 from CINAHL). A total of 8 relevant journal articles were identified, all of which were published between 2010 and 2013. One-half of the studies were prospective observational studies that included only PRP treatment; the rest were prospective comparative studies including both PRP and controls-2 were randomized controlled trials. Of the 4 comparative studies, 3 compared PRP with hyaluronic acid, which was considered as a commonly used effective treatment for knee OA; the other one used saline injection (ie, placebo) as the control. Although most of the analyses suffered from small sample size and was thus inconclusive, the findings consistently indicated that PRP might have better outcomes in patients with a lesser degree of degeneration and in younger patients. PRP intra-articular injections of the knee may be an effective alternative treatment for knee OA. However, current studies are at best inconclusive regarding the efficacy of the PRP treatment. A large, multicenter randomized trial study is needed to further assess the efficacy of PRP treatment for patients with knee OA. Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.

PubMed

Herman, Amir; Botser, Itamar Busheri; Tenenbaum, Shay; Chechick, Ahron

2009-09-01

The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials. We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data. Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique. In most of the randomized clinical trials published in the orthopaedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to orthopaedic randomized clinical trials and their analysis.

Random Amplification and Pyrosequencing for Identification of Novel Viral Genome Sequences

PubMed Central

Hang, Jun; Forshey, Brett M.; Kochel, Tadeusz J.; Li, Tao; Solórzano, Víctor Fiestas; Halsey, Eric S.; Kuschner, Robert A.

2012-01-01

ssRNA viruses have high levels of genomic divergence, which can lead to difficulty in genomic characterization of new viruses using traditional PCR amplification and sequencing methods. In this study, random reverse transcription, anchored random PCR amplification, and high-throughput pyrosequencing were used to identify orthobunyavirus sequences from total RNA extracted from viral cultures of acute febrile illness specimens. Draft genome sequence for the orthobunyavirus L segment was assembled and sequentially extended using de novo assembly contigs from pyrosequencing reads and orthobunyavirus sequences in GenBank as guidance. Accuracy and continuous coverage were achieved by mapping all reads to the L segment draft sequence. Subsequently, RT-PCR and Sanger sequencing were used to complete the genome sequence. The complete L segment was found to be 6936 bases in length, encoding a 2248-aa putative RNA polymerase. The identified L segment was distinct from previously published South American orthobunyaviruses, sharing 63% and 54% identity at the nucleotide and amino acid level, respectively, with the complete Oropouche virus L segment and 73% and 81% identity at the nucleotide and amino acid level, respectively, with a partial Caraparu virus L segment. The result demonstrated the effectiveness of a sequence-independent amplification and next-generation sequencing approach for obtaining complete viral genomes from total nucleic acid extracts and its use in pathogen discovery. PMID:22468136

Allowing for uncertainty due to missing continuous outcome data in pairwise and network meta-analysis.

PubMed

Mavridis, Dimitris; White, Ian R; Higgins, Julian P T; Cipriani, Andrea; Salanti, Georgia

2015-02-28

Missing outcome data are commonly encountered in randomized controlled trials and hence may need to be addressed in a meta-analysis of multiple trials. A common and simple approach to deal with missing data is to restrict analysis to individuals for whom the outcome was obtained (complete case analysis). However, estimated treatment effects from complete case analyses are potentially biased if informative missing data are ignored. We develop methods for estimating meta-analytic summary treatment effects for continuous outcomes in the presence of missing data for some of the individuals within the trials. We build on a method previously developed for binary outcomes, which quantifies the degree of departure from a missing at random assumption via the informative missingness odds ratio. Our new model quantifies the degree of departure from missing at random using either an informative missingness difference of means or an informative missingness ratio of means, both of which relate the mean value of the missing outcome data to that of the observed data. We propose estimating the treatment effects, adjusted for informative missingness, and their standard errors by a Taylor series approximation and by a Monte Carlo method. We apply the methodology to examples of both pairwise and network meta-analysis with multi-arm trials. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

PubMed

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Novel method of extracting motion from natural movies.

PubMed

Suzuki, Wataru; Ichinohe, Noritaka; Tani, Toshiki; Hayami, Taku; Miyakawa, Naohisa; Watanabe, Satoshi; Takeichi, Hiroshige

2017-11-01

The visual system in primates can be segregated into motion and shape pathways. Interaction occurs at multiple stages along these pathways. Processing of shape-from-motion and biological motion is considered to be a higher-order integration process involving motion and shape information. However, relatively limited types of stimuli have been used in previous studies on these integration processes. We propose a new algorithm to extract object motion information from natural movies and to move random dots in accordance with the information. The object motion information is extracted by estimating the dynamics of local normal vectors of the image intensity projected onto the x-y plane of the movie. An electrophysiological experiment on two adult common marmoset monkeys (Callithrix jacchus) showed that the natural and random dot movies generated with this new algorithm yielded comparable neural responses in the middle temporal visual area. In principle, this algorithm provided random dot motion stimuli containing shape information for arbitrary natural movies. This new method is expected to expand the neurophysiological and psychophysical experimental protocols to elucidate the integration processing of motion and shape information in biological systems. The novel algorithm proposed here was effective in extracting object motion information from natural movies and provided new motion stimuli to investigate higher-order motion information processing. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

PubMed Central

Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

2015-01-01

Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS).

PubMed

Fukuoka, Masahiro; Wu, Yi-Long; Thongprasert, Sumitra; Sunpaweravong, Patrapim; Leong, Swan-Swan; Sriuranpong, Virote; Chao, Tsu-Yi; Nakagawa, Kazuhiko; Chu, Da-Tong; Saijo, Nagahiro; Duffield, Emma L; Rukazenkov, Yuri; Speake, Georgina; Jiang, Haiyi; Armour, Alison A; To, Ka-Fai; Yang, James Chih-Hsin; Mok, Tony S K

2011-07-20

The results of the Iressa Pan-Asia Study (IPASS), which compared gefitinib and carboplatin/paclitaxel in previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma were published previously. This report presents overall survival (OS) and efficacy according to epidermal growth factor receptor (EGFR) biomarker status. In all, 1,217 patients were randomly assigned. Biomarkers analyzed were EGFR mutation (amplification mutation refractory system; 437 patients evaluable), EGFR gene copy number (fluorescent in situ hybridization; 406 patients evaluable), and EGFR protein expression (immunohistochemistry; 365 patients evaluable). OS analysis was performed at 78% maturity. A Cox proportional hazards model was used to assess biomarker status by randomly assigned treatment interactions for progression-free survival (PFS) and OS. OS (954 deaths) was similar for gefitinib and carboplatin/paclitaxel with no significant difference between treatments overall (hazard ratio [HR], 0.90; 95% CI, 0.79 to 1.02; P = .109) or in EGFR mutation-positive (HR, 1.00; 95% CI, 0.76 to 1.33; P = .990) or EGFR mutation-negative (HR, 1.18; 95% CI, 0.86 to 1.63; P = .309; treatment by EGFR mutation interaction P = .480) subgroups. A high proportion (64.3%) of EGFR mutation-positive patients randomly assigned to carboplatin/paclitaxel received subsequent EGFR tyrosine kinase inhibitors. PFS was significantly longer with gefitinib for patients whose tumors had both high EGFR gene copy number and EGFR mutation (HR, 0.48; 95% CI, 0.34 to 0.67) but significantly shorter when high EGFR gene copy number was not accompanied by EGFR mutation (HR, 3.85; 95% CI, 2.09 to 7.09). EGFR mutations are the strongest predictive biomarker for PFS and tumor response to first-line gefitinib versus carboplatin/paclitaxel. The predictive value of EGFR gene copy number was driven by coexisting EGFR mutation (post hoc analysis). Treatment-related differences observed for PFS in the EGFR mutation-positive subgroup were not apparent for OS. OS results were likely confounded by the high proportion of patients crossing over to the alternative treatment.

Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer.

PubMed

Bell, R; Brown, J; Parmar, M; Toi, M; Suter, T; Steger, G G; Pivot, X; Mackey, J; Jackisch, C; Dent, R; Hall, P; Xu, N; Morales, L; Provencher, L; Hegg, R; Vanlemmens, L; Kirsch, A; Schneeweiss, A; Masuda, N; Overkamp, F; Cameron, D

2017-04-01

The purpose of this analysis was to assess the long-term impact of adding bevacizumab to adjuvant chemotherapy for early triple-negative breast cancer (TNBC). Patients eligible for the open-label randomized phase III BEATRICE trial had centrally confirmed triple-negative operable primary invasive breast cancer (pT1a-pT3). Investigators selected anthracycline- and/or taxane-based chemotherapy for each patient. After definitive surgery, patients were randomized 1:1 to receive ≥4 cycles of chemotherapy alone or with 1 year of bevacizumab (5 mg/kg/week equivalent). Stratification factors were nodal status, selected chemotherapy, hormone receptor status, and type of surgery. The primary end point was invasive disease-free survival (IDFS; previously reported). Secondary outcome measures included overall survival (OS) and safety. After 56 months' median follow-up, 293 of 2591 randomized patients had died. There was no statistically significant difference in OS between treatment arms in either the total population (hazard ratio 0.93, 95% confidence interval [CI] 0.74-1.17; P = 0.52) or pre-specified subgroups. The 5-year OS rate was 88% (95% CI 86-90%) in both treatment arms. Updated IDFS results were consistent with the primary IDFS analysis. Five-year IDFS rates were 77% (95% CI 75-79%) with chemotherapy alone versus 80% (95% CI 77-82%) with bevacizumab. From 18 months after first study dose to study end, new grade ≥3 adverse events occurred in 4.6% and 4.5% of patients in the two arms, respectively. Final OS results showed no significant benefit from bevacizumab therapy for early TNBC. Late-onset toxicities were rare in both groups. Five-year OS and IDFS rates suggest that the prognosis for patients with TNBC is better than previously thought. NCT00528567. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.

PubMed

Lee, Kevin; Murphy, Patrick B; Ingves, Matthew V; Duncan, Audra; DeRose, Guy; Dubois, Luc; Forbes, Thomas L; Power, Adam

2017-12-01

The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. A single-center, randomized, controlled trial was performed at an academic tertiary medical center. Patients with previous femoral artery surgical exposure, body mass index of >30 kg/m 2 or the presence of ischemic tissue loss were classified as a high-risk patient for SSI. All wounds were closed primarily and patients were randomized to either NPWT or standard dressing. The primary outcome of the trial was postoperative 30-day SSI in the groin wound. The secondary outcomes included 90-day SSI, hospital duration of stay, readmissions or reoperations for SSI, and mortality. A total of 102 patients were randomized between August 2014 and December 2015. Patients were classified as at high risk owing to the presence of previous femoral artery cut down (29%), body mass index of >30 kg/m 2 (39%) or presence of ischemic tissue loss (32%). Revascularization procedures performed included femoral to distal artery bypass (57%), femoral endarterectomy (18%), femoral to femoral artery crossover (17%), and other procedures (8%). The primary outcome of 30-day SSI was 11% in NPWT group versus 19% in standard dressing group (P = .24). There was a statistically significant shorter mean duration of hospital stay in the NPWT group (6.4 days) compared with the standard group (8.9 days; P = .01). There was no difference in readmission or reoperation for SSI or mortality between the two groups. This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Phase II randomized trial of radiation therapy, cetuximab, and pemetrexed with or without bevacizumab in patients with locally advanced head and neck cancer.

PubMed

Argiris, A; Bauman, J E; Ohr, J; Gooding, W E; Heron, D E; Duvvuri, U; Kubicek, G J; Posluszny, D M; Vassilakopoulou, M; Kim, S; Grandis, J R; Johnson, J T; Gibson, M K; Clump, D A; Flaherty, J T; Chiosea, S I; Branstetter, B; Ferris, R L

2016-08-01

We previously reported the safety of concurrent cetuximab, an antibody against epidermal growth factor receptor (EGFR), pemetrexed, and radiation therapy (RT) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In this non-comparative phase II randomized trial, we evaluated this non-platinum combination with or without bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF). Patients with previously untreated stage III-IVB SCCHN were randomized to receive: conventionally fractionated radiation (70 Gy), concurrent cetuximab, and concurrent pemetrexed (arm A); or the identical regimen plus concurrent bevacizumab followed by bevacizumab maintenance for 24 weeks (arm B). The primary end point was 2-year progression-free survival (PFS), with each arm compared with historical control. Exploratory analyses included the relationship of established prognostic factors to PFS and quality of life (QoL). Seventy-eight patients were randomized: 66 oropharynx (42 HPV-positive, 15 HPV-negative, 9 unknown) and 12 larynx; 38 (49%) had heavy tobacco exposure. Two-year PFS was 79% [90% confidence interval (CI) 0.69-0.92; P < 0.0001] for arm A and 75% (90% CI 0.64-0.88; P < 0.0001) for arm B, both higher than historical control. No differences in PFS were observed for stage, tobacco history, HPV status, or type of center (community versus academic). A significantly increased rate of hemorrhage occurred in arm B. SCCHN-specific QoL declined acutely, with marked improvement but residual symptom burden 1 year post-treatment. RT with a concurrent non-platinum regimen of cetuximab and pemetrexed is feasible in academic and community settings, demonstrating expected toxicities and promising efficacy. Adding bevacizumab increased toxicity without apparent improvement in efficacy, countering the hypothesis that dual EGFR-VEGF targeting would overcome radiation resistance, and enhance clinical benefit. Further development of cetuximab, pemetrexed, and RT will require additional prospective study in defined, high-risk populations where treatment intensification is justified. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Sensitivity to prediction error in reach adaptation

PubMed Central

Haith, Adrian M.; Harran, Michelle D.; Shadmehr, Reza

2012-01-01

It has been proposed that the brain predicts the sensory consequences of a movement and compares it to the actual sensory feedback. When the two differ, an error signal is formed, driving adaptation. How does an error in one trial alter performance in the subsequent trial? Here we show that the sensitivity to error is not constant but declines as a function of error magnitude. That is, one learns relatively less from large errors compared with small errors. We performed an experiment in which humans made reaching movements and randomly experienced an error in both their visual and proprioceptive feedback. Proprioceptive errors were created with force fields, and visual errors were formed by perturbing the cursor trajectory to create a visual error that was smaller, the same size, or larger than the proprioceptive error. We measured single-trial adaptation and calculated sensitivity to error, i.e., the ratio of the trial-to-trial change in motor commands to error size. We found that for both sensory modalities sensitivity decreased with increasing error size. A reanalysis of a number of previously published psychophysical results also exhibited this feature. Finally, we asked how the brain might encode sensitivity to error. We reanalyzed previously published probabilities of cerebellar complex spikes (CSs) and found that this probability declined with increasing error size. From this we posit that a CS may be representative of the sensitivity to error, and not error itself, a hypothesis that may explain conflicting reports about CSs and their relationship to error. PMID:22773782

Which dogs with appendicular osteosarcoma benefit most from chemotherapy after surgery? Results from an individual patient data meta-analysis.

PubMed

Schmidt, A F; Groenwold, R H H; Amsellem, P; Bacon, N; Klungel, O H; Hoes, A W; de Boer, A; Kow, K; Maritato, K; Kirpensteijn, J; Nielen, M

2016-03-01

Osteosarcoma (OS) is a malignant tumor of mesenchymal origin that produces osteoid. Given that the prognosis can vary considerably between dogs, we aimed to explore whether treatment could be tailored towards patient subgroups, characterized by their predicted risk of mortality. For the current study, a subset of five nonrandomized studies (400 subjects of whom 88 were dead at 5 months follow-up) was used from a previously published 20 study individual patient data meta-analysis. Missing data was dependent on observed variables and was imputed to correct for this dependency. Based on a previously published multivariable prognostic model, the 5-month mortality risk was predicted. Subsequently, in surgically treated dogs, using a logistic regression model with a random intercept for a study indicator, we explored whether chemotherapy effectiveness depended on predicted 5-month mortality risk. After adjustment for potential confounders the main effect of any chemotherapy was 0.48 (odds ratio) (95%CI 0.30; 0.78). Testing for chemotherapy by predicted 5-month mortality risk interaction revealed that the effects of any chemotherapy decreased with increasing predicted risk; interaction OR 3.41 (1.07; 10.84). Results from individually comparing carboplatin, cisplatin, doxorubicin and doxorubicin combination therapy to no chemotherapy, were similar in magnitude and direction. These results indicate that the main treatment effects of chemotherapy do not necessarily apply to all patients. Copyright © 2015 Elsevier B.V. All rights reserved.

Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

PubMed

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.

Rapid assessment of avoidable blindness and diabetic retinopathy in Republic of Moldova.

PubMed

Zatic, Tatiana; Bendelic, Eugen; Paduca, Ala; Rabiu, Mansour; Corduneanu, Angela; Garaba, Angela; Novac, Victoria; Curca, Cristina; Sorbala, Inga; Chiaburu, Andrei; Verega, Florentina; Andronic, Victoria; Guzun, Irina; Căpăţină, Olga; Zamă-Mardari, Iulea

2015-06-01

To evaluate the prevalence and causes of blindness and visual impairment, the prevalence of diabetes mellitus and diabetic retinopathy among people aged ≥50 years in the Republic of Moldova using Rapid Assessment of Avoidable Blindness plus Diabetic Retinopathy ('RAAB+DR') techniques. 111 communities of people aged ≥50 years were randomly selected. In addition to standard RAAB procedures in all people with diabetes (previous history of the disease or with a random blood glucose level >11.1 mm/L (200 mg/dL)), a dilated fundus examination was performed to assess the presence and the degree of diabetic retinopathy using the Scottish DR grading system. 3877 (98%) people out of the 3885 eligible people were examined. The prevalence of blindness was 1.4% (95% CI 1.0% to 1.8%). The major causes of blindness and severe visual impairment were untreated cataract (58.2%), glaucoma (10.9%), and other posterior segment causes (10.9%). The estimated prevalence of diabetes was 11.4%. Among all people with diabetes, 55.9% had some form of retinopathy, and sight threatening diabetic retinopathy affected 14.6%. The RAAB+DR survey in the Republic of Moldova established that untreated cataract is the major cause of avoidable blindness in rural areas. This needs to be tackled by expanding the geographical coverage of cataract surgical services. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Closed-form solution for the Wigner phase-space distribution function for diffuse reflection and small-angle scattering in a random medium.

PubMed

Yura, H T; Thrane, L; Andersen, P E

2000-12-01

Within the paraxial approximation, a closed-form solution for the Wigner phase-space distribution function is derived for diffuse reflection and small-angle scattering in a random medium. This solution is based on the extended Huygens-Fresnel principle for the optical field, which is widely used in studies of wave propagation through random media. The results are general in that they apply to both an arbitrary small-angle volume scattering function, and arbitrary (real) ABCD optical systems. Furthermore, they are valid in both the single- and multiple-scattering regimes. Some general features of the Wigner phase-space distribution function are discussed, and analytic results are obtained for various types of scattering functions in the asymptotic limit s > 1, where s is the optical depth. In particular, explicit results are presented for optical coherence tomography (OCT) systems. On this basis, a novel way of creating OCT images based on measurements of the momentum width of the Wigner phase-space distribution is suggested, and the advantage over conventional OCT images is discussed. Because all previous published studies regarding the Wigner function are carried out in the transmission geometry, it is important to note that the extended Huygens-Fresnel principle and the ABCD matrix formalism may be used successfully to describe this geometry (within the paraxial approximation). Therefore for completeness we present in an appendix the general closed-form solution for the Wigner phase-space distribution function in ABCD paraxial optical systems for direct propagation through random media, and in a second appendix absorption effects are included.

A shift to randomness of brain oscillations in people with autism.

PubMed

Lai, Meng-Chuan; Lombardo, Michael V; Chakrabarti, Bhismadev; Sadek, Susan A; Pasco, Greg; Wheelwright, Sally J; Bullmore, Edward T; Baron-Cohen, Simon; Suckling, John

2010-12-15

Resting-state functional magnetic resonance imaging (fMRI) enables investigation of the intrinsic functional organization of the brain. Fractal parameters such as the Hurst exponent, H, describe the complexity of endogenous low-frequency fMRI time series on a continuum from random (H = .5) to ordered (H = 1). Shifts in fractal scaling of physiological time series have been associated with neurological and cardiac conditions. Resting-state fMRI time series were recorded in 30 male adults with an autism spectrum condition (ASC) and 33 age- and IQ-matched male volunteers. The Hurst exponent was estimated in the wavelet domain and between-group differences were investigated at global and voxel level and in regions known to be involved in autism. Complex fractal scaling of fMRI time series was found in both groups but globally there was a significant shift to randomness in the ASC (mean H = .758, SD = .045) compared with neurotypical volunteers (mean H = .788, SD = .047). Between-group differences in H, which was always reduced in the ASC group, were seen in most regions previously reported to be involved in autism, including cortical midline structures, medial temporal structures, lateral temporal and parietal structures, insula, amygdala, basal ganglia, thalamus, and inferior frontal gyrus. Severity of autistic symptoms was negatively correlated with H in retrosplenial and right anterior insular cortex. Autism is associated with a small but significant shift to randomness of endogenous brain oscillations. Complexity measures may provide physiological indicators for autism as they have done for other medical conditions. Copyright © 2010 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

PubMed Central

Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

2013-01-01

Background The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration–approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. Methods and Findings We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose). From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0.02), adverse events (73% versus 45%, p<0.001), and serious adverse events (99% versus 63%, p<0.001). The main study limitation was that we considered only the publication describing the results for the primary outcomes. Conclusions Our results highlight the need to search ClinicalTrials.gov for both unpublished and published trials. Trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article. Please see later in the article for the Editors' Summary PMID:24311990

Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline.

PubMed

Lutz, Stephen; Balboni, Tracy; Jones, Joshua; Lo, Simon; Petit, Joshua; Rich, Shayna E; Wong, Rebecca; Hahn, Carol

The purpose is to provide an update the Bone Metastases Guideline published in 2011 based on evidence complemented by expert opinion. The update will discuss new high-quality literature for the 8 key questions from the original guideline and implications for practice. A systematic PubMed search from the last date included in the original Guideline yielded 414 relevant articles. Ultimately, 20 randomized controlled trials, 32 prospective nonrandomized studies, and 4 meta-analyses/pooled analyses were selected and abstracted into evidence tables. The authors synthesized the evidence and reached consensus on the included recommendations. Available literature continues to support pain relief equivalency between single and multiple fraction regimens for bone metastases. High-quality data confirm single fraction radiation therapy may be delivered to spine lesions with acceptable late toxicity. One prospective, randomized trial confirms both peripheral and spine-based painful metastases can be successfully and safely palliated with retreatment for recurrence pain with adherence to published dosing constraints. Advanced radiation therapy techniques such as stereotactic body radiation therapy lack high-quality data, leading the panel to favor its use on a clinical trial or when results will be collected in a registry. The panel's conclusion remains that surgery, radionuclides, bisphosphonates, and kyphoplasty/vertebroplasty do not obviate the need for external beam radiation therapy. Updated data analysis confirms that radiation therapy provides excellent palliation for painful bone metastases and that retreatment is safe and effective. Although adherence to evidence-based medicine is critical, thorough expert radiation oncology physician judgment and discretion regarding number of fractions and advanced techniques are also essential to optimize outcomes when considering the patient's overall health, life expectancy, comorbidities, tumor biology, anatomy, previous treatment including prior radiation at or near current site of treatment, tumor and normal tissue response history to local and systemic therapies, and other factors related to the patient, tumor characteristics, or treatment. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Quantum walks with tuneable self-avoidance in one dimension

PubMed Central

Camilleri, Elizabeth; Rohde, Peter P.; Twamley, Jason

2014-01-01

Quantum walks exhibit many unique characteristics compared to classical random walks. In the classical setting, self-avoiding random walks have been studied as a variation on the usual classical random walk. Here the walker has memory of its previous locations and preferentially avoids stepping back to locations where it has previously resided. Classical self-avoiding random walks have found numerous algorithmic applications, most notably in the modelling of protein folding. We consider the analogous problem in the quantum setting – a quantum walk in one dimension with tunable levels of self-avoidance. We complement a quantum walk with a memory register that records where the walker has previously resided. The walker is then able to avoid returning back to previously visited sites or apply more general memory conditioned operations to control the walk. We characterise this walk by examining the variance of the walker's distribution against time, the standard metric for quantifying how quantum or classical a walk is. We parameterise the strength of the memory recording and the strength of the memory back-action on the walker, and investigate their effect on the dynamics of the walk. We find that by manipulating these parameters, which dictate the degree of self-avoidance, the walk can be made to reproduce ideal quantum or classical random walk statistics, or a plethora of more elaborate diffusive phenomena. In some parameter regimes we observe a close correspondence between classical self-avoiding random walks and the quantum self-avoiding walk. PMID:24762398

Cost utility and budget impact of third-generation aromatase inhibitors for advanced breast cancer: a literature-based model analysis of costs in the Italian National Health Service.

PubMed

Marchetti, Monia; Caruggi, Mauro; Colombo, Giorgio

2004-09-01

Third-generation aromatase inhibitors are effective alternatives to tamoxifen in patients with advanced breast cancer. However, their acquisition costs might burden fixed-budget health care systems. This study is a decision analysis of the clinical and economic consequences of alternative first-line hormone therapies for postmenopausal women with estrogen receptor-positive metastatic breast cancer in a real-life Italian health care setting. A Markov model was developed to describe disease evolution according to data from previously published, randomized clinical trials. The costs incurred by a local community hospital in the Italian National Health Service were considered (year-2003 values). Clinical data were taken from previously published trials. A 3% discount rate was applied to both resources and life-years gained. Based on model estimates, mean survival times with the third-generation aromatase inhibitors anastrozole and letrozole were 30.72 and 30.64 months, respectively, as opposed to 27.28 months with tamoxifen. Mean survival times after adjustment for quality of life were 18.84 and 18.78 months with anastrozole and letrozole, respectively, and 16.14 months with tamoxifen. Baseline analysis produced incremental cost-effectiveness ratios per quality-adjusted life-year gained of 10,795 Euro (95% CI, 7737 Euro-12,899 Euro) and 16,886 Euro (95% CI, 9117 Euro-15,465 Euro) for anastrozole and letrozole, respectively, compared with tamoxifen. The observed difference between the 2 cost-utility ratios may have been mainly due to the higher acquisition costs of letrozole compared with anastrozole. Despite similar incremental cost-effectiveness ratios, anastrozole and letrozole might increase the budget for advanced breast cancer care by 12% and 18%, respectively, based on the year-2003 Italian market prices of the 2 drugs. In this cost-effectiveness analysis using previously published clinical data and year-2003 cost data from a community hospital in the Italian National Health Service, anastrozole and letrozole were both cost-effective alternatives to tamoxifen for first-line therapy of postmenopausal women with advanced estrogen receptor-positive breast cancer.

Prediction of Fat-Free Mass in Kidney Transplant Recipients.

PubMed

Størset, Elisabet; von Düring, Marit Elizabeth; Godang, Kristin; Bergan, Stein; Midtvedt, Karsten; Åsberg, Anders

2016-08-01

Individualization of drug doses is essential in kidney transplant recipients. For many drugs, the individual dose is better predicted when using fat-free mass (FFM) as a scaling factor. Multiple equations have been developed to predict FFM based on healthy subjects. These equations have not been evaluated in kidney transplant recipients. The objectives of this study were to develop a kidney transplant specific equation for FFM prediction and to evaluate its predictive performance compared with previously published equations. Ten weeks after transplantation, FFM was measured by dual-energy X-ray absorptiometry. Data from a consecutive cohort of 369 kidney transplant recipients were randomly assigned to an equation development data set (n = 245) or an evaluation data set (n = 124). Prediction equations were developed using linear and nonlinear regression analysis. The predictive performance of the developed equation and previously published equations in the evaluation data set was assessed. The following equation was developed: FFM (kg) = {FFMmax × body weight (kg)/[81.3 + body weight (kg)]} × [1 + height (cm) × 0.052] × [1-age (years) × 0.0007], where FFMmax was estimated to be 11.4 in males and 10.2 in females. This equation provided an unbiased, precise prediction of FFM in the evaluation data set: mean error (ME) (95% CI), -0.71 kg (-1.60 to 0.19 kg) in males and -0.36 kg (-1.52 to 0.80 kg) in females, root mean squared error 4.21 kg (1.65-6.77 kg) in males and 3.49 kg (1.15-5.84 kg) in females. Using previously published equations, FFM was systematically overpredicted in kidney-transplanted males [ME +1.33 kg (0.40-2.25 kg) to +5.01 kg (4.06-5.95 kg)], but not in females [ME -2.99 kg (-4.07 to -1.90 kg) to +3.45 kg (2.29-4.61) kg]. A new equation for FFM prediction in kidney transplant recipients has been developed. The equation may be used for population pharmacokinetic modeling and clinical dose selection in kidney transplant recipients.

Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

ERIC Educational Resources Information Center

Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

2009-01-01

Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

[Risk factors for infection in total knee artrhoplasty, including previously unreported intraoperative fracture and deep venous thrombosis].

PubMed

de Dios, M; Cordero-Ampuero, J

2015-01-01

To carry out a statistical analysis on the significant risk factors for deep late infection (prosthetic joint infection, PJI) in patients with a knee arthroplasty (TKA). A retrospective observational case-control study was conducted on a case series of 32 consecutive knee infections, using an analysis of all the risk factors reported in the literature. A control series of 100 randomly selected patients operated in the same Department of a University General Hospital during the same period of time, with no sign of deep infection in their knee arthroplasty during follow-up. Statistical comparisons were made using Pearson for qualitative and ANOVA for quantitative variables. The significant (p>0.05) factors found in the series were: Preoperative previous knee surgery, glucocorticoids, immunosuppressants, inflammatory arthritis. prolonged surgical time, inadequate antibiotic prophylaxis, intraoperative fractures. Postoperative secretion of the wound longer than 10 days, deep palpable haematoma, need for a new surgery, and deep venous thrombosis in lower limbs. Distant infections cutaneous, generalized sepsis, urinary tract, pneumonia, abdominal. This is the first report of intraoperative fractures and deep venous thrombosis as significantly more frequent factors in infected TKAs. Other previously described risk factors for TKA PJI are also confirmed. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

Lung Recruitment Maneuvers for Adult Patients with Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis.

PubMed

Goligher, Ewan C; Hodgson, Carol L; Adhikari, Neill K J; Meade, Maureen O; Wunsch, Hannah; Uleryk, Elizabeth; Gajic, Ognjen; Amato, Marcelo P B; Ferguson, Niall D; Rubenfeld, Gordon D; Fan, Eddy

2017-10-01

In patients with acute respiratory distress syndrome (ARDS), lung recruitment maneuvers (LRMs) may prevent ventilator-induced lung injury and improve survival. To summarize the current evidence in support of the use of LRMs in adult patients with ARDS and to inform the recently published American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine clinical practice guideline on mechanical ventilation in ARDS. We conducted a systematic review and meta-analysis of randomized trials comparing mechanical ventilation strategies with and without LRMs. Eligible trials were identified from among previously published systematic reviews and an updated literature search. Data on 28-day mortality, oxygenation, adverse events, and use of rescue therapy were collected, and results were pooled using random effects models weighted by inverse variance. Strength of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation methodology. We screened 430 citations and previous systematic reviews and found six trials eligible for inclusion (n = 1,423 patients in total). The type of LRM varied widely between trials, and five of the trials involved a cointervention with a higher positive end-expiratory pressure (PEEP) ventilation strategy. Risk of bias was deemed high in one trial. In the primary analysis, the only trial without a cointervention showed that LRMs were associated with reduced mortality (one trial; risk ratio [RR], 0.62; 95% confidence interval [CI], 0.39-0.98; evidence grade = low). Meta-analysis of all six trials also suggested a significant mortality reduction (six trials; RR, 0.81; 95% CI, 0.69-0.95; evidence grade = moderate), and the use of a higher PEEP cointervention did not significantly modify the mortality effect (P = 0.27 for heterogeneity). LRMs were also associated with improved oxygenation after 24 hours (six trials; mean increase, 52 mm Hg; 95% CI, 23-81 mm Hg) and less frequent requirement for rescue therapy (three trials; RR, 0.65; 95% CI, 0.45-0.94). LRMs were not associated with an increased rate of barotrauma (four trials; RR, 0.84; 95% CI, 0.46-1.55). The rate of hemodynamic compromise was not significantly increased with LRMs (three trials; RR, 1.30; 95% CI, 0.92-1.78). Randomized trials suggest that LRMs in combination with a higher PEEP ventilation strategy reduce mortality, but confidence in this finding is limited. Further trials are required to confirm benefit from LRMs in adults with ARDS.

Effect of community health clubs on child diarrhoea in western Rwanda: cluster-randomised controlled trial.

PubMed

Sinharoy, Sheela S; Schmidt, Wolf-Peter; Wendt, Ronald; Mfura, Leodomir; Crossett, Erin; Grépin, Karen A; Jack, William; Rwabufigiri, Bernard Ngabo; Habyarimana, James; Clasen, Thomas

2017-07-01

Community health clubs are multi-session village-level gatherings led by trained facilitators and designed to promote healthy behaviours mainly related to water, sanitation, and hygiene. They have been implemented in several African and Asian countries but have never been evaluated rigorously. We aimed to evaluate the effect of two versions of the community health club model on child health and nutrition outcomes. We did a cluster-randomised trial in Rusizi district, western Rwanda. We defined villages as clusters. We assessed villages for eligibility then randomly selected 150 for the study using a simple random sampling routine in Stata. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver-reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n=50), eight community health club sessions (Lite intervention; n=50), or 20 community health club sessions (Classic intervention; n=50). Households in these villages were enrolled in 2013 for a baseline survey, then re-enrolled in 2015 for an endline survey. The primary outcome was caregiver-reported diarrhoea within the previous 7 days in children younger than 5 years. Analysis was by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT01836731. At the baseline survey undertaken between May, 2013, and August, 2013, 8734 households with children younger than 5 years of age were enrolled. At the endline survey undertaken between Sept 21, 2015, and Dec 22, 2015, 7934 (91%) of the households were re-enrolled. Among children younger than 5 years, the prevalence of caregiver-reported diarrhoea in the previous 7 days was 514 (14%) of 3616 assigned the control, 453 (14%) of 3196 allocated the Lite intervention (prevalence ratio compared with control 0·97, 95% CI 0·81-1·16; p=0·74), and 495 (14%) of 3464 assigned the Classic intervention (prevalence ratio compared with control 0·99, 0·85-1·15; p=0·87). Community health clubs, in this setting in western Rwanda, had no effect on caregiver-reported diarrhoea among children younger than 5 years. Our results question the value of implementing this intervention at scale for the aim of achieving health gains. Bill & Melinda Gates Foundation. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

The New York Trade Publishers and CD-ROM: Where Are They Heading?

ERIC Educational Resources Information Center

Newmark, Eileen

1994-01-01

Discusses the strategies top trade publishers, including Putnam New Media, Paramount Communications, Random House, Penguin USA, and Reader's Digest, are taking toward CD-ROM publishing. Strategies include purchasing electronic media companies; setting up an independent business; and building a new media business by integrating new efforts into the…

Large-scale meta-analysis of interleukin-1 beta and interleukin-1 receptor antagonist polymorphisms on risk of radiographic hip and knee osteoarthritis and severity of knee osteoarthritis.

PubMed

Kerkhof, H J M; Doherty, M; Arden, N K; Abramson, S B; Attur, M; Bos, S D; Cooper, C; Dennison, E M; Doherty, S A; Evangelou, E; Hart, D J; Hofman, A; Javaid, K; Kerna, I; Kisand, K; Kloppenburg, M; Krasnokutsky, S; Maciewicz, R A; Meulenbelt, I; Muir, K R; Rivadeneira, F; Samuels, J; Sezgin, M; Slagboom, E; Smith, A J P; Spector, T D; Tamm, A; Tamm, A; Uitterlinden, A G; Wheeler, M; Zhai, G; Zhang, W; van Meurs, J B J; Valdes, A M

2011-03-01

To clarify the role of common genetic variation in the Interleukin-1β (IL1B) and Interleukin-1R antagonist (IL1RN) genes on risk of knee and hip osteoarthritis (OA) and severity of knee OA by means of large-scale meta-analyses. We searched PubMed for articles assessing the role of IL1B and IL1RN polymorphisms/haplotypes on the risk of hip and/or knee OA. Novel data were included from eight unpublished studies. Meta-analyses were performed using fixed- and random-effects models with a total of 3595 hip OA and 5013 knee OA cases, and 6559 and 9132 controls respectively. The role of ILRN haplotypes on radiographic severity of knee OA was tested in 1918 cases with Kellgren-Lawrence (K/L) 1 or 2 compared to 199 cases with K/L 3 or 4. The meta-analysis of six published studies retrieved from the literature search and eight unpublished studies showed no evidence of association between common genetic variation in the IL1B or IL1RN genes and risk of hip OA or knee OA (P>0.05 for rs16944, rs1143634, rs419598 and haplotype C-G-C (rs1143634, rs16944 and rs419598) previously implicated in risk of hip OA). The C-T-A haplotype formed by rs419598, rs315952 and rs9005, previously implicated in radiographic severity of knee OA, was associated with reduced severity of knee OA (odds ratio (OR)=0.71 95%CI 0.56-0.91; P=0.006, I(2)=74%), and achieved borderline statistical significance in a random-effects model (OR=0.61 95%CI 0.35-1.06 P=0.08). Common genetic variation in the Interleukin-1 region is not associated with prevalence of hip or knee OA but our data suggest that IL1RN might have a role in severity of knee OA. Copyright © 2010 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Reference Accuracy among Research Articles Published in "Research on Social Work Practice"

ERIC Educational Resources Information Center

Wilks, Scott E.; Geiger, Jennifer R.; Bates, Samantha M.; Wright, Amy L.

2017-01-01

Objective: The objective was to examine reference errors in research articles published in Research on Social Work Practice. High rates of reference errors in other top social work journals have been noted in previous studies. Methods: Via a sampling frame of 22,177 total references among 464 research articles published in the previous decade, a…

Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

PubMed

Gabriels, Robin L; Pan, Zhaoxing; Dechant, Briar; Agnew, John A; Brim, Natalie; Mesibov, Gary

2015-07-01

This study expands previous equine-assisted intervention research by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD). Participants with ASD (aged 6-16 years; N = 127) were stratified by nonverbal IQ standard scores (≤85 or >85) and randomized to 1 of 2 groups for 10 weeks: THR intervention or a barn activity (BA) control group without horses that used similar methods. The fidelity of the THR intervention was monitored. Participants were evaluated within 1 month pre- and postintervention by raters blinded to intervention conditions and unblinded caregiver questionnaires. During the intervention, caregivers rated participants' behaviors weekly. Intent-to-treat analysis conducted on the 116 participants who completed a baseline assessment (THR n = 58; BA control n = 58) revealed significant improvements in the THR group compared to the control on measures of irritability (primary outcome) (p = .02; effect size [ES] = 0.50) and hyperactivity (p = .01; ES = 0.53), beginning by week 5 of the intervention. Significant improvements in the THR group were also observed on a measure of social cognition (p = .05; ES = 0.41) and social communication (p = .003; ES = 0.63), along with the total number of words (p = .01; ES = 0.54) and new words (p = .01; ES = 0.54) spoken during a standardized language sample. Sensitivity analyses adjusting for age, IQ, and per protocol analyses produced consistent results. This is the first large-scale, randomized, controlled trial demonstrating efficacy of THR for the ASD population, and findings are consistent with previous equine-assisted intervention studies. Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder; http://clinicaltrials.gov; NCT02301195. Published by Elsevier Inc.

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

PubMed

Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A spatial scaling relationship for soil moisture in a semiarid landscape, using spatial scaling relationships for pedology

NASA Astrophysics Data System (ADS)

Willgoose, G. R.; Chen, M.; Cohen, S.; Saco, P. M.; Hancock, G. R.

2013-12-01

In humid areas it is generally considered that soil moisture scales spatially according to the wetness index of the landscape. This scaling arises from lateral flow downslope of ground water within the soil zone. However, in semi-arid and drier regions, this lateral flow is small and fluxes are dominated by vertical flows driven by infiltration and evapotranspiration. Thus, in the absence of runon processes, soil moisture at a location is more driven by local factors such as soil and vegetation properties at that location rather than upstream processes draining to that point. The 'apparent' spatial randomness of soil and vegetation properties generally suggests that soil moisture for semi-arid regions is spatially random. In this presentation a new analysis of neutron probe data during summer from the Tarrawarra site near Melbourne, Australia shows persistent spatial organisation of soil moisture over several years. This suggests a link between permanent features of the catchment (e.g. soil properties) and soil moisture distribution, even though the spatial pattern of soil moisture during the 4 summers monitored appears spatially random. This and other data establishes a prima facie case that soil variations drive spatial variation in soil moisture. Accordingly, we used a previously published spatial scaling relationship for soil properties derived using the mARM pedogenesis model to simulate the spatial variation of soil grading. This soil grading distribution was used in the Rosetta pedotransfer model to derive a spatial distribution of soil functional properties (e.g. saturated hydraulic conductivity, porosity). These functional properties were then input into the HYDRUS-1D soil moisture model and soil moisture simulated for 3 years at daily resolution. The HYDRUS model used had previously been calibrated to field observed soil moisture data at our SASMAS field site. The scaling behaviour of soil moisture derived from this modelling will be discussed and compared with observed data from our SASMAS field sites.

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

PubMed

Essebag, Vidal; Verma, Atul; Healey, Jeff S; Krahn, Andrew D; Kalfon, Eli; Coutu, Benoit; Ayala-Paredes, Felix; Tang, Anthony S; Sapp, John; Sturmer, Marcio; Keren, Arieh; Wells, George A; Birnie, David H

2016-03-22

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial.

PubMed

Usall, Judith; Huerta-Ramos, Elena; Labad, Javier; Cobo, Jesús; Núñez, Christian; Creus, Marta; Parés, Gemma García; Cuadras, Daniel; Franco, José; Miquel, Eva; Reyes, Julio César; Roca, Mercedes

2016-03-01

The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. NCT01573637. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Update on the Methodological Quality of Research Published in The American Journal of Sports Medicine: Comparing 2011-2013 to 10 and 20 Years Prior.

PubMed

Brophy, Robert H; Kluck, Dylan; Marx, Robert G

2016-05-01

In recent years, the number of articles in The American Journal of Sports Medicine (AJSM) has risen dramatically, with an increasing emphasis on evidence-based medicine in orthopaedics and sports medicine. Despite the increase in the number of articles published in AJSM over the past decade, the methodological quality of articles in 2011-2013 has improved relative to those in 2001-2003 and 1991-1993. Meta-analysis. All articles published in AJSM during 2011-2013 were reviewed and classified by study design. For each article, the use of pertinent methodologies, such as prospective data collection, randomization, control groups, and blinding, was recorded. The frequency of each article type and the use of evidence-based techniques were compared relative to 1991-1993 and 2001-2003 by use of Pearson χ(2) testing. The number of research articles published in AJSM more than doubled from 402 in 1991-1993 and 423 in 2001-2003 to 953 in 2011-2013. Case reports decreased from 15.2% to 10.6% to 2.1% of articles published over the study period (P < .001). Cadaveric/human studies and meta-analysis/literature review studies increased from 5.7% to 7.1% to 12.4% (P < .001) and from 0.2% to 0.9% to 2.3% (P = .01), respectively. Randomized, prospective clinical trials increased from 2.7% to 5.9% to 7.4% (P = .007). Fewer studies used retrospective compared with prospective data collection (P < .001). More studies tested an explicit hypothesis (P < .001) and used controls (P < .001), randomization (P < .001), and blinding of those assessing outcomes (P < .001). Multi-investigator trials increased (P < .001), as did the proportion of articles citing a funding source (P < .001). Despite a dramatic increase in the number of published articles, the research published in AJSM shifted toward more prospective, randomized, controlled, and blinded designs during 2011-2013 compared with 2001-2003 and 1991-1993, demonstrating a continued improvement in methodological quality. © 2015 The Author(s).

An e-mail survey identified unpublished studies for systematic reviews.

PubMed

Reveiz, Ludovic; Cardona, Andres Felipe; Ospina, Edgar Guillermo; de Agular, Sylvia

2006-07-01

A large number of trials remain difficult to locate or unpublished for systematic reviews. The objective of this article was to determine the usefulness of making e-mail contact with authors of clinical trials and literature reviews found in MEDLINE to identify unpublished or difficult to locate Randomized Controlled Trials (RCTs). A structured search for detecting RCTs in MEDLINE was made from January 1999 to June 2003; a questionnaire was sent to a random sample of 525 author's mails. Those RCTs obtained were sought in MEDLINE, EMBASE, the Cochrane Controlled Trials Register, LILACS, and ongoing registers. 40 (7.6%) replies were received; 10 previously undescribed and unpublished RCTs and 21 unregistered ongoing RCTs were found. The most frequently given reasons for not publishing were: lack of time for finalizing the statistical analysis and preparing the manuscript, contractual obligations with the pharmaceutical industry, methodologic errors in designing, and editorial rejection. Using the e-mails of authors detected by the search in electronic databases could contribute toward detecting potentially relevant ongoing or unpublished RCTs enabling rapid, straightforward, low-cost systematic review; in addition, the results of this study support the need of universal registration of all studies at their inception.

Robotic Surgery in Gynecology: An Updated Systematic Review

PubMed Central

Weinberg, Lori; Rao, Sanjay; Escobar, Pedro F.

2011-01-01

The introduction of da Vinci Robotic Surgery to the field of Gynecology has resulted in large changes in surgical management. The robotic platform allows less experienced laparoscopic surgeons to perform more complex procedures. In general gynecology and reproductive gynecology, the robot is being increasingly used for procedures such as hysterectomies, myomectomies, adnexal surgery, and tubal anastomosis. Among urogynecology the robot is being utilized for sacrocolopexies. In the field of gynecologic oncology, the robot is being increasingly used for hysterectomies and lymphadenectomies in oncologic diseases. Despite the rapid and widespread adoption of robotic surgery in gynecology, there are no randomized trials comparing its efficacy and safety to other traditional surgical approaches. Our aim is to update previously published reviews with a focus on only comparative observational studies. We determined that, with the right amount of training and skill, along with appropriate patient selection, robotic surgery can be highly advantageous. Patients will likely have less blood loss, less post-operative pain, faster recoveries, and fewer complications compared to open surgery and potentially even laparoscopy. However, until larger, well-designed observational studies or randomized control trials are completed which report long-term outcomes, we cannot definitively state the superiority of robotic surgery over other surgical methods. PMID:22190948

A quarter of a century of the DBQ: some supplementary notes on its validity with regard to accidents.

PubMed

de Winter, Joost C F; Dodou, Dimitra; Stanton, Neville A

2015-01-01

This article synthesises the latest information on the relationship between the Driver Behaviour Questionnaire (DBQ) and accidents. We show by means of computer simulation that correlations with accidents are necessarily small because accidents are rare events. An updated meta-analysis on the zero-order correlations between the DBQ and self-reported accidents yielded an overall r of .13 (fixed-effect and random-effects models) for violations (57,480 participants; 67 samples) and .09 (fixed-effect and random-effects models) for errors (66,028 participants; 56 samples). An analysis of a previously published DBQ dataset (975 participants) showed that by aggregating across four measurement occasions, the correlation coefficient with self-reported accidents increased from .14 to .24 for violations and from .11 to .19 for errors. Our meta-analysis also showed that DBQ violations (r = .24; 6353 participants; 20 samples) but not DBQ errors (r = - .08; 1086 participants; 16 samples) correlated with recorded vehicle speed. Practitioner Summary: The DBQ is probably the most widely used self-report questionnaire in driver behaviour research. This study shows that DBQ violations and errors correlate moderately with self-reported traffic accidents.

High resolution identity testing of inactivated poliovirus vaccines.

PubMed

Mee, Edward T; Minor, Philip D; Martin, Javier

2015-07-09

Definitive identification of poliovirus strains in vaccines is essential for quality control, particularly where multiple wild-type and Sabin strains are produced in the same facility. Sequence-based identification provides the ultimate in identity testing and would offer several advantages over serological methods. We employed random RT-PCR and high throughput sequencing to recover full-length genome sequences from monovalent and trivalent poliovirus vaccine products at various stages of the manufacturing process. All expected strains were detected in previously characterised products and the method permitted identification of strains comprising as little as 0.1% of sequence reads. Highly similar Mahoney and Sabin 1 strains were readily discriminated on the basis of specific variant positions. Analysis of a product known to contain incorrect strains demonstrated that the method correctly identified the contaminants. Random RT-PCR and shotgun sequencing provided high resolution identification of vaccine components. In addition to the recovery of full-length genome sequences, the method could also be easily adapted to the characterisation of minor variant frequencies and distinction of closely related products on the basis of distinguishing consensus and low frequency polymorphisms. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data.

PubMed

Moffa, Adriano H; Brunoni, André R; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M; Daskalakis, Zafiris J; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K

2017-10-15

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD. Copyright © 2017. Published by Elsevier B.V.

[Robotic surgery in gynecology].

PubMed

Csorba, Roland

2012-06-24

Minimally invasive surgery has revolutionized gynecological interventions over the past 30 years. The introduction of the da Vinci robotic surgery in 2005 has resulted in large changes in surgical management. The robotic platform allows less experienced laparoscopic surgeons to perform more complex procedures. It can be utilized mainly in general gynecology and reproductive gynecology. The robot is being increasingly used for procedures such as hysterectomy, myomectomy, adnexal surgery, and tubal anastomosis. In urogynecology, the robot is being utilized for sacrocolopexy as well. In the field of gynecologic oncology, the robot is being increasingly used for hysterectomy and lymphadenectomy in oncologic diseases. Despite the rapid and widespread adaption of robotic surgery in gynecology, there are no randomized trials comparing its efficacy and safety to other traditional surgical approaches. This article presents the development, technical aspects and indications of robotic surgery in gynecology, based on the previously published reviews. Robotic surgery can be highly advantageous with the right amount of training, along with appropriate patient selection. Patients will have less blood loss, less post-operative pain, faster recovery, and fewer complications compared to open surgery and laparoscopy. However, until larger randomized control trials are completed which report long-term outcomes, robotic surgery cannot be stated to have priority over other surgical methods.

Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial.

PubMed

Motes, Michael A; Yezhuvath, Uma S; Aslan, Sina; Spence, Jeffrey S; Rypma, Bart; Chapman, Sandra B

2018-02-01

Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

PubMed

Oyama, M A; Ellenberg, S S; Shaw, P A

2017-07-01

Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Healing of donor site in bone-tendon-bone ACL reconstruction accelerated with plasma rich in growth factors: a randomized clinical trial.

PubMed

Seijas, Roberto; Rius, Marta; Ares, Oscar; García-Balletbó, Montserrat; Serra, Iván; Cugat, Ramón

2015-04-01

To determine whether the use of plasma rich in growth factors accelerates healing of the donor site in bone-tendon-bone anterior cruciate ligament (ACL) reconstruction (patellar graft). The use of the patellar graft presents post-operative problems such as anterior knee pain, which limits its use and leads to preference being taken for alternative grafts. A double-blind, randomized, clinical trial was performed comparing two groups of patients who underwent ACL reconstruction using patellar tendon graft and comparing the use of plasma rich in growth factors at the donor site after graft harvest in terms of local regeneration by ultrasound assessment. The plasma rich in growth factors group shows earlier donor site regeneration in comparison with the control group (2 months earlier), with significant differences in the first 4 months of the follow-up. The application of plasma rich in growth factors shows accelerated tissue regeneration processes with respect to the control group. This fact, together with the previously published with similar conclusions, can create a knowledge basis in order to set out new recovery guidelines following ACL reconstruction. Therapeutic study, Level I.

Positive Results Bias and Impact Factor in Ophthalmology.

PubMed

Mimouni, Michael; Krauthammer, Mark; Gershoni, Assaf; Mimouni, Francis; Nesher, Ronit

2015-01-01

Previous studies in several fields of medicine have reported an association between the result of a trial (positive versus negative) and the impact factor of the journal in which it is published. The purpose of this study was to test the hypotheses that in the field of ophthalmology: (1) studies with positive results have a greater chance of being published in journals with a higher impact factor; (2) likewise, studies with a larger number of participants are more likely to be published in journals with a higher impact factor. In this retrospective study, consecutive randomized, controlled trials conducted in the field of ophthalmology between 1 January 2010 and 1 January 2013 were retrieved from PubMed. Each study was classified as having either a positive or negative result. A positive result was defined as a study in which there was a statistically significant difference between groups (p < 0.05). The impact factor of the journal in which the study was published was retrieved. The number of patients enrolled and whether or not the trial was placebo controlled was documented as well. Out of 2524 studies identified, 892 met the inclusion criteria. Studies with positive results were published in journals with a significantly higher impact factor than that of the journals in which negative result studies were published (p < 0.001). Studies with positive results had a slightly larger number of participants than studies with negative results (p = 0.028). In multiple regression analysis, the ranked impact factor was significantly predicted by the primary outcome (positive versus negative results) and the number of participants in a study (total R(2 )= 2.95, p < 0.001). In the field of ophthalmology, articles with positive results are currently published in journals with a higher impact factor. This finding supports the ongoing occurrence of positive results bias in the field of ophthalmology.

Calibrating random forests for probability estimation.

PubMed

Dankowski, Theresa; Ziegler, Andreas

2016-09-30

Probabilities can be consistently estimated using random forests. It is, however, unclear how random forests should be updated to make predictions for other centers or at different time points. In this work, we present two approaches for updating random forests for probability estimation. The first method has been proposed by Elkan and may be used for updating any machine learning approach yielding consistent probabilities, so-called probability machines. The second approach is a new strategy specifically developed for random forests. Using the terminal nodes, which represent conditional probabilities, the random forest is first translated to logistic regression models. These are, in turn, used for re-calibration. The two updating strategies were compared in a simulation study and are illustrated with data from the German Stroke Study Collaboration. In most simulation scenarios, both methods led to similar improvements. In the simulation scenario in which the stricter assumptions of Elkan's method were not met, the logistic regression-based re-calibration approach for random forests outperformed Elkan's method. It also performed better on the stroke data than Elkan's method. The strength of Elkan's method is its general applicability to any probability machine. However, if the strict assumptions underlying this approach are not met, the logistic regression-based approach is preferable for updating random forests for probability estimation. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Safety and tolerability of frovatriptan in the acute treatment of migraine and prevention of menstrual migraine: Results of a new analysis of data from five previously published studies.

PubMed

MacGregor, E Anne; Pawsey, Stephen P; Campbell, John C; Hu, Xiaojun

2010-04-01

Triptans are a recommended first-line treatment for moderate to severe migraine. Using clinical trial data, we evaluated the safety and tolerability of frovatriptan as acute treatment (AT) and as short-term preventive (STP) therapy for menstrual migraine (MM). Data from 2 Phase III AT trials (AT1: randomized, placebo controlled, 1 attack; AT2: 12-months, noncomparative, open label) and 3 Phase IIIb STP trials in MM (MMP1 and MMP2: randomized, placebo controlled, double blind, 3 perimenstrual periods; MMP3: open label, noncomparative, 12 perimenstrual periods) were analyzed. In AT1, patients treated each attack with frovatriptan 2.5 mg, sumatriptan 100 mg, or placebo. In AT2, they used frovatriptan 2.5 mg. In MMP1 and MMP2, women administered frovatriptan 2.5 mg for 6 days during the perimenstrual period, taking a loading dose of 2 or 4 tablets on day 1, followed by once-daily or BID frovatriptan 2.5 mg, respectively; in MMP3, they used BID frovatriptan 2.5 mg. In AT1, which was previously published in part, group differences in adverse events (AEs) were analyzed using the Fisher exact test, and response rates were compared using logistic regression. Post hoc analyses of sustained pain-free status with no AEs (SNAE) and sustained pain response with no AEs (SPRNAE) were performed using a 2-sample test for equality of proportions without continuity correction. For AT2 and the STP studies, data were summarized using descriptive statistics. Results of individual safety analyses for the STP studies were previously reported; the present report includes new results from a pooled analysis of MMP1 and MMP2 and a new analysis of MMP3 in which AEs were coded using Medical Dictionary for Regulatory Activities version 8.0. AT1 included 1206 patients in the safety group; AT2 included 496. In the STP studies, safety data were collected for 1487 women. In AT1 and AT2, 85.6% and 88.3%, respectively, of enrolled patients were women. Overall, AEs were generally mild to moderate (AT studies: 82.3%-90.0%; STP studies: 78.9%89.5%). In AT1, 27.3% (131/480) of frovatriptan patients, 33.4% (161/482) of sumatriptan patients, and 14.8% (36/244) of placebo patients experienced an AE considered possibly or probably related to treatment (P < 0.001 for either drug vs placebo).There were no significant differences between frovatriptan and sumatriptan in SNAE at 4 to 24 hours or in SPRNAE at 2 to 24 hours or at 4 to 24 hours. In randomized, controlled STP trials for MM, AEs were reported by 57.8% (166/287, BID) and 63.4% (210/331, once daily) of frovatriptan users versus 62.8% (216/344) of placebo recipients. There were no consistent differences in AEs reported by patients with potential cardiovascular risk or in AEs related to the use of estrogencontaining contraceptives (ECCs). In randomized controlled trials and 12-month open-label studies, frovatriptan was well tolerated in these women during AT and STP therapy for MM. Subgroup analyses provide preliminary evidence of tolerability in women using ECCs and in women with comorbidities that do not contraindicate triptan use but may be suggestive of cardiovascular risk. 2010 Excerpta Medica Inc. All rights reserved.

Cell phone cardiopulmonary resuscitation: audio instructions when needed by lay rescuers: a randomized, controlled trial.

PubMed

Merchant, Raina M; Abella, Benjamin S; Abotsi, Edem J; Smith, Thomas M; Long, Judith A; Trudeau, Martha E; Leary, Marion; Groeneveld, Peter W; Becker, Lance B; Asch, David A

2010-06-01

Given the ubiquitous presence of cellular telephones, we seek to evaluate the extent to which prerecorded audio cardiopulmonary resuscitation (CPR) instructions delivered by a cell telephone will improve the quality of CPR provided by untrained and trained lay rescuers. We randomly assigned both previously CPR trained and untrained volunteers to perform CPR on a manikin for 3 minutes with or without audio assistance from a cell telephone programmed to provide CPR instructions. We measured CPR quality metrics-pauses (ie, no flow time), compression rate (minute), depth (millimeters), and hand placement (percentage correct)-across the 4 groups defined by being either CPR trained or untrained and receiving or not receiving cell telephone CPR instructions. There was no difference in CPR measures for participants who had or had not received previous CPR training. Participants using the cell telephone aid performed better compression rate (100/minute [95% confidence interval (CI) 97 to 103/minute] versus 44/minute [95% CI 38 to 50/minute]), compression depth (41 mm [95% CI 38 to 44 mm] versus 31 mm [95% CI 28 to 34 mm]), hand placement (97% [95% CI 94% to 100%] versus 75% [95% CI 68% to 83%] correct), and fewer pauses (74 seconds [95% CI 72 to 76 seconds] versus 89 seconds [95% CI 80 to 98 seconds]) compared with participants without the cell telephone aid. A simple audio program that can be made available for cell telephones increases the quality of bystander CPR in a manikin simulation. Copyright (c) 2009 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

The RIVUR Trial: Profile and Baseline Clinical Associations of Children With Vesicoureteral Reflux

PubMed Central

Hoberman, Alejandro; Mattoo, Tej K.; Mathews, Ranjiv; Keren, Ron; Chesney, Russell W.; Moxey-Mims, Marva; Greenfield, Saul P.

2013-01-01

BACKGROUND AND OBJECTIVE: Vesicoureteral reflux (VUR) is diagnosed in ∼30% to 40% of children who have imaging studies after urinary tract infections (UTIs). Our goal is to characterize children enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial and to compare our study cohort with those from previously published studies. METHODS: RIVUR investigators from 19 pediatric sites in the United States recruited 607 children with grade I through IV VUR. Children were enrolled after a first or second UTI. This cross-sectional report of baseline data includes extensive clinical, parental report, and imaging study results. RESULTS: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%), or IV (8%) reflux. The median age was 12 months, and most children (91%) were enrolled after their first UTI. The UTI leading to enrollment was both febrile and symptomatic for 323 children, febrile only in 197 children, and symptomatic only in 86. Renal involvement at baseline as documented by a 99mTc dimercaptosuccinic acid scan was uncommon with cortical defects identified in 89 (15%) children. Bladder and bowel dysfunction was identified in 71 (56%) of 126 toilet-trained subjects assessed. CONCLUSIONS: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. The study sample comprises patients from 19 pediatric clinical sites in the United States, whose demographic and clinical characteristics may differ from those of children enrolled in previous trials from other countries. PMID:23753091

The serum uric acid concentration is not causally linked to diabetic nephropathy in type 1 diabetes.

PubMed

Ahola, Aila J; Sandholm, Niina; Forsblom, Carol; Harjutsalo, Valma; Dahlström, Emma; Groop, Per-Henrik

2017-05-01

Previous studies have shown a relationship between uric acid concentration and progression of renal disease. Here we studied causality between the serum uric acid concentration and progression of diabetic nephropathy in 3895 individuals with type 1 diabetes in the FinnDiane Study. The renal status was assessed with the urinary albumin excretion rate and estimated glomerular filtration rate (eGFR) at baseline and at the end of the follow-up. Based on previous genomewide association studies on serum uric acid concentration, 23 single nucleotide polymorphisms (SNPs) with good imputation quality were selected for the SNP score. This score was used to assess the causality between serum uric acid and renal complications using a Mendelian randomization approach. At baseline, the serum uric acid concentration was higher with worsening renal status. In multivariable Cox regression analyses, baseline serum uric acid concentration was not independently associated with progression of diabetic nephropathy over a mean follow-up of 7 years. However, over the same period, baseline serum uric acid was independently associated with the decline in eGFR. In the cross-sectional logistic regression analyses, the SNP score was associated with the serum uric acid concentration. Nevertheless, the Mendelian randomization showed no causality between uric acid and diabetic nephropathy, eGFR categories, or eGFR as a continuous variable. Thus, our results suggest that the serum uric acid concentration is not causally related to diabetic nephropathy but is a downstream marker of kidney damage. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Maximum likelihood estimation of correction for dilution bias in simple linear regression using replicates from subjects with extreme first measurements.

PubMed

Berglund, Lars; Garmo, Hans; Lindbäck, Johan; Svärdsudd, Kurt; Zethelius, Björn

2008-09-30

The least-squares estimator of the slope in a simple linear regression model is biased towards zero when the predictor is measured with random error. A corrected slope may be estimated by adding data from a reliability study, which comprises a subset of subjects from the main study. The precision of this corrected slope depends on the design of the reliability study and estimator choice. Previous work has assumed that the reliability study constitutes a random sample from the main study. A more efficient design is to use subjects with extreme values on their first measurement. Previously, we published a variance formula for the corrected slope, when the correction factor is the slope in the regression of the second measurement on the first. In this paper we show that both designs improve by maximum likelihood estimation (MLE). The precision gain is explained by the inclusion of data from all subjects for estimation of the predictor's variance and by the use of the second measurement for estimation of the covariance between response and predictor. The gain of MLE enhances with stronger true relationship between response and predictor and with lower precision in the predictor measurements. We present a real data example on the relationship between fasting insulin, a surrogate marker, and true insulin sensitivity measured by a gold-standard euglycaemic insulin clamp, and simulations, where the behavior of profile-likelihood-based confidence intervals is examined. MLE was shown to be a robust estimator for non-normal distributions and efficient for small sample situations. Copyright (c) 2008 John Wiley & Sons, Ltd.

Asthma and lung cancer, after accounting for co-occurring respiratory diseases and allergic conditions: a systematic review protocol.

PubMed

Denholm, Rachel; Crellin, Elizabeth; Arvind, Ashwini; Quint, Jennifer

2017-01-16

Asthma is one of the most frequently diagnosed respiratory diseases in the UK, and commonly co-occurs with other respiratory and allergic diseases, such as chronic obstructive pulmonary disease (COPD) and atopic dermatitis. Previous studies have shown an increased risk of lung cancer related to asthma, but the evidence is mixed when accounting for co-occurring respiratory diseases and allergic conditions. A systematic review of published data that investigate the relationship between asthma and lung cancer, accounting for co-occurring respiratory and allergic diseases, will be conducted to investigate the independent association of asthma with lung cancer. A systematic review will be conducted, and include original reports of cohort, cross-sectional and case-control studies of the association of asthma with lung cancer after accounting for co-occurring respiratory diseases. Articles published up to June 2016 will be included, and their selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A standardised data extraction form will be developed and pretested, and descriptive analyses will be used to summarise the available literature. If appropriate, pooled effect estimates of the association between asthma and lung cancer, given adjustment for a specific co-occurring condition will be estimated using random effects models. Potential sources of heterogeneity and between study heterogeneity will also be investigated. The study will be a review of published data and does not require ethical approval. Results will be disseminated through a peer-reviewed publication. International Prospective Register for Systematic Reviews (PROSPERO) number CRD42016043341. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Emotional tone of ontario newspaper articles on the health effects of industrial wind turbines before and after policy change.

PubMed

Deignan, Benjamin; Hoffman-Goetz, Laurie

2015-01-01

Newspapers are often a primary source of health information for the public about emerging technologies. Information in newspapers can amplify or attenuate readers' perceptions of health risk depending on how it is presented. Five geographically distinct wind energy installations in Ontario, Canada were identified, and newspapers published in their surrounding communities were systematically searched for articles on health effects from industrial wind turbines from May 2007 to April 2011. The authors retrieved 421 articles from 13 community, 2 provincial, and 2 national newspapers. To measure the emotional tone of the articles, the authors used a list of negative and positive words, informed from previous studies as well as from a random sample of newspaper articles included in this study. The majority of newspaper articles (64.6%, n = 272) emphasized negative rather than positive/neutral tone, with community newspapers publishing a higher proportion of negative articles than provincial or national newspapers, χ(2)(2) = 15.1, p < .001. Articles were more likely to be negative when published 2 years after compared with 2 years before provincial legislation to reduce dependence on fossil fuels (the Green Energy Act), χ(2)(3) = 9.7, p < .05. Repeated public exposure to negative newspaper content may heighten readers' health risk perceptions about wind energy.

An updated review of the efficacy of cupping therapy.

PubMed

Cao, Huijuan; Li, Xun; Liu, Jianping

2012-01-01

Since 1950, traditional Chinese medicine (TCM) cupping therapy has been applied as a formal modality in hospitals throughout China and elsewhere in the world. Based on a previous systematic literature review of clinical studies on cupping therapy, this study presents a thorough review of randomized controlled trials (RCTs) to evaluate the therapeutic effect of cupping therapy. Six databases were searched for articles published through 2010. RCTs on cupping therapy for various diseases were included. Studies on cupping therapy combined with other TCM treatments versus non-TCM therapies were excluded. 135 RCTs published from 1992 through 2010 were identified. The studies were generally of low methodological quality. Diseases for which cupping therapy was commonly applied were herpes zoster, facial paralysis (Bell palsy), cough and dyspnea, acne, lumbar disc herniation, and cervical spondylosis. Wet cupping was used in most trials, followed by retained cupping, moving cupping, and flash cupping. Meta-analysis showed cupping therapy combined with other TCM treatments was significantly superior to other treatments alone in increasing the number of cured patients with herpes zoster, facial paralysis, acne, and cervical spondylosis. No serious adverse effects were reported in the trials. Numerous RCTs on cupping therapy have been conducted and published during the past decades. This review showed that cupping has potential effect in the treatment of herpes zoster and other specific conditions. However, further rigorously designed trials on its use for other conditions are warranted.

Treatment effects for dysphagia in Parkinson's disease: a systematic review.

PubMed

van Hooren, M R A; Baijens, L W J; Voskuilen, S; Oosterloo, M; Kremer, B

2014-08-01

Dysphagia remains a common problem in Parkinson's disease (PD). Previous systematic reviews on therapy effects for oropharyngeal dysphagia in PD have shown a lack of evidence. In the past 5 years several placebo or sham-controlled trials with varying results have been published. The aim of this systematic literature review is to summarize and qualitatively analyze the published studies on this matter. Studies published up to December 2013 were found via a systematic comprehensive electronic database search using PubMed, Embase, and The Cochrane Library. Two reviewers independently assessed the studies using strict inclusion criteria. Twelve studies were included and qualitatively analyzed using critical appraisal items. The review includes rehabilitative (exercises, electrical stimulation, bolus modification etc.) and pharmacologic treatment. Some well-designed controlled trials were included. However, none of the included studies fulfilled all criteria for external and internal validity. A meta-analysis was not carried out as most of the studies were not of sufficient quality to warrant doing so. Expiratory Muscle Strength Training (EMST) and Video-Assisted Swallowing Therapy (VAST) may be effective dysphagia treatments solely or in addition to dopaminergic therapy for PD. However, these preliminary results warrant further investigation concerning their clinical applicability, and further research should be based on randomized sham-controlled trials to determine the effectiveness and long-term effects of different therapies for dysphagia in PD. Copyright © 2014 Elsevier Ltd. All rights reserved.

Complex refractive index measurements for BaF 2 and CaF 2 via single-angle infrared reflectance spectroscopy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kelly-Gorham, Molly Rose K.; DeVetter, Brent M.; Brauer, Carolyn S.

We have re-investigated the optical constants n and k for the homologous series of inorganic salts barium fluoride (BaF2) and calcium fluoride (CaF2) using a single-angle near-normal incidence reflectance device in combination with a calibrated Fourier transform infrared (FTIR) spectrometer. Our results are in good qualitative agreement with most previous works. However, certain features of the previously published data near the reststrahlen band exhibit distinct differences in spectral characteristics. Notably, our measurements of BaF2 do not include a spectral feature in the ~250 cm-1 reststrahlen band that was previously published. Additionally, CaF2 exhibits a distinct wavelength shift relative to themore » model derived from previously published data. We confirmed our results with recently published works that use significantly more modern instrumentation and data reduction techniques« less

Assessing quality of reports on randomized clinical trials in nursing journals.

PubMed

Parent, Nicole; Hanley, James A

2009-01-01

Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Implementing falls prevention research into policy and practice in Australia: past, present and future.

PubMed

Lord, Stephen R; Sherrington, Catherine; Cameron, Ian D; Close, Jacqueline C T

2011-12-01

Falls in older Australians are a significant public health issue with one in three older people falling one or more times each year. Many fall prevention randomized controlled trials have been conducted in Australia as well as across the world. The findings of these studies now constitute a substantial evidence base that can provide direction for health and lifestyle interventions for preventing falls in older people. This research evidence has contributed to health policy in Australia to some extent, but is yet to be widely implemented into practice. This opinion piece overviews previous policy initiatives and describes a new Partnership research program funded by the Australian National Health and Medical Research Council (NHMRC), which seeks to further influence health policy and address the ongoing research-practice gap. Copyright © 2011. Published by Elsevier Ltd.

A 6-year-old boy with Cornelia de Lange syndrome and Coats disease: case report and review of the literature.

PubMed

Stacey, Andrew W; Sparagna, Cristina; Borri, Melissa; Rizzo, Stanislao; Hadjistilianou, Theodora

2015-10-01

Cornelia de Lange syndrome (CdLS) can result in multiple congenital abnormalities and numerous ocular findings. We report the case of a 6-year-old boy with history of CdLS who presented with Coats disease. The findings in this case are compared to those found in the two previously reported cases of concomitant CdLS and Coats disease. The low incidence of these two disorders makes it highly unlikely that the connection is random in these 3 cases. The number of patients with both Cornelia de Lange syndrome and Coats disease is likely underestimated due to the difficulty in examining the peripheral retina in this patient population. Copyright © 2015 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

An Assessment of the Risk of Bias in Randomized Controlled Trial Reports Published in Prosthodontic and Implant Dentistry Journals.

PubMed

Papageorgiou, Spyridon N; Kloukos, Dimitrios; Petridis, Haralampos; Pandis, Nikolaos

2015-01-01

The objective of this study was to assess the risk of bias of randomized controlled trials (RCTs) published in prosthodontic and implant dentistry journals. The last 30 issues of 9 journals in the field of prosthodontic and implant dentistry (Clinical Implant Dentistry and Related Research, Clinical Oral Implants Research, Implant Dentistry, International Journal of Oral & Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, International Journal of Prosthodontics, Journal of Dentistry, Journal of Oral Rehabilitation, and Journal of Prosthetic Dentistry) were hand-searched for RCTs. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool and analyzed descriptively. From the 3,667 articles screened, a total of 147 RCTs were identified and included. The number of published RCTs increased with time. The overall distribution of a high risk of bias assessment varied across the domains of the Cochrane risk of bias tool: 8% for random sequence generation, 18% for allocation concealment, 41% for masking, 47% for blinding of outcome assessment, 7% for incomplete outcome data, 12% for selective reporting, and 41% for other biases. The distribution of high risk of bias for RCTs published in the selected prosthodontic and implant dentistry journals varied among journals and ranged from 8% to 47%, which can be considered as substantial.

Book review: The Wilderness Debate Rages On: Continuing the Great New Wilderness Debate

Treesearch

Peter Landres

2009-01-01

The Wilderness Debate Rages On is a collection of mostly previously published papers about the meaning, value, and role of wilderness and continues the discussion that was propelled by the editors' previous book The Great New Wilderness Debate (also a collection of papers) published in 1998. The editors state that this sequel to their previous book is mandated...

Design, objectives, execution and reporting of published open-label extension studies.

PubMed

Megan, Bowers; Pickering, Ruth M; Weatherall, Mark

2012-04-01

Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. © 2010 Blackwell Publishing Ltd.

Prevalence of rosacea in the general population of Germany and Russia - The RISE study.

PubMed

Tan, J; Schöfer, H; Araviiskaia, E; Audibert, F; Kerrouche, N; Berg, M

2016-03-01

There is an unmet need for general population-based epidemiological data on rosacea based on contemporary diagnostic criteria and validated population survey methodology. To evaluate the prevalence of rosacea in the general population of Germany and Russia. General population screening was conducted in 9-10 cities per country to ensure adequate geographic representation. In Part I of this two-phase study, screening of a representative sample of the general population (every fifth person or every fifth door using a fixed-step procedure on a random route sample) was expedited with use of a questionnaire and algorithm based on current diagnostic criteria for rosacea. Of the subjects that screened positive in the initial phase, a randomly selected sample (every third subject) t`hen underwent diagnostic confirmation by a dermatologist in Part II. A total of 3052 and 3013 subjects (aged 18-65 years) were screened in Germany and Russia respectively. Rosacea prevalence was 12.3% [95%CI, 10.2-14.4] in Germany and 5.0% [95%CI, 2.8-7.2] in Russia. The profile of subjects with rosacea (75% women; mean age of 40 years; mainly skin phototype II or III, majority of subjects with sensitive facial skin) and subtype distribution were similar. Overall, 18% of subjects diagnosed with rosacea were aged 18-30 years. Over 80% were not previously diagnosed. Within the previous year, 47.5% of subjects had received no rosacea care and 23.7% had received topical and/or systemic drugs. Over one-third (35% Germany, 43% Russia) of rosacea subjects reported a moderate to severe adverse impact on quality of life. Rosacea is highly prevalent in Germany (12.3%) and Russia (5.0%). The demographic profile of rosacea subjects was similar between countries and the majority were previously undiagnosed. © 2016 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS).

PubMed

Jang, Saeheon; Jung, Sungwon; Pae, Chiun; Kimberly, Blanchard Portland; Craig Nelson, J; Patkar, Ashwin A

2013-12-01

We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥ 14 and a CGI-S score of ≥ 3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e., lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD. © 2013 Published by Elsevier B.V.

Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.

PubMed

Aikin, Kathryn J; Southwell, Brian G; Paquin, Ryan S; Rupert, Douglas J; O'Donoghue, Amie C; Betts, Kevin R; Lee, Philip K

Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. These results extend previous research to a new health condition and hold implications for regulatory policy. Published by Elsevier Inc.

An Updated Meta-Analysis of Risk of Multiple Sclerosis following Infectious Mononucleosis

PubMed Central

Handel, Adam E.; Williamson, Alexander J.; Disanto, Giulio; Handunnetthi, Lahiru; Giovannoni, Gavin; Ramagopalan, Sreeram V.

2010-01-01

Background Multiple sclerosis (MS) appears to develop in genetically susceptible individuals as a result of environmental exposures. Epstein-Barr virus (EBV) infection is an almost universal finding among individuals with MS. Symptomatic EBV infection as manifested by infectious mononucleosis (IM) has been shown in a previous meta-analysis to be associated with the risk of MS, however a number of much larger studies have since been published. Methods/Principal Findings We performed a Medline search to identify articles published since the original meta-analysis investigating MS risk following IM. A total of 18 articles were included in this study, including 19390 MS patients and 16007 controls. We calculated the relative risk of MS following IM using a generic inverse variance with random effects model. This showed that the risk of MS was strongly associated with IM (relative risk (RR) 2.17; 95% confidence interval 1.97–2.39; p<10−54). Discussion Our results establish firmly that a history of infectious mononucleosis significantly increases the risk of multiple sclerosis. Future work should focus on the mechanism of this association and interaction with other risk factors. PMID:20824132

More female patients and fewer stimuli per session are associated with the short-term antidepressant properties of repetitive transcranial magnetic stimulation (rTMS): a meta-analysis of 54 sham-controlled studies published between 1997–2013

PubMed Central

Kedzior, Karina Karolina; Azorina, Valeriya; Reitz, Sarah Kim

2014-01-01

Background Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) appears to have short-term antidepressant properties. The aim of the current study was to update our previous meta-analysis and to investigate factors associated with the antidepressant properties of rTMS. Method Following a systematic literature search conducted in Medline and PsycInfo, N=14 sham-controlled, parallel design studies (published after 2008 to August 2013) that had utilized rTMS of the DLPFC in major depression were included in the current meta-analysis. The sensitivity and moderator analyses also included data from N=40 studies (published in 1997–2008) from our previous meta-analysis. The effect size (Cohen’s d) in each study was the standardized difference in mean depression scores (on Hamilton Depression Rating Scale, Beck Depression Inventory, Montgomery Åsberg Depression Rating Scale) from baseline to final (after last session) in rTMS compared to sham groups. Results According to a random-effects model with inverse-variance weights, depression scores were significantly reduced after rTMS compared to sham in studies published from 2008–2013 based on N=659 patients (overall mean weighted d=−0.42, 95% confidence interval: −0.66, −0.18, P=0.001). Combining studies from our past and current meta-analyses (published in 1997–2013; N=54) revealed that depression was significantly reduced after left-fast (>1 Hz), right-slow (≤1 Hz), and bilateral (or sequential) rTMS of DLPFC compared to sham. Significant antidepressant properties of rTMS were observed in studies with patients who were treatment resistant, unipolar (or bipolar), non-psychotic, medication-free (or started on antidepressants concurrently with rTMS). According to univariate meta-regressions, depression scores were significantly lower in studies with more female patients and fewer stimuli per session. There was little evidence that publication bias occurred in the analysis. Conclusion According to this study, the largest meta-analysis to date, short-term antidepressant properties of rTMS are independent of concurrent antidepressants and might depend on sex and the number of stimuli per session. PMID:24855360

No. 348-Joint SOGC-CCMG Guideline: Update on Prenatal Screening for Fetal Aneuploidy, Fetal Anomalies, and Adverse Pregnancy Outcomes.

PubMed

Audibert, Francois; De Bie, Isabelle; Johnson, Jo-Ann; Okun, Nanette; Wilson, R Douglas; Armour, Christine; Chitayat, David; Kim, Raymond

2017-09-01

To review the available prenatal screening options in light of the recent technical advances and to provide an update of previous guidelines in the field of prenatal screening. Health care providers involved in prenatal screening, including general practitioners, obstetricians, midwives, maternal fetal medicine specialists, geneticists, and radiologists. All pregnant women receiving counselling and providing informed consent for prenatal screening. Published literature was retrieved through searches of Medline, PubMed, and the Cochrane Library in and prior to March 2016 using an appropriate controlled vocabulary (prenatal diagnosis, amniocentesis, chorionic villi sampling, non-invasive prenatal screening) and key words (prenatal screening, prenatal genetic counselling). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1985 to May 2016. Searches were updated on a regular basis and incorporated in the guideline. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical speciality societies. Evidence will be reviewed 5 years after publication to determine whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

An Evaluation of the Plant Density Estimator the Point-Centred Quarter Method (PCQM) Using Monte Carlo Simulation.

PubMed

Khan, Md Nabiul Islam; Hijbeek, Renske; Berger, Uta; Koedam, Nico; Grueters, Uwe; Islam, S M Zahirul; Hasan, Md Asadul; Dahdouh-Guebas, Farid

2016-01-01

In the Point-Centred Quarter Method (PCQM), the mean distance of the first nearest plants in each quadrant of a number of random sample points is converted to plant density. It is a quick method for plant density estimation. In recent publications the estimator equations of simple PCQM (PCQM1) and higher order ones (PCQM2 and PCQM3, which uses the distance of the second and third nearest plants, respectively) show discrepancy. This study attempts to review PCQM estimators in order to find the most accurate equation form. We tested the accuracy of different PCQM equations using Monte Carlo Simulations in simulated (having 'random', 'aggregated' and 'regular' spatial patterns) plant populations and empirical ones. PCQM requires at least 50 sample points to ensure a desired level of accuracy. PCQM with a corrected estimator is more accurate than with a previously published estimator. The published PCQM versions (PCQM1, PCQM2 and PCQM3) show significant differences in accuracy of density estimation, i.e. the higher order PCQM provides higher accuracy. However, the corrected PCQM versions show no significant differences among them as tested in various spatial patterns except in plant assemblages with a strong repulsion (plant competition). If N is number of sample points and R is distance, the corrected estimator of PCQM1 is 4(4N - 1)/(π ∑ R2) but not 12N/(π ∑ R2), of PCQM2 is 4(8N - 1)/(π ∑ R2) but not 28N/(π ∑ R2) and of PCQM3 is 4(12N - 1)/(π ∑ R2) but not 44N/(π ∑ R2) as published. If the spatial pattern of a plant association is random, PCQM1 with a corrected equation estimator and over 50 sample points would be sufficient to provide accurate density estimation. PCQM using just the nearest tree in each quadrant is therefore sufficient, which facilitates sampling of trees, particularly in areas with just a few hundred trees per hectare. PCQM3 provides the best density estimations for all types of plant assemblages including the repulsion process. Since in practice, the spatial pattern of a plant association remains unknown before starting a vegetation survey, for field applications the use of PCQM3 along with the corrected estimator is recommended. However, for sparse plant populations, where the use of PCQM3 may pose practical limitations, the PCQM2 or PCQM1 would be applied. During application of PCQM in the field, care should be taken to summarize the distance data based on 'the inverse summation of squared distances' but not 'the summation of inverse squared distances' as erroneously published.

Effects of linking a soil-water-balance model with a groundwater-flow model

USGS Publications Warehouse

Stanton, Jennifer S.; Ryter, Derek W.; Peterson, Steven M.

2013-01-01

A previously published regional groundwater-flow model in north-central Nebraska was sequentially linked with the recently developed soil-water-balance (SWB) model to analyze effects to groundwater-flow model parameters and calibration results. The linked models provided a more detailed spatial and temporal distribution of simulated recharge based on hydrologic processes, improvement of simulated groundwater-level changes and base flows at specific sites in agricultural areas, and a physically based assessment of the relative magnitude of recharge for grassland, nonirrigated cropland, and irrigated cropland areas. Root-mean-squared (RMS) differences between the simulated and estimated or measured target values for the previously published model and linked models were relatively similar and did not improve for all types of calibration targets. However, without any adjustment to the SWB-generated recharge, the RMS difference between simulated and estimated base-flow target values for the groundwater-flow model was slightly smaller than for the previously published model, possibly indicating that the volume of recharge simulated by the SWB code was closer to actual hydrogeologic conditions than the previously published model provided. Groundwater-level and base-flow hydrographs showed that temporal patterns of simulated groundwater levels and base flows were more accurate for the linked models than for the previously published model at several sites, particularly in agricultural areas.

From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource.

PubMed

Muñoz, Ricardo F; Aguilera, Adrian; Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J

2012-06-27

Internet interventions have the potential to address many of the health problems that produce the greatest global burden of disease. We present a study illustrating this potential. The Spanish/English San Francisco Stop Smoking Internet site, which yielded quit rates of 20% or more at 12 months in published randomized controlled trials (RCTs), was modified to make it accessible to Spanish- and English-speaking smokers 18 years of age or older anywhere in the world. To illustrate that Internet interventions designed to conduct RCTs can be adapted to serve as universal health care resources. We also examine quit rates obtained in the current participant preference study (in which users could choose from all elements tested in previous RCTs) to determine whether they differ from the quit rates found in the RCTs. We modified the San Francisco Stop Smoking Internet site so that, instead of being randomly assigned to a specific intervention, participants could personalize the site by choosing among nine site elements (eg, stop smoking guide, reminder emails, journal, mood management intervention, or virtual group). Participants completed a baseline assessment, and reported smoking and mood data at 1-, 3-, 6-, and 12-month follow-ups. We assessed the modified website's reach and outcomes (quit rates), and compared the quit rates of the current participant preference study with those of the previous RCTs. In the first year of recruitment, 94,158 individuals from 152 countries and territories visited the site; 13,488 participants left some data; 9173 signed consent; 7763 completed the baseline survey; and 1955, 1362, 1106, and 1096 left 1-, 3-, 6-, and 12-month data, respectively. Observed quit rates were 38.1% (n = 668), 44.9% (n = 546), 43.6% (n = 431), and 45.4% (n = 449), respectively. The current participant preference study yielded higher observed quit rates (odds ratio 1.30) than the previous RCT when controlling for individuals' demographic and smoking characteristics. After strict RCTs are completed, Internet intervention sites can be made into worldwide health intervention resources without reducing their effectiveness. Clinicaltrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/66npiZF4y).

8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information.

PubMed

Zhang, Rujun; Persaud, Navindra

2017-01-01

We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Double blinded, multi-centred, randomized placebo-controlled study. 14 clinics in the United States. 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. Not registered.

Near-optimal matrix recovery from random linear measurements.

PubMed

Romanov, Elad; Gavish, Matan

2018-06-25

In matrix recovery from random linear measurements, one is interested in recovering an unknown M-by-N matrix [Formula: see text] from [Formula: see text] measurements [Formula: see text], where each [Formula: see text] is an M-by-N measurement matrix with i.i.d. random entries, [Formula: see text] We present a matrix recovery algorithm, based on approximate message passing, which iteratively applies an optimal singular-value shrinker-a nonconvex nonlinearity tailored specifically for matrix estimation. Our algorithm typically converges exponentially fast, offering a significant speedup over previously suggested matrix recovery algorithms, such as iterative solvers for nuclear norm minimization (NNM). It is well known that there is a recovery tradeoff between the information content of the object [Formula: see text] to be recovered (specifically, its matrix rank r) and the number of linear measurements n from which recovery is to be attempted. The precise tradeoff between r and n, beyond which recovery by a given algorithm becomes possible, traces the so-called phase transition curve of that algorithm in the [Formula: see text] plane. The phase transition curve of our algorithm is noticeably better than that of NNM. Interestingly, it is close to the information-theoretic lower bound for the minimal number of measurements needed for matrix recovery, making it not only state of the art in terms of convergence rate, but also near optimal in terms of the matrices it successfully recovers. Copyright © 2018 the Author(s). Published by PNAS.

A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene-citrate-resistant polycystic ovary syndrome.

PubMed

El-khayat, Waleed; Abdel Moety, Ghada; Al Mohammady, Maged; Hamed, Dalia

2016-02-01

To examine the efficacy of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone among women with polycystic ovary syndrome (PCOS) resistant to clomifene citrate. A prospective double-blind randomized controlled trial of women younger than 40 years who had primary/secondary infertility associated with PCOS and had not ovulated in response to clomifene citrate regimens previously was conducted at a center in Cairo, Egypt, between August 1, 2013, and December 31, 2014. Computer-generated random number tables and opaque envelopes were used to assign participants to group A or group B. Participants allocated to group A received 100mg clomifene citrate daily for 5 days from the third day of the menstrual cycle, whereas those in group B received 5mg letrozole daily in the same regimen. All patients received 850 mg metformin and 15 mg pioglitazone for 10 days from the first day of the menstrual cycle. The primary outcome was cumulative ovulation rate. Analyses were by intention to treat. Fifty women were assigned to each group. Ovulation occurred in 108 (92.3%) of 117 cycles in group A and 93 (86.9%) of 107 cycles in Group B (P=0.184). Combined treatment with letrozole, metformin, and pioglitazone was efficacious among women with PCOS resistant to clomifene citrate. ClinicalTrials.gov: NCT01909141. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial for the effect of passive stretching on measures of hamstring extensibility, passive stiffness, strength, and stretch tolerance.

PubMed

Marshall, Paul W M; Cashman, Anthony; Cheema, Birinder S

2011-11-01

To measure hamstring extensibility, stiffness, stretch tolerance, and strength following a 4-week passive stretching program. Randomized controlled trial. Twenty-two healthy participants were randomly assigned to either a 4-week stretching program consisting of 4 hamstring and hip stretches performed 5 times per week, or a non-stretching control group. Hamstring extensibility and stiffness were measured before and after training using the instrumented straight leg raise test (iSLR). Stretch tolerance was measured as the pain intensity (visual analog scale; VAS) elicited during the maximal stretch. Hamstring strength was measured using isokinetic dynamometry at 30 and 120° s(-1). Hamstring extensibility increased by 20.9% in the intervention group following 4 weeks of training (p<0.001; d=0.86). Passive stiffness was reduced by 31% in the intervention group (p<0.05; d=-0.89). Stretch tolerance VAS scores were not different between groups at either time point, and no changes were observed following training. There were no changes in hamstring concentric strength measured at 30 and 120° s(-1). Passive stretching increases hamstring extensibility and decreases passive stiffness, with no change in stretch tolerance defined by pain intensity during the stretch. Compared to previous research, the volume of stretching was higher in this study. The volume of prescribed stretching is important for eliciting the strong clinical effect observed in this study. Copyright © 2011 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Assessing the significance of pedobarographic signals using random field theory.

PubMed

Pataky, Todd C

2008-08-07

Traditional pedobarographic statistical analyses are conducted over discrete regions. Recent studies have demonstrated that regionalization can corrupt pedobarographic field data through conflation when arbitrary dividing lines inappropriately delineate smooth field processes. An alternative is to register images such that homologous structures optimally overlap and then conduct statistical tests at each pixel to generate statistical parametric maps (SPMs). The significance of SPM processes may be assessed within the framework of random field theory (RFT). RFT is ideally suited to pedobarographic image analysis because its fundamental data unit is a lattice sampling of a smooth and continuous spatial field. To correct for the vast number of multiple comparisons inherent in such data, recent pedobarographic studies have employed a Bonferroni correction to retain a constant family-wise error rate. This approach unfortunately neglects the spatial correlation of neighbouring pixels, so provides an overly conservative (albeit valid) statistical threshold. RFT generally relaxes the threshold depending on field smoothness and on the geometry of the search area, but it also provides a framework for assigning p values to suprathreshold clusters based on their spatial extent. The current paper provides an overview of basic RFT concepts and uses simulated and experimental data to validate both RFT-relevant field smoothness estimations and RFT predictions regarding the topological characteristics of random pedobarographic fields. Finally, previously published experimental data are re-analysed using RFT inference procedures to demonstrate how RFT yields easily understandable statistical results that may be incorporated into routine clinical and laboratory analyses.

The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial.

PubMed

John, Jacob; Giri, Sidhartha; Karthikeyan, Arun S; Lata, Dipti; Jeyapaul, Shalini; Rajan, Anand K; Kumar, Nirmal; Dhanapal, Pavithra; Venkatesan, Jayalakshmi; Mani, Mohanraj; Hanusha, Janardhanan; Raman, Uma; Moses, Prabhakar D; Abraham, Asha; Bahl, Sunil; Bandyopadhyay, Ananda S; Ahmad, Mohammad; Grassly, Nicholas C; Kang, Gagandeep

2017-02-15

In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication. We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1-4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months. For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53-0.87] for A versus C, and 0.70 [0.55-0.90] for B versus C). Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month. CTRI/2014/09/004979. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

Anxiety Outcomes after Physical Activity Interventions: Meta-Analysis Findings

PubMed Central

Conn, Vicki S.

2011-01-01

Background Although numerous primary studies have documented the mental health benefits of physical activity (PA), no previous quantitative synthesis has examined anxiety outcomes of interventions to increase PA. Objectives This meta-analysis integrates extant research about anxiety outcomes from interventions to increase PA among healthy adults. Method Extensive literature searching located published and unpublished PA intervention studies with anxiety outcomes. Eligible studies reported findings from interventions designed to increase PA delivered to healthy adults without anxiety disorders. Data were coded from primary studies. Random-effects meta-analytic procedures were completed. Exploratory moderator analyses using meta-analysis ANOVA and regression analogues were conducted to determine if report, methods, sample, or intervention characteristics were associated with differences in anxiety outcomes. Results Data were synthesized across 3,289 subjects from 19 eligible reports. The overall mean anxiety effect size (d-index) for two-group comparisons was 0.22 with significant heterogeneity (Q = 32.15). Exploratory moderator analyses found larger anxiety improvement effect sizes among studies that included larger samples, used random allocation of subjects to treatment and control conditions, targeted only PA behavior instead of multiple health behaviors, included supervised exercise (vs. home-based PA), used moderate or high-intensity instead of low-intensity PA, and suggested subjects exercise at a fitness facility (vs. home) following interventions. Discussion These findings document that some interventions can decrease anxiety symptoms among healthy adults. Exploratory moderator analyses suggest possible directions for future primary research to compare interventions in randomized trials to confirm causal relationships. PMID:20410849

Risk of bias reporting in the recent animal focal cerebral ischaemia literature.

PubMed

Bahor, Zsanett; Liao, Jing; Macleod, Malcolm R; Bannach-Brown, Alexandra; McCann, Sarah K; Wever, Kimberley E; Thomas, James; Ottavi, Thomas; Howells, David W; Rice, Andrew; Ananiadou, Sophia; Sena, Emily

2017-10-15

Findings from in vivo research may be less reliable where studies do not report measures to reduce risks of bias. The experimental stroke community has been at the forefront of implementing changes to improve reporting, but it is not known whether these efforts are associated with continuous improvements. Our aims here were firstly to validate an automated tool to assess risks of bias in published works, and secondly to assess the reporting of measures taken to reduce the risk of bias within recent literature for two experimental models of stroke. We developed and used text analytic approaches to automatically ascertain reporting of measures to reduce risk of bias from full-text articles describing animal experiments inducing middle cerebral artery occlusion (MCAO) or modelling lacunar stroke. Compared with previous assessments, there were improvements in the reporting of measures taken to reduce risks of bias in the MCAO literature but not in the lacunar stroke literature. Accuracy of automated annotation of risk of bias in the MCAO literature was 86% (randomization), 94% (blinding) and 100% (sample size calculation); and in the lacunar stroke literature accuracy was 67% (randomization), 91% (blinding) and 96% (sample size calculation). There remains substantial opportunity for improvement in the reporting of animal research modelling stroke, particularly in the lacunar stroke literature. Further, automated tools perform sufficiently well to identify whether studies report blinded assessment of outcome, but improvements are required in the tools to ascertain whether randomization and a sample size calculation were reported. © 2017 The Author(s).

Improvements in haemolysis and indicators of erythrocyte survival do not correlate with acute vaso-occlusive crises in patients with sickle cell disease: a phase III randomized, placebo-controlled, double-blind study of the Gardos channel blocker senicapoc (ICA-17043).

PubMed

Ataga, Kenneth I; Reid, Marvin; Ballas, Samir K; Yasin, Zahida; Bigelow, Carolyn; James, Luther St; Smith, Wally R; Galacteros, Frederic; Kutlar, Abdullah; Hull, James H; Stocker, Jonathan W

2011-04-01

Red blood cell (RBC) hydration is regulated in part by the Ca(2+) -activated K(+) efflux (Gardos) channel. Senicapoc selectively blocks potassium efflux through the Gardos channel, reducing RBC dehydration and haemolysis, and increasing haemoglobin levels in sickle cell disease (SCD). This randomized, placebo-controlled trial was designed to determine the safety and clinical efficacy of senicapoc in SCD patients. One hundred and forty-five patients were randomized to receive senicapoc and 144 patients to receive placebo for 52 weeks. Consistent with a previous study, patients in the senicapoc group had significantly increased haematocrit, haemoglobin, and decreased numbers of both dense erythrocytes and reticulocytes when compared to the placebo group. The unblinded Data Monitoring Committee terminated this study early due to a lack of efficacy when it determined that, despite improvements in anaemia and haemolysis, no significant improvement in the rate of sickle cell painful crises was observed in patients treated with senicapoc compared to those on placebo (0·38 vs. 0·31, respectively). Comparisons of the times to first, second and third crises between the senicapoc and placebo groups were not statistically significant. Nausea and urinary tract infections occurred more frequently in the senicapoc group than placebo. Serious adverse events were similar in the two groups. © 2011 Blackwell Publishing Ltd.

Is caffeine intake a risk factor leading to infertility? A protocol of an epidemiological systematic review of controlled clinical studies.

PubMed

Cao, Huijuan; Ren, Jun; Feng, Xue; Yang, Guoyan; Liu, Jianping

2016-03-15

Previous studies showed that high dose of caffeine intake may induce some specific human reproductive system diseases, even lead to infertility. In consideration of the high consumption of caffeine according to the latest population-based survey, this review is aimed to systematically review the evidence from all controlled clinical studies of caffeine intake for infertility. Relevant randomized/quasi-randomized controlled trials, non-randomized clinical studies, cohort studies, and case-control studies will be included in this review. Participants will be either those without a history of infertility who are willing to have a baby (for prospective studies) or infertile patients with confirmed diagnosis (for retrospective studies). Caffeine or caffeine-containing beverage will be observed as the exposure factor. The key outcome will be the diagnosis of infertility in participants. All relevant published/unpublished or ongoing studies will be searched from seven databases and four online systems until December 2015. Two authors will screen the literatures and extract the data independently. Methodological quality of the included studies will be assessed by two authors according to either Risk of Bias Assessment or Newcastle-Ottawa Scale. We will use R software to analyze the data. Dose of caffeine will be quantified on a daily basis, and relative risk with their 95 % confidence interval will be measured. If data permit, meta-analysis and dose-response analysis will be conducted. Summary of findings tables will be generated using Guideline Development Tool online. PROSPERO CRD42015015714.

Effects of structured education program on organ donor designation of nursing students and their families: A randomized controlled trial.

PubMed

Murakami, Minoru; Fukuma, Shingo; Ikezoe, Masaya; Iizuka, Chizuko; Izawa, Satoshi; Yamamoto, Yosuke; Yamazaki, Shin; Fukuhara, Shunichi

2016-11-01

Little is known about the effect of education programs on changing attitudes and behaviors of participants and their families toward deceased organ donation. The subjects of this randomized trial were Japanese nursing students who were not previously designated organ donors. They were randomly assigned to either the education program or information booklet group. The program comprised a lecture followed by group discussion and information booklet. The primary outcome was self-reported organ donor designation. Outcomes were assessed by questionnaire. Data of 203 (99.0%) students were analyzed. At study end, seven of 102 students (6.9%) of the program group and one of 101 students (1.0%) of the booklet group consented to donate organs (proportion ratio 6.93 [95% CI 0.87-55.32]). There were significant between-group differences in willingness to consent for donation (54.9% vs 39.6%; proportion ratio 1.39 [95% CI 1.03-1.87]), family discussion (31.4% vs 15.9%; 1.98 [1.16-3.38]), and organ donor designation of family members (11.8% vs 2.0%; 5.94 [1.36-25.88]). No group differences were found in willingness for organ donation by students and family members. Although there were no significant between-group differences in organ donor designation, the program seems to indirectly promote consent to organ donation by their families. © 2016 The Authors. Clinical Transplantation Published by John Wiley & Sons Ltd.

How effective is drug testing as a workplace safety strategy? A systematic review of the evidence.

PubMed

Pidd, Ken; Roche, Ann M

2014-10-01

The growing prevalence of workplace drug testing and the narrow scope of previous reviews of the evidence base necessitate a comprehensive review of research concerning the efficacy of drug testing as a workplace strategy. A systematic qualitative review of relevant research published between January 1990 and January 2013 was undertaken. Inclusion criteria were studies that evaluated the effectiveness of drug testing in deterring employee drug use or reducing workplace accident or injury rates. Methodological adequacy was assessed using a published assessment tool specifically designed to assess the quality of intervention studies. A total of 23 studies were reviewed and assessed, six of which reported on the effectiveness of testing in reducing employee drug use and 17 which reported on occupational accident or injury rates. No studies involved randomised control trials. Only one study was assessed as demonstrating strong methodological rigour. That study found random alcohol testing reduced fatal accidents in the transport industry. The majority of studies reviewed contained methodological weaknesses including; inappropriate study design, limited sample representativeness, the use of ecological data to evaluate individual behaviour change and failure to adequately control for potentially confounding variables. This latter finding is consistent with previous reviews and indicates the evidence base for the effectiveness of testing in improving workplace safety is at best tenuous. Better dissemination of the current evidence in relation to workplace drug testing is required to support evidence-informed policy and practice. There is also a pressing need for more methodologically rigorous research to evaluate the efficacy and utility of drug testing. Copyright © 2014 Elsevier Ltd. All rights reserved.

Breast implants and the risk of breast cancer: a meta-analysis of cohort studies.

PubMed

Noels, Eline C; Lapid, Oren; Lindeman, Jan H N; Bastiaannet, Esther

2015-01-01

The popularity of cosmetic breast augmentation and the incidence of breast cancer have been increasing worldwide. It has been hypothesized that the risk of breast cancer may be greater among patients who have undergone cosmetic breast implantation. The authors performed a meta-analysis of the available literature on the risk of breast cancer among women with cosmetic breast implants. The study was designed as a meta-analysis of observational studies. A systematic search of the English literature (published by August 28, 2013) was conducted in PubMed and EMBASE. Eligible reports were those that included relative risk (RR; the increased or decreased risk of breast cancer associated with breast implants) or the standardized incidence ratio (SIR) of the observed number of cases of breast cancer to the expected number of cases among patients that previously underwent cosmetic breast augmentation. Seventeen studies representing 7 cohorts were selected. Some of these were follow-up reports of previously published studies; in such cases, only the most recent reports were included in the meta-analysis. Summary SIR and RR rates and the corresponding 95% confidence intervals (CIs) were calculated with a random-effects (SIR) or fixed-effects (RR) model. The overall SIR estimate was 0.69 (95% CI, 0.56-0.85), and the overall RR, based on 4 studies, was 0.63 (95% CI, 0.56-0.71). Finding of this meta-analysis suggest that women who have undergone cosmetic breast implantation do not have an increased risk of breast cancer. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Pathophysiological mechanisms of neuropathic pain: comparison of sensory phenotypes in patients and human surrogate pain models.

PubMed

Vollert, Jan; Magerl, Walter; Baron, Ralf; Binder, Andreas; Enax-Krumova, Elena K; Geisslinger, Gerd; Gierthmühlen, Janne; Henrich, Florian; Hüllemann, Philipp; Klein, Thomas; Lötsch, Jörn; Maier, Christoph; Oertel, Bruno; Schuh-Hofer, Sigrid; Tölle, Thomas R; Treede, Rolf-Detlef

2018-06-01

As an indirect approach to relate previously identified sensory phenotypes of patients suffering from peripheral neuropathic pain to underlying mechanisms, we used a published sorting algorithm to estimate the prevalence of denervation, peripheral and central sensitization in 657 healthy subjects undergoing experimental models of nerve block (NB) (compression block and topical lidocaine), primary hyperalgesia (PH) (sunburn and topical capsaicin), or secondary hyperalgesia (intradermal capsaicin and electrical high-frequency stimulation), and in 902 patients suffering from neuropathic pain. Some of the data have been previously published. Randomized split-half analysis verified a good concordance with a priori mechanistic sensory profile assignment in the training (79%, Cohen κ = 0.54, n = 265) and the test set (81%, Cohen κ = 0.56, n = 279). Nerve blocks were characterized by pronounced thermal and mechanical sensory loss, but also mild pinprick hyperalgesia and paradoxical heat sensations. Primary hyperalgesia was characterized by pronounced gain for heat, pressure and pinprick pain, and mild thermal sensory loss. Secondary hyperalgesia was characterized by pronounced pinprick hyperalgesia and mild thermal sensory loss. Topical lidocaine plus topical capsaicin induced a combined phenotype of NB plus PH. Topical menthol was the only model with significant cold hyperalgesia. Sorting of the 902 patients into these mechanistic phenotypes led to a similar distribution as the original heuristic clustering (65% identity, Cohen κ = 0.44), but the denervation phenotype was more frequent than in heuristic clustering. These data suggest that sorting according to human surrogate models may be useful for mechanism-based stratification of neuropathic pain patients for future clinical trials, as encouraged by the European Medicines Agency.

Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation.

PubMed

Hart, Robert G; Pearce, Lesly A; Aguilar, Maria I

2007-06-19

Atrial fibrillation is a strong independent risk factor for stroke. To characterize the efficacy and safety of antithrombotic agents for stroke prevention in patients who have atrial fibrillation, adding 13 recent randomized trials to a previous meta-analysis. Randomized trials identified by using the Cochrane Stroke Group search strategy, 1966 to March 2007, unrestricted by language. All published randomized trials with a mean follow-up of 3 months or longer that tested antithrombotic agents in patients who have nonvalvular atrial fibrillation. Two coauthors independently extracted information regarding interventions; participants; and occurrences of ischemic and hemorrhagic stroke, major extracranial bleeding, and death. Twenty-nine trials included 28,044 participants (mean age, 71 years; mean follow-up, 1.5 years). Compared with the control, adjusted-dose warfarin (6 trials, 2900 participants) and antiplatelet agents (8 trials, 4876 participants) reduced stroke by 64% (95% CI, 49% to 74%) and 22% (CI, 6% to 35%), respectively. Adjusted-dose warfarin was substantially more efficacious than antiplatelet therapy (relative risk reduction, 39% [CI, 22% to 52%]) (12 trials, 12 963 participants). Other randomized comparisons were inconclusive. Absolute increases in major extracranial hemorrhage were small (< or =0.3% per year) on the basis of meta-analysis. Methodological features and quality varied substantially and often were incompletely reported. Adjusted-dose warfarin and antiplatelet agents reduce stroke by approximately 60% and by approximately 20%, respectively, in patients who have atrial fibrillation. Warfarin is substantially more efficacious (by approximately 40%) than antiplatelet therapy. Absolute increases in major extracranial hemorrhage associated with antithrombotic therapy in participants from the trials included in this meta-analysis were less than the absolute reductions in stroke. Judicious use of antithrombotic therapy importantly reduces stroke for most patients who have atrial fibrillation.

Receipt of Preventive Services After Oregon's Randomized Medicaid Experiment.

PubMed

Marino, Miguel; Bailey, Steffani R; Gold, Rachel; Hoopes, Megan J; O'Malley, Jean P; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K John; DeVoe, Jennifer E

2016-02-01

It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S., primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon's 2008 randomized Medicaid expansion ("Oregon Experiment") on receipt of 12 preventive care services in community health centers using electronic health record data. Demographic data from adult (aged 19-64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008-2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012-2014; analysis performed in 2014-2015). Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for 8 of 12 assessed preventive services. In intent-to-treat analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Therapeutic Exercise Training to Reduce Chronic Headache in Working Women: Design of a Randomized Controlled Trial.

PubMed

Rinne, Marjo; Garam, Sanna; Häkkinen, Arja; Ylinen, Jari; Kukkonen-Harjula, Katriina; Nikander, Riku

2016-05-01

Cervicogenic headache and migraine are common causes of visits to physicians and physical therapists. Few randomized trials utilizing active physical therapy and progressive therapeutic exercise have been previously published. The existing evidence on active treatment methods supports a moderate effect on cervicogenic headache. The aim of this study is to investigate whether a progressive, group-based therapeutic exercise program decreases the intensity and frequency of chronic headache among women compared with a control group receiving a sham dose of transcutaneous electrical nerve stimulation (TENS) and stretching exercises. A randomized controlled trial with 6-month intervention and follow-up was developed. The participants were randomly assigned to either a treatment group or a control group. The study is being conducted at 2 study centers. The participants are women aged 18 to 60 years with chronic cervicogenic headache or migraine. The treatment group's exercise program consisted of 6 progressive therapeutic exercise modules, including proprioceptive low-load progressive craniocervical and cervical exercises and high-load exercises for the neck muscles. The participants in the control group received 6 individually performed sham TENS treatment sessions. The primary outcome is the intensity of headache. The secondary outcomes are changes in frequency and duration of headache, neck muscle strength, neck and shoulder flexibility, impact of headache on daily life, neck disability, fear-avoidance beliefs, work ability, and quality of life. Between-group differences will be analyzed separately at 6, 12, and 24 months with generalized linear mixed models. In the case of count data (eg, frequency of headache), Poisson or negative binomial regression will be used. The therapists are not blinded. The effects of specific therapeutic exercises on frequency, intensity, and duration of chronic headache and migraine will be reported. © 2016 American Physical Therapy Association.

A meta-analysis of MTHFR C677T and A1298C polymorphisms and risk of acute lymphoblastic leukemia in children.

PubMed

Yan, Jingrong; Yin, Ming; Dreyer, ZoAnn E; Scheurer, Michael E; Kamdar, Kala; Wei, Qingyi; Okcu, M Fatih

2012-04-01

Methylenetetrahydrofolate reductase (MTHFR) C677T and A1298C polymorphisms have been implicated in childhood acute lymphoblastic leukemia (ALL) risk, but previously published studies were inconsistent and recent meta-analyses were not adequate. In a meta-analysis of 21 publications with 4,706 cases and 7,414 controls, we used more stringent inclusion method and summarized data on associations between MTHFR C677T and A1298C polymorphisms and childhood ALL risk. We found an overall association between 677T variant genotypes and reduced childhood ALL risk. Specifically, in the dominant genetic model, an association was found in a fixed-effect (TT + CT vs. CC: OR = 0.92; 95% CI = 0.85-0.99) but not random-effect model, whereas such an association was observed in both homozygote genetic model (TT vs. CC: OR = 0.80; 95% CI = 0.70-0.93 by fixed effects and OR = 0.78; 95% CI = 0.65-0.93 by random effects) and recessive genetic model (TT vs. CC + CT: OR = 0.83; 95% CI = 0.72-0.95 by fixed effects and OR = 0.84; 95% CI = 0.73-0.97 by random effects). These associations were also observed in subgroups by ethnicity: for Asians in all models except for the dominant genetic model by random effect and for Caucasians in all models except for the recessive genetic model. However, the A1298C polymorphism did not appear to have an effect on childhood ALL risk. These results suggest that the MTHFR C677T, but not A1298C, polymorphism is a potential biomarker for childhood ALL risk. Copyright © 2011 Wiley Periodicals, Inc.

A Randomized Trial of Acceptability and Effects of Values-Based Advance Care Planning in Outpatient Oncology: Person-Centered Oncologic Care and Choices (P-COCC).

PubMed

Epstein, Andrew S; O'Reilly, Eileen M; Shuk, Elyse; Romano, Danielle; Li, Yuelin; Breitbart, William; Volandes, Angelo E

2018-05-02

No standard advance care planning (ACP) process exists in oncology. We previously developed and validated the values questions for Person-Centered Oncologic Care and Choices (P-COCC), a novel ACP intervention combining a patient values interview with an informational care goals video. To pilot study acceptability, and, using randomization, explore potential utility of P-COCC. Eligibility included patients with advanced gastrointestinal cancer cared for at a comprehensive cancer center. Participants were randomized 2:2:1 to P-COCC vs. video alone vs. usual care. Validated assessments of wellbeing and decisional conflict were completed. Participants in the P-COCC arm also completed 3 Likert scales (was the intervention helpful, comfortable, and recommended to others); a positive score on at least 1 of 3 indicated acceptability. Patients were screened from 9/2014-11/2016; 151 were consented and randomized, 99 whom completed study measures (most common attrition reason: disease progression or death). The primary aim was met: Among 33 participants, P-COCC was acceptable to 32 (97%, 95%CI: 0.84-0.99, p<0.001). Mean distress scores (0-10) increased (0.43) in the P-COCC arm but decreased in the video alone (-0.04) and usual care (-0.21) arms (p=0.03 and 0.04, P-COCC versus video alone and usual care arms, respectively). There were no significant pre-post change scores on other measures of wellbeing (e.g., anxiety, depression, stress), or intergroup differences in decisional conflict. Our values-based ACP paradigm is acceptable but may increase distress in cancer outpatients. Further studies are investigating the underpinnings of these effects and ways to best support cancer patients in ACP. Copyright © 2018. Published by Elsevier Inc.

Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE).

PubMed

Duceppe, Emmanuelle; Yusuf, Salim; Tandon, Vikas; Rodseth, Reitze; Biccard, Bruce M; Xavier, Denis; Szczeklik, Wojciech; Meyhoff, Christian S; Franzosi, Maria Grazia; Vincent, Jessica; Srinathan, Sadeesh K; Parlow, Joel; Magloire, Patrick; Neary, John; Rao, Mangala; Chaudhry, Navneet K; Mayosi, Bongani; de Nadal, Miriam; Popova, Ekaterine; Villar, Juan Carlos; Botto, Fernando; Berwanger, Otavio; Guyatt, Gordon; Eikelboom, John W; Sessler, Daniel I; Kearon, Clive; Pettit, Shirley; Connolly, Stuart J; Sharma, Mukul; Bangdiwala, Shrikant I; Devereaux, P J

2018-03-01

Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Fleischhacker, W Wolfgang; Hobart, Mary; Ouyang, John; Forbes, Andy; Pfister, Stephanie; McQuade, Robert D; Carson, William H; Sanchez, Raymond; Nyilas, Margareta; Weiller, Emmanuelle

2017-01-01

Brexpiprazole has previously demonstrated efficacy in acute schizophrenia trials. The objective of this trial was to assess the efficacy, safety, and tolerability of maintenance treatment with brexpiprazole in adults with schizophrenia. Patients with an acute exacerbation of psychotic symptoms were converted to brexpiprazole (1-4mg/d) over 1 to 4 weeks and entered a single-blind stabilization phase. Those patients who met stability criteria for 12 weeks were randomized 1:1 to double-blind maintenance treatment with either brexpiprazole (at their stabilization dose) or placebo for up to 52 weeks. The primary efficacy endpoint was the time from randomization to impending relapse. Safety and tolerability were also assessed. A total of 524 patients were enrolled, 202 of whom were stabilized on brexpiprazole and randomized to brexpiprazole (n=97) or placebo (n=105). Efficacy was demonstrated at a prespecified interim analysis (conducted after 45 events), and so the trial was terminated early. The final analysis showed that time to impending relapse was statistically significantly delayed with brexpiprazole treatment compared with placebo (P<.0001, log-rank test). The hazard ratio for the final analysis was 0.292 (95% confidence interval: 0.156, 0.548); mean dose at last visit, 3.6mg. The proportion of patients meeting the criteria for impending relapse was 13.5% with brexpiprazole and 38.5% with placebo (P<.0001). During the maintenance phase, the incidence of adverse events was comparable to placebo. or patients with schizophrenia already stabilized on brexpiprazole, maintenance treatment with brexpiprazole was efficacious, with a favorable safety profile. © The Author 2016. Published by Oxford University Press on behalf of CINP.

Analysis of fluctuations in semiconductor devices

NASA Astrophysics Data System (ADS)

Andrei, Petru

The random nature of ion implantation and diffusion processes as well as inevitable tolerances in fabrication result in random fluctuations of doping concentrations and oxide thickness in semiconductor devices. These fluctuations are especially pronounced in ultrasmall (nanoscale) semiconductor devices when the spatial scale of doping and oxide thickness variations become comparable with the geometric dimensions of devices. In the dissertation, the effects of these fluctuations on device characteristics are analyzed by using a new technique for the analysis of random doping and oxide thickness induced fluctuations. This technique is universal in nature in the sense that it is applicable to any transport model (drift-diffusion, semiclassical transport, quantum transport etc.) and it can be naturally extended to take into account random fluctuations of the oxide (trapped) charges and channel length. The technique is based on linearization of the transport equations with respect to the fluctuating quantities. It is computationally much (a few orders of magnitude) more efficient than the traditional Monte-Carlo approach and it yields information on the sensitivity of fluctuations of parameters of interest (e.g. threshold voltage, small-signal parameters, cut-off frequencies, etc.) to the locations of doping and oxide thickness fluctuations. For this reason, it can be very instrumental in the design of fluctuation-resistant structures of semiconductor devices. Quantum mechanical effects are taken into account by using the density-gradient model as well as through self-consistent Poisson-Schrodinger computations. Special attention is paid to the presenting of the technique in a form that is suitable for implementation on commercial device simulators. The numerical implementation of the technique is discussed in detail and numerous computational results are presented and compared with those previously published in literature.

Prenatal therapy with pyrimethamine + sulfadiazine versus spiramycin to reduce placental transmission of toxoplasmosis : A multicenter, randomized trial.

PubMed

Mandelbrot, Laurent; Kieffer, François; Sitta, Rémi; Laurichesse-Delmas, Hélène; Winer, Norbert; Mesnard, Louis; Berrebi, Alain; Le Bouar, Gwenaëlle; Bory, Jean-Paul; Cordier, Anne-Gaëlle; Ville, Yves; Perrotin, Franck; Jouannic, Jean-Marie; Biquard, Florence; d'Ercole, Claude; Houfflin-Debarge, Véronique; Villena, Isabelle; Thiébaut, Rodolphe

2018-06-02

The efficacy of prophylaxis to prevent prenatal toxoplasmosis transmission is controversial, without any previous randomized clinical trial. In France, spiramycin (S) is usually prescribed for maternal seroconversions. A more potent pyrimethamine + sulfadiazine (PS) regimen is used to treat congenital toxoplasmosis and is offered in some countries as prophylaxis. To compare the efficacy and tolerance of PS vs S to reduce placental transmission. A randomized, open-label trial in 36 French centers, comparing pyrimethamine (50 mg qd) + sulfadiazine (1g tid) with folinic acid vs spiramycin (1g tid) following toxoplasmosis seroconversion. 143 women were randomized from 11/2010 to 01/2014. An amniocentesis was later performed in 131 cases, with a positive T. gondii PCR in 7/67 (10.4%) in the PS group vs. 13/64 (20.3%) in the S group. Cerebral ultrasound anomalies appeared in 0/73 fetuses in the PS group, vs 6/70 in the S group (p=0.01). Two of these pregnancies were terminated. Transmission rates, excluding 18 children with undefined status, were 12/65 in the PS group (18.5%), vs 18/60 in the S group (30%, p = 0.147), equivalent to an Odds ratio = 0.53 (95% CI 0.23-1.22) and which after adjustment tended to be stronger (p=0.03 for interaction) when treatment started within 3 weeks of seroconversion (95% CI 0.00-1.63). Two women had severe rashes, both with PS. There was a trend towards lower transmission with PS, but it did not reach statistical significance, possibly for lack of statistical power because enrollment was discontinued. There were also no fetal cerebral toxoplasmosis lesions in the PS group. These promising results encourage further research on chemoprophylaxis to prevent congenital toxoplasmosis. Copyright © 2018. Published by Elsevier Inc.

Carotid artery stenting vs. carotid endarterectomy in the management of carotid artery stenosis: Lessons learned from randomized controlled trials

PubMed Central

Salem, Mohamed M.; Alturki, Abdulrahman Y.; Fusco, Matthew R.; Thomas, Ajith J.; Carter, Bob S.; Chen, Clark C.; Kasper, Ekkehard M.

2018-01-01

Background: Carotid artery stenosis, both symptomatic and asymptomatic, has been well studied with several multicenter randomized trials. The superiority of carotid endarterectomy (CEA) to medical therapy alone in both symptomatic and asymptomatic carotid artery stenosis has been well established in previous trials in the 1990s. The consequent era of endovascular carotid artery stenting (CAS) has offered another option for treating carotid artery stenosis. A series of randomized trials have now been conducted to compare CEA and CAS in the treatment of carotid artery disease. The large number of similar trials has created some confusion due to inconsistent results. Here, the authors review the trials that compare CEA and CAS in the management of carotid artery stenosis. Methods: The PubMed database was searched systematically for randomized controlled trials published in English that compared CEA and CAS. Only human studies on adult patients were assessed. The references of identified articles were reviewed for additional manuscripts to be included if inclusion criteria were met. The following terms were used during search: carotid stenosis, endarterectomy, stenting. Retrospective or single-center studies were excluded from the review. Results: Thirteen reports of seven large-scale prospective multicenter studies, comparing both interventions for symptomatic or asymptomatic extracranial carotid artery stenosis, were identified. Conclusions: While the superiority of intervention to medical management for symptomatic patients has been well established in the literatures, careful selection of asymptomatic patients for intervention should be undertaken and only be pursued after institution of appropriate medical therapy until further reports on trials comparing medical therapy to intervention in this patient group are available. PMID:29740506

Red and processed meat consumption and breast cancer: UK Biobank cohort study and meta-analysis.

PubMed

Anderson, Jana J; Darwis, Narisa D M; Mackay, Daniel F; Celis-Morales, Carlos A; Lyall, Donald M; Sattar, Naveed; Gill, Jason M R; Pell, Jill P

2018-02-01

Red and processed meat may be risk factors for breast cancer due to their iron content, administration of oestrogens to cattle or mutagens created during cooking. We studied the associations in UK Biobank and then included the results in a meta-analysis of published cohort studies. UK Biobank, a general population cohort study, recruited participants aged 40-69 years. Incident breast cancer was ascertained via linkage to routine hospital admission, cancer registry and death certificate data. Univariate and multivariable Cox proportional hazard models were used to explore the associations between red and processed meat consumption and breast cancer. Previously published cohort studies were identified from a systematic review using PubMed and Ovid and a meta-analysis conducted using a random effects model. Over a median of 7 years follow-up, 4819 of the 262,195 women developed breast cancer. The risk was increased in the highest tertile (>9 g/day) of processed meat consumption (adjusted hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.08-1.35, p = 0.001). Collation with 10 previous cohort studies provided data on 40,257 incident breast cancers in 1.65 million women. On meta-analysis, processed meat consumption was associated with overall (relative risk [RR] 1.06, 95% CI 1.01-1.11) and post-menopausal (RR 1.09, 95% CI 1.03-1.15), but not pre-menopausal (RR 0.99, 95% CI 0.88-1.10), breast cancer. In UK Biobank and the meta-analysis, red meat consumption was not associated with breast cancer (adjusted HR 0.99 95% CI 0.88-1.12 and RR 1.03, 95% CI 0.99-1.08, respectively). Consumption of processed meat, but not red meat, may increase the risk of breast cancer. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

A reexamination of age-related variation in body weight and morphometry of Maryland nutria

USGS Publications Warehouse

Sherfy, M.H.; Mollett, T.A.; McGowan, K.R.; Daugherty, S.L.

2006-01-01

Age-related variation in morphometry has been documented for many species. Knowledge of growth patterns can be useful for modeling energetics, detecting physiological influences on populations, and predicting age. These benefits have shown value in understanding population dynamics of invasive species, particularly in developing efficient control and eradication programs. However, development and evaluation of descriptive and predictive models is a critical initial step in this process. Accordingly, we used data from necropsies of 1,544 nutria (Myocastor coypus) collected in Maryland, USA, to evaluate the accuracy of previously published models for prediction of nutria age from body weight. Published models underestimated body weights of our animals, especially for ages <3. We used cross-validation procedures to develop and evaluate models for describing nutria growth patterns and for predicting nutria age. We derived models from a randomly selected model-building data set (n = 192-193 M, 217-222 F) and evaluated them with the remaining animals (n = 487-488 M, 642-647 F). We used nonlinear regression to develop Gompertz growth-curve models relating morphometric variables to age. Predicted values of morphometric variables fell within the 95% confidence limits of their true values for most age classes. We also developed predictive models for estimating nutria age from morphometry, using linear regression of log-transformed age on morphometric variables. The evaluation data set corresponded with 95% prediction intervals from the new models. Predictive models for body weight and length provided greater accuracy and less bias than models for foot length and axillary girth. Our growth models accurately described age-related variation in nutria morphometry, and our predictive models provided accurate estimates of ages from morphometry that will be useful for live-captured individuals. Our models offer better accuracy and precision than previously published models, providing a capacity for modeling energetics and growth patterns of Maryland nutria as well as an empirical basis for determining population age structure from live-captured animals.

Reporting clinical outcomes of breast reconstruction: a systematic review.

PubMed

Potter, S; Brigic, A; Whiting, P F; Cawthorn, S J; Avery, K N L; Donovan, J L; Blazeby, J M

2011-01-05

Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

Will Exercise Advice Be Sufficient for Treatment of Young Adults With Prehypertension and Hypertension? A Systematic Review and Meta-Analysis.

PubMed

Williamson, Wilby; Foster, Charlie; Reid, Hamish; Kelly, Paul; Lewandowski, Adam James; Boardman, Henry; Roberts, Nia; McCartney, David; Huckstep, Odaro; Newton, Julia; Dawes, Helen; Gerry, Stephen; Leeson, Paul

2016-07-01

Previous studies report benefits of exercise for blood pressure control in middle age and older adults, but longer-term effectiveness in younger adults is not well established. We performed a systematic review and meta-analysis of published randomized control trials with meta-regression of potential effect modifiers. An information specialist completed a comprehensive search of available data sources, including studies published up to June 2015. Authors applied strict inclusion and exclusion criteria to screen 9524 titles. Eligible studies recruited younger adults with a cardiovascular risk factor (with at least 25% of cohort aged 18-40 years); the intervention had a defined physical activity strategy and reported blood pressure as primary or secondary outcome. Meta-analysis included 14 studies randomizing 3614 participants, mean age 42.2±6.3 (SD) years. At 3 to 6 months, exercise was associated with a reduction in systolic blood pressure of -4.40 mm Hg (95% confidence interval, -5.78 to -3.01) and in diastolic blood pressure of -4.17 mm Hg (95% confidence interval, -5.42 to -2.93). Intervention effect was not significantly influenced by baseline blood pressure, body weight, or subsequent weight loss. Observed intervention effect was lost after 12 months of follow-up with no reported benefit over control, mean difference in systolic blood pressure -1.02 mm Hg (95% confidence interval, -2.34 to 0.29), and in diastolic blood pressure -0.91 mm Hg (95% confidence interval, -1.85 to 0.02). Current exercise guidance provided to reduce blood pressure in younger adults is unlikely to benefit long-term cardiovascular risk. There is need for continued research to improve age-specific strategies and recommendations for hypertension prevention and management in young adults. © 2016 The Authors.

Random Survival Forest in practice: a method for modelling complex metabolomics data in time to event analysis.

PubMed

Dietrich, Stefan; Floegel, Anna; Troll, Martina; Kühn, Tilman; Rathmann, Wolfgang; Peters, Anette; Sookthai, Disorn; von Bergen, Martin; Kaaks, Rudolf; Adamski, Jerzy; Prehn, Cornelia; Boeing, Heiner; Schulze, Matthias B; Illig, Thomas; Pischon, Tobias; Knüppel, Sven; Wang-Sattler, Rui; Drogan, Dagmar

2016-10-01

The application of metabolomics in prospective cohort studies is statistically challenging. Given the importance of appropriate statistical methods for selection of disease-associated metabolites in highly correlated complex data, we combined random survival forest (RSF) with an automated backward elimination procedure that addresses such issues. Our RSF approach was illustrated with data from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam study, with concentrations of 127 serum metabolites as exposure variables and time to development of type 2 diabetes mellitus (T2D) as outcome variable. Out of this data set, Cox regression with a stepwise selection method was recently published. Replication of methodical comparison (RSF and Cox regression) was conducted in two independent cohorts. Finally, the R-code for implementing the metabolite selection procedure into the RSF-syntax is provided. The application of the RSF approach in EPIC-Potsdam resulted in the identification of 16 incident T2D-associated metabolites which slightly improved prediction of T2D when used in addition to traditional T2D risk factors and also when used together with classical biomarkers. The identified metabolites partly agreed with previous findings using Cox regression, though RSF selected a higher number of highly correlated metabolites. The RSF method appeared to be a promising approach for identification of disease-associated variables in complex data with time to event as outcome. The demonstrated RSF approach provides comparable findings as the generally used Cox regression, but also addresses the problem of multicollinearity and is suitable for high-dimensional data. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Misrepresenting random sampling? A systematic review of research papers in the Journal of Advanced Nursing.

PubMed

Williamson, Graham R

2003-11-01

This paper discusses the theoretical limitations of the use of random sampling and probability theory in the production of a significance level (or P-value) in nursing research. Potential alternatives, in the form of randomization tests, are proposed. Research papers in nursing, medicine and psychology frequently misrepresent their statistical findings, as the P-values reported assume random sampling. In this systematic review of studies published between January 1995 and June 2002 in the Journal of Advanced Nursing, 89 (68%) studies broke this assumption because they used convenience samples or entire populations. As a result, some of the findings may be questionable. The key ideas of random sampling and probability theory for statistical testing (for generating a P-value) are outlined. The result of a systematic review of research papers published in the Journal of Advanced Nursing is then presented, showing how frequently random sampling appears to have been misrepresented. Useful alternative techniques that might overcome these limitations are then discussed. REVIEW LIMITATIONS: This review is limited in scope because it is applied to one journal, and so the findings cannot be generalized to other nursing journals or to nursing research in general. However, it is possible that other nursing journals are also publishing research articles based on the misrepresentation of random sampling. The review is also limited because in several of the articles the sampling method was not completely clearly stated, and in this circumstance a judgment has been made as to the sampling method employed, based on the indications given by author(s). Quantitative researchers in nursing should be very careful that the statistical techniques they use are appropriate for the design and sampling methods of their studies. If the techniques they employ are not appropriate, they run the risk of misinterpreting findings by using inappropriate, unrepresentative and biased samples.

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

PubMed Central

Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

2015-01-01

Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

True Randomness from Big Data.

PubMed

Papakonstantinou, Periklis A; Woodruff, David P; Yang, Guang

2016-09-26

Generating random bits is a difficult task, which is important for physical systems simulation, cryptography, and many applications that rely on high-quality random bits. Our contribution is to show how to generate provably random bits from uncertain events whose outcomes are routinely recorded in the form of massive data sets. These include scientific data sets, such as in astronomics, genomics, as well as data produced by individuals, such as internet search logs, sensor networks, and social network feeds. We view the generation of such data as the sampling process from a big source, which is a random variable of size at least a few gigabytes. Our view initiates the study of big sources in the randomness extraction literature. Previous approaches for big sources rely on statistical assumptions about the samples. We introduce a general method that provably extracts almost-uniform random bits from big sources and extensively validate it empirically on real data sets. The experimental findings indicate that our method is efficient enough to handle large enough sources, while previous extractor constructions are not efficient enough to be practical. Quality-wise, our method at least matches quantum randomness expanders and classical world empirical extractors as measured by standardized tests.

True Randomness from Big Data

NASA Astrophysics Data System (ADS)

Papakonstantinou, Periklis A.; Woodruff, David P.; Yang, Guang

2016-09-01

Generating random bits is a difficult task, which is important for physical systems simulation, cryptography, and many applications that rely on high-quality random bits. Our contribution is to show how to generate provably random bits from uncertain events whose outcomes are routinely recorded in the form of massive data sets. These include scientific data sets, such as in astronomics, genomics, as well as data produced by individuals, such as internet search logs, sensor networks, and social network feeds. We view the generation of such data as the sampling process from a big source, which is a random variable of size at least a few gigabytes. Our view initiates the study of big sources in the randomness extraction literature. Previous approaches for big sources rely on statistical assumptions about the samples. We introduce a general method that provably extracts almost-uniform random bits from big sources and extensively validate it empirically on real data sets. The experimental findings indicate that our method is efficient enough to handle large enough sources, while previous extractor constructions are not efficient enough to be practical. Quality-wise, our method at least matches quantum randomness expanders and classical world empirical extractors as measured by standardized tests.

True Randomness from Big Data

PubMed Central

Papakonstantinou, Periklis A.; Woodruff, David P.; Yang, Guang

2016-01-01

Generating random bits is a difficult task, which is important for physical systems simulation, cryptography, and many applications that rely on high-quality random bits. Our contribution is to show how to generate provably random bits from uncertain events whose outcomes are routinely recorded in the form of massive data sets. These include scientific data sets, such as in astronomics, genomics, as well as data produced by individuals, such as internet search logs, sensor networks, and social network feeds. We view the generation of such data as the sampling process from a big source, which is a random variable of size at least a few gigabytes. Our view initiates the study of big sources in the randomness extraction literature. Previous approaches for big sources rely on statistical assumptions about the samples. We introduce a general method that provably extracts almost-uniform random bits from big sources and extensively validate it empirically on real data sets. The experimental findings indicate that our method is efficient enough to handle large enough sources, while previous extractor constructions are not efficient enough to be practical. Quality-wise, our method at least matches quantum randomness expanders and classical world empirical extractors as measured by standardized tests. PMID:27666514

A descriptive analysis of oral health systematic reviews published 1991-2012: cross sectional study.

PubMed

Saltaji, Humam; Cummings, Greta G; Armijo-Olivo, Susan; Major, Michael P; Amin, Maryam; Major, Paul W; Hartling, Lisa; Flores-Mir, Carlos

2013-01-01

To identify all systematic reviews (SRs) published in the domain of oral health research and describe them in terms of their epidemiological and descriptive characteristics. Cross sectional, descriptive study. An electronic search of seven databases was performed from inception through May 2012; bibliographies of relevant publications were also reviewed. Studies were considered for inclusion if they were oral health SRs defined as therapeutic or non-therapeutic investigations that studied a topic or an intervention related to dental, oral or craniofacial diseases/disorders. Data were extracted from all the SRs based on a number of epidemiological and descriptive characteristics. Data were analysed descriptively for all the SRs, within each of the nine dental specialities, and for Cochrane and non-Cochrane SRs separately. 1,188 oral health (126 Cochrane and 1062 non-Cochrane) SRs published from 1991 through May 2012 were identified, encompassing the nine dental specialties. Over half (n = 676; 56.9%) of the SRs were published in specialty oral health journals, with almost all (n = 1,178; 99.2%) of the SRs published in English and almost none of the non-Cochrane SRs (n = 11; 0.9%) consisting of updates of previously published SRs. 75.3% of the SRs were categorized as therapeutic, with 64.5% examining non-drug interventions, while approximately half (n = 150/294; 51%) of the non-therapeutic SRs were classified as epidemiological SRs. The SRs included a median of 15 studies, with a meta-analysis conducted in 43.6%, in which a median of 9 studies/1 randomized trial were included in the largest meta-analysis conducted. Funding was received for 25.1% of the SRs, including nearly three-quarters (n = 96; 76.2%) of the Cochrane SRs. Epidemiological and descriptive characteristics of the 1,188 oral health SRs varied across the nine dental specialties and by SR category (Cochrane vs. non-Cochrane). There is a clear need for more updates of SRs in all the dental specialties.

Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis.

PubMed

Benham, J L; Yamamoto, J M; Friedenreich, C M; Rabi, D M; Sigal, R J

2018-06-12

Preliminary evidence suggests exercise in polycystic ovary syndrome (PCOS) may improve reproductive and cardiometabolic parameters. Our primary aim was to determine the impact of exercise training on reproductive health in women with PCOS. Our secondary aim was to determine the effect of exercise training on cardiometabolic indices. A systematic review of published literature was conducted using MEDLINE and EMBASE based on a pre-published protocol (PROSPERO CRD42017065324). The search was not limited by year. Randomized controlled trials, non-randomized controlled trials and uncontrolled trials that evaluated an exercise intervention in women with PCOS and reported reproductive outcomes were included. Reproductive outcomes were analysed semi-quantitatively and a meta-analysis was conducted for reported cardiometabolic outcomes. Of 517 screened abstracts, 14 studies involving 617 women with PCOS were included: seven randomized controlled trials, one non-randomized controlled trial and six uncontrolled trials. There were insufficient published data to describe the effect of exercise interventions on ovulation quantitatively, but semi-quantitative analysis suggested that exercise interventions may improve menstrual regularity, pregnancy and ovulation rates. Our meta-analysis found that exercise improved lipid profiles and decreased waist circumference, systolic blood pressure and fasting insulin. The impact of exercise interventions on reproductive function remains unclear. However, our meta-analysis suggests that exercise interventions may improve cardiometabolic profiles in women with PCOS. © 2018 World Obesity Federation.

Incentive Spirometry after Lung Resection: A Randomized Controlled Trial.

PubMed

Malik, Peter Ra; Fahim, Christine; Vernon, Jordyn; Thomas, Priya; Schieman, Colin; Finley, Christian J; Agzarian, John; Shargall, Yaron; Farrokhyar, Forough; Hanna, Wael C

2018-04-24

Incentive spirometry (IS) is thought to reduce the incidence of postoperative pulmonary complications (PPC) after lung resection. We sought to determine whether the addition of IS to routine physiotherapy following lung resection results in a lower rate of PPC, as compared to physiotherapy alone. A single-blind prospective randomized controlled trial was conducted in adults undergoing lung resection. Individuals with previous lung surgery or home oxygen were excluded. Participants randomized to the control arm (PHY) received routine physiotherapy alone (deep breathing, ambulation and shoulder exercises). Those randomized to the intervention arm (PHY/IS) received IS in addition to routine physiotherapy. The trial was powered to detect a 10% difference in the rate of PPC (beta=80%). Student's t-test and chi-square were utilized for continuous and categorical variables respectively, with a significance level of p=0.05. A total of 387 participants (n=195 PHY/IS; n=192 PHY) were randomized between 2014-2017. Baseline characteristics were comparable for both arms. The majority of patients underwent a pulmonary lobectomy (PHY/IS=59.5%, PHY=61.0%, p=0.84), with no difference in the rates of minimally invasive and open procedures. There were no differences in the incidence of PPC at 30 days postoperatively (PHY/IS=12.3%, PHY=13.0%, p=0.88). There were no differences in rates of pneumonia (PHY/IS=4.6%, PHY=7.8%, p=0.21), mechanical ventilation (PHY/IS=2.1%, PHY=1.0%, p=0.41), home-oxygen (PHY/IS=13.8%, PHY=14.6%, p=0.89), hospital length of stay (PHY/IS=4 days, PHY=4 days, p=0.34), or rate of readmission to hospital (PHY/IS=10.3%, PH=9.9%, p=1.00). The addition of IS to routine postoperative physiotherapy does not reduce the incidence of PPC after lung resection. Copyright © 2018. Published by Elsevier Inc.

Field evaluation of a random forest activity classifier for wrist-worn accelerometer data.

PubMed

Pavey, Toby G; Gilson, Nicholas D; Gomersall, Sjaan R; Clark, Bronwyn; Trost, Stewart G

2017-01-01

Wrist-worn accelerometers are convenient to wear and associated with greater wear-time compliance. Previous work has generally relied on choreographed activity trials to train and test classification models. However, validity in free-living contexts is starting to emerge. Study aims were: (1) train and test a random forest activity classifier for wrist accelerometer data; and (2) determine if models trained on laboratory data perform well under free-living conditions. Twenty-one participants (mean age=27.6±6.2) completed seven lab-based activity trials and a 24h free-living trial (N=16). Participants wore a GENEActiv monitor on the non-dominant wrist. Classification models recognising four activity classes (sedentary, stationary+, walking, and running) were trained using time and frequency domain features extracted from 10-s non-overlapping windows. Model performance was evaluated using leave-one-out-cross-validation. Models were implemented using the randomForest package within R. Classifier accuracy during the 24h free living trial was evaluated by calculating agreement with concurrently worn activPAL monitors. Overall classification accuracy for the random forest algorithm was 92.7%. Recognition accuracy for sedentary, stationary+, walking, and running was 80.1%, 95.7%, 91.7%, and 93.7%, respectively for the laboratory protocol. Agreement with the activPAL data (stepping vs. non-stepping) during the 24h free-living trial was excellent and, on average, exceeded 90%. The ICC for stepping time was 0.92 (95% CI=0.75-0.97). However, sensitivity and positive predictive values were modest. Mean bias was 10.3min/d (95% LOA=-46.0 to 25.4min/d). The random forest classifier for wrist accelerometer data yielded accurate group-level predictions under controlled conditions, but was less accurate at identifying stepping verse non-stepping behaviour in free living conditions Future studies should conduct more rigorous field-based evaluations using observation as a criterion measure. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

15 CFR 10.10 - Review of published standards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Review of published standards. 10.10... DEVELOPMENT OF VOLUNTARY PRODUCT STANDARDS § 10.10 Review of published standards. (a) Each standard published... considered until a replacement standard is published. (b) Each standard published under these or previous...

Anonymous authenticated communications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beaver, Cheryl L; Schroeppel, Richard C; Snyder, Lillian A

2007-06-19

A method of performing electronic communications between members of a group wherein the communications are authenticated as being from a member of the group and have not been altered, comprising: generating a plurality of random numbers; distributing in a digital medium the plurality of random numbers to the members of the group; publishing a hash value of contents of the digital medium; distributing to the members of the group public-key-encrypted messages each containing a same token comprising a random number; and encrypting a message with a key generated from the token and the plurality of random numbers.

Dynamic self-organisation of haematopoiesis and (a)symmetric cell division.

PubMed

Måløy, Marthe; Måløy, Frode; Jakobsen, Per; Olav Brandsdal, Bjørn

2017-02-07

A model of haematopoiesis that links self-organisation with symmetric and asymmetric cell division is presented in this paper. It is assumed that all cell divisions are completely random events, and that the daughter cells resulting from symmetric and asymmetric stem cell divisions are, in general, phenotypically identical, and still, the haematopoietic system has the flexibility to self-renew, produce mature cells by differentiation, and regenerate undifferentiated and differentiated cells when necessary, due to self-organisation. As far as we know, no previous model implements symmetric and asymmetric division as the result of self-organisation. The model presented in this paper is inspired by experiments on the Drosophila germline stem cell, which imply that under normal conditions, the stem cells typically divide asymmetrically, whereas during regeneration, the rate of symmetric division increases. Moreover, the model can reproduce several of the results from experiments on female Safari cats. In particular, the model can explain why significant fluctuation in the phenotypes of haematopoietic cells was observed in some cats, when the haematopoietic system had reached normal population level after regeneration. To our knowledge, no previous model of haematopoiesis in Safari cats has captured this phenomenon. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Landscape and Residential Variables Associated with Plague-Endemic Villages in the West Nile Region of Uganda

PubMed Central

MacMillan, Katherine; Enscore, Russell E.; Ogen-Odoi, Asaph; Borchert, Jeff N.; Babi, Nackson; Amatre, Gerald; Atiku, Linda A.; Mead, Paul S.; Gage, Kenneth L.; Eisen, Rebecca J.

2011-01-01

Plague, caused by the bacteria Yersinia pestis, is a severe, often fatal disease. This study focuses on the plague-endemic West Nile region of Uganda, where limited information is available regarding environmental and behavioral risk factors associated with plague infection. We conducted observational surveys of 10 randomly selected huts within historically classified case and control villages (four each) two times during the dry season of 2006 (N = 78 case huts and N = 80 control huts), which immediately preceded a large plague outbreak. By coupling a previously published landscape-level statistical model of plague risk with this observational survey, we were able to identify potential residence-based risk factors for plague associated with huts within historic case or control villages (e.g., distance to neighboring homestead and presence of pigs near the home) and huts within areas previously predicted as elevated risk or low risk (e.g., corn and other annual crops grown near the home, water storage in the home, and processed commercial foods stored in the home). The identified variables are consistent with current ecologic theories on plague transmission dynamics. This preliminary study serves as a foundation for future case control studies in the area. PMID:21363983

REMOVED: Mindfulness meditation with incarcerated youth: A randomized controlled trial informed by neuropsychosocial theories of adolescence.

PubMed

Evans-Chase, Michelle

2015-12-01

This article has been removed: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal) This meeting abstract has been removed by the Publisher. Due to an administrative error, abstracts that were not presented at the ISDN 2014 meeting were inadvertently published in the meeting's abstract supplement. The Publisher apologizes to the authors and readers for this error. Copyright © 2015. Published by Elsevier Ltd.

Survey Research in Educational Administration: A Critical Analysis.

ERIC Educational Resources Information Center

Miskel, Cecil; Sandlin, Terry

In order to assess the methodological merit of the published research in educational administration based on surveys, the authors analyzed data from a random sample of 24 survey studies published in the "Education Administration Quarterly" and the "Journal of Educational Administration." Each article was evaluated according to…

Parasitic worms: how many really?

PubMed

Strona, Giovanni; Fattorini, Simone

2014-04-01

Accumulation curves are useful tools to estimate species diversity. Here we argue that they can also be used in the study of global parasite species richness. Although this basic idea is not completely new, our approach differs from the previous ones as it treats each host species as an independent sample. We show that randomly resampling host-parasite records from the existing databases makes it possible to empirically model the relationship between the number of investigated host species, and the corresponding number of parasite species retrieved from those hosts. This method was tested on 21 inclusive lists of parasitic worms occurring on vertebrate hosts. All of the obtained models conform well to a power law curve. These curves were then used to estimate global parasite species richness. Results obtained with the new method suggest that current predictions are likely to severely overestimate parasite diversity. Copyright © 2014 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.

Cost-effectiveness of Maintenance Treatment with a Barrier-strengthening Moisturizing Cream in Patients with Atopic Dermatitis in Finland, Norway and Sweden.

PubMed

Norrlid, Hanna; Hjalte, Frida; Lundqvist, Adam; Svensson, Åke; Tennvall, Gunnel Ragnarson

2016-02-01

Atopic dermatitis is a chronic skin disorder with high prevalence, especially in the Nordic countries. Effective maintenance therapy during symptom-free episodes may prolong the time to eczema relapse according to a previously published clinical trial. The present study evaluates the cost-effectiveness of a barrier-strengthening moisturizer containing 5% urea, compared with a moisturizer with no active ingredients during eczema-free periods. A health economic microsimulation model, based on efficacy data from the randomized clinical trial, analysed the cost-effectiveness of the barrier-strengthening treatment in Finland, Norway and Sweden. The barrier-strengthening moisturizer was cost-saving compared with the moisturizer with no active ingredients in all 3 countries. The result was confirmed in all but one sensitivity analysis. In conclusion, the barrier-strengthening moisturizer is cost-effective as maintenance therapy for patients with atopic dermatitis compared with a moisturizer with no active ingredients.

Treatment outcomes in 4 modes of orthodontic practice.

PubMed

Poulton, Donald; Vlaskalic, Vicki; Baumrind, Sheldon

2005-03-01

This study is a continuation of a previously published report on the outcome of orthodontic treatment provided in offices representing different modes of practice. The sample consisted of duplicate pretreatment (T1) and posttreatment (T2) dental casts of 348 patients from traditional private orthodontic practices (5 offices, 134 patients), company-owned practices (5 offices, 107 patients), offices associated with practice-management organizations (2 offices, 60 patients), and general dental practices (2 offices, 47 patients). Methods were used to obtain random, representative samples from each office, starting with lists of patients who were treated consecutively with full fixed orthodontic appliances. The dental casts were measured by 2 independent judges who used the unweighted PAR score. Good interjudge agreement was shown on the initial casts, but the agreement was not as strong on the final casts. The measurements showed that treatment outcomes were generally satisfactory, although some significant differences between offices and management modes were shown.

Thermodynamic prediction of protein neutrality.

PubMed

Bloom, Jesse D; Silberg, Jonathan J; Wilke, Claus O; Drummond, D Allan; Adami, Christoph; Arnold, Frances H

2005-01-18

We present a simple theory that uses thermodynamic parameters to predict the probability that a protein retains the wild-type structure after one or more random amino acid substitutions. Our theory predicts that for large numbers of substitutions the probability that a protein retains its structure will decline exponentially with the number of substitutions, with the severity of this decline determined by properties of the structure. Our theory also predicts that a protein can gain extra robustness to the first few substitutions by increasing its thermodynamic stability. We validate our theory with simulations on lattice protein models and by showing that it quantitatively predicts previously published experimental measurements on subtilisin and our own measurements on variants of TEM1 beta-lactamase. Our work unifies observations about the clustering of functional proteins in sequence space, and provides a basis for interpreting the response of proteins to substitutions in protein engineering applications.

Thermodynamic prediction of protein neutrality

PubMed Central

Bloom, Jesse D.; Silberg, Jonathan J.; Wilke, Claus O.; Drummond, D. Allan; Adami, Christoph; Arnold, Frances H.

2005-01-01

We present a simple theory that uses thermodynamic parameters to predict the probability that a protein retains the wild-type structure after one or more random amino acid substitutions. Our theory predicts that for large numbers of substitutions the probability that a protein retains its structure will decline exponentially with the number of substitutions, with the severity of this decline determined by properties of the structure. Our theory also predicts that a protein can gain extra robustness to the first few substitutions by increasing its thermodynamic stability. We validate our theory with simulations on lattice protein models and by showing that it quantitatively predicts previously published experimental measurements on subtilisin and our own measurements on variants of TEM1 β-lactamase. Our work unifies observations about the clustering of functional proteins in sequence space, and provides a basis for interpreting the response of proteins to substitutions in protein engineering applications. PMID:15644440

Supplemental Vitamins and Minerals for CVD Prevention and Treatment.

PubMed

Jenkins, David J A; Spence, J David; Giovannucci, Edward L; Kim, Young-In; Josse, Robert; Vieth, Reinhold; Blanco Mejia, Sonia; Viguiliouk, Effie; Nishi, Stephanie; Sahye-Pudaruth, Sandhya; Paquette, Melanie; Patel, Darshna; Mitchell, Sandy; Kavanagh, Meaghan; Tsirakis, Tom; Bachiri, Lina; Maran, Atherai; Umatheva, Narmada; McKay, Taylor; Trinidad, Gelaine; Bernstein, Daniel; Chowdhury, Awad; Correa-Betanzo, Julieta; Del Principe, Gabriella; Hajizadeh, Anisa; Jayaraman, Rohit; Jenkins, Amy; Jenkins, Wendy; Kalaichandran, Ruben; Kirupaharan, Geithayini; Manisekaran, Preveena; Qutta, Tina; Shahid, Ramsha; Silver, Alexis; Villegas, Cleo; White, Jessica; Kendall, Cyril W C; Pichika, Sathish C; Sievenpiper, John L

2018-06-05

The authors identified individual randomized controlled trials from previous meta-analyses and additional searches, and then performed meta-analyses on cardiovascular disease outcomes and all-cause mortality. The authors assessed publications from 2012, both before and including the U.S. Preventive Service Task Force review. Their systematic reviews and meta-analyses showed generally moderate- or low-quality evidence for preventive benefits (folic acid for total cardiovascular disease, folic acid and B-vitamins for stroke), no effect (multivitamins, vitamins C, D, β-carotene, calcium, and selenium), or increased risk (antioxidant mixtures and niacin [with a statin] for all-cause mortality). Conclusive evidence for the benefit of any supplement across all dietary backgrounds (including deficiency and sufficiency) was not demonstrated; therefore, any benefits seen must be balanced against possible risks. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Approach to injuries in active people

PubMed Central

Shrier, Ian

2006-01-01

OBJECTIVE To review the basic principles underlying treatment of injuries in active people. SOURCES OF INFORMATION Basic science texts and reports of observational and randomized trials on treatment of musculoskeletal injuries were retrieved during previous exhaustive systematic reviews published by the author on a variety of musculoskeletal injury topics. MAIN MESSAGE After an injury, further damage or re-injury can be prevented either by decreasing the stress on the tissue or increasing the stress the tissue can withstand. Regardless of the type of injury, clinicians should aim to restore function; aim to increase activity without increasing pain; recommend that patients start slowly and increase activity gradually; revisit diagnosis and treatment if patients are not responding; and treat the patient, not the condition. CONCLUSION Most musculoskeletal injuries in the general population can be managed effectively by family physicians. Management should follow the basic principles of exercise training. PMID:16812964

A theoretical and experimental investigation of cylindrical electrostatic probes at arbitrary incidence in flowing plasma

NASA Technical Reports Server (NTRS)

Jenkins, R. V.; Jones, W. L., Jr.

1974-01-01

The theory for calculating the current collected by a negatively biased cylindrical electrostatic probe at an arbitrary angle of attack in a weakley ionized flowing plasma is presented. The theory was constructed by considering both random and directed motion simultaneous with dynamic coupling of the flow properties and of the electric field of the probe. This direct approach yielded a theory that is more general than static plasma theories modified to account for flow. Theoretical calculations are compared with experimental electrostatic probe data obtained in the free stream of an arc-heated hypersonic wind tunnel. The theoretical calculations are based on flow conditions and plasma electron densities measured by an independent microwave interferometer technique. In addition, the theory is compared with laboratory and satellite data previously published by other investigators. In each case the comparison gives good agreement.

The impact of an 8-day intensive treatment for adolescent panic disorder and agoraphobia on comorbid diagnoses.

PubMed

Gallo, Kaitlin P; Chan, Priscilla T; Buzzella, Brian A; Whitton, Sarah W; Pincus, Donna B

2012-03-01

Previous research findings have shown positive effects of cognitive-behavioral therapy for primary anxiety disorders as well as for nonprimary, co-occurring anxiety disorders. In this study, we analyzed data from an existing randomized controlled trial of intensive treatment for panic disorder with or without agoraphobia (PDA) to examine the effects of the treatment on comorbid psychiatric diagnoses. The overall frequency and severity of aggregated comorbid diagnoses decreased in a group of adolescents who received an 8-day treatment for PDA. Results suggest that an 8-day treatment for PDA can alleviate the symptoms of some specific comorbid clinical diagnoses; in particular specific phobias, generalized anxiety disorder, and social phobia. These findings suggest that an intensive treatment for PDA is associated with reductions in comorbid symptoms even though disorders other than PDA are not specific treatment targets. Copyright © 2011. Published by Elsevier Ltd.

Modal sound transmission loss of a single leaf panel: Asymptotic solutions.

PubMed

Wang, Chong

2015-12-01

In a previously published paper [C. Wang, J. Acoust. Soc. Am. 137(6), 3514-3522 (2015)], the modal sound transmission coefficients of a single leaf panel were discussed with regard to the inter-modal coupling effects. By incorporating such effect into the equivalent modal radiation impedance, which is directly related to the modal sound transmission coefficient of each mode, the overall sound transmission loss for both normal and randomized sound incidences was computed through a simple modal superposition. Benefiting from the analytical expressions of the equivalent modal impedance and modal transmission coefficients, in this paper, behaviors of modal sound transmission coefficients in several typical frequency ranges are discussed in detail. Asymptotic solutions are also given for the panels with relatively low bending stiffnesses, for which the sound transmission loss has been assumed to follow the mass law of a limp panel. Results are also compared to numerical analysis and the renowned mass law theories.

Identifying the effects of social media on health behavior: Data from a large-scale online experiment.

PubMed

Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Centola, Damon

2015-12-01

Sedentary lifestyle is an escalating epidemic. Little is known about whether or how social media can be used to design a cost-effective solution for sedentary lifestyle. In this article we describe the data from a randomized controlled trial (RCT) that evaluated two prominent strategies for conducting exercise interventions using elements of social media: motivational media campaigns and online peer networks. The data file includes 217 participants' basic demographic information, number of exercise class enrollments over 13 weeks, and self-reported number of days for exercise activities in the previous 7 days at baseline. Among the 217, 164 also have data on self-reported number of days for exercise activities at the post-program. Data are supplied with this article. The interpretation of these data can be found in the research article published by the authors in Preventive Medicine Reports in 2015 [1].

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial.

PubMed

Wright, Cassandra Jc; Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan Sc

2017-05-25

Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b). ©Cassandra JC Wright, Paul M Dietze, Paul A Agius, Emmanuel Kuntsche, Robin Room, Michael Livingston, Margaret Hellard, Megan SC Lim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2017.

Measurement of breast-tissue x-ray attenuation by spectral mammography: solid lesions

NASA Astrophysics Data System (ADS)

Fredenberg, Erik; Kilburn-Toppin, Fleur; Willsher, Paula; Moa, Elin; Danielsson, Mats; Dance, David R.; Young, Kenneth C.; Wallis, Matthew G.

2016-04-01

Knowledge of x-ray attenuation is essential for developing and evaluating x-ray imaging technologies. For instance, techniques to distinguish between cysts and solid tumours at mammography screening would be highly desirable to reduce recalls, but the development requires knowledge of the x-ray attenuation for cysts and tumours. We have previously measured the attenuation of cyst fluid using photon-counting spectral mammography. Data on x-ray attenuation for solid breast lesions are available in the literature, but cover a relatively wide range, likely caused by natural spread between samples, random measurement errors, and different experimental conditions. In this study, we have adapted a previously developed spectral method to measure the linear attenuation of solid breast lesions. A total of 56 malignant and 5 benign lesions were included in the study. The samples were placed in a holder that allowed for thickness measurement. Spectral (energy-resolved) images of the samples were acquired and the image signal was mapped to equivalent thicknesses of two known reference materials, which can be used to derive the x-ray attenuation as a function of energy. The spread in equivalent material thicknesses was relatively large between samples, which is likely to be caused mainly by natural variation and only to a minor extent by random measurement errors and sample inhomogeneity. No significant difference in attenuation was found between benign and malignant solid lesions. The separation between cyst-fluid and tumour attenuation was, however, significant, which suggests it may be possible to distinguish cystic from solid breast lesions, and the results lay the groundwork for a clinical trial. In addition, the study adds a relatively large sample set to the published data and may contribute to a reduction in the overall uncertainty in the literature.

Another Look at the PART-O Using the Traumatic Brain Injury Model Systems National Database: Scoring to Optimize Psychometrics.

PubMed

Malec, James F; Whiteneck, Gale G; Bogner, Jennifer A

2016-02-01

To integrate previous approaches to scoring the Participation Assessment with Recombined Tools-Objective (PART-O) in a unidimensional scale. Retrospective analysis of PART-O data from the Traumatic Brain Injury Model Systems. Community. Data from individuals (N=469) selected randomly from participants who completed 1-year follow-up in the Traumatic Brain Injury Model Systems were used in Rasch model development. The model was subsequently tested on data from additional random samples of similar size at 1-, 2-, 5-, 10-, and >15-year follow-ups. Not applicable. PART-O. After combining items for productivity and social interaction, the initial analysis at 1-year follow-up indicated relatively good fit to the Rasch model (person reliability=.80) but also suggested item misfit and that the 0-to-5 scale used for most items did not consistently show clear separation between rating levels. Reducing item rating scales to 3 levels (except combined and dichotomous items) resolved these issues and demonstrated good item level discrimination, fit, and person reliability (.81), with no evidence of multidimensionality. These results replicated in analyses at each additional follow-up period. Modifications to item scoring for the PART-O resulted in a unidimensional parametric equivalent measure that addresses previous concerns about competing item relations, and it fit the Rasch model consistently across follow-up periods. The person-item map shows a progression toward greater community participation from solitary and dyadic activities, such as leaving the house and having a friend through social and productivity activities, to group activities with others who share interests or beliefs. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

National Emphysema Treatment Trial redux: accentuating the positive.

PubMed

Sanchez, Pablo Gerardo; Kucharczuk, John Charles; Su, Stacey; Kaiser, Larry Robert; Cooper, Joel David

2010-09-01

Under the Freedom of Information Act, we obtained the follow-up data of the National Emphysema Treatment Trial (NETT) to determine the long-term outcome for "a heterogeneous distribution of emphysema with upper lobe predominance," postulated by the NETT hypothesis to be optimal candidates for lung volume reduction surgery. Using the NETT database, we identified patients with heterogeneous distribution of emphysema with upper lobe predominance and analyzed for the first time follow-up data for those receiving lung volume reduction surgery and those receiving medical management. Furthermore, we compared the results of the NETT reduction surgery group with a previously reported consecutive case series of 250 patients undergoing bilateral lung volume reduction surgery using similar selection criteria. Of the 1218 patients enrolled, 511 (42%) conformed to the NETT hypothesis selection criteria and received the randomly assigned surgical or medical treatment (surgical = 261; medical = 250). Lung volume reduction surgery resulted in a 5-year survival benefit (70% vs 60%; P = .02). Results at 3 years compared with baseline data favored surgical reduction in terms of residual volume reduction (25% vs 2%; P < .001), University of California San Diego dyspnea score (16 vs 0 points; P < .001), and improved St George Respiratory Questionnaire quality of life score (12 points vs 0 points; P < .001). For the 513 patients with a homogeneous pattern of emphysema randomized to surgical or medical treatment, lung volume reduction surgery produced no survival advantage and very limited functional benefit. Patients most likely to benefit from lung volume reduction surgery have heterogeneously distributed emphysema involving the upper lung zones predominantly. Such patients in the NETT trial had results nearly identical to those previously reported in a nonrandomized series of similar patients undergoing lung volume reduction surgery. 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Medical Abortion Provided by Nurse-Midwives or Physicians in a High Resource Setting: A Cost-Effectiveness Analysis.

PubMed

Sjöström, Susanne; Kopp Kallner, Helena; Simeonova, Emilia; Madestam, Andreas; Gemzell-Danielsson, Kristina

2016-01-01

The objective of the present study is to calculate the cost-effectiveness of early medical abortion performed by nurse-midwifes in comparison to physicians in a high resource setting where ultrasound dating is part of the protocol. Non-physician health care professionals have previously been shown to provide medical abortion as effectively and safely as physicians, but the cost-effectiveness of such task shifting remains to be established. A cost effectiveness analysis was conducted based on data from a previously published randomized-controlled equivalence study including 1180 healthy women randomized to the standard procedure, early medical abortion provided by physicians, or the intervention, provision by nurse-midwifes. A 1.6% risk difference for efficacy defined as complete abortion without surgical interventions in favor of midwife provision was established which means that for every 100 procedures, the intervention treatment resulted in 1.6 fewer incomplete abortions needing surgical intervention than the standard treatment. The average direct and indirect costs and the incremental cost-effectiveness ratio (ICER) were calculated. The study was conducted at a university hospital in Stockholm, Sweden. The average direct costs per procedure were EUR 45 for the intervention compared to EUR 58.3 for the standard procedure. Both the cost and the efficacy of the intervention were superior to the standard treatment resulting in a negative ICER at EUR -831 based on direct costs and EUR -1769 considering total costs per surgical intervention avoided. Early medical abortion provided by nurse-midwives is more cost-effective than provision by physicians. This evidence provides clinicians and decision makers with an important tool that may influence policy and clinical practice and eventually increase numbers of abortion providers and reduce one barrier to women's access to safe abortion.

Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment.

PubMed

Hróbjartsson, A; Gøtzsche, P C

2004-08-01

It is widely believed that placebo interventions induce powerful effects. We could not confirm this in a systematic review of 114 randomized trials that compared placebo-treated with untreated patients. To study whether a new sample of trials would reproduce our earlier findings, and to update the review. Systematic review of trials that were published since our last search (or not previously identified), and of all available trials. Data was available in 42 out of 52 new trials (3212 patients). The results were similar to our previous findings. The updated review summarizes data from 156 trials (11 737 patients). We found no statistically significant pooled effect in 38 trials with binary outcomes, relative risk 0.95 (95% confidence interval 0.89-1.01). The effect on continuous outcomes decreased with increasing sample size, and there was considerable variation in effect also between large trials; the effect estimates should therefore be interpreted cautiously. If this bias is disregarded, the pooled standardized mean difference in 118 trials with continuous outcomes was -0.24 (-0.31 to -0.17). For trials with patient-reported outcomes the effect was -0.30 (-0.38 to -0.21), but only -0.10 (-0.20 to 0.01) for trials with observer-reported outcomes. Of 10 clinical conditions investigated in three trials or more, placebo had a statistically significant pooled effect only on pain or phobia on continuous scales. We found no evidence of a generally large effect of placebo interventions. A possible small effect on patient-reported continuous outcomes, especially pain, could not be clearly distinguished from bias.

Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial.

PubMed

Yardley, Marianne; Gullestad, Lars; Bendz, Bjørn; Bjørkelund, Elisabeth; Rolid, Katrine; Arora, Satish; Nytrøen, Kari

2017-01-01

Previous studies have demonstrated that high-intensity interval training (HIT) is superior to moderate-continuous exercise in general and in cardiovascular diseases. Recently, we also found HIT safe and efficient after heart transplantation (HTx). This study reports the 5-year long-term effects. Forty-one HTx patients who had completed the previous 12-month randomized controlled trial, comparing HIT intervention with usual care, were eligible. In particular, we measured VO 2peak , muscular capacity, intravascular ultrasound, and questionnaires measuring physical and mental health. The baseline mean±SD values were as follows: age; 49.1±16.5 years, men; 68%, time since HTx: 4.1±2.2 years. Within the HIT group, initial VO 2peak increased significantly from 27.7±5.7 to 31.2±5.3 mL/kg/min. However, during the next 4 years, VO 2peak decreased to 26.0±6.2 mL/kg/min. The control group showed slightly decreasing VO 2peak values during the entire 5-year period. The HIT group reported significantly less anxiety symptoms, but there were no long-term differences in VO 2peak , muscular capacity, or cardiac allograft vasculopathy between the groups. The similar VO 2peak values correspond to our findings of similar everyday activity. Our findings suggest that intermittent periods of HIT may be necessary to maintain the initial benefits gained from the intervention. However, HIT probably reduces the burden of anxiety, which is a frequent health issue following HTx. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparative Effectiveness of Blood Pressure-lowering Drugs in Patients who have Already Suffered From Stroke

PubMed Central

Wang, Wei-Ting; You, Li-Kai; Chiang, Chern-En; Sung, Shih-Hsien; Chuang, Shao-Yuan; Cheng, Hao-Min; Chen, Chen-Huan

2016-01-01

Abstract Hypertension is the most important risk factor for stroke and stroke recurrence. However, the preferred blood pressure (BP)-lowering drug class for patients who have suffered from a stroke has yet to be determined. To investigate the relative effects of BP-lowering therapies [angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blockers (ARB), β blockers, calcium channel blockers (CCBs), diuretics, and combinations of these drugs] in patients with a prior stroke history, we performed a systematic review and meta-analysis using both traditional frequentist and Bayesian random-effects models and meta-regression of randomized controlled trials (RCTs) on the outcomes of recurrent stroke, coronary heart disease (CHD), and any major adverse cardiac and cerebrovascular events (MACCE). Trials were identified from searches of published hypertension guidelines, electronic databases, and previous systematic reviews. Fifteen RCTs composed of 39,329 participants with previous stroke were identified. Compared with the placebo, only ACEI along with diuretics significantly reduced recurrent stroke events [odds ratio (OR) = 0.54, 95% credibility interval (95% CI) 0.33–0.90]. On the basis of the distribution of posterior probabilities, the treatment ranking consistently identified ACEI along with diuretics as the preferred BP-lowering strategy for the reduction of recurrent stroke and CHD (31% and 35%, respectively). For preventing MACCE, diuretics appeared to be the preferred agent for stroke survivors (34%). Moreover, the meta-regression analysis failed to demonstrate a statistical significance between BP reduction and all outcomes (P = 0.1618 for total stroke, 0.4933 for CHD, and 0.2411 for MACCE). Evidence from RCTs supports the use of diuretics-based treatment, especially when combined with ACEI, for the secondary prevention of recurrent stroke and any vascular events in patients who have suffered from stroke. PMID:27082571

Using Self-affirmation to Increase the Effects of Emotive Health Warnings on Smoking: A Randomized Exploratory Trial.

PubMed

Memish, Kate E; Schüz, Natalie; Frandsen, Mai; Ferguson, Stuart G; Schüz, Benjamin

2017-10-01

Emotive health messages are widely used tools in tobacco control. However, under some circumstances, they can be less effective than desired by eliciting defensive responses in smokers. This study tests whether enhancing a currently used emotive graphic smoking health warning with a self-affirmation component reduces cigarette consumption and whether potential effects are stronger in heavier smokers, as suggested by previous research. Participants (n = 265) were randomly allocated to a self-affirmation (reflecting on personal values and positive traits using a questionnaire) or matched control condition before viewing an emotive graphic health message from a current Australian government public health campaign. The primary outcome (cigarettes per day [CPD]) was assessed both before and a week following the intervention. No main effect of self-affirmation on smoking, but as hypothesized, a significant interaction between baseline smoking and self-affirmation was found that showed that heavier smokers (>21 CPD) who self-affirmed significantly reduced CPD compared to nonaffirmed smokers. These findings support the use of self-affirmation to enhance smoking awareness campaigns in heavier smokers. This study shows that enhancing emotive graphic smoking health messages with self-affirmation (the act of reflecting on positive aspects of oneself) increases their effectiveness in heavier smokers. This suggests that self-affirmation might be a particularly useful tool for health promotion targeting heavier smokers. This study adds to previous research in that it is the first to test the add-on effects of self-affirmation to current graphic health messages on smoking rather than smoking-related cognitions. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Nonanatomic Simulation Training of Novice Arthroscopy Skills.

PubMed

Sandberg, Rory P; Sherman, Nathan C; Latt, L Daniel; Hardy, Jolene C

2017-11-01

The goal of this study was to validate the cigar box arthroscopy trainer (CBAT) as a training tool and then compare its effectiveness to didactic training and to another previously validated low-fidelity but anatomic model, the anatomic knee arthroscopy trainer (AKAT). A nonanatomic knee arthroscopy training module was developed at our institution. Twenty-four medical students with no prior arthroscopic or laparoscopic experience were enrolled as subjects. Eight subjects served as controls. The remaining 16 subjects were randomized to participate in 4 hours of either the CBAT or a previously validated AKAT. Subjects' skills were assessed by 1 of 2 faculty members through repeated attempts at performing a diagnostic knee arthroscopy on a cadaveric specimen. Objective scores were given using a minimally adapted version of the Basic Arthroscopic Knee Skill Scoring System. Total cost differences were calculated. Seventy-five percent of subjects in the CBAT and AKAT groups succeeded in reaching minimum proficiency in the allotted time compared with 25% in the control group (P < .05). There was no significant difference in the number of attempts to reach proficiency between the CBAT and AKAT groups. The cost to build the CBAT was $44.12, whereas the cost was $324.33 for the AKAT. This pilot study suggests the CBAT is an effective knee arthroscopy trainer that may decrease the learning curve of residents without significant cost to a residency program. This study demonstrates the need for an agreed-upon objective scoring system to properly evaluate residents and compare the effectiveness of different training tools. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Comparative effect of a new mouthrinse containing chlorhexidine, triclosan and zinc on volatile sulphur compounds: a randomized, crossover, double-blind study.

PubMed

Mendes, L; Coimbra, J; Pereira, A L; Resende, M; Pinto, M G

2016-08-01

The aims of this study were to compare the volatile sulphur compounds (VSC)-reducing effect of two commercial mouthrinses using a morning bad breath model and to assess the role of mechanical plaque control (MPC) when performed previously to mouthrinse use. Eleven volunteers with good oral health were enrolled in a double-blind, randomized, six-step crossover design study with a 7-day washout period. Two commercial mouthrinses were tested using a saline solution (NaCl 0.9%) as a negative control: one mouthrinse contained 0.05% chlorhexidine, 0.05% cetylpyridinium chloride and 0.14% zinc lactate (CHX-CPC-Zn), while the other contained 0.05% chlorhexidine, 0.15% triclosan and 0.18% zinc pidolate (CHX-triclosan-Zn). A portable sulphide monitor (Halimeter(®) ) was used for VSC quantification. Measurements were made at baseline, and 1, 3 and 5 h after rinsing. Significant differences were detected by analysis of variance. No significant differences between groups were detected at baseline. We were unable to demonstrate a significant influence of mechanical plaque control on the reduction of VSC levels when performed before mouthrinse use (P = 0.631). Both mouthrinses effectively lowered VSC levels in all test intervals (P < 0.05). No statistically significant differences were found between mouthrinses in any of the test intervals (P = 0.629, 0.069 and 0.598 at 1, 3 and 5 h). This study demonstrated that CHX-CPC-Zn and CHX-triclosan-Zn have significant and similar effects in reducing VSC levels, which persist for at least 5 h. Such effects were independent of previous MPC, which failed to improve on the results of mouthrinse use alone. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effect of a Pheromone on Stress-Associated Reactivation of Feline Herpesvirus-1 in Experimentally Inoculated Kittens.

PubMed

Contreras, Elena T; Hodgkins, E; Tynes, V; Beck, A; Olea-Popelka, F; Lappin, M R

2018-01-01

Stress contributes to reactivation of feline herpesvirus-1 (FHV-1). The usage of pheromones to decrease stress in FHV-1 experimentally inoculated kittens has not previously been investigated. To determine whether a feline pheromone would lessen stress, resulting in decreased recurrence of FHV-1-associated illness in kittens. Twelve 5-month-old, purpose-bred kittens. Randomized, double-blind, placebo-controlled clinical trial. Kittens previously infected with the same dose of FHV-1 were randomized into 2 separate but identical group rooms. After a 2-week equilibration period, a diffuser containing either the pheromone or placebo was placed in each of the rooms, and the kittens acclimated for an additional 2 weeks. Every 2 weeks thereafter, for the 8-week study period, housing was alternated between kennel- and group housing. Blinded observers applied a standardized clinical and behavioral scoring rubric daily. After each 2-week period, serum cortisol concentrations and quantitative PCR for FHV-1 and glyceraldehyde 3-phosphate dehydrogenase (GAPDH) ratios were evaluated. Clinical, behavioral, and laboratory test results were compared between groups within individual and combined study periods. Sneezing occurred more frequently in the placebo group during individual (P = 0.006) and combined study periods (P = 0.001). Sleep at the end of observation periods occurred more frequently in the pheromone group during individual (P = 0.006) and combined study periods (P < 0.001). The findings suggest that the pheromone decreased stress, and the decrease in stress response may have resulted in decreased sneezing associated with FHV-1. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Optimal patient education for cancer pain: a systematic review and theory-based meta-analysis.

PubMed

Marie, N; Luckett, T; Davidson, P M; Lovell, M; Lal, S

2013-12-01

Previous systematic reviews have found patient education to be moderately efficacious in decreasing the intensity of cancer pain, but variation in results warrants analysis aimed at identifying which strategies are optimal. A systematic review and meta-analysis was undertaken using a theory-based approach to classifying and comparing educational interventions for cancer pain. The reference lists of previous reviews and MEDLINE, PsycINFO, and CENTRAL were searched in May 2012. Studies had to be published in a peer-reviewed English language journal and compare the effect on cancer pain intensity of education with usual care. Meta-analyses used standardized effect sizes (ES) and a random effects model. Subgroup analyses compared intervention components categorized using the Michie et al. (Implement Sci 6:42, 2011) capability, opportunity, and motivation behavior (COM-B) model. Fifteen randomized controlled trials met the criteria. As expected, meta-analysis identified a small-moderate ES favoring education versus usual care (ES, 0.27 [-0.47, -0.07]; P = 0.007) with substantial heterogeneity (I² = 71 %). Subgroup analyses based on the taxonomy found that interventions using "enablement" were efficacious (ES, 0.35 [-0.63, -0.08]; P = 0.01), whereas those lacking this component were not (ES, 0.18 [-0.46, 0.10]; P = 0.20). However, the subgroup effect was nonsignificant (P = 0.39), and heterogeneity was not reduced. Factoring in the variable of individualized versus non-individualized influenced neither efficacy nor heterogeneity. The current meta-analysis follows a trend in using theory to understand the mechanisms of complex interventions. We suggest that future efforts focus on interventions that target patient self-efficacy. Authors are encouraged to report comprehensive details of interventions and methods to inform synthesis, replication, and refinement.

Can Nonexperimental Estimates Replicate Estimates Based on Random Assignment in Evaluations of School Choice? A Within-Study Comparison

ERIC Educational Resources Information Center

Bifulco, Robert

2012-01-01

The ability of nonexperimental estimators to match impact estimates derived from random assignment is examined using data from the evaluation of two interdistrict magnet schools. As in previous within-study comparisons, nonexperimental estimates differ from estimates based on random assignment when nonexperimental estimators are implemented…

Retention of Statistical Concepts in a Preliminary Randomization-Based Introductory Statistics Curriculum

ERIC Educational Resources Information Center

Tintle, Nathan; Topliff, Kylie; VanderStoep, Jill; Holmes, Vicki-Lynn; Swanson, Todd

2012-01-01

Previous research suggests that a randomization-based introductory statistics course may improve student learning compared to the consensus curriculum. However, it is unclear whether these gains are retained by students post-course. We compared the conceptual understanding of a cohort of students who took a randomization-based curriculum (n = 76)…

Dynamic probability of reinforcement for cooperation: Random game termination in the centipede game.

PubMed

Krockow, Eva M; Colman, Andrew M; Pulford, Briony D

2018-03-01

Experimental games have previously been used to study principles of human interaction. Many such games are characterized by iterated or repeated designs that model dynamic relationships, including reciprocal cooperation. To enable the study of infinite game repetitions and to avoid endgame effects of lower cooperation toward the final game round, investigators have introduced random termination rules. This study extends previous research that has focused narrowly on repeated Prisoner's Dilemma games by conducting a controlled experiment of two-player, random termination Centipede games involving probabilistic reinforcement and characterized by the longest decision sequences reported in the empirical literature to date (24 decision nodes). Specifically, we assessed mean exit points and cooperation rates, and compared the effects of four different termination rules: no random game termination, random game termination with constant termination probability, random game termination with increasing termination probability, and random game termination with decreasing termination probability. We found that although mean exit points were lower for games with shorter expected game lengths, the subjects' cooperativeness was significantly reduced only in the most extreme condition with decreasing computer termination probability and an expected game length of two decision nodes. © 2018 Society for the Experimental Analysis of Behavior.

The Canadian critical care nutrition guidelines in 2013: an update on current recommendations and implementation strategies.

PubMed

Dhaliwal, Rupinder; Cahill, Naomi; Lemieux, Margot; Heyland, Daren K

2014-02-01

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioners and patient decisions about appropriate healthcare for specific clinical circumstances, and are designed to minimize practice variation, improve costs, and improve clinical outcomes. The Canadian Critical Care Practice Guidelines (CCPGs) were first published in 2003 and most recently updated in 2013. A total of 68 new randomized controlled trials were identified since the last version in 2009, 50 of them published between 2009 and 2013. The remaining articles were trials published before 2009 but were not identified in previous iterations of the CCPGs. For clinical practice guidelines to be useful to practitioners, they need to be up-to-date and be reflective of the current body of evidence. Herein we describe the process by which the CCPGs were updated. This process resulted in 10 new sections or clinical topics. Of the old clinical topics, 3 recommendations were upgraded, 4 were downgraded, and 27 remained the same. To influence decision making at the bedside, these updated guidelines need to be accompanied by active guideline implementation strategies. Optimal implementation strategies should be guided by local contextual factors including barriers and facilitators to best practice recommendations. Moreover, evaluating and monitoring performance, such as participating in the International Nutrition Survey of practice, should be part of any intensive care unit's performance improvement strategy. The active implementation of the updated CCPGs may lead to better nutrition care and improved patient outcomes in the critical care setting.

The prevalence of pathological gambling among college students: a meta-analytic synthesis, 2005-2013.

PubMed

Nowak, Donald E; Aloe, Ariel M

2014-12-01

The problem of gambling addiction can be especially noteworthy among college and university students, many of whom have the resources, proximity, free time, and desire to become involved in the myriad options of gambling now available. Although limited attention has been paid specifically to college student gambling in the body of literature, there have been two published meta-analyses estimating the prevalence of probable pathological gambling among college students. This present study aims to be the third, presenting an up-to-date proportion of those students exhibiting gambling pathology, and is the first to include international studies from outside the United States and Canada. The purpose of this study was to use the most up-to-date meta-analytical procedures to synthesize the rates of probable pathological gambling for college and university students worldwide. A thorough literature review and coding procedure resulted in 19 independent data estimates retrieved from 18 studies conducted between 2005 and 2013. To synthesize the studies, a random effects model for meta-analysis was applied. The estimated proportion of probable pathological gamblers among the over 13,000 college students surveyed was computed at 10.23%, considerably higher than either of the two previously published meta-analyses, and more than double the rate reported in the first meta-analysis of this type published in 1999. Implications and recommendations for future practice in dealing with college students and gambling addiction are outlined and described for both administrators and mental health professionals.

An Updated Review of the Efficacy of Cupping Therapy

PubMed Central

Cao, Huijuan; Li, Xun; Liu, Jianping

2012-01-01

Background Since 1950, traditional Chinese medicine (TCM) cupping therapy has been applied as a formal modality in hospitals throughout China and elsewhere in the world. Based on a previous systematic literature review of clinical studies on cupping therapy, this study presents a thorough review of randomized controlled trials (RCTs) to evaluate the therapeutic effect of cupping therapy. Method Six databases were searched for articles published through 2010. RCTs on cupping therapy for various diseases were included. Studies on cupping therapy combined with other TCM treatments versus non-TCM therapies were excluded. Results 135 RCTs published from 1992 through 2010 were identified. The studies were generally of low methodological quality. Diseases for which cupping therapy was commonly applied were herpes zoster, facial paralysis (Bell palsy), cough and dyspnea, acne, lumbar disc herniation, and cervical spondylosis. Wet cupping was used in most trials, followed by retained cupping, moving cupping, and flash cupping. Meta-analysis showed cupping therapy combined with other TCM treatments was significantly superior to other treatments alone in increasing the number of cured patients with herpes zoster, facial paralysis, acne, and cervical spondylosis. No serious adverse effects were reported in the trials. Conclusions Numerous RCTs on cupping therapy have been conducted and published during the past decades. This review showed that cupping has potential effect in the treatment of herpes zoster and other specific conditions. However, further rigorously designed trials on its use for other conditions are warranted. PMID:22389674

Characteristics of Academic Detailing: Results of a Literature Review

PubMed Central

Van Hoof, Thomas J.; Harrison, Lisa G.; Miller, Nicole E.; Pappas, Maryanne S.; Fischer, Michael A.

2015-01-01

Background Academic detailing is an evidence-based strategy to improve patient care. Efforts to understand the intervention and to use it strategically require an understanding of its important characteristics. A recent systematic review and a subsequent reporting framework call for more accurate and complete reporting of continuing medical education interventions. Objectives Building on a previously published systematic review of 69 studies, we sought to determine how an expanded set of 106 academic detailing studies, including many recently published articles, fared with respect to reporting of important data about this intervention. Methods We conducted a search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature (clinical) database, and Scopus, from which we identified 38 additional randomized controlled trials published from August 2007 through March 2013. Including the original 69 studies, we abstracted 106 available English-language studies and quantitatively analyzed information about 4 important characteristics of academic detailing: content of visits, clinicians being visited, communication process underlying visits, and outreach workers making visits. Results We found considerable variation (36.5%-100%) in the extent of reporting intervention characteristics, especially about the communication process underlying visits and the outreach workers making visits. The best overall documentation of intervention characteristics of any single study was 68%. Results also demonstrate wide variation in the approach to academic detailing. Conclusions This study demonstrates the need for a standardized approach to collecting and reporting data about academic detailing interventions. Our findings also highlight opportunities for using academic detailing more effectively in research and quality-improvement efforts. PMID:26702333

Characteristics of Academic Detailing: Results of a Literature Review.

PubMed

Van Hoof, Thomas J; Harrison, Lisa G; Miller, Nicole E; Pappas, Maryanne S; Fischer, Michael A

2015-11-01

Academic detailing is an evidence-based strategy to improve patient care. Efforts to understand the intervention and to use it strategically require an understanding of its important characteristics. A recent systematic review and a subsequent reporting framework call for more accurate and complete reporting of continuing medical education interventions. Building on a previously published systematic review of 69 studies, we sought to determine how an expanded set of 106 academic detailing studies, including many recently published articles, fared with respect to reporting of important data about this intervention. We conducted a search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature (clinical) database, and Scopus, from which we identified 38 additional randomized controlled trials published from August 2007 through March 2013. Including the original 69 studies, we abstracted 106 available English-language studies and quantitatively analyzed information about 4 important characteristics of academic detailing: content of visits, clinicians being visited, communication process underlying visits, and outreach workers making visits. We found considerable variation (36.5%-100%) in the extent of reporting intervention characteristics, especially about the communication process underlying visits and the outreach workers making visits. The best overall documentation of intervention characteristics of any single study was 68%. Results also demonstrate wide variation in the approach to academic detailing. This study demonstrates the need for a standardized approach to collecting and reporting data about academic detailing interventions. Our findings also highlight opportunities for using academic detailing more effectively in research and quality-improvement efforts.

Statins as anti-arrhythmics: a systematic review part II: effects on risk of ventricular arrhythmias.

PubMed

Abuissa, Hussam; O'Keefe, James H; Bybee, Kevin A

2009-10-01

Recent studies have demonstrated that statins may possess anti-arrhythmic properties in addition to their lipid-lowering effects. Studies which reported the association of statins with the incidence of ventricular arrhythmias were identified through a systematic review of the published literature. Statins have been associated with a significant reductions in ventricular arrhythmia in cardiomyopathy patients with an implantable cardioverter defibrillator, although randomized trials have not been completed. Published data suggests that statins may possess anti-arrhythmic properties that reduce the propensity for ventricular arrhythmias. Most of this data is observational; more randomized, placebo-controlled trials are needed.

Economic evaluation of the DiAMOND randomized trial: cost and outcomes of 2 decision aids for mode of delivery among women with a previous cesarean section.

PubMed

Hollinghurst, Sandra; Emmett, Clare; Peters, Tim J; Watson, Helen; Fahey, Tom; Murphy, Deirdre J; Montgomery, Alan

2010-01-01

Maternal preferences should be considered in decisions about mode of delivery following a previous cesarean, but risks and benefits are unclear. Decision aids can help decision making, although few studies have assessed costs in conjunction with effectiveness. Economic evaluation of 2 decision aids for women with 1 previous cesarean. Cost-consequences analysis. Data sources were self-reported resource use and outcome and published national unit costs. The target population was women with 1 previous cesarean. The time horizon was 37 weeks' gestation and 6 weeks postnatal. The perspective was health care delivery system. The interventions were usual care, usual care plus an information program, and usual care plus a decision analysis program. The outcome measures were costs to the National Health Service (NHS) in the United Kingdom (UK), score on the Decisional Conflict Scale, and mode of delivery. RESULTS OF MAIN ANALYSIS: Cost of delivery represented 84% of the total cost; mode of delivery was the most important determinant of cost differences across the groups. Mean (SD) total cost per mother and baby: 2033 (677) for usual care, 2069 (738) for information program, and 2019 (741) for decision analysis program. Decision aids reduced decisional conflict. Women using the decision analysis program had fewest cesarean deliveries. Applying a cost premium to emergency cesareans over electives had little effect on group comparisons. Conclusions were unaffected. Disparity in timing of outcomes and costs, data completeness, and quality. Decision aids can reduce decisional conflict in women with a previous cesarean section when deciding on mode of delivery. The information program could be implemented at no extra cost to the NHS. The decision analysis program might reduce the rate of cesarean sections without any increase in costs.

Statins as antiarrhythmics: a systematic review part I: effects on risk of atrial fibrillation.

PubMed

Abuissa, Hussam; O'Keefe, James H; Bybee, Kevin A

2009-10-01

Recent studies have demonstrated that statins may possess antiarrhythmic properties in addition to their lipid-lowering effects. Studies which reported the association of statins with the incidence of atrial arrhythmias were identified through a systematic review of published literature. One randomized, placebo-controlled trial of 200 patients undergoing cardiac surgery showed that atorvastatin decreased the incidence of postoperative atrial fibrillation by 61%. Observational studies in patients with stable coronary disease, left ventricular dysfunction, or those undergoing cardiac or noncardiac surgery show that statin therapy is associated with an approximately 50% lower rate of atrial fibrillation. Two small randomized trials reported conflicting results: one showing that atorvastatin reduced the recurrence of AF after electrical cardioversion and the other finding that pravastatin did not. Published data suggests that statins may possess antiarrhythmic properties that reduce the propensity for atrial fibrillation. Most of this data is observational; more randomized, placebo-controlled trials are needed.

Balancing commercial and public interests

PubMed Central

Furberg, Curt D; Hall, Mark A; Sevick, Mary Ann

2004-01-01

A large number of randomized clinical trials with important health outcomes are completed each year. Those with favorable findings are typically reported and published rapidly, while the publication of those with unfavorable results is often delayed or given a positive "spin." This observation applies primarily to industry-sponsored trials. Our objectives are to discuss the responsibility of pharmaceutical firms to the public with respect to timely, complete, and unbiased information from all randomized clinical trials and to propose solutions for improvements. We believe that in addition to financial obligations to their shareholders, pharmaceutical companies have social responsibilities to the public and to health care providers. However, private markets do not reward or compel optimal disclosure of drug safety or inferiority information on a voluntary basis. A problem which has not previously been identified relates to non-comparability of drugs. A case report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) illustrates how public interests may be violated due to failure to inform about drug inferiority. The current system for dissemination of relevant medical information could be improved if all involved parties collaborated fully. However, full disclosure of trial results is unlikely when research results are unfavorable to the firm. We conclude that expanded government regulations will be required for a satisfactory solution to the problem. PMID:15239846

Perspectives on the American College of Cardiology/American Heart Association guidelines for the prevention of infective endocarditis.

PubMed

Bach, David S

2009-05-19

In 2007, the American Heart Association published a guideline statement dramatically changing its previous position on the use of antibiotic prophylaxis in patients at risk of infective endocarditis (IE). This year, these views were incorporated in an update of the 2006 American College of Cardiology/American Heart Association Guidelines for the Management of Patients With Valvular Heart Disease. The new recommendations represent a dramatic shift with regard to which patients should receive antibiotic prophylaxis for prevention of IE and for what procedures. The shift in recommendations is striking in that the recommendations are based not on new data, but on no data. (There are no large, prospective, randomized double-blind trials testing the efficacy of IE prophylaxis.) However, available data suggest that there may be no real risk associated with IE prophylaxis. Even if few cases of IE are successfully prevented using antibiotic prophylaxis, those few cases may represent a favorable risk-benefit ratio. On an individual basis, patients with organic heart valve disease who are trying to delay or avoid surgical intervention have something very real to risk if they develop IE, and a very real benefit if they avoid it. Pending data from prospective randomized trials, a strategy of individual decision-making by informed patients may be best.

Off-label prescription of antineoplastic drugs: an Italian prospective, observational, multicenter survey.

PubMed

Roila, Fausto; Ballatori, Enzo; Labianca, Roberto; De Braud, Filippo; Borgonovo, Karen; Martelli, Olga; Gallo, Ciro; Tinazzi, Angelo; Perrone, Francesco

2009-01-01

An appropriate use of drugs should follow the registered indications. Different reasons can induce oncologists to prescribe drugs off-label. The aim of this study was to describe incidence and characteristics of these prescriptions in Italy. Patients submitted to chemotherapy in 15 Italian oncology centers were evaluated for two randomized non-consecutive days of two weeks in May 2006. The study enrolled 644 patients receiving 1,053 drugs. Overall, 199 of 1053 (18.9%) prescriptions were off-label. In 92 of 199 cases (46.2%), the drugs were used for a neoplasm for which they were not approved, but there was scientific evidence (one or more randomized clinical trials or more phase II studies published in a major oncology journal) justifying the prescription. In 27 cases (13.6%), the drugs were prescribed for a rare neoplasm (cisplatin and gemcitabine in mesothelioma). In 20/21 cases (10.1%/10.5%), drugs were used in association/alone in contrast with the approved use (capecitabine in association in colorectal cancer). In 28/11 cases (14.0%/5.6%), the drugs were used in lines of chemotherapy subsequent/previous to that approved. Off-label use of antineoplastic drugs, in this observational survey, represents less than 20% of the prescriptions, and most of them are based on scientific evidence of efficacy.

Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis.

PubMed

Müller, M W; Friess, H; Martin, D J; Hinz, U; Dahmen, R; Büchler, M W

2008-03-01

Duodenum-preserving pancreatic head resection according to Beger and the pylorus-preserving Whipple (ppWhipple) procedure were compared in patients with chronic pancreatitis (CP) in a randomized clinical trial. Perioperative data and short-term outcome have been reported previously. The present study evaluated long-term follow-up. Forty patients were enrolled originally, 20 in each group. Long-term follow-up included mortality, morbidity, pain status, occupational rehabilitation, quality of life (QoL), and endocrine and exocrine function at median follow-up of 7 and 14 years. One patient who had a ppWhipple procedure was lost to follow-up. There were five late deaths in each group. No differences were noted in pain status and exocrine pancreatic function. Loss of appetite was significantly worse in the ppWhipple group at 14 years' follow-up, but there were no other differences in QoL parameters examined. After 14 years, diabetes mellitus was present in seven of 15 patients who had the Beger procedure and 11 of 14 patients after ppWhipple resection (P = 0.128). After long-term follow-up of up to 14 years early advantages of the Beger procedure were no longer present. 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

A 3-year randomized therapeutic trial of nitisinone in alkaptonuria.

PubMed

Introne, Wendy J; Perry, Monique B; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A; Suwannarat, Pim; O'Brien, Kevin E; Bryant, Joy; Sachdev, Vandana; Reynolds, James C; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A

2011-08-01

Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. Published by Elsevier Inc.

Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial.

PubMed

Kipping, Belinda; Rodger, Sylvia; Miller, Kate; Kimble, Roy M

2012-08-01

Effective pain management remains a challenge for adolescents during conscious burn wound care procedures. Virtual reality (VR) shows promise as a non-pharmacological adjunct in reducing pain. This study assessed off-the-shelf VR for (1) its effect on reducing acute pain intensity during adolescent burn wound care, and (2) its clinical utility in a busy hospital setting. Forty-one adolescents (11-17 years) participated in this prospective randomized controlled trial. Acute pain outcomes including adolescent self-report, nursing staff behavioral observation, caregiver observation and physiological measures were collected. Length of procedure times and adolescent reactions were also recorded to inform clinical utility. Nursing staff reported a statistically significant reduction in pain scores during dressing removal, and significantly less rescue doses of Entonox given to those receiving VR, compared to those receiving standard distraction. For all other pain outcomes and length of treatment, there was a trend for lower pain scores and treatment times for those receiving VR, but these differences were not statistically significant. Despite only minimal pain reduction achieved using off-the-shelf VR, other results from this trial and previous research on younger children with burns suggest a customized, adolescent and hospital friendly device may be more effective in pain reduction. Copyright © 2012. Published by Elsevier Ltd.

Discovering cell types in flow cytometry data with random matrix theory

NASA Astrophysics Data System (ADS)

Shen, Yang; Nussenblatt, Robert; Losert, Wolfgang

Flow cytometry is a widely used experimental technique in immunology research. During the experiments, peripheral blood mononuclear cells (PBMC) from a single patient, labeled with multiple fluorescent stains that bind to different proteins, are illuminated by a laser. The intensity of each stain on a single cell is recorded and reflects the amount of protein expressed by that cell. The data analysis focuses on identifying specific cell types related to a disease. Different cell types can be identified by the type and amount of protein they express. To date, this has most often been done manually by labelling a protein as expressed or not while ignoring the amount of expression. Using a cross correlation matrix of stain intensities, which contains both information on the proteins expressed and their amount, has been largely ignored by researchers as it suffers from measurement noise. Here we present an algorithm to identify cell types in flow cytometry data which uses random matrix theory (RMT) to reduce noise in a cross correlation matrix. We demonstrate our method using a published flow cytometry data set. Compared with previous analysis techniques, we were able to rediscover relevant cell types in an automatic way. Department of Physics, University of Maryland, College Park, MD 20742.

Three months of simvastatin therapy vs. placebo for severe portal hypertension in cirrhosis: A randomized controlled trial.

PubMed

Pollo-Flores, Priscila; Soldan, Mônica; Santos, Ubiratan Cassano; Kunz, Danielle Gobbi; Mattos, Denise Espindola; da Silva, Alexandre Cerqueira; Marchiori, Roberta Cabral; Rezende, Guilherme Ferreira da Motta

2015-11-01

Pleiotropic effects of statins decrease intrahepatic resistance and portal hypertension. We evaluated the effects of simvastatin on hepatic venous pressure gradient (HVPG) and azygos vein blood flow in cirrhotic patients. A 3-month prospective, randomized, triple-blind trial with simvastatin (40 mg/day) vs. placebo was conducted in patients with cirrhotic portal hypertension. HVPG and azygos blood flow, measured by colour Doppler endoscopic ultrasound, were assessed before and after treatment. The primary endpoint was a decrease in the HVPG of at least 20% from baseline or to ≤12 mmHg after the treatment. 34 patients were prospectively enrolled, and 24 completed the protocol. In the simvastatin group 6/11 patients (55%) presented a clinically relevant decrease in the HVPG; no decrease was observed in the placebo group (p=0.036). Patients with medium/large oesophageal varices and previous variceal bleeding had a higher response rate to simvastatin. HVPG and azygos blood flow values were not correlated. No significant adverse events occurred. Simvastatin lowers portal pressure and may even improve liver function. The haemodynamic effect appears to be more evident in patients with severe portal hypertension. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Effect of oxygen therapy on chest pain in patients with ST elevation myocardial infarction: results from the randomized SOCCER trial.

PubMed

Khoshnood, Ardavan; Akbarzadeh, Mahin; Carlsson, Marcus; Sparv, David; Bhiladvala, Pallonji; Mokhtari, Arash; Erlinge, David; Ekelund, Ulf

2018-04-01

Oxygen (O 2 ) have been a cornerstone in the treatment of acute myocardial infarction. Studies have been inconclusive regarding the cardiovascular and analgesic effects of oxygen in these patients. In the SOCCER trial, we compared the effects of oxygen treatment versus room air in patients with ST-elevation myocardial infarction (STEMI). There was no difference in myocardial salvage index or infarct size assessed with cardiac magnetic resonance imaging. In the present subanalysis, we wanted to evaluate the effect of O 2 on chest pain in patients with STEMI. Normoxic patients with first time STEMI were randomized in the ambulance to standard care with 10 l/min O 2 or room air until the end of the percutaneous coronary intervention (PCI). The ambulance personnel noted the patients´ chest pain on a visual analog scale (VAS; 1-10) before randomization and after the transport but before the start of the PCI, and also registered the amount of morphine given. 160 patients were randomized to O 2 (n = 85) or room air (n = 75). The O 2 group had a higher median VAS at randomization than the air group (7.0 ± 2.3 vs 6.0 ± 2.9; p = .02) and also received a higher median total dose of morphine (5.0 mg ± 4.4 vs 4.0 mg ± 3.7; p = .02). There was no difference between the O 2 and air groups in VAS at the start of the PCI (4.0 ± 2.4 vs 3.0 ± 2.5; p = .05) or in the median VAS decrease from randomization to the start of the PCI (-2.0 ± 2.2 vs -1.0 ± 2.9; p = .18). Taken together with previously published data, these results do not support a significant analgesic effect of oxygen in patients with STEMI. European Clinical Trials Database (EudraCT): 2011-001452-11. ClinicalTrials.gov Identifier: NCT01423929.

The Quality of Randomized Controlled Trials in Pediatric Orthopaedics: Are We Improving?

PubMed

Dodwell, Emily; Dua, Shiv; Dulai, Sukhdeep K; Astone, Kristina; Mulpuri, Kishore

2015-01-01

The quality of randomized controlled trials (RCTs) in orthopaedics is a topic of considerable importance, as RCTs play a major role in guiding clinical practice. The quality of RCTs published between 1995 and 2005 has previously been documented. The purpose of the current study was to assess and describe the quality of pediatric orthopaedic RCTs published from 2005 to 2012, by identifying study characteristics associated with higher quality and outlining areas for improvement. A standardized literature search was used to identify pediatric orthopaedic RCTs published in 7 well-recognized journals between September 2005 and July 2012 inclusive. The Detsky Quality Assessment Scale and the CONSORT checklist for Non-Pharmacologic Trials were used to assess the quality of the RCTs. Scores for the Detsky and CONSORT were calculated by 2 independent blinded orthopaedic surgeon reviewers with epidemiologic training. Forty RCTs were included in this analysis. The mean percentage score on the Detsky quality scale was 67%. Sixteen (40%) of the articles satisfied the threshold for a satisfactory level of methodological quality (Detsky >75%). Twenty-five (63%) of these studies were negative studies, concluding no difference between treatment arms. In 52% of the negative studies, an a priori sample size analysis was absent, and 28% were self-described as underpowered. In multiple variable regression analysis, only working with a statistician was significantly associated with higher Detsky percentage scores (P=0.01). There is a trend for improving quality in pediatric orthopaedic RCTs. Compared with past reports, the mean Detsky score improved from 53% to 67%, and the proportion meeting an acceptable level of quality improved from 19% to 40%. One of the most concerning findings of this study was the lack of attention to sample size and power analysis, and the potential for underpowered studies. Ongoing efforts are necessary to improve the conduct and reporting of clinical trials in pediatric orthopaedics. Pediatric orthopaedic surgeons, JPO, and POSNA are working toward improving levels of quality in pediatric orthopaedic research. This paper highlights progress that has been made, and addresses some high-yield areas for future improvement.

Heart rate as a predictor of stroke in high-risk, hypertensive patients with previous stroke or transient ischemic attack.

PubMed

Sandset, Else Charlotte; Berge, Eivind; Kjeldsen, Sverre E; Julius, Stevo; Holzhauer, Björn; Krarup, Lars-Henrik; Hua, Tsushung A

2014-01-01

Risk factors for first stroke are well established, but less is known about risk factors for recurrent stroke. In the present analysis, we aimed to assess the effect of heart rate and other possible predictors of stroke in a hypertensive population with previous stroke or transient ischemic attack (TIA). The Valsartan Antihypertensive Long-Term Use Evaluation trial was a multicentre, double-masked, randomized controlled, parallel group trial comparing the effects of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) in patients with hypertension and high cardiovascular risk. We used Cox proportional hazard models to investigate the effect of baseline variables on the risk of stroke. Quadratic terms of the continuous variables were entered in the models to test for linearity. Of 15,245 patients included in the trial, 3014 had a previous stroke or TIA at baseline and were included in the present analysis. Stroke recurrence occurred in 239 patients (7.9%) during a median of 4.5 years of follow-up. Resting heart rate (per 10 beats per minute; hazard ratio [HR], 2.78; 95% confidence interval [CI], 1.18-6.58) and diabetes mellitus at baseline (HR, 1.47; 95% CI, 1.03-2.10) were significantly associated with an increased risk of stroke recurrence in the multivariable analysis. In high-risk, hypertensive patients with previous stroke or TIA, resting heart rate was the strongest predictor of recurrent stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis.

PubMed

Neal, Joseph M

2016-01-01

In 2010, the American Society of Regional Anesthesia and Pain Medicine's evidence-based medicine assessment of ultrasound (US)-guided regional anesthesia (UGRA) analyzed the effect of this nerve localization technology on patient safety. That analysis focused on 4 important regional anesthesia complications: peripheral nerve injury, local anesthetic systemic toxicity (LAST), hemidiaphragmatic paresis (HDP), and pneumothorax. In the intervening 5 years, further research has allowed us to refine our original conclusions. This update reviews previous findings and critically evaluates new literature published since late 2009 that compares the patient safety attributes of UGRA with those of traditional nerve localization methods. As with the previous version of this exercise, analysis focused on randomized controlled trials that compared UGRA with an alternative neural localization method and case series of more than 500 patients. The Jadad score was used to grade individual study quality, and conclusions were graded as to strength of evidence. Of those randomized controlled trials identified by our search techniques, 28 compared the incidence of postoperative nerve symptoms, 27 assessed LAST parameters, 7 studied HDP, and 9 reported the incidence of pneumothorax. The current analysis strengthens our original conclusions that US guidance has no significant effect on the incidence of postoperative neurologic symptoms and that UGRA reduces the incidence and intensity of HDP but does so in an unpredictable manner. Conversely, emerging evidence supports the effectiveness of US guidance for reducing LAST across its clinical presentation continuum. The predicted frequency of pneumothorax has grown smaller in tandem with increased experience with US-guided supraclavicular block. This evidence-based review summarizes both the power and the limitations of UGRA as a tool for improving patient safety. Since the original 2010 publication of this analysis, evidence has continued to support the concept that ultrasound (US) guidance does not meaningfully affect the incidence of peripheral nerve injury (PNI) associated with regional anesthesia. Similar confirmatory evidence attests to US guidance reducing the incidence and intensity of hemidiaphragmatic paresis (HDP) but not eliminating it. Literature published since late 2009 reports the effective role of US guidance in reducing the incidence of local anesthetic systemic toxicity and allows calculation of a lower predicted frequency of pneumothorax associated with US-guided supraclavicular blocks.

Individual determinants of research utilization by nurses: a systematic review update.

PubMed

Squires, Janet E; Estabrooks, Carole A; Gustavsson, Petter; Wallin, Lars

2011-01-05

Interventions that have a better than random chance of increasing nurses' use of research are important to the delivery of quality patient care. However, few reports exist of successful research utilization in nursing interventions. Systematic identification and evaluation of individual characteristics associated with and predicting research utilization may inform the development of research utilization interventions. To update the evidence published in a previous systematic review on individual characteristics influencing research utilization by nurses. As part of a larger systematic review on research utilization instruments, 12 online bibliographic databases were searched. Hand searching of specialized journals and an ancestry search was also conducted. Randomized controlled trials, clinical trials, and observational study designs examining the association between individual characteristics and nurses' use of research were eligible for inclusion. Studies were limited to those published in the English, Danish, Swedish, and Norwegian languages. A vote counting approach to data synthesis was taken. A total of 42,770 titles were identified, of which 501 were retrieved. Of these 501 articles, 45 satisfied our inclusion criteria. Articles assessed research utilization in general (n = 39) or kinds of research utilization (n = 6) using self-report survey measures. Individual nurse characteristics were classified according to six categories: beliefs and attitudes, involvement in research activities, information seeking, education, professional characteristics, and socio-demographic/socio-economic characteristics. A seventh category, critical thinking, emerged in studies examining kinds of research utilization. Positive relationships, at statistically significant levels, for general research utilization were found in four categories: beliefs and attitudes, information seeking, education, and professional characteristics. The only characteristic assessed in a sufficient number of studies and with consistent findings for the kinds of research utilization was attitude towards research; this characteristic had a positive association with instrumental and overall research utilization. This review reinforced conclusions in the previous review with respect to positive relationships between general research utilization and: beliefs and attitudes, and current role. Furthermore, attending conferences/in-services, having a graduate degree in nursing, working in a specialty area, and job satisfaction were also identified as individual characteristics important to research utilization. While these findings hold promise as potential targets of future research utilization interventions, there were methodological problems inherent in many of the studies that necessitate their findings be replicated in further research using more robust study designs and multivariate assessment methods.

Individual determinants of research utilization by nurses: a systematic review update

PubMed Central

2011-01-01

Background Interventions that have a better than random chance of increasing nurses' use of research are important to the delivery of quality patient care. However, few reports exist of successful research utilization in nursing interventions. Systematic identification and evaluation of individual characteristics associated with and predicting research utilization may inform the development of research utilization interventions. Objective To update the evidence published in a previous systematic review on individual characteristics influencing research utilization by nurses. Methods As part of a larger systematic review on research utilization instruments, 12 online bibliographic databases were searched. Hand searching of specialized journals and an ancestry search was also conducted. Randomized controlled trials, clinical trials, and observational study designs examining the association between individual characteristics and nurses' use of research were eligible for inclusion. Studies were limited to those published in the English, Danish, Swedish, and Norwegian languages. A vote counting approach to data synthesis was taken. Results A total of 42,770 titles were identified, of which 501 were retrieved. Of these 501 articles, 45 satisfied our inclusion criteria. Articles assessed research utilization in general (n = 39) or kinds of research utilization (n = 6) using self-report survey measures. Individual nurse characteristics were classified according to six categories: beliefs and attitudes, involvement in research activities, information seeking, education, professional characteristics, and socio-demographic/socio-economic characteristics. A seventh category, critical thinking, emerged in studies examining kinds of research utilization. Positive relationships, at statistically significant levels, for general research utilization were found in four categories: beliefs and attitudes, information seeking, education, and professional characteristics. The only characteristic assessed in a sufficient number of studies and with consistent findings for the kinds of research utilization was attitude towards research; this characteristic had a positive association with instrumental and overall research utilization. Conclusions This review reinforced conclusions in the previous review with respect to positive relationships between general research utilization and: beliefs and attitudes, and current role. Furthermore, attending conferences/in-services, having a graduate degree in nursing, working in a specialty area, and job satisfaction were also identified as individual characteristics important to research utilization. While these findings hold promise as potential targets of future research utilization interventions, there were methodological problems inherent in many of the studies that necessitate their findings be replicated in further research using more robust study designs and multivariate assessment methods. PMID:21208425

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

ERIC Educational Resources Information Center

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…

Chaos Modeling: Increasing Educational Researchers' Awareness of a New Tool.

ERIC Educational Resources Information Center

Bobner, Ronald F.; And Others

Chaos theory is being used as a tool to study a wide variety of phenomena. It is a philosophical and empirical approach that attempts to explain relationships previously thought to be totally random. Although some relationships are truly random, many data appear to be random but reveal repeatable patterns of behavior under further investigation.…

Treatment of restless legs syndrome: Evidence-based review and implications for clinical practice (Revised 2017)§.

PubMed

Winkelmann, Juliane; Allen, Richard P; Högl, Birgit; Inoue, Yuichi; Oertel, Wolfgang; Salminen, Aaro V; Winkelman, John W; Trenkwalder, Claudia; Sampaio, Cristina

2018-05-14

The objective of the current review was to update the previous evidence-based medicine review of treatments for restless legs syndrome published in 2008. All randomized, controlled trials (level I) with a high quality score published between January 2007 and January 2017 were reviewed. Forty new studies qualified for efficacy review. Pregabalin, gabapentin enacarbil, and oxycodone/naloxone, which did not appear in the previous review, have accrued data to be considered efficacious. Likewise, new data enable the modification of the level of efficacy for rotigotine from likely efficacious to efficacious. Intravenous ferric carboxymaltose and pneumatic compression devices are considered likely efficacious in idiopathic restless legs syndrome. Bupropion and clonidine were reviewed, but the lack of data determined a rating of insufficient evidence for efficacy. The following interventions continue to be considered efficacious as in 2008: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Bromocriptine, oxycodone, carbamazepine, and valproic acid are considered likely efficacious. Oral iron is nonefficacious in iron-sufficient subjects, but its benefit for patients with low peripheral iron status has not been adequately evaluated. Restless legs syndrome augmentation has been identified as a significant long-term treatment complication for pramipexole more than pregabalin and possibly for all dopaminergic agents more than α2δ ligands. Therefore, special monitoring for augmentation is required for all dopaminergic medications as well as tramadol. Other drugs also require special safety monitoring: cabergoline, pergolide, oxycodone, methadone, tramadol, carbamazepine, and valproic acid. Finally, we also highlighted gaps and needs for future clinical research and studies of restless legs syndrome. © 2018 International Parkinson and Movement Disorder Society. © 2018 International Parkinson and Movement Disorder Society.

Reexamining Sample Size Requirements for Multivariate, Abundance-Based Community Research: When Resources are Limited, the Research Does Not Have to Be.

PubMed

Forcino, Frank L; Leighton, Lindsey R; Twerdy, Pamela; Cahill, James F

2015-01-01

Community ecologists commonly perform multivariate techniques (e.g., ordination, cluster analysis) to assess patterns and gradients of taxonomic variation. A critical requirement for a meaningful statistical analysis is accurate information on the taxa found within an ecological sample. However, oversampling (too many individuals counted per sample) also comes at a cost, particularly for ecological systems in which identification and quantification is substantially more resource consuming than the field expedition itself. In such systems, an increasingly larger sample size will eventually result in diminishing returns in improving any pattern or gradient revealed by the data, but will also lead to continually increasing costs. Here, we examine 396 datasets: 44 previously published and 352 created datasets. Using meta-analytic and simulation-based approaches, the research within the present paper seeks (1) to determine minimal sample sizes required to produce robust multivariate statistical results when conducting abundance-based, community ecology research. Furthermore, we seek (2) to determine the dataset parameters (i.e., evenness, number of taxa, number of samples) that require larger sample sizes, regardless of resource availability. We found that in the 44 previously published and the 220 created datasets with randomly chosen abundances, a conservative estimate of a sample size of 58 produced the same multivariate results as all larger sample sizes. However, this minimal number varies as a function of evenness, where increased evenness resulted in increased minimal sample sizes. Sample sizes as small as 58 individuals are sufficient for a broad range of multivariate abundance-based research. In cases when resource availability is the limiting factor for conducting a project (e.g., small university, time to conduct the research project), statistically viable results can still be obtained with less of an investment.

Mixed Model Association with Family-Biased Case-Control Ascertainment.

PubMed

Hayeck, Tristan J; Loh, Po-Ru; Pollack, Samuela; Gusev, Alexander; Patterson, Nick; Zaitlen, Noah A; Price, Alkes L

2017-01-05

Mixed models have become the tool of choice for genetic association studies; however, standard mixed model methods may be poorly calibrated or underpowered under family sampling bias and/or case-control ascertainment. Previously, we introduced a liability threshold-based mixed model association statistic (LTMLM) to address case-control ascertainment in unrelated samples. Here, we consider family-biased case-control ascertainment, where case and control subjects are ascertained non-randomly with respect to family relatedness. Previous work has shown that this type of ascertainment can severely bias heritability estimates; we show here that it also impacts mixed model association statistics. We introduce a family-based association statistic (LT-Fam) that is robust to this problem. Similar to LTMLM, LT-Fam is computed from posterior mean liabilities (PML) under a liability threshold model; however, LT-Fam uses published narrow-sense heritability estimates to avoid the problem of biased heritability estimation, enabling correct calibration. In simulations with family-biased case-control ascertainment, LT-Fam was correctly calibrated (average χ 2 = 1.00-1.02 for null SNPs), whereas the Armitage trend test (ATT), standard mixed model association (MLM), and case-control retrospective association test (CARAT) were mis-calibrated (e.g., average χ 2 = 0.50-1.22 for MLM, 0.89-2.65 for CARAT). LT-Fam also attained higher power than other methods in some settings. In 1,259 type 2 diabetes-affected case subjects and 5,765 control subjects from the CARe cohort, downsampled to induce family-biased ascertainment, LT-Fam was correctly calibrated whereas ATT, MLM, and CARAT were again mis-calibrated. Our results highlight the importance of modeling family sampling bias in case-control datasets with related samples. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

An Open-Access Modeled Passenger Flow Matrix for the Global Air Network in 2010

PubMed Central

Huang, Zhuojie; Wu, Xiao; Garcia, Andres J.; Fik, Timothy J.; Tatem, Andrew J.

2013-01-01

The expanding global air network provides rapid and wide-reaching connections accelerating both domestic and international travel. To understand human movement patterns on the network and their socioeconomic, environmental and epidemiological implications, information on passenger flow is required. However, comprehensive data on global passenger flow remain difficult and expensive to obtain, prompting researchers to rely on scheduled flight seat capacity data or simple models of flow. This study describes the construction of an open-access modeled passenger flow matrix for all airports with a host city-population of more than 100,000 and within two transfers of air travel from various publicly available air travel datasets. Data on network characteristics, city population, and local area GDP amongst others are utilized as covariates in a spatial interaction framework to predict the air transportation flows between airports. Training datasets based on information from various transportation organizations in the United States, Canada and the European Union were assembled. A log-linear model controlling the random effects on origin, destination and the airport hierarchy was then built to predict passenger flows on the network, and compared to the results produced using previously published models. Validation analyses showed that the model presented here produced improved predictive power and accuracy compared to previously published models, yielding the highest successful prediction rate at the global scale. Based on this model, passenger flows between 1,491 airports on 644,406 unique routes were estimated in the prediction dataset. The airport node characteristics and estimated passenger flows are freely available as part of the Vector-Borne Disease Airline Importation Risk (VBD-Air) project at: www.vbd-air.com/data. PMID:23691194

Making Sense of a Negative Clinical Trial Result: A Bayesian Analysis of a Clinical Trial of Lorazepam and Diazepam for Pediatric Status Epilepticus.

PubMed

Chamberlain, Daniel B; Chamberlain, James M

2017-01-01

We demonstrate the application of a Bayesian approach to a recent negative clinical trial result. A Bayesian analysis of such a trial can provide a more useful interpretation of results and can incorporate previous evidence. This was a secondary analysis of the efficacy and safety results of the Pediatric Seizure Study, a randomized clinical trial of lorazepam versus diazepam for pediatric status epilepticus. We included the published results from the only prospective pediatric study of status in a Bayesian hierarchic model, and we performed sensitivity analyses on the amount of pooling between studies. We evaluated 3 summary analyses for the results: superiority, noninferiority (margin <-10%), and practical equivalence (within ±10%). Consistent with the original study's classic analysis of study results, we did not demonstrate superiority of lorazepam over diazepam. There is a 95% probability that the true efficacy of lorazepam is in the range of 66% to 80%. For both the efficacy and safety outcomes, there was greater than 95% probability that lorazepam is noninferior to diazepam, and there was greater than 90% probability that the 2 medications are practically equivalent. The results were largely driven by the current study because of the sample sizes of our study (n=273) and the previous pediatric study (n=61). Because Bayesian analysis estimates the probability of one or more hypotheses, such an approach can provide more useful information about the meaning of the results of a negative trial outcome. In the case of pediatric status epilepticus, it is highly likely that lorazepam is noninferior and practically equivalent to diazepam. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

An open-access modeled passenger flow matrix for the global air network in 2010.

PubMed

Huang, Zhuojie; Wu, Xiao; Garcia, Andres J; Fik, Timothy J; Tatem, Andrew J

2013-01-01

The expanding global air network provides rapid and wide-reaching connections accelerating both domestic and international travel. To understand human movement patterns on the network and their socioeconomic, environmental and epidemiological implications, information on passenger flow is required. However, comprehensive data on global passenger flow remain difficult and expensive to obtain, prompting researchers to rely on scheduled flight seat capacity data or simple models of flow. This study describes the construction of an open-access modeled passenger flow matrix for all airports with a host city-population of more than 100,000 and within two transfers of air travel from various publicly available air travel datasets. Data on network characteristics, city population, and local area GDP amongst others are utilized as covariates in a spatial interaction framework to predict the air transportation flows between airports. Training datasets based on information from various transportation organizations in the United States, Canada and the European Union were assembled. A log-linear model controlling the random effects on origin, destination and the airport hierarchy was then built to predict passenger flows on the network, and compared to the results produced using previously published models. Validation analyses showed that the model presented here produced improved predictive power and accuracy compared to previously published models, yielding the highest successful prediction rate at the global scale. Based on this model, passenger flows between 1,491 airports on 644,406 unique routes were estimated in the prediction dataset. The airport node characteristics and estimated passenger flows are freely available as part of the Vector-Borne Disease Airline Importation Risk (VBD-Air) project at: www.vbd-air.com/data.

[Psychotherapies for the Treatment of Phantom Limb Pain].

PubMed

Cárdenas, Katherine; Aranda, Mariana

The phantom limb pain has been described as a condition in which patients experience a feeling of itching, spasm or pain in a limb or body part that has been previously amputated. Such pain can be induced by a conflict between the representation of the visual and proprioceptive feedback of the previously healthy limb. The phantom limb pain occurs in at least 42 to 90% of amputees. Regular drug treatment of phantom limb pain is almost never effective. A systematic review of the literature was conducted in Medline and Cochrane using the MESH terms "phantom limb pain" and "psychotherapy", published in the last 10 years, in English and Spanish, finding 49 items. After reviewing the abstracts, 25 articles were excluded for not being related to the objective of the research. Additionally cross references of included articles and literature were reviewed. To describe the psychotherapies used in the management of phantom limb pain, their effectiveness and clinical application reported in the literature. The mechanisms underlying phantom limb pain were initially explained, as were the published studies on the usefulness of some psychotherapies such as mirror visual feedback and immersive virtual reality, visual imagery, desensitization and reprocessing eye movements and hypnosis. The phantom limb pain is a complex syndrome that requires pharmacological and psychotherapeutic intervention. The psychotherapies that have been used the most as adjuvants in the treatment of phantom limb pain are mirror visual feedback, desensitization and reprocessing eye movements, imagery and hypnosis. Studies with more representative samples, specifically randomized trials are required. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

No Causal Association between 25-Hydroxyvitamin D and Features of Skin Aging: Evidence from a Bidirectional Mendelian Randomization Study.

PubMed

Noordam, Raymond; Hamer, Merel A; Pardo, Luba M; van der Nat, Tamara; Kiefte-de Jong, Jessica C; Kayser, Manfred; Slagboom, P Eline; Uitterlinden, André; Zillikens, M Carola; Beekman, Marian; Nijsten, Tamar; van Heemst, Diana; Gunn, David A

2017-11-01

Data from in vitro experiments suggest that vitamin D reduces the rate of skin aging, whereas population studies suggest the opposite, most likely due to confounding by UV exposure. We investigated whether there are causal associations between 25-hydroxyvitamin D concentrations and features of skin aging in a bidirectional Mendelian randomization study. In the Rotterdam Study (N = 3,831; 58.2% women, median age 66.5 years) and Leiden Longevity Study (N = 661; 50.5% women, median age 63.1 years), facial skin aging features (perceived age, wrinkling, pigmented spots) were assessed either manually or digitally. Associations between 25-hydroxyvitamin D and skin aging features were tested by multivariable linear regression. Mendelian randomization analyses were performed using single nucleotide polymorphisms identified from previous genome-wide association studies. After meta-analysis of the two cohorts, we observed that higher serum 25-hydroxyvitamin D was associated with a higher perceived age (P-value = 3.6 × 10 -7 ), more skin wrinkling (P-value = 2.6 × 10 -16 ), but not with more pigmented spots (P-value = 0.30). In contrast, a genetically determined 25-hydroxyvitamin D concentration was not associated with any skin aging feature (P-values > 0.05). Furthermore, a genetically determined higher degree of pigmented spots was not associated with higher 25-hydroxyvitamin D (P-values > 0.05). Our study did not indicate that associations between 25-hydroxyvitamin D and features of skin aging are causal. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

EEG signatures accompanying auditory figure-ground segregation.

PubMed

Tóth, Brigitta; Kocsis, Zsuzsanna; Háden, Gábor P; Szerafin, Ágnes; Shinn-Cunningham, Barbara G; Winkler, István

2016-11-01

In everyday acoustic scenes, figure-ground segregation typically requires one to group together sound elements over both time and frequency. Electroencephalogram was recorded while listeners detected repeating tonal complexes composed of a random set of pure tones within stimuli consisting of randomly varying tonal elements. The repeating pattern was perceived as a figure over the randomly changing background. It was found that detection performance improved both as the number of pure tones making up each repeated complex (figure coherence) increased, and as the number of repeated complexes (duration) increased - i.e., detection was easier when either the spectral or temporal structure of the figure was enhanced. Figure detection was accompanied by the elicitation of the object related negativity (ORN) and the P400 event-related potentials (ERPs), which have been previously shown to be evoked by the presence of two concurrent sounds. Both ERP components had generators within and outside of auditory cortex. The amplitudes of the ORN and the P400 increased with both figure coherence and figure duration. However, only the P400 amplitude correlated with detection performance. These results suggest that 1) the ORN and P400 reflect processes involved in detecting the emergence of a new auditory object in the presence of other concurrent auditory objects; 2) the ORN corresponds to the likelihood of the presence of two or more concurrent sound objects, whereas the P400 reflects the perceptual recognition of the presence of multiple auditory objects and/or preparation for reporting the detection of a target object. Copyright © 2016. Published by Elsevier Inc.

Transition From Peer Review to Peer Learning: Experience in a Radiology Department.

PubMed

Donnelly, Lane F; Dorfman, Scott R; Jones, Jeremy; Bisset, George S

2017-10-18

To describe the process by which a radiology department moved from peer review to peer collaborative improvement (PCI) and review data from the first 16 months of the PCI process. Data from the first 16 months after PCI were reviewed: number of case reviews performed, number of learning opportunities identified, percentage yield of learning opportunities identified, type of learning opportunities identified, and comparison of the previous parameters between case randomly reviewed versus actively pushed (issues actively identified and entered). Changes in actively pushed cases were also assessed as volume per month over the 16 months (run chart). Faculty members were surveyed about their perception of the conversion to PCI. In all, 12,197 cases were peer reviewed, yielding 1,140 learning opportunities (9.34%). The most common types of learning opportunities for all reviewed cases included perception (5.1%) and reporting (1.9%). The yield of learning opportunities from actively pushed cases was 96.3% compared with 3.88% for randomly reviewed cases. The number of actively pushed cases per month increased over the course of the period and established two new confidence intervals. The faculty survey revealed that the faculty perceived the new PCI process as positive, nonpunitive, and focused on improvement. The study demonstrates that a switch to PCI is perceived as nonpunitive and associated with increased radiologist submission of learning opportunities. Active entering of identified learning opportunities had a greater yield and perceived value, compared with random review of cases. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial.

PubMed

von Piekartz, Harry; Hall, Toby

2013-08-01

There is evidence that temporomandibular disorder (TMD) may be a contributing factor to cervicogenic headache (CGH), in part because of the influence of dysfunction of the temporomandibular joint on the cervical spine. The purpose of this randomized controlled trial was to determine whether orofacial treatment in addition to cervical manual therapy, was more effective than cervical manual therapy alone on measures of cervical movement impairment in patients with features of CGH and signs of TMD. In this study, 43 patients (27 women) with headache for more than 3-months and with some features of CGH and signs of TMD were randomly assigned to receive either cervical manual therapy (usual care) or orofacial manual therapy to address TMD in addition to usual care. Subjects were assessed at baseline, after 6 treatment sessions (3-months), and at 6-months follow-up. 38 subjects (25 female) completed all analysis at 6-months follow-up. The outcome criteria were: cervical range of movement (including the C1-2 flexion-rotation test) and manual examination of the upper 3 cervical vertebra. The group that received orofacial treatment in addition to usual care showed significant reduction in all aspects of cervical impairment after the treatment period. These improvements persisted to the 6-month follow-up, but were not observed in the usual care group at any point. These observations together with previous reports indicate that manual therapists should look for features of TMD when examining patients with headache, particularly if treatment fails when directed to the cervical spine. Copyright © 2013. Published by Elsevier Ltd.

Comparison of two contraceptive pills containing drospirenone and 20 μg or 30 μg ethinyl estradiol for polycystic ovary syndrome.

PubMed

Bhattacharya, Sudhindra M; Jha, Ayan; DasMukhopadhyay, Lipika

2016-02-01

To compare the effects of 30 μg and 20 μg ethinyl estradiol (EE) among women with polycystic ovary syndrome (PCOS). In a randomized study, patients with PCOS, a history of six or fewer menstrual cycles in the previous 12 months, and abnormal body hair growth were enrolled at a center in Kolkata, India, between May 1, 2012, and January 31, 2014. Participants were randomly assigned (1:1) using a computer-generated randomization table to receive an oral contraceptive pill containing 3mg drospirenone and either 30 μg EE or 20 μg EE. Patients were followed up after 6 and 12 months. The primary outcome was the absolute change in the free androgen index. Participants were masked to group assignment but investigators were not. Analyses were by intention to treat. Overall, 112 patients were enrolled. At 6 months, the free androgen index had decreased by 4.96±6.01 among patients receiving 30 μg (n=55) and by 4.81±6.03 among those receiving 20 μg (n=57; P=0.89). At 12 months, the decrease from baseline was 5.23±5.79 with 30 μg and 4.99±5.86 with 20 μg (P=0.82). Among patients with PCOS, an oral contraceptive pill containing 20 μg EE has similar effects on androgen levels to those of a pill containing 30 μg. CTRI/2012/04/002571. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Early low-dose erythropoiesis-stimulating agent therapy and progression of moderate chronic kidney disease: a randomized, placebo-controlled trial.

PubMed

Fliser, Danilo; Dellanna, Frank; Koch, Michael; Wiggenhauser, Alfons

2017-02-01

It is unknown whether early intervention with low-dose erythropoiesis-stimulating agents (ESAs) in non-anaemic patients delays progression of chronic kidney disease (CKD). In a single-blind, 24-month trial, adults with estimated glomerular filtration rate (eGFR) 30–59 mL/min/1.73 m2 and either Type 2 diabetes mellitus or previous kidney transplantation were randomized to low-dose continuous erythropoiesis receptor activator (CERA; monthly dose 30–75 µg; n = 115) or placebo (n = 120). The primary endpoint was the annual change in eGFR (abbreviated Modification of Diet in Renal Disease formula). Mean (standard deviation) eGFR was 40.7 (9.8) mL/min/1.73 m2 versus 39.8 (9.2) mL/min/1.73 m2 at baseline for CERA and placebo, respectively, and 39.0 (11.6) g/dL versus 39.7 (10.6) g/dL at the final visit. The median (interquartile range) annual reduction in eGFR was 0.5 (−2.2, 3.8) mL/min/1.73 m2 with CERA versus 0.4 (−2.0, 3.2) mL/min/1.73 m2 with placebo (P = 0.657). No significant difference in the annual change in eGFR was observed between treatment groups in the subpopulations with Type 2 diabetes or kidney transplant. Adverse events with a suspected relation to study drug occurred in 22.0% and 16.2% of patients randomized to CERA or placebo, respectively, and adverse events led to study drug discontinuation in 11.0% and 8.5% of patients. Patients with moderate CKD and Type 2 diabetes or previous kidney transplantation showed stable renal function that was unaffected by administration of low-dose ESA. In addition, there was no clinically meaningful effect of 2-year low-dose ESA treatment on albuminuria, an important surrogate marker of kidney injury. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Effects of sodium intake and diet on racial differences in urinary potassium excretion: results from the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial.

PubMed

Turban, Sharon; Thompson, Carol B; Parekh, Rulan S; Appel, Lawrence J

2013-01-01

We previously showed that African Americans excreted less urinary potassium than whites, even while consuming similar diets in the Dietary Approaches to Stop Hypertension (DASH) trial. We hypothesized that a low-sodium diet may eliminate these differences. Data from the DASH-Sodium randomized controlled feeding trial were analyzed. 412 adults with prehypertension or stage 1 hypertension. Random assignment to either a typical American "control" diet (1.7 g [43 mEq] potassium/2,100 kcal/d) or the DASH diet (4.1 g [105 mEq] potassium/2,100 kcal/d). Within each diet, participants received 3 levels of sodium intake in random order for 30 days. 24-hour urine samples were analyzed at the end of each period. The primary outcome was urinary potassium excretion. On the DASH diet, African Americans consistently excreted significantly less urinary potassium (mean 24-hour urinary potassium excretion, 2,594 ± 961 mg [66 ± 25 mEq]) than whites (3,412 ± 1,016 mg [87 ± 26 mEq]) at the highest sodium level; adjusted (P < 0.001); this difference was not altered by sodium level (P = 0.6 comparing white to African American difference in urinary potassium excretion on high- vs low-sodium diet). In contrast, there was a smaller but significant white-African American difference in mean daily urinary potassium excretion in participants fed the control/high-sodium diet that was not present in the control/low-sodium diet (adjusted differences of 281 mg [7 mEq]/d vs 20 mg [0.5 mEq]/d, respectively; P = 0.007). Significant interactions were found between race and diet (P < 0.001) and between race and sodium (P = 0.02). Single rather than multiple urine collections were available at each time. Lack of stool potassium and sweat potassium values. Racial differences in urinary potassium excretion depend on sodium intake and diet. Our results may help explain the previously documented large variability in urinary potassium excretion. Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Externalities and article citations: experience of a national public health journal (Gaceta Sanitaria).

PubMed

Ruano-Ravina, Alberto; Álvarez-Dardet, Carlos; Domínguez-Berjón, M Felicitas; Fernández, Esteve; García, Ana M; Borrell, Carme

2016-01-01

The purpose of the study was to analyze the determinants of citations such as publication year, article type, article topic, article selected for a press release, number of articles previously published by the corresponding author, and publication language in a Spanish journal of public health. Observational study including all articles published in Gaceta Sanitaria during 2007-2011. We retrieved the number of citations from the ISI Web of Knowledge database in June 2013 and also information on other variables such as number of articles published by the corresponding author in the previous 5 years (searched through PubMed), selection for a press release, publication language, article type and topic, and others. We included 542 articles. Of these, 62.5% were cited in the period considered. We observed an increased odds ratio of citations for articles selected for a press release and also with the number of articles published previously by the corresponding author. Articles published in English do not seem to increase their citations. Certain externalities such as number of articles published by the corresponding author and being selected for a press release seem to influence the number of citations in national journals. Copyright © 2016 Elsevier Inc. All rights reserved.

Study Design Rigor in Animal-Experimental Research Published in Anesthesia Journals.

PubMed

Hoerauf, Janine M; Moss, Angela F; Fernandez-Bustamante, Ana; Bartels, Karsten

2018-01-01

Lack of reproducibility of preclinical studies has been identified as an impediment for translation of basic mechanistic research into effective clinical therapies. Indeed, the National Institutes of Health has revised its grant application process to require more rigorous study design, including sample size calculations, blinding procedures, and randomization steps. We hypothesized that the reporting of such metrics of study design rigor has increased over time for animal-experimental research published in anesthesia journals. PubMed was searched for animal-experimental studies published in 2005, 2010, and 2015 in primarily English-language anesthesia journals. A total of 1466 publications were graded on the performance of sample size estimation, randomization, and blinding. Cochran-Armitage test was used to assess linear trends over time for the primary outcome of whether or not a metric was reported. Interrater agreement for each of the 3 metrics (power, randomization, and blinding) was assessed using the weighted κ coefficient in a 10% random sample of articles rerated by a second investigator blinded to the ratings of the first investigator. A total of 1466 manuscripts were analyzed. Reporting for all 3 metrics of experimental design rigor increased over time (2005 to 2010 to 2015): for power analysis, from 5% (27/516), to 12% (59/485), to 17% (77/465); for randomization, from 41% (213/516), to 50% (243/485), to 54% (253/465); and for blinding, from 26% (135/516), to 38% (186/485), to 47% (217/465). The weighted κ coefficients and 98.3% confidence interval indicate almost perfect agreement between the 2 raters beyond that which occurs by chance alone (power, 0.93 [0.85, 1.0], randomization, 0.91 [0.85, 0.98], and blinding, 0.90 [0.84, 0.96]). Our hypothesis that reported metrics of rigor in animal-experimental studies in anesthesia journals have increased during the past decade was confirmed. More consistent reporting, or explicit justification for absence, of sample size calculations, blinding techniques, and randomization procedures could better enable readers to evaluate potential sources of bias in animal-experimental research manuscripts. Future studies should assess whether such steps lead to improved translation of animal-experimental anesthesia research into successful clinical trials.

Do we need primer for orthodontic bonding? A randomized controlled trial.

PubMed

Nandhra, Sarabjit Singh; Littlewood, Simon J; Houghton, Nadine; Luther, Friedy; Prabhu, Jagadish; Munyombwe, Theresa; Wood, Simon R

2015-04-01

To evaluate the clinical performance of APC™II Victory Series™ (3M Unitek) brackets in direct orthodontic bonding with and without the use of primer. A single-operator, two-centre prospective, non-inferiority randomized controlled clinical trial. The Orthodontic departments at the Leeds Dental Institute and St Luke's Hospital, Bradford, UK. Ethical approval was granted by Leeds (East) Research Ethics Committee on 18th of December 2009 (Reference 09/H1306/102). The protocol was not published prior to trial commencement. Ninety-two patients requiring orthodontic treatment with fixed appliances were randomly allocated to the control (bonded with primer) or test groups (bonded without primer). Patients were randomly allocated to either the control or experimental group. This was performed by preparing opaque numbered sealed envelopes in advance using a random numbers table generated by a computer by an independent third party . Once the envelopes were opened, blinding of the operator and the patient was no longer possible due to the nature of the intervention. Patients were approached for inclusion in the trial if they qualified for NHS orthodontic treatment requiring fixed appliances and had no previous orthodontic treatment. Number of bracket failures, time to bond-up appliances, and the adhesive remnant index (ARI) when bracket failure occurred, over a 12-month period Failure rate with primer was 11.1 per cent and without primer was 15.8 per cent. Bonding without primer was shown statistically to be non-inferior to bonding with primer odds ratio 0.95-2.25 (P = 0.08). Mean difference in bond-up time per bracket was 0.068 minutes (4 seconds), which was not statistically significant (P = 0.402). There was a statistically significant difference in the Adhesive Remnant Index - ARI 0 with primer 49.4 per cent, no primer 76.5 per cent, (P < 0.0001). As the study was only performed by one operator, the results can therefore only be truly be applied to their practice. Also this study was powered to ascertain if there was no difference between the 2 groups up to 5%, however orthodontists may consider a change in the bracket failure rate of 2% to be clinically significant. When bonding with APC™II Victory Series™ brackets without primer was shown statistically to be non-inferior to bonding with primer (P =0.08). There was no significant difference in bond-up times. Bond failure was more likely to happen at the composite-enamel interface when bonded without a primer. No conflict of interest for all authors. No funding sources were used. Study was not registered on external databases. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal.

PubMed

Mehrazmay, Alireza; Karambakhsh, Alireza; Salesi, Mahmood

2015-07-01

Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality. The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale. Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014. This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs.

Assessment of Chiropractic Treatment for Low Back Pain, Military Readiness and Smoking Cessation in Military Active Duty Personnel

DTIC Science & Technology

reporting period the study: Published primary results manuscript (in print), drafted secondary outcomes manuscripts. ACT 2 is a randomized controlled trial...of response and reaction times in Special Operations Forces at Ft. Campbell, KY. The study is complete and sites are closed. We published the

Search protocols for hidden forensic objects beneath floors and within walls.

PubMed

Ruffell, Alastair; Pringle, Jamie K; Forbes, Shari

2014-04-01

The burial of objects (human remains, explosives, weapons) below or behind concrete, brick, plaster or tiling may be associated with serious crime and are difficult locations to search. These are quite common forensic search scenarios but little has been published on them to-date. Most documented discoveries are accidental or from suspect/witness testimony. The problem in locating such hidden objects means a random or chance-based approach is not advisable. A preliminary strategy is presented here, based on previous studies, augmented by primary research where new technology or applications are required. This blend allows a rudimentary search workflow, from remote desktop study, to non-destructive investigation through to recommendations as to how the above may inform excavation, demonstrated here with a case study from a homicide investigation. Published case studies on the search for human remains demonstrate the problems encountered when trying to find and recover sealed-in and sealed-over locations. Established methods include desktop study, photography, geophysics and search dogs: these are integrated with new technology (LiDAR and laser scanning; photographic rectification; close-quarter aerial imagery; ground-penetrating radar on walls and gamma-ray/neutron activation radiography) to propose this possible search strategy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Effects of music therapy and music-based interventions in the treatment of substance use disorders: A systematic review

PubMed Central

Hohmann, Louisa; Bradt, Joke; Stegemann, Thomas; Koelsch, Stefan

2017-01-01

Music therapy (MT) and music-based interventions (MBIs) are increasingly used for the treatment of substance use disorders (SUD). Previous reviews on the efficacy of MT emphasized the dearth of research evidence for this topic, although various positive effects were identified. Therefore, we conducted a systematic search on published articles examining effects of music, MT and MBIs and found 34 quantitative and six qualitative studies. There was a clear increase in the number of randomized controlled trials (RCTs) during the past few years. We had planned for a meta-analysis, but due to the diversity of the quantitative studies, effect sizes were not computed. Beneficial effects of MT/ MBI on emotional and motivational outcomes, participation, locus of control, and perceived helpfulness were reported, but results were inconsistent across studies. Furthermore, many RCTs focused on effects of single sessions. No published longitudinal trials could be found. The analysis of the qualitative studies revealed four themes: emotional expression, group interaction, development of skills, and improvement of quality of life. Considering these issues for quantitative research, there is a need to examine social and health variables in future studies. In conclusion, due to the heterogeneity of the studies, the efficacy of MT/ MBI in SUD treatment still remains unclear. PMID:29141012

Novel formulation of the ℳ model through the Generalized-K distribution for atmospheric optical channels.

PubMed

Garrido-Balsells, José María; Jurado-Navas, Antonio; Paris, José Francisco; Castillo-Vazquez, Miguel; Puerta-Notario, Antonio

2015-03-09

In this paper, a novel and deeper physical interpretation on the recently published Málaga or ℳ statistical distribution is provided. This distribution, which is having a wide acceptance by the scientific community, models the optical irradiance scintillation induced by the atmospheric turbulence. Here, the analytical expressions previously published are modified in order to express them by a mixture of the known Generalized-K and discrete Binomial and Negative Binomial distributions. In particular, the probability density function (pdf) of the ℳ model is now obtained as a linear combination of these Generalized-K pdf, in which the coefficients depend directly on the parameters of the ℳ distribution. In this way, the Málaga model can be physically interpreted as a superposition of different optical sub-channels each of them described by the corresponding Generalized-K fading model and weighted by the ℳ dependent coefficients. The expressions here proposed are simpler than the equations of the original ℳ model and are validated by means of numerical simulations by generating ℳ -distributed random sequences and their associated histogram. This novel interpretation of the Málaga statistical distribution provides a valuable tool for analyzing the performance of atmospheric optical channels for every turbulence condition.

Knowledge diffusion in the collaboration hypernetwork

NASA Astrophysics Data System (ADS)

Yang, Guang-Yong; Hu, Zhao-Long; Liu, Jian-Guo

2015-02-01

As knowledge constitutes a primary productive force, it is important to understand the performance of knowledge diffusion. In this paper, we present a knowledge diffusion model based on the local-world non-uniform hypernetwork, which introduces the preferential diffusion mechanism and the knowledge absorptive capability αj, where αj is correlated with the hyperdegree dH(j) of node j. At each time step, we randomly select a node i as the sender; a receiver node is selected from the set of nodes that the sender i has published with previously, with probability proportional to the number of papers they have published together. Applying the average knowledge stock V bar(t) , the variance σ2(t) and the variance coefficient c(t) of knowledge stock to measure the growth and diffusion of knowledge and the adequacy of knowledge diffusion, we have made 3 groups of comparative experiments to investigate how different network structures, hypernetwork sizes and knowledge evolution mechanisms affect the knowledge diffusion, respectively. As the diffusion mechanisms based on the hypernetwork combine with the hyperdegree of node, the hypernetwork is more suitable for investigating the performance of knowledge diffusion. Therefore, the proposed model could be helpful for deeply understanding the process of the knowledge diffusion in the collaboration hypernetwork.

Genome editing of bread wheat using biolistic delivery of CRISPR/Cas9 in vitro transcripts or ribonucleoproteins.

PubMed

Liang, Zhen; Chen, Kunling; Zhang, Yi; Liu, Jinxing; Yin, Kangquan; Qiu, Jin-Long; Gao, Caixia

2018-03-01

This protocol is an extension to: Nat. Protoc. 9, 2395-2410 (2014); doi:10.1038/nprot.2014.157; published online 18 September 2014In recent years, CRISPR/Cas9 has emerged as a powerful tool for improving crop traits. Conventional plant genome editing mainly relies on plasmid-carrying cassettes delivered by Agrobacterium or particle bombardment. Here, we describe DNA-free editing of bread wheat by delivering in vitro transcripts (IVTs) or ribonucleoprotein complexes (RNPs) of CRISPR/Cas9 by particle bombardment. This protocol serves as an extension of our previously published protocol on genome editing in bread wheat using CRISPR/Cas9 plasmids delivered by particle bombardment. The methods we describe not only eliminate random integration of CRISPR/Cas9 into genomic DNA, but also reduce off-target effects. In this protocol extension article, we present detailed protocols for preparation of IVTs and RNPs; validation by PCR/restriction enzyme (RE) and next-generation sequencing; delivery by biolistics; and recovery of mutants and identification of mutants by pooling methods and Sanger sequencing. To use these protocols, researchers should have basic skills and experience in molecular biology and biolistic transformation. By using these protocols, plants edited without the use of any foreign DNA can be generated and identified within 9-11 weeks.

World Health Organization Guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer.

PubMed

Santesso, Nancy; Mustafa, Reem A; Schünemann, Holger J; Arbyn, Marc; Blumenthal, Paul D; Cain, Joanna; Chirenje, Michael; Denny, Lynette; De Vuyst, Hugo; Eckert, Linda O'Neal; Forhan, Sara E; Franco, Eduardo L; Gage, Julia C; Garcia, Francisco; Herrero, Rolando; Jeronimo, José; Lu, Enriquito R; Luciani, Silvana; Quek, Swee Chong; Sankaranarayanan, Rengaswamy; Tsu, Vivien; Broutet, Nathalie

2016-03-01

It is estimated that 1%-2% of women develop cervical intraepithelial neoplasia grade 2-3 (CIN 2-3) annually worldwide. The prevalence among women living with HIV is higher, at 10%. If left untreated, CIN 2-3 can progress to cervical cancer. WHO has previously published guidelines for strategies to screen and treat precancerous cervical lesions and for treatment of histologically confirmed CIN 2-3. Guidelines were developed using the WHO Handbook for Guideline Development and the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. A multidisciplinary guideline panel was created. Systematic reviews of randomized controlled trials and observational studies were conducted. Evidence tables and Evidence to Recommendations Tables were prepared and presented to the panel. There are nine recommendations for screen-and-treat strategies to prevent cervical cancer, including the HPV test, cytology, and visual inspection with acetic acid. There are seven for treatment of CIN with cryotherapy, loop electrosurgical excision procedure, and cold knife conization. Recommendations have been produced on the basis of the best available evidence. However, high-quality evidence was not available. Such evidence is needed, in particular for screen-and-treat strategies that are relevant to low- and middle-income countries. Copyright © 2015. Published by Elsevier Ireland Ltd.

A CO-FISH assay to assess sister chromatid segregation patterns in mitosis of mouse embryonic stem cells.

PubMed

Sauer, Stephan; Burkett, Sandra S; Lewandoski, Mark; Klar, Amar J S

2013-05-01

Sister chromatids contain identical DNA sequence but are chiral with respect to both their helical handedness and their replication history. Emerging evidence from various model organisms suggests that certain stem cells segregate sister chromatids nonrandomly to either maintain genome integrity or to bias cellular differentiation in asymmetric cell divisions. Conventional methods for tracing of old vs. newly synthesized DNA strands generally lack resolution for individual chromosomes and employ halogenated thymidine analogs with profound cytotoxic effects on rapidly dividing cells. Here, we present a modified chromosome orientation fluorescence in situ hybridization (CO-FISH) assay, where identification of individual chromosomes and their replication history is achieved in subsequent hybridization steps with chromosome-specific DNA probes and PNA telomere probes. Importantly, we tackle the issue of BrdU cytotoxicity and show that our method is compatible with normal mouse ES cell biology, unlike a recently published related protocol. Results from our CO-FISH assay show that mitotic segregation of mouse chromosome 7 is random in ES cells, which contrasts previously published results from our laboratory and settles a controversy. Our straightforward protocol represents a useful resource for future studies on chromatid segregation patterns of in vitro-cultured cells from distinct model organisms.

Positive concomitant test reactions to allergens in the standard patch test series.

PubMed

Landeck, Lilla; González, Ernesto; Baden, Lynn; Neumann, Konrad; Schalock, Peter

2010-05-01

Patch testing is performed to evaluate suspected allergic contact dermatitis. Common wisdom suggests that various allergens cross-react but only a few larger studies have published confirmations of this. The purpose of our study was to identify significant correlations between positive test reactions in a screening series. A total of 1235 patients undergoing patch testing to the Hermal standard series at the Massachusetts General Hospital, Contact Dermatitis Clinic between 1990 and 2006 were investigated. Two or more positive reactions were seen in 411 patients (33.3%). Sensitizations to eight pairs of allergens were found to have significant correlation (P

TOC: Table of Contents Practices of Primary Journals--Recommendations for Monolingual, Multilingual and International Journals.

ERIC Educational Resources Information Center

Juhasz, Stephen; And Others

Table of contents (TOC) practices of some 120 primary journals were analyzed. The journals were randomly selected. The method of randomization is described. The samples were selected from a university library with a holding of approximately 12,000 titles published worldwide. A questionnaire was designed. Purpose was to find uniformity and…

A Multisite Cluster Randomized Field Trial of Open Court Reading

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

2008-01-01

In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73).

PubMed

Ramsden, Christopher E; Zamora, Daisy; Majchrzak-Hong, Sharon; Faurot, Keturah R; Broste, Steven K; Frantz, Robert P; Davis, John M; Ringel, Amit; Suchindran, Chirayath M; Hibbeln, Joseph R

2016-04-12

To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic review and meta-analysis. The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol. Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators. Further, a systematic review and meta-analyses of randomized controlled trials that lowered serum cholesterol by providing vegetable oil rich in linoleic acid in place of saturated fat without confounding by concomitant interventions was conducted. One nursing home and six state mental hospitals in Minnesota, United States. Unpublished documents with completed analyses for the randomized cohort of 9423 women and men aged 20-97; longitudinal data on serum cholesterol for the 2355 participants exposed to the study diets for a year or more; 149 completed autopsy files. Serum cholesterol lowering diet that replaced saturated fat with linoleic acid (from corn oil and corn oil polyunsaturated margarine). Control diet was high in saturated fat from animal fats, common margarines, and shortenings. Death from all causes; association between changes in serum cholesterol and death; and coronary atherosclerosis and myocardial infarcts detected at autopsy. The intervention group had significant reduction in serum cholesterol compared with controls (mean change from baseline -13.8%v-1.0%; P<0.001). Kaplan Meier graphs showed no mortality benefit for the intervention group in the full randomized cohort or for any prespecified subgroup. There was a 22% higher risk of death for each 30 mg/dL (0.78 mmol/L) reduction in serum cholesterol in covariate adjusted Cox regression models (hazard ratio 1.22, 95% confidence interval 1.14 to 1.32; P<0.001). There was no evidence of benefit in the intervention group for coronary atherosclerosis or myocardial infarcts. Systematic review identified five randomized controlled trials for inclusion (n=10,808). In meta-analyses, these cholesterol lowering interventions showed no evidence of benefit on mortality from coronary heart disease (1.13, 0.83 to 1.54) or all cause mortality (1.07, 0.90 to 1.27). Available evidence from randomized controlled trials shows that replacement of saturated fat in the diet with linoleic acid effectively lowers serum cholesterol but does not support the hypothesis that this translates to a lower risk of death from coronary heart disease or all causes. Findings from the Minnesota Coronary Experiment add to growing evidence that incomplete publication has contributed to overestimation of the benefits of replacing saturated fat with vegetable oils rich in linoleic acid. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Impact of Guided Notes on Post-Secondary Student Achievement: A Meta-Analysis

ERIC Educational Resources Information Center

Larwin, Karen H.; Larwin, David A.

2013-01-01

The common practice of using of guided notes in the post-secondary classroom is not fully appreciated or understood. In an effort to add to the existing research about this phenomenon, the current investigation expands on previously published research and one previously published meta-analysis that examined the impact of guided notes on…

Random drift versus selection in academic vocabulary: an evolutionary analysis of published keywords.

PubMed

Bentley, R Alexander

2008-08-27

The evolution of vocabulary in academic publishing is characterized via keyword frequencies recorded in the ISI Web of Science citations database. In four distinct case-studies, evolutionary analysis of keyword frequency change through time is compared to a model of random copying used as the null hypothesis, such that selection may be identified against it. The case studies from the physical sciences indicate greater selection in keyword choice than in the social sciences. Similar evolutionary analyses can be applied to a wide range of phenomena; wherever the popularity of multiple items through time has been recorded, as with web searches, or sales of popular music and books, for example.

Random Drift versus Selection in Academic Vocabulary: An Evolutionary Analysis of Published Keywords

PubMed Central

Bentley, R. Alexander

2008-01-01

The evolution of vocabulary in academic publishing is characterized via keyword frequencies recorded in the ISI Web of Science citations database. In four distinct case-studies, evolutionary analysis of keyword frequency change through time is compared to a model of random copying used as the null hypothesis, such that selection may be identified against it. The case studies from the physical sciences indicate greater selection in keyword choice than in the social sciences. Similar evolutionary analyses can be applied to a wide range of phenomena; wherever the popularity of multiple items through time has been recorded, as with web searches, or sales of popular music and books, for example. PMID:18728786

Twenty years of meta-analyses in orthopaedic surgery: has quality kept up with quantity?

PubMed

Dijkman, Bernadette G; Abouali, Jihad A K; Kooistra, Bauke W; Conter, Henry J; Poolman, Rudolf W; Kulkarni, Abhaya V; Tornetta, Paul; Bhandari, Mohit

2010-01-01

As the number of studies in the literature is increasing, orthopaedic surgeons highly depend on meta-analyses as their primary source of scientific evidence. The objectives of this review were to assess the scientific quality and number of published meta-analyses on orthopaedics-related topics over time. We conducted, in duplicate and independently, a systematic review of published meta-analyses in orthopaedics in the years 2005 and 2008 and compared them with a previous systematic review of meta-analyses from 1969 to 1999. A search of electronic databases (MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews) was performed to identify meta-analyses published in 2005 and 2008. We searched bibliographies and contacted content experts to identify additional relevant studies. Two investigators independently assessed the quality of the studies, using the Oxman and Guyatt index, and abstracted relevant data. We included forty-five and forty-four meta-analyses from 2005 and 2008, respectively. While the number of meta-analyses increased fivefold from 1999 to 2008, the mean quality score did not change significantly over time (p = 0.067). In the later years, a significantly lower proportion of meta-analyses had methodological flaws (56% in 2005 and 68% in 2008) compared with meta-analyses published prior to 2000 (88%) (p = 0.006). In 2005 and 2008, respectively, 18% and 30% of the meta-analyses had major to extensive flaws in their methodology. Studies from 2008 with positive conclusions used and described appropriate criteria for the validity assessment less often than did those with negative results. The use of random-effects and fixed-effects models as pooling methods became more popular toward 2008. Although the methodological quality of orthopaedic meta-analyses has increased in the past twenty years, a substantial proportion continues to show major to extensive flaws. As the number of published meta-analyses is increasing, a routine checklist for scientific quality should be used in the peer-review process to ensure methodological standards for publication.

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

PubMed

Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

Enzyme replacement and substrate reduction therapy for Gaucher disease.

PubMed

Shemesh, Elad; Deroma, Laura; Bembi, Bruno; Deegan, Patrick; Hollak, Carla; Weinreb, Neal J; Cox, Timothy M

2015-03-27

Gaucher disease, a rare disorder, is caused by inherited deficiency of the enzyme glucocerebrosidase. It is unique among the ultra-orphan disorders in that four treatments are currently approved by various regulatory authorities for use in routine clinical practice. Hitherto, because of the relatively few people affected worldwide, many of whom started therapy during a prolonged period when there were essentially no alternatives to imiglucerase, these treatments have not been systematically evaluated in studies such as randomized controlled trials now considered necessary to generate the highest level of clinical evidence. To summarize all available randomized controlled study data on the efficacy and safety of enzyme replacement therapies and substrate reduction therapy for treating Gaucher disease. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register. Additional searches were conducted on ClinicalTrials.gov for any ongoing studies with potential interim results, and through PubMed. We also searched the reference lists of relevant articles and reviews.Date of last search: 07 August 2014. All randomized and quasi-randomized controlled studies (including open-label studies and cross-over studies) assessing enzyme replacement therapy or substrate reduction therapy, or both, in all types of Gaucher disease were included. Two authors independently assessed the risk of bias in the included studies, and extracted relevant data. Of the 488 studies retrieved by the electronic searches, eight met the inclusion criteria and were analysed (300 participants). Response parameters were restricted to haemoglobin concentration, platelet count, spleen and liver volume and serum biomarkers (chitotriosidase and CCL18). Only one publication reported a 'low risk of bias' score in all parameters assessed, and all studies included were randomized.Four studies reported the responses to enzyme replacement therapy of previously untreated individuals with type 1 Gaucher disease. Two studies investigated maintenance enzyme replacement therapy in people with stable type 1 Gaucher disease previously treated for at least two years. One study compared substrate reduction therapy, enzyme replacement therapy and a combination thereof as maintenance therapy in people with type 1 Gaucher disease previously treated with enzyme replacement therapy. One study examined substrate reduction therapy in people with chronic neuronopathic (type 3) Gaucher disease who continued to receive enzyme replacement therapy.Treatment-naïve participants had similar increases in haemoglobin when comparing those receiving imiglucerase or alglucerase at 60 units/kg, imiglucerase or velaglucerase alfa at 60 U/kg, taliglucerase alfa at 30 units/kg or 60 units/kg, and velaglucerase alfa at 45 units/g or 60 units/kg. For platelet count response in participants with intact spleens, a benefit for imiglucerase over velaglucerase alfa at 60 units/kg was observed, mean difference -79.87 (95% confidence interval -137.57 to -22.17). There were no other significant differences in platelet count response when comparing different doses of velaglucerase alfa and of taliglucerase alfa, and when comparing imiglucerase to alglucerase. Spleen and liver volume reductions were not significantly different in any enzyme replacement therapy product or dose comparison study. Although a dose effect on serum biomarkers was not seen after nine months, a significantly greater reduction with higher dose was reported after 12 months in the velaglucerase study, mean difference 16.70 (95% confidence intervaI 1.51 to 31.89). In the two enzyme replacement therapy maintenance studies comparing infusions every two weeks and every four weeks, there were no significant differences in haemoglobin concentration, platelet count, and spleen and liver volumes over a 6 to 12 month period when participants were treated with the same cumulative dose.A total of 25 serious adverse events were reported, nearly all deemed unrelated to treatment.There are, as yet, no randomized trials of substrate reduction therapy in treatment-naïve patients that can be evaluated. Miglustat monotherapy appeared as effective as continued enzyme replacement therapy for maintenance of hematological, organ and biomarker responses in people with type 1 Gaucher disease previously treated with imiglucerase for at least two years. In those with neuronopathic Gaucher disease, no significant improvements in haemoglobin concentration, platelet count or organ volumes occurred when enzyme replacement therapy was augmented with miglustat.One randomized controlled study assessing substrate reduction therapy was published immediately prior to producing the final version of this review, and this, along with a further ongoing study (expected to be published in the near future), will be assessed for eligibility in a future update of the review. The results reflect the limitations of analysing evidence restricted to prospective randomized controlled trials, especially when dealing with chronic rare diseases. This analysis suggests that, during the first year of treatment, different recombinant glucocerebrosidases are bio-similar and non-inferior in safety and efficacy for surrogate biological response parameters. Enzyme replacement therapy given at 30 to 45 units/kg body weight every two to four weeks was generally as effective as the 60 unit/kg dose for the assessed clinical outcomes. The analysis emphasise the need to determine whether it is realistic to carry out multi-decade prospective clinical trials for rare diseases such as type 1 Gaucher disease. With large treatment effects on the classical manifestations of the disorder, therapeutic investigations in Gaucher disease mandate innovative trial designs and methodology to secure decisive data concerning long-term efficacy and safety - with the realization that knowledge about disease-modifying actions that are sustained are of crucial importance to people with this chronic condition.

8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information

PubMed Central

Zhang, Rujun; Persaud, Navindra

2017-01-01

Objectives We report information about an unpublished 1970s study (“8-way” Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Design Double blinded, multi-centred, randomized placebo-controlled study. Setting 14 clinics in the United States. Participants 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Interventions Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Outcomes Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Results Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were “evaluated moderate or excellent” was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. Conclusion The available information about this “8-way Bendectin” trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. Trial registration Not registered. PMID:28052111

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma.

PubMed

Al-Batran, S-E; Van Cutsem, E; Oh, S C; Bodoky, G; Shimada, Y; Hironaka, S; Sugimoto, N; Lipatov, O N; Kim, T-Y; Cunningham, D; Rougier, P; Muro, K; Liepa, A M; Chandrawansa, K; Emig, M; Ohtsu, A; Wilke, H

2016-04-01

The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. NCT01170663. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Oxidation Mechanisms of Toluene and Benzene

NASA Technical Reports Server (NTRS)

Bittker, David A.

1995-01-01

An expanded and improved version of a previously published benzene oxidation mechanism is presented and shown to model published experimental data fairly successfully. This benzene submodel is coupled to a modified version of a toluene oxidation submodel from the recent literature. This complete mechanism is shown to successfully model published experimental toluene oxidation data for a highly mixed flow reactor and for higher temperature ignition delay times in a shock tube. A comprehensive sensitivity analysis showing the most important reactions is presented for both the benzene and toluene reacting systems. The NASA Lewis toluene mechanism's modeling capability is found to be equivalent to that of the previously published mechanism which contains a somewhat different benzene submodel.

Validating internet research: a test of the psychometric equivalence of internet and in-person samples.

PubMed

Meyerson, Paul; Tryon, Warren W

2003-11-01

This study evaluated the psychometric equivalency of Web-based research. The Sexual Boredom Scale was presented via the World-Wide Web along with five additional scales used to validate it. A subset of 533 participants that matched a previously published sample (Watt & Ewing, 1996) on age, gender, and race was identified. An 8 x 8 correlation matrix from the matched Internet sample was compared via structural equation modeling with a similar 8 x 8 correlation matrix from the previously published study. The Internet and previously published samples were psychometrically equivalent. Coefficient alpha values calculated on the matched Internet sample yielded reliability coefficients almost identical to those for the previously published sample. Factors such as computer administration and uncontrollable administration settings did not appear to affect the results. Demographic data indicated an overrepresentation of males by about 6% and Caucasians by about 13% relative to the U.S. Census (2000). A total of 2,230 participants were obtained in about 8 months without remuneration. These results suggest that data collection on the Web is (1) reliable, (2) valid, (3) reasonably representative, (4) cost effective, and (5) efficient.

WORD FREQUENCY IN THE MODERN GERMAN SHORT STORY. FINAL REPORT.

ERIC Educational Resources Information Center

SCHERER, GEORGE A.; AND OTHERS

A LIST OF THE MOST FREQUENTLY USED WORDS IN MODERN GERMAN SHORT STORIES WAS COMPILED. AN ANTHOLOGY OF 702 RECENTLY PUBLISHED, GERMAN SHORT STORIES WAS OBTAINED AND USED FOR A WORD COUNT, INVOLVING THE RANDOM SELECTION OF 4 WORDS IN EVERY 100-WORD PASSAGE. TWO INDEPENDENT RANDOM SAMPLES OF ABOUT 80,000 WORDS EACH WERE DRAWN FROM NEARLY 2 MILLION…

Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study.

PubMed

Long, G V; Flaherty, K T; Stroyakovskiy, D; Gogas, H; Levchenko, E; de Braud, F; Larkin, J; Garbe, C; Jouary, T; Hauschild, A; Chiarion-Sileni, V; Lebbe, C; Mandalà, M; Millward, M; Arance, A; Bondarenko, I; Haanen, J B A G; Hansson, J; Utikal, J; Ferraresi, V; Mohr, P; Probachai, V; Schadendorf, D; Nathan, P; Robert, C; Ribas, A; Davies, M A; Lane, S R; Legos, J J; Mookerjee, B; Grob, J-J

2017-07-01

Previous analysis of COMBI-d (NCT01584648) demonstrated improved progression-free survival (PFS) and overall survival (OS) with combination dabrafenib and trametinib versus dabrafenib monotherapy in BRAF V600E/K-mutant metastatic melanoma. This study was continued to assess 3-year landmark efficacy and safety after ≥36-month follow-up for all living patients. This double-blind, phase 3 study enrolled previously untreated patients with BRAF V600E/K-mutant unresectable stage IIIC or stage IV melanoma. Patients were randomized to receive dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or dabrafenib plus placebo. The primary endpoint was PFS; secondary endpoints were OS, overall response, duration of response, safety, and pharmacokinetics. Between 4 May and 30 November 2012, a total of 423 of 947 screened patients were randomly assigned to receive dabrafenib plus trametinib (n = 211) or dabrafenib monotherapy (n = 212). At data cut-off (15 February 2016), outcomes remained superior with the combination: 3-year PFS was 22% with dabrafenib plus trametinib versus 12% with monotherapy, and 3-year OS was 44% versus 32%, respectively. Twenty-five patients receiving monotherapy crossed over to combination therapy, with continued follow-up under the monotherapy arm (per intent-to-treat principle). Of combination-arm patients alive at 3 years, 58% remained on dabrafenib plus trametinib. Three-year OS with the combination reached 62% in the most favourable subgroup (normal lactate dehydrogenase and <3 organ sites with metastasis) versus only 25% in the unfavourable subgroup (elevated lactate dehydrogenase). The dabrafenib plus trametinib safety profile was consistent with previous clinical trial observations, and no new safety signals were detected with long-term use. These data demonstrate that durable (≥3 years) survival is achievable with dabrafenib plus trametinib in patients with BRAF V600-mutant metastatic melanoma and support long-term first-line use of the combination in this setting. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Surgical Treatment of Extraesophageal Manifestations of Gastroesophageal Reflux Disease.

PubMed

Sidwa, Feroze; Moore, Alessandra L; Alligood, Elaine; Fisichella, P Marco

2017-10-01

To review the current literature on the role of antireflux surgery (ARS) for the treatment of extraesophageal manifestations of GERD. The extraesophageal manifestations of gastroesophageal reflux disease (GERD) include chronic cough, laryngopharyngeal reflux, and asthma. They are responsible for significant morbidity in affected patients and a high economic burden on healthcare resources. We recently published a larger review on the symptoms, diagnosis, medical, and surgical treatment of the extraesophageal manifestations of GERD. Through our investigation, we found that the role of ARS for respiratory symptoms was unclear. Hence, we resorted through the data of our previous meta-analysis to compile a comprehensive and focused review on the role of ARS for respiratory symptoms. Using the archive of our previous meta-analysis, we selected studies extracted from the MEDLINE, Cochran, PubMed, Google Scholar, and Embase databases pertaining to the surgical treatment of extraesophageal manifestations of reflux (cough laryngopharyngeal reflux, and asthma). We applied a similar reporting methodology as was used in our previous manuscript and then hand searched the bibliographies of included studies yielding a total of 27 articles for review. We graded the level of evidence and classified recommendations by size of treatment effect per the American Heart Association Task Force on Practice Guidelines. Observational data indicated that syndromes of chronic cough, laryngopharyngeal reflux and asthma might improve after antireflux surgery only in highly selected patients-likely those with non-acid reflux-while those patients with objective markers of asthma severity do not. Because of the varied methods of diagnosis and surgical technique, non-comparative observational data may be unreliable. Additionally, our search found no randomized controlled trials (RCTs) comparing antireflux surgery to medical therapy in the treatment of cough or laryngopharyngeal reflux. One RCT compared medical treatment to antireflux surgery in patients with asthma, but medical treatment included high-dose H 2 blockers instead of PPIs. Extraesophageal manifestations of GERD are common, costly, and difficult to treat. ARS might be effective in highly selected patients, especially in those whose extraesophageal manifestations are caused by non-acid reflux. The available data to date are generally of poor quality or outdated. Well-designed randomized controlled trials or large-scale observational cohort studies are urgently needed.

Third-order elastic constants of diamond determined from experimental data

DOE PAGES

Winey, J. M.; Hmiel, A.; Gupta, Y. M.

2016-06-01

The pressure derivatives of the second-order elastic constants (SOECs) of diamond were determined by analyzing previous sound velocity measurements under hydrostatic stress [McSkimin and Andreatch, J. Appl. Phys. 43, 294 (1972)]. Furthermore, our analysis corrects an error in the previously reported results.We present a complete and corrected set of third-order elastic constants (TOECs) using the corrected pressure derivatives, together with published data for the nonlinear elastic response of shock compressed diamond [Lang and Gupta, Phys. Rev. Lett. 106, 125502 (2011)] and it differs significantly from TOECs published previously.

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Parent Stress in a Randomized Clinical Trial of Atomoxetine and Parent Training for Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Lecavalier, Luc; Pan, Xueliang; Smith, Tristram; Handen, Benjamin L.; Arnold, L. Eugene; Silverman, Laura; Tumuluru, Rameshwari V.; Hollway, Jill; Aman, Michael G.

2018-01-01

We previously reported a 2 × 2 randomized clinical trial of atomoxetine (ATX) and parent training (PT) for attention deficit hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 children with autism spectrum disorder, ages 5-14 years. Children were randomized to one of four conditions: ATX alone, placebo alone, ATX + PT, or…

Vitamin C with metabolites: additional analysis suggests favorable changes in oxalate.

PubMed

Moyad, Mark A; Combs, Maile A; Baisley, Joshua E; Evans, Malkanthi

2009-01-01

A previously published randomized trial found a significant difference in the proportion of individuals experiencing oxalate reduction with a vitamin C with metabolites product compared with ascorbic acid (vitamin C). This represented a notable finding, which argued against the possibility of a chance finding due to the design and consistency of results. However, these researchers believed it was necessary to further analyze this study to continue to garner more insight on the strength or weakness of original findings. All favorable, neutral, and non-favorable changes of 24-hour oxalate from the previous clinical trial were grouped. Oxalate was considered to "decrease" or "increase" with each intervention only if a 10% or larger change occurred in the 24-hour oxalate baseline value when taking one product compared to another. A greater proportion of subjects taking both products at different time periods experienced favorable oxalate changes with vitamin C with metabolites product compared to ascorbic acid. If this reflects the true clinical scenario, this would represent an important clinical finding on a population level because at least 20% more individuals would experience a more favorable change. Regardless, this further analysis continues to suggest that the original observations were valid and could have positive clinical implications for some patients.

Progressing MoodSwings. The upgrade and evaluation of MoodSwings 2.0: An online intervention for bipolar disorder.

PubMed

Lauder, S; Cosgrove, V E; Gliddon, E; Grimm, D; Dodd, S; Berk, L; Castle, D; Suppes, T S; Berk, M

2017-05-01

MoodSwings 2.0 is a self-guided online intervention for bipolar disorder. The intervention incorporates technological improvements on an earlier validated version of the intervention (MoodSwings 1.0). The previous MoodSwings trial provides this study with a unique opportunity to progress previous work, whilst being able to take into consideration lesson learnt, and technological enhancements. The structure and technology of MoodSwings 2.0 are described and the relevance to other online health interventions is highlighted. An international team from Australia and the US updated and improved the programs content pursuant to changes in DSM-5, added multimedia components and included larger numbers of participants in the group discussion boards. Greater methodological rigour in this trial includes an attention control condition, quarterly telephone assessments, and red flag alerts for significant clinical change. This paper outlines these improvements, including additional security and safety measures. A 3 arm RCT is currently evaluating the enhanced program to assess the efficacy of MS 2.0; the primary outcome is change in depressive and manic symptoms. To our knowledge this is the first randomized controlled online bipolar study with a discussion board attention control and meets the key methodological criteria for online interventions. Copyright © 2017. Published by Elsevier Inc.

Effects of resistance training on performance in previously trained endurance runners: A systematic review.

PubMed

Alcaraz-Ibañez, Manuel; Rodríguez-Pérez, Manuel

2018-03-01

The aim of this work was to identify, synthesize and evaluate the results of randomized controlled trials examining the effects of resistance training on performance indicators in previously trained endurance runners. A database search was carried out in PubMed, Science Direct, OvidSPMedLine, Wiley, Web of Science, ProQuest and Google Scholar. In accordance with the PRISMA checklist, 18 published articles dated prior to May 2016 involving 321 endurance runners were reviewed using the PEDro scale. Resistance training led to general improvements in muscular strength, running economy, muscle power factors, and direct performance in distances between 1,500 and 10,000 m. Such improvements were not accompanied by a significant increase in body mass or signs of overtraining. However, improvements did not occur in all cases, suggesting that they might depend on the specific characteristics of the resistance training applied. Although current evidence supports the effectiveness of resistance training to improve performance in already trained endurance runners, the methodological inconsistencies identified suggest that the results should be interpreted with caution. Future studies ought to investigate the benefits of resistance training in endurance runners while considering the existence of possible differentiated effects based on the specific characteristics of the resistance training carried out.

Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers.

PubMed

Rasmussen, Scott; Horkan, Kathleen Halabuk; Kotler, Mitchell

2018-02-02

Smoking continues to be a major preventable cause of early mortality worldwide, and nicotine replacement therapy has been demonstrated to increase rates of abstinence among smokers attempting to quit. Nicotine transdermal systems (also known as nicotine patches) attach to the skin via an adhesive layer composed of a mixture of different-molecular-weight polyisobutylenes (PIBs) in a specific ratio. This randomized, single-dose, 2-treatment, crossover pharmacokinetic (PK) trial assessed the bioequivalence of nicotine patches including a replacement PIB adhesive (test) compared with the PIB adhesive historically used on marketed patches (reference). The test and reference patches were bioequivalent, as determined by the PK parameters of C max and AUC 0-t . In addition, the parameters T max and t 1/2 did not significantly differ between the 2 patches, supporting the bioequivalence finding from the primary analysis. The tolerability profiles of the patches containing the replacement and previously used PIB adhesives were similar; application-site adverse events did not significantly differ between test and reference patches. Overall, these data establish the bioequivalence of the nicotine patch with the replacement PIB adhesive formulation and the previously utilized PIB adhesive formulation. © 2018 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

Network meta-analyses could be improved by searching more sources and by involving a librarian.

PubMed

Li, Lun; Tian, Jinhui; Tian, Hongliang; Moher, David; Liang, Fuxiang; Jiang, Tongxiao; Yao, Liang; Yang, Kehu

2014-09-01

Network meta-analyses (NMAs) aim to rank the benefits (or harms) of interventions, based on all available randomized controlled trials. Thus, the identification of relevant data is critical. We assessed the conduct of the literature searches in NMAs. Published NMAs were retrieved by searching electronic bibliographic databases and other sources. Two independent reviewers selected studies and five trained reviewers abstracted data regarding literature searches, in duplicate. Search method details were examined using descriptive statistics. Two hundred forty-nine NMAs were included. Eight used previous systematic reviews to identify primary studies without further searching, and five did not report any literature searches. In the 236 studies that used electronic databases to identify primary studies, the median number of databases was 3 (interquartile range: 3-5). MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were the most commonly used databases. The most common supplemental search methods included reference lists of included studies (48%), reference lists of previous systematic reviews (40%), and clinical trial registries (32%). None of these supplemental methods was conducted in more than 50% of the NMAs. Literature searches in NMAs could be improved by searching more sources, and by involving a librarian or information specialist. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles.

PubMed

Dain, Lena; Ojha, Kamal; Bider, David; Levron, Jacob; Zinchenko, Viktor; Walster, Sharon; Dirnfeld, Martha

2014-10-01

To evaluate the effect of local endometrial injury (LEI) on clinical outcomes in ovum donation recipients. Retrospective cohort analysis of ovum donation cycles conducted from 2005 to 2012. Two private IVF centers. Total 737 ovum donation cycles. LEI by endometrial "scratch" with the use of a Pipelle catheter. Clinical pregnancy and live birth rates. No statistically significant differences were found in clinical pregnancy rates and live birth rates in cycles subjected to LEI compared with those without. Combination of LEI with fibroid uterus resulted with significantly higher clinical pregnancy rates compared with LEI in normal uterine anatomy. This is the first study done in ovum recipients who underwent LEI by a "scratch" procedure after failed implantation. Unlike most previous reports, which found improved pregnancy rates with the use of "scratch effect" or "minor endometrial injury" after repeated implantation failures in standard IVF with own eggs, we did not find any changes in implantation rates in a population of egg recipients following this procedure. In view of a possible positive effect of LEI in cycles with a previous four or more failures, prospective randomized controlled studies are warranted to better define the target population who may benefit from this intervention. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effects of advanced life support versus basic life support on the mortality rates of patients with trauma in prehospital settings: a study protocol for a systematic review and meta-analysis

PubMed Central

Kondo, Yutaka; Fukuda, Tatsuma; Uchimido, Ryo; Hifumi, Toru; Hayashida, Kei

2017-01-01

Introduction Advanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature. Methods and analysis We will perform searches in PubMed, Embase and the Cochrane Central Register of Controlled Trials for published observational studies, controlled before-and-after studies, randomised controlled trials and other controlled trials conducted in humans and published until March 2017. We will screen search results, assess study selection, extract data and assess the risk of bias in duplicate; disagreements will be resolved through discussions. Data from clinically homogeneous studies will be pooled using a random-effects meta-analysis, heterogeneity of effects will be assessed using the χ2 test of homogeneity, and any observed heterogeneity will be quantified using the I2 statistic. Last, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to rate the quality of the evidence. Ethics and dissemination Our study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information. Trial registration number PROSPERO (International Prospective Register of Systematic Reviews) registration number CRD42017054389. PMID:29061611

Publication rate of abstracts presented at the 2010 Canadian Ophthalmological Society Annual Meeting.

PubMed

Basilious, Alfred; Benavides Vargas, Ana Maria; Buys, Yvonne M

2017-08-01

To evaluate the publication rate of submitted abstracts accepted for presentation at the 2010 Canadian Ophthalmological Society (COS) Annual Meeting in peer-reviewed journals. A retrospective analysis and literature search of abstracts presented at the 2010 COS Annual Meeting. Abstracts accepted as an oral presentation or poster from the 2010 COS Annual Meeting were tabulated by type of presentation (oral vs poster), subspecialty, study design, number of authors, and principal investigator's institution. A PubMed search was conducted for each abstract by key word, first author, and last author. The year of publication, journal, and impact factor were recorded for identified publications. Publication rate was calculated by type of presentation, subspecialty, study design, number of authors, and institution. A total of 175 abstracts were presented at the 2010 COS Annual Meeting. There were 105 oral (60%) and 70 poster (40%) presentations. The overall publication rate was 45.7%; 49.5% for oral presentations and 40.0% for posters. Cornea (57.6%) and public health (54.5%) had the highest publication rates of all subspecialties. Randomized control trials (71.4%) and cohort studies (70.0%) had higher publication rates than other study designs. Overall, 28.8% of abstracts were published in the Canadian Journal of Ophthalmology. The average impact factor of all publications was 2.73. Of abstracts presented at the 2010 COS Annual Meeting, 45.7% were published within 5 years after the conference. This publication rate is within the upper end of previously reported meeting publication rates for medical societies. Copyright © 2017 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Meta-assessment of bias in science

PubMed Central

Fanelli, Daniele; Costas, Rodrigo; Ioannidis, John P. A.

2017-01-01

Numerous biases are believed to affect the scientific literature, but their actual prevalence across disciplines is unknown. To gain a comprehensive picture of the potential imprint of bias in science, we probed for the most commonly postulated bias-related patterns and risk factors, in a large random sample of meta-analyses taken from all disciplines. The magnitude of these biases varied widely across fields and was overall relatively small. However, we consistently observed a significant risk of small, early, and highly cited studies to overestimate effects and of studies not published in peer-reviewed journals to underestimate them. We also found at least partial confirmation of previous evidence suggesting that US studies and early studies might report more extreme effects, although these effects were smaller and more heterogeneously distributed across meta-analyses and disciplines. Authors publishing at high rates and receiving many citations were, overall, not at greater risk of bias. However, effect sizes were likely to be overestimated by early-career researchers, those working in small or long-distance collaborations, and those responsible for scientific misconduct, supporting hypotheses that connect bias to situational factors, lack of mutual control, and individual integrity. Some of these patterns and risk factors might have modestly increased in intensity over time, particularly in the social sciences. Our findings suggest that, besides one being routinely cautious that published small, highly-cited, and earlier studies may yield inflated results, the feasibility and costs of interventions to attenuate biases in the literature might need to be discussed on a discipline-specific and topic-specific basis. PMID:28320937

An empirical examination of WISE/NEOWISE asteroid analysis and results

NASA Astrophysics Data System (ADS)

Myhrvold, Nathan

2017-10-01

Observations made by the WISE space telescope and subsequent analysis by the NEOWISE project represent the largest corpus of asteroid data to date, describing the diameter, albedo, and other properties of the ~164,000 asteroids in the collection. I present a critical reanalysis of the WISE observational data, and NEOWISE results published in numerous papers and in the JPL Planetary Data System (PDS). This analysis reveals shortcomings and a lack of clarity, both in the original analysis and in the presentation of results. The procedures used to generate NEOWISE results fall short of established thermal modelling standards. Rather than using a uniform protocol, 10 modelling methods were applied to 12 combinations of WISE band data. Over half the NEOWISE results are based on a single band of data. Most NEOWISE curve fits are poor quality, frequently missing many or all the data points. About 30% of the single-band results miss all the data; 43% of the results derived from the most common multiple-band combinations miss all the data in at least one band. The NEOWISE data processing procedures rely on inconsistent assumptions, and introduce bias by systematically discarding much of the original data. I show that error estimates for the WISE observational data have a true uncertainty factor of ~1.2 to 1.9 times larger than previously described, and that the error estimates do not fit a normal distribution. These issues call into question the validity of the NEOWISE Monte-Carlo error analysis. Comparing published NEOWISE diameters to published estimates using radar, occultation, or spacecraft measurements (ROS) reveals 150 for which the NEOWISE diameters were copied exactly from the ROS source. My findings show that the accuracy of diameter estimates for NEOWISE results depend heavily on the choice of data bands and model. Systematic errors in the diameter estimates are much larger than previously described. Systematic errors for diameters in the PDS range from -3% to +27%. Random errors range from -14% to +19% when using all four WISE bands, and from -45% to +74% in cases using only the W2 band. The results presented here show that much work remains to be done towards understanding asteroid data from WISE/NEOWISE.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

PubMed

Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

2013-10-01

Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

Ensemble Bayesian forecasting system Part I: Theory and algorithms

NASA Astrophysics Data System (ADS)

Herr, Henry D.; Krzysztofowicz, Roman

2015-05-01

The ensemble Bayesian forecasting system (EBFS), whose theory was published in 2001, is developed for the purpose of quantifying the total uncertainty about a discrete-time, continuous-state, non-stationary stochastic process such as a time series of stages, discharges, or volumes at a river gauge. The EBFS is built of three components: an input ensemble forecaster (IEF), which simulates the uncertainty associated with random inputs; a deterministic hydrologic model (of any complexity), which simulates physical processes within a river basin; and a hydrologic uncertainty processor (HUP), which simulates the hydrologic uncertainty (an aggregate of all uncertainties except input). It works as a Monte Carlo simulator: an ensemble of time series of inputs (e.g., precipitation amounts) generated by the IEF is transformed deterministically through a hydrologic model into an ensemble of time series of outputs, which is next transformed stochastically by the HUP into an ensemble of time series of predictands (e.g., river stages). Previous research indicated that in order to attain an acceptable sampling error, the ensemble size must be on the order of hundreds (for probabilistic river stage forecasts and probabilistic flood forecasts) or even thousands (for probabilistic stage transition forecasts). The computing time needed to run the hydrologic model this many times renders the straightforward simulations operationally infeasible. This motivates the development of the ensemble Bayesian forecasting system with randomization (EBFSR), which takes full advantage of the analytic meta-Gaussian HUP and generates multiple ensemble members after each run of the hydrologic model; this auxiliary randomization reduces the required size of the meteorological input ensemble and makes it operationally feasible to generate a Bayesian ensemble forecast of large size. Such a forecast quantifies the total uncertainty, is well calibrated against the prior (climatic) distribution of predictand, possesses a Bayesian coherence property, constitutes a random sample of the predictand, and has an acceptable sampling error-which makes it suitable for rational decision making under uncertainty.

The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis.

PubMed

Aksamit, Timothy; Bandel, Tiemo-Joerg; Criollo, Margarita; De Soyza, Anthony; Elborn, J Stuart; Operschall, Elisabeth; Polverino, Eva; Roth, Katrin; Winthrop, Kevin L; Wilson, Robert

2017-07-01

The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis (NCFB) are to reduce the number of exacerbations, and improve quality of life. However, currently no therapies are licensed for this. Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients. The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design. Adult patients with idiopathic or post-infectious NCFB, a history of ≥2 exacerbations in the previous 12months, and positive sputum culture for one of seven pre-specified pathogens, undergo stratified randomization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5mg or placebo using a pocket-sized inhaler in one of two regimens: 28days on/off treatment or 14days on/off treatment. The treatment period is 48weeks plus an 8-week follow-up after the last dose. The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation. Secondary endpoints, including frequency of events using different exacerbation definitions, microbiology, quality of life and lung function will also be evaluated. The RESPIRE trials will determine the efficacy and safety of Ciprofloxacin DPI. The strict entry criteria and stratified randomization, the inclusion of two treatment regimens and a stringent definition of exacerbation should clarify the patient population best positioned to benefit from long-term inhaled antibiotic therapy. Additionally RESPIRE will increase understanding of NCFB treatment and could lead to an important new therapy for sufferers. The RESPIRE trials are registered in ClinicalTrials.gov, ID number NCT01764841 (RESPIRE 1; date of registration January 8, 2013) and NCT02106832 (RESPIRE 2; date of registration April 4, 2014). Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Twenty-four month results from a randomized trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

PubMed

Gibson, Kathleen; Morrison, Nick; Kolluri, Raghu; Vasquez, Michael; Weiss, Robert; Cher, Daniel; Madsen, Monte; Jones, Andrew

2018-06-15

We previously reported 3-month and 12-month occlusion rates after treatment of clinically symptomatic saphenous vein reflux with either cyanoacrylate closure (CAC) using the VenaSeal Closure System (Medtronic, Dublin, Ireland) or radiofrequency ablation (RFA) in a randomized, multicenter, clinical trial, VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). Herein we report the 24-month follow-up results of the VeClose trial. There were 222 patients with symptomatic great saphenous vein (GSV) incompetence who were randomly assigned to receive either CAC (n = 108) or RFA (n = 114). Patients were not allowed to receive adjunctive treatment of tributary varicosities until after the 3-month visit. Duplex ultrasound of the target vein was performed at day 3 and months 1, 3, 6, 12, and 24 after treatment, and closure was assessed by ultrasound by the treating physician. Overall 24-month success rates were compared; in addition, time to first reopening of the target vein was evaluated using survival analysis. End points such as Venous Clinical Severity Score, EuroQoL-5 Dimension, and Aberdeen Varicose Vein Questionnaire were evaluated. Of 222 randomized patients, 171 completed the 24-month follow-up, which included 87 from the CAC group and 84 from the RFA group. The 24-month complete closure rate was 95.3% in the CAC group and 94.0% in the RFA group, demonstrating continued noninferiority of CAC compared with RFA (P = .0034). Symptoms and quality of life improved similarly in both groups. No clinically significant device- or procedure-related late adverse events occurred. Both CAC and RFA were effective in closure of the target GSV, resulting in similar and significant improvements in the patient's quality of life through 24 months. These results suggest that CAC of the GSV is safe and durable out to 2 years. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Accurate Diabetes Risk Stratification Using Machine Learning: Role of Missing Value and Outliers.

PubMed

Maniruzzaman, Md; Rahman, Md Jahanur; Al-MehediHasan, Md; Suri, Harman S; Abedin, Md Menhazul; El-Baz, Ayman; Suri, Jasjit S

2018-04-10

Diabetes mellitus is a group of metabolic diseases in which blood sugar levels are too high. About 8.8% of the world was diabetic in 2017. It is projected that this will reach nearly 10% by 2045. The major challenge is that when machine learning-based classifiers are applied to such data sets for risk stratification, leads to lower performance. Thus, our objective is to develop an optimized and robust machine learning (ML) system under the assumption that missing values or outliers if replaced by a median configuration will yield higher risk stratification accuracy. This ML-based risk stratification is designed, optimized and evaluated, where: (i) the features are extracted and optimized from the six feature selection techniques (random forest, logistic regression, mutual information, principal component analysis, analysis of variance, and Fisher discriminant ratio) and combined with ten different types of classifiers (linear discriminant analysis, quadratic discriminant analysis, naïve Bayes, Gaussian process classification, support vector machine, artificial neural network, Adaboost, logistic regression, decision tree, and random forest) under the hypothesis that both missing values and outliers when replaced by computed medians will improve the risk stratification accuracy. Pima Indian diabetic dataset (768 patients: 268 diabetic and 500 controls) was used. Our results demonstrate that on replacing the missing values and outliers by group median and median values, respectively and further using the combination of random forest feature selection and random forest classification technique yields an accuracy, sensitivity, specificity, positive predictive value, negative predictive value and area under the curve as: 92.26%, 95.96%, 79.72%, 91.14%, 91.20%, and 0.93, respectively. This is an improvement of 10% over previously developed techniques published in literature. The system was validated for its stability and reliability. RF-based model showed the best performance when outliers are replaced by median values.

Using published data in Mendelian randomization: a blueprint for efficient identification of causal risk factors.

PubMed

Burgess, Stephen; Scott, Robert A; Timpson, Nicholas J; Davey Smith, George; Thompson, Simon G

2015-07-01

Finding individual-level data for adequately-powered Mendelian randomization analyses may be problematic. As publicly-available summarized data on genetic associations with disease outcomes from large consortia are becoming more abundant, use of published data is an attractive analysis strategy for obtaining precise estimates of the causal effects of risk factors on outcomes. We detail the necessary steps for conducting Mendelian randomization investigations using published data, and present novel statistical methods for combining data on the associations of multiple (correlated or uncorrelated) genetic variants with the risk factor and outcome into a single causal effect estimate. A two-sample analysis strategy may be employed, in which evidence on the gene-risk factor and gene-outcome associations are taken from different data sources. These approaches allow the efficient identification of risk factors that are suitable targets for clinical intervention from published data, although the ability to assess the assumptions necessary for causal inference is diminished. Methods and guidance are illustrated using the example of the causal effect of serum calcium levels on fasting glucose concentrations. The estimated causal effect of a 1 standard deviation (0.13 mmol/L) increase in calcium levels on fasting glucose (mM) using a single lead variant from the CASR gene region is 0.044 (95 % credible interval -0.002, 0.100). In contrast, using our method to account for the correlation between variants, the corresponding estimate using 17 genetic variants is 0.022 (95 % credible interval 0.009, 0.035), a more clearly positive causal effect.

Precise algorithm to generate random sequential adsorption of hard polygons at saturation

NASA Astrophysics Data System (ADS)

Zhang, G.

2018-04-01

Random sequential adsorption (RSA) is a time-dependent packing process, in which particles of certain shapes are randomly and sequentially placed into an empty space without overlap. In the infinite-time limit, the density approaches a "saturation" limit. Although this limit has attracted particular research interest, the majority of past studies could only probe this limit by extrapolation. We have previously found an algorithm to reach this limit using finite computational time for spherical particles and could thus determine the saturation density of spheres with high accuracy. In this paper, we generalize this algorithm to generate saturated RSA packings of two-dimensional polygons. We also calculate the saturation density for regular polygons of three to ten sides and obtain results that are consistent with previous, extrapolation-based studies.

Precise algorithm to generate random sequential adsorption of hard polygons at saturation.

PubMed

Zhang, G

2018-04-01

Random sequential adsorption (RSA) is a time-dependent packing process, in which particles of certain shapes are randomly and sequentially placed into an empty space without overlap. In the infinite-time limit, the density approaches a "saturation" limit. Although this limit has attracted particular research interest, the majority of past studies could only probe this limit by extrapolation. We have previously found an algorithm to reach this limit using finite computational time for spherical particles and could thus determine the saturation density of spheres with high accuracy. In this paper, we generalize this algorithm to generate saturated RSA packings of two-dimensional polygons. We also calculate the saturation density for regular polygons of three to ten sides and obtain results that are consistent with previous, extrapolation-based studies.

Correlation, evaluation, and extension of linearized theories for tire motion and wheel shimmy

NASA Technical Reports Server (NTRS)

Smiley, Robert F

1957-01-01

An evaluation is made of the existing theories of a linearized tire motion and wheel shimmy. It is demonstrated that most of the previously published theories represent varying degrees of approximation to a summary theory developed in this report which is a minor modification of the basic theory of Von Schlippe and Dietrich. In most cases where strong differences exist between the previously published theories and summary theory, the previously published theories are shown to possess certain deficiencies. A series of systematic approximations to the summary theory is developed for the treatment of problems too simple to merit the use of the complete summary theory, and procedures are discussed for applying the summary theory and its systematic approximations to the shimmy of more complex landing-gear structures than have previously been considered. Comparisons of the existing experimental data with the predictions of the summary theory and the systematic approximations provide a fair substantiation of the more detailed approximate theories.

A Descriptive Analysis of Oral Health Systematic Reviews Published 1991–2012: Cross Sectional Study

PubMed Central

Saltaji, Humam; Cummings, Greta G.; Armijo-Olivo, Susan; Major, Michael P.; Amin, Maryam; Major, Paul W.; Hartling, Lisa; Flores-Mir, Carlos

2013-01-01

Objectives To identify all systematic reviews (SRs) published in the domain of oral health research and describe them in terms of their epidemiological and descriptive characteristics. Design Cross sectional, descriptive study. Methods An electronic search of seven databases was performed from inception through May 2012; bibliographies of relevant publications were also reviewed. Studies were considered for inclusion if they were oral health SRs defined as therapeutic or non-therapeutic investigations that studied a topic or an intervention related to dental, oral or craniofacial diseases/disorders. Data were extracted from all the SRs based on a number of epidemiological and descriptive characteristics. Data were analysed descriptively for all the SRs, within each of the nine dental specialities, and for Cochrane and non-Cochrane SRs separately. Results 1,188 oral health (126 Cochrane and 1062 non-Cochrane) SRs published from 1991 through May 2012 were identified, encompassing the nine dental specialties. Over half (n = 676; 56.9%) of the SRs were published in specialty oral health journals, with almost all (n = 1,178; 99.2%) of the SRs published in English and almost none of the non-Cochrane SRs (n = 11; 0.9%) consisting of updates of previously published SRs. 75.3% of the SRs were categorized as therapeutic, with 64.5% examining non-drug interventions, while approximately half (n = 150/294; 51%) of the non-therapeutic SRs were classified as epidemiological SRs. The SRs included a median of 15 studies, with a meta-analysis conducted in 43.6%, in which a median of 9 studies/1 randomized trial were included in the largest meta-analysis conducted. Funding was received for 25.1% of the SRs, including nearly three-quarters (n = 96; 76.2%) of the Cochrane SRs. Conclusion Epidemiological and descriptive characteristics of the 1,188 oral health SRs varied across the nine dental specialties and by SR category (Cochrane vs. non-Cochrane). There is a clear need for more updates of SRs in all the dental specialties. PMID:24098657

Towards an accurate real-time locator of infrasonic sources

NASA Astrophysics Data System (ADS)

Pinsky, V.; Blom, P.; Polozov, A.; Marcillo, O.; Arrowsmith, S.; Hofstetter, A.

2017-11-01

Infrasonic signals propagate from an atmospheric source via media with stochastic and fast space-varying conditions. Hence, their travel time, the amplitude at sensor recordings and even manifestation in the so-called "shadow zones" are random. Therefore, the traditional least-squares technique for locating infrasonic sources is often not effective, and the problem for the best solution must be formulated in probabilistic terms. Recently, a series of papers has been published about Bayesian Infrasonic Source Localization (BISL) method based on the computation of the posterior probability density function (PPDF) of the source location, as a convolution of a priori probability distribution function (APDF) of the propagation model parameters with likelihood function (LF) of observations. The present study is devoted to the further development of BISL for higher accuracy and stability of the source location results and decreasing of computational load. We critically analyse previous algorithms and propose several new ones. First of all, we describe the general PPDF formulation and demonstrate that this relatively slow algorithm might be among the most accurate algorithms, provided the adequate APDF and LF are used. Then, we suggest using summation instead of integration in a general PPDF calculation for increased robustness, but this leads us to the 3D space-time optimization problem. Two different forms of APDF approximation are considered and applied for the PPDF calculation in our study. One of them is previously suggested, but not yet properly used is the so-called "celerity-range histograms" (CRHs). Another is the outcome from previous findings of linear mean travel time for the four first infrasonic phases in the overlapping consecutive distance ranges. This stochastic model is extended here to the regional distance of 1000 km, and the APDF introduced is the probabilistic form of the junction between this travel time model and range-dependent probability distributions of the phase arrival time picks. To illustrate the improvements in both computation time and location accuracy achieved, we compare location results for the new algorithms, previously published BISL-type algorithms and the least-squares location technique. This comparison is provided via a case study of different typical spatial data distributions and statistical experiment using the database of 36 ground-truth explosions from the Utah Test and Training Range (UTTR) recorded during the US summer season at USArray transportable seismic stations when they were near the site between 2006 and 2008.

A prediction model for early death in non-small cell lung cancer patients following curative-intent chemoradiotherapy.

PubMed

Jochems, Arthur; El-Naqa, Issam; Kessler, Marc; Mayo, Charles S; Jolly, Shruti; Matuszak, Martha; Faivre-Finn, Corinne; Price, Gareth; Holloway, Lois; Vinod, Shalini; Field, Matthew; Barakat, Mohamed Samir; Thwaites, David; de Ruysscher, Dirk; Dekker, Andre; Lambin, Philippe

2018-02-01

Early death after a treatment can be seen as a therapeutic failure. Accurate prediction of patients at risk for early mortality is crucial to avoid unnecessary harm and reducing costs. The goal of our work is two-fold: first, to evaluate the performance of a previously published model for early death in our cohorts. Second, to develop a prognostic model for early death prediction following radiotherapy. Patients with NSCLC treated with chemoradiotherapy or radiotherapy alone were included in this study. Four different cohorts from different countries were available for this work (N = 1540). The previous model used age, gender, performance status, tumor stage, income deprivation, no previous treatment given (yes/no) and body mass index to make predictions. A random forest model was developed by learning on the Maastro cohort (N = 698). The new model used performance status, age, gender, T and N stage, total tumor volume (cc), total tumor dose (Gy) and chemotherapy timing (none, sequential, concurrent) to make predictions. Death within 4 months of receiving the first radiotherapy fraction was used as the outcome. Early death rates ranged from 6 to 11% within the four cohorts. The previous model performed with AUC values ranging from 0.54 to 0.64 on the validation cohorts. Our newly developed model had improved AUC values ranging from 0.62 to 0.71 on the validation cohorts. Using advanced machine learning methods and informative variables, prognostic models for early mortality can be developed. Development of accurate prognostic tools for early mortality is important to inform patients about treatment options and optimize care.

Diabetes, plasma glucose and incidence of pancreatic cancer: A prospective study of 0.5 million Chinese adults and a meta‐analysis of 22 cohort studies

PubMed Central

Pang, Yuanjie; Guo, Yu; Bragg, Fiona; Yang, Ling; Bian, Zheng; Chen, Yiping; Iona, Andri; Millwood, Iona Y; Lv, Jun; Yu, Canqing; Chen, Junshi; Li, Liming; Holmes, Michael V; Chen, Zhengming

2017-01-01

Diabetes is associated with an increased risk of pancreatic cancer (PC) in Western populations. Uncertainty remains, however, about the relevance of plasma glucose for PC among people without diabetes and about the associations of diabetes and high blood glucose with PC in China where the increase in diabetes prevalence has been very recent. The prospective China Kadoorie Biobank (CKB) study recruited 512,000 adults aged 30‐79 years from 10 diverse areas of China during 2004‐2008, recording 595 PC cases during 8 years of follow‐up. Cox regression yielded adjusted hazard ratios (HRs) for PC associated with diabetes (previously diagnosed or screen‐detected) and, among those without previously diagnosed diabetes, with levels of random plasma glucose (RPG). These were further meta‐analysed with 22 published prospective studies. Overall 5.8% of CKB participants had diabetes at baseline. Diabetes was associated with almost twofold increased risk of PC (adjusted HR = 1.87, 95% CI 1.48‐2.37), with excess risk higher in those with longer duration since diagnosis (p for trend = 0.01). Among those without previously diagnosed diabetes, each 1 mmol/L higher usual RPG was associated with a HR of 1.12 (1.04‐1.21). In meta‐analysis of CKB and 22 other studies, previously diagnosed diabetes was associated with a 52% excess risk (1.52, 1.43‐1.63). Among those without diabetes, each 1 mmol/L higher blood glucose was associated with a 15% (1.15, 1.09‐1.21) excess risk. In Chinese and non‐Chinese populations, diabetes and higher blood glucose levels among those without diabetes are associated with an increased risk of PC. PMID:28063165

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

Esophagus segmentation in CT via 3D fully convolutional neural network and random walk.

PubMed

Fechter, Tobias; Adebahr, Sonja; Baltas, Dimos; Ben Ayed, Ismail; Desrosiers, Christian; Dolz, Jose

2017-12-01

Precise delineation of organs at risk is a crucial task in radiotherapy treatment planning for delivering high doses to the tumor while sparing healthy tissues. In recent years, automated segmentation methods have shown an increasingly high performance for the delineation of various anatomical structures. However, this task remains challenging for organs like the esophagus, which have a versatile shape and poor contrast to neighboring tissues. For human experts, segmenting the esophagus from CT images is a time-consuming and error-prone process. To tackle these issues, we propose a random walker approach driven by a 3D fully convolutional neural network (CNN) to automatically segment the esophagus from CT images. First, a soft probability map is generated by the CNN. Then, an active contour model (ACM) is fitted to the CNN soft probability map to get a first estimation of the esophagus location. The outputs of the CNN and ACM are then used in conjunction with a probability model based on CT Hounsfield (HU) values to drive the random walker. Training and evaluation were done on 50 CTs from two different datasets, with clinically used peer-reviewed esophagus contours. Results were assessed regarding spatial overlap and shape similarity. The esophagus contours generated by the proposed algorithm showed a mean Dice coefficient of 0.76 ± 0.11, an average symmetric square distance of 1.36 ± 0.90 mm, and an average Hausdorff distance of 11.68 ± 6.80, compared to the reference contours. These results translate to a very good agreement with reference contours and an increase in accuracy compared to existing methods. Furthermore, when considering the results reported in the literature for the publicly available Synapse dataset, our method outperformed all existing approaches, which suggests that the proposed method represents the current state-of-the-art for automatic esophagus segmentation. We show that a CNN can yield accurate estimations of esophagus location, and that the results of this model can be refined by a random walk step taking pixel intensities and neighborhood relationships into account. One of the main advantages of our network over previous methods is that it performs 3D convolutions, thus fully exploiting the 3D spatial context and performing an efficient volume-wise prediction. The whole segmentation process is fully automatic and yields esophagus delineations in very good agreement with the gold standard, showing that it can compete with previously published methods. © 2017 American Association of Physicists in Medicine.

Dairy consumption, systolic blood pressure, and risk of hypertension: Mendelian randomization study

USDA-ARS?s Scientific Manuscript database

Objective: To examine whether previous observed inverse associations of dairy intake with systolic blood pressure and risk of hypertension were causal. Design: Mendelian randomization study using the single nucleotide polymorphism rs4988235 related to lactase persistence as an instrumental variable...

Early Behavioral Intervention Is Associated With Normalized Brain Activity in Young Children With Autism

PubMed Central

Dawson, Geraldine; Jones, Emily J.H.; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J.; Webb, Sara J.

2013-01-01

Objective A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Method Forty-eight 18- to 30-month-old children with autism spectrum disorder were randomized to receive the ESDM or referral to community intervention for 2 years. After the intervention (age 48 to 77 months), EEG activity (event-related potentials and spectral power) was measured during the presentation of faces versus objects. Age-matched typical children were also assessed. Results The ESDM group exhibited greater improvements in autism symptoms, IQ, language, and adaptive and social behaviors than the community intervention group. The ESDM group and typical children showed a shorter Nc latency and increased cortical activation (decreased α power and increased θ power) when viewing faces, whereas the community intervention group showed the opposite pattern (shorter latency event-related potential [ERP] and greater cortical activation when viewing objects). Greater cortical activation while viewing faces was associated with improved social behavior. Conclusions This was the first trial to demonstrate that early behavioral intervention is associated with normalized patterns of brain activity, which is associated with improvements in social behavior, in young children with autism spectrum disorder. PMID:23101741

Neural correlates of improved recognition of happy faces after erythropoietin treatment in bipolar disorder.

PubMed

Miskowiak, K W; Petersen, N A; Harmer, C J; Ehrenreich, E; Kessing, L V; Vinberg, M; Macoveanu, J; Siebner, H R

2018-06-07

Bipolar disorder is associated with impairments in social cognition including the recognition of happy faces. This is accompanied by imbalanced cortico-limbic response to emotional faces. We found that EPO improved the recognition of happy faces in patients with bipolar disorder. This randomized, controlled, longitudinal fMRI study explores the neuronal underpinnings of this effect. Forty-four patients with bipolar disorder in full or partial remission were randomized to eight weekly erythropoietin (EPO; 40 000 IU) or saline (NaCl 0.9%) infusions in a double-blind, parallel-group design. Participants underwent whole-brain fMRI at 3T, mood ratings and blood tests at baseline and week 14. During fMRI, participants viewed happy and fearful faces and performed a gender discrimination task. Thirty-four patients had complete pre- and post-treatment fMRI data (EPO: N = 18, saline: N = 16). Erythropoietin vs. saline increased right superior frontal response to happy vs. fearful faces. This correlated with improved happiness recognition in the EPO group. Erythropoietin also enhanced gender discrimination accuracy for happy faces. These effects were not influenced by medication, mood, red blood cells or blood pressure. Together with previous findings, the present observation suggests that increased dorsal prefrontal attention control is a common mechanism of EPO-associated improvements across several cognitive domains. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Oligometastatic Disease in the Peritoneal Space with Gastrointestinal Cancer

PubMed Central

Rau, Beate; Brandl, Andreas; Pascher, Andreas; Raue, Wieland; Sugarbaker, Paul

2017-01-01

Objectives Treatment options for patients with gastrointestinal cancer and oligometastastic disease remain the domain of the medical oncologist. However, in selected cases, attempts to remove or destroy the tumor burden seem appropriate. Background Data During the last decade, the treatment of localized and isolated tumor nodules, such as lung, liver or peritoneal metastasis, has changed. Previously, these patients with metastatic disease only received palliative chemotherapy. Combined treatment approaches and new techniques demonstrate that additional surgery to destroy or remove the metastases seem to be of major benefit to patients. Methods The recently published important literature regarding peritoneal metastases and oligometastases in gastrointestinal cancer was analyzed. Results The most important factor in the treatment of peritoneal metastases and in cytoreductive surgery is patient selection. Resection of peritoneal metastases should be considered. Hyperthermic intraperitoneal chemotherapy is feasible. However, further results of randomized trials are necessary. Several randomized trials are on the way and will be available in 1–2 years. Systemic chemotherapy alone as an adequate management plan for all sites of metastatic disease is not compatible with a high standard of care. Formulating an optimal plan combining re-operative surgery with regional plus systemic chemotherapy is a necessary task of the multidisciplinary team. Conclusions In oligometastastic disease of gastrointestinal cancer origin, the selection process is the most important factor for survival. Further studies are needed to determine optimal treatment options. PMID:28612016

Personalized ovarian stimulation for assisted reproductive technology: study design considerations to move from hype to added value for patients.

PubMed

Mol, Ben W; Bossuyt, Patrick M; Sunkara, Sesh K; Garcia Velasco, Juan A; Venetis, Christos; Sakkas, Denny; Lundin, Kersti; Simón, Carlos; Taylor, Hugh S; Wan, Robert; Longobardi, Salvatore; Cottell, Evelyn; D'Hooghe, Thomas

2018-06-01

Although most medical treatments are designed for the average patient with a one-size-fits-all-approach, they may not benefit all. Better understanding of the function of genes, proteins, and metabolite, and of personal and environmental factors has led to a call for personalized medicine. Personalized reproductive medicine is still in its infancy, without clear guidance on treatment aspects that could be personalized and on trial design to evaluate personalized treatment effect and benefit-harm balance. While the rationale for a personalized approach often relies on retrospective analyses of large observational studies or real-world data, solid evidence of superiority of a personalized approach will come from randomized trials comparing outcomes and safety between a personalized and one-size-fits-all strategy. A more efficient, targeted randomized trial design may recruit only patients or couples for which the personalized approach would differ from the previous, standard approach. Multiple monocenter studies using the same study protocol (allowing future meta-analysis) might reduce the major center effect associated with multicenter studies. In certain cases, single-arm observational studies can generate the necessary evidence for a personalized approach. This review describes each of the main segments of patient care in assisted reproductive technologies treatment, addressing which aspects could be personalized, emphasizing current evidence and relevant study design. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review.

PubMed

Yang, Xianrui; Xue, Chaoran; He, Yiruo; Zhao, Mengyuan; Luo, Mengqi; Wang, Peiqi; Bai, Ding

2018-01-01

Self-ligating brackets (SLBs) were compared to conventional brackets (CBs) regarding their effectiveness on transversal changes and space closure, as well as the efficiency of alignment and treatment time. All previously published randomized controlled clinical trials (RCTs) dealing with SLBs and CBs were searched via electronic databases, e.g., MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, World Health Organization International Clinical Trials Registry Platform, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, relevant journals were searched manually. Data extraction was performed independently by two reviewers and assessment of the risk of bias was executed using Cochrane Collaboration's tool. Discrepancies were resolved by discussion with a third reviewer. Meta-analyses were conducted using Review Manager (version 5.3). A total of 976 patients in 17 RCTs were included in the study, of which 11 could be produced quantitatively and 2 showed a low risk of bias. Meta-analyses were found to favor CB for mandibular intercanine width expansion, while passive SLBs were more effective in posterior expansion. Moreover, CBs had an apparent advantage during short treatment periods. However, SLBs and CBs did not differ in closing spaces. Based on current clinical evidence obtained from RCTs, SLBs do not show clinical superiority compared to CBs in expanding transversal dimensions, space closure, or orthodontic efficiency. Further high-level studies involving randomized, controlled, clinical trials are warranted to confirm these results.

Influence of Teachers' Personal Health Behaviors on Operationalizing Obesity Prevention Policy in Head Start Preschools: A Project of the Children's Healthy Living Program (CHL).

PubMed

Esquivel, Monica Kazlausky; Nigg, Claudio R; Fialkowski, Marie K; Braun, Kathryn L; Li, Fenfang; Novotny, Rachel

2016-05-01

To quantify the Head Start (HS) teacher mediating and moderating influence on the effect of a wellness policy intervention. Intervention trial within a larger randomized community trial. HS preschools in Hawaii. Twenty-three HS classrooms located within 2 previously randomized communities. Seven-month multi-component intervention with policy changes to food served and service style, initiatives for employee wellness, classroom activities for preschoolers promoting physical activity (PA) and healthy eating, and training and technical assistance. The Environment and Policy Assessment and Observation (EPAO) classroom scores and teacher questionnaires assessing on knowledge, beliefs, priorities, and misconceptions around child nutrition and changes in personal health behaviors and status were the main outcome measures. Paired t tests and linear regression analysis tested the intervention effects on the classroom and mediating and moderating effects of the teacher variables on the classroom environment. General linear model test showed greater intervention effect on the EPAO score where teachers reported higher than average improvements in their own health status and behaviors (estimate [SE] = -2.47 (0.78), P < .05). Strategies to improve teacher health status and behaviors included in a multi-component policy intervention aimed at child obesity prevention may produce a greater effect on classroom environments. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial.

PubMed

Reusch, A; Weiland, R; Gerlich, C; Dreger, K; Derra, C; Mainos, D; Tuschhoff, T; Berding, A; Witte, C; Kaltz, B; Faller, H

2016-12-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Assessment of the methodological and ethical quality of clinical trials published in family medicine journals

PubMed

Castaño-García, Alberto; Guillén-Grima, Francisco; León-Sanz, Pilar

2018-01-01

To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013). Copyright: © 2018 SecretarÍa de Salud

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

Random sequential adsorption of cubes

NASA Astrophysics Data System (ADS)

Cieśla, Michał; Kubala, Piotr

2018-01-01

Random packings built of cubes are studied numerically using a random sequential adsorption algorithm. To compare the obtained results with previous reports, three different models of cube orientation sampling were used. Also, three different cube-cube intersection algorithms were tested to find the most efficient one. The study focuses on the mean saturated packing fraction as well as kinetics of packing growth. Microstructural properties of packings were analyzed using density autocorrelation function.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

PubMed

Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

PubMed

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

2016-01-01

The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. To assess the methodological quality of RCTs published in Spanish-language dermatology journals. By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Elective cesarean section for women living with HIV: a systematic review of risks and benefits.

PubMed

Kennedy, Caitlin E; Yeh, Ping T; Pandey, Shristi; Betran, Ana P; Narasimhan, Manjulaa

2017-07-17

To inform WHO guidelines, we conducted a systematic review and meta-analysis to assess maternal and perinatal outcomes comparing cesarean section (c-section) before labor and rupture of membranes [elective c-section (ECS)] with other modes of delivery for women living with HIV. We searched PubMed, CINAHL, Embase, CENTRAL, and previous reviews to identify published trials and observational studies through October 2015. Results were synthesized using random-effects meta-analysis, stratifying for combination antiretroviral therapy (cART), CD4/viral load (VL), delivery at term, and low-income/middle-income countries. From 2567 citations identified, 36 articles met inclusion criteria. The single randomized trial, published in 1999, reported minimal maternal morbidity and significantly fewer infant HIV infections with ECS [odds ratio (OR) 0.2, 95% confidence interval (CI) 0.0-0.5]. Across observational studies, ECS was associated with increased maternal morbidity compared with vaginal delivery (OR 3.12, 95% CI 2.21-4.41). ECS was also associated with decreased infant HIV infection overall (OR 0.43, 95% CI 0.30-0.63) and in low-income/middle-income countries (OR 0.27, 95% CI 0.16-0.45), but not among women on cART (OR 0.82, 95% CI 0.47-1.43) or with CD4 cell count more than 200/VL less than 400/term delivery (OR 0.59, 95% CI 0.21-1.63). Infant morbidity moderately increased with ECS. Although ECS may reduce infant HIV infection, this effect was not statistically significant in the context of cART and viral suppression. As ECS poses other risks, routine ECS for all women living with HIV may not be appropriate. Risks and benefits will differ across settings, depending on underlying risks of ECS complications and vertical transmission during delivery. Understanding individual client risks and benefits and respecting women's autonomy remain important.

Prevalence of burnout among doctors of chiropractic in the northeastern United States.

PubMed

Williams, Shawn; Zipp, Genevieve P; Cahill, Terrence; Parasher, Raju K

2013-01-01

The purpose of this study was to measure the prevalence of burnout among doctors of chiropractic (DCs) in the New York, New Jersey, and Pennsylvania geographical region and compare these results with burnout data from other health care professions. This exploratory study applied cross-sectional data collection methods. Using nonprobability convenience sampling, a New York-New Jersey-Pennsylvania chiropractic governance body provided contact information of a randomized sample of licensed DCs from their membership directory. Participants included any DC licensed to practice chiropractic whose primary occupation encompassed the chiropractic profession. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and a demographic questionnaire were e-mailed to a randomized sample of licensed DCs. Of the 772 surveys deployed, 90 returned the survey with usable data. Nearly 40% of the DCs reported a moderate (24%) or high (18%) level of emotional exhaustion, whereas the majority of respondents scored a high (72%) level of personal accomplishment. In total, only 2 participants (2%) met the criteria for high burnout, whereas 42 participants (47%) were low. Statistically significant relationships (P < .001) were found between burnout subscales and the effect of time dedicated to administrative duties, the type of practice setting, the varying chiropractic philosophical perspectives, the public's opinion of chiropractic, and the effect of suffering from a work-related injury. When compared with data from previously published studies using the MBI-HSS for other health professions (ie, medical, nursing, physical therapy, occupational therapy, and dentistry), the values for DCs were significantly lower. The sample of DCs in this study fared more favorably on all 3 dimensions of burnout. They reported lower emotional exhaustion and depersonalization scores and higher personal accomplishment scores than their medical, nursing, physical therapy, occupational therapy, and dentistry colleagues who have been evaluated using the MBI-HSS. However, the levels of emotional exhaustion remain a concern for this professional group. Copyright © 2013 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Laterality defects are influenced by timing of treatments and animal model.

PubMed

Vandenberg, Laura N

2012-01-01

The timing of when the embryonic left-right (LR) axis is first established and the mechanisms driving this process are subjects of strong debate. While groups have focused on the role of cilia in establishing the LR axis during gastrula and neurula stages, many animals appear to orient the LR axis prior to the appearance of, or without the benefit of, motile cilia. Because of the large amount of data available in the published literature and the similarities in the type of data collected across laboratories, I have examined relationships between the studies that do and do not implicate cilia, the choice of animal model, the kinds of LR patterning defects observed, and the penetrance of LR phenotypes. I found that treatments affecting cilia structure and motility had a higher penetrance for both altered gene expression and improper organ placement compared to treatments that affect processes in early cleavage stage embryos. I also found differences in penetrance that could be attributed to the animal models used; the mouse is highly prone to LR randomization. Additionally, the data were examined to address whether gene expression can be used to predict randomized organ placement. Using regression analysis, gene expression was found to be predictive of organ placement in frogs, but much less so in the other animals examined. Together, these results challenge previous ideas about the conservation of LR mechanisms, with the mouse model being significantly different from fish, frogs, and chick in almost every aspect examined. Additionally, this analysis indicates that there may be missing pieces in the molecular pathways that dictate how genetic information becomes organ positional information in vertebrates; these gaps will be important for future studies to identify, as LR asymmetry is not only a fundamentally fascinating aspect of development but also of considerable biomedical importance. Copyright © 2011 International Society of Differentiation. Published by Elsevier B.V. All rights reserved.

Effects of Systemic Magnesium on Post-operative Analgesia: Is the Current Evidence Strong Enough?

PubMed

Guo, Bao-Lin; Lin, Yan; Hu, Wei; Zhen, Chen-Xi; Bao-Cheng, Zhao; Wu, Huang-Hui; Kaye, Alan David; Duan, Jian-Hong; Qu, Yan

2015-01-01

Clinical studies have been previously carried out on the efficacy of systemic magnesium to minimize postoperative pain, however, with controversial results. A quantitative meta-analysis was performed to evaluate the analgesic efficacy and safety of systemic magnesium on post-operative pain. Comprehensive systematic review of all relevant, publsished randomized controlled trials. A search was conducted of published literature in MEDLINE, PsycINFO, Scopus, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception to Sep-Oct 2014. Randomized controlled trials (RCTs) that compared magnesium with placebo were identified. Effects were summarized using standardized mean differences (SMDs), weighed mean differences (WMD), or odds ratio (OR) with suitable effect model. Twenty-seven RCTs involving 1,504 patients were included. In total, peri-operative magnesium significantly reduced the pain score at rest (SMD, -1.43, 95% CI, -2.74 to -0.12, < 0.01). Magnesium significantly reduced analgesic consumption (SMD, -1.72, 95% CI, -3.21 to -0.23) in patients undergoing urogenital, orthopaedic, and cardiovascular surgeries, but was inconclusive for patients receiving gastrointestinal surgeries. The obvious analgesia of systemic magnesium was observed on reducing the pain score during movement at 24 hours after operation (SMD, -0.05, 95% CI, -0.43 to 0.32). Moreover, magnesium administration showed a beneficial effect with regard to intra-operative hemodynamics and reduced extubation time in the cardiovascular surgery patients (WMD, -29.34 min, 95% CI, -35.74 to -22.94, P < 0.01). Focused only on the quality of analgesia on postoperative pain with regards to surgery type. Our study suggests that systemic magnesium during general anesthesia significantly decreases post-operative pain scores without increasing adverse events. It should be noted that since there are 18 ongoing RCTs without published data, it is still premature to draw conclusions on the long-term analgesic effects of magnesium as well as potential gender or age difference.

Perceptions of coping with non-disease-related life stress for women with osteoarthritis: a qualitative analysis.

PubMed

Harris, Melissa L; Byles, Julie E; Townsend, Natalie; Loxton, Deborah

2016-05-17

Coping with arthritis-related stress has been extensively studied. However, limited evidence exists regarding coping with stress extraneous to the disease (life stress). This study explored life stress and coping in a subset of older women with osteoarthritis from a larger longitudinal study. An Australian regional university. This qualitative study involved semistructured telephone interviews. Potential participants were mailed a letter of invitation/participant information statement by the Australian Longitudinal Study on Women's Health (ALSWH). Invitations were sent out in small batches (primarily 10). Interviews were conducted until data saturation was achieved using a systematic process (n=19). Digitally recorded interviews were transcribed verbatim and deidentified. Data were thematically analysed. Women who indicated being diagnosed or treated for arthritis in the previous 3 years in the fifth survey of the ALSWH (conducted in 2007) provided the sampling frame. Potential participants were randomly sampled by a blinded data manager using a random number generator. Coping with life stress involved both attitudinal coping processes developed early in life (ie, stoicism) and transient cognitive and support-based responses. Women also described a dualistic process involving a reduction in the ability to cope with ongoing stress over time, coupled with personal growth. This is the first study to examine how individuals cope with non-arthritis-related stress. The findings add to the current understanding of stress and coping, and have implications regarding the prevention of arthritis in women. Importantly, this study highlighted the potential detrimental impact of persistent coping patterns developed early in life. Public health campaigns aimed at stress mitigation and facilitation of adaptive coping mechanisms in childhood and adolescence may assist with arthritis prevention. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study.

PubMed

Locatelli, Francesco; Aljama, Pedro; Canaud, Bernard; Covic, Adrian; De Francisco, Angel; Macdougall, Iain C; Wiecek, Andrzej; Vanholder, Raymond

2010-09-01

The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006-07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes, chronic kidney disease not on dialysis, and anaemia who were randomized to complete anaemia correction (haemoglobin target of 13 g/dL using darbepoetin alpha) or placebo (with a haemoglobin rescue value of 9 g/dL). Following the findings of the TREAT study, the Anaemia Working Group of ERBP maintains its view that 'Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL' and that the doses of ESA therapy to achieve the target haemoglobin should also be considered. More caution is suggested when treating anaemia with ESA therapy in patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages). In those with ischaemic heart disease or with a previous history of stroke, possible benefits should be weighed up against an increased risk of stroke recurrence, when deciding which Hb level to aim for. These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.

Patent foramen ovale closure vs medical therapy for stroke prevention: meta-analysis of randomized trials and review of heterogeneity in meta-analyses.

PubMed

Udell, Jacob A; Opotowsky, Alexander R; Khairy, Paul; Silversides, Candice K; Gladstone, David J; O'Gara, Patrick T; Landzberg, Michael J

2014-10-01

Patent foramen ovale (PFO) might be a risk factor for unexplained ("cryptogenic") stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke. We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed. Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09). Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

PubMed

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-07-01

Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. Copyright © 2017 Elsevier Inc. All rights reserved.

Citicoline for Acute Ischemic Stroke: A Systematic Review and Formal Meta-analysis of Randomized, Double-Blind, and Placebo-Controlled Trials.

PubMed

Secades, Julio J; Alvarez-Sabín, José; Castillo, José; Díez-Tejedor, Exuperio; Martínez-Vila, Eduardo; Ríos, José; Oudovenko, Natalia

2016-08-01

Citicoline is a drug approved for the treatment of acute ischemic stroke. Although evidence of its efficacy has been reported, recently published results of a large placebo-controlled clinical trial did not show differences. This study aims to assess whether starting citicoline treatment within 14 days after stroke onset improves the outcome in patients with acute ischemic stroke, as compared with placebo. A systematic search was performed to identify all published, unconfounded, randomized, double-blind, and placebo-controlled clinical trials of citicoline in acute ischemic stroke. Ten randomized clinical trials met our inclusion criteria. The administration of citicoline was associated with a significant higher rate of independence, independently of the method of evaluation used (odds ratio [OR] 1.56, 95% confidence interval [CI] = 1.12-2.16 under random effects; OR 1.20, 95% CI = 1.06-1.36 under fixed effects). After studying the cumulative meta-analysis, and with the results obtained with the subgroup of patients who were not treated with recombinant tissue plasminogen activator (rtPA) (OR 1.63, 95% CI = 1.18-2.24 under random effects; OR 1.42, 95% CI = 1.22-1.66 under fixed effects), our hypothesis of dilution of the effect of citicoline was confirmed. When we analyzed the effect of citicoline in patients who were not treated with rtPA and were receiving the highest dose of citicoline started in the first 24 hours after onset, based on more recent trials, there was no heterogeneity, and the size of the effect has an OR of 1.27 (95% CI = 1.05-1.53). This systematic review supports some benefits of citicoline in the treatment of acute ischemic stroke. But, on top of the best treatment available (rtPA), citicoline offers a limited benefit. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.

PubMed

Lomax, A; Patel, S; Wang, N; Kakar, K; Kakar, A; Bosma, M L

2017-11-01

In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use. © 2016 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.

Effect of a Combination of Intranasal Ketorolac and Nitrous Oxide on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

PubMed

Stentz, Daniel; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

2018-01-01

Previous studies in patients with irreversible pulpitis have reported increased success of the inferior alveolar nerve block (IANB) using premedication with ketorolac. Preemptive nitrous oxide administration has also shown an increase in the success of the IANB. Recently, ketorolac has been made available for intranasal delivery. Perhaps combining ketorolac and nitrous oxide would increase success. Therefore, the purpose of this prospective, randomized, double-blind study was to determine the effect of a combination of intranasal ketorolac and nitrous oxide/oxygen on the anesthetic success of the IANB in patients presenting with symptomatic irreversible pulpitis. One hundred two patients experiencing spontaneous moderate to severe pain with symptomatic irreversible pulpitis in a mandibular posterior tooth participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac or intranasal saline placebo 20 minutes before the administration of nitrous oxide/oxygen. Ten minutes after the administration of nitrous oxide/oxygen, the IANB was given. After profound lip numbness, endodontic treatment was performed. Success was defined as the ability to perform endodontic access and instrumentation with no pain or mild pain. The odds of success for the IANB was 1.631 in the intranasal saline/nitrous oxide group versus the intranasal ketorolac/nitrous oxide group with no significant difference between the groups (P = .2523). Premedication with intranasal ketorolac did not significantly increase the odds of success for the IANB over the use of nitrous oxide/oxygen alone. Supplemental anesthesia will still be needed to achieve adequate anesthesia. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial.

PubMed

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity , a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N -back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations.

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

2013-02-01

The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

PubMed

Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

2015-03-26

An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

Randomized, controlled, multicentre clinical trial of the antipyretic effect of intravenous paracetamol in patients admitted to hospital with infection.

PubMed

Tsaganos, Thomas; Tseti, Ioulia K; Tziolos, Nikolaos; Soumelas, Georgios-Stefanos; Koupetori, Marina; Pyrpasopoulou, Athina; Akinosoglou, Karolina; Gogos, Charalambos; Tsokos, Nikolaos; Karagiannis, Asterios; Sympardi, Styliani; Giamarellos-Bourboulis, Evangelos J

2017-04-01

No randomized study has been conducted to investigate the use of intravenous paracetamol (acetaminophen, APAP) for the management of fever due to infection. The present study evaluated a new ready-made infusion of paracetamol. Eighty patients with a body temperature onset ≥38.5°C in the previous 24 h due to infection were randomized to a single administration of placebo (n = 39) or 1 g paracetamol (n = 41), and their temperature was recorded at standard intervals. Rescue medication with 1 g paracetamol was allowed. Serum samples were collected for the measurement of APAP and its metabolites. The primary endpoint was defervescence, defined as a core temperature ≤37.1°C. During the first 6 h, defervescence was achieved in 15 (38.5%) patients treated with placebo compared with 33 (80.5%) patients treated with paracetamol 1 g (P < 0.0001). The median time to defervescence with paracetamol 1 g was 3 h. Rescue medication was given to 15 (38.5%) and five (12.2%) patients allocated to placebo and paracetamol, respectively (P = 0.007); nine (60.0%) and two (40.0%) of these patients, respectively, experienced defervescence. No further antipyretic medication was needed for patients becoming afebrile with rescue medication. Serum glucuronide-APAP concentrations were significantly greater in the serum of patients who did not experience defervescence with paracetamol. The efficacy of paracetamol was not affected by serum creatinine. No drug-related adverse events were reported. The 1 g paracetamol formulation has a rapid and sustainable antipyretic effect on fever due to infection. Its efficacy is dependent on hepatic metabolism. © 2016 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Comparison of the effect of two endodontic irrigation protocols on the elimination of bacteria from root canal system: a prospective, randomized clinical trial.

PubMed

Beus, Christopher; Safavi, Kamran; Stratton, Jeffrey; Kaufman, Blythe

2012-11-01

The purpose of this prospective, randomized clinical study was to compare the results of a nonactivated single-irrigation protocol (NAI) that used only 1% NaOCl with a passive ultrasonic multi-irrigation protocol (PUI) that used 1% NaOCl, 17% ethylenediaminetetraacetic acid, and 2% chlorhexidine in rendering canals bacteria free. In addition, the effect of a second-visit instrumentation after intra-appointment calcium hydroxide (CaOH(2)) was also evaluated in bacterial elimination. Fifty patients were recruited with a posterior tooth requiring primary endodontic treatment of apical periodontitis. Standard nonsurgical endodontic therapy was performed on both groups in a 2-visit approach by using calcium hydroxide intracanal medicament. Teeth were randomly treated with the NAI or PUI protocols in the first visit after complete instrumentation. Bacterial cultures were obtained at 4 periods during treatment from the canals: (1) before instrumentation, (2) after irrigation protocol, (3) after CaOH(2) medication, and (4) before obturation. Statistical analysis was performed on data by using the Fisher exact test and multivariate analysis. NAI and PUI rendered canals 80% and 84% bacteria free, respectively, at the end of the first visit. After CaOH(2) medication the total sample (NAI + PUI) had increased to 87% bacteria free, and the second-visit instrumentation resulted in a total of 91% bacteria free. These differences were not significant (P > .05). There was no statistical difference between irrigation methods. Each protocol resulted in a high frequency of negative cultures. This high frequency of negative cultures obtained in 1 visit is most likely related to an increased volume and depth of irrigation compared with previously reported protocols. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Tuberculosis and diabetes in Guyana.

PubMed

Alladin, Bibi; Mack, Steve; Singh, Aruna; Singh, Chaitra; Smith, Belinda; Cummings, Emmanuel; Hershfield, Earl; Mohanlall, Jeetendra; Ramotar, Karam; La Fleur, Curtis

2011-12-01

This study was conducted to determine the prevalence of diabetes mellitus among tuberculosis (TB) patients attending three TB clinics in Guyana. A cross-sectional study was conducted among TB patients attending TB clinics in three regions in Guyana. A structured questionnaire was used to collect demographic, clinical, and risk factor data. Random blood sugar testing was done using the OneTouch UltraSmart glucometer (LifeScan, Inc., 2002). One hundred TB patients were recruited; 90 had pulmonary TB and 10 had extrapulmonary disease. Fourteen patients were classified as diabetic: 12 had been previously diagnosed as diabetic by a physician and two had abnormally high random blood sugar at the time of enrolment. Of the 12 known diabetics, seven had been diagnosed before TB was discovered, three were identified at the time TB was diagnosed, and two after TB was diagnosed. All 14 diabetic patients presented with pulmonary TB. Thirty-one patients were HIV-positive and 28 of these had pulmonary TB, whereas three had extrapulmonary TB. None of the diabetics were infected with HIV. TB-diabetic patients tended to be older than non-diabetics (median age 44 vs. 36.5 years), were more likely to have been incarcerated at the time of TB diagnosis than non-diabetics (p=0.06), and were more likely to have an elevated (random) blood sugar level (p=0.02). Clinically, diabetes did not influence the presentation of TB. This study clearly highlights that diabetes and HIV are frequent in Guyanese TB patients. Routine screening of TB patients for diabetes and diabetic patients for TB should be speedily implemented. The National TB Programme should work closely with the diabetes clinics so that TB patients who are diabetics are optimally managed. Copyright © 2011 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention.

PubMed

Heinz, Tina; Schuchardt, Jan Philipp; Möller, Katharina; Hadji, Peyman; Hahn, Andreas

2016-10-01

Hypercholesterolemia and elevated homocysteine concentrations are associated with cardiovascular risk. Previous studies have demonstrated a cholesterol-lowering effect of red yeast rice (RYR) supplements which contained 5 to 10 mg of monacolin K. We hypothesized that the intake of a low monacolin K dose may likewise reduce low-density lipoprotein-cholesterol (LDL-C) and other plasma lipids. In secondary analyses, we tested the homocysteine lowering effect of folic acid, which was also included in the study preparation. Therefore, we conducted a randomized, double-blind, and placebo-controlled intervention study. One hundred forty-two nonstatin-treated participants with hypercholesterolemia (LDL-C ≥ 4.14 ≤ 5.69 mmol/L) were randomized to the supplement group with RYR or the placebo group. Participants of the supplement group consumed 3 mg monacolin K and 200 μg folic acid per day. A significant (P < .001) reduction of LDL-C (-14.8%), total cholesterol (-11.2%), and homocysteine (-12.5%) was determined in the supplement group after 12 weeks. A total of 51% of the participants treated with RYR achieved the limit of LDL-C <4.14 mmol/L advised and 26% reached the threshold level of homocysteine <10 μmol/L. No significant changes were exhibited within the placebo group. Other parameters remained unchanged and no intolerances or serious adverse events were observed. In conclusion, we demonstrated that a low dose of daily 3 mg monacolin K from RYR reduces the concentration of LDL-C; a risk factor for cardiovascular diseases. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

PubMed

Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

2016-07-01

There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Automatic environmental disinfection with hydrogen peroxide and silver ions versus manual environmental disinfection with sodium hypochlorite: a multicentre randomized before-and-after trial.

PubMed

Mosci, D; Marmo, G W; Sciolino, L; Zaccaro, C; Antonellini, R; Accogli, L; Lazzarotto, T; Mongardi, M; Landini, M P

2017-10-01

New technologies for automated disinfection have been developed, including the use of hydrogen peroxide atomized by specific equipment, with associated silver compounds. To compare the effectiveness of an automated disinfection system with hydrogen peroxide <8% and silver ion versus a manual method with 0.5% sodium hypochlorite solution when evaluating the reduction of microbial mesophilic contamination and Clostridium difficile presence; and to evaluate the time required for both of these processes. This was a randomized multicentre trial performed in different hospital wards that had been occupied previously by patients with Clostridium difficile infection. When patients were discharged their rooms were randomized to one of two decontamination arms. The surfaces where sampled using swabs, before and after disinfection. Swab samples were cultured for quantitative detection of microbial mesophilic contamination and qualitative detection of C. difficile. Before disinfection, 13% of surfaces decontaminated with hydrogen peroxide and silver ions and 20% of surfaces decontaminated with sodium hypochlorite showed presence of C. difficile spores. After disinfection, the samples containing C. difficile were 0% (P < 0.001) in the group decontaminated with hydrogen peroxide and silver ions, and were 3% (P < 0.001) in the group decontaminated with sodium hypochlorite. This difference was not statistically significant; nor was the difference in the reduction of the microbial mesophilic contamination. The differences between the groups were not statistically significant; however, the disinfection with hydrogen peroxide and silver ions is preferable due to less dependence on operators. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Bias and inference from misspecified mixed‐effect models in stepped wedge trial analysis

PubMed Central

Fielding, Katherine L.; Davey, Calum; Aiken, Alexander M.; Hargreaves, James R.; Hayes, Richard J.

2017-01-01

Many stepped wedge trials (SWTs) are analysed by using a mixed‐effect model with a random intercept and fixed effects for the intervention and time periods (referred to here as the standard model). However, it is not known whether this model is robust to misspecification. We simulated SWTs with three groups of clusters and two time periods; one group received the intervention during the first period and two groups in the second period. We simulated period and intervention effects that were either common‐to‐all or varied‐between clusters. Data were analysed with the standard model or with additional random effects for period effect or intervention effect. In a second simulation study, we explored the weight given to within‐cluster comparisons by simulating a larger intervention effect in the group of the trial that experienced both the control and intervention conditions and applying the three analysis models described previously. Across 500 simulations, we computed bias and confidence interval coverage of the estimated intervention effect. We found up to 50% bias in intervention effect estimates when period or intervention effects varied between clusters and were treated as fixed effects in the analysis. All misspecified models showed undercoverage of 95% confidence intervals, particularly the standard model. A large weight was given to within‐cluster comparisons in the standard model. In the SWTs simulated here, mixed‐effect models were highly sensitive to departures from the model assumptions, which can be explained by the high dependence on within‐cluster comparisons. Trialists should consider including a random effect for time period in their SWT analysis model. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:28556355

Fractional Brownian motion and multivariate-t models for longitudinal biomedical data, with application to CD4 counts in HIV-positive patients.

PubMed

Stirrup, Oliver T; Babiker, Abdel G; Carpenter, James R; Copas, Andrew J

2016-04-30

Longitudinal data are widely analysed using linear mixed models, with 'random slopes' models particularly common. However, when modelling, for example, longitudinal pre-treatment CD4 cell counts in HIV-positive patients, the incorporation of non-stationary stochastic processes such as Brownian motion has been shown to lead to a more biologically plausible model and a substantial improvement in model fit. In this article, we propose two further extensions. Firstly, we propose the addition of a fractional Brownian motion component, and secondly, we generalise the model to follow a multivariate-t distribution. These extensions are biologically plausible, and each demonstrated substantially improved fit on application to example data from the Concerted Action on SeroConversion to AIDS and Death in Europe study. We also propose novel procedures for residual diagnostic plots that allow such models to be assessed. Cohorts of patients were simulated from the previously reported and newly developed models in order to evaluate differences in predictions made for the timing of treatment initiation under different clinical management strategies. A further simulation study was performed to demonstrate the substantial biases in parameter estimates of the mean slope of CD4 decline with time that can occur when random slopes models are applied in the presence of censoring because of treatment initiation, with the degree of bias found to depend strongly on the treatment initiation rule applied. Our findings indicate that researchers should consider more complex and flexible models for the analysis of longitudinal biomarker data, particularly when there are substantial missing data, and that the parameter estimates from random slopes models must be interpreted with caution. © 2015 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL.

PubMed

Yale, Jean-François; Berard, Lori; Groleau, Mélanie; Javadi, Pasha; Stewart, John; Harris, Stewart B

2017-10-01

It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. This was a 12-week, open-label, randomized, multicentre pilot study. Participants were randomly assigned to 1 of 2 algorithms: they either increased their dosage by 1 unit/day (INSIGHT, n=108) or the dose was adjusted by the investigator at least once weekly, but no more often than every 3 days (EDITION, n=104). The target fasting self-monitored blood glucose was in the range of 4.4 to 5.6 mmol/L. The percentages of participants reaching the primary endpoint of fasting self-monitored blood glucose ≤5.6 mmol/L without nocturnal hypoglycemia were 19.4% (INSIGHT) and 18.3% (EDITION). At week 12, 26.9% (INSIGHT) and 28.8% (EDITION) of participants achieved a glycated hemoglobin value of ≤7%. No differences in the incidence of hypoglycemia of any category were noted between algorithms. Participants in both arms of the study were much more satisfied with their new treatment as assessed by the Diabetes Treatment Satisfaction Questionnaire. Most health-care professionals (86%) preferred the INSIGHT over the EDITION algorithm. The frequency of adverse events was similar between algorithms. A patient-driven titration algorithm of 1 unit/day with GLA-300 is effective and comparable to the previously tested EDITION algorithm and is preferred by health-care professionals. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial

PubMed Central

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M.

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity, a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N-back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations. PMID:29163136

Comparison of methods to monitor the distribution and impacts of unauthorized travel routes in a border park

USGS Publications Warehouse

Esque, Todd C.; Inman, Rich; Nussear, Kenneth E.; Webb, Robert; Girard, M.M.; DeGayner, J.

2016-01-01

The distribution and abundance of human-caused disturbances vary greatly through space and time and are cause for concern among land stewards in natural areas of the southwestern border-lands between the USA and Mexico. Human migration and border protection along the international boundary create Unauthorized Trail and Road (UTR) networks across National Park Service lands and other natural areas. UTRs may cause soil erosion and compaction, damage to vegetation and cultural resources, and may stress wildlife or impede their movements. We quantify the density and severity of UTR disturbances in relation to soils, and compare the use of previously established targeted trail assessments (hereafter — targeted assessments) against randomly placed transects to detect trail densities at Coronado National Memorial in Arizona in 2011. While trail distributions were similar between methods, targeted assessments estimated a large portion of the park to have the lowest density category (0–5 trail encounters per/km2), whereas the random transects in 2011 estimated more of the park as having the higher density categories (e.g., 15–20 encounters per km2category). Soil vulnerability categories that were assigned, a priori, based on published soil texture and composition did not accurately predict the impact of UTRs on soil, indicating that empirical methods may be better suited for identifying severity of compaction. While the estimates of UTR encounter frequencies were greater using the random transects than the targeted assessments for a relatively short period of time, it is difficult to determine whether this difference is dependent on greater cross-border activity, differences in technique, or from confounding environmental factors. Future surveys using standardized sampling techniques would increase accuracy.

A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation.

PubMed

Stevens, R B; Wrenshall, L E; Miles, C D; Farney, A C; Jie, T; Sandoz, J P; Rigley, T H; Osama Gaber, A

2016-06-01

A previous nonblinded, randomized, single-center renal transplantation trial of single-dose rabbit anti-thymocyte globulin induction (SD-rATG) showed improved efficacy compared with conventional divided-dose (DD-rATG) administration. The present multicenter, double-blind/double-dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD-rATG versus DD-rATG induction for noninferiority in early (7-day) safety and tolerability. Ninety-five patients (randomized 1:1) received 6 mg/kg SD-rATG or 1.5 mg/kg/dose DD-rATG, with tacrolimus-mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12-month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD-rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD-rATG induction to be noninferior to DD-rATG induction in early tolerability and equivalent in 12-month safety. (Clinical Trials.gov #NCT00906204.). © Copyright 2016 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of the American Society of Transplantation and the American Society of Transplant Surgeons.

Does perioperative nutrition and oral carbohydrate load sustainably preserve muscle mass after bariatric surgery? A randomized control trial.

PubMed

Azagury, D E; Ris, F; Pichard, C; Volonté, F; Karsegard, L; Huber, O

2015-01-01

Perioperative nutrition and preoperative oral carbohydrate loading (CHL) have a beneficial impact on the outcomes of gastrointestinal oncological surgery. However no data exists on their effect on morbidly obese patients. Our aim was to establish the short-term and long-term impact of these modalities, notably on metabolically active lean body mass (LBM) - an important factor in maintaining long-term weight loss. Patients undergoing laparoscopic Roux-en-Y gastric bypass were randomized to standard management or intervention: CHL drinks consumed 12 and 2 hours presurgery, and immediate postoperative peripheral parenteral nutrition. The primary outcome measured was LBM, measured by Bioelectrical Impedance Analysis (BIA), one and 12 months postsurgery. Secondary outcomes included excess weight loss (EBWL), 30-day complication rate, and length of stay. Of the 203 randomized patients, 198 were included in the analysis. All 101 patients in the control group completed the one-year follow up and 76 completed the BIA. In the intervention group, 93 of 97 patients completed the one-year follow-up and 71 completed the BIA. At one and 12 months follow-up, body composition, LBM, or EBWL were comparable. There was no difference in operative outcomes, complications rates, or length of stay. There was no adverse effect in the intervention group. In a highly homogeneous group of morbidly obese patients with one-year follow-up, CHL and short-term parenteral nutrition did not lead to significant or sustained LBM preservation or modification in EBWL. There was no significant decrease in complications or length of stay. Our study confirms the safety of these interventions, even in previously unstudied Type 2 diabetic patients. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial.

PubMed

Elewski, Boni E; Okun, Martin M; Papp, Kim; Baker, Christopher S; Crowley, Jeffrey J; Guillet, Gérard; Sundaram, Murali; Poulin, Yves; Gu, Yihua; Geng, Ziqian; Williams, David A; Rich, Phoebe A

2018-01-01

Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. Patients with less than 5% BSA involvement were not eligible for enrollment. After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Lagrangian particles with mixing. I. Simulating scalar transport

NASA Astrophysics Data System (ADS)

Klimenko, A. Y.

2009-06-01

The physical similarity and mathematical equivalence of continuous diffusion and particle random walk forms one of the cornerstones of modern physics and the theory of stochastic processes. The randomly walking particles do not need to posses any properties other than location in physical space. However, particles used in many models dealing with simulating turbulent transport and turbulent combustion do posses a set of scalar properties and mixing between particle properties is performed to reflect the dissipative nature of the diffusion processes. We show that the continuous scalar transport and diffusion can be accurately specified by means of localized mixing between randomly walking Lagrangian particles with scalar properties and assess errors associated with this scheme. Particles with scalar properties and localized mixing represent an alternative formulation for the process, which is selected to represent the continuous diffusion. Simulating diffusion by Lagrangian particles with mixing involves three main competing requirements: minimizing stochastic uncertainty, minimizing bias introduced by numerical diffusion, and preserving independence of particles. These requirements are analyzed for two limited cases of mixing between two particles and mixing between a large number of particles. The problem of possible dependences between particles is most complicated. This problem is analyzed using a coupled chain of equations that has similarities with Bogolubov-Born-Green-Kirkwood-Yvon chain in statistical physics. Dependences between particles can be significant in close proximity of the particles resulting in a reduced rate of mixing. This work develops further ideas introduced in the previously published letter [Phys. Fluids 19, 031702 (2007)]. Paper I of this work is followed by Paper II [Phys. Fluids 19, 065102 (2009)] where modeling of turbulent reacting flows by Lagrangian particles with localized mixing is specifically considered.

AZD3480, a novel nicotinic receptor agonist, for the treatment of attention-deficit/hyperactivity disorder in adults.

PubMed

Potter, Alexandra S; Dunbar, Geoffrey; Mazzulla, Emily; Hosford, David; Newhouse, Paul A

2014-02-01

Laboratory studies have found that acute stimulation of nicotinic acetylcholine receptors improves cognition in adult attention-deficit/hyperactivity disorder (ADHD). Clinical trials of nicotinic agonists have been mixed, underscoring the need to understand the mechanisms for individual differences in clinical response. Using cognitive models within a clinical trial framework may provide insight into these differences. This was a within-subjects, randomized, placebo-controlled double-blind trial of the nicotinic agonist AZD3480 (also termed TC-1734) at doses of 5 mg and 50 mg and placebo in adults with ADHD. The order of the 2-week treatment periods was randomized, and a 3-week wash out separated each drug treatment period. Response inhibition (Stop Signal Task [SST]) and clinical efficacy (Investigator Rated Conners Adult ADHD Rating Scale [CAARS-INV]) were the a priori primary outcome measures of cognitive and clinical effects. We hypothesized that AZD3480 treatment would improve SST performance and clinical symptoms (CAARS-INV Total ADHD Symptoms Score). Thirty subjects were randomized, with 24 included in the intent-to-treat analyses. SST performance and total ADHD symptoms were significantly improved with 50 mg of AZD3480. CAARS-INV ratings of inattention, memory problems, and emotional lability/impulsivity were significantly improved with 50 mg of AZD3480. These results support previous work suggesting that nicotinic agonists are viable as treatments for adult ADHD. Measuring cognitive endophenotypes related to both the disorder and mechanism of treatment may help further rational drug development for dimensional features that cross-cut psychiatric disorders. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Is Mutation Random or Targeted?: No Evidence for Hypermutability in Snail Toxin Genes.

PubMed

Roy, Scott W

2016-10-01

Ever since Luria and Delbruck, the notion that mutation is random with respect to fitness has been foundational to modern biology. However, various studies have claimed striking exceptions to this rule. One influential case involves toxin-encoding genes in snails of the genus Conus, termed conotoxins, a large gene family that undergoes rapid diversification of their protein-coding sequences by positive selection. Previous reconstructions of the sequence evolution of conotoxin genes claimed striking patterns: (1) elevated synonymous change, interpreted as being due to targeted "hypermutation" in this region; (2) elevated transversion-to-transition ratios, interpreted as reflective of the particular mechanism of hypermutation; and (3) much lower rates of synonymous change in the codons encoding several highly conserved cysteine residues, interpreted as strong position-specific codon bias. This work has spawned a variety of studies on the potential mechanisms of hypermutation and on causes for cysteine codon bias, and has inspired hypermutation hypotheses for various other fast-evolving genes. Here, I show that all three findings are likely to be artifacts of statistical reconstruction. First, by simulating nonsynonymous change I show that high rates of dN can lead to overestimation of dS. Second, I show that there is no evidence for any of these three patterns in comparisons of closely related conotoxin sequences, suggesting that the reported findings are due to breakdown of statistical methods at high levels of sequence divergence. The current findings suggest that mutation and codon bias in conotoxin genes may not be atypical, and that random mutation and selection can explain the evolution of even these exceptional loci. © The Author 2016. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Intranasal Oxytocin to Prevent Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial in Emergency Department Patients.

PubMed

van Zuiden, Mirjam; Frijling, Jessie L; Nawijn, Laura; Koch, Saskia B J; Goslings, J Carel; Luitse, Jan S; Biesheuvel, Tessa H; Honig, Adriaan; Veltman, Dick J; Olff, Miranda

2017-06-15

There are currently few preventive interventions available for posttraumatic stress disorder (PTSD). Intranasal oxytocin administration early after trauma may prevent PTSD, because oxytocin administration was previously found to beneficially impact PTSD vulnerability factors, including neural fear responsiveness, peripheral stress reactivity, and socioemotional functioning. Therefore, we investigated the effects of intranasal oxytocin administration early after trauma on subsequent clinician-rated PTSD symptoms. We then assessed whether baseline characteristics moderated the intervention's effects. We performed a multicenter, randomized, double-blind, placebo-controlled clinical trial. Adult emergency department patients with moderate to severe acute distress (n = 120; 85% accident victims) were randomized to intranasal oxytocin (8 days/40 IU twice daily) or placebo (8 days/10 puffs twice daily), initiated within 12 days posttrauma. The Clinician-Administered PTSD Scale (CAPS) was administered at baseline (within 10 days posttrauma) and at 1.5, 3, and 6 months posttrauma. The intention-to-treat sample included 107 participants (oxytocin: n = 53; placebo: n = 54). We did not observe a significant group difference in CAPS total score at 1.5 months posttrauma (primary outcome) or across follow-up (secondary outcome). Secondary analyses showed that participants with high baseline CAPS scores receiving oxytocin had significantly lower CAPS scores across follow-up than participants with high baseline CAPS scores receiving placebo. Oxytocin administration early after trauma did not attenuate clinician-rated PTSD symptoms in all trauma-exposed participants with acute distress. However, participants with high acute clinician-rated PTSD symptom severity did show beneficial effects of oxytocin. Although replication is warranted, these findings suggest that oxytocin administration is a promising preventive intervention for PTSD for individuals with high acute PTSD symptoms. Copyright © 2016 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

2GETHER - The Dual Protection Project: Design and rationale of a randomized controlled trial to increase dual protection strategy selection and adherence among African American adolescent females.

PubMed

Ewing, Alexander C; Kottke, Melissa J; Kraft, Joan Marie; Sales, Jessica M; Brown, Jennifer L; Goedken, Peggy; Wiener, Jeffrey; Kourtis, Athena P

2017-03-01

African American adolescent females are at elevated risk for unintended pregnancy and sexually transmitted infections (STIs). Dual protection (DP) is defined as concurrent prevention of pregnancy and STIs. This can be achieved by abstinence, consistent condom use, or the dual methods of condoms plus an effective non-barrier contraceptive. Previous clinic-based interventions showed short-term effects on increasing dual method use, but evidence of sustained effects on dual method use and decreased incident pregnancies and STIs are lacking. This manuscript describes the 2GETHER Project. 2GETHER is a randomized controlled trial of a multi-component intervention to increase dual protection use among sexually active African American females aged 14-19years not desiring pregnancy at a Title X clinic in Atlanta, GA. The intervention is clinic-based and includes a culturally tailored interactive multimedia component and counseling sessions, both to assist in selection of a DP method and to reinforce use of the DP method. The participants are randomized to the study intervention or the standard of care, and followed for 12months to evaluate how the intervention influences DP method selection and adherence, pregnancy and STI incidence, and participants' DP knowledge, intentions, and self-efficacy. The 2GETHER Project is a novel trial to reduce unintended pregnancies and STIs among African American adolescents. The intervention is unique in the comprehensive and complementary nature of its components and its individual tailoring of provider-patient interaction. If the trial interventions are shown to be effective, then it will be reasonable to assess their scalability and applicability in other populations. Published by Elsevier Inc.

Genetic variation in the ADIPOQ gene, adiponectin concentrations and risk of colorectal cancer: a Mendelian Randomization analysis using data from three large cohort studies.

PubMed

Nimptsch, Katharina; Song, Mingyang; Aleksandrova, Krasimira; Katsoulis, Michail; Freisling, Heinz; Jenab, Mazda; Gunter, Marc J; Tsilidis, Konstantinos K; Weiderpass, Elisabete; Bueno-De-Mesquita, H Bas; Chong, Dawn Q; Jensen, Majken K; Wu, Chunsen; Overvad, Kim; Kühn, Tilman; Barrdahl, Myrto; Melander, Olle; Jirström, Karin; Peeters, Petra H; Sieri, Sabina; Panico, Salvatore; Cross, Amanda J; Riboli, Elio; Van Guelpen, Bethany; Myte, Robin; Huerta, José María; Rodriguez-Barranco, Miguel; Quirós, José Ramón; Dorronsoro, Miren; Tjønneland, Anne; Olsen, Anja; Travis, Ruth; Boutron-Ruault, Marie-Christine; Carbonnel, Franck; Severi, Gianluca; Bonet, Catalina; Palli, Domenico; Janke, Jürgen; Lee, Young-Ae; Boeing, Heiner; Giovannucci, Edward L; Ogino, Shuji; Fuchs, Charles S; Rimm, Eric; Wu, Kana; Chan, Andrew T; Pischon, Tobias

2017-05-01

Higher levels of circulating adiponectin have been related to lower risk of colorectal cancer in several prospective cohort studies, but it remains unclear whether this association may be causal. We aimed to improve causal inference in a Mendelian Randomization meta-analysis using nested case-control studies of the European Prospective Investigation into Cancer and Nutrition (EPIC, 623 cases, 623 matched controls), the Health Professionals Follow-up Study (HPFS, 231 cases, 230 controls) and the Nurses' Health Study (NHS, 399 cases, 774 controls) with available data on pre-diagnostic adiponectin concentrations and selected single nucleotide polymorphisms in the ADIPOQ gene. We created an ADIPOQ allele score that explained approximately 3% of the interindividual variation in adiponectin concentrations. The ADIPOQ allele score was not associated with risk of colorectal cancer in logistic regression analyses (pooled OR per score-unit unit 0.97, 95% CI 0.91, 1.04). Genetically determined twofold higher adiponectin was not significantly associated with risk of colorectal cancer using the ADIPOQ allele score as instrumental variable (pooled OR 0.73, 95% CI 0.40, 1.34). In a summary instrumental variable analysis (based on previously published data) with higher statistical power, no association between genetically determined twofold higher adiponectin and risk of colorectal cancer was observed (0.99, 95% CI 0.93, 1.06 in women and 0.94, 95% CI 0.88, 1.01 in men). Thus, our study does not support a causal effect of circulating adiponectin on colorectal cancer risk. Due to the limited genetic determination of adiponectin, larger Mendelian Randomization studies are necessary to clarify whether adiponectin is causally related to lower risk of colorectal cancer.

Intraclass correlation estimates for cancer screening outcomes: estimates and applications in the design of group-randomized cancer screening studies.

PubMed

Hade, Erinn M; Murray, David M; Pennell, Michael L; Rhoda, Dale; Paskett, Electra D; Champion, Victoria L; Crabtree, Benjamin F; Dietrich, Allen; Dignan, Mark B; Farmer, Melissa; Fenton, Joshua J; Flocke, Susan; Hiatt, Robert A; Hudson, Shawna V; Mitchell, Michael; Monahan, Patrick; Shariff-Marco, Salma; Slone, Stacey L; Stange, Kurt; Stewart, Susan L; Strickland, Pamela A Ohman

2010-01-01

Screening has become one of our best tools for early detection and prevention of cancer. The group-randomized trial is the most rigorous experimental design for evaluating multilevel interventions. However, identifying the proper sample size for a group-randomized trial requires reliable estimates of intraclass correlation (ICC) for screening outcomes, which are not available to researchers. We present crude and adjusted ICC estimates for cancer screening outcomes for various levels of aggregation (physician, clinic, and county) and provide an example of how these ICC estimates may be used in the design of a future trial. Investigators working in the area of cancer screening were contacted and asked to provide crude and adjusted ICC estimates using the analysis of variance method estimator. Of the 29 investigators identified, estimates were obtained from 10 investigators who had relevant data. ICC estimates were calculated from 13 different studies, with more than half of the studies collecting information on colorectal screening. In the majority of cases, ICC estimates could be adjusted for age, education, and other demographic characteristics, leading to a reduction in the ICC. ICC estimates varied considerably by cancer site and level of aggregation of the groups. Previously, only two articles had published ICCs for cancer screening outcomes. We have complied more than 130 crude and adjusted ICC estimates covering breast, cervical, colon, and prostate screening and have detailed them by level of aggregation, screening measure, and study characteristics. We have also demonstrated their use in planning a future trial and the need for the evaluation of the proposed interval estimator for binary outcomes under conditions typically seen in GRTs.

A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.

PubMed

Wang, Jingyun; Neely, Daniel E; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G; Kovarik, Jessica; Bowsher, James; Smith, Heather A; Donaldson, Dana; Haider, Kathryn M; Roberts, Gavin J; Sprunger, Derek T; Plager, David A

2016-08-01

To compare the effectiveness of intermittent occlusion therapy (IO therapy) using liquid crystal glasses and continuous occlusion therapy using traditional adhesive patches for treating amblyopia. Children 3-8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled in this randomized controlled trial. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn any optimal refractive correction for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO therapy group with liquid crystal glasses (Amblyz), set at 30-second opaque/transparent intervals (occluded 50% of wear time), and a 2-hour continuous patching group (occluded 100% of wear time). For each patient, visual acuity was measured using ATS-HOTV before and after 12 weeks of treatment. Data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15 ± 0.12 logMAR (95% CI, 0.09-0.15) in the IO therapy group (n = 19) and 0.15 ± 0.11 logMAR (95% CI, 0.1-0.15) in the patching group (n = 15). In both groups improvement was significant, but the difference between groups was not (P = 0.73). No adverse effects were reported. In this pilot study, IO therapy with liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3-8 years of age with moderate amblyopia. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

The use of genetic programming to develop a predictor of swash excursion on sandy beaches

NASA Astrophysics Data System (ADS)

Passarella, Marinella; Goldstein, Evan B.; De Muro, Sandro; Coco, Giovanni

2018-02-01

We use genetic programming (GP), a type of machine learning (ML) approach, to predict the total and infragravity swash excursion using previously published data sets that have been used extensively in swash prediction studies. Three previously published works with a range of new conditions are added to this data set to extend the range of measured swash conditions. Using this newly compiled data set we demonstrate that a ML approach can reduce the prediction errors compared to well-established parameterizations and therefore it may improve coastal hazards assessment (e.g. coastal inundation). Predictors obtained using GP can also be physically sound and replicate the functionality and dependencies of previous published formulas. Overall, we show that ML techniques are capable of both improving predictability (compared to classical regression approaches) and providing physical insight into coastal processes.

E-Cigarette Awareness, Use, and Harm Perception among Adults: A Meta-Analysis of Observational Studies.

PubMed

Xu, Ying; Guo, Yanfang; Liu, Kaiqian; Liu, Zheng; Wang, Xiaobo

2016-01-01

The aim of this study is to systematically review the published literature on the awareness, previous and current use, and harm perceptions of electronic cigarettes (e-cigarettes) among adults. A search of the most current literature using the PubMed and Scopus database to identify articles published since 2003 yielded a total of 28 relevant articles. The pooled prevalence of awareness, previous use, current use of e-cigarettes and perceived healthier of e-cigarettes than regular cigarettes (healthier perception) among adults were 61.2% (95% confidence interval (CI): 51.5-70.8%), 16.8% (95% CI: 14.0-19.6%), 11.1% (95% CI: 9.2-13.1%), and 52.6% (95% CI: 42.5-62.6%), respectively, using a random effects model. The subgroup analysis showed that pooled estimates were highest in the group of current smokers of regular cigarettes, except that the highest pooled rate of current use was seen in the group of former smokers of regular cigarettes (the corresponding rates were 71.9% (95% CI: 57.5-86.3%), 27.2% (95% CI: 18.8-35.6%), 16.8% (95% CI: 7.2-26.3%), and 63.1% (95% CI: 52.1-74.1%)), and the lowest pooled rates were in the group of non-smokers, except for the rate of healthier perception in the users of e-cigarettes (and the corresponding rates were 46.8% (95% CI: 26.8-66.8%), 2.5% (95% CI: 1.1-5.6%), 1.2% (95% CI: 0.4-2.1%), and 37.9% (95% CI: -0.5-76.3%)). The cumulative meta-analysis found that awareness increased over time, while the prevalence of previous use, current use, and healthier perception first experienced an increase followed by a decrease and remained stable thereafter. E-cigarette awareness has been increasing, and e-cigarette use and perceived health risks are nearly invariable between 2009 and 2014. Given the substantial heterogeneity in the prevalence rate estimates, there is a need for more accurate and comparable prevalence estimates for e-cigarettes across the world.

R. A. Fisher and his advocacy of randomization.

PubMed

Hall, Nancy S

2007-01-01

The requirement of randomization in experimental design was first stated by R. A. Fisher, statistician and geneticist, in 1925 in his book Statistical Methods for Research Workers. Earlier designs were systematic and involved the judgment of the experimenter; this led to possible bias and inaccurate interpretation of the data. Fisher's dictum was that randomization eliminates bias and permits a valid test of significance. Randomization in experimenting had been used by Charles Sanders Peirce in 1885 but the practice was not continued. Fisher developed his concepts of randomizing as he considered the mathematics of small samples, in discussions with "Student," William Sealy Gosset. Fisher published extensively. His principles of experimental design were spread worldwide by the many "voluntary workers" who came from other institutions to Rothamsted Agricultural Station in England to learn Fisher's methods.

Cluster randomization and political philosophy.

PubMed

Chwang, Eric

2012-11-01

In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

Dairy consumption, systolic blood pressure, and risk of hypertension: Mendelian randomization study

USDA-ARS?s Scientific Manuscript database

This study examined whether previous observed inverse associations of dairy intake with systolic blood pressure and risk of hypertension were causal. A Mendelian randomization study was employed, using the single nucleotide polymorphism rs4988235 related to lactase persistence as an instrumental var...

Occurrence of aflatoxin M₁ in commercial pasteurized milk samples in Sari, Mazandaran province, Iran.

PubMed

Mohammadi, Hamidreza; Shokrzadeh, Mohammad; Aliabadi, Zahra; Riahi-Zanjani, Bamdad

2016-05-01

The frequency and levels of aflatoxin M1 (AFM1) in pasteurized milk samples in Sari, located in Mazandaran province, Iran, were determined by enzyme immunoassay. Seventy-six samples of pasteurized milk from different retail stores were randomly collected over four seasons during the year 2015. AFM1 contamination was detected in all milk samples. The mean concentration of aflatoxin M1 was 65.8 ng/l, with a range of 11.7-106.6 ng/l. The highest AFM1 level was detected in milk samples collected during spring. Forty-six (60.53 %) samples had AFM1 levels that exceeded the maximum acceptable levels (50 ng/l) recommended by the European Union (EU). Comparison of these results with previously published data for AFM1 in milk in Iran shows that the percentage of samples exceeding the EU maximum level is consistently high over the years, indicating a general problem related to AFB1 contamination in dairy feedingstuff.

cisTEM, user-friendly software for single-particle image processing.

PubMed

Grant, Timothy; Rohou, Alexis; Grigorieff, Nikolaus

2018-03-07

We have developed new open-source software called cis TEM (computational imaging system for transmission electron microscopy) for the processing of data for high-resolution electron cryo-microscopy and single-particle averaging. cis TEM features a graphical user interface that is used to submit jobs, monitor their progress, and display results. It implements a full processing pipeline including movie processing, image defocus determination, automatic particle picking, 2D classification, ab-initio 3D map generation from random parameters, 3D classification, and high-resolution refinement and reconstruction. Some of these steps implement newly-developed algorithms; others were adapted from previously published algorithms. The software is optimized to enable processing of typical datasets (2000 micrographs, 200 k - 300 k particles) on a high-end, CPU-based workstation in half a day or less, comparable to GPU-accelerated processing. Jobs can also be scheduled on large computer clusters using flexible run profiles that can be adapted for most computing environments. cis TEM is available for download from cistem.org. © 2018, Grant et al.

Reducing alcohol consumption to minimize weight gain and facilitate smoking cessation among military beneficiaries.

PubMed

Sobell, Mark B; Peterson, Alan L; Sobell, Linda Carter; Brundige, Antoinette; Hunter, Christopher M; Hunter, Christine M; Goodie, Jeffrey L; Agrawal, Sangeeta; Hrysko-Mullen, Ann S; Isler, William C

2017-12-01

Smoking cessation-related weight gain can have significant negative health and career consequences for military personnel. Alcohol reduction combined with smoking cessation may decrease weight gain and relapse. A randomized clinical trial of military beneficiaries compared a standard smoking cessation (i.e., brief informational) intervention (N=159), with a brief motivational smoking cessation intervention that emphasized reduced drinking to lessen caloric intake and minimize weight gain (N=158). Participants who received the motivational intervention were significantly more likely to quit smoking at the 3-month follow-up (p=0.02), but the differences were not maintained at 6 (p=0.18) or 12months (p=0.16). Neither weight change nor alcohol reduction distinguished the 2 groups. Smoking cessation rates at 12months (motivational group=32.91%, informational group=25.79%) were comparable to previous studies, but successful cessation was not mediated by reduced drinking. Alcohol reduction combined with smoking cessation did not result in decreased weight gain or improved outcomes. Copyright © 2017. Published by Elsevier Ltd.

The anomalous demagnetization behaviour of chondritic meteorites

NASA Astrophysics Data System (ADS)

Morden, S. J.

1992-06-01

Alternating field (AF) demagnetization of chondritic samples often shows anomalous results such as large directional and intensity changes; 'saw-tooth' intensity vs. demagnetizing field curves are also prevalent. An attempt to explain this behaviour is presented, using a computer model in which individual 'mineral grains' can be 'magnetized' in a variety of different ways. A simulated demagnetization can then be carried out to examine the results. It was found that the experimental behaviour of chondrites can be successfully mimicked by loading the computer model with a series of randomly orientated and sized vectors. The parameters of the model can be changed to reflect different trends seen in experimental data. Many published results can be modelled using this method. A known magnetic mineralogy can be modelled, and an unknown mineralogy deduced from AF demagnetization curves. Only by comparing data from mutually orientated samples can true stable regions for palaeointensity measurements be identified, calling into question some previous estimates of field strength from meteorites.

A many-body states picture of electronic friction: The case of multiple orbitals and multiple electronic states

NASA Astrophysics Data System (ADS)

Dou, Wenjie; Subotnik, Joseph E.

2016-08-01

We present a very general form of electronic friction as present when a molecule with multiple orbitals hybridizes with a metal electrode. To develop this picture of friction, we embed the quantum-classical Liouville equation (QCLE) within a classical master equation (CME). Thus, this article extends our previous work analyzing the case of one electronic level, as we may now treat the case of multiple levels and many electronic molecular states. We show that, in the adiabatic limit, where electron transitions are much faster than nuclear motion, the QCLE-CME reduces to a Fokker-Planck equation, such that nuclei feel an average force as well as friction and a random force—as caused by their interaction with the metallic electrons. Finally, we show numerically and analytically that our frictional results agree with other published results calculated using non-equilibrium Green's functions. Numerical recipes for solving this QCLE-CME will be provided in a subsequent paper.

cisTEM, user-friendly software for single-particle image processing

PubMed Central

2018-01-01

We have developed new open-source software called cisTEM (computational imaging system for transmission electron microscopy) for the processing of data for high-resolution electron cryo-microscopy and single-particle averaging. cisTEM features a graphical user interface that is used to submit jobs, monitor their progress, and display results. It implements a full processing pipeline including movie processing, image defocus determination, automatic particle picking, 2D classification, ab-initio 3D map generation from random parameters, 3D classification, and high-resolution refinement and reconstruction. Some of these steps implement newly-developed algorithms; others were adapted from previously published algorithms. The software is optimized to enable processing of typical datasets (2000 micrographs, 200 k – 300 k particles) on a high-end, CPU-based workstation in half a day or less, comparable to GPU-accelerated processing. Jobs can also be scheduled on large computer clusters using flexible run profiles that can be adapted for most computing environments. cisTEM is available for download from cistem.org. PMID:29513216

A many-body states picture of electronic friction: The case of multiple orbitals and multiple electronic states

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dou, Wenjie; Subotnik, Joseph E.

We present a very general form of electronic friction as present when a molecule with multiple orbitals hybridizes with a metal electrode. To develop this picture of friction, we embed the quantum-classical Liouville equation (QCLE) within a classical master equation (CME). Thus, this article extends our previous work analyzing the case of one electronic level, as we may now treat the case of multiple levels and many electronic molecular states. We show that, in the adiabatic limit, where electron transitions are much faster than nuclear motion, the QCLE-CME reduces to a Fokker-Planck equation, such that nuclei feel an average forcemore » as well as friction and a random force—as caused by their interaction with the metallic electrons. Finally, we show numerically and analytically that our frictional results agree with other published results calculated using non-equilibrium Green’s functions. Numerical recipes for solving this QCLE-CME will be provided in a subsequent paper.« less

No evidence of Bartonella quintana but detection of Acinetobacter baumannii in head lice from elementary schoolchildren in Paris.

PubMed

Bouvresse, Sophie; Socolovshi, Cristina; Berdjane, Zohra; Durand, Rémy; Izri, Arezki; Raoult, Didier; Chosidow, Olivier; Brouqui, Philippe

2011-12-01

The human body louse is the only known vector of Bartonella quintana. However, the presence of this bacterium has recently been detected in the head lice of homeless individuals and Nepalese slum children. Previous studies have reported the isolation of Acinetobacter baumannii from the body lice of homeless individuals. An epidemiological survey including 74 schools was conducted between 2008 and 2009 in Paris. After a first visual examination, the hair of children with suspected pediculosis was combed with a fine-tooth comb to collect live adult head lice. Molecular studies were performed on randomly selected DNA samples to detect B. quintana and A. baumannii by specific quantitative real-time PCR. Among a collection of 288 DNA samples, B. quintana was not detected, but A. baumannii was detected in 95 DNA samples (33%). Further study is needed to determine the significance of the finding of A. baumannii in head lice. 2011. Published by Elsevier Ltd. All rights reserved.

Can We Train Machine Learning Methods to Outperform the High-dimensional Propensity Score Algorithm?

PubMed

Karim, Mohammad Ehsanul; Pang, Menglan; Platt, Robert W

2018-03-01

The use of retrospective health care claims datasets is frequently criticized for the lack of complete information on potential confounders. Utilizing patient's health status-related information from claims datasets as surrogates or proxies for mismeasured and unobserved confounders, the high-dimensional propensity score algorithm enables us to reduce bias. Using a previously published cohort study of postmyocardial infarction statin use (1998-2012), we compare the performance of the algorithm with a number of popular machine learning approaches for confounder selection in high-dimensional covariate spaces: random forest, least absolute shrinkage and selection operator, and elastic net. Our results suggest that, when the data analysis is done with epidemiologic principles in mind, machine learning methods perform as well as the high-dimensional propensity score algorithm. Using a plasmode framework that mimicked the empirical data, we also showed that a hybrid of machine learning and high-dimensional propensity score algorithms generally perform slightly better than both in terms of mean squared error, when a bias-based analysis is used.

Botulinum toxin for vaginismus treatment.

PubMed

Ferreira, Juliana Rocha; Souza, Renan Pedra

2012-01-01

Vaginismus is characterized by recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted. Recent results have suggested the use of botulinum toxin for the treatment of vaginismus. Here, we assessed previously published data to evaluate the therapeutic effectiveness of botulinum toxin for vaginismus. We have carried out a systematic review followed by a meta-analysis. Our results indicate that botulinum toxin is an effective therapeutic option for patients with vaginismus (pooled odds ratio of 8.723 with 95% confidence interval limits of 1.942 and 39.162, p = 0.005). This may hold particularly true in treatment-refractory patients because most of the studies included in this meta-analysis have enrolled these subjects in their primary analysis. Botulinum toxin appears to bea reasonable intervention for vaginismus. However, this conclusion should be read carefully because of the deficiency of placebo-controlled randomized clinical trials and the quality issues presented in the existing ones.

Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses.

PubMed

Blom, Kerstin; Jernelöv, Susanna; Rück, Christian; Lindefors, Nils; Kaldo, Viktor

2017-08-01

This 3-year follow-up compared insomnia treatment to depression treatment for patients with both diagnoses. Forty-three participants were randomized to either treatment, in the form of Internet-delivered therapist-guided cognitive behavior therapy (CBT), and 37 (86%) participants provided primary outcome data at the 3-year follow-up. After 3 years, reductions on depression severity were similar in both groups (between-group effect size, d = 0.33, p = .45), while the insomnia treatment had superior effects on insomnia severity (d = 0.66, p < .05). Overall, insomnia treatment was thus more beneficial than depression treatment. The implication for practitioners, supported by previous research, is that patients with co-occurring depression and insomnia should be offered CBT for insomnia, in addition to medication or psychological treatment for depression. © 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.

Structural Basis for Modulation of Quality Control Fate in a Marginally Stable Protein.

PubMed

Brock, Kelly P; Abraham, Ayelet-chen; Amen, Triana; Kaganovich, Daniel; England, Jeremy L

2015-07-07

The human von Hippel-Lindau (VHL) tumor suppressor is a marginally stable protein previously used as a model substrate of eukaryotic refolding and degradation pathways. When expressed in the absence of its cofactors, VHL cannot fold and is quickly degraded by the quality control machinery of the cell. We combined computational methods with in vivo experiments to examine the basis of the misfolding propensity of VHL. By expressing a set of randomly mutated VHL sequences in yeast, we discovered a more stable mutant form. Subsequent modeling suggested the mutation had caused a conformational change affecting cofactor and chaperone interaction, and this hypothesis was then confirmed by additional knockout and overexpression experiments targeting a yeast cofactor homolog. These findings offer a detailed structural basis for the modulation of quality control fate in a model misfolded protein and highlight burial mode modeling as a rapid means to detect functionally important conformational changes in marginally stable globular domains. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Reduced content of chloroatranol and atranol in oak moss absolute significantly reduces the elicitation potential of this fragrance material.

PubMed

Andersen, Flemming; Andersen, Kirsten H; Bernois, Armand; Brault, Christophe; Bruze, Magnus; Eudes, Hervé; Gadras, Catherine; Signoret, Anne-Cécile J; Mose, Kristian F; Müller, Boris P; Toulemonde, Bernard; Andersen, Klaus Ejner

2015-02-01

Oak moss absolute, an extract from the lichen Evernia prunastri, is a valued perfume ingredient but contains extreme allergens. To compare the elicitation properties of two preparations of oak moss absolute: 'classic oak moss', the historically used preparation, and 'new oak moss', with reduced contents of the major allergens atranol and chloroatranol. The two preparations were compared in randomized double-blinded repeated open application tests and serial dilution patch tests in 30 oak moss-sensitive volunteers and 30 non-allergic control subjects. In both test models, new oak moss elicited significantly less allergic contact dermatitis in oak moss-sensitive subjects than classic oak moss. The control subjects did not react to either of the preparations. New oak moss is still a fragrance allergen, but elicits less allergic contact dermatitis in previously oak moss-sensitized individuals, suggesting that new oak moss is less allergenic to non-sensitized individuals. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Coherence solution for bidirectional reflectance distributions of surfaces with wavelength-scale statistics.

PubMed

Hoover, Brian G; Gamiz, Victor L

2006-02-01

The scalar bidirectional reflectance distribution function (BRDF) due to a perfectly conducting surface with roughness and autocorrelation width comparable with the illumination wavelength is derived from coherence theory on the assumption of a random reflective phase screen and an expansion valid for large effective roughness. A general quadratic expansion of the two-dimensional isotropic surface autocorrelation function near the origin yields representative Cauchy and Gaussian BRDF solutions and an intermediate general solution as the sum of an incoherent component and a nonspecular coherent component proportional to an integral of the plasma dispersion function in the complex plane. Plots illustrate agreement of the derived general solution with original bistatic BRDF data due to a machined aluminum surface, and comparisons are drawn with previously published data in the examination of variations with incident angle, roughness, illumination wavelength, and autocorrelation coefficients in the bistatic and monostatic geometries. The general quadratic autocorrelation expansion provides a BRDF solution that smoothly interpolates between the well-known results of the linear and parabolic approximations.

Need to Recalibrate Research Outcomes in Alzheimer's Disease: Focus on Neuropsychiatric Symptoms.

PubMed

Canevelli, Marco; Cesari, Matteo; Lucchini, Flaminia; Valletta, Martina; Sabino, Michele; Lacorte, Eleonora; Vanacore, Nicola; Bruno, Giuseppe

2017-09-01

To determine whether neuropsychiatric symptoms (NPSs) are adequately considered in clinical research on Alzheimer's disease (AD). Systematic review. Randomized controlled trials (RCTs) recruiting individuals with AD and published during the last 10 years in 16 major general medicine, neurology, psychiatry, and geriatric psychiatry journals and RCTs registered on clinicaltrials.gov and currently enrolling individuals with AD. Individuals with AD. Outcome measures adopted by the included studies. Only 21.4% of the included studies identified through the bibliographic searches had measures of NPSs as a primary outcome. Only 17.7% of the studies retrieved on clinicaltrials.gov made a specific effort to test the effect of pharmacological or nonpharmacological interventions on NPSs. These findings show how rarely previous and current research on AD has considered NPSs as primary research targets. Although these symptoms are widely recognized as the most-stressful and -challenging manifestations of dementia, they are addressed much less often than other research targets. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

An efficient parallel-processing method for transposing large matrices in place.

PubMed

Portnoff, M R

1999-01-01

We have developed an efficient algorithm for transposing large matrices in place. The algorithm is efficient because data are accessed either sequentially in blocks or randomly within blocks small enough to fit in cache, and because the same indexing calculations are shared among identical procedures operating on independent subsets of the data. This inherent parallelism makes the method well suited for a multiprocessor computing environment. The algorithm is easy to implement because the same two procedures are applied to the data in various groupings to carry out the complete transpose operation. Using only a single processor, we have demonstrated nearly an order of magnitude increase in speed over the previously published algorithm by Gate and Twigg for transposing a large rectangular matrix in place. With multiple processors operating in parallel, the processing speed increases almost linearly with the number of processors. A simplified version of the algorithm for square matrices is presented as well as an extension for matrices large enough to require virtual memory.

Active music classes in infancy enhance musical, communicative and social development.

PubMed

Gerry, David; Unrau, Andrea; Trainor, Laurel J

2012-05-01

Previous studies suggest that musical training in children can positively affect various aspects of development. However, it remains unknown as to how early in development musical experience can have an effect, the nature of any such effects, and whether different types of music experience affect development differently. We found that random assignment to 6 months of active participatory musical experience beginning at 6 months of age accelerates acquisition of culture-specific knowledge of Western tonality in comparison to a similar amount of passive exposure to music. Furthermore, infants assigned to the active musical experience showed superior development of prelinguistic communicative gestures and social behaviour compared to infants assigned to the passive musical experience. These results indicate that (1) infants can engage in meaningful musical training when appropriate pedagogical approaches are used, (2) active musical participation in infancy enhances culture-specific musical acquisition, and (3) active musical participation in infancy impacts social and communication development. © 2012 Blackwell Publishing Ltd.

The Role of Unilateral Balloon Kyphoplasty for the Treatment of Patients with OVCFS: A Systematic Review and Meta-Analysis.

PubMed

Xiang, Guang-Heng; Tong, Min-Ji; Lou, Chao; Zhu, Si-Pin; Guo, Wei Jun; Ke, Chen Rong

2018-05-01

An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs). However, the efficacy and safety of unilateral kyphoplasty and whether a unilateral or a bilateral approach is superior is controversial. The purpose of this study was to evaluate the role of unilateral balloon kyphoplasty and use meta-analysis to compare the efficacy and safety of unilateral and bilateral kyphoplasty in patients with OVCFs. A systematic literature search was conducted from 1970 to April 2017 using Medline database and the Cochrane Central Register of Controlled Trials. Articles were limited to those published in English. Randomized controlled trials and nonrandomized comparative studies were also included. The following search terms were used: "osteoporotic vertebral compression fractures," or "OVCF," and "unilateral kyphoplasty," or "unipedicular approach," or "single balloon kyphoplasty," or "one balloon kyphoplasty." A comprehensive search of reference lists of retrieved articles and previous published reviews was also performed to ensure inclusion of all possible studies. All potential articles were independently reviewed by 2 investigators for inclusion into the final analysis. MINORS score was used for nonrandomized studies, and Detsky quality index was applied for prospective randomized controlled trials. Systematic review and meta-analysis was performed for the included studies. After unilateral balloon kyphoplasty the mean postoperative visual analog score (VAS) was from 1.74 to 4.77, mean postoperative kyphotic angle was from 5.9º to 11.22º, and complications involving cement leaks was from 6.8 to 21.9% or adjacent level fractures was from 0 to 5.6%). Unilateral kyphoplasty had significantly lower operative time, and less bone cement volume; however, the postoperative VAS, Oswestry Disability Index (ODI), vertebral height restoration rate, and cement leakage and adjacent vertebral fracture rate, were similar to bilateral kyphoplasty. Only 6 randomized controlled trials and 3 retrospective comparative studies were selected for analysis. Heterogeneity was detected among the studies when we pooled the outcomes. Based on the available evidence, the clinical and radiological results of unilateral balloon kyphoplasty were as good as those of bilateral balloon kyphoplasty for the treatment of OVCFs. And unilateral kyphoplasty had advantages in terms of operation time, radiation exposure, and cost. Unilateral balloon kyphoplasty, bilateral balloon kyphoplasty, osteoporotic vertebral compression fractures, complications of balloon kyphoplasty, meta-analysis.

Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.

PubMed

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M; Browning, David J; Chalam, K V; Davis, Matthew; Ferris, Frederick L; Glassman, Adam R; Maturi, Raj K; Stockdale, Cynthia R; Topping, Trexler M

2011-12-01

To describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Discussion of treatment protocol for DME. Subjects with vision loss resulting from DME involving the center of the macula. The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser treatment in eyes with vision loss resulting from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. To share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Clinical guidelines based on a DRCR.net protocol. The treatment protocol required real-time feedback from a web-based data entry system for intravitreal injections, focal/grid laser treatment, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Evaluation of a new neutron energy spectrum unfolding code based on an Adaptive Neuro-Fuzzy Inference System (ANFIS).

PubMed

Hosseini, Seyed Abolfazl; Esmaili Paeen Afrakoti, Iman

2018-01-17

The purpose of the present study was to reconstruct the energy spectrum of a poly-energetic neutron source using an algorithm developed based on an Adaptive Neuro-Fuzzy Inference System (ANFIS). ANFIS is a kind of artificial neural network based on the Takagi-Sugeno fuzzy inference system. The ANFIS algorithm uses the advantages of both fuzzy inference systems and artificial neural networks to improve the effectiveness of algorithms in various applications such as modeling, control and classification. The neutron pulse height distributions used as input data in the training procedure for the ANFIS algorithm were obtained from the simulations performed by MCNPX-ESUT computational code (MCNPX-Energy engineering of Sharif University of Technology). Taking into account the normalization condition of each energy spectrum, 4300 neutron energy spectra were generated randomly. (The value in each bin was generated randomly, and finally a normalization of each generated energy spectrum was performed). The randomly generated neutron energy spectra were considered as output data of the developed ANFIS computational code in the training step. To calculate the neutron energy spectrum using conventional methods, an inverse problem with an approximately singular response matrix (with the determinant of the matrix close to zero) should be solved. The solution of the inverse problem using the conventional methods unfold neutron energy spectrum with low accuracy. Application of the iterative algorithms in the solution of such a problem, or utilizing the intelligent algorithms (in which there is no need to solve the problem), is usually preferred for unfolding of the energy spectrum. Therefore, the main reason for development of intelligent algorithms like ANFIS for unfolding of neutron energy spectra is to avoid solving the inverse problem. In the present study, the unfolded neutron energy spectra of 252Cf and 241Am-9Be neutron sources using the developed computational code were found to have excellent agreement with the reference data. Also, the unfolded energy spectra of the neutron sources as obtained using ANFIS were more accurate than the results reported from calculations performed using artificial neural networks in previously published papers. © The Author(s) 2018. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

Preliminary Multivariable Cost Model for Space Telescopes

NASA Technical Reports Server (NTRS)

Stahl, H. Philip

2010-01-01

Parametric cost models are routinely used to plan missions, compare concepts and justify technology investments. Previously, the authors published two single variable cost models based on 19 flight missions. The current paper presents the development of a multi-variable space telescopes cost model. The validity of previously published models are tested. Cost estimating relationships which are and are not significant cost drivers are identified. And, interrelationships between variables are explored

Convergence in High Probability of the Quantum Diffusion in a Random Band Matrix Model

NASA Astrophysics Data System (ADS)

Margarint, Vlad

2018-06-01

We consider Hermitian random band matrices H in d ≥slant 1 dimensions. The matrix elements H_{xy}, indexed by x, y \\in Λ \\subset Z^d, are independent, uniformly distributed random variable if |x-y| is less than the band width W, and zero otherwise. We update the previous results of the converge of quantum diffusion in a random band matrix model from convergence of the expectation to convergence in high probability. The result is uniformly in the size |Λ| of the matrix.

Grey literature in meta-analyses of randomized trials of health care interventions.

PubMed

Hopewell, S; McDonald, S; Clarke, M; Egger, M

2007-04-18

The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most common types of grey literature were abstracts (55%) and unpublished data (30%). There is limited evidence to show whether grey trials are of poorer methodological quality than published trials. This review shows that published trials tend to be larger and show an overall greater treatment effect than grey trials. This has important implications for reviewers who need to ensure they identify grey trials, in order to minimise the risk of introducing bias into their review.

Nonuniform sampling theorems for random signals in the linear canonical transform domain

NASA Astrophysics Data System (ADS)

Shuiqing, Xu; Congmei, Jiang; Yi, Chai; Youqiang, Hu; Lei, Huang

2018-06-01

Nonuniform sampling can be encountered in various practical processes because of random events or poor timebase. The analysis and applications of the nonuniform sampling for deterministic signals related to the linear canonical transform (LCT) have been well considered and researched, but up to now no papers have been published regarding the various nonuniform sampling theorems for random signals related to the LCT. The aim of this article is to explore the nonuniform sampling and reconstruction of random signals associated with the LCT. First, some special nonuniform sampling models are briefly introduced. Second, based on these models, some reconstruction theorems for random signals from various nonuniform samples associated with the LCT have been derived. Finally, the simulation results are made to prove the accuracy of the sampling theorems. In addition, the latent real practices of the nonuniform sampling for random signals have been also discussed.

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

PubMed

Saunders, Gabrielle H; Biswas, Kousick; Serpi, Tracey; McGovern, Stephanie; Groer, Shirley; Stock, Eileen M; Magruder, Kathryn M; Storzbach, Daniel; Skelton, Kelly; Abrams, Thad; McCranie, Mark; Richerson, Joan; Dorn, Patricia A; Huang, Grant D; Fallon, Michael T

2017-11-01

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD. Published by Elsevier Inc.

Diabetes in pregnancy outcomes: a systematic review and proposed codification of definitions.

PubMed

Feig, Denice S; Corcoy, Rosa; Jensen, Dorte Moller; Kautzky-Willer, Alexandra; Nolan, Christopher J; Oats, Jeremy J N; Sacks, David A; Caimari, Francisca; McIntyre, H David

2015-10-01

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed

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.

Meta-Analysis of the Effect of Chest Shielding on Preventing Patent Ductus Arteriosus in Premature Infants.

PubMed

Mannan, Javed; Amin, Sanjiv B

2017-03-01

Objective  This study aims to perform a meta-analysis of randomized studies to evaluate if chest shielding during phototherapy is associated with decreased incidence of patent ductus arteriosus (PDA) in premature infants. Design/Methods  We used published guidelines for the meta-analysis of clinical trials. The search strategy included electronic searches of CINAHL, CENTRAL Cochrane Library, MEDLINE, PubMed, and abstracts presented at the Pediatric Academic Societies. Inclusion criteria were randomized controlled trials (RCTs), quasi-RCTs or cluster RCTs published in English and involving chest shielding during phototherapy in premature infants with PDA as an outcome. Exclusion criteria involved case reports, case series, and multiple publications from the same author. Heterogeneity testing using Q statistics was performed to evaluate the variance between studies. Results  Two RCTs met study criteria. There was heterogeneity (I 2 : 55.4%) between the two trials. Meta-analysis of RCTs using the random effect model demonstrated that chest shielding during phototherapy was associated with decreased incidence of PDA (odds ratio: 0.47, 95% confidence interval: 0.23-0.96). There was no publication bias on Eggers test. Heterogeneity was seen in gestational age, gender, prophylactic use of postnatal indomethacin, duration of phototherapy, and assessment of PDA. Conclusion  Chest shielding during phototherapy may be associated with decreased incidence of PDA among premature infants. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Precise algorithm to generate random sequential adsorption of hard polygons at saturation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, G.

Random sequential adsorption (RSA) is a time-dependent packing process, in which particles of certain shapes are randomly and sequentially placed into an empty space without overlap. In the infinite-time limit, the density approaches a "saturation'' limit. Although this limit has attracted particular research interest, the majority of past studies could only probe this limit by extrapolation. We have previously found an algorithm to reach this limit using finite computational time for spherical particles, and could thus determine the saturation density of spheres with high accuracy. Here in this paper, we generalize this algorithm to generate saturated RSA packings of two-dimensionalmore » polygons. We also calculate the saturation density for regular polygons of three to ten sides, and obtain results that are consistent with previous, extrapolation-based studies.« less

Precise algorithm to generate random sequential adsorption of hard polygons at saturation

DOE PAGES

Zhang, G.

2018-04-30

Random sequential adsorption (RSA) is a time-dependent packing process, in which particles of certain shapes are randomly and sequentially placed into an empty space without overlap. In the infinite-time limit, the density approaches a "saturation'' limit. Although this limit has attracted particular research interest, the majority of past studies could only probe this limit by extrapolation. We have previously found an algorithm to reach this limit using finite computational time for spherical particles, and could thus determine the saturation density of spheres with high accuracy. Here in this paper, we generalize this algorithm to generate saturated RSA packings of two-dimensionalmore » polygons. We also calculate the saturation density for regular polygons of three to ten sides, and obtain results that are consistent with previous, extrapolation-based studies.« less

Generation of physical random numbers by using homodyne detection

NASA Astrophysics Data System (ADS)

Hirakawa, Kodai; Oya, Shota; Oguri, Yusuke; Ichikawa, Tsubasa; Eto, Yujiro; Hirano, Takuya; Tsurumaru, Toyohiro

2016-10-01

Physical random numbers generated by quantum measurements are, in principle, impossible to predict. We have demonstrated the generation of physical random numbers by using a high-speed balanced photodetector to measure the quadrature amplitudes of vacuum states. Using this method, random numbers were generated at 500 Mbps, which is more than one order of magnitude faster than previously [Gabriel et al:, Nature Photonics 4, 711-715 (2010)]. The Crush test battery of the TestU01 suite consists of 31 tests in 144 variations, and we used them to statistically analyze these numbers. The generated random numbers passed 14 of the 31 tests. To improve the randomness, we performed a hash operation, in which each random number was multiplied by a random Toeplitz matrix; the resulting numbers passed all of the tests in the TestU01 Crush battery.

Staggered chiral random matrix theory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Osborn, James C.

2011-02-01

We present a random matrix theory for the staggered lattice QCD Dirac operator. The staggered random matrix theory is equivalent to the zero-momentum limit of the staggered chiral Lagrangian and includes all taste breaking terms at their leading order. This is an extension of previous work which only included some of the taste breaking terms. We will also present some results for the taste breaking contributions to the partition function and the Dirac eigenvalues.

CALL FOR PAPERS: Special issue on the random search problem: trends and perspectives

NASA Astrophysics Data System (ADS)

da Luz, Marcos G. E.; Grosberg, Alexander Y.; Raposo, Ernesto P.; Viswanathan, Gandhi M.

2008-11-01

This is a call for contributions to a special issue of Journal of Physics A: Mathematical and Theoretical dedicated to the subject of the random search problem. The motivation behind this special issue is to summarize in a single comprehensive publication, the main aspects (past and present), latest developments, different viewpoints and the directions being followed in this multidisciplinary field. We hope that such a special issue could become a particularly valuable reference for the broad scientific community working with the general random search problem. The Editorial Board has invited Marcos G E da Luz, Alexander Y Grosberg, Ernesto P Raposo and Gandhi M Viswanathan to serve as Guest Editors for the special issue. The general question of how to optimize the search for specific target objects in either continuous or discrete environments when the information available is limited is of significant importance in a broad range of fields. Representative examples include ecology (animal foraging, dispersion of populations), geology (oil recovery from mature reservoirs), information theory (automated researchers of registers in high-capacity database), molecular biology (proteins searching for their sites, e.g., on DNA ), etc. One reason underlying the richness of the random search problem relates to the `ignorance' of the locations of the randomly located `targets'. A statistical approach to the search problem can deal adequately with incomplete information and so stochastic strategies become advantageous. The general problem of how to search efficiently for randomly located target sites can thus be quantitatively described using the concepts and methods of statistical physics and stochastic processes. Scope Thus far, to the best of our knowledge, no recent textbook or review article in a physics journal has appeared on this topic. This makes a special issue with review and research articles attractive to those interested in acquiring a general introduction to the field. The subject can be approached from the perspective of different fields: ecology, networks, transport problems, molecular biology, etc. The study of the problem is particularly suited to the concepts and methods of statistical physics and stochastic processes; for example, fractals, random walks, anomalous diffusion. Discrete landscapes can be approached via graph theory, random lattices and complex networks. Such topics are regularly discussed in Journal of Physics A: Mathematical and Theoretical. All such aspects of the problem fall within the scope and focus of this special issue on the random search problem: trends and perspectives. Editorial policy All contributions to the special issue will be refereed in accordance with the refereeing policy of the journal. In particular, all research papers will be expected to be original work reporting substantial new results. The issue will also contain a number of review articles by invitation only. The Guest Editors reserve the right to judge whether a contribution fits the scope of the special issue. Guidelines for preparation of contributions We aim to publish the special issue in August 2009. To realize this, the DEADLINE for contributed papers is 15 January 2009. There is a page limit of 15 printed pages (approximately 9000 words) per contribution. For papers exceeding this limit, the Guest Editors reserve the right to request a reduction in length. Further advice on document preparation can be found at www.iop.org/Journals/jphysa. Contributions to the special issue should if possible be submitted electronically by web upload at www.iop.org/Journals/jphysa, or by email to jphysa@iop.org, quoting 'J. Phys. A Special Issue— Random Search Problem'. Please state whether the paper has been invited or is contributed. Submissions should ideally be in standard LaTeX form. Please see the website for further information on electronic submissions. Authors unable to submit electronically may send hard-copy contributions to: Publishing Administrators, Journal of Physics A, Institute of Physics Publishing, Dirac House, Temple Back, Bristol BS1 6BE, UK, enclosing electronic code on CD if available and quoting 'J. Phys. A Special Issue—Random Search Problem'. All contributions should be accompanied by a read-me file or covering letter giving the postal and e-mail addresses for correspondence. The Publishing Office should be notified of any subsequent change of address. This special issue will be published in the paper and online version of the journal. The corresponding author of each contribution will receive a complimentary copy of the issue.

Random Start Ovarian Stimulation for Oocyte or Embryo Cryopreservation in Women Desiring Fertility Preservation Prior to Gonadotoxic Cancer Therapy.

PubMed

Danis, Rachel B; Pereira, Nigel; Elias, Rony T

2017-11-10

Women of reproductive age diagnosed with cancer are often interested in preserving gametes or reproductive tissue that would allow for future genetic parenthood. Preservation of fertility is often accomplished in young cancer patients via ovarian stimulation followed by oocyte or embryo cryopreservation. Conventional stimulation protocols, however, require 2-4 weeks to complete ovarian stimulation, oocyte retrieval and possible fertilization. Such a strategy may not be feasible in patients requiring urgent cancer treatment. Recent studies have highlighted that random start ovarian stimulation can be initiated irrespective of the phase of the menstrual cycle and is an attractive alternative to conventional ovarian stimulation. The primary aim of the current review is to discuss the feasibility and success of random start ovarian stimulation for oocyte or embryo cryopreservation in women desiring fertility preservation prior to gonadotoxic cancer therapy. We performed a systematic review of medical literature published between January 2000 to June 2017 reporting the utility of random start ovarian stimulation for fertility preservation. Search terms included "fertility preservation," "cancer," "ovarian stimulation," "random-start ovarian stimulation," "embryo cryopreservation, and" "oocyte cryopreservation." Publications were included in this review only if patients underwent random start ovarian stimulation prior to cancer therapy. Nineteen publications were identified and perused by the authors. Most publications described the utility of random start ovarian stimulation in the setting of breast cancer. Radom-start stimulation was associated with a reduced time interval between ovarian stimulation initiation and oocyte or embryo cryopreservation. The yield of mature oocytes and their developmental potential into embryos was comparable between conventional and random-start protocols, albeit with higher gonadotropin doses in the latter. The current review suggests that random start ovarian stimulation can shorten the interval between ovarian stimulation and oocyte retrieval, with the yield of oocytes and embryos being comparable to conventional stimulation protocols. Thus, random start ovarian stimulation may serve as a better option for fertility preservation in patients requiring urgent cancer treatment. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

ASSISTments Dataset from Multiple Randomized Controlled Experiments

ERIC Educational Resources Information Center

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.…

Writing and Publishing Handbook.

ERIC Educational Resources Information Center

Hansen, William F., Ed.

Intended to provide guidance in academic publishing to faculty members, especially younger faculty members, this handbook is a compilation of four previously published essays by different authors. Following a preface and an introduction, the four essays and their authors are as follows: (1) "One Writer's Secrets" (Donald M. Murray); (2)…

Correction to: Durability of treatment effects of the sleep position trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial.

PubMed

de Ruiter, Maurits H T; Benoist, Linda B L; de Vries, Nico; de Lange, Jan

2018-05-01

The article "Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial", by M. H. T. de Ruiter et al., was originally published online in SpringerLink on 15 September 2017 without open access.

Changes & Challenges: Hot Topics in a New Era of Schools. Proceedings of the Education Law Association Winter Seminar (Park City, UT, March 15-18, 2001). Seminar Outlines.

ERIC Educational Resources Information Center

Education Law Association, Dayton, OH.

The following are outlines presented by individuals at the Education Law Association 2001 winter seminar: "Academic Freedom and the Religiously Affiliated University" (the freedom to teach, research, and publish has never been--and still is not--without limits); "How Random and Suspicionless May School Searches Be" (random and suspicionless drug…

[On the extinction of populations with several types in a random environment].

PubMed

Bacaër, Nicolas

2018-03-01

This study focuses on the extinction rate of a population that follows a continuous-time multi-type branching process in a random environment. Numerical computations in a particular example inspired by an epidemic model suggest an explicit formula for this extinction rate, but only for certain parameter values. Copyright © 2018 Académie des sciences. Published by Elsevier Masson SAS. All rights reserved.

The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: a Global Allergy and Asthma European Network (GA(2)LEN) article.

PubMed

Bousquet, Philippe J; Calderón, Moisés A; Demoly, Pascal; Larenas, Désirée; Passalacqua, Giovanni; Bachert, Claus; Brozek, Jan; Canonica, G Walter; Casale, Thomas; Fonseca, Joao; Dahl, Ronald; Durham, Stephen R; Merk, Hans; Worm, Margitta; Wahn, Ulrich; Zuberbier, Torsten; Schünemann, Holger J; Bousquet, Jean

2011-01-01

Randomized trials provide evidence to inform treatment decisions. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a set of recommendations for the reporting of trials. We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria. The reporting of the procedure, randomization, dropouts, strict conduct of intention-to-treat (ITT) analysis, and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy (SLIT) blind, placebo-controlled randomized trials published between 1996 and 2009 in English. One subcutaneous immunotherapy (2.2%) and 3 SLIT (6.6%) trials met CONSORT Statement criteria. These were used for the registration of sublingual tablets to the European Medicines Agency. In subcutaneous immunotherapy, 16 (35%) studies reported a CONSORT flow chart, and 12 (26%) provided a description of dropouts. Adequate randomization was reported in 9 (35%) studies, and incomplete randomization was reported in 15 (33%). Power analysis was reported in 15 (33%) studies. In SLIT, 20 (42%) studies reported a CONSORT flow chart, and 16 (32%) a description of dropouts. ITT analysis was carried out in 1 (2.2%) SLIT study, and a modified ITT analysis was used in 1 (2.2%) subcutaneous immunotherapy study and 2 (4.4%) SLIT studies. Adequate randomization was reported in 6 (12%) studies, and incomplete randomization was reported in 16 (32%). Power analysis was reported in 15 (27%) studies. As in other areas of medicine, the quality of reporting of most immunotherapy trials is low, and only 4.2% of SLIT randomized controlled trials met all of the criteria of the CONSORT Statement. Use of the CONSORT criteria should be encouraged. Copyright © 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Empirical retrocausality: Testing physics hypotheses with parapsychological experiments

NASA Astrophysics Data System (ADS)

Dobyns, York

2017-05-01

In 2011, Daryl Bem published a report of nine parapsychological experiments showing evidence of retrocausal information transfer. Earlier in 2016, the team of Bem, Tressoldi, Rabeyron, and Duggan published the results of a meta-analysis containing 81 independent replications of the original Bem experiments (total of 90 with the originals).[1] This much larger database continues to show positive results of generally comparable effect size, thus demonstrating that the effects claimed by Bem can be replicated by independent researchers and greatly strengthening the case for empirically observed retrocausation. Earlier (2011) work by this author showed how a modification of one of Bem's original experiments could be used to test the mechanism implicitly proposed by Echeverria, Klinkhammer, and Thorne to explain how retrocausal phenomena can exist without any risk of self-contradictory event sequences (time paradoxes). In light of the new publication and new evidence, the current work generalizes the previous analysis which was restricted to only one of Bem's experimental genres (precognitive approach and avoidance). The current analysis shows how minor modifications can be made in Bem's other experimental genres of retroactive priming, retroactive habituation, and retroactive facilitation of recall to test the EKT anti-paradox mechanism. If the EKT hypothesis is correct, the modified experiments, while continuing to show replicable retrocausal phenomena, will also show a characteristic pattern of distortion in the statistics of the random selections used to drive the experiments.

Risk of Death in Infants Who Have Experienced a Brief Resolved Unexplained Event: A Meta-Analysis.

PubMed

Brand, Donald A; Fazzari, Melissa J

2018-06-01

To estimate an upper bound on the risk of death after a brief resolved unexplained event (BRUE), a sudden alteration in an infant's breathing, color, tone, or responsiveness, previously labeled "apparent life-threatening event" (ALTE). The meta-analysis incorporated observational studies of patients with ALTE that included data on in-hospital and post-discharge deaths with at least 1 week of follow-up after hospital discharge. Pertinent studies were identified from a published review of the literature from 1970 through 2014 and a supplementary PubMed query through February 2017. The 12 included studies (n = 3005) reported 12 deaths, of which 8 occurred within 4 months of the event. Applying a Poisson-normal random effects model to the 8 proximate deaths using a 4-month time horizon yielded a post-ALTE mortality rate of about 1 in 800, which constitutes an upper bound on the risk of death after a BRUE. This risk is about the same as the baseline risk of death during the first year of life. The meta-analysis therefore supports the return-home approach advocated in a recently published clinical practice guideline-not routine hospitalization-for BRUE patients who have been evaluated in the emergency department and determined to be at lower risk. Copyright © 2017 Elsevier Inc. All rights reserved.

Using direct mail to promote organ donor registration: Two campaigns and a meta-analysis.

PubMed

Feeley, Thomas H; Quick, Brian L; Lee, Seyoung

2016-12-01

Two direct mail campaigns were undertaken in Rochester and Buffalo, New York, with the goal of enrolling adults aged 50-64 years into the state organ and tissue donation electronic registry. Meta-analytic methods were used to summarize the body of research on the effects of direct mail marketing to promote organ donation registration. In the first study, 40 000 mailers were sent to targeted adults in Rochester, New York, and varied by brochure-only, letter-only, and letter plus brochure mailing conditions. A follow-up mailer using letter-only was sent to 20 000 individuals in Buffalo, New York area. In a second study, campaign results were combined with previously published direct mail campaigns in a random-effects meta-analysis. The overall registration rates were 1.6% and 4.6% for the Rochester and Buffalo campaigns, and the letter-only condition outperformed the brochure-only and letter plus brochure conditions in the Rochester area campaigns. Meta-analysis indicated a 3.3% registration rates across 15 campaigns and 329 137 targeted individuals. Registration rates were higher when targeting 18-year-olds and when direct mail letters were authored by officials affiliated with state departments. Use of direct mail to promote organ donor registration is an inexpensive method to increase enrollments in state registries. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Motivators and barriers of tamoxifen use as risk-reducing medication amongst women at increased breast cancer risk: a systematic literature review.

PubMed

Meiser, B; Wong, W K T; Peate, M; Julian-Reynier, C; Kirk, J; Mitchell, G

2017-01-01

Selective estrogen receptor modulators, such as tamoxifen, reduce breast cancer risk by up to 50% in women at increased risk for breast cancer. Despite tamoxifen's well-established efficacy, many studies show that most women are not taking up tamoxifen. This systematic literature review aimed to identify the motivators and barriers to tamoxifen use 's amongst high-risk women. Using MEDLINE, PsycINFO, and Embase plus reviewing reference lists of relevant articles published between 1995 and 2016, 31 studies (published in 35 articles) were identified, which addressed high-risk women's decisions about risk-reducing medication to prevent breast cancer and were peer-reviewed primary clinical studies. A range of factors were identified as motivators of, and barriers to, tamoxifen uptake including: perceived risk, breast-cancer-related anxiety, health professional recommendation, perceived drug effectiveness, concerns about side-effects, knowledge and access to information about side-effects, beliefs about the role of risk-reducing medication, provision of a biomarker, preference for other forms of breast cancer risk reduction, previous treatment experience, concerns about randomization in clinical trial protocols and finally altruism. Results indicate that the decision for high-risk women regarding tamoxifen use or non-use as a risk-reducing medication is not straightforward. Support of women making this decision is essential and needs to encompass the full range of factors, both informational and psychological.

Designing, testing, and implementing a sustainable nurse home visiting program: right@home.

PubMed

Goldfeld, Sharon; Price, Anna; Kemp, Lynn

2018-05-01

Nurse home visiting (NHV) offers a potential platform to both address the factors that limit access to services for families experiencing adversity and provide effective interventions. Currently, the ability to examine program implementation is hampered by a lack of detailed description of actual, rather than expected, program development and delivery in published studies. Home visiting implementation remains a black box in relation to quality and sustainability. However, previous literature would suggest that efforts to both report and improve program implementation are vital for NHV to have population impact and policy sustainability. In this paper, we provide a case study of the design, testing, and implementation of the right@home program, an Australian NHV program and randomized controlled trial. We address existing gaps related to implementation of NHV programs by describing the processes used to develop the program to be trialed, summarizing its effectiveness, and detailing the quality processes and implementation evaluation. The weight of our evidence suggests that NHV can be a powerful and sustainable platform for addressing inequitable outcomes, particularly when the program focuses on parent engagement and partnership, delivers evidence-based strategies shown to improve outcomes, includes fidelity monitoring, and is adapted to and embedded within existing service delivery systems. © 2018 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of The New York Academy of Sciences.

Non-every day statin administration--a literature review.

PubMed

Elis, Avishay; Lishner, Michael

2012-07-01

Statins are the treatment of choice for lowering LDL-C levels and reducing cardiovascular events. They have a remarkable safety profile, although some patients do not tolerate them. The aim of the study was to summarize the existing data on non-every day statin administration regimens. We searched the MEDLINE databases to identify articles on non-every day statin administration, published between 1990 and January 2010. All publications regardless of methodology, design, size, or language were included. Data extracted included study design, duration and aims, type of statin, therapeutic regimen, patient characteristics, effectiveness, tolerability, and costs. The 21 retrieved articles were characterized by small sample size, short follow up period, and a preponderance of males and "primary" prevention cases. Several lacked randomization or a control group. The heterogeneity of the study groups, medications, doses, design and aims precluded a pooled or meta-analysis. The most reported and effective regimens were atorvastatin and rosuvastatin on alternate days. These regimens, with or without other lipid lowering agents, were well tolerated even among subjects with previous statin intolerance, and produced meaningful cost savings. Nevertheless, the effectiveness of these regimens on cardiovascular events was not clarified. Atorvastatin or rosuvastatin on alternate days might be considered for patients who are intolerant to statin therapy. Further studies are needed to evaluate the effect of these regimens on cardiovascular events. Copyright © 2012 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Factors Influencing Efficacy of Nutrition Education Interventions: A Systematic Review.

PubMed

Murimi, Mary W; Kanyi, Michael; Mupfudze, Tatenda; Amin, Md Ruhul; Mbogori, Teresia; Aldubayan, Khalid

2017-02-01

To examine systematically factors that contribute to the efficacy of nutrition education interventions in promoting behavior change for good health based on their stated objective. In a departure from previous reviews, the researchers investigated factors that lead to success of various types of interventions. Critical analysis of these factors constituted the outcome of this review. This study followed Preferred Reporting Items for Systematic Reviews and Meta-analysis criteria. A total of 246 original articles published between 2009 and 2015 in PubMed, Medline, Web of Science, Academic Search Complete, Science Direct, Cochrane Reviews, ERIC, and PsychLIT were initially considered. The number was screened and scaled down to 40 publications for the final analysis. Quality assessment was based on the Cochrane Handbook for Systematic Reviews of Intervention. Studies were rated as having low risk of bias, moderate risk, or high risk. Efficacy of nutrition education interventions depended on major factors: interventions that lasted ≥5 months; having ≤3 focused objectives; appropriate design and use of theories; fidelity in interventions; and support from policy makers and management for worksite environmental interventions. Intervention duration of ≥5 months, ≤3 focused objectives, randomization, use of theories, and fidelity are factors that enhance success of interventions based on the results of this study. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.