Sample records for a-site randomness effect

  1. Using Multisite Experiments to Study Cross-Site Variation in Treatment Effects: A Hybrid Approach with Fixed Intercepts and A Random Treatment Coefficient

    ERIC Educational Resources Information Center

    Bloom, Howard S.; Raudenbush, Stephen W.; Weiss, Michael J.; Porter, Kristin

    2017-01-01

    The present article considers a fundamental question in evaluation research: "By how much do program effects vary across sites?" The article first presents a theoretical model of cross-site impact variation and a related estimation model with a random treatment coefficient and fixed site-specific intercepts. This approach eliminates…

  2. Financial Management of a Large Multi-site Randomized Clinical Trial

    PubMed Central

    Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

    2014-01-01

    Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

  3. Effective dynamics of a random walker on a heterogeneous ring: Exact results

    NASA Astrophysics Data System (ADS)

    Masharian, S. R.

    2018-07-01

    In this paper, by considering a biased random walker hopping on a one-dimensional lattice with a ring geometry, we investigate the fluctuations of the speed of the random walker. We assume that the lattice is heterogeneous i.e. the hopping rate of the random walker between the first and the last lattice sites is different from the hopping rate of the random walker between the other links of the lattice. Assuming that the average speed of the random walker in the steady-state is v∗, we have been able to find the unconditional effective dynamics of the random walker where the absolute value of the average speed of the random walker is -v∗. Using a perturbative method in the large system-size limit, we have also been able to show that the effective hopping rates of the random walker near the defective link are highly site-dependent.

  4. How Much Do the Effects of Education and Training Programs Vary across Sites? Evidence from Past Multisite Randomized Trials

    ERIC Educational Resources Information Center

    Weiss, Michael J.; Bloom, Howard S.; Verbitsky-Savitz, Natalya; Gupta, Himani; Vigil, Alma E.; Cullinan, Daniel N.

    2017-01-01

    Multisite trials, in which individuals are randomly assigned to alternative treatment arms within sites, offer an excellent opportunity to estimate the cross-site average effect of treatment assignment (intent to treat or ITT) "and" the amount by which this impact varies across sites. Although both of these statistics are substantively…

  5. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  6. Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

    PubMed

    Demaerschalk, Bart M; Brown, Robert D; Roubin, Gary S; Howard, Virginia J; Cesko, Eldina; Barrett, Kevin M; Longbottom, Mary E; Voeks, Jenifer H; Chaturvedi, Seemant; Brott, Thomas G; Lal, Brajesh K; Meschia, James F; Howard, George

    2017-09-01

    Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection. In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type. For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. © 2017

  7. The effects of Alkanna tinctoria Tausch on split-thickness skin graft donor site management: a randomized, blinded placebo-controlled trial.

    PubMed

    Kheiri, Aliasghar; Amini, Shahideh; Javidan, Abbas Norouzi; Saghafi, Mohammad Mehdi; Khorasani, Ghasemali

    2017-05-08

    A prospective, randomized, placebo-controlled clinical trial was conducted to compare the healing effectiveness of Alkanna tinctoria (L.) Tausch (Boraginaceae) with standard dressing on wound healing at the donor site after removal of the skin graft. Enrolled patients were randomly allocated to receive topicalA. tinctoria extract ointment (20%) or standard dressing (dressing with base ointment) daily. Wound healing was assessed using the Bates-Jenson assessment tool at the 2 nd and 4 th weeks after intervention. Decreases in wound score were significantly greater in the A. tinctoria group compared with the placebo group (P <0.05). The surface areas of graft donor sites in the A. tinctoria group were significantly reduced as compared with the control group at day 28 of the intervention (P < 0.05). The proportion of patients in the A. tinctoria group achieving complete wound healing within 2 to 4 weeks was 50% and 96.66%, respectively, significantly higher than in patients receiving standard care: 0% and 23.3%, respectively. This clinical study showed that A. tinctoria dressing accelerates wound healing after graft harvesting. IRCT ID: IRCT201511165781N2 .

  8. Effects of injection-site splinting on the incidence of phlebitis in patients taking peripherally infused amiodarone: A randomized clinical trial.

    PubMed

    Ayat-Isfahani, Farah; Pashang, Mina; Davoudi, Bita; Sadeghian, Saeed; Jalali, Arash

    2017-03-01

    Intravenous amiodarone is considered an effective treatment option for cardiac ventricular and atrial arrhythmias. Peripheral infusion of amiodarone may cause blood vessels irritation and phlebitis that is the most common complication of this drug by this route even when it is administered within recommended dosing limits. The effect of injection-site splinting on the occurrence of phlebitis among a group of cardiac arrhythmia patients receiving peripherally infused amiodarone. This research is a clinical trial on patients of Tehran Heart Center who were hospitalized due to cardiac arrhythmias. A sample of 60 patients with mean age 65 ± 14 years were randomly divided into control and test groups. In the experimental group with close splint and restrict the movement of the injection site until the end of the infusion and control groups without closing brace, at the same time received amiodarone. Injection protocol was similar for both groups. The results were analyzed with Spss18. The results of this research still significantly reduced the incidence of amiodarone injection-site phlebitis in the injection time (P = .005). Copyright © 2016 Society for Vascular Nursing, Inc. Published by Elsevier Inc. All rights reserved.

  9. Effect-site concentration of propofol required for LMA-Supreme™ insertion with and without remifentanil: a randomized controlled trial.

    PubMed

    Zaballos, Matilde; Bastida, Emilia; Agustí, Salomé; Portas, Maite; Jiménez, Consuelo; López-Gil, Maite

    2015-10-06

    A new supraglottic device, the LMA-Supreme™, has recently become available for clinical use. Information on anaesthetic and co-adjuvant requirements for insertion of the LMA-Supreme™ is limited. The present study aimed to evaluate the optimal effect-site concentration of propofol in 50 % (EC50) of adults necessary for successful insertion of the LMA-Supreme™ and to examine remifentanil's effect on propofol requirements. Fifty-eight elective patients (aged 18-60 years; ASA (American Society Anaesthesiologists) physical status classification I and II) scheduled for day surgery were randomly assigned to one of two groups: propofol with saline or propofol with remifentanil. Anaesthesia was induced by target-controlled infusion according to predetermined effect-site concentrations of propofol and remifentanil (5 ng.mL(-1)). The EC50 was calculated using Dixon's up-and-down method. Ten minutes following drug administration, LMA-Supreme™ insertion was attempted without the use of muscle relaxant drugs. In the propofol + saline group, the EC50 of propofol required for LMA-Supreme™ insertion was 6.32 ± 0.67 μg.mL(-1) (95 % CI, 5.69-6.94 μg.mL(-1)). With the addition of remifentanil at an effect-site concentration of 5 ng.mL(-1), the EC50 of propofol required for LMA-Supreme™ insertion was 2.50 ± 0.80 μg.mL(-1) (95 % CI, 1.82-3.17 μg.mL(-1); p < 0.0001). The propofol requirement for smooth insertion of the LMA-Supreme™ was 60 % less when remifentanil (5 ng.mL(-1)) was co-administered. Identified as NCT01974648 at www.clinicaltrials.gov .

  10. Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

    2016-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

  11. Effect-site concentration of remifentanil required to blunt haemodynamic responses during tracheal intubation: A randomized comparison between single- and double-lumen tubes.

    PubMed

    Kim, Tae Kyong; Hong, Deok Man; Lee, Seo Hee; Paik, Hyesun; Min, Se Hee; Seo, Jeong-Hwa; Jung, Chul-Woo; Bahk, Jae-Hyon

    2018-01-01

    Objective To investigate the effect-site concentration of remifentanil required to blunt haemodynamic responses during tracheal intubation with a single-lumen tube (SLT) or a double-lumen tube (DLT). Methods Patients scheduled for thoracic surgery requiring one-lung ventilation were randomly allocated to either the SLT or DLT group. All patients received a target-controlled infusion of propofol and a predetermined concentration of remifentanil. Haemodynamic parameters during intubation were recorded. The effect-site concentration of remifentanil was determined using a delayed up-and-down sequential allocation method. Results A total of 92 patients were enrolled in the study. The effective effect-site concentrations of remifentanil required to blunt haemodynamic responses in 50% of patients (EC 50 ) estimated by isotonic regression with bootstrapping was higher in the DLT than the SLT group (8.5 ng/ml [95% confidence interval (CI) 8.0-9.5 ng/ml] versus 6.5 ng/ml [95% CI 5.6-6.7 ng/ml], respectively). Similarly, the effective effect-site concentrations of remifentanil in 95% of patients in the DLT group was higher than the SLT group (9.9 ng/ml [95% CI 9.8-10.0 ng/ml] versus 7.0 ng/ml [95% CI 6.9-7.0 ng/ml], respectively). Conclusions This study demonstrated that a DLT requires a 30% higher EC 50 of remifentanil than does an SLT to blunt haemodynamic responses during tracheal intubation when combined with a target-controlled infusion of propofol. Trial registration Clinicaltrials.gov identifier: NCT01542099.

  12. RF-Phos: A Novel General Phosphorylation Site Prediction Tool Based on Random Forest.

    PubMed

    Ismail, Hamid D; Jones, Ahoi; Kim, Jung H; Newman, Robert H; Kc, Dukka B

    2016-01-01

    Protein phosphorylation is one of the most widespread regulatory mechanisms in eukaryotes. Over the past decade, phosphorylation site prediction has emerged as an important problem in the field of bioinformatics. Here, we report a new method, termed Random Forest-based Phosphosite predictor 2.0 (RF-Phos 2.0), to predict phosphorylation sites given only the primary amino acid sequence of a protein as input. RF-Phos 2.0, which uses random forest with sequence and structural features, is able to identify putative sites of phosphorylation across many protein families. In side-by-side comparisons based on 10-fold cross validation and an independent dataset, RF-Phos 2.0 compares favorably to other popular mammalian phosphosite prediction methods, such as PhosphoSVM, GPS2.1, and Musite.

  13. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

    PubMed

    Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

    2016-08-31

    In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

  14. Computerized stratified random site-selection approaches for design of a ground-water-quality sampling network

    USGS Publications Warehouse

    Scott, J.C.

    1990-01-01

    Computer software was written to randomly select sites for a ground-water-quality sampling network. The software uses digital cartographic techniques and subroutines from a proprietary geographic information system. The report presents the approaches, computer software, and sample applications. It is often desirable to collect ground-water-quality samples from various areas in a study region that have different values of a spatial characteristic, such as land-use or hydrogeologic setting. A stratified network can be used for testing hypotheses about relations between spatial characteristics and water quality, or for calculating statistical descriptions of water-quality data that account for variations that correspond to the spatial characteristic. In the software described, a study region is subdivided into areal subsets that have a common spatial characteristic to stratify the population into several categories from which sampling sites are selected. Different numbers of sites may be selected from each category of areal subsets. A population of potential sampling sites may be defined by either specifying a fixed population of existing sites, or by preparing an equally spaced population of potential sites. In either case, each site is identified with a single category, depending on the value of the spatial characteristic of the areal subset in which the site is located. Sites are selected from one category at a time. One of two approaches may be used to select sites. Sites may be selected randomly, or the areal subsets in the category can be grouped into cells and sites selected randomly from each cell.

  15. A randomized trial of povidone-iodine compared with iodine tincture for venipuncture site disinfection: effects on rates of blood culture contamination.

    PubMed

    Little, J R; Murray, P R; Traynor, P S; Spitznagel, E

    1999-08-01

    Contamination of blood cultures creates problems in their interpretation and unneeded resource utilization. Because skin flora comprise the major group of contaminant species, more effective skin disinfection at the venipuncture site could reduce contamination. We performed a randomized trial in adult inpatients at a tertiary care teaching hospital. Antecubital venipuncture sites were randomly disinfected with povidone-iodine or iodine tincture, and blood cultures (two bottles, 10 mL of blood) were drawn by professional phlebotomists. Scoring of contaminant species was restricted to skin flora. Hospital resource utilization was compared among patients with contaminated blood cultures and those with sterile blood cultures. Of the 3,851 blood cultures collected during the study, 120 (3.1%) were contaminated with skin flora. The contamination rate for blood cultures collected after povidone-iodine was 3.8% (74 of 1,947), compared with a rate of 2.4% (46 of 1,904, P = 0.01) after iodine tincture. The difference in mean total hospital costs for patients with contaminated blood cultures and those with sterile blood cultures was $4,100 (95% confidence interval: $740 to $7,400, P = 0.02). Iodine tincture is superior to povidone-iodine for venipuncture site antisepsis before blood culture sampling. Because of the high costs associated with contaminated blood cultures, hospitals should consider switching from povidone-iodine to iodine tincture. Reduction of the contamination rate may improve the quality of patient care and reduce hospital costs.

  16. Stochastic Seismic Response of an Algiers Site with Random Depth to Bedrock

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

    Badaoui, M.; Mebarki, A.; Berrah, M. K.

    2010-05-21

    Among the important effects of the Boumerdes earthquake (Algeria, May 21{sup st} 2003) was that, within the same zone, the destructions in certain parts were more important than in others. This phenomenon is due to site effects which alter the characteristics of seismic motions and cause concentration of damage during earthquakes. Local site effects such as thickness and mechanical properties of soil layers have important effects on the surface ground motions.This paper deals with the effect of the randomness aspect of the depth to bedrock (soil layers heights) which is assumed to be a random variable with lognormal distribution. Thismore » distribution is suitable for strictly non-negative random variables with large values of the coefficient of variation. In this case, Monte Carlo simulations are combined with the stiffness matrix method, used herein as a deterministic method, for evaluating the effect of the depth to bedrock uncertainty on the seismic response of a multilayered soil. This study considers a P and SV wave propagation pattern using input accelerations collected at Keddara station, located at 20 km from the epicenter, as it is located directly on the bedrock.A parametric study is conducted do derive the stochastic behavior of the peak ground acceleration and its response spectrum, the transfer function and the amplification factors. It is found that the soil height heterogeneity causes a widening of the frequency content and an increase in the fundamental frequency of the soil profile, indicating that the resonance phenomenon concerns a larger number of structures.« less

  17. Stochastic Seismic Response of an Algiers Site with Random Depth to Bedrock

    NASA Astrophysics Data System (ADS)

    Badaoui, M.; Berrah, M. K.; Mébarki, A.

    2010-05-01

    Among the important effects of the Boumerdes earthquake (Algeria, May 21st 2003) was that, within the same zone, the destructions in certain parts were more important than in others. This phenomenon is due to site effects which alter the characteristics of seismic motions and cause concentration of damage during earthquakes. Local site effects such as thickness and mechanical properties of soil layers have important effects on the surface ground motions. This paper deals with the effect of the randomness aspect of the depth to bedrock (soil layers heights) which is assumed to be a random variable with lognormal distribution. This distribution is suitable for strictly non-negative random variables with large values of the coefficient of variation. In this case, Monte Carlo simulations are combined with the stiffness matrix method, used herein as a deterministic method, for evaluating the effect of the depth to bedrock uncertainty on the seismic response of a multilayered soil. This study considers a P and SV wave propagation pattern using input accelerations collected at Keddara station, located at 20 km from the epicenter, as it is located directly on the bedrock. A parametric study is conducted do derive the stochastic behavior of the peak ground acceleration and its response spectrum, the transfer function and the amplification factors. It is found that the soil height heterogeneity causes a widening of the frequency content and an increase in the fundamental frequency of the soil profile, indicating that the resonance phenomenon concerns a larger number of structures.

  18. Effects of supplemental oxygen and dexamethasone on surgical site infection: a factorial randomized trial‡.

    PubMed

    Kurz, A; Fleischmann, E; Sessler, D I; Buggy, D J; Apfel, C; Akça, O

    2015-09-01

    Tissue oxygenation is a strong predictor of surgical site infection. Improving tissue oxygenation should thus reduce wound infection risk. Supplemental inspired oxygen can improve tissue oxygenation, but whether it reduces infection risk remains controversial. Low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting, but steroid-induced immunosuppression can increase infection risk. We therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it. Using a factorial design, patients having colorectal resections expected to last ≥2 h were randomly assigned to 30% (n=270) or 80% (n=285) inspired oxygen during and for 1 h after surgery, and to 4 mg intraoperative dexamethasone (n=283) or placebo (n=272). Physicians blinded to group assignments evaluated wounds postoperatively, using US Centers for Disease Control criteria. Subject and surgical characteristics were similar among study groups. Surgical site infection incidence was similar among groups: 30% oxygen 15.6%, 80% oxygen 15.8% (P=1.00); dexamethasone 15.9%, placebo 15.4%, (P=0.91). Supplemental oxygen did not reduce surgical site infection risk. The preponderance of clinical evidence suggests that administration of 80% supplemental inspired oxygen does not reduce infection risk. We did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone, indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections. ClinicalTrials.gov number: NCT00273377. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial.

    PubMed

    Ngai, Ivan M; Van Arsdale, Anne; Govindappagari, Shravya; Judge, Nancy E; Neto, Nicole K; Bernstein, Jeffrey; Bernstein, Peter S; Garry, David J

    2015-12-01

    To compare chlorhexidine with alcohol, povidone-iodine with alcohol, and both applied sequentially to estimate their relative effectiveness in prevention of surgical site infections after cesarean delivery. Women undergoing nonemergent cesarean birth at greater than 37 0/7 weeks of gestation were randomly allocated to one of three antiseptic skin preparations: povidone-iodine with alcohol, chlorhexidine with alcohol, or the sequential combination of both solutions. The primary outcome was surgical site infection reported within the first 30 days postpartum. Based on a surgical site infection rate of 12%, an anticipated 50% reduction for the combination group relative to either single skin preparation group, with a power of 0.90 and an α of 0.05, 430 women per group were needed to detect a difference. From January 2013 to July 2014, 1,404 women were randomly assigned to one of three groups: povidone-iodine with alcohol (n=463), chlorhexidine with alcohol (n=474), or both (n=467). The groups were similar with respect to demographics, medical disorders, indication for cesarean delivery, operative time, and blood loss. The overall rate of surgical site infection-4.3%-was lower than anticipated. The skin preparation groups had similar surgical site infection rates: povidone-iodine 4.6%, chlorhexidine with alcohol 4.5%, and sequential 3.9% (P=.85). The skin preparation techniques resulted in similar rates of surgical site infections. Our study provides no support for any particular method of skin preparation before cesarean delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01870583. I.

  20. Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice.

    PubMed

    Kutner, Jean; Smith, Marlaine; Mellis, Karen; Felton, Sue; Yamashita, Traci; Corbin, Lisa

    2010-06-01

    Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.

  1. Percolation of the site random-cluster model by Monte Carlo method

    NASA Astrophysics Data System (ADS)

    Wang, Songsong; Zhang, Wanzhou; Ding, Chengxiang

    2015-08-01

    We propose a site random-cluster model by introducing an additional cluster weight in the partition function of the traditional site percolation. To simulate the model on a square lattice, we combine the color-assignation and the Swendsen-Wang methods to design a highly efficient cluster algorithm with a small critical slowing-down phenomenon. To verify whether or not it is consistent with the bond random-cluster model, we measure several quantities, such as the wrapping probability Re, the percolating cluster density P∞, and the magnetic susceptibility per site χp, as well as two exponents, such as the thermal exponent yt and the fractal dimension yh of the percolating cluster. We find that for different exponents of cluster weight q =1.5 , 2, 2.5 , 3, 3.5 , and 4, the numerical estimation of the exponents yt and yh are consistent with the theoretical values. The universalities of the site random-cluster model and the bond random-cluster model are completely identical. For larger values of q , we find obvious signatures of the first-order percolation transition by the histograms and the hysteresis loops of percolating cluster density and the energy per site. Our results are helpful for the understanding of the percolation of traditional statistical models.

  2. Effect of Intraoperative Platelet-Rich Plasma Treatment on Postoperative Donor Site Knee Pain in Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: A Double-Blind Randomized Controlled Trial.

    PubMed

    Walters, Brian L; Porter, David A; Hobart, Sarah J; Bedford, Benjamin B; Hogan, Daniel E; McHugh, Malachy M; Klein, Devon A; Harousseau, Kendall; Nicholas, Stephen J

    2018-05-01

    Donor site morbidity in the form of anterior knee pain is a frequent complication after bone-patellar tendon-bone (BPTB) autograft anterior cruciate ligament (ACL) reconstruction. Hypothesis/Purpose: The purpose was to examine the effect of the intraoperative administration of platelet-rich plasma (PRP) on postoperative kneeling pain. It was hypothesized that PRP treatment would reduce knee pain. Randomized controlled trial; Level of evidence, 2. Fifty patients (mean ± SD age, 30 ± 12 years) undergoing BPTB ACL autograft reconstruction were randomized to the PRP (n = 27) or sham (n = 23) treatment. In either case, 10 mL of venous blood was drawn before the induction of anesthesia and either discarded (sham) or processed (PRP) for preparation of a PRP gel to be later mixed with donor site bone chips and inserted into the patellar defect. At 12 weeks, 6 months, 1 year, and 2 years after surgery, patients completed International Knee Documentation Committee (IKDC) forms and visual analog scale pain scores for activities of daily living and kneeling. Healing indices at the donor site were assessed by routine noncontrast magnetic resonance imaging (MRI) at 6 months. Mixed-model analysis of variance was used to assess the effect of PRP on patient symptoms and MRI indices of donor site healing, as measured by the width of the donor site defect. Kneeling pain, pain with activities of daily living, and IKDC scores were not different between treatment groups at any of the time intervals ( P = .08-.83). Kneeling pain improved from 12 weeks to 6 months and from 1 to 2 years ( P < .05). IKDC scores improved substantially from 12 weeks to 6 months ( P < .001) and continued to improve to 2 years (PRP, 86 ± 19; sham, 89 ± 10). MRI indices of donor site healing were not different between treatment groups ( P = .53-.90). Whether randomized to receive PRP in their patellar defect or not, patients continued to have similar levels of kneeling pain and patellar defect sizes after

  3. A Two-site Randomized Clinical Trial of Integrated Psychosocial Treatment for ADHD-Inattentive Type

    PubMed Central

    Pfiffner, Linda J.; Hinshaw, Stephen P.; Owens, Elizabeth; Zalecki, Christine; Kaiser, Nina M.; Villodas, Miguel; McBurnett, Keith

    2014-01-01

    Objective This study evaluated the efficacy of the Child Life and Attention Skills (CLAS) program, a behavioral psychosocial treatment integrated across home and school, for youth with Attention Deficit Hyperactivity Disorder-Inattentive Type (ADHD-I). Method In a two-site randomized controlled trial, 199 children (ages 7-11) were randomized to CLAS (N=74), parent-focused treatment (PFT, N=74), or treatment as usual (TAU, N=51). We compared groups on parent and teacher ratings of inattention symptoms, organizational skills, social skills, and global improvement at post-treatment, and also at follow-up during the subsequent school year. Results CLAS resulted in greater improvements in teacher-reported inattention, organizational skills, social skills, and global functioning relative to both PFT and TAU at post-treatment. Parents of children in CLAS reported greater improvement in organizational skills than PFT and greater improvements on all outcomes relative to TAU at post-treatment. Differences between CLAS and TAU were maintained at follow-up for most parent-reported measures but were not significant for teacher-reported outcomes. Conclusions These findings extend support for CLAS across two study sites, revealing that integrating parent, teacher, and child treatment components, specifically adapted for ADHD-I, is superior to parent training alone and to usual care. Direct involvement of teachers and children in CLAS appears to amplify effects at school and home and underscores the importance of coordinating parent, teacher, and child treatment components for cross-setting effects on symptoms and impairment associated with ADHD-I. PMID:24865871

  4. Mapping of RNA accessible sites by extension of random oligonucleotide libraries with reverse transcriptase.

    PubMed Central

    Allawi, H T; Dong, F; Ip, H S; Neri, B P; Lyamichev, V I

    2001-01-01

    A rapid and simple method for determining accessible sites in RNA that is independent of the length of target RNA and does not require RNA labeling is described. In this method, target RNA is allowed to hybridize with sequence-randomized libraries of DNA oligonucleotides linked to a common tag sequence at their 5'-end. Annealed oligonucleotides are extended with reverse transcriptase and the extended products are then amplified by using PCR with a primer corresponding to the tag sequence and a second primer specific to the target RNA sequence. We used the combination of both the lengths of the RT-PCR products and the location of the binding site of the RNA-specific primer to determine which regions of the RNA molecules were RNA extendible sites, that is, sites available for oligonucleotide binding and extension. We then employed this reverse transcription with the random oligonucleotide libraries (RT-ROL) method to determine the accessible sites on four mRNA targets, human activated ras (ha-ras), human intercellular adhesion molecule-1 (ICAM-1), rabbit beta-globin, and human interferon-gamma (IFN-gamma). Our results were concordant with those of other researchers who had used RNase H cleavage or hybridization with arrays of oligonucleotides to identify accessible sites on some of these targets. Further, we found good correlation between sites when we compared the location of extendible sites identified by RT-ROL with hybridization sites of effective antisense oligonucleotides on ICAM-1 mRNA in antisense inhibition studies. Finally, we discuss the relationship between RNA extendible sites and RNA accessibility. PMID:11233988

  5. Skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial.

    PubMed

    Dettenkofer, M; Wilson, C; Gratwohl, A; Schmoor, C; Bertz, H; Frei, R; Heim, D; Luft, D; Schulz, S; Widmer, A F

    2010-06-01

    To compare the efficacy of two commercially available, alcohol-based antiseptic solutions for preparation and care of central venous catheter (CVC) insertion sites, with and without octenidine dihydrochloride, a double-blind, randomized, controlled trial was undertaken in the haematology units and in one surgical unit of two university hospitals. Adult patients with a non-tunnelled CVC were randomly assigned to two different skin disinfection regimens at the insertion site: 0.1% octenidine with 30% 1-propanol and 45% 2-propanol, and as control 74% ethanol with 10% 2-propanol. Endpoints were (i) skin colonization at the insertion site; (ii) positive culture from the catheter tip (> or = 15 CFU); and (iii) occurrence of CVC-associated bloodstream infection (defined according to criteria set by the CDC). Four hundred patients with inserted CVC were enrolled from May 2002 through April 2005. Both groups were similar in respect of patient characteristics and co-morbidities. Skin colonization at the CVC insertion site during the first 10 days was significantly reduced by octenidine treatment (relative difference octenidine vs. control: 0.21; 95%CI: 0.11-0.39, p <0.0001). Positive culture of the catheter tip was significantly less frequent in the octenidine group (7.9%) than in the control group (17.8%): OR = 0.39 (95%CI: 0.20-0.80, p 0.009). Patients treated with octenidine had a non-significant reduction in catheter-associated bloodstream infections (4.1% vs. 8.3%; OR = 0.44; 95%CI: 0.18-1.08, p 0.081). Side effects were similar in both groups. This randomized controlled trial supports the results of two observational studies demonstrating octenidine in alcoholic solution to be a better option than alcohol alone for the prevention of CVC-associated infections.

  6. Under What Assumptions Do Site-by-Treatment Instruments Identify Average Causal Effects?

    ERIC Educational Resources Information Center

    Reardon, Sean F.; Raudenbush, Stephen W.

    2013-01-01

    The increasing availability of data from multi-site randomized trials provides a potential opportunity to use instrumental variables methods to study the effects of multiple hypothesized mediators of the effect of a treatment. We derive nine assumptions needed to identify the effects of multiple mediators when using site-by-treatment interactions…

  7. Effect of perioperative oxygen supplementation on 30-day surgical site infection rate in abdominal, gynecologic, and breast surgery: the ISO2 randomized controlled trial.

    PubMed

    Thibon, Pascal; Borgey, France; Boutreux, Sébastien; Hanouz, Jean-Luc; Le Coutour, Xavier; Parienti, Jean-Jacques

    2012-09-01

    Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.

  8. SAS Code for Calculating Intraclass Correlation Coefficients and Effect Size Benchmarks for Site-Randomized Education Experiments

    ERIC Educational Resources Information Center

    Brandon, Paul R.; Harrison, George M.; Lawton, Brian E.

    2013-01-01

    When evaluators plan site-randomized experiments, they must conduct the appropriate statistical power analyses. These analyses are most likely to be valid when they are based on data from the jurisdictions in which the studies are to be conducted. In this method note, we provide software code, in the form of a SAS macro, for producing statistical…

  9. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial.

    PubMed

    Duggal, Neena; Poddatoori, Vineela; Poddatorri, Vineela; Noroozkhani, Sara; Siddik-Ahmad, R Iram; Caughey, Aaron B

    2013-07-01

    To evaluate whether supplemental perioperative oxygen decreases surgical site wound infections or endometritis. This was a prospective, randomized trial. Patients who were to undergo cesarean delivery were recruited and randomly allocated to either 30% or 80% oxygen during the cesarean delivery and for 1 hour after surgery. The obstetricians and patients were blinded to the concentration of oxygen used. Patients were evaluated for wound infection or endometritis during their hospital stay and by 6 weeks postpartum. The primary end point was a composite of either surgical site infection or endometritis. Eight hundred thirty-one patients were recruited. Of these, 415 participants received 30% oxygen perioperatively and 416 received 80% oxygen. The groups were well matched for age, race, parity, diabetes, number of previous cesarean deliveries, and scheduled compared with unscheduled cesarean deliveries. An intention-to-treat analysis was used. There was no difference in the primary composite outcome (8.2% in women who received 30% oxygen compared with 8.2% in women who received 80% oxygen, P=.89), no difference in surgical site infection in the two groups (5.5% compared with 5.8%, P=.98), and no significant difference in endometritis in the two groups (2.7% compared with 2.4%, P=.66), respectively. Women who received 80% supplemental oxygen perioperatively did not have a lower rate of a surgical site infection or endometritis as compared with women who received 30% supplemental oxygen concentration. ClinicalTrials.gov, www.clincaltrials.gov, NCT00876005. I.

  10. Exit-Site Dressing and Infection in Peritoneal Dialysis: A Randomized Controlled Pilot Trial.

    PubMed

    Mushahar, Lily; Mei, Lim Wei; Yusuf, Wan Shaariah; Sivathasan, Sudhaharan; Kamaruddin, Norilah; Idzham, Nor Juliana Mohd

    2016-01-01

    ♦ Peritoneal dialysis (PD)-related infection is a common cause of catheter loss and the main reason for PD drop-out. Exit-site infection (ESI) is a pathway to developing tunnel infection and peritonitis, hence rigorous exit-site care has always been emphasized in PD therapy. The aim of this study was to evaluate the effect of exit-site dressing vs non-dressing on the rate of PD-related infection. ♦ A prospective randomized controlled study was conducted in prevalent PD patients at the Hospital Tuanku Jaafar Seremban, Negeri Sembilan, Malaysia, from April 2011 until April 2013. All patients were required to perform daily washing of the exit site with antibacterial soap during a shower. In the dressing group (n = 54), patients were required to clean their exit site using povidone-iodine after drying, followed by topical mupirocin antibiotic application to the exit site. The exit site was then covered with a sterile gauze dressing and the catheter immobilized with tape. In the non-dressing group (n = 54), patients were not required to do any further dressing after drying. They were only required to apply mupirocin cream to the exit site and then left the exit site uncovered. The catheter was immobilized with tape. The primary outcome was ESI. The secondary outcomes were evidence of tunnel infection or peritonitis. ♦ A total of 97 patients completed the study. There were a total of 12 ESI episodes: 4 episodes in 4 patients in the dressing group vs 8 episodes in 4 patients in the non-dressing group. This corresponds to 1 episode per 241.3 patient-months vs 1 episode per 111.1 patient-months in the dressing and non-dressing groups respectively. Median time to first ESI episode was shorter in the non-dressing than in the dressing group, but not significant (p = 0.25). The incidence of gram-positive ESI in both groups was similar. There were no gram-negative ESI in the non-dressing group compared with 2 in the dressing group. The peritonitis rate was 1 per 37

  11. A comparison of online versus on-site training in health research methodology: a randomized study.

    PubMed

    Aggarwal, Rakesh; Gupte, Nikhil; Kass, Nancy; Taylor, Holly; Ali, Joseph; Bhan, Anant; Aggarwal, Amita; Sisson, Stephen D; Kanchanaraksa, Sukon; McKenzie-White, Jane; McGready, John; Miotti, Paolo; Bollinger, Robert C

    2011-06-17

    Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses. Volunteer Indian scientists were randomly assigned to one of two arms. Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Improvement in knowledge immediately and 3-months after course completion, compared to baseline. Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14). On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly

  12. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver.

    PubMed

    Biffi, Roberto; Fattori, Luca; Bertani, Emilio; Radice, Davide; Rotmensz, Nicole; Misitano, Pasquale; Cenciarelli, Sabine; Chiappa, Antonio; Tadini, Liliana; Mancini, Marina; Pesenti, Giovanni; Andreoni, Bruno; Nespoli, Angelo

    2012-05-23

    An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. A total of 112 patients (58 in the experimental arm and 54 in the control group) qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5%) than in controls (14.3% center 1, 24.2% center 2, overall 20.4%), but the observed difference was not statistically significant (P = 0.451), even with respect to surgical-site infection grade 1 (superficial) versus grades 2 and 3, or grade 1 and 2 versus grade 3. This randomized trial did not confirm a statistically significant superiority of Aquacel Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Clinicaltrials.gov: NCT00981110.

  13. A random rule model of surface growth

    NASA Astrophysics Data System (ADS)

    Mello, Bernardo A.

    2015-02-01

    Stochastic models of surface growth are usually based on randomly choosing a substrate site to perform iterative steps, as in the etching model, Mello et al. (2001) [5]. In this paper I modify the etching model to perform sequential, instead of random, substrate scan. The randomicity is introduced not in the site selection but in the choice of the rule to be followed in each site. The change positively affects the study of dynamic and asymptotic properties, by reducing the finite size effect and the short-time anomaly and by increasing the saturation time. It also has computational benefits: better use of the cache memory and the possibility of parallel implementation.

  14. Effect of self-deflection on a totally asymmetric simple exclusion process with functions of site assignments

    NASA Astrophysics Data System (ADS)

    Tsuzuki, Satori; Yanagisawa, Daichi; Nishinari, Katsuhiro

    2018-04-01

    This study proposes a model of a totally asymmetric simple exclusion process on a single-channel lane with functions of site assignments along the pit lane. The system model attempts to insert a new particle to the leftmost site at a certain probability by randomly selecting one of the empty sites in the pit lane, and reserving it for the particle. Thereafter, the particle is directed to stop at the site only once during its travel. Recently, the system was determined to show a self-deflection effect, in which the site usage distribution biases spontaneously toward the leftmost site, and the throughput becomes maximum when the site usage distribution is slightly biased to the rightmost site. Our exact analysis describes this deflection effect and show a good agreement with simulations.

  15. The Ecological Effects of Universal and Selective Violence Prevention Programs for Middle School Students: A Randomized Trial

    ERIC Educational Resources Information Center

    Simon, Thomas R.; Ikeda, Robin M.; Smith, Emilie Phillips; Reese, Le'Roy E.; Rabiner, David L.; Miller, Shari; Winn, Donna-Marie; Dodge, Kenneth A.; Asher, Steven R.; Horne, Arthur M.; Orpinas, Pamela; Martin, Roy; Quinn, William H.; Tolan, Patrick H.; Gorman-Smith, Deborah; Henry, David B.; Gay, Franklin N.; Schoeny, Michael; Farrell, Albert D.; Meyer, Aleta L.; Sullivan, Terri N.; Allison, Kevin W.

    2009-01-01

    This study reports the findings of a multisite randomized trial evaluating the separate and combined effects of 2 school-based approaches to reduce violence among early adolescents. A total of 37 schools at 4 sites were randomized to 4 conditions: (1) a universal intervention that involved implementing a student curriculum and teacher training…

  16. Modeling Training Site Vegetation Coverage Probability with a Random Optimizing Procedure: An Artificial Neural Network Approach.

    DTIC Science & Technology

    1998-05-01

    Coverage Probability with a Random Optimization Procedure: An Artificial Neural Network Approach by Biing T. Guan, George Z. Gertner, and Alan B...Modeling Training Site Vegetation Coverage Probability with a Random Optimizing Procedure: An Artificial Neural Network Approach 6. AUTHOR(S) Biing...coverage based on past coverage. Approach A literature survey was conducted to identify artificial neural network analysis techniques applicable for

  17. Application of Poisson random effect models for highway network screening.

    PubMed

    Jiang, Ximiao; Abdel-Aty, Mohamed; Alamili, Samer

    2014-02-01

    In recent years, Bayesian random effect models that account for the temporal and spatial correlations of crash data became popular in traffic safety research. This study employs random effect Poisson Log-Normal models for crash risk hotspot identification. Both the temporal and spatial correlations of crash data were considered. Potential for Safety Improvement (PSI) were adopted as a measure of the crash risk. Using the fatal and injury crashes that occurred on urban 4-lane divided arterials from 2006 to 2009 in the Central Florida area, the random effect approaches were compared to the traditional Empirical Bayesian (EB) method and the conventional Bayesian Poisson Log-Normal model. A series of method examination tests were conducted to evaluate the performance of different approaches. These tests include the previously developed site consistence test, method consistence test, total rank difference test, and the modified total score test, as well as the newly proposed total safety performance measure difference test. Results show that the Bayesian Poisson model accounting for both temporal and spatial random effects (PTSRE) outperforms the model that with only temporal random effect, and both are superior to the conventional Poisson Log-Normal model (PLN) and the EB model in the fitting of crash data. Additionally, the method evaluation tests indicate that the PTSRE model is significantly superior to the PLN model and the EB model in consistently identifying hotspots during successive time periods. The results suggest that the PTSRE model is a superior alternative for road site crash risk hotspot identification. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. A multi-site analysis of random error in tower-based measurements of carbon and energy fluxes

    Treesearch

    Andrew D. Richardson; David Y. Hollinger; George G. Burba; Kenneth J. Davis; Lawrence B. Flanagan; Gabriel G. Katul; J. William Munger; Daniel M. Ricciuto; Paul C. Stoy; Andrew E. Suyker; Shashi B. Verma; Steven C. Wofsy; Steven C. Wofsy

    2006-01-01

    Measured surface-atmosphere fluxes of energy (sensible heat, H, and latent heat, LE) and CO2 (FCO2) represent the ``true?? flux plus or minus potential random and systematic measurement errors. Here, we use data from seven sites in the AmeriFlux network, including five forested sites (two of which include ``tall tower?? instrumentation), one grassland site, and one...

  19. Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

    PubMed

    2016-09-01

    Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  20. Modeling Randomness in Judging Rating Scales with a Random-Effects Rating Scale Model

    ERIC Educational Resources Information Center

    Wang, Wen-Chung; Wilson, Mark; Shih, Ching-Lin

    2006-01-01

    This study presents the random-effects rating scale model (RE-RSM) which takes into account randomness in the thresholds over persons by treating them as random-effects and adding a random variable for each threshold in the rating scale model (RSM) (Andrich, 1978). The RE-RSM turns out to be a special case of the multidimensional random…

  1. Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

    ERIC Educational Resources Information Center

    Westine, Carl D.

    2015-01-01

    A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

  2. The effectiveness of an intervention to reduce alcohol-related violence in premises licensed for the sale and on-site consumption of alcohol: a randomized controlled trial.

    PubMed

    Moore, Simon C; Alam, M Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

    2017-11-01

    Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of

  3. The effectiveness of an intervention to reduce alcohol‐related violence in premises licensed for the sale and on‐site consumption of alcohol: a randomized controlled trial

    PubMed Central

    Alam, M. Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

    2017-01-01

    Abstract Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault‐related injury through poor operational practices that, if addressed, could reduce violence. We tested the real‐world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police‐recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow‐up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455‐day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention‐to‐treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20–1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow‐up visits). Conclusion An Environmental Health Practitioner‐led intervention in premises licensed for the sale and on‐site consumption of alcohol resulted in an

  4. Effective band structure of random III-V alloys

    NASA Astrophysics Data System (ADS)

    Popescu, Voicu; Zunger, Alex

    2010-03-01

    Random substitutional alloys have no long range order (LRO) or translational symmetry so rigorously speaking they have no E(k) band structure or manifestations thereof. Yet, many experiments on alloys are interpreted using the language of band theory, e.g. inferring Van Hove singularities, band dispersion and effective masses. Many standard alloy theories (VCA- or CPA-based) have the LRO imposed on the alloy Hamiltonian, assuming only on-site disorder, so they can not be used to judge the extent of LRO that really exists. We adopt the opposite way, by using large (thousand atom) randomly generated supercells in which chemically identical alloy atoms are allowed to have different local environments (a polymorphous representation). This then drives site-dependent atomic relaxation as well as potential fluctuations. The eigenstates from such supercells are then mapped onto the Brillouin zone (BZ) of the primitive cell, producing effective band dispersion. Results for (In,Ga)X show band-like behaviour only near the centre and faces of the BZ but rapidly lose such characteristics away from γ or for higher bands. We further analyse the effects of stoichiometry variation, internal relaxation, and short-range order on the alloy band structure.

  5. Perioperative supplemental oxygen therapy and surgical site infection: a meta-analysis of randomized controlled trials.

    PubMed

    Qadan, Motaz; Akça, Ozan; Mahid, Suhal S; Hornung, Carlton A; Polk, Hiram C

    2009-04-01

    To conduct a meta-analysis of randomized controlled trials in which high inspired oxygen concentrations were compared with standard concentrations to assess the effect on the development of surgical site infections (SSIs). A systematic literature search was conducted using the MEDLINE, EMBASE, and Cochrane databases and included a manual search of references of original articles, poster presentations, and abstracts from major meetings ("gray" literature). Twenty-one of 2167 articles met the inclusion criteria. Of these, 5 randomized controlled trials (3001 patients) assessed the effect of perioperative supplemental oxygen use on the SSI rate. Studies used a treatment-inspired oxygen concentration of 80%. Maximum follow-up was 30 days. Data were abstracted by 3 independent reviewers using a standardized data collection form. Relative risks were reported using a fixed-effects model. Results were subjected to publication bias testing and sensitivity analyses. Infection rates were 12.0% in the control group and 9.0% in the hyperoxic group, with relative risk reduction of 25.3% (95% confidence interval [CI], 8.1%-40.1%) and absolute risk reduction of 3.0% (1.1%-5.3%). The overall risk ratio was 0.742 (95% CI, 0.599-0.919; P = .006). The benefit from increasing oxygen concentration was greater in colorectal-specific procedures, with a risk ratio of 0.556 (95% CI, 0.383-0.808; P = .002). Perioperative supplemental oxygen therapy exerts a significant beneficial effect in the prevention of SSIs. We recommend its use along with maintenance of normothermia, meticulous glycemic control, and preservation of intravascular volume perioperatively in the prevention of SSIs.

  6. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

    PubMed

    Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

    2014-09-30

    Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as < 50% patients receiving ≥ 3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

  7. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial.

    PubMed

    Valent, Amy M; DeArmond, Chris; Houston, Judy M; Reddy, Srinidhi; Masters, Heather R; Gold, Alison; Boldt, Michael; DeFranco, Emily; Evans, Arthur T; Warshak, Carri R

    2017-09-19

    The rate of obesity among US women has been increasing, and obesity is associated with increased risk of surgical site infection (SSI) following cesarean delivery. The optimal perioperative antibiotic prophylactic regimen in this high-risk population undergoing cesarean delivery is unknown. To determine rates of SSI among obese women who receive prophylactic oral cephalexin and metronidazole vs placebo for 48 hours following cesarean delivery. Randomized, double-blind clinical trial comparing oral cephalexin and metronidazole vs placebo for 48 hours following cesarean delivery for the prevention of SSI in obese women (prepregnancy BMI ≥30) who had received standard intravenous preoperative cephalosporin prophylaxis. Randomization was stratified by intact vs rupture of membranes prior to delivery. The study was conducted at the University of Cincinnati Medical Center, Cincinnati, Ohio, an academic and urban setting, between October 2010 and December 2015, with final follow-up through February 2016. Participants were randomly assigned to receive oral cephalexin, 500 mg, and metronidazole, 500 mg (n = 202 participants), vs identical-appearing placebo (n = 201 participants) every 8 hours for a total of 48 hours following cesarean delivery. The primary outcome was SSI, defined as any superficial incisional, deep incisional, or organ/space infections within 30 days after cesarean delivery. Among 403 randomized participants who were included (mean age, 28 [SD, 6] years; mean BMI, 39.7 [SD, 7.8]), 382 (94.6%) completed the trial. The overall rate of SSI was 10.9% (95% CI, 7.9%-14.0%). Surgical site infection was diagnosed in 13 women (6.4%) in the cephalexin-metronidazole group vs 31 women (15.4%) in the placebo group (difference, 9.0% [95% CI, 2.9%-15.0%]; relative risk, 0.41 [95% CI, 0.22-0.77]; P = .01). There were no serious adverse events, including allergic reaction, reported in either the antibiotic group or the placebo group. Among obese women

  8. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    PubMed

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  9. Pain in donor site after BTB-ACL reconstruction with PRGF: a randomized trial.

    PubMed

    Seijas, Roberto; Cuscó, Xavier; Sallent, Andrea; Serra, Iván; Ares, Oscar; Cugat, Ramón

    2016-06-01

    Anterior cruciate ligament (ACL) tears are highly incident injuries in young athletes within our work area. The use of the patellar graft, despite being the treatment of choice, presents post-operative problems such as anterior knee pain, which limits its use and leads to preference being taken for alternative grafts. Our aim was to evaluate if the application of PRGF reduces anterior knee pain in donor site in BTB-ACL reconstruction. 43 patients were included in the double-blinded and randomized clinical trial comparing two patient groups who underwent ACL reconstruction using patellar tendon graft, comparing anterior knee pain with and without the application of PRGF at the donor site after harvesting the graft. The PRGF group showed decreased donor site pain in comparison to the control group, with significant differences in the first two months of follow-up. The application of PRGF decreased donor site pain compared to the control group.

  10. The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

    PubMed Central

    Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

    2014-01-01

    Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who

  11. Effect of integrated infectious disease training and on-site support on the management of childhood illnesses in Uganda: a cluster randomized trial.

    PubMed

    Imani, Peace; Jakech, Brian; Kirunda, Ibrahim; Mbonye, Martin K; Naikoba, Sarah; Weaver, Marcia R

    2015-08-28

    The Integrated Infectious Disease Capacity-Building Evaluation (IDCAP) was designed to test the effects of two interventions, Integrated Management of Infectious Disease (IMID) training and on-site support (OSS), on clinical practice of mid-level practitioners. This article reports the effects of these interventions on clinical practice in management of common childhood illnesses. Two trainees from each of 36 health facilities participated in the IMID training. IMID was a three-week core course, two one-week boost courses, and distance learning over nine months. Eighteen of the 36 health facilities were then randomly assigned to arm A, and participated in OSS, while the other 18 health facilities assigned to arm B did not. Clinical faculty assessed trainee practice on clinical practice of six sets of tasks: patient history, physical examination, laboratory tests, diagnosis, treatment, and patient/caregiver education. The effects of IMID were measured by the post/pre adjusted relative risk (aRR) of appropriate practice in arm B. The incremental effects of OSS were measured by the adjusted ratio of relative risks (aRRR) in arm A compared to arm B. All hypotheses were tested at a 5% level of significance. Patient samples were comparable across arms at baseline and endline. The majority of children were aged under five years; 84% at baseline and 97% at endline. The effects of IMID on patient history (aRR = 1.12; 95% CI = 1.04-1.21) and physical examination (aRR = 1.40; 95% CI = 1.16-1.68) tasks were statistically significant. OSS was associated with incremental improvement in patient history (aRRR = 1.18; 95% CI = 1.06-1.31), and physical examination (aRRR = 1.27; 95% CI = 1.02-1.59) tasks. Improvements in laboratory testing, diagnosis, treatment, and patient/caregiver education were not statistically significant. IMID training was associated with improved patient history taking and physical examination, and OSS further improved these clinical practices. On-site

  12. Multiple scattering of waves in random media: Application to the study of the city-site effect in Mexico City area.

    NASA Astrophysics Data System (ADS)

    Ishizawa, O. A.; Clouteau, D.

    2007-12-01

    Long-duration, amplifications and spatial response's variability of the seismic records registered in Mexico City during the September 1985 earthquake cannot only be explained by the soil velocity model. We will try to explain these phenomena by studying the extent of the effect of buildings' diffracted wave fields during an earthquake. The main question is whether the presence of a large number of buildings can significantly modify the seismic wave field. We are interested in the interaction between the incident wave field propagating in a stratified half- space and a large number of structures at the free surface, i.e., the coupled city-site effect. We study and characterize the seismic wave propagation regimes in a city using the theory of wave propagation in random media. In the coupled city-site system, the buildings are modeled as resonant scatterers uniformly distributed at the surface of a deterministic, horizontally layered elastic half-space representing the soil. Based on the mean-field and the field correlation equations, we build a theoretical model which takes into account the multiple scattering of seismic waves and allows us to describe the coupled city-site system behavior in a simple and rapid way. The results obtained for the configurationally averaged field quantities are validated by means of 3D results for the seismic response of a deterministic model. The numerical simulations of this model are computed with MISS3D code based on classical Soil-Structure Interaction techniques and on a variational coupling between Boundary Integral Equations for a layered soil and a modal Finite Element approach for the buildings. This work proposes a detailed numerical and a theoretical analysis of the city-site interaction (CSI) in Mexico City area. The principal parameters in the study of the CSI are the buildings resonant frequency distribution, the soil characteristics of the site, the urban density and position of the buildings in the city, as well as

  13. Using partial site aggregation to reduce bias in random utility travel cost models

    NASA Astrophysics Data System (ADS)

    Lupi, Frank; Feather, Peter M.

    1998-12-01

    We propose a "partial aggregation" strategy for defining the recreation sites that enter choice sets in random utility models. Under the proposal, the most popular sites and sites that will be the subject of policy analysis enter choice sets as individual sites while remaining sites are aggregated into groups of similar sites. The scheme balances the desire to include all potential substitute sites in the choice sets with practical data and modeling constraints. Unlike fully aggregate models, our analysis and empirical applications suggest that the partial aggregation approach reasonably approximates the results of a disaggregate model. The partial aggregation approach offers all of the data and computational advantages of models with aggregate sites but does not suffer from the same degree of bias as fully aggregate models.

  14. Topical Botulinum Toxin Type A Liposomal Cream for Primary Axillary Hyperhidrosis: A Double-Blind, Randomized, Split-Site, Vehicle-Controlled Study.

    PubMed

    Lueangarun, Suparuj; Sermsilp, Chairat; Tempark, Therdpong

    2018-04-13

    Despite its effectiveness in treating primary axillary hyperhidrosis (PAH), topical botulinum toxin type A (BTX-A) is highly resistant to transdermal absorption. Topical BTX-A liposomal cream is recommended as a novel, noninvasive modality to enhance skin penetration. To evaluate the efficacy and safety of topical BTX-A liposomal cream in comparison with liposomal vehicle cream alone in the treatment of PAH. A prospective, randomized, double-blinded, split-site study was conducted in 20 subjects, aged 18 to 50 years, all of whom had symmetrical axillary sweating with Hyperhidrosis Disease Severity Scale scores between 2 to 4. All subjects were double-blinded to treatment regimens and randomly given 2 bottles, one containing topical BTX-A liposomal cream and one containing the vehicle cream without BTX-A, to be applied consistently to the same axilla nightly for 7 consecutive days. Clinical improvement and adverse reactions were evaluated at every follow-up visit. Axillary skin treated with topical BTX-A demonstrated superior sweat reduction and patient satisfaction to vehicle cream-treated axillary skin, with clinical and statistical significance, at baseline, weeks 2, 4, 6, and 8 of follow-up, without adverse effects. Topical BTX-A liposomal cream pharmaceutically enhances drug delivery, is painless, cost-effective, and overall an innovative treatment of PAH.

  15. COMPARISON OF RANDOM AND SYSTEMATIC SITE SELECTION FOR ASSESSING ATTAINMENT OF AQUATIC LIFE USES IN SEGMENTS OF THE OHIO RIVER

    EPA Science Inventory

    This report is a description of field work and data analysis results comparing a design comparable to systematic site selection with one based on random selection of sites. The report is expected to validate the use of random site selection in the bioassessment program for the O...

  16. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial.

    PubMed

    Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

    2016-06-01

    In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It was decided randomly which port site would be closed with SA. The opposite site was closed with TS. Wounds were assessed after 7-12 days and after 3 months. Cosmetic outcome was measured by a visual analogue scale (VAS) completed by the patient, by the Hollander wound evaluation scale (HWES) and by the judgement of blinded investigators. Seventy-seven subjects were randomized. Complete data from the 3-month follow-up visit were available from 56 patients (72.7 %). The VAS scale ranged from 0 to 100 mm with "0" representing the best possible cosmetic outcome. Median satisfaction was 2 mm in the TS group and 3 mm in the SA group. The mean was high in both groups 4.6 (s = 13.1) versus 3.8 mm (s = 4.6). The outcome was neither clinically nor statistically significant. Cosmetic outcome was assessed by an investigator, and the HWES showed no difference. In regard to complications, no difference was found between SA and TS, either. In conclusion this study demonstrated that closure of laparoscopic port-site wounds leads to equivalent outcomes whether SAs or TSs are used. Complications are rare in both methods. Thus, SAs seem to be a valid alternative to sutures in laparoscopic surgery. Registration site: www.clinicaltrials.gov . NCT02179723.

  17. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms.

    PubMed

    Kalman, Douglas S; Schwartz, Howard I; Alvarez, Patricia; Feldman, Samantha; Pezzullo, John C; Krieger, Diane R

    2009-11-18

    This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Sixty-one adults were enrolled (age 36.5 +/- 12.6 years; height 165.1 +/- 9.2 cm; weight 75.4 +/- 17.3 kg) and randomized to either Digestive Advantage Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. ClinicalTrials.gov Identifier: NCT00881322.

  18. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

    PubMed Central

    2009-01-01

    Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322 PMID:19922649

  19. Site Matters: Multisite Randomized Trial of Motivational Enhancement Therapy in Community Drug Abuse Clinics

    PubMed Central

    Ball, Samuel A.; Martino, Steve; Nich, Charla; Frankforter, Tami L.; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E.; Obert, Jeanne L.; Farentinos, Christiane; Carroll, Kathleen M.

    2007-01-01

    The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. PMID:17663610

  20. Site matters: multisite randomized trial of motivational enhancement therapy in community drug abuse clinics.

    PubMed

    Ball, Samuel A; Martino, Steve; Nich, Charla; Frankforter, Tami L; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E; Obert, Jeanne L; Farentinos, Christiane; Carroll, Kathleen M

    2007-08-01

    The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention differences between the 2 brief intervention conditions. Although both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. This finding was complicated by program site main effects and higher level interactions. MET resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites.

  1. [Comparative study between fast and slow induction of propofol given by target-controlled infusion: expected propofol concentration at the effect site. Randomized controlled trial].

    PubMed

    Simoni, Ricardo Francisco; Miziara, Luiz Eduardo de Paula Gomes; Esteves, Luis Otávio; Silva, Diógenes de Oliveira; Ribeiro, Cristina Alves; Smith, Mariana Oki; Paula, Leonardo Ferreira de; Cangiani, Luis Henrique

    2015-01-01

    studies have shown that rate of propofol infusion may influence the predicted propofol concentration at the effect site (Es). The aim of this study was to evaluate the Es predicted by the Marsh pharmacokinetic model (ke0 0.26min(-1)) in loss of consciousness during fast or slow induction. the study included 28 patients randomly divided into two equal groups. In slow induction group (S), target-controlled infusion (TCI) of propofol with plasma, Marsh pharmacokinetic model (ke0 0.26min(-1)) with target concentration (Tc) at 2.0-μg.mL(-1) were administered. When the predicted propofol concentration at the effect site (Es) reached half of Es value, Es was increased to previous Es + 1μg.mL(-1), successively, until loss of consciousness. In rapid induction group (R), patients were induced with TCI of propofol with plasma (6.0μg.ml(-1)) at Es, and waited until loss of consciousness. in rapid induction group, Tc for loss of consciousness was significantly lower compared to slow induction group (1.67±0.76 and 2.50±0.56μg.mL(-1), respectively, p=0.004). the predicted propofol concentration at the effect site for loss of consciousness is different for rapid induction and slow induction, even with the same pharmacokinetic model of propofol and the same balance constant between plasma and effect site. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  2. A random effects meta-analysis model with Box-Cox transformation.

    PubMed

    Yamaguchi, Yusuke; Maruo, Kazushi; Partlett, Christopher; Riley, Richard D

    2017-07-19

    In a random effects meta-analysis model, true treatment effects for each study are routinely assumed to follow a normal distribution. However, normality is a restrictive assumption and the misspecification of the random effects distribution may result in a misleading estimate of overall mean for the treatment effect, an inappropriate quantification of heterogeneity across studies and a wrongly symmetric prediction interval. We focus on problems caused by an inappropriate normality assumption of the random effects distribution, and propose a novel random effects meta-analysis model where a Box-Cox transformation is applied to the observed treatment effect estimates. The proposed model aims to normalise an overall distribution of observed treatment effect estimates, which is sum of the within-study sampling distributions and the random effects distribution. When sampling distributions are approximately normal, non-normality in the overall distribution will be mainly due to the random effects distribution, especially when the between-study variation is large relative to the within-study variation. The Box-Cox transformation addresses this flexibly according to the observed departure from normality. We use a Bayesian approach for estimating parameters in the proposed model, and suggest summarising the meta-analysis results by an overall median, an interquartile range and a prediction interval. The model can be applied for any kind of variables once the treatment effect estimate is defined from the variable. A simulation study suggested that when the overall distribution of treatment effect estimates are skewed, the overall mean and conventional I 2 from the normal random effects model could be inappropriate summaries, and the proposed model helped reduce this issue. We illustrated the proposed model using two examples, which revealed some important differences on summary results, heterogeneity measures and prediction intervals from the normal random effects model. The

  3. Exit-Site Infection of Peritoneal Catheter is Reduced by the Use of Polyhexanide. Results of a Prospective Randomized Trial

    PubMed Central

    Núñez-Moral, M.; Sánchez-Álvarez, E.; González-Díaz, I.; Peláez-Requejo, B.; Fernández-Viña, A.; Quintana-Fernández, A.; Rodríguez-Suárez, C.

    2014-01-01

    ♦ Background: One of the most common and severe complications affecting peritoneal dialysis (PD) patients is exit-site infection of the peritoneal catheter; it is therefore of vital importance to prevent it. This complication has a negative impact on the success of the technique. In spite of this, there are no clear guidelines concerning how to take care of the exit site. The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period. ♦ Methods: We designed a single-center, prospective, open-labeled, randomized controlled clinical trial with parallel groups. Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study. Patients were randomized to be daily cured as follows: Group A: traditional care with saline serum and povidone-iodine; and Group B: polyhexanide solution. Exit sites were evaluated at baseline and every four to six weeks or if any event occurred, according to the Twardowski criteria. ♦ Results: Of the 60 included patients, 46 completed the 12-month follow-up period. Six underwent transplantation, five died and three were transferred to hemodialysis (HD). The treatment was well tolerated, with no side effects nor abandonments due to such effects. Throughout the study period, six patients (20%) undergoing traditional care and only two (6,7%) receiving polyhexanide developed an exit-site infection (p = 0.032). There were a total number of 12 infections; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide (p = 0.037). The germs responsible for the infections were: S. aureus (six cases), Corynebacterium jeikeium (two cases) and P. aeruginosa (one case) in the saline serum and povidone-iodine group and

  4. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site.

    PubMed

    Hugos, Cinda L; Cameron, Michelle H; Chen, Zunqiu; Chen, Yiyi; Bourdette, Dennis

    2018-05-01

    A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. Assess FTC for a delayed effect on fatigue. Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC -8.9 (confidence interval (CI): 32.2, 45), MSTC -2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

  5. Cost-effectiveness of on-site versus off-site collaborative care for depression in rural FQHCs.

    PubMed

    Pyne, Jeffrey M; Fortney, John C; Mouden, Sip; Lu, Liya; Hudson, Teresa J; Mittal, Dinesh

    2015-05-01

    Collaborative care for depression in primary care settings is effective and cost-effective. However, there is minimal evidence to support the choice of on-site versus off-site models. This study examined the cost-effectiveness of on-site practice-based collaborative care (PBCC) versus off-site telemedicine-based collaborative care (TBCC) for depression in federally qualified health centers (FQHCs). In a multisite, randomized, pragmatic comparative cost-effectiveness trial, 19,285 patients were screened for depression, 2,863 (14.8%) screened positive, and 364 were enrolled. Telephone interview data were collected at baseline and at six, 12, and 18 months. Base case analysis used Arkansas FQHC health care costs, and secondary analysis used national cost estimates. Effectiveness measures were depression-free days and quality-adjusted life years (QALYs) derived from depression-free days, the 12-Item Short-Form Survey, and the Quality of Well-Being (QWB) Scale. Nonparametric bootstrap with replacement methods were used to generate an empirical joint distribution of incremental costs and QALYs and acceptability curves. The TBCC intervention resulted in more depression-free days and QALYs but at a greater cost than the PBCC intervention. The disease-specific (depression-free day) and generic (QALY) incremental cost-effectiveness ratios (ICERs) were below their respective ICER thresholds for implementation, suggesting that the TBCC intervention was more cost effective than the PBCC intervention. These results support the cost-effectiveness of TBCC in medically underserved primary care settings. Information about whether to insource (make) or outsource (buy) depression care management is important, given the current interest in patient-centered medical homes, value-based purchasing, and bundled payments for depression care.

  6. A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine.

    PubMed

    Saper, Joel R; Mathew, Ninan T; Loder, Elizabeth W; DeGryse, Ronald; VanDenburgh, Amanda M

    2007-09-01

    Several randomized, controlled studies have reported benefits of botulinum toxin type A (BoNTA; Allergan Inc., Irvine, CA, USA) over placebo in the treatment of migraine. Some studies reported significant benefits at dosages as low as 16 U, while other studies reported safety, tolerability, and efficacy at dosages up to 260 U. However, the optimal treatment paradigm and patient population have yet to be defined. To compare different injection sites and doses of BoNTA in the prevention of episodic migraine. This was a randomized, double-blind, placebo-controlled study of 232 patients with a history of four to eight moderate to severe migraines per month, with or without aura. Patients were randomized to placebo or one of four BoNTA groups that received injections into different muscle regions: frontal (10 U), temporal (6 U), glabellar (9 U), or all three areas (total dose 25 U). For 3 months following a single treatment, patients recorded migraine-related variables in a daily diary. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines (P > or = 0.411). In general, no statistically significant differences were observed for any efficacy variable. The overall rates of adverse events (any type) or treatment-related adverse events were similar among the groups. In this exploratory study of episodic migraine patients, low-dose injections of BoNTA into the frontal, temporal, and/or glabellar muscle regions were not more effective than placebo. BoNTA was safe and well tolerated. Future studies may examine higher BoNTA doses, flexible injection sites, multiple treatments, and disallow concomitant prophylactic medications.

  7. Effects of fire on spotted owl site occupancy in a late-successional forest

    USGS Publications Warehouse

    Roberts, Susan L.; van Wagtendonk, Jan W.; Miles, A. Keith; Kelt, Douglas A.

    2011-01-01

    The spotted owl (Strix occidentalis) is a late-successional forest dependent species that is sensitive to forest management practices throughout its range. An increase in the frequency and spatial extent of standreplacing fires in western North America has prompted concern for the persistence of spotted owls and other sensitive late-successional forest associated species. However, there is sparse information on the effects of fire on spotted owls to guide conservation policies. In 2004-2005, we surveyed for California spotted owls during the breeding season at 32 random sites (16 burned, 16 unburned) throughout late-successional montane forest in Yosemite National Park, California. Our burned areas burned at all severities, but predominately involved low to moderate fire severity. Based on an information theoretic approach, spotted owl detection and occupancy rates were similar between burned and unburned sites. Nest and roost site occupancy was best explained by a model that combined total tree basal area (positive effect) with cover by coarse woody debris (negative effect). The density estimates of California spotted owl pairs were similar in burned and unburned forests, and the overall mean density estimate for Yosemite was higher than previously reported for montane forests. Our results indicate that low to moderate severity fires, historically common within montane forests of the Sierra Nevada, California, maintain habitat characteristics essential for spotted owl site occupancy. These results suggest that managed fires that emulate the historic fire regime of these forests may maintain spotted owl habitat and protect this species from the effects of future catastrophic fires.

  8. Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial).

    PubMed

    Vaghardoost, Reza; Momeni, Mahnoush; Kazemikhoo, Nooshafarin; Mokmeli, Soheila; Dahmardehei, Mostafa; Ansari, Fereshteh; Nilforoushzadeh, Mohammad Ali; Sabr Joo, Parisa; Mey Abadi, Sara; Naderi Gharagheshlagh, Soheila; Sassani, Saeed

    2018-04-01

    Skin graft is a standard therapeutic technique in patients with deep ulcers, but managing donor site after grafting is very important. Although several modern dressings are available to enhance the comfort of donor site, using techniques that accelerate wound healing may enhance patient satisfaction. Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers, but there is not any report of using this method for healing of donor site in burn patients. The protocols and informed consent were reviewed according to Medical Ethics Board of Shahid Beheshti University of Medical Sciences (IR.SBMU.REC.1394.363) and Iranian Registry of Clinical Trials (IRCT2016020226069N2). Eighteen donor sites in 11 patients with grade 3 burn ulcer were selected. Donor areas were divided into 2 parts, for laser irradiation and control randomly. Laser area was irradiated by a red, 655-nm laser light, 150 mW, 2 J/cm 2 , on days 0 (immediately after surgery), 3, 5, and 7. Dressing and other therapeutic care for both sites were the same. The patients and the person who analyzed the results were blinded. The size of donor site reduced in both groups during the 7-day study period (P < 0.01) and this reduction was significantly greater in the laser group (P = 0.01). In the present study, for the first time, we evaluate the effects of LLLT on the healing process of donor site in burn patients. The results showed that local irradiation of red laser accelerates wound healing process significantly.

  9. A randomized controlled trial of the effect of participatory ergonomic low back pain training on workplace improvement

    PubMed Central

    Kajiki, Shigeyuki; Izumi, Hiroyuki; Hayashida, Kenshi; Kusumoto, Akira; Nagata, Tomohisa; Mori, Koji

    2017-01-01

    Objectives: This study aimed to determine the effects of participatory workplace improvement (PWI) -based provision of ergonomic training and ergonomic action checklists (ACLs) to on-site managers on workplace improvement activities for low back pain (LBP). Methods: A randomized controlled trial (RCT) was conducted at a manufacturing company in Japan. Teams entered in the study were randomly assigned to a control and an intervention group. A total of three interventional training sessions on methods of ergonomics were provided to on-site managers in the intervention group, with 1-month intervals between sessions. Ergonomic ACLs were provided at the same time. After completion of the training sessions, each team then provided a report of improvements each month for the next 10 months. Two people in charge of safety and health chose two major objectives of the implemented activities from the five categories. The reported number of improvements was analyzed using a Poisson regression model. Results: In the intervention group, although the incident rate ratio (IRR) of PWIs in countermeasures for the LBP category was significantly elevated after the training sessions, the IRR of improvements decreased over time during the 10-month follow-up period. No significant difference was observed in the IRR of total PWIs in either the control or intervention group. Conclusions: PWI-based provision of ergonomic training sessions and ergonomics ACLs to on-site managers was shown to be effective for workplace improvement activities targeted at LBP. However, because the effects decrease over time, efforts should be made to maintain the effects through regular interventions. PMID:28320978

  10. A randomized controlled trial of the effect of participatory ergonomic low back pain training on workplace improvement.

    PubMed

    Kajiki, Shigeyuki; Izumi, Hiroyuki; Hayashida, Kenshi; Kusumoto, Akira; Nagata, Tomohisa; Mori, Koji

    2017-05-25

    This study aimed to determine the effects of participatory workplace improvement (PWI) -based provision of ergonomic training and ergonomic action checklists (ACLs) to on-site managers on workplace improvement activities for low back pain (LBP). A randomized controlled trial (RCT) was conducted at a manufacturing company in Japan. Teams entered in the study were randomly assigned to a control and an intervention group. A total of three interventional training sessions on methods of ergonomics were provided to on-site managers in the intervention group, with 1-month intervals between sessions. Ergonomic ACLs were provided at the same time. After completion of the training sessions, each team then provided a report of improvements each month for the next 10 months. Two people in charge of safety and health chose two major objectives of the implemented activities from the five categories. The reported number of improvements was analyzed using a Poisson regression model. In the intervention group, although the incident rate ratio (IRR) of PWIs in countermeasures for the LBP category was significantly elevated after the training sessions, the IRR of improvements decreased over time during the 10-month follow-up period. No significant difference was observed in the IRR of total PWIs in either the control or intervention group. PWI-based provision of ergonomic training sessions and ergonomics ACLs to on-site managers was shown to be effective for workplace improvement activities targeted at LBP. However, because the effects decrease over time, efforts should be made to maintain the effects through regular interventions.

  11. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial.

    PubMed

    Schackman, Bruce R; Metsch, Lisa R; Colfax, Grant N; Leff, Jared A; Wong, Angela; Scott, Callie A; Feaster, Daniel J; Gooden, Lauren; Matheson, Tim; Haynes, Louise F; Paltiel, A David; Walensky, Rochelle P

    2013-02-01

    The President's National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit. A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio <$100,000/QALY. Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  12. The Cost-effectiveness of Rapid HIV Testing in Substance Abuse Treatment: Results of a Randomized Trial*

    PubMed Central

    Schackman, Bruce R.; Metsch, Lisa R.; Colfax, Grant N.; Leff, Jared A.; Wong, Angela; Scott, Callie A.; Feaster, Daniel J.; Gooden, Lauren; Matheson, Tim; Haynes, Louise F.; Paltiel, A. David; Walensky, Rochelle P.

    2012-01-01

    BACKGROUND The President’s National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. METHODS We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. RESULTS Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit. CONCLUSIONS A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio <$100,000/QALY. Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested. PMID:22971593

  13. Effect of Escitalopram on Hot Flash Interference: A Randomized, Controlled Trial

    PubMed Central

    Carpenter, Janet S.; Guthrie, Katherine A.; Larson, Joseph C.; Freeman, Ellen W.; Joffe, Hadine; Reed, Susan D.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2012-01-01

    Objectives To estimate the effect of escitalopram 10–20 mg/day versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life. Design Multi-site, randomized, double-blind, placebo-controlled clinical trial. Patients 205 midlife women (46% African-American) who met criteria participated. Setting MsFLASH clinical sites in Boston, Indianapolis, Oakland, and Philadelphia. Intervention After baseline, women were randomized to 1 pill of escitalopram 10 mg/day (n=104) or placebo (n=101) with follow-up at 4- and 8-weeks. At week 4, those not achieving 50% fewer hot flashes were increased to 2 pills daily (20 mg/day or 2 placebo pills). Main outcome measures The Hot Flash Related Daily Interference Scale; Correlates were variables from hot flash diaries; Predictors were baseline demographics, clinical variables, depression, anxiety, sleep quality, and hot flashes. Results Compared to placebo, escitalopram significantly reduced hot flash interference by 6.0 points at week 4 and 3.4 points at week 8 more than placebo (p=0.012). Reductions in hot flash interference correlated with changes in hot flash diary variables. However, baseline variables did not significantly predict reductions in hot flash interference. Conclusions Escitalopram 10–20mg/day for 8 weeks improves women’s quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables. PMID:22480818

  14. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure).

    PubMed

    Pancholy, Samir B; Joshi, Pankaj; Shah, Sanjay; Rao, Sunil V; Bertrand, Olivier F; Patel, Tejas M

    2015-08-17

    This study sought to perform a randomized noninferiority trial of radiation exposure during cardiac catheterization comparing femoral access (FA) with left radial access (LRA) and right radial access (RRA). Increased radiation exposure with radial approach compared with femoral approach remains a controversial issue. This study randomized 1,493 patients undergoing cardiac catheterization at a tertiary care center to FA, LRA, and RRA in a 1:1:1 fashion. The primary endpoint was air kerma. The secondary endpoints included dose-area product, fluoroscopy time and operator dose per procedure, number of cineangiograms, and number of catheters. Baseline and procedural characteristics were similar among groups. No significant differences were observed in air kerma (medians: FA: 421 mGy [interquartile range (IQR): 337 to 574 mGy], LRA: 454 mGy [IQR: 331 to 643 mGy], and RRA: 483 mGy [IQR: 382 to 592 mGy], p = 0.146), dose-area product (medians: FA: 25.5 Gy cm(2) [IQR: 19.6 to 34.5 Gy cm(2)], LRA: 26.6 Gy cm(2) [IQR: 19.5 to 37.5 Gy cm(2)], and RRA: 27.7 Gy cm(2) [IQR: 21.9 to 34.4 Gy cm(2)], p = 0.40), or fluoroscopy time (medians: FA: 1.3 min [IQR: 1.0 to 1.7 min], LRA: 1.3 min [IQR: 1.0 to 1.7 min], and RRA: 1.32 min [IQR: 1.0 to 1.7 min], p = 0.19) among the 3 access sites. Median operator exposure was higher in the LRA group (3 mrem [IQR: 2 to 5 mrem], p = 0.001 vs. FA, and p = 0.0001 vs. RRA) compared with the FA (2 mrem [IQR: 2 to 4 mrem] and RRA groups (3 mrem [IQR: 2 to 5 mrem]). Radiation exposure to patients was similar during diagnostic coronary angiography with FA, RRA, and LRA. However, LRA was associated with significantly higher operator radiation exposure than were FA and RRA procedures. (Randomized Evaluation of Vascular Entry Site and Radiation Exposure [REVERE]; NCT01677481). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  15. Computational prediction of muon stopping sites using ab initio random structure searching (AIRSS)

    NASA Astrophysics Data System (ADS)

    Liborio, Leandro; Sturniolo, Simone; Jochym, Dominik

    2018-04-01

    The stopping site of the muon in a muon-spin relaxation experiment is in general unknown. There are some techniques that can be used to guess the muon stopping site, but they often rely on approximations and are not generally applicable to all cases. In this work, we propose a purely theoretical method to predict muon stopping sites in crystalline materials from first principles. The method is based on a combination of ab initio calculations, random structure searching, and machine learning, and it has successfully predicted the MuT and MuBC stopping sites of muonium in Si, diamond, and Ge, as well as the muonium stopping site in LiF, without any recourse to experimental results. The method makes use of Soprano, a Python library developed to aid ab initio computational crystallography, that was publicly released and contains all the software tools necessary to reproduce our analysis.

  16. Enhancing superconducting critical current by randomness

    DOE PAGES

    Wang, Y. L.; Thoutam, L. R.; Xiao, Z. L.; ...

    2016-01-11

    The key ingredient of high critical currents in a type-II superconductor is defect sites that pin vortices. Here, we demonstrate that a random pinscape, an overlooked pinning system in nanopatterned superconductors, can lead to a substantially larger critical current enhancement at high magnetic fields than an ordered array of vortex pin sites. We reveal that the better performance of a random pinscape is due to the variation of the local density of its pinning sites, which mitigates the motion of vortices. This is confirmed by achieving even higher enhancement of the critical current through a conformally mapped random pinscape, wheremore » the distribution of the local density of pinning sites is further enlarged. Our findings highlight the potential of random pinscapes in enhancing the superconducting critical currents of applied superconductors in which random pin sites of nanoscale defects emerging in the materials synthesis process or through ex-situ irradiation are the only practical choice for large-scale production. Our results may also stimulate research on effects of a random pinscape in other complementary systems such as colloidal crystals, Bose-Einstein condensates, and Luttinger liquids.« less

  17. Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis patients-A prospective, randomized controlled trial.

    PubMed

    Wang, Hsi-Hao; Hung, Shih-Yuan; Chang, Min-Yu; Lee, Yi-Che; Lin, Hsiu-Fang; Lin, Tsun-Mei; Yang, Su-Pen; Lin, Hsi-Hsun; Yang, Su-Ching; Wang, Jiun-Ling

    2017-01-01

    Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients were not known. We performed a prospective, randomized controlled trial enrolling 89 PD patients. After stratification by initial Staphylococcus aureus (SA) carrier status, patients were randomly assigned to receive daily 4% chlorhexidine care (intervention group) or normal saline (control group) at the exit site. Monthly, we cultured bacteria from the exit site and nasal swabs for 1 year. The SA colonization rates at exit site at 6 and 12 months were significantly lower in the intervention group than the control group (5.0% vs. 22.9%, p = 0.023 and 8.6% vs. 28.1%, p = 0.037 for 6 and 12 months, respectively). The Methicillin-resistant SA (MRSA) colonization rate at exit site at 6 months was similar (5.7% vs. 2.5%,p = 0.596) in control and intervention group, but significantly lower in the intervention group than the control group at exit site at 12months (0% vs. 12.5%, p = 0.047). The gram-negative bacilli (GNB) colonization rates were similar between the intervention and control groups at 6 and 12 months. Genotyping of all MRSA isolates showed ST (sequence type) 59 was the most predominant clone. In conclusion, chlorhexidine care at the exit site in PD patients may be a good strategy for SA and MRSA decolonization. ClinicalTrials.gov NCT02446158.

  18. A Weighting Method for Assessing Between-Site Heterogeneity in Causal Mediation Mechanism

    ERIC Educational Resources Information Center

    Qin, Xu; Hong, Guanglei

    2017-01-01

    When a multisite randomized trial reveals between-site variation in program impact, methods are needed for further investigating heterogeneous mediation mechanisms across the sites. We conceptualize and identify a joint distribution of site-specific direct and indirect effects under the potential outcomes framework. A method-of-moments procedure…

  19. Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

    PubMed

    Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

    2014-03-01

    Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. Published by Elsevier Inc.

  20. Effect of application site, clothing barrier, and application site washing on testosterone transfer with a 1.62% testosterone gel.

    PubMed

    Stahlman, Jodi; Britto, Margaret; Fitzpatrick, Sherahe; McWhirter, Cecilia; Testino, Samuel A; Brennan, John J; Zumbrunnen, Troy L

    2012-02-01

    To evaluate the effect of application site location, clothing barrier, and application site washing on testosterone transfer from males dosed with 1.62% testosterone gel to female partners. Open-label, randomized, parallel group, crossover study performed in 24 healthy male/female couples. 2.5 or 5.0 g of gel was applied to upper arms and shoulders or abdomens of male subjects. Skin contact occurred 2 hours after gel application between male and female subjects to compare the effect of wearing or not wearing a t-shirt, washing or not washing before contact, and the effect of differing application sites. Treatments were separated by a 1-week washout period. On each dosing day, 15 minutes of supervised skin contact occurred between the dosed male and female partner. Contact was either abdomen to abdomen (male to female), or upper arms/shoulders (male) to upper arms/shoulders, wrists and hands (female), depending on the male application site. Serum samples were collected from females at baseline and after contact to assess secondary testosterone exposure. C(max) (maximum serum concentration), AUC(0-24) (area under serum concentration-time curve from 0-24 hours), and C(av) (time-averaged concentration over 24-hour post-contact period) were assessed. Subjects were monitored for adverse events. Testosterone exposure (C(av) and C(max)) in females increased by up to 27% (2.5 g) or up to 280% (5.0 g) from baseline after direct skin contact at 2 hours after gel application, although C(av) remained within the female eugonadal range. Transfer from the abdomen was prevented when a t-shirt was worn (2.5-g dose). When the application site was washed before contact, mean C(av) was comparable to baseline, and C(max) was slightly higher (14%). Transfer was higher after direct skin-to-skin contact when the application and contact sites were upper arms/shoulders versus the abdomen. Testosterone concentrations returned to baseline within 48 hours after last skin contact. There is

  1. Superfluid-insulator transition in a disordered two-dimensional quantum rotor model with random on-site interactions

    NASA Astrophysics Data System (ADS)

    An, Taeyang; Cha, Min-Chul

    2013-03-01

    We study the superfluid-insulator quantum phase transition in a disordered two-dimensional quantum rotor model with random on-site interactions in the presence of particle-hole symmetry. Via worm-algorithm Monte Carlo calculations of superfluid density and compressibility, we find the dynamical critical exponent z ~ 1 . 13 (2) and the correlation length critical exponent 1 / ν ~ 1 . 1 (1) . These exponents suggest that the insulating phase is a incompressible Mott glass rather than a Bose glass.

  2. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.

    PubMed

    Elul, Batya; Lahuerta, Maria; Abacassamo, Fatima; Lamb, Matthew R; Ahoua, Laurence; McNairy, Margaret L; Tomo, Maria; Horowitz, Deborah; Sutton, Roberta; Mussa, Antonio; Gurr, Danielle; Jani, Ilesh

    2014-10-15

    Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real

  3. Assessing the use of existing data to compare plains fish assemblages collected from random and fixed sites in Colorado

    USGS Publications Warehouse

    Zuellig, Robert E.; Crockett, Harry J.

    2013-01-01

    The U.S. Geological Survey, in cooperation with Colorado Parks and Wildlife, assessed the potential use of combining recently (2007 to 2010) and formerly (1992 to 1996) collected data to compare plains fish assemblages sampled from random and fixed sites located in the South Platte and Arkansas River Basins in Colorado. The first step was to determine if fish assemblages collected between 1992 and 1996 were comparable to samples collected at the same sites between 2007 and 2010. If samples from the two time periods were comparable, then it was considered reasonable that the combined time-period data could be used to make comparisons between random and fixed sites. In contrast, if differences were found between the two time periods, then it was considered unreasonable to use these data to make comparisons between random and fixed sites. One-hundred samples collected during the 1990s and 2000s from 50 sites dispersed among 19 streams in both basins were compiled from a database maintained by Colorado Parks and Wildlife. Nonparametric multivariate two-way analysis of similarities was used to test for fish-assemblage differences between time periods while accounting for stream-to-stream differences. Results indicated relatively weak but significant time-period differences in fish assemblages. Weak time-period differences in this case possibly were related to changes in fish assemblages associated with environmental factors; however, it is difficult to separate other possible explanations such as limited replication of paired time-period samples in many of the streams or perhaps differences in sampling efficiency and effort between the time periods. Regardless, using the 1990s data to fill data gaps to compare random and fixed-site fish-assemblage data is ill advised based on the significant separation in fish assemblages between time periods and the inability to determine conclusive explanations for these results. These findings indicated that additional sampling will

  4. Supported employment: cost-effectiveness across six European sites

    PubMed Central

    Knapp, Martin; Patel, Anita; Curran, Claire; Latimer, Eric; Catty, Jocelyn; Becker, Thomas; Drake, Robert E; Fioritti, Angelo; Kilian, Reinhold; Lauber, Christoph; Rössler, Wulf; Tomov, Toma; van Busschbach, Jooske; Comas-Herrera, Adelina; White, Sarah; Wiersma, Durk; Burns, Tom

    2013-01-01

    A high proportion of people with severe mental health problems are unemployed but would like to work. Individual Placement and Support (IPS) offers a promising approach to establishing people in paid employment. In a randomized controlled trial across six European countries, we investigated the economic case for IPS for people with severe mental health problems compared to standard vocational rehabilitation. Individuals (n=312) were randomized to receive either IPS or standard vocational services and followed for 18 months. Service use and outcome data were collected. Cost-effectiveness analysis was conducted with two primary outcomes: additional days worked in competitive settings and additional percentage of individuals who worked at least 1 day. Analyses distinguished country effects. A partial cost-benefit analysis was also conducted. IPS produced better outcomes than alternative vocational services at lower cost overall to the health and social care systems. This pattern also held in disaggregated analyses for five of the six European sites. The inclusion of imputed values for missing cost data supported these findings. IPS would be viewed as more cost-effective than standard vocational services. Further analysis demonstrated cost-benefit arguments for IPS. Compared to standard vocational rehabilitation services, IPS is, therefore, probably cost-saving and almost certainly more cost-effective as a way to help people with severe mental health problems into competitive employment. PMID:23471803

  5. Laparoendoscopic single-site surgery versus standard laparoscopic simple nephrectomy: a prospective randomized study.

    PubMed

    Tugcu, Volkan; Ilbey, Yusuf Ozlem; Mutlu, Bircan; Tasci, Ali Ihsan

    2010-08-01

    Laparoendoscopic single-site surgery (LESS), an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions, has been developed recently. Our aim was to compare LESS simple nephrectomy (LESS-SN) and conventional transperitoneal laparoscopic simple nephrectomy (CTL-SN). In this randomized study that was conducted between December 2008 and September 2009, 27 patients who needed simple nephrectomy were randomized to either LESS-SN or CTL-SN. All procedures in both groups were performed by the first author, who is experienced in laparoscopic surgery. Patient characteristics, perioperative details, and time to return to work were recorded. Postoperative evaluation of pain and use of analgesic medication were recorded. There was no difference in median operative time (117.5 vs 114 min, P = 0.52), blood loss (50.71 vs 47.15 mL, P = 0.60), transfusion rates (0% for both), and hospitalization time (2.07 vs 2.11 days, P = 0.74) between the LESS-SN and CTL-SN groups. Time to return to normal activities was shorter in the LESS-SN group compared with the CTL-SN group (10.7 vs 13.5 days, P = 0.001). Both the visual analogue scale and the postoperative use of analgesics were significantly lower during postoperative days 1, 2, and 3 in patients who underwent LESS-SN, compared with patients who underwent CTL-SN. There were no intraoperative or postoperative complications in both groups. Compared with CTL-SN, LESS-SN was more expensive, but all patients undergoing LESS-SN were very pleased with the cosmetic outcome (no visible scars). The early experience described in this study suggests that LESS-SN is a safe and effective alternative to CTL-SN that provides surgeons with a minimally invasive surgical option and the ability to hide the surgical incision within the umbilicus; however, a larger series is necessary to confirm these findings and to determine if there are any benefits in pain

  6. Effect of muscle injection site on preanaesthetic sedation in dogs.

    PubMed

    Self, I A; Hughes, J M L; Kenny, D A; Clutton, R E

    2009-03-14

    The demeanour of 122 dogs was assessed, and a mixture of 0.025 mg/kg acepromazine and 0.3 mg/kg morphine was injected intramuscularly into one of four randomly assigned muscle sites (cervical epaxial, triceps brachii, middle gluteal and quadriceps femoris) and the dogs' reactions to the injections were assessed. The development of sedation and the occurrence of side effects were assessed after 10, 20 and 30 minutes, and each dog's reaction to venous catheterisation was scored. All the dogs became similarly sedated after 30 minutes. The degree of sedation and the incidence of side effects were independent of the injection site, but the dogs receiving intragluteal injections had lower sedation scores after 10 minutes. The dogs' demeanour had no effect on their response to venous catheterisation. The dogs receiving an injection into the postural quadriceps and triceps muscles showed more marked reactions than those injected into the non-postural cervical epaxial and gluteal muscles.

  7. [On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

    PubMed

    Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

    2014-02-01

    To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

  8. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial.

    PubMed

    Lee, Janet T; Marquez, Thao T; Clerc, Daniel; Gie, Olivier; Demartines, Nicolas; Madoff, Robert D; Rothenberger, David A; Christoforidis, Dimitrios

    2014-11-01

    Surgical site infection after stoma reversal is common. The optimal skin closure technique after stoma reversal has been widely debated in the literature. We hypothesized that pursestring near-complete closure of the stoma site would lead to fewer surgical site infections compared with conventional primary closure. This study was a parallel prospective multicenter randomized controlled trial. This study was conducted at 2 university medical centers. Patients (N = 122) presenting for elective colostomy or ileostomy reversal were selected. Pursestring versus conventional primary closure of stoma sites were compared. Stoma site surgical site infection within 30 days of surgery, overall surgical site infection, delayed healing (open wound for >30 days), time to wound epithelialization, and patient satisfaction were the primary outcomes measured. The pursestring group had a significantly lower stoma site infection rate (2% vs 15%, p = 0.01). There was no difference in delayed healing or patient satisfaction between groups. Time to epithelialization was measured in only 51 patients but was significantly longer in the pursestring group (34.6 ± 20 days vs 24.1 ± 17 days, p = 0.02). This study was limited by the variability in procedures and surgeons, the limited follow-up after 30 days, and the inability to perform blinding. Pursestring closure after stoma reversal has a lower risk of stoma site surgical site infection than conventional primary closure, although wounds may take longer to heal with the use of this approach. NCT01713452 (www.clinicaltrials.gov).

  9. Summer School Effects in a Randomized Field Trial

    ERIC Educational Resources Information Center

    Zvoch, Keith; Stevens, Joseph J.

    2013-01-01

    This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

  10. Cost Effectiveness of On-site versus Off-site Depression Collaborative Care in Rural Federally Qualified Health Centers

    PubMed Central

    Pyne, Jeffrey M.; Fortney, John C.; Mouden, Sip; Lu, Liya; Hudson, Teresa J; Mittal, Dinesh

    2018-01-01

    Objective Collaborative care for depression is effective and cost-effective in primary care settings. However, there is minimal evidence to inform the choice of on-site versus off-site models. This study examined the cost-effectiveness of on-site practice-based collaborative care (PBCC) versus off-site telemedicine-based collaborative care (TBCC) for depression in Federally Qualified Health Centers (FQHCs). Methods Multi-site randomized pragmatic comparative cost-effectiveness trial. 19,285 patients were screened for depression, 14.8% (n=2,863) screened positive (PHQ9 ≥10) and 364 were enrolled. Telephone interview data were collected at baseline, 6-, 12-, and 18-months. Base case analysis used Arkansas FQHC healthcare costs and secondary analysis used national cost estimates. Effectiveness measures were depression-free days and quality-adjusted life years (QALYs) derived from depression-free days, Medical Outcomes Study SF-12, and Quality of Well Being scale (QWB). Nonparametric bootstrap with replacement methods were used to generate an empirical joint distribution of incremental costs and QALYs and acceptability curves. Results Mean base case FQHC incremental cost-effectiveness ratio (ICER) using depression-free days was $10.78/depression-free day. Mean base case ICERs using QALYs ranged from $14,754/QALY (depression-free day QALY) to $37,261/QALY (QWB QALY). Mean secondary national ICER using depression-free days was $8.43/depression-free day and using QALYs ranged from $11,532/QALY (depression-free day QALY) to $29,234/QALY (QWB QALY). Conclusions These results support the cost-effectiveness of the TBCC intervention in medically underserved primary care settings. Results can inform the decision about whether to insource (make) or outsource (buy) depression care management in the FQHC setting within the current context of Patient-Centered Medical Home, value-based purchasing, and potential bundled payments for depression care. The www.clinicaltrials.gov # for

  11. Effects of a drill diameter on the temperature rise in a bone during implant site preparation under clinical conditions.

    PubMed

    Bogovič, Valerija; Svete, Andrej; Bajsić, Ivan

    2016-10-01

    Heat, generated during the drilling of a dental implant site preparation, leads to a temperature rise and consequently to a thermal injury of the bone tissue surrounding the implant site, which can cause the subsequent implant failure. In this article, we present new findings related to the temperature rise during implant site drilling under real conditions on a bovine rib bone specimen. The experiments were designed with the help of a full-factorial design in randomized complete blocks, where the main effects of the drill diameter in combination with the drilling force and the drilling speed, and their interactions, on the temperature rise were determined. The temperature rise in the bone under real conditions was measured as the implant site was being prepared by a dentist using intermittent, graduated drilling and external irrigation. Results show that the drill diameter has statistically significant effect, independent of the drilling procedure used. Among the examined drilling parameters, the drill diameter has the greatest effect, where an increase in the drill diameter first causes a decrease in the temperature rise and further increase in the drill diameter causes its increase. During the continuous and one-step drilling, the temperatures of the bones were up to 40.5 °C and during the drilling under actual conditions up to 30.11 °C. © IMechE 2016.

  12. A randomized trial comparing concise and standard consent forms in the START trial

    PubMed Central

    Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

    2017-01-01

    Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008

  13. Work-site cardiovascular risk reduction: a randomized trial of health risk assessment, education, counseling, and incentives.

    PubMed Central

    Gomel, M; Oldenburg, B; Simpson, J M; Owen, N

    1993-01-01

    OBJECTIVES. This study reports an efficacy trial of four work-site health promotion programs. It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies. METHODS. Twenty-eight work sites were randomly allocated to a health risk assessment, risk factor education, behavioral counseling, or behavioral counseling plus incentives intervention. Participants were assessed before the intervention and at 3, 6, and 12 months. RESULTS. Compared with the average of the health risk assessment and risk factor education conditions, there were significantly higher validated continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions. The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition. On average among all groups, there was a short-term increase in aerobic capacity followed by a return to baseline levels. CONCLUSIONS. Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and, if implemented routinely, can have a significant public health impact. PMID:8362997

  14. 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

  15. Effects of Check and Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

    2014-01-01

    Objectives: This study examined the effects of Check & Connect (C&C) on the attendance, behavior, and academic outcomes of at-risk youth in a field-based effectiveness trial. Method: A multisite randomized block design was used, wherein 260 primarily Hispanic (89%) and economically disadvantaged (74%) students were randomized to treatment…

  16. Extensively Parameterized Mutation-Selection Models Reliably Capture Site-Specific Selective Constraint.

    PubMed

    Spielman, Stephanie J; Wilke, Claus O

    2016-11-01

    The mutation-selection model of coding sequence evolution has received renewed attention for its use in estimating site-specific amino acid propensities and selection coefficient distributions. Two computationally tractable mutation-selection inference frameworks have been introduced: One framework employs a fixed-effects, highly parameterized maximum likelihood approach, whereas the other employs a random-effects Bayesian Dirichlet Process approach. While both implementations follow the same model, they appear to make distinct predictions about the distribution of selection coefficients. The fixed-effects framework estimates a large proportion of highly deleterious substitutions, whereas the random-effects framework estimates that all substitutions are either nearly neutral or weakly deleterious. It remains unknown, however, how accurately each method infers evolutionary constraints at individual sites. Indeed, selection coefficient distributions pool all site-specific inferences, thereby obscuring a precise assessment of site-specific estimates. Therefore, in this study, we use a simulation-based strategy to determine how accurately each approach recapitulates the selective constraint at individual sites. We find that the fixed-effects approach, despite its extensive parameterization, consistently and accurately estimates site-specific evolutionary constraint. By contrast, the random-effects Bayesian approach systematically underestimates the strength of natural selection, particularly for slowly evolving sites. We also find that, despite the strong differences between their inferred selection coefficient distributions, the fixed- and random-effects approaches yield surprisingly similar inferences of site-specific selective constraint. We conclude that the fixed-effects mutation-selection framework provides the more reliable software platform for model application and future development. © The Author 2016. Published by Oxford University Press on behalf of the

  17. Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

    PubMed

    Backes, Manouk; Dingemans, Siem A; Dijkgraaf, Marcel G W; van den Berg, H Rogier; van Dijkman, Bart; Hoogendoorn, Jochem M; Joosse, Pieter; Ritchie, Ewan D; Roerdink, W Herbert; Schots, Judith P M; Sosef, Nico L; Spijkerman, Ingrid J B; Twigt, Bas A; van der Veen, Alexander H; van Veen, Ruben N; Vermeulen, Jefrey; Vos, Dagmar I; Winkelhagen, Jasper; Goslings, J Carel; Schepers, Tim

    2017-12-26

    Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of

  18. Bias and Bias Correction in Multi-Site Instrumental Variables Analysis of Heterogeneous Mediator Effects

    ERIC Educational Resources Information Center

    Reardon, Sean F.; Unlu, Faith; Zhu, Pei; Bloom, Howard

    2013-01-01

    We explore the use of instrumental variables (IV) analysis with a multi-site randomized trial to estimate the effect of a mediating variable on an outcome in cases where it can be assumed that the observed mediator is the only mechanism linking treatment assignment to outcomes, as assumption known in the instrumental variables literature as the…

  19. Analgesic effects of preinjection low-level laser/light therapy (LLLT) before third molar surgery: a double-blind randomized controlled trial.

    PubMed

    Tuk, Jacco G C; van Wijk, Arjen J; Mertens, Ine C; Keleş, Zühal; Lindeboom, Jérôme A H; Milstein, Dan M J

    2017-09-01

    The aim of this study was to evaluate the analgesic effects of low-level laser therapy (LLLT) on preinjection sites in patients scheduled for third molar removal. This double-blind randomized controlled trial included 163 healthy patients undergoing third molar extractions. The study participants were randomly divided into an LLLT and a placebo group. Objective and subjective data sets were obtained from physiologic feedback (heart rate and sweat response) and a questionnaire, respectively. In the LLLT group, each targeted injection site was irradiated twice with 198 mW continuous wave for 30 seconds with a 0.088 cm 2 focal spot at an applied energy of 5.94 J and fluence of 67.50 J/cm 2 . Measurements were recorded from 4 time-points during data acquisition. There was no significant difference between the LLLT and placebo groups in pain experience scores associated with the injected sites for maxillary or mandibular third molar extractions. Mean heart rates before and during injection were lower in the LLLT group than in the placebo group for both maxillary and mandibular regions. No statistically significant differences were observed for any remaining parameters. The present data indicated that preinjection LLLT did not effectively decrease the pain felt during local anesthetic injections before third molar surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial.

    PubMed

    Dodick, David W; Silberstein, Stephen D; Bigal, Marcelo E; Yeung, Paul P; Goadsby, Peter J; Blankenbiller, Tricia; Grozinski-Wolff, Melissa; Yang, Ronghua; Ma, Yuju; Aycardi, Ernesto

    2018-05-15

    Fremanezumab, a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, may be effective for treating episodic migraine. To assess the efficacy of fremanezumab compared with placebo for prevention of episodic migraine with a monthly dosing regimen or a single higher dose. Randomized, double-blind, placebo-controlled, parallel-group trial conducted at 123 sites in 9 countries from March 23, 2016 (first patient randomized), to April 10, 2017, consisting of a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation at week 12. Study participants were aged 18 to 70 years with episodic migraine (6-14 headache days, with at least 4 migraine days, during 28-day pretreatment period). Patients who had previous treatment failure with 2 classes of migraine-preventive medication were excluded. Patients were randomized 1:1:1 to receive subcutaneous monthly dosing of fremanezumab (n = 290; 225 mg at baseline, week 4, and week 8); a single higher dose of fremanezumab, as intended to support a quarterly dose regimen (n = 291; 675 mg of fremanezumab at baseline; placebo at weeks 4 and 8); or placebo (n = 294; at baseline, week 4, and week 8). The primary end point was mean change in mean number of monthly migraine days during the 12-week period after the first dose. Among 875 patients who were randomized (mean age, 41.8 [SD, 12.1] years; 742 women [85%]), 791 (90.4%) completed the trial. From baseline to 12 weeks, mean migraine days per month decreased from 8.9 days to 4.9 days in the fremanezumab monthly dosing group, from 9.2 days to 5.3 days in the fremanezumab single-higher-dose group, and from 9.1 days to 6.5 days in the placebo group. This resulted in a difference with monthly dosing vs placebo of -1.5 days (95% CI, -2.01 to -0.93 days; P < .001) and with single higher dosing vs placebo of -1.3 days (95% CI, -1.79 to -0.72 days; P < .001). The most common adverse events that led to

  1. Comparative effects of urea fertilizer and red alder in a site III, coast Douglas-fir plantation in the Washington Cascade Range.

    Treesearch

    Richard E. Miller; Harry W. Anderson; Marshall Murray; Rick. Leon

    2005-01-01

    Five randomly assigned treatments were used to quantify effects of adding varying numbers of red alder (Alnus rubra Bong.) or nitrogen (N) fertilization on growth of a 10-year-old conifer plantation at a medium quality site in the western Washington Cascade Range. Zero, 20, 40, and 80 alder trees per acre were retained along with about 300 conifers...

  2. A random wave model for the Aharonov-Bohm effect

    NASA Astrophysics Data System (ADS)

    Houston, Alexander J. H.; Gradhand, Martin; Dennis, Mark R.

    2017-05-01

    We study an ensemble of random waves subject to the Aharonov-Bohm effect. The introduction of a point with a magnetic flux of arbitrary strength into a random wave ensemble gives a family of wavefunctions whose distribution of vortices (complex zeros) is responsible for the topological phase associated with the Aharonov-Bohm effect. Analytical expressions are found for the vortex number and topological charge densities as functions of distance from the flux point. Comparison is made with the distribution of vortices in the isotropic random wave model. The results indicate that as the flux approaches half-integer values, a vortex with the same sign as the fractional part of the flux is attracted to the flux point, merging with it in the limit of half-integer flux. We construct a statistical model of the neighbourhood of the flux point to study how this vortex-flux merger occurs in more detail. Other features of the Aharonov-Bohm vortex distribution are also explored.

  3. Postural stability effects of random vibration at the feet of construction workers in simulated elevation.

    PubMed

    Simeonov, P; Hsiao, H; Powers, J; Ammons, D; Kau, T; Amendola, A

    2011-07-01

    The risk of falls from height on a construction site increases under conditions which degrade workers' postural control. At elevation, workers depend heavily on sensory information from their feet to maintain balance. The study tested two hypotheses: "sensory enhancement"--sub-sensory (undetectable) random mechanical vibrations at the plantar surface of the feet can improve worker's balance at elevation; and "sensory suppression"--supra-sensory (detectable) random mechanical vibrations can have a degrading effect on balance in the same experimental settings. Six young (age 20-35) and six aging (age 45-60) construction workers were tested while standing in standard and semi-tandem postures on instrumented gel insoles. The insoles applied sub- or supra-sensory levels of random mechanical vibrations to the feet. The tests were conducted in a surround-screen virtual reality system, which simulated a narrow plank at elevation on a construction site. Upper body kinematics was assessed with a motion-measurement system. Postural stability effects were evaluated by conventional and statistical mechanics sway measures, as well as trunk angular displacement parameters. Analysis of variance did not confirm the "sensory enhancement" hypothesis, but provided evidence for the "sensory suppression" hypothesis. The supra-sensory vibration had a destabilizing effect, which was considerably stronger in the semi-tandem posture and affected most of the sway variables. Sensory suppression associated with elevated vibration levels on a construction site may increase the danger of losing balance. Construction workers at elevation, e.g., on a beam or narrow plank might be at increased risk of fall if they can detect vibrations under their feet. To reduce the possibility of losing balance, mechanical vibration to supporting structures used as walking/working surfaces should be minimized when performing construction tasks at elevation. Published by Elsevier Ltd.

  4. Cumulative Evidence of Randomized Controlled and Observational Studies on Catheter-Related Infection Risk of Central Venous Catheter Insertion Site in ICU Patients: A Pairwise and Network Meta-Analysis.

    PubMed

    Arvaniti, Kostoula; Lathyris, Dimitrios; Blot, Stijn; Apostolidou-Kiouti, Fani; Koulenti, Despoina; Haidich, Anna-Bettina

    2017-04-01

    Selection of central venous catheter insertion site in ICU patients could help reduce catheter-related infections. Although subclavian was considered the most appropriate site, its preferential use in ICU patients is not generalized and questioned by contradicted meta-analysis results. In addition, conflicting data exist on alternative site selection whenever subclavian is contraindicated. To compare catheter-related bloodstream infection and colonization risk between the three sites (subclavian, internal jugular, and femoral) in adult ICU patients. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled trials, CINAHL, and ClinicalTrials.gov. Eligible studies were randomized controlled trials and observational ones. Extracted data were analyzed by pairwise and network meta-analysis. Twenty studies were included; 11 were observational, seven were randomized controlled trials for other outcomes, and two were randomized controlled trials for sites. We evaluated 18,554 central venous catheters: 9,331 from observational studies, 5,482 from randomized controlled trials for other outcomes, and 3,741 from randomized controlled trials for sites. Colonization risk was higher for internal jugular (relative risk, 2.25 [95% CI, 1.84-2.75]; I = 0%) and femoral (relative risk, 2.92 [95% CI, 2.11-4.04]; I = 24%), compared with subclavian. Catheter-related bloodstream infection risk was comparable for internal jugular and subclavian, higher for femoral than subclavian (relative risk, 2.44 [95% CI, 1.25-4.75]; I = 61%), and lower for internal jugular than femoral (relative risk, 0.55 [95% CI, 0.34-0.89]; I = 61%). When observational studies that did not control for baseline characteristics were excluded, catheter-related bloodstream infection risk was comparable between the sites. In ICU patients, internal jugular and subclavian may, similarly, decrease catheter-related bloodstream infection risk, when compared with femoral. Subclavian could be suggested as the most

  5. Exploration properties of biased evanescent random walkers on a one-dimensional lattice

    NASA Astrophysics Data System (ADS)

    Esguerra, Jose Perico; Reyes, Jelian

    2017-08-01

    We investigate the combined effects of bias and evanescence on the characteristics of random walks on a one-dimensional lattice. We calculate the time-dependent return probability, eventual return probability, conditional mean return time, and the time-dependent mean number of visited sites of biased immortal and evanescent discrete-time random walkers on a one-dimensional lattice. We then extend the calculations to the case of a continuous-time step-coupled biased evanescent random walk on a one-dimensional lattice with an exponential waiting time distribution.

  6. Effects of promoting longer-term and exclusive breastfeeding on childhood eating attitudes: a cluster-randomized trial.

    PubMed

    Skugarevsky, Oleg; Wade, Kaitlin H; Richmond, Rebecca C; Martin, Richard M; Tilling, Kate; Patel, Rita; Vilchuck, Konstantin; Bogdanovich, Natalia; Sergeichick, Natalia; Davey Smith, George; Gillman, Matthew W; Oken, Emily; Kramer, Michael S

    2014-08-01

    Observational studies suggest that breastfeeding benefits later maternal child-feeding practices, which in turn may contribute to positive eating attitudes. We investigated the effect of a randomized intervention to increase duration and exclusivity of breastfeeding on pre-adolescent eating attitudes. Long-term follow-up of the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial in 31 maternity hospitals and affiliated polyclinics in Belarus. Sites were randomly assigned an experimental intervention to promote longer duration and exclusivity of breastfeeding in mothers who initiated breastfeeding (n = 16 sites), or a control intervention of continuing usual care (n = 15 sites); 17 046 healthy infants were enrolled in 1996-7, of whom 13 751 (80.7%) completed the Children's Eating Attitude Test (ChEAT) at 11.5 years of age. A ChEAT score ≥ 22.5 (85th percentile) was used as an indicator of problematic eating attitudes. Analysis was based on intention-to-treat, accounting for clustering within hospitals/clinics. Compared with the control arm, the experimental intervention substantially increased breastfeeding exclusivity (43.3% vs 6.4% exclusively breastfed at 3 months of age) and duration of any breastfeeding throughout infancy. The proportion of children with ChEAT scores ≥ 22.5 was lower in the experimental than control arm (boys 11.4% vs 17.2%; girls 18.5% vs 23.4%) [cluster-adjusted odds ratio (OR), boys: 0.44; 95% confidence interval (CI): 0.21,0.93; girls: 0.51; 95% CI: 0.27,0.99). Results were robust to adjustment for potential confounders and using a ChEAT score ≥ 25.5 (91st percentile) as the outcome (OR: 0.53; 95% CI: 0.28,1.03). An intervention to improve the duration and exclusivity of breastfeeding among term infants in Belarus was associated with a reduction in problematic eating attitudes at 11.5 years of age. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the

  7. Medical-grade honey does not reduce skin colonization at central venous catheter-insertion sites of critically ill patients: a randomized controlled trial

    PubMed Central

    2012-01-01

    Introduction Catheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites. Methods A prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location. Results Colonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity. Conclusions Medical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0

  8. Medical-grade honey does not reduce skin colonization at central venous catheter-insertion sites of critically ill patients: a randomized controlled trial.

    PubMed

    Kwakman, Paulus H; Müller, Marcella C; Binnekade, Jan M; van den Akker, Johannes P; de Borgie, Corianne A; Schultz, Marcus J; Zaat, Sebastian A

    2012-10-30

    Catheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites. A prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location. Colonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity. Medical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0.5% chlorhexidine in 70% alcohol. Netherlands Trial

  9. Randomized clinical trial of peritoneal lavage for preventing surgical site infection in elective liver surgery.

    PubMed

    Tanaka, Kuniya; Matsuo, Kenichi; Kawaguchi, Daisuke; Murakami, Takashi; Hiroshima, Yukihiko; Hirano, Atsushi; Sato, Sho; Endo, Itaru; Taguri, Masataka; Koda, Keiji

    2015-06-01

    Although intraoperative peritoneal lavage is often performed routinely with the aim of reducing peritoneal contamination, little evidence of lavage benefits in elective liver resection without bile duct resection is available. We addressed the issue with a randomized clinical trial. We prospectively and randomly assigned consecutive patients undergoing liver resection to a lavage group or a non-lavage group. Peritoneal lavage was performed at the end of operation for patients in the lavage group. The primary endpoint was the rate of surgical site infection. Ninety-six patients were assigned to the lavage group and 97 to the non-lavage group. When superficial/deep incisional infection and organ/space infection were considered together, no significant difference in surgical site infection rate was evident between lavage (21.9%) and non-lavage groups (13.4%, P = 0.135). However, organ/space infection was significantly more frequent in the lavage group (16.7%) than the non-lavage group (7.2%, P = 0.048). Peritoneal lavage was identified as a risk factor for organ/space infection by multivariate analysis (relative risk, 2.977; confidence interval, 1.094 to 8.100; P = 0.033). Intraoperative peritoneal lavage does not reduce overall incidence of surgical site infection and may increase risk of organ/space infection. © 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  10. A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

    PubMed Central

    Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

    2014-01-01

    Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

  11. A note on variance estimation in random effects meta-regression.

    PubMed

    Sidik, Kurex; Jonkman, Jeffrey N

    2005-01-01

    For random effects meta-regression inference, variance estimation for the parameter estimates is discussed. Because estimated weights are used for meta-regression analysis in practice, the assumed or estimated covariance matrix used in meta-regression is not strictly correct, due to possible errors in estimating the weights. Therefore, this note investigates the use of a robust variance estimation approach for obtaining variances of the parameter estimates in random effects meta-regression inference. This method treats the assumed covariance matrix of the effect measure variables as a working covariance matrix. Using an example of meta-analysis data from clinical trials of a vaccine, the robust variance estimation approach is illustrated in comparison with two other methods of variance estimation. A simulation study is presented, comparing the three methods of variance estimation in terms of bias and coverage probability. We find that, despite the seeming suitability of the robust estimator for random effects meta-regression, the improved variance estimator of Knapp and Hartung (2003) yields the best performance among the three estimators, and thus may provide the best protection against errors in the estimated weights.

  12. Effective Perron-Frobenius eigenvalue for a correlated random map

    NASA Astrophysics Data System (ADS)

    Pool, Roman R.; Cáceres, Manuel O.

    2010-09-01

    We investigate the evolution of random positive linear maps with various type of disorder by analytic perturbation and direct simulation. Our theoretical result indicates that the statistics of a random linear map can be successfully described for long time by the mean-value vector state. The growth rate can be characterized by an effective Perron-Frobenius eigenvalue that strongly depends on the type of correlation between the elements of the projection matrix. We apply this approach to an age-structured population dynamics model. We show that the asymptotic mean-value vector state characterizes the population growth rate when the age-structured model has random vital parameters. In this case our approach reveals the nontrivial dependence of the effective growth rate with cross correlations. The problem was reduced to the calculation of the smallest positive root of a secular polynomial, which can be obtained by perturbations in terms of Green’s function diagrammatic technique built with noncommutative cumulants for arbitrary n -point correlations.

  13. A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

    PubMed

    Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

    2018-06-01

    Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

  14. Full Bayes Poisson gamma, Poisson lognormal, and zero inflated random effects models: Comparing the precision of crash frequency estimates.

    PubMed

    Aguero-Valverde, Jonathan

    2013-01-01

    In recent years, complex statistical modeling approaches have being proposed to handle the unobserved heterogeneity and the excess of zeros frequently found in crash data, including random effects and zero inflated models. This research compares random effects, zero inflated, and zero inflated random effects models using a full Bayes hierarchical approach. The models are compared not just in terms of goodness-of-fit measures but also in terms of precision of posterior crash frequency estimates since the precision of these estimates is vital for ranking of sites for engineering improvement. Fixed-over-time random effects models are also compared to independent-over-time random effects models. For the crash dataset being analyzed, it was found that once the random effects are included in the zero inflated models, the probability of being in the zero state is drastically reduced, and the zero inflated models degenerate to their non zero inflated counterparts. Also by fixing the random effects over time the fit of the models and the precision of the crash frequency estimates are significantly increased. It was found that the rankings of the fixed-over-time random effects models are very consistent among them. In addition, the results show that by fixing the random effects over time, the standard errors of the crash frequency estimates are significantly reduced for the majority of the segments on the top of the ranking. Copyright © 2012 Elsevier Ltd. All rights reserved.

  15. Role of Statistical Random-Effects Linear Models in Personalized Medicine

    PubMed Central

    Diaz, Francisco J; Yeh, Hung-Wen; de Leon, Jose

    2012-01-01

    Some empirical studies and recent developments in pharmacokinetic theory suggest that statistical random-effects linear models are valuable tools that allow describing simultaneously patient populations as a whole and patients as individuals. This remarkable characteristic indicates that these models may be useful in the development of personalized medicine, which aims at finding treatment regimes that are appropriate for particular patients, not just appropriate for the average patient. In fact, published developments show that random-effects linear models may provide a solid theoretical framework for drug dosage individualization in chronic diseases. In particular, individualized dosages computed with these models by means of an empirical Bayesian approach may produce better results than dosages computed with some methods routinely used in therapeutic drug monitoring. This is further supported by published empirical and theoretical findings that show that random effects linear models may provide accurate representations of phase III and IV steady-state pharmacokinetic data, and may be useful for dosage computations. These models have applications in the design of clinical algorithms for drug dosage individualization in chronic diseases; in the computation of dose correction factors; computation of the minimum number of blood samples from a patient that are necessary for calculating an optimal individualized drug dosage in therapeutic drug monitoring; measure of the clinical importance of clinical, demographic, environmental or genetic covariates; study of drug-drug interactions in clinical settings; the implementation of computational tools for web-site-based evidence farming; design of pharmacogenomic studies; and in the development of a pharmacological theory of dosage individualization. PMID:23467392

  16. Role of Statistical Random-Effects Linear Models in Personalized Medicine.

    PubMed

    Diaz, Francisco J; Yeh, Hung-Wen; de Leon, Jose

    2012-03-01

    Some empirical studies and recent developments in pharmacokinetic theory suggest that statistical random-effects linear models are valuable tools that allow describing simultaneously patient populations as a whole and patients as individuals. This remarkable characteristic indicates that these models may be useful in the development of personalized medicine, which aims at finding treatment regimes that are appropriate for particular patients, not just appropriate for the average patient. In fact, published developments show that random-effects linear models may provide a solid theoretical framework for drug dosage individualization in chronic diseases. In particular, individualized dosages computed with these models by means of an empirical Bayesian approach may produce better results than dosages computed with some methods routinely used in therapeutic drug monitoring. This is further supported by published empirical and theoretical findings that show that random effects linear models may provide accurate representations of phase III and IV steady-state pharmacokinetic data, and may be useful for dosage computations. These models have applications in the design of clinical algorithms for drug dosage individualization in chronic diseases; in the computation of dose correction factors; computation of the minimum number of blood samples from a patient that are necessary for calculating an optimal individualized drug dosage in therapeutic drug monitoring; measure of the clinical importance of clinical, demographic, environmental or genetic covariates; study of drug-drug interactions in clinical settings; the implementation of computational tools for web-site-based evidence farming; design of pharmacogenomic studies; and in the development of a pharmacological theory of dosage individualization.

  17. Financial management of a large multisite randomized clinical trial.

    PubMed

    Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

    2014-08-01

    The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

  18. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

    PubMed

    Rao, Sunil V; Hess, Connie N; Barham, Britt; Aberle, Laura H; Anstrom, Kevin J; Patel, Tejan B; Jorgensen, Jesse P; Mazzaferri, Ernest L; Jolly, Sanjit S; Jacobs, Alice; Newby, L Kristin; Gibson, C Michael; Kong, David F; Mehran, Roxana; Waksman, Ron; Gilchrist, Ian C; McCourt, Brian J; Messenger, John C; Peterson, Eric D; Harrington, Robert A; Krucoff, Mitchell W

    2014-08-01

    This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc

  19. A Gompertzian model with random effects to cervical cancer growth

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

    Mazlan, Mazma Syahidatul Ayuni; Rosli, Norhayati

    2015-05-15

    In this paper, a Gompertzian model with random effects is introduced to describe the cervical cancer growth. The parameters values of the mathematical model are estimated via maximum likehood estimation. We apply 4-stage Runge-Kutta (SRK4) for solving the stochastic model numerically. The efficiency of mathematical model is measured by comparing the simulated result and the clinical data of the cervical cancer growth. Low values of root mean-square error (RMSE) of Gompertzian model with random effect indicate good fits.

  20. The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

    PubMed

    Eldabe, Sam; Thomson, Simon; Duarte, Rui; Brookes, Morag; deBelder, Mark; Raphael, Jon; Davies, Ed; Taylor, Rod

    2016-01-01

    Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial. © 2015 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of

  1. The Differential Effects of Social Media Sites for Promoting Cancer Risk Reduction.

    PubMed

    Lauckner, Carolyn; Whitten, Pamela

    2016-09-01

    Social media are potentially valuable tools for disseminating cancer education messages, but the differential effects of various sites on persuasive outcomes are unknown. In an effort to inform future health promotion, this research tested the effects of Facebook, YouTube, Twitter, and blogs for delivering a cancer risk reduction message. Using an experimental design, participants were randomly placed in several conditions that delivered the same message but with different forms of social media. Effects on comprehension and attitudes were examined, as they are important variables in the behavior change process. YouTube led to higher comprehension and stronger attitudes toward cancer risk reduction than Twitter, but there were no differences between other sites. Additionally, YouTube led to stronger attitudes toward cancer risk reduction as compared to Facebook, but not any other sites. These results demonstrate that, even if the message is kept constant, the form of social media used to deliver content can have an effect on persuasive outcomes. More research is needed to determine the mechanisms behind the differences found, however. Altogether, this line of research is valuable for any individuals seeking to use social media for health promotion purposes and could have direct implications for the development of cancer risk reduction campaigns.

  2. Simplified biased random walk model for RecA-protein-mediated homology recognition offers rapid and accurate self-assembly of long linear arrays of binding sites

    NASA Astrophysics Data System (ADS)

    Kates-Harbeck, Julian; Tilloy, Antoine; Prentiss, Mara

    2013-07-01

    Inspired by RecA-protein-based homology recognition, we consider the pairing of two long linear arrays of binding sites. We propose a fully reversible, physically realizable biased random walk model for rapid and accurate self-assembly due to the spontaneous pairing of matching binding sites, where the statistics of the searched sample are included. In the model, there are two bound conformations, and the free energy for each conformation is a weakly nonlinear function of the number of contiguous matched bound sites.

  3. Prediction of Protein-Protein Interaction Sites by Random Forest Algorithm with mRMR and IFS

    PubMed Central

    Li, Bi-Qing; Feng, Kai-Yan; Chen, Lei; Huang, Tao; Cai, Yu-Dong

    2012-01-01

    Prediction of protein-protein interaction (PPI) sites is one of the most challenging problems in computational biology. Although great progress has been made by employing various machine learning approaches with numerous characteristic features, the problem is still far from being solved. In this study, we developed a novel predictor based on Random Forest (RF) algorithm with the Minimum Redundancy Maximal Relevance (mRMR) method followed by incremental feature selection (IFS). We incorporated features of physicochemical/biochemical properties, sequence conservation, residual disorder, secondary structure and solvent accessibility. We also included five 3D structural features to predict protein-protein interaction sites and achieved an overall accuracy of 0.672997 and MCC of 0.347977. Feature analysis showed that 3D structural features such as Depth Index (DPX) and surface curvature (SC) contributed most to the prediction of protein-protein interaction sites. It was also shown via site-specific feature analysis that the features of individual residues from PPI sites contribute most to the determination of protein-protein interaction sites. It is anticipated that our prediction method will become a useful tool for identifying PPI sites, and that the feature analysis described in this paper will provide useful insights into the mechanisms of interaction. PMID:22937126

  4. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    PubMed

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  5. Effect of pre-cooling injection site on pain perception in pediatric dentistry: “A randomized clinical trial”

    PubMed Central

    Ghaderi, Faezeh; Banakar, Shahin; Rostami, Shima

    2013-01-01

    Background: Injection of local anesthesia is one of the most important reasons for development of avoidance behavior in children. Efforts have been performed to decrease pain perception of injection. The present research evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. Materials and Methods: A prospective single-blind crossover clinical trial was used to investigate pain perception in 50 healthy pediatric patients who needed bilateral buccal infiltration of local anesthetics for dental treatment. They received a topical anesthetic agent (Benzocaine) on one side (control) for 1 min and topical anesthetic agent plus one minute of ice pack on the other side (trial) prior to the injection. A dentist blind to the study assessed the patients’ reaction during injection. Wilcoxon and Mann-Whitney U tests were used for statistical analysis. Statistical significance was defined at P < 0.05. Results: The means of sound, eye, and motor scales (SEM) were 4.06 ± 1.32 and 5.44 ± 1.79 for the study and control groups, respectively. The means of visual analogue scales (VAS) for the study and control groups were 42.20 ± 12.70 and 58.40 ± 16.83, respectively; with statistically significant differences between the two groups (P < 0.05). Conclusion: Cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients. PMID:24379869

  6. Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain.

    PubMed

    Healy, Ciaran; Greig, Aina V H; Murphy, Adrian D; Powell, Christopher; Pinder, Richard J; Saour, Samer; Abela, Christopher; Knight, William; Geh, Jenny L C

    2013-07-01

    Pain at split skin graft donor sites is common. Fibrin sealant has been demonstrated to reduce time to hemostasis at wound sites, and patients receiving this treatment were incidentally noted to report less pain. This study aimed to evaluate pain and incapacity in split skin graft donor sites treated with and without fibrin sealant. Fifty patients requiring thigh donor-site split skin grafts were prospectively randomized to receive either a self-adhesive fabric dressing alone or fibrin sealant plus the self-adhesive fabric dressing as primary donor-site dressings. External secondary dressings were the same. Patients were blinded with regard to treatment group. Using visual analogue scales (scored 0 to 5), patients rated their donor-site pain and incapacity for 14 days postoperatively. Secondary endpoints were length of hospital stay and duration of requirement for dressings. Forty patients were included in the study analysis and completed self-reported pain and incapacity scores. Twenty received the fibrin sealant plus self-adhesive fabric dressing and 20 received the fabric dressing only (controls). Patients using the fibrin sealant plus the dressing reported significantly less pain (mean score, 0.42 versus 1.60, p < 0.001) and significantly less incapacity (mean score, 0.48 versus 1.71, p < 0.001). Patients allocated to the fibrin sealant group recorded shorter lengths of stay and faster time to discontinuation of dressing, though statistical significance was not achieved. Patients whose split skin graft donor sites were dressed with fibrin sealant plus self-adhesive fabric dressing experienced significantly less pain and incapacity than patients with self-adhesive fabric dressings alone, allowing a more rapid return to normal activity. Therapeutic, II.

  7. A Mixed Effects Randomized Item Response Model

    ERIC Educational Resources Information Center

    Fox, J.-P.; Wyrick, Cheryl

    2008-01-01

    The randomized response technique ensures that individual item responses, denoted as true item responses, are randomized before observing them and so-called randomized item responses are observed. A relationship is specified between randomized item response data and true item response data. True item response data are modeled with a (non)linear…

  8. On random field Completely Automated Public Turing Test to Tell Computers and Humans Apart generation.

    PubMed

    Kouritzin, Michael A; Newton, Fraser; Wu, Biao

    2013-04-01

    Herein, we propose generating CAPTCHAs through random field simulation and give a novel, effective and efficient algorithm to do so. Indeed, we demonstrate that sufficient information about word tests for easy human recognition is contained in the site marginal probabilities and the site-to-nearby-site covariances and that these quantities can be embedded directly into certain conditional probabilities, designed for effective simulation. The CAPTCHAs are then partial random realizations of the random CAPTCHA word. We start with an initial random field (e.g., randomly scattered letter pieces) and use Gibbs resampling to re-simulate portions of the field repeatedly using these conditional probabilities until the word becomes human-readable. The residual randomness from the initial random field together with the random implementation of the CAPTCHA word provide significant resistance to attack. This results in a CAPTCHA, which is unrecognizable to modern optical character recognition but is recognized about 95% of the time in a human readability study.

  9. Side effects from intense pulsed light: Importance of skin pigmentation, fluence level and ultraviolet radiation-A randomized controlled trial.

    PubMed

    Thaysen-Petersen, Daniel; Erlendsson, Andres M; Nash, J F; Beerwerth, Frank; Philipsen, Peter A; Wulf, Hans C; Paasch, Uwe; Haedersdal, Merete

    2017-01-01

    Intense pulsed light (IPL) is a mainstream treatment for hair removal. Side effects after IPL are known, but risk factors remain to be investigated. The objective of this study was to assess the contribution of skin pigmentation, fluence level, and ultraviolet radiation (UVR) on IPL-induced side effects. The study was a blinded, randomized intra-individual controlled trial including 16 healthy subjects with Fitzpatrick Skin Types (FST) II-V. Three test areas were each divided into four sites, randomized to a single IPL exposure of 22, 34, 46 J/cm 2 or triple stacking of 46 J/cm 2 . Areas were subsequently randomized to no UVR or single solar-simulated UVR exposure of 3 Standard Erythema Dose at 30 minutes or 24 hours after IPL. Each area had a corresponding control, resulting in 15 treatment sites. Follow-up visits were scheduled up to 4 weeks after IPL. Outcome measures were: (i) blinded clinical skin reactions; (ii) objectively measured erythema and pigmentation; (iii) pain measured by visual analog scale (VAS); (iv) histology (H&E, Fontana-Masson); and (v) mRNA-expression of p53. Fifteen subjects with FST II-IV completed the protocol. IPL induced a wide range of skin reactions, including erythema (87% of subjects), purpura (27%), blisters (20%), edema (13%), crusting (13%), hyper- (60%), and hypopigmentation (20%). Darker skin pigmentation and increasing IPL fluence were determinants for IPL-induced side effects (P ≤ 0.002), while a single exposure of UVR did not exacerbate side effects (P ≥ 0.180). Clinical findings were confirmed objectively by reflectance spectrometry and qualitatively by histological changes in skin architecture, inflammatory infiltration, and pigmentation. Marker of cellular DNA damage, that is, p53, did not increase after IPL (P ≥ 0.24). Skin pigmentation and IPL fluence are major determinants of side effects after IPL exposure, while a single exposure to three SED of UVR at 30 minutes or 24 hours after IPL

  10. The prompted optional randomization trial: a new design for comparative effectiveness research.

    PubMed

    Flory, James; Karlawish, Jason

    2012-12-01

    Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.

  11. How Does a Multi-Site Institution Plan Effectively?

    ERIC Educational Resources Information Center

    Jefferson, Curtis F.

    A multi-site college plans effectively by having in place planning and evaluation systems that enhance its capability to respond effectively to changes in the environment in order to continue to provide high quality educational programs and services for the people in its service area. The effectiveness of these systems is dependent on clearly…

  12. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial.

    PubMed

    Chambers, S T; Sanders, J; Patton, W N; Ganly, P; Birch, M; Crump, J A; Spearing, R L

    2005-09-01

    Exit-site and tunnel infections of tunnelled central intravascular catheters are a frequent source of morbidity among neutropenic patients and may necessitate catheter removal. They require antimicrobial therapy that increases healthcare costs and is associated with adverse drug reactions. A prospective randomized clinical trial was conducted among adult patients undergoing chemotherapy in a haematology unit. Tunnelled intravascular catheters were randomized to receive the control of a standard dressing regimen as recommended by the British Committee for Standards in Haematology, or to receive the intervention of a sustained-release chlorhexidine dressing. Follow-up data were available in 112 of 114 tunnelled intravascular catheters which were randomized. Exit-site or combined exit-site/tunnel infections occurred in 23 (43%) of 54 catheters in the control group, and five (9%) of 58 catheters in the intervention group [odds ratio (OR) for intervention group compared with control group =0.13, 95% confidence intervals (CI) 0.04-0.37, P<0.001]. More tunnelled intravascular catheters were prematurely removed from the control group than the intervention group for documented infections [20/54 (37%) vs 6/58 (10%), OR=0.20, 95%CI 0.53-0.07]. However, there was no difference in the numbers of tunnelled intravascular catheters removed for all proven and suspected intravascular catheter-related infections [21/54 (39%) vs 19/58 (33%)], or in the time to removal of catheters for any reason other than death or end of treatment for underlying disease. Thus chlorhexidine dressings reduced the incidence of exit-site/tunnel infections of indwelling tunnelled intravascular catheters without prolonging catheter survival in neutropenic patients, and could be considered as part of the routine management of indwelling tunnelled intravascular catheters among neutropenic patients.

  13. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. PMID:25456014

  14. Integrating Tobacco Treatment into Cancer Care: Study Protocol for a Randomized Controlled Comparative Effectiveness Trial

    PubMed Central

    Park, Elyse R.; Ostroff, Jamie S.; Perez, Giselle K.; Hyland, Kelly A.; Rigotti, Nancy A.; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R.; Levy, Douglas E.; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O’Brien, Maureen; de León-Sanchez, Suhana; Will Whitlock, C.

    2016-01-01

    Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. PMID:27444428

  15. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi.

    PubMed

    van Lettow, Monique; Tweya, Hannock; Rosenberg, Nora E; Trapence, Clement; Kayoyo, Virginia; Kasende, Florence; Kaunda, Blessings; Hosseinipour, Mina C; Eliya, Michael; Cataldo, Fabian; Gugsa, Salem; Phiri, Sam

    2017-07-11

    Malawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96%

  16. Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial.

    PubMed

    Ajam, Amna A; Nguyen, Xuan V; Kelly, Ronda A; Ladapo, Joseph A; Lang, Elvira V

    2017-07-01

    The aim of this study was to assess the effects of team training on operational efficiency during outpatient MRI. In this institutional review board-approved, HIPAA-compliant study, six MRI outpatient sites of a midwestern hospital system were randomized to serve as controls or have their teams trained in advanced communication skills. The fourth quarter of fiscal year 2015 was the trial baseline. The trial ended in the third quarter (Q3) of fiscal year 2016 (FY16). Equipment utilization (completed scans/available slots), hourly scan rates (total orders completed per machine per hour of operation), and no-show rates stratified by time were analyzed using the Cochran-Mantel-Haenszel method, with individual comparisons performed with Bonferroni correction. The study encompassed 27,425 MRI examinations. Overall volume peaked at baseline and then declined over the following quarters. Compared with baseline, untrained sites experienced significant drops in equipment utilization (P < .01 for the first quarter of FY16 and P < .0001 for the second quarter of FY16 and Q3 FY16), decreasing from 77% to 65% over the study period, corresponding to a decrease from 1.15 to 0.97 in hourly scan rates. For trained sites, these metrics showed no significant change, with maintenance of hourly scan rates of 1.23 and 1.27 and equipment utilization rates of 83% and 85% between baseline and Q3 FY16. No-show rates remained stable at trained sites but increased at untrained sites in the last two quarters (P < .05). Nationally benchmarked patient satisfaction percentile ranking gradually increased at trained sites from 56th at baseline to 70th and successively decreased at untrained sites from 66th to 44th. MRI outpatient facilities trained in advanced communication techniques may have more favorable operational efficiency than untrained sites in a saturated market. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  17. Effect of 4% chlorhexidine gluconate predisinfection skin scrub prior to hepatectomy: a double-blinded, randomized control study.

    PubMed

    Hsieh, Ching-Shui; Cheng, Hsiu-Chi; Lin, Jen-Shiou; Kuo, Shou-Jen; Chen, Yao-Li

    2014-01-01

    This trial was designed to compare the efficacy of 4% chlorhexidine gluconate (CHG) with normal saline (NS) as a predisinfection skin-scrub solution prior to standard presurgical skin preparation. Data was collected at a single transplantation center where patients electing resection of hepatic tumors were recruited between October 2011 and September 2012. In total, 100 patients were consecutively enrolled for random assignment to either 4% CHG or NS as a predisinfection skin-scrub solution prior to surgery. Our aim was to assess the comparative antiseptic efficacy of CHG in this setting, focusing on cutaneous microbial colonization (at baseline, preoperatively, and postoperatively) and postsurgical site infections as primary outcome measures. Positivity rates of baseline, preoperative, and postoperative cultures were similar for both groups, showing significant declines (relative to baseline) after skin preparation and no significant postsurgical rebound. Rates of surgical site infection were also similar in both groups (CHG, 6.0%; NS, 4.1%; P = 1.0). For patients with hepatic tumors undergoing hepatectomy, the effect of 4% CHG as a predisinfection scrub solution was similar to that of NS in terms of skin decontamination and surgical site infections.

  18. Mini-intervention for subacute low back pain: a randomized controlled trial.

    PubMed

    Karjalainen, Kaija; Malmivaara, Antti; Pohjolainen, Timo; Hurri, Heikki; Mutanen, Pertti; Rissanen, Pekka; Pahkajärvi, Helena; Levon, Heikki; Karpoff, Hanna; Roine, Risto

    2003-03-15

    Randomized controlled trial. To investigate the effectiveness and costs of a mini-intervention, provided in addition to the usual care, and the incremental effect of a work site visit for patients with subacute disabling low back pain. There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain. A total of 164 patients with subacute low back pain were randomized to a mini-intervention group (A), a work site visit group (B), or a usual care group (C). Groups A (n = 56) and B (n = 51) underwent one assessment by a physician plus a physiotherapist. Group B received a work site visit in addition. Group C served as controls (n = 57) and was treated in municipal primary health care. All patients received a leaflet on back pain. Pain, disability, specific and generic health-related quality of life, satisfaction with care, days on sick leave, and use and costs of health care consumption were measured at 3-, 6-, and 12-month follow-ups. During follow-up, fewer subjects had daily pain in Groups A and B than in Group C (Group A Group C, = 0.002; Group B Group C, = 0.030). In Group A, pain was less bothersome (Group A Group C, = 0.032) and interfered less with daily life (Group A Group C, = 0.040) than among controls. Average days on sick leave were 19 in Group A, 28 in Group B, and 41 in Group C (Group A Group C, = 0.019). Treatment satisfaction was better in the intervention groups than among the controls, and costs were lowest in the mini-intervention group. Mini-intervention reduced daily back pain symptoms and sickness absence, improved adaptation to pain and patient satisfaction among patients with subacute low back pain, without increasing health care costs. A work site visit did not increase effectiveness.

  19. Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

    PubMed

    Carlson, Linda E; Zelinski, Erin L; Speca, Michael; Balneaves, Lynda G; Jones, Jennifer M; Santa Mina, Daniel; Wayne, Peter M; Campbell, Tavis S; Giese-Davis, Janine; Faris, Peter; Zwicker, Jennifer; Patel, Kamala; Beattie, Tara L; Cole, Steve; Toivonen, Kirsti; Nation, Jill; Peng, Philip; Thong, Bruce; Wong, Raimond; Vohra, Sunita

    2017-08-01

    A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Neighborhood effects in a behavioral randomized controlled trial.

    PubMed

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

    2014-11-01

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

  1. Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

    PubMed

    DiDiodato, Giulio; McArthur, Leslie

    2016-01-01

    The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium

  2. Improving Adherence to Smoking Cessation Treatment: Intervention Effects in a Web-Based Randomized Trial.

    PubMed

    Graham, Amanda L; Papandonatos, George D; Cha, Sarah; Erar, Bahar; Amato, Michael S; Cobb, Nathan K; Niaura, Raymond S; Abrams, David B

    2017-03-01

    Web-based smoking cessation interventions can deliver evidence-based treatments to a wide swath of the population, but effectiveness is often limited by insufficient adherence to proven treatment components. This study evaluated the impact of a social network (SN) intervention and free nicotine replacement therapy (NRT) on adherence to evidence-based components of smoking cessation treatment in the context of a Web-based intervention. A sample of adult U.S. smokers (N = 5290) was recruited via BecomeAnEX.org, a free smoking cessation Web site. Smokers were randomized to one of four arms: (1) an interactive, evidence-based smoking cessation Web site (WEB) alone; (2) WEB in conjunction with an SN intervention designed to integrate participants into the online community (WEB+SN); (3) WEB plus free NRT (WEB+NRT); and (4) the combination of all treatments (WEB+SN+NRT). Adherence outcomes assessed at 3-month follow-up were as follows: Web site utilization metrics, use of skills training components, intratreatment social support, and pharmacotherapy use. WEB+SN+NRT outperformed all others on Web site utilization metrics, use of practical counseling tools, intratreatment social support, and NRT use. It was the only intervention to promote the sending of private messages and the viewing of community pages over WEB alone. Both social network arms outperformed WEB on most metrics of online community engagement. Both NRT arms showed higher medication use compared to WEB alone. This study demonstrated the effectiveness of two approaches for improving adherence to evidence-based components of smoking cessation treatment. Integrated approaches to medication provision and social network engagement can enhance adherence to components known to improve cessation. This study demonstrated that an integrated approach to medication provision and social network integration, when delivered through an online program, can enhance adherence across all three recommended components of an

  3. Effects of organizational complexity and resources on construction site risk.

    PubMed

    Forteza, Francisco J; Carretero-Gómez, Jose M; Sesé, Albert

    2017-09-01

    Our research is aimed at studying the relationship between risk level and organizational complexity and resources on constructions sites. Our general hypothesis is that site complexity increases risk, whereas more resources of the structure decrease risk. A Structural Equation Model (SEM) approach was adopted to validate our theoretical model. To develop our study, 957 building sites in Spain were visited and assessed in 2003-2009. All needed data were obtained using a specific tool developed by the authors to assess site risk, structure and resources (Construction Sites Risk Assessment Tool, or CONSRAT). This tool operationalizes the variables to fit our model, specifically, via a site risk index (SRI) and 10 organizational variables. Our random sample is composed largely of small building sites with general high levels of risk, moderate complexity, and low resources on site. The model obtained adequate fit, and results showed empirical evidence that the factors of complexity and resources can be considered predictors of site risk level. Consequently, these results can help companies, managers of construction and regulators to identify which organizational aspects should be improved to prevent risks on sites and consequently accidents. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

  4. Cogestion and recreation site demand: a model of demand-induced quality effects

    USGS Publications Warehouse

    Douglas, Aaron J.; Johnson, Richard L.

    1993-01-01

    This analysis focuses on problems of estimating site-specific dollar benefits conferred by outdoor recreation sites in the face of congestion costs. Encounters, crowding effects and congestion costs have often been treated by natural resource economists in a piecemeal fashion. In the current paper, encounters and crowding effects are treated systematically. We emphasize the quantitative impact of congestion costs on site-specific estimates of benefits conferred by improvements in outdoor recreation sites. The principal analytic conclusion is that techniques that streamline on data requirements produce biased estimates of benefits conferred by site improvements at facilities with significant crowding effects. The principal policy recommendation is that the Federal and state agencies should collect and store information on visitation rates, encounter levels and congestion costs at various outdoor recreation sites.

  5. Mindfulness-Based Cognitive Therapy for Individuals Whose Lives Have Been Affected by Cancer: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Foley, Elizabeth; Baillie, Andrew; Huxter, Malcolm; Price, Melanie; Sinclair, Emma

    2010-01-01

    Objective: This study evaluated the effectiveness of mindfulness-based cognitive therapy (MBCT) for individuals with a diagnosis of cancer. Method: Participants (N = 115) diagnosed with cancer, across site and stage, were randomly allocated to either the treatment or the wait-list condition. Treatment was conducted at 1 site, by a single…

  6. A randomized prospective multicenter trial of a novel vascular sealant.

    PubMed

    Stone, William M; Cull, David L; Money, Samuel R

    2012-11-01

    Increasing use of anticoagulant medications, particularly antiplatelet therapies, can increase the difficulty in obtaining adequate suture line hemostasis. Multiple vascular sealants have been used as adjuncts to surgical procedures, but none of them have been universally successful. The aim of this study was to evaluate the safety and effectiveness of a new prophylactic vascular sealant in arterial surgery. A randomized prospective multi-institutional trial was undertaken comparing ArterX Vascular Sealant (AVS) with Gelfoam Plus during open arterial reconstruction. Three hundred thirty-one anastomotic sites in 217 patients were randomized. One hundred one of 167 (60.5%) anastomotic sites in the AVS group achieved immediate hemostasis compared with 65 of 164 (39.6%) in the control group (P = 0.001). In anastomoses with polytetrafluoroethylene grafts, 105 of 167 (62.5%) in the AVS group achieved immediate hemostasis compared with 56 of 164 (34.0%) in the control group (P < 0.001). No significant differences were noted in morbidity or mortality. Operative time was significantly less in the AVS group compared with the control group (3.2 vs. 3.8 hours, P < 0.01). Use of AVS results in superior hemostatic effectiveness compared with Gelfoam Plus, with no difference in safety. Although no cost analysis was performed, cost savings likely resulted from significantly decreased operative time. Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

  7. Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

    ERIC Educational Resources Information Center

    Schroder, Kerstin E. E.

    2011-01-01

    Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

  8. Goal-directed fluid therapy for reducing risk of surgical site infections following abdominal surgery - A systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Yuan, Jianhu; Sun, Yanxia; Pan, Chuxiong; Li, Tianzuo

    2017-03-01

    Surgical site infections (SSIs) become a key indicator of quality of care. This meta-analysis aimed to determine the effect of goal-directed fluid therapy (GDFT) on the risk of SSIs after abdominal surgery. MEDLINE, Embase, CINAHL, Scopus, the Cochrane Controlled Trials Register, and Cochrane Database of Systematic Reviews were searched for randomized controlled trials (RCTs), from inception to May 2016 that compared the incidence of SSIs in abdominal surgical patients with or without GDFT treatment. . Data were pooled and risk ratio (RR) as well as weighted mean differences (WMD) with their 95% confidence intervals (CI) was calculated using either fixed or random effects models, depending on heterogeneity (I 2 ). A total of 29 eligible RCTs with 5317 patients were included in this analysis. GDFT significantly reduced the incidence of SSIs after abdominal surgery. The pooled RR was 0.74 (95% CI: 0.63 to 0.86) with low heterogeneity (I 2  = 4%). Length of hospital stay was significantly reduced in the GDFT group (WMD: -1.16 days, 95% CI: -1.92 to -0.40, p = 0.003; I 2  = 81%). This systematic review suggests that perioperative GDFT is associated with a reduction in the incidence of SSIs after abdominal surgery. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  9. Effectiveness of a bundled intervention of decolonization and prophylaxis to decrease Gram positive surgical site infections after cardiac or orthopedic surgery: systematic review and meta-analysis.

    PubMed

    Schweizer, Marin; Perencevich, Eli; McDanel, Jennifer; Carson, Jennifer; Formanek, Michelle; Hafner, Joanne; Braun, Barbara; Herwaldt, Loreen

    2013-06-13

    To evaluate studies assessing the effectiveness of a bundle of nasal decolonization and glycopeptide prophylaxis for preventing surgical site infections caused by Gram positive bacteria among patients undergoing cardiac operations or total joint replacement procedures. Systematic review and meta-analysis. PubMed (1995 to 2011), the Cochrane database of systematic reviews, CINAHL, Embase, and clinicaltrials.gov were searched to identify relevant studies. Pertinent journals and conference abstracts were hand searched. Study authors were contacted if more data were needed. Randomized controlled trials, quasi-experimental studies, and cohort studies that assessed nasal decolonization or glycopeptide prophylaxis, or both, for preventing Gram positive surgical site infections compared with standard care. Patients undergoing cardiac operations or total joint replacement procedures. DATA EXTRACTION AND STUDY APPRAISAL: Two authors independently extracted data from each paper and a random effects model was used to obtain summary estimates. Risk of bias was assessed using the Downs and Black or the Cochrane scales. Heterogeneity was assessed using the Cochran Q and I(2) statistics. 39 studies were included. Pooled effects of 17 studies showed that nasal decolonization had a significantly protective effect against surgical site infections associated with Staphylococcus aureus (pooled relative risk 0.39, 95% confidence interval 0.31 to 0.50) when all patients underwent decolonization (0.40, 0.29 to 0.55) and when only S aureus carriers underwent decolonization (0.36, 0.22 to 0.57). Pooled effects of 15 prophylaxis studies showed that glycopeptide prophylaxis was significantly protective against surgical site infections related to methicillin (meticillin) resistant S aureus (MRSA) compared with prophylaxis using β lactam antibiotics (0.40, 0.20 to 0.80), and a non-significant risk factor for methicillin susceptible S aureus infections (1.47, 0.91 to 2.38). Seven studies

  10. Estimation of the Nonlinear Random Coefficient Model when Some Random Effects Are Separable

    ERIC Educational Resources Information Center

    du Toit, Stephen H. C.; Cudeck, Robert

    2009-01-01

    A method is presented for marginal maximum likelihood estimation of the nonlinear random coefficient model when the response function has some linear parameters. This is done by writing the marginal distribution of the repeated measures as a conditional distribution of the response given the nonlinear random effects. The resulting distribution…

  11. Random effects coefficient of determination for mixed and meta-analysis models.

    PubMed

    Demidenko, Eugene; Sargent, James; Onega, Tracy

    2012-01-01

    The key feature of a mixed model is the presence of random effects. We have developed a coefficient, called the random effects coefficient of determination, [Formula: see text], that estimates the proportion of the conditional variance of the dependent variable explained by random effects. This coefficient takes values from 0 to 1 and indicates how strong the random effects are. The difference from the earlier suggested fixed effects coefficient of determination is emphasized. If [Formula: see text] is close to 0, there is weak support for random effects in the model because the reduction of the variance of the dependent variable due to random effects is small; consequently, random effects may be ignored and the model simplifies to standard linear regression. The value of [Formula: see text] apart from 0 indicates the evidence of the variance reduction in support of the mixed model. If random effects coefficient of determination is close to 1 the variance of random effects is very large and random effects turn into free fixed effects-the model can be estimated using the dummy variable approach. We derive explicit formulas for [Formula: see text] in three special cases: the random intercept model, the growth curve model, and meta-analysis model. Theoretical results are illustrated with three mixed model examples: (1) travel time to the nearest cancer center for women with breast cancer in the U.S., (2) cumulative time watching alcohol related scenes in movies among young U.S. teens, as a risk factor for early drinking onset, and (3) the classic example of the meta-analysis model for combination of 13 studies on tuberculosis vaccine.

  12. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study.

    PubMed

    Rodeo, Scott A; Delos, Demetris; Williams, Riley J; Adler, Ronald S; Pearle, Andrew; Warren, Russell F

    2012-06-01

    There is a strong need for methods to improve the biological potential of rotator cuff tendon healing. Platelet-rich fibrin matrix (PRFM) allows delivery of autologous cytokines to healing tissue, and limited evidence suggests a positive effect of platelet-rich plasma on tendon biology. To evaluate the effect of platelet-rich fibrin matrix on rotator cuff tendon healing. Randomized controlled trial; Level of evidence, 2. Seventy-nine patients undergoing arthroscopic rotator cuff tendon repair were randomized intraoperatively to either receive PRFM at the tendon-bone interface (n = 40) or standard repair with no PRFM (n = 39). Standardized repair techniques were used for all patients. The postoperative rehabilitation protocol was the same in both groups. The primary outcome was tendon healing evaluated by ultrasound (intact vs defect at repair site) at 6 and 12 weeks. Power Doppler ultrasound was also used to evaluate vascularity in the peribursal, peritendinous, and musculotendinous and insertion site areas of the tendon and bone anchor site. Secondary outcomes included standardized shoulder outcome scales (American Shoulder and Elbow Surgeons [ASES] and L'Insalata) and strength measurements using a handheld dynamometer. Patients and the evaluator were blinded to treatment group. All patients were evaluated at minimum 1-year follow-up. A logistic regression model was used to predict outcome (healed vs defect) based on tear severity, repair type, treatment type (PRFM or control), and platelet count. Overall, there were no differences in tendon-to-bone healing between the PRFM and control groups. Complete tendon-to-bone healing (intact repair) was found in 24 of 36 (67%) in the PRFM group and 25 of 31 (81%) in the control group (P = .20). There were no significant differences in healing by ultrasound between 6 and 12 weeks. There were gradual increases in ASES and L'Insalata scores over time in both groups, but there were no differences in scores between the groups

  13. Structure-based Markov random field model for representing evolutionary constraints on functional sites.

    PubMed

    Jeong, Chan-Seok; Kim, Dongsup

    2016-02-24

    Elucidating the cooperative mechanism of interconnected residues is an important component toward understanding the biological function of a protein. Coevolution analysis has been developed to model the coevolutionary information reflecting structural and functional constraints. Recently, several methods have been developed based on a probabilistic graphical model called the Markov random field (MRF), which have led to significant improvements for coevolution analysis; however, thus far, the performance of these models has mainly been assessed by focusing on the aspect of protein structure. In this study, we built an MRF model whose graphical topology is determined by the residue proximity in the protein structure, and derived a novel positional coevolution estimate utilizing the node weight of the MRF model. This structure-based MRF method was evaluated for three data sets, each of which annotates catalytic site, allosteric site, and comprehensively determined functional site information. We demonstrate that the structure-based MRF architecture can encode the evolutionary information associated with biological function. Furthermore, we show that the node weight can more accurately represent positional coevolution information compared to the edge weight. Lastly, we demonstrate that the structure-based MRF model can be reliably built with only a few aligned sequences in linear time. The results show that adoption of a structure-based architecture could be an acceptable approximation for coevolution modeling with efficient computation complexity.

  14. Effect Sizes in Cluster-Randomized Designs

    ERIC Educational Resources Information Center

    Hedges, Larry V.

    2007-01-01

    Multisite research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Researchers would like to compute effect size indexes based on the standardized mean difference to compare the results of cluster-randomized studies (and corresponding quasi-experiments) with other studies and to…

  15. Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

    PubMed

    Heisler, Michele; Hofer, Timothy P; Klamerus, Mandi L; Schmittdiel, Julie; Selby, Joe; Hogan, Mary M; Bosworth, Hayden B; Tremblay, Adam; Kerr, Eve A

    2010-10-12

    Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. The ClinicalTrials.gov registration number is NCT00495794.

  16. Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

    PubMed Central

    Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

    2010-01-01

    OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

  17. Random effects coefficient of determination for mixed and meta-analysis models

    PubMed Central

    Demidenko, Eugene; Sargent, James; Onega, Tracy

    2011-01-01

    The key feature of a mixed model is the presence of random effects. We have developed a coefficient, called the random effects coefficient of determination, Rr2, that estimates the proportion of the conditional variance of the dependent variable explained by random effects. This coefficient takes values from 0 to 1 and indicates how strong the random effects are. The difference from the earlier suggested fixed effects coefficient of determination is emphasized. If Rr2 is close to 0, there is weak support for random effects in the model because the reduction of the variance of the dependent variable due to random effects is small; consequently, random effects may be ignored and the model simplifies to standard linear regression. The value of Rr2 apart from 0 indicates the evidence of the variance reduction in support of the mixed model. If random effects coefficient of determination is close to 1 the variance of random effects is very large and random effects turn into free fixed effects—the model can be estimated using the dummy variable approach. We derive explicit formulas for Rr2 in three special cases: the random intercept model, the growth curve model, and meta-analysis model. Theoretical results are illustrated with three mixed model examples: (1) travel time to the nearest cancer center for women with breast cancer in the U.S., (2) cumulative time watching alcohol related scenes in movies among young U.S. teens, as a risk factor for early drinking onset, and (3) the classic example of the meta-analysis model for combination of 13 studies on tuberculosis vaccine. PMID:23750070

  18. The causal effect of red blood cell folate on genome-wide methylation in cord blood: a Mendelian randomization approach.

    PubMed

    Binder, Alexandra M; Michels, Karin B

    2013-12-04

    Investigation of the biological mechanism by which folate acts to affect fetal development can inform appraisal of expected benefits and risk management. This research is ethically imperative given the ubiquity of folic acid fortified products in the US. Considering that folate is an essential component in the one-carbon metabolism pathway that provides methyl groups for DNA methylation, epigenetic modifications provide a putative molecular mechanism mediating the effect of folic acid supplementation on neonatal and pediatric outcomes. In this study we use a Mendelian Randomization Unnecessary approach to assess the effect of red blood cell (RBC) folate on genome-wide DNA methylation in cord blood. Site-specific CpG methylation within the proximal promoter regions of approximately 14,500 genes was analyzed using the Illumina Infinium Human Methylation27 Bead Chip for 50 infants from the Epigenetic Birth Cohort at Brigham and Women's Hospital in Boston. Using methylenetetrahydrofolate reductase genotype as the instrument, the Mendelian Randomization approach identified 7 CpG loci with a significant (mostly positive) association between RBC folate and methylation level. Among the genes in closest proximity to this significant subset of CpG loci, several enriched biologic processes were involved in nucleic acid transport and metabolic processing. Compared to the standard ordinary least squares regression method, our estimates were demonstrated to be more robust to unmeasured confounding. To the authors' knowledge, this is the largest genome-wide analysis of the effects of folate on methylation pattern, and the first to employ Mendelian Randomization to assess the effects of an exposure on epigenetic modifications. These results can help guide future analyses of the causal effects of periconceptional folate levels on candidate pathways.

  19. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    PubMed

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  20. General Framework for Effect Sizes in Cluster Randomized Experiments

    ERIC Educational Resources Information Center

    VanHoudnos, Nathan

    2016-01-01

    Cluster randomized experiments are ubiquitous in modern education research. Although a variety of modeling approaches are used to analyze these data, perhaps the most common methodology is a normal mixed effects model where some effects, such as the treatment effect, are regarded as fixed, and others, such as the effect of group random assignment…

  1. Random diffusion and leverage effect in financial markets.

    PubMed

    Perelló, Josep; Masoliver, Jaume

    2003-03-01

    We prove that Brownian market models with random diffusion coefficients provide an exact measure of the leverage effect [J-P. Bouchaud et al., Phys. Rev. Lett. 87, 228701 (2001)]. This empirical fact asserts that past returns are anticorrelated with future diffusion coefficient. Several models with random diffusion have been suggested but without a quantitative study of the leverage effect. Our analysis lets us to fully estimate all parameters involved and allows a deeper study of correlated random diffusion models that may have practical implications for many aspects of financial markets.

  2. 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. Methods and design The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams. The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the

  3. 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial.

    PubMed

    Sørensen, Jette Led; Van der Vleuten, Cees; Lindschou, Jane; Gluud, Christian; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Albrechtsen, Charlotte Krebs; Pedersen, Berit Woetman; Kjærgaard, Hanne; Weikop, Pia; Ottesen, Bent

    2013-07-17

    Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams.The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video

  4. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes.

    PubMed

    Li, Baoyue; Lingsma, Hester F; Steyerberg, Ewout W; Lesaffre, Emmanuel

    2011-05-23

    Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model

  5. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes

    PubMed Central

    2011-01-01

    Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability

  6. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites.

    PubMed

    Thoma, Daniel S; Zeltner, Marco; Hilbe, Monika; Hämmerle, Christoph H F; Hüsler, Jürg; Jung, Ronald E

    2016-10-01

    To test whether or not the use of a collagen matrix (VCMX) results in short-term soft tissue volume increase at implant sites non-inferior to an autogenous subepithelial connective tissue graft (SCTG), and to evaluate safety and tissue integration of VCMX and SCTG. In 20 patients with a volume deficiency at single-tooth implant sites, soft tissue volume augmentation was performed randomly allocating VCMX or SCTG. Soft tissue thickness, patient-reported outcome measures (PROMs), and safety were assessed up to 90 days (FU-90). At FU-90 (abutment connection), tissue samples were obtained for histological analysis. Descriptive analysis was computed for both groups. Non-parametric tests were applied to test non-inferiority for the gain in soft tissue thickness at the occlusal site. Median soft tissue thickness increased between BL and FU-90 by 1.8 mm (Q1:0.5; Q3:2.0) (VCMX) (p = 0.018) and 0.5 mm (-1.0; 2.0) (SCTG) (p = 0.395) (occlusal) and by 1.0 mm (0.5; 2.0) (VCMX) (p = 0.074) and 1.5 mm (-2.0; 2.0) (SCTG) (p = 0.563) (buccal). Non-inferiority with a non-inferiority margin of 1 mm could be demonstrated (p = 0.020); the difference between the two group medians (1.3 mm) for occlusal sites indicated no relevant, but not significant superiority of VCMX versus SCTG (primary endpoint). Pain medication consumption and pain perceived were non-significantly higher in group SCTG up to day 3. Median physical pain (OHIP-14) at day 7 was 100% higher for SCTG than for VCMX. The histological analysis revealed well-integrated grafts. Soft tissue augmentation at implant sites resulted in a similar or higher soft tissue volume increase after 90 days for VCMX versus SCTG. PROMs did not reveal relevant differences between the two groups. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. A multi-level intervention in subsidized housing sites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Live Well, Viva Bien' cluster randomized trial.

    PubMed

    Gans, Kim M; Gorham, Gemma; Risica, Patricia M; Dulin-Keita, Akilah; Dionne, Laura; Gao, Tina; Peters, Sarah; Principato, Ludovica

    2016-06-28

    Adequate fruit and vegetable (F&V) intake is important for disease prevention. Yet, most Americans, especially low-income and racial/ethnic minorities, do not eat adequate amounts. These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable, healthful food and easy access to inexpensive, unhealthful foods. Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising, year-round strategy for improving dietary behaviors and reducing F&V intake disparities. However, to date, there have been no randomized controlled trials studying their effectiveness. The objective of the 'Live Well, Viva Bien' (LWVB) cluster randomized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes. One housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. The intervention group received bimonthly, discount, mobile, fresh F&V markets in conjunction with a nutrition education intervention (two F&V campaigns, newsletters, DVDs and cooking demonstrations) for 12 months. The control group received physical activity and stress reduction interventions. Outcome measures include F&V intake (measured by two validated F&V screeners at baseline, six-month and twelve-months) along with potential psychosocial mediating variables. Extensive quantitative and qualitative process evaluation was also conducted throughout the study. Modifying neighborhood food environments in ways that increase access to affordable, healthful food is a promising strategy for improving dietary behaviors among low-income, racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases. Discount, mobile F&V markets

  8. [A meta-analysis of perioperative hyperoxia for the surgical site infections in patients with general surgery].

    PubMed

    Zhang, H Y; Zhao, C L; Ye, Y W; Zhao, H C; Sun, N

    2016-05-31

    To systemically analyze the effect of perioperative hyperoxia for the surgical site infections in patients with general surgery. Electronic databases consisting of Pubmed, Embase, Cochrane Library, Wanfang Database, CNKI and VIP were systemically searched from established time to November 18, 2015. The randomized controlled trials about perioperative high and low-concentration oxygen for the surgical site infections in patients with general surgery were screened strictly and analyzed by the software of Revman 5.3. The included trials were stratified according to the colorectal or non-colorectal surgery, the duration of oxygen inhalation and the kinds of mixed gas to perform subgroup analyses. Sensitivity analysis was conducted by removing the low-quality trials, etc. The outcome was the surgical site infections. There were 989 relevant articles were searched out. At last, 9 randomized controlled trials consisting of 3 281 patients were included. The 80% oxygen group and 30% oxygen group consists of 1 644 and 1 637 patients, respectively. The rates of surgical site infection were 15.1% (248/1 644) and 17.5% (286/1 637) in the two group. Heterogeneity existed between the included trials and random-effect model was used, the RR=0.80, 95%CI: 0.60-1.08, P=0.15. Therefore, statistically significant difference was not found for the surgical site infections in the general surgery between the perioperative high and low-concentration oxygen. However, the results of subgroup analyses showed that the perioperative hyperoxia decreaced the surgical site infections significant in the subgroups of colorectal surgery and intraoperative plus postoperative 6 h oxygen inhalation. Perioperative hyperoxia does not reduce surgical site infections in patients with general surgery. However, the results of two subgroup analyses (colorectal surgery and intraoperative plus postoperative 6 h oxygen inhalation trials) show a significantly benefit for perioperative hyperoxia in decreasing

  9. Safe-Site Effects on Rhizosphere Bacterial Communities in a High-Altitude Alpine Environment

    PubMed Central

    Zerbe, Stefan

    2014-01-01

    The rhizosphere effect on bacterial communities associated with three floristic communities (RW, FI, and M sites) which differed for the developmental stages was studied in a high-altitude alpine ecosystem. RW site was an early developmental stage, FI was an intermediate stage, M was a later more matured stage. The N and C contents in the soils confirmed a different developmental stage with a kind of gradient from the unvegetated bare soil (BS) site through RW, FI up to M site. The floristic communities were composed of 21 pioneer plants belonging to 14 species. Automated ribosomal intergenic spacer analysis showed different bacterial genetic structures per each floristic consortium which differed also from the BS site. When plants of the same species occurred within the same site, almost all their bacterial communities clustered together exhibiting a plant species effect. Unifrac significance value (P < 0.05) on 16S rRNA gene diversity revealed significant differences (P < 0.05) between BS site and the vegetated sites with a weak similarity to the RW site. The intermediate plant colonization stage FI did not differ significantly from the RW and the M vegetated sites. These results pointed out the effect of different floristic communities rhizospheres on their soil bacterial communities. PMID:24995302

  10. Deep Sequencing of Random Mutant Libraries Reveals the Active Site of the Narrow Specificity CphA Metallo-β-Lactamase is Fragile to Mutations.

    PubMed

    Sun, Zhizeng; Mehta, Shrenik C; Adamski, Carolyn J; Gibbs, Richard A; Palzkill, Timothy

    2016-09-12

    CphA is a Zn(2+)-dependent metallo-β-lactamase that efficiently hydrolyzes only carbapenem antibiotics. To understand the sequence requirements for CphA function, single codon random mutant libraries were constructed for residues in and near the active site and mutants were selected for E. coli growth on increasing concentrations of imipenem, a carbapenem antibiotic. At high concentrations of imipenem that select for phenotypically wild-type mutants, the active-site residues exhibit stringent sequence requirements in that nearly all residues in positions that contact zinc, the substrate, or the catalytic water do not tolerate amino acid substitutions. In addition, at high imipenem concentrations a number of residues that do not directly contact zinc or substrate are also essential and do not tolerate substitutions. Biochemical analysis confirmed that amino acid substitutions at essential positions decreased the stability or catalytic activity of the CphA enzyme. Therefore, the CphA active - site is fragile to substitutions, suggesting active-site residues are optimized for imipenem hydrolysis. These results also suggest that resistance to inhibitors targeted to the CphA active site would be slow to develop because of the strong sequence constraints on function.

  11. Autologous platelet-rich plasma gel to reduce donor-site morbidity after patellar tendon graft harvesting for anterior cruciate ligament reconstruction: a randomized, controlled clinical study.

    PubMed

    Cervellin, M; de Girolamo, L; Bait, C; Denti, M; Volpi, P

    2012-01-01

    Bone-patellar tendon-bone technique (BPTB) for anterior cruciate ligament injuries is associated with a higher risk of donor-site morbidity. To evaluate whether platelet-rich plasma (PRP), due to its anti-inflammatory properties and capacity to stimulate tissue regeneration, was able to reduce the anterior knee pain, the kneeling pain, and donor-site morbidity, as evidenced by evaluation of VISA and VAS scoring scales and MRI analysis of the tendon and bone defect, we performed a clinical randomized controlled study where PRP gel was applied to donor site after ACL reconstruction with BPTB. Forty young athletes with the indication of ACL reconstruction with patellar tendon grafts were randomly assigned to group A (n = 20 patients, control group) or group B (n = 20 patients, PRP group). The autologous PRP gel was applied to both the patellar and tendon bone plug harvest site and stabilized by the peritenon suture. At 12-month follow-up, all patients underwent clinical examination and VAS and VISA questionnaires, respectively, evaluating the average daily pain of the knee and the pain during particular activities involving the knee, were filled. MRI at the same time point was also performed. VISA scores were significantly higher in the patients treated with PRP (84.5 ± 11.8 and 97.8 ± 2.5 for group A and for group B; P = 0.041), whereas no significant difference in postoperative VAS scores between the two groups was observed (1 ± 1.4 and 0.6 ± 0.9 for group A and group B, n.s.). In 85% of PRP group patients, the tibial and patellar bone defect was satisfactorily filled by new bony tissue (>70% of bone gap filled), whereas this percentage was just of 60% in control group patients, but this difference was not statistically significant. The study shows the usefulness of PRP in reducing subjective pain at the donor-site level after ACL reconstruction with BPTB. However, this approach deserves further investigations to confirm PRP efficacy and to

  12. Clinical and microbiological effects of levofloxacin in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial.

    PubMed

    Pradeep, Avani R; Singh, Sonender P; Martande, Santosh S; Naik, Savitha B; N, Priyanka; Kalra, Nitish; Suke, Deepak K

    2015-08-01

    The aim of the present study was to evaluate the clinical and microbiological effect of systemic levofloxacin (LFX) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis (CP). Sixty-five patients with CP were randomly divided into a test (n = 33, SRP and LFX 500 mg, once daily [o.d.]) and a control group (n = 32, SRP and placebo, o.d.). Plaque index (PI), gingival index (GI), percentage of sites with bleeding on probing (%BoP), probing depth (PD), and clinical attachment level (CAL) were recorded at baseline, 10 days, and 1-, 3-, and 6-month intervals. The percentage of sites positive for Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Porphyromonas gingivalis, and Tannerella forsythia were recorded at baseline and at 3 and 6 months. Patients receiving LFX showed statistically-significant improvements in mean PD and CAL. The intergroup difference in PI, GI, and%BoP was not significant at any interval. There was a reduction in the percentage of sites positive for periodontopathic bacteria over the duration of the study in both groups, and a statistically-significant reduction in the number of sites positive for A. actinomycetemcomitans in the LFX group (P < 0.001). Levofloxacin was found to significantly improve the clinical and microbiological parameters in CP individuals. © 2014 Wiley Publishing Asia Pty Ltd.

  13. A Randomized Controlled Trial of a Tailored Interactive Computer-Delivered Intervention to Promote Colorectal Cancer Screening: Sometimes More is Just the Same

    PubMed Central

    Bartholomew, Leona K.; McQueen, Amy; Bettencourt, Judy L.; Greisinger, Anthony; Coan, Sharon P.; Lairson, David; Chan, Wenyaw; Hawley, S. T.; Myers, R. E.

    2012-01-01

    Background There have been few studies of tailored interventions to promote colorectal cancer (CRC) screening. Purpose We conducted a randomized trial of a tailored, interactive intervention to increase CRC screening. Methods Patients 50–70 years completed a baseline survey, were randomized to one of three groups, and attended a wellness exam after being exposed to a tailored intervention about CRC screening (tailored group), a public web site about CRC screening (web site group), or no intervention (survey-only group). The primary outcome was completion of any recommended CRC screening by 6 months. Results There was no statistically significant difference in screening by 6 months: 30%, 31%, and 28% of the survey-only, web site, and tailored groups were screened. Exposure to the tailored intervention was associated with increased knowledge and CRC screening self-efficacy at 2 weeks and 6 months. Family history, prior screening, stage of change, and physician recommendation moderated the intervention effects. Conclusions A tailored intervention was not more effective at increasing screening than a public web site or only being surveyed. PMID:21271365

  14. A mathematical model of single target site location by Brownian movement in subcellular compartments.

    PubMed

    Kuthan, Hartmut

    2003-03-07

    The location of distinct sites is mandatory for many cellular processes. In the subcompartments of the cell nucleus, only very small numbers of diffusing macromolecules and specific target sites of some types may be present. In this case, we are faced with the Brownian movement of individual macromolecules and their "random search" for single/few specific target sites, rather than bulk-averaged diffusion and multiple sites. In this article, I consider the location of a distant central target site, e.g. a globular protein, by individual macromolecules executing unbiased (i.e. drift-free) random walks in a spherical compartment. For this walk-and-capture model, the closed-form analytic solution of the first passage time probability density function (p.d.f.) has been obtained as well as the first and second moment. In the limit of a large ratio of the radii of the spherical diffusion space and central target, well-known relations for the variance and the first two moments for the exponential p.d.f. were found to hold with high accuracy. These calculations reinforce earlier numerical results and Monte Carlo simulations. A major implication derivable from the model is that non-directed random movement is an effective means for locating single sites in submicron-sized compartments, even when the diffusion coefficients are comparatively small and the diffusing species are present in one copy only. These theoretical conclusions are underscored numerically for effective diffusion constants ranging from 0.5 to 10.0 microm(2) s(-1), which have been reported for a couple of nuclear proteins in their physiological environment. Spherical compartments of submicron size are, for example, the Cajal bodies (size: 0.1-1.0 microm), which are present in 1-5 copies in the cell nucleus. Within a small Cajal body of radius 0.1 microm a single diffusing protein molecule (with D=0.5 microm(2) s(-1)) would encounter a medium-sized protein of radius 2.5 nm within 1 s with a probability near

  15. A spatial error model with continuous random effects and an application to growth convergence

    NASA Astrophysics Data System (ADS)

    Laurini, Márcio Poletti

    2017-10-01

    We propose a spatial error model with continuous random effects based on Matérn covariance functions and apply this model for the analysis of income convergence processes (β -convergence). The use of a model with continuous random effects permits a clearer visualization and interpretation of the spatial dependency patterns, avoids the problems of defining neighborhoods in spatial econometrics models, and allows projecting the spatial effects for every possible location in the continuous space, circumventing the existing aggregations in discrete lattice representations. We apply this model approach to analyze the economic growth of Brazilian municipalities between 1991 and 2010 using unconditional and conditional formulations and a spatiotemporal model of convergence. The results indicate that the estimated spatial random effects are consistent with the existence of income convergence clubs for Brazilian municipalities in this period.

  16. Cluster-Randomized Trial of Personalized Site Performance Feedback in Get With The Guidelines-Heart Failure.

    PubMed

    DeVore, Adam D; Cox, Margueritte; Heidenreich, Paul A; Fonarow, Gregg C; Yancy, Clyde W; Eapen, Zubin J; Peterson, Eric D; Hernandez, Adrian F

    2015-07-01

    There is significant variation in the delivery of evidence-based care for patients with heart failure (HF), but there is limited evidence defining the best methods to improve the quality of care. We performed a cluster-randomized trial of personalized site performance feedback at 147 hospitals participating in the Get With The Guidelines-Heart Failure quality improvement program from October 2009 to March 2011. The intervention provided sites with specific data on their heart failure achievement and quality measures in addition to the usual Get With The Guidelines-Heart Failure tools. The primary outcome for our trial was improvement in site composite quality of care score. Overall, 73 hospitals (n=33 886 patients) received the intervention, whereas 74 hospitals (n=37 943 patients) did not. One year after the intervention, both the intervention and control arms had a similar mean change in percentage points in their composite quality score (absolute change, +0.31 [SE, 1.51] versus +3.18 [SE, 1.68] in control; P=0.21). Similarly, none of the individual achievement measures or quality measures improved more at intervention versus control hospitals. Our site-based intervention, which included personalized site feedback on adherence to quality metrics, was not able to elicit more quality improvement beyond that already associated with participation in the Get With The Guidelines-Heart Failure program. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00979264. © 2015 American Heart Association, Inc.

  17. Continued benefits of a technical assistance web site to local tobacco control coalitions during a state budget shortfall.

    PubMed

    Buller, David B; Young, Walter F; Bettinghaus, Erwin P; Borland, Ron; Walther, Joseph B; Helme, Donald; Andersen, Peter A; Cutter, Gary R; Maloy, Julie A

    2011-01-01

    A state budget shortfall defunded 10 local tobacco coalitions during a randomized trial but defunded coalitions continued to have access to 2 technical assistance Web sites. To test the ability of Web-based technology to provide technical assistance to local tobacco control coalitions. Randomized 2-group trial with local tobacco control coalitions as the unit of randomization. Local communities (ie, counties) within the State of Colorado. Leaders and members in 34 local tobacco control coalitions funded by the state health department in Colorado. Two technical assistance Web sites: A Basic Web site with text-based information and a multimedia Enhanced Web site containing learning modules, resources, and communication features. Use of the Web sites in minutes, pages, and session and evaluations of coalition functioning on coalition development, conflict resolution, leadership satisfaction, decision-making satisfaction, shared mission, personal involvement, and organization involvement in survey of leaders and members. Coalitions that were defunded but had access to the multimedia Enhanced Web site during the Fully Funded period and after defunding continued to use it (treatment group × funding status × period, F(3,714) = 3.18, P = .0234). Coalitions with access to the Basic Web site had low Web site use throughout and use by defunded coalitions was nearly zero when funding ceased. Members in defunded Basic Web site coalitions reported that their coalitions functioned worse than defunded Enhanced Web site coalitions (coalition development: group × status, F(1,360) = 4.81, P = .029; conflict resolution: group × status, F(1,306) = 5.69, P = .018; leadership satisfaction: group × status, F(1,342) = 5.69, P = .023). The Enhanced Web site may have had a protective effect on defunded coalitions. Defunded coalitions may have increased their capacity by using the Enhanced Web site when fully funded or by continuing to use the available online resources after defunding

  18. Assessing adverse effects of intra-articular botulinum toxin A in healthy Beagle dogs: A placebo-controlled, blinded, randomized trial.

    PubMed

    Heikkilä, Helka M; Jokinen, Tarja S; Syrjä, Pernilla; Junnila, Jouni; Hielm-Björkman, Anna; Laitinen-Vapaavuori, Outi

    2018-01-01

    To investigate the clinical, cytological, and histopathological adverse effects of intra-articularly injected botulinum toxin A in dogs and to study whether the toxin spreads from the joint after the injection. A longitudinal, placebo-controlled, randomized clinical trial was conducted with six healthy laboratory Beagle dogs. Stifle joints were randomized to receive either 30 IU of onabotulinum toxin A or placebo in a 1:1 ratio. Adverse effects and spread of the toxin were examined by evaluating dynamic and static weight-bearing of the injected limbs, by assessing painless range of motion and pain on palpation of joints, and by performing synovial fluid analysis, neurological examination, and electrophysiological recordings at different examination time-points in a 12-week period after the injections. The dogs were then euthanized and autopsy and histopathological examination of joint structures and adjacent muscles and nerves were performed. Intra-articular botulinum toxin A did not cause local weakness or injection site pain. Instead, static weight-bearing and painless range of motion of stifle joints decreased in the placebo limbs. No clinically significant abnormalities associated with intra-articular botulinum toxin A were detected in the neurological examinations. Electrophysiological recordings showed low compound muscle action potentials in two dogs in the botulinum toxin A-injected limb. No significant changes were detected in the synovial fluid. Autopsy and histopathological examination of the joint and adjacent muscles and nerves did not reveal histopathological adverse effects of the toxin. Intra-articular botulinum toxin A does not produce significant clinical, cytological, or histopathological adverse effects in healthy dogs. Based on the electrophysiological recordings, the toxin may spread from the joint, but its clinical impact seems to be low.

  19. Effects of mindfulness meditation on chronic pain: a randomized controlled trial.

    PubMed

    la Cour, Peter; Petersen, Marian

    2015-04-01

    This randomized controlled clinical trial investigated the effects of mindfulness meditation on chronic pain. A total of 109 patients with nonspecific chronic pain were randomized to either a standardized mindfulness meditation program (mindfulness-based stress reduction [MBSR]) or to a wait list control. Pain, physical function, mental function, pain acceptance, and health-related quality of life were measured. The SF36 vitality scale was chosen as the primary outcome measure; the primary end point was after completing the MBSR course. Within a 2.5-year period, 43 of the 109 randomized patients completed the mindfulness program, while 47 remained in the control group. Data were compared at three time points: at baseline, after completion of the course/waiting period, and at the 6-month follow-up. Significant effect (Cohen's d = 0.39) was found on the primary outcome measure, the SF36 vitality scale. On the secondary variables, significant medium to large size effects (Cohen's d = 0.37-0.71) were found for lower general anxiety and depression, better mental quality of life (psychological well-being), feeling in control of the pain, and higher pain acceptance. Small (nonsignificant) effect sizes were found for pain measures. There were no significant differences in the measures just after the intervention vs the 6-month follow-up. A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions in patients with long-lasting chronic pain. © 2014 American Academy of Pain Medicine.

  20. Effects of Edge on-Site Potential in a Honeycomb Topological Magnon Insulator

    NASA Astrophysics Data System (ADS)

    Pantaleón, Pierre A.; Xian, Yang

    2018-06-01

    While the deviation of the edge on-site potential from the bulk values in a magnonic topological honeycomb lattice leads to the formation of edge states in a bearded boundary, this is not the case for a zigzag termination, where no edge state is found. In a semi-infinite lattice, the intrinsic on-site interactions along the boundary sites generate an effective defect and this gives rise to Tamm-like edge states. If a nontrivial gap is induced, both Tamm-like and topologically protected edge states appear in the band structure. The effective defect can be strengthened by an external on-site potential, and the dispersion relation, velocity and magnon density of the edge states all become tunable.

  1. Estimating overall exposure effects for the clustered and censored outcome using random effect Tobit regression models.

    PubMed

    Wang, Wei; Griswold, Michael E

    2016-11-30

    The random effect Tobit model is a regression model that accommodates both left- and/or right-censoring and within-cluster dependence of the outcome variable. Regression coefficients of random effect Tobit models have conditional interpretations on a constructed latent dependent variable and do not provide inference of overall exposure effects on the original outcome scale. Marginalized random effects model (MREM) permits likelihood-based estimation of marginal mean parameters for the clustered data. For random effect Tobit models, we extend the MREM to marginalize over both the random effects and the normal space and boundary components of the censored response to estimate overall exposure effects at population level. We also extend the 'Average Predicted Value' method to estimate the model-predicted marginal means for each person under different exposure status in a designated reference group by integrating over the random effects and then use the calculated difference to assess the overall exposure effect. The maximum likelihood estimation is proposed utilizing a quasi-Newton optimization algorithm with Gauss-Hermite quadrature to approximate the integration of the random effects. We use these methods to carefully analyze two real datasets. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Design of a cluster-randomized minority recruitment trial: RECRUIT.

    PubMed

    Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

    2017-06-01

    greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

  3. The Effectiveness and Cost of Clinical Supervision for Motivational Interviewing: A Randomized Controlled Trial

    PubMed Central

    Martino, Steve; Paris, Manuel; Añez, Luis; Nich, Charla; Canning-Ball, Monica; Hunkele, Karen; Olmstead, Todd A.; Carroll, Kathleen M.

    2016-01-01

    The effectiveness of a competency-based supervision approach called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP) was compared to Supervision-As-Usual (SAU) for increasing clinicians’ motivational interviewing (MI) adherence and competence and client retention and primary substance abstinence in a multisite Hybrid Type 2 effectiveness-implementation randomized controlled trial. Participants were 66 clinicians and 450 clients within one of eleven outpatient substance abuse programs. An independent evaluation of audio recorded supervision sessions indicated that MIA: STEP and SAU were highly and comparably discriminable across sites. While clinicians in both supervision conditions improved their MI performance, clinician supervised with MIA: STEP, compared to those in SAU, showed significantly greater increases in the competency in which they used fundamental and advanced MI strategies when using MI across seven intakes through a 16-week follow-up. There were no retention or substance use differences among the clients seen by clinicians in MIA: STEP or SAU. MIA: STEP was substantially more expensive to deliver than SAU. Innovative alternatives to resource-intensive competency-based supervision approaches such as MIA: STEP are needed to promote the implementation of evidence-based practices. PMID:27431042

  4. Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention.

    PubMed

    Phillips-Salimi, Celeste R; Donovan Stickler, Molly A; Stegenga, Kristin; Lee, Melissa; Haase, Joan E

    2011-08-01

    Although treatment fidelity strategies for enhancing the integrity of behavioral interventions have been well described, little has been written about monitoring data collection integrity. This article describes the principles and strategies developed to monitor data collection integrity of the "Stories and Music for Adolescent/Young Adult Resilience During Transplant" study (R01NR008583, U10CA098543, and U10CA095861)-a multi-site Children's Oncology Group randomized clinical trial of a music therapy intervention for adolescents and young adults undergoing stem cell transplant. The principles and strategies outlined in this article provide one model for development and evaluation of a data collection integrity monitoring plan for behavioral interventions that may be adapted by investigators and may be useful to funding agencies and grant application reviewers in evaluating proposals. Copyright © 2011 Wiley Periodicals, Inc.

  5. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.

    PubMed

    Allen, Sophia I; Foulds, Jonathan; Pachas, Gladys N; Veldheer, Susan; Cather, Corinne; Azzouz, Nour; Hrabovsky, Shari; Hameed, Ahmad; Yingst, Jessica; Hammett, Erin; Modesto, Jennifer; Krebs, Nicolle M; Zhu, Junjia; Liao, Jason; Muscat, Joshua E; Richie, John; Evins, A Eden

    2017-01-19

    The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks. Adult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8

  6. On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial.

    PubMed

    Frimpong, Jemima A; D'Aunno, Thomas; Perlman, David C; Strauss, Shiela M; Mallow, Alissa; Hernandez, Diana; Schackman, Bruce R; Feaster, Daniel J; Metsch, Lisa R

    2016-03-03

    More than 1.2 million people in the United States are living with human immunodeficiency virus (HIV), and 3.2 million are living with hepatitis C virus (HCV). An estimated 25 % of persons living with HIV also have HCV. It is therefore of great public health importance to ensure the prompt diagnosis of both HIV and HCV in populations that have the highest prevalence of both infections, including individuals with substance use disorders (SUD). In this theory-driven, efficacy-effectiveness-implementation hybrid study, we will develop and test an on-site bundled rapid HIV/HCV testing intervention for SUD treatment programs. Its aim is to increase the receipt of HIV and HCV test results among SUD treatment patients. Using a rigorous process involving patients, providers, and program managers, we will incorporate rapid HCV testing into evidence-based HIV testing and linkage to care interventions. We will then test, in a randomized controlled trial, the extent to which this bundled rapid HIV/HCV testing approach increases receipt of HIV and HCV test results. Lastly, we will conduct formative research to understand the barriers to, and facilitators of, the adoption, implementation, and sustainability of the bundled rapid testing strategy in SUD treatment programs. Novel approaches that effectively integrate on-site rapid HIV and rapid HCV testing are needed to address both the HIV and HCV epidemics. If feasible and efficacious, bundled rapid HIV/HCV testing may offer a scalable, potentially cost-effective approach to testing high-risk populations, such as patients of SUD treatment programs. It may ultimately lead to improved linkage to care and progress through the HIV and HCV care and treatment cascades. ClinicalTrials.gov: NCT02355080 . (30 January 2015).

  7. Er:YAG laser in the treatment of periodontal sites with recurring chronic inflammation: a 12-month randomized, controlled clinical trial.

    PubMed

    Krohn-Dale, Ivar; Bøe, Olav E; Enersen, Morten; Leknes, Knut N

    2012-08-01

    The objective of this randomized, controlled clinical trial was to compare the clinical and microbiological effects of pocket debridement using erbium-doped: yttrium, aluminium and garnet (Er:YAG) laser with conventional debridement in maintenance patients. Fifteen patients, all smokers, having at least four teeth with residual probing depth (PD) ≥ 5 mm were recruited. Two pockets in two jaw quadrants were randomly assigned to subgingival debridement using an Er:YAG laser (test) or ultrasonic scaler/curette (control) at 3-month intervals. Relative attachment level (RAL), PD, bleeding on probing and dental plaque were recorded at baseline and at 6 and 12 months. Microbiological subgingival samples were taken at the same time points and analysed using a checkerboard DNA-DNA hybridization technique. A significant decrease in PD took place in both treatments from baseline to 12 months (p < 0.01). In the control, the mean initial PD decreased from 5.4 to 4.0 mm at 12 months. For the test, a similar decrease occurred. No significant between-treatment differences were shown at any time point. The mean RAL showed no overall significant inter- or intra-treatment differences (p > 0.05). No significant between-treatment differences were observed in subgingival microbiological composition or total pathogens. The results failed to support that an Er:YAG laser may be superior to conventional debridement in the treatment of smokers with recurring chronic inflammation. This appears to be the first time that repeated Er-YAG laser instrumentation has been compared with mechanical instrumentation of periodontal sites with recurring chronic inflammation over a clinically relevant time period. © 2012 John Wiley & Sons A/S.

  8. Evaluation of some random effects methodology applicable to bird ringing data

    USGS Publications Warehouse

    Burnham, K.P.; White, Gary C.

    2002-01-01

    Existing models for ring recovery and recapture data analysis treat temporal variations in annual survival probability (S) as fixed effects. Often there is no explainable structure to the temporal variation in S1,..., Sk; random effects can then be a useful model: Si = E(S) + ??i. Here, the temporal variation in survival probability is treated as random with average value E(??2) = ??2. This random effects model can now be fit in program MARK. Resultant inferences include point and interval estimation for process variation, ??2, estimation of E(S) and var (E??(S)) where the latter includes a component for ??2 as well as the traditional component for v??ar(S??\\S??). Furthermore, the random effects model leads to shrinkage estimates, Si, as improved (in mean square error) estimators of Si compared to the MLE, S??i, from the unrestricted time-effects model. Appropriate confidence intervals based on the Si are also provided. In addition, AIC has been generalized to random effects models. This paper presents results of a Monte Carlo evaluation of inference performance under the simple random effects model. Examined by simulation, under the simple one group Cormack-Jolly-Seber (CJS) model, are issues such as bias of ??s2, confidence interval coverage on ??2, coverage and mean square error comparisons for inference about Si based on shrinkage versus maximum likelihood estimators, and performance of AIC model selection over three models: Si ??? S (no effects), Si = E(S) + ??i (random effects), and S1,..., Sk (fixed effects). For the cases simulated, the random effects methods performed well and were uniformly better than fixed effects MLE for the Si.

  9. Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

    2013-01-01

    Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

  10. Intensive Group Learning and On-Site Services to Improve Sexual and Reproductive Health Among Young Adults in Liberia: A Randomized Evaluation of HealthyActions.

    PubMed

    Firestone, Rebecca; Moorsmith, Reid; James, Simon; Urey, Marilyn; Greifinger, Rena; Lloyd, Danielle; Hartenberger-Toby, Lisa; Gausman, Jewel; Sanoe, Musa

    2016-09-28

    Young Liberians, particularly undereducated young adults, face substantial sexual and reproductive health (SRH) challenges, with low uptake of contraceptive methods, high rates of unintended pregnancy, and low levels of knowledge about HIV status. The purpose of this study was to assess the impact of a 6-day intensive group learning intervention combined with on-site SRH services (called HealthyActions) among out-of-school young adults, implemented through an existing alternative education program, on uptake of contraception and HIV testing and counseling (HTC). The intervention was implemented among young women and men ages 15-35 who were enrolled in alternative basic education learning sites in 5 counties of Liberia. We conducted a randomized evaluation to assess program impact. Baseline data were collected in January-March 2014, and endline data in June-July 2014. Key outcomes of condom use, contraceptive use, and HTC were estimated with difference-in-difference models using fixed effects. All analyses were conducted in Stata 13. We assessed outcomes for 1,157 learners at baseline and 1,052 learners at endline, across 29 treatment and 26 control sites. After adjusting for potential confounders, learners in the HealthyActions intervention group were 12% less likely to report never using a condom with a regular partner over the last month compared with the control group (P = .02). Female learners who received HealthyActions were 13% more likely to use any form of modern contraception compared with learners in control sites (P<.001), with the greatest increase in the use of contraceptive implants. Learners in HealthyActions sites were 45% more likely to have received HTC (P<.001). Providing intensive group learning in a supportive environment coupled with on-site health services improved SRH outcomes among participating learners. The focus of HealthyActions on participatory learning for low-literacy populations presents an adaptable solution for health

  11. Intensive Group Learning and On-Site Services to Improve Sexual and Reproductive Health Among Young Adults in Liberia: A Randomized Evaluation of HealthyActions

    PubMed Central

    Firestone, Rebecca; Moorsmith, Reid; James, Simon; Urey, Marilyn; Greifinger, Rena; Lloyd, Danielle; Hartenberger-Toby, Lisa; Gausman, Jewel; Sanoe, Musa

    2016-01-01

    ABSTRACT Introduction: Young Liberians, particularly undereducated young adults, face substantial sexual and reproductive health (SRH) challenges, with low uptake of contraceptive methods, high rates of unintended pregnancy, and low levels of knowledge about HIV status. The purpose of this study was to assess the impact of a 6-day intensive group learning intervention combined with on-site SRH services (called HealthyActions) among out-of-school young adults, implemented through an existing alternative education program, on uptake of contraception and HIV testing and counseling (HTC). Methods: The intervention was implemented among young women and men ages 15–35 who were enrolled in alternative basic education learning sites in 5 counties of Liberia. We conducted a randomized evaluation to assess program impact. Baseline data were collected in January–March 2014, and endline data in June–July 2014. Key outcomes of condom use, contraceptive use, and HTC were estimated with difference-in-difference models using fixed effects. All analyses were conducted in Stata 13. Results: We assessed outcomes for 1,157 learners at baseline and 1,052 learners at endline, across 29 treatment and 26 control sites. After adjusting for potential confounders, learners in the HealthyActions intervention group were 12% less likely to report never using a condom with a regular partner over the last month compared with the control group (P = .02). Female learners who received HealthyActions were 13% more likely to use any form of modern contraception compared with learners in control sites (P<.001), with the greatest increase in the use of contraceptive implants. Learners in HealthyActions sites were 45% more likely to have received HTC (P<.001). Conclusion: Providing intensive group learning in a supportive environment coupled with on-site health services improved SRH outcomes among participating learners. The focus of HealthyActions on participatory learning for low

  12. Meta-analysis in evidence-based healthcare: a paradigm shift away from random effects is overdue.

    PubMed

    Doi, Suhail A R; Furuya-Kanamori, Luis; Thalib, Lukman; Barendregt, Jan J

    2017-12-01

    Each year up to 20 000 systematic reviews and meta-analyses are published whose results influence healthcare decisions, thus making the robustness and reliability of meta-analytic methods one of the world's top clinical and public health priorities. The evidence synthesis makes use of either fixed-effect or random-effects statistical methods. The fixed-effect method has largely been replaced by the random-effects method as heterogeneity of study effects led to poor error estimation. However, despite the widespread use and acceptance of the random-effects method to correct this, it too remains unsatisfactory and continues to suffer from defective error estimation, posing a serious threat to decision-making in evidence-based clinical and public health practice. We discuss here the problem with the random-effects approach and demonstrate that there exist better estimators under the fixed-effect model framework that can achieve optimal error estimation. We argue for an urgent return to the earlier framework with updates that address these problems and conclude that doing so can markedly improve the reliability of meta-analytical findings and thus decision-making in healthcare.

  13. Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).

    PubMed

    Lee, Joon-Hyop; Suh, Yong Joon; Song, Ra-Yeong; Yi, Jin Wook; Yu, Hyeong Won; Kwon, Hyungju; Choi, June Young; Lee, Kyu Eun

    2017-06-01

    Clinical trials on bilateral axillo-breast approach (BABA) thyroidectomy show that levobupivacaine and ropivacaine significantly reduce postoperative pain, but they focused on BABA robotic thyroidectomy only and did not identify specific sites of significant pain relief. Our objective was to assess the pain reduction at various sites and safety of ropivacaine-epinephrine flap injection in BABA thyroidectomy. This prospective double-blinded randomized controlled trial was conducted in compliance with the revised CONSORT statement (ClinicalTrials.gov registration no. NCT02112370). Patients were randomized into the ropivacaine-epinephrine arm or control (normal saline) arm. From January 2014 to May 2016, 148 patients participated. The primary endpoint was site-specific pain, as measured by numeric rating scale 12 hours after surgery. The ropivacaine-epinephrine group exhibited significantly less swallowing difficulty (P = .008), anterior neck pain (P = .016), and right (P = .019) and left (P = .035) chest pain. Secondary endpoints were systolic (P = .402), diastolic (P = .827) blood pressure, and pulse rate (P = .397) after injection before incision and during surgery. The vital signs of the groups just after injection did not differ. During surgery, the ropivacaine-epinephrine patients had higher pulse rates (99 ± 13.3 vs 88 ± 16.1, P < .001) but within normal range. There were no adverse events such as postoperative nausea and vomiting. There was no significant difference in pain scores in either patient group between patients who underwent robotic or endoscopic interventions. BABA flap-site injection with ropivacaine and epinephrine mix before incision effectively and safely reduced postoperative pain. Future studies should focus on tailoring ropivacaine and epinephrine dosage for individuals.

  14. Relatively Random: Context Effects on Perceived Randomness and Predicted Outcomes

    ERIC Educational Resources Information Center

    Matthews, William J.

    2013-01-01

    This article concerns the effect of context on people's judgments about sequences of chance outcomes. In Experiment 1, participants judged whether sequences were produced by random, mechanical processes (such as a roulette wheel) or skilled human action (such as basketball shots). Sequences with lower alternation rates were judged more likely to…

  15. The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial.

    PubMed

    Holt, Jane; Lord, Jonathan; Acharya, Umesh; White, Adrian; O'Neill, Nyree; Shaw, Steve; Barton, Andy

    2009-06-01

    To determine whether foot reflexology, a complementary therapy, has an effect greater than sham reflexology on induction of ovulation. Sham-controlled randomized trial with patients and statistician blinded. Infertility clinic in Plymouth, United Kingdom. Forty-eight women attending the clinic with anovulation. Women were randomized to receive eight sessions of either genuine foot reflexology or sham reflexology with gentle massage over 10 weeks. The primary outcome was ovulation detected by serum progesterone level of >30 nmol/L during the study period. Twenty-six patients were randomized to genuine reflexology and 22 to sham (one randomized patient was withdrawn). Patients remained blinded throughout the trial. The rate of ovulation during true reflexology was 11 out of 26 (42%), and during sham reflexology it was 10 out of 22 (46%). Pregnancy rates were 4 out of 26 in the true group and 2 out of 22 in the control group. Because of recruitment difficulties, the required sample size of 104 women was not achieved. Patient blinding of reflexology studies is feasible. Although this study was too small to reach a definitive conclusion on the specific effect of foot reflexology, the results suggest that any effect on ovulation would not be clinically relevant. Sham reflexology may have a beneficial general effect, which this study was not designed to detect.

  16. Lessons learned from a practice-based, multi-site intervention study with nurse participants

    PubMed Central

    Friese, Christopher R.; Mendelsohn-Victor, Kari; Ginex, Pamela; McMahon, Carol M.; Fauer, Alex J.; McCullagh, Marjorie C.

    2016-01-01

    Purpose To identify challenges and solutions to the efficient conduct of a multi-site, practice-based randomized controlled trial to improve nurses’ adherence to personal protective equipment use in ambulatory oncology settings. Design The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a web-based continuing education video. Approach The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies. Findings Noteworthy challenges included variation in human subjects protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled web conferences, site-based study champions, site visits by the principal investigator, and centrally-based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials. Conclusions Multi-site studies of nursing personnel are rare and challenging to existing infrastructure. These barriers can be overcome with strong engagement and planning. Clinical Relevance Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial. PMID:28098951

  17. Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial.

    PubMed

    Thompson, Kirsten M J; Rocca, Corinne H; Kohn, Julia E; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J Joseph; Darney, Philip D; Harper, Cynthia C

    2016-03-01

    We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Public funding and provider training substantially improve LARC access.

  18. Laparoscopic-assisted Rectus Sheath Block as a Novel Technique is Effective and Safe: A Randomized Controlled Trial.

    PubMed

    Miyazaki, Dai; Shichinohe, Toshiaki; Ebihara, Yuma; Kurashima, Yo; Murakami, Soichi; Noji, Takehiro; Nakamura, Toru; Tsuchikawa, Takahiro; Okamura, Keisuke; Hirano, Satoshi

    2017-02-01

    We developed laparoscopic-assisted rectus sheath block (LRSB) as a novel technique and report on its safety and effectiveness. Patients were randomly enrolled to an LRSB or control group (n=19 each). In the LRSB group, after the umbilical wound was closed, local anesthetic was injected transcutaneous at each of 4 sites (3 cm above and below the umbilicus bilaterally) with 10 mL of 0.25% levobupivacaine, laparoscopically. The control group received conventional postoperative pain management. The primary endpoint was visual analogue scale (VAS) pain score at the end of surgery. Secondary endpoints were VAS and Prince Henry pain scale after surgery, number of administrations of analgesics, and side effects of anesthesia. No significant differences in background were seen between groups. VAS at the end of surgery was significantly lower in the LRSB group than in controls (P<0.01). VAS and Prince Henry pain scale were significantly lower in the LRSB group from soon after surgery to postoperative day 2. No complications related to LRSB were encountered. LRSB was particularly effective at the end of surgery and pain scores were significantly lower in the LRSB group long after surgery. Our study shows LRSB is effective and safe for laparoscopic abdominal surgery.

  19. Effects of Check & Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

    2014-01-01

    The present study evaluates the effectiveness of Check & Connect (C&C) in a randomly assigned sample of students who were all receiving Communities in Schools (CIS) services. The research questions for the study include: Are there differences in attendance, academics, and behavior for CIS students who also receive C&C compared to…

  20. Zero-inflated count models for longitudinal measurements with heterogeneous random effects.

    PubMed

    Zhu, Huirong; Luo, Sheng; DeSantis, Stacia M

    2017-08-01

    Longitudinal zero-inflated count data arise frequently in substance use research when assessing the effects of behavioral and pharmacological interventions. Zero-inflated count models (e.g. zero-inflated Poisson or zero-inflated negative binomial) with random effects have been developed to analyze this type of data. In random effects zero-inflated count models, the random effects covariance matrix is typically assumed to be homogeneous (constant across subjects). However, in many situations this matrix may be heterogeneous (differ by measured covariates). In this paper, we extend zero-inflated count models to account for random effects heterogeneity by modeling their variance as a function of covariates. We show via simulation that ignoring intervention and covariate-specific heterogeneity can produce biased estimates of covariate and random effect estimates. Moreover, those biased estimates can be rectified by correctly modeling the random effects covariance structure. The methodological development is motivated by and applied to the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study, the largest clinical trial of alcohol dependence performed in United States with 1383 individuals.

  1. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

    PubMed

    Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

    2013-05-01

    This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

  2. Effects of a randomized intervention to improve workplace social capital in community health centers in China.

    PubMed

    Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

    2014-01-01

    To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. This study was conducted in 20 community health centers of similar size in Jinan of China during 2012-2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings.

  3. Effects of a Randomized Intervention to Improve Workplace Social Capital in Community Health Centers in China

    PubMed Central

    Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

    2014-01-01

    Objective To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. Methods This study was conducted in 20 community health centers of similar size in Jinan of China during 2012–2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. Results No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. Conclusions The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings. PMID:25503627

  4. A Multisite Randomized Trial of Social Norms Marketing Campaigns to Reduce College Student Drinking: A Replication Failure

    ERIC Educational Resources Information Center

    DeJong, William; Schneider, Shari Kessel; Towvim, Laura Gomberg; Murphy, Melissa J.; Doerr, Emily E.; Simonsen, Neal R.; Mason, Karen E.; Scribner, Richard A.

    2009-01-01

    A 14-site randomized trial tested the effectiveness of social norms marketing (SNM) campaigns, which present accurate student survey data in order to correct misperceptions of subjective drinking norms and thereby drive down alcohol use. Cross-sectional student surveys were conducted by mail at baseline and at posttest 3 years later. Hierarchical…

  5. A multi-site randomized study to compare the effects of Eye Movement Desensitization and Reprocessing (EMDR) added to TAU versus TAU to reduce craving and drinking behavior in alcohol dependent outpatients: study protocol.

    PubMed

    Markus, Wiebren; de Weert-van Oene, Gerdien H; Becker, Eni S; DeJong, Cor A J

    2015-03-18

    Addiction constitutes a major public health problem, and despite treatment, relapse rates remain very high. Preliminary findings suggest that Eye Movement Desensitization and Reprocessing (EMDR), an evidence-based treatment for PTSD, may also reduce craving and relapse rates when applied in substance abuse. This study aims to determine the feasibility, efficacy and effectiveness of EMDR when added to treatment as usual (TAU) for addiction in alcohol dependent outpatients, compared to TAU only. A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites, will be enrolled. After baseline assessment participants will be allocated to one of two treatment conditions (allocation ratio of 1:1) using a stratified (per site, per care pathway), blocked randomization procedure. The intervention consists of EMDR (seven weekly 90 minute sessions) + TAU or TAU only. Assessments are scheduled pre-treatment (t0), post-treatment (t0 + eight weeks), and one and six months post treatment. The effects of both treatment arms are compared on indices of (a) drinking behavior, (b) mediators, moderators and predictors of treatment outcome, (c) quality of life and d) safety, acceptability and feasibility of treatment. Repeated measures ANOVA's will be conducted using an intention-to-treat and per-protocol approach. Multiple imputation will be used to deal with missing values when possible. This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma. ClinicalTrial.gov: NCT01828866.

  6. Assessing adverse effects of intra-articular botulinum toxin A in healthy Beagle dogs: A placebo-controlled, blinded, randomized trial

    PubMed Central

    Jokinen, Tarja S.; Syrjä, Pernilla; Junnila, Jouni; Hielm-Björkman, Anna; Laitinen-Vapaavuori, Outi

    2018-01-01

    Objective To investigate the clinical, cytological, and histopathological adverse effects of intra-articularly injected botulinum toxin A in dogs and to study whether the toxin spreads from the joint after the injection. Methods A longitudinal, placebo-controlled, randomized clinical trial was conducted with six healthy laboratory Beagle dogs. Stifle joints were randomized to receive either 30 IU of onabotulinum toxin A or placebo in a 1:1 ratio. Adverse effects and spread of the toxin were examined by evaluating dynamic and static weight-bearing of the injected limbs, by assessing painless range of motion and pain on palpation of joints, and by performing synovial fluid analysis, neurological examination, and electrophysiological recordings at different examination time-points in a 12-week period after the injections. The dogs were then euthanized and autopsy and histopathological examination of joint structures and adjacent muscles and nerves were performed. Results Intra-articular botulinum toxin A did not cause local weakness or injection site pain. Instead, static weight-bearing and painless range of motion of stifle joints decreased in the placebo limbs. No clinically significant abnormalities associated with intra-articular botulinum toxin A were detected in the neurological examinations. Electrophysiological recordings showed low compound muscle action potentials in two dogs in the botulinum toxin A-injected limb. No significant changes were detected in the synovial fluid. Autopsy and histopathological examination of the joint and adjacent muscles and nerves did not reveal histopathological adverse effects of the toxin. Conclusion Intra-articular botulinum toxin A does not produce significant clinical, cytological, or histopathological adverse effects in healthy dogs. Based on the electrophysiological recordings, the toxin may spread from the joint, but its clinical impact seems to be low. PMID:29320549

  7. Coupled continuous time-random walks in quenched random environment

    NASA Astrophysics Data System (ADS)

    Magdziarz, M.; Szczotka, W.

    2018-02-01

    We introduce a coupled continuous-time random walk with coupling which is characteristic for Lévy walks. Additionally we assume that the walker moves in a quenched random environment, i.e. the site disorder at each lattice point is fixed in time. We analyze the scaling limit of such a random walk. We show that for large times the behaviour of the analyzed process is exactly the same as in the case of uncoupled quenched trap model for Lévy flights.

  8. Effects of Vegetation Structure on the Location of Lion Kill Sites in African Thicket.

    PubMed

    Davies, Andrew B; Tambling, Craig J; Kerley, Graham I H; Asner, Gregory P

    2016-01-01

    Predator-prey relationships are integral to ecosystem stability and functioning. These relationships are, however, difficult to maintain in protected areas where large predators are increasingly being reintroduced and confined. Where predators make kills has a profound influence on their role in ecosystems, but the relative importance of environmental variables in determining kill sites, and how these might vary across ecosystems is poorly known. We investigated kill sites for lions in South Africa's thicket biome, testing the importance of vegetation structure for kill site locations compared to other environmental variables. Kill sites were located over four years using GPS telemetry and compared to non-kill sites that had been occupied by lions, as well as to random sites within lion ranges. Measurements of 3D vegetation structure obtained from Light Detection and Ranging (LiDAR) were used to calculate the visible area (viewshed) around each site and, along with wind and moonlight data, used to compare kill sites between lion sexes, prey species and prey sexes. Viewshed area was the most important predictor of kill sites (sites in dense vegetation were twice as likely to be kill sites compared to open areas), followed by wind speed and, less so, moonlight. Kill sites for different prey species varied with vegetation structure, and male prey were killed when wind speeds were higher compared to female prey of the same species. Our results demonstrate that vegetation structure is an important component of predator-prey interactions, with varying effects across ecosystems. Such differences require consideration in terms of the ecological roles performed by predators, and in predator and prey conservation.

  9. Effects of Vegetation Structure on the Location of Lion Kill Sites in African Thicket

    PubMed Central

    Davies, Andrew B.; Tambling, Craig J.; Kerley, Graham I. H.; Asner, Gregory P.

    2016-01-01

    Predator-prey relationships are integral to ecosystem stability and functioning. These relationships are, however, difficult to maintain in protected areas where large predators are increasingly being reintroduced and confined. Where predators make kills has a profound influence on their role in ecosystems, but the relative importance of environmental variables in determining kill sites, and how these might vary across ecosystems is poorly known. We investigated kill sites for lions in South Africa’s thicket biome, testing the importance of vegetation structure for kill site locations compared to other environmental variables. Kill sites were located over four years using GPS telemetry and compared to non-kill sites that had been occupied by lions, as well as to random sites within lion ranges. Measurements of 3D vegetation structure obtained from Light Detection and Ranging (LiDAR) were used to calculate the visible area (viewshed) around each site and, along with wind and moonlight data, used to compare kill sites between lion sexes, prey species and prey sexes. Viewshed area was the most important predictor of kill sites (sites in dense vegetation were twice as likely to be kill sites compared to open areas), followed by wind speed and, less so, moonlight. Kill sites for different prey species varied with vegetation structure, and male prey were killed when wind speeds were higher compared to female prey of the same species. Our results demonstrate that vegetation structure is an important component of predator-prey interactions, with varying effects across ecosystems. Such differences require consideration in terms of the ecological roles performed by predators, and in predator and prey conservation. PMID:26910832

  10. 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.

  11. Behavioral effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    PubMed

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

    2015-09-01

    Neurofeedback has been proposed as a potentially effective intervention for reducing Attention Deficit Hyperactivity Disorder (ADHD) symptoms. However, it remains unclear whether neurofeedback is of additional value to treatment as usual (TAU) for adolescents with clinical ADHD symptoms. Using a multicenter parallel-randomized controlled trial design, adolescents with ADHD symptoms were randomized to receive either a combination of TAU and neurofeedback (NFB + TAU, n = 45) or TAU-only (n = 26). Randomization was computer generated and stratified for age group (ages 12 through 16, 16 through 20, 20 through 24). Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Primary behavioral outcome measures included the ADHD-rating scale, Youth Self Report, and Child Behavior Checklist all assessed pre- and post-intervention. Behavioral problems decreased equally for both groups with medium to large effect sizes, range of partial η2 = 0.08-0.31, p < 0.05. Hence, the combination of NFB + TAU was not more effective than TAU-only on the behavioral outcome measures. In addition, reported adverse effects were similar for both groups. On behavioral outcome measures, the combination of neurofeedback and TAU was as effective as TAU-only for adolescents with ADHD symptoms. Considering the absence of additional behavioral effects in the current study, in combination with the limited knowledge of specific treatment effects, it is questionable whether theta/SMR neurofeedback for adolescents with ADHD and comorbid disorders in clinical practice should be used. Further research is warranted to investigate possible working mechanisms and (long-term) specific treatment effects of neurofeedback.

  12. Firm-Related Training Tracks: A Random Effects Ordered Probit Model

    ERIC Educational Resources Information Center

    Groot, Wim; van den Brink, Henriette Maassen

    2003-01-01

    A random effects ordered response model of training is estimated to analyze the existence of training tracks and time varying coefficients in training frequency. Two waves of a Dutch panel survey of workers are used covering the period 1992-1996. The amount of training received by workers increased during the period 1994-1996 compared to…

  13. The Effect of Insertion Torque on the Clinical Outcome of Single Implants: A Randomized Clinical Trial.

    PubMed

    Barone, Antonio; Alfonsi, Fortunato; Derchi, Giacomo; Tonelli, Paolo; Toti, Paolo; Marchionni, Saverio; Covani, Ugo

    2016-06-01

    The insertion torque value has been extensively used as an indicator for implant primary stability, which is considered a determining parameter for the implants success. The primary goal of the present randomized clinical trial was to evaluate and compare the clinical outcome for implants placed with high insertion torque (between 50 Ncm and 100 Ncm) and regular insertion torque (within 50 Ncm) in healed ridges. Partially edentulous patients, missing one or more mandibular or maxillary teeth, having an adequate amount of bone, requiring implant placement, were randomized to receive Blossom CT implants with regular insertion torque (<50 Ncm) or CT implants with high insertion torque (≥50 Ncm). Implants were left to heal submerged for 3 months. Implants were restored with individualized abutments and cemented metal-ceramic crowns. Acquired measurements were: insertion torque values (IT), thickness of buccal bone plate after implant osteotomy preparation (BBT), marginal bone level (MBL), and facial soft tissue level (FST). All patients were followed 12 months after implant placement. One hundred sixteen implants were placed in one hundred sixteen patients and enrolled for the study. Fifty-eight implants were randomly allocated in regular-IT and high-IT groups with a mean insertion torque ranging from 20 Ncm to 50 Ncm and from 50 Ncm to 100 Ncm, respectively. Three implants failed, and another five implants showed at the 12-month evaluation a marginal bone loss (ΔMBL) greater than 1.5 mm, being considered unsuccessful. The findings suggested that implants inserted with high-IT (≥50 Ncm) in healed bone ridges showed more peri-implant bone remodeling and buccal soft tissue recession than implants inserted with a regular-IT (<50 Ncm). Moreover, sites with a thick buccal bone wall (≥1 mm) - after implant osteotomy site preparation - seemed to be less prone to buccal soft tissue recession after 12 months than sites with a thin buccal bone

  14. Motivational Interviewing as a Supervision Strategy in Probation: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Walters, Scott T.; Vader, Amanda M.; Nguyen, Norma; Harris, T. Robert; Eells, Jennifer

    2010-01-01

    Motivational interviewing (MI) has been recommended as a supervision style in probation. This project examined the effectiveness of an MI training curriculum on probation officer MI skill and subsequent probationer outcome. Twenty probation officers were randomized to receive MI training, or to a waiting list control, while an additional group of…

  15. Effect of random vacancies on the electronic properties of graphene and T graphene: a theoretical approach

    NASA Astrophysics Data System (ADS)

    Sadhukhan, B.; Nayak, A.; Mookerjee, A.

    2017-12-01

    In this communication we present together four distinct techniques for the study of electronic structure of solids: the tight-binding linear muffin-tin orbitals, the real space and augmented space recursions and the modified exchange-correlation. Using this we investigate the effect of random vacancies on the electronic properties of the carbon hexagonal allotrope, graphene, and the non-hexagonal allotrope, planar T graphene. We have inserted random vacancies at different concentrations, to simulate disorder in pristine graphene and planar T graphene sheets. The resulting disorder, both on-site (diagonal disorder) as well as in the hopping integrals (off-diagonal disorder), introduces sharp peaks in the vicinity of the Dirac point built up from localized states for both hexagonal and non-hexagonal structures. These peaks become resonances with increasing vacancy concentration. We find that in presence of vacancies, graphene-like linear dispersion appears in planar T graphene and the cross points form a loop in the first Brillouin zone similar to buckled T graphene that originates from π and π* bands without regular hexagonal symmetry. We also calculate the single-particle relaxation time, τ (ěc {q}) of ěc {q} labeled quantum electronic states which originates from scattering due to presence of vacancies, causing quantum level broadening.

  16. Transport properties of random media: A new effective medium theory

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

    Busch, K.; Soukoulis, C.M.

    We present a new method for efficient, accurate calculations of transport properties of random media. It is based on the principle that the wave energy density should be uniform when averaged over length scales larger than the size of the scatterers. This scheme captures the effects of resonant scattering of the individual scatterer exactly, as well as the multiple scattering in a mean-field sense. It has been successfully applied to both ``scalar`` and ``vector`` classical wave calculations. Results for the energy transport velocity are in agreement with experiment. This approach is of general use and can be easily extended tomore » treat different types of wave propagation in random media. {copyright} {ital 1995} {ital The} {ital American} {ital Physical} {ital Society}.« less

  17. Prophylactic treatment of local reactions to i.v. vinorelbine: a randomized study.

    PubMed

    Quant, Eva; Bergman, Bengt

    2012-08-01

    Local reactions on the site of infusion are common with i.v. vinorelbine treatment. The study aims were to evaluate whether an i.v. saline infusion or steroid injection, or the combination of these measures, could decrease vinorelbine-related local reactions and to study to what extent such reactions actually occur. Patients with lung cancer and planned chemotherapy containing i.v. vinorelbine were randomized in a 2 × 2 factorial design to receive either 4 mg betamethasone or placebo i.v. prior to and either 20 or 250 ml saline infusion following the vinorelbine infusion. Local infusion site signs and symptoms were recorded during and 1 h after the vinorelbine infusion and collected by a study-specific diary 24-48 h following each treatment course. A total of 79 patients were randomized and evaluable. Local infusion site signs, symptoms and reactions occurred in 63% of all patients (49% during vinorelbine monotherapy courses), with local pain being most frequently reported. Pre-treatment with i.v. betamethasone was associated with a reduced risk of local pain (5/38 vs. 20/39; p < 0.001) or any symptoms (14/38 vs. 29/39; p = 0.01) compared with placebo during the 48 h following the vinorelbine infusion. The reduced pain effect was seen both during vinorelbine monotherapy courses and during combination chemotherapy with carboplatin. In contrast, there was no difference between post-treatment infusion with 20 or 250 ml saline with regard to local signs or symptoms. Local infusion site side effects are common with i.v. vinorelbine. Pre-treatment with 4 mg betamethasone i.v. is associated with a reduced risk of local symptoms or reactions, local pain in particular.

  18. A multi-sites analysis on the ozone effects on Gross Primary Production of European forests.

    PubMed

    Proietti, C; Anav, A; De Marco, A; Sicard, P; Vitale, M

    2016-06-15

    Ozone (O3) is both a greenhouse gas and a secondary air pollutant causing adverse impacts on forests ecosystems at different scales, from cellular to ecosystem level. Specifically, the phytotoxic nature of O3 can impair CO2 assimilation that, in turn affects forest productivity. This study aims to evaluate the effects of tropospheric O3 on Gross Primary Production (GPP) at 37 European forest sites during the time period 2000-2010. Due to the lack of carbon assimilation data at O3 monitoring stations (and vice-versa) this study makes a first attempt to combine high resolution MODIS Gross Primary Production (GPP) estimates and O3 measurement data. Partial Correlations, Anomalies Analysis and the Random Forests Analysis (RFA) were used to quantify the effects of tropospheric O3 concentration and its uptake on GPP and to evaluate the most important factors affecting inter-annual GPP changes. Our results showed, along a North-West/South-East European transect, a negative impact of O3 on GPP ranging from 0.4% to 30%, although a key role of meteorological parameters respect to pollutant variables in affecting GPP was found. In particular, meteorological parameters, namely air temperature (T), soil water content (SWC) and relative humidity (RH) are the most important predictors at 81% of test sites. Moreover, it is interesting to highlight a key role of SWC in the Mediterranean areas (Spanish, Italian and French test sites) confirming that, soil moisture and soil water availability affect vegetation growth and photosynthesis especially in arid or semi-arid ecosystems such as the Mediterranean climate regions. Considering the pivotal role of GPP in the global carbon balance and the O3 ability to reduce primary productivity of the forests, this study can help in assessing the O3 impacts on ecosystem services, including wood production and carbon sequestration. Copyright © 2016 Elsevier B.V. All rights reserved.

  19. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  20. Random Effects: Variance Is the Spice of Life.

    PubMed

    Jupiter, Daniel C

    Covariates in regression analyses allow us to understand how independent variables of interest impact our dependent outcome variable. Often, we consider fixed effects covariates (e.g., gender or diabetes status) for which we examine subjects at each value of the covariate. We examine both men and women and, within each gender, examine both diabetic and nondiabetic patients. Occasionally, however, we consider random effects covariates for which we do not examine subjects at every value. For example, we examine patients from only a sample of hospitals and, within each hospital, examine both diabetic and nondiabetic patients. The random sampling of hospitals is in contrast to the complete coverage of all genders. In this column I explore the differences in meaning and analysis when thinking about fixed and random effects variables. Copyright © 2016 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  1. Random forests of interaction trees for estimating individualized treatment effects in randomized trials.

    PubMed

    Su, Xiaogang; Peña, Annette T; Liu, Lei; Levine, Richard A

    2018-04-29

    Assessing heterogeneous treatment effects is a growing interest in advancing precision medicine. Individualized treatment effects (ITEs) play a critical role in such an endeavor. Concerning experimental data collected from randomized trials, we put forward a method, termed random forests of interaction trees (RFIT), for estimating ITE on the basis of interaction trees. To this end, we propose a smooth sigmoid surrogate method, as an alternative to greedy search, to speed up tree construction. The RFIT outperforms the "separate regression" approach in estimating ITE. Furthermore, standard errors for the estimated ITE via RFIT are obtained with the infinitesimal jackknife method. We assess and illustrate the use of RFIT via both simulation and the analysis of data from an acupuncture headache trial. Copyright © 2018 John Wiley & Sons, Ltd.

  2. Treatment of Adolescent Marijuana Abuse: A Randomized Clinical Trial. Presentation 1: Structure of the Cannabis Youth Treatment Study.

    ERIC Educational Resources Information Center

    Titus, Janet C.; Dennis, Michael L.; Diamond, Guy; Godley, Susan H.; Babor, Thomas; Donaldson, Jean; Herrell, James; Tims, Frank; Webb, Charles

    The Cannabis Youth Treatment (CYT) study is a multi-site randomized field experiment examining five outpatient treatment protocols for adolescents who abuse or are dependent on marijuana. The purpose of the CYT project is twofold: (a) to test the relative clinical effectiveness and cost-effectiveness of five promising interventions targeted at…

  3. Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

    PubMed

    Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

    2017-01-01

    Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing

  4. Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial.

    PubMed

    Bell, Susan P; Schnipper, Jeffrey L; Goggins, Kathryn; Bian, Aihua; Shintani, Ayumi; Roumie, Christianne L; Dalal, Anuj K; Jacobson, Terry A; Rask, Kimberly J; Vaccarino, Viola; Gandhi, Tejal K; Labonville, Stephanie A; Johnson, Daniel; Neal, Erin B; Kripalani, Sunil

    2016-05-01

    Reduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal. The aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge. Randomized, controlled trial with concealed allocation and blinded outcome assessors Two tertiary care academic medical centers Adults hospitalized with a diagnosis of ACS and/or ADHF. Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge The primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) are reported. A total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women's Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR = 1.04, 95% CI 0.78-1.39). There was an interaction of treatment effect by site (p = 0.04 for interaction); VUH aHR = 0.77, 95% CI 0.51-1.15; BWH aHR = 1.44 (95% CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95% CI 0.17-1.00). There was no difference in treatment effect by patient cognition. A tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post

  5. Effects of trap type, placement and ash distribution on emerald ash borer captures in a low density site.

    PubMed

    McCullough, Deborah G; Siegert, Nathan W; Poland, Therese M; Pierce, Steven J; Ahn, Su Zie

    2011-10-01

    Effective methods for early detection of newly established, low density emerald ash borer (Agrilus planipennis Fairmaire) infestations are critically needed in North America. We assessed adult A. planipennis captures on four types of traps in a 16-ha site in central Michigan. The site was divided into 16 blocks, each comprised of four 50- by 50-m cells. Green ash trees (Fraxinus pennsylvanica Marshall) were inventoried by diameter class and ash phloem area was estimated for each cell. One trap type was randomly assigned to each cell in each block. Because initial sampling showed that A. planipennis density was extremely low, infested ash logs were introduced into the center of the site. In total, 87 beetles were captured during the summer. Purple double-decker traps baited with a blend of ash leaf volatiles, Manuka oil, and ethanol captured 65% of all A. planipennis beetles. Similarly baited, green double-decker traps captured 18% of the beetles, whereas sticky bands on girdled trees captured 11% of the beetles. Purple traps baited with Manuka oil and suspended in the canopies of live ash trees captured only 5% of the beetles. At least one beetle was captured on 81% of the purple double-decker traps, 56% of the green double-decker traps, 42% of sticky bands, and 25% of the canopy traps. Abundance of ash phloem near traps had no effect on captures and trap location and sun exposure had only weak effects on captures. Twelve girdled and 29 nongirdled trees were felled and sampled in winter. Current-year larvae were present in 100% of the girdled trees and 72% of the nongirdled trees, but larval density was five times higher on girdled than nongirdled trees.

  6. Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial.

    PubMed

    An, T W; Boone, S L; Boyer, M I; Gelberman, R H; Osei, D A; Calfee, R P

    2016-11-01

    This prospective, randomized controlled study was designed to determine if applying ice to the site of corticosteroid injections in the hand and wrist reduces post-injection pain. Patients receiving corticosteroid injections in the hand or wrist at a tertiary institution were enrolled. Subjects were randomized to apply ice to the injection site and take scheduled over-the-counter analgesics ( n = 36) or take scheduled over-the-counter analgesics alone ( n = 32). There were no significant differences in the mean pain score between the two groups at any time-point (pre-injection or 1-5 days post-injection). In regression modelling, the application of ice did not predict pain after injection. Visual analogue pain scores increased at least 2 points (0-10 scale) after injection in 17 out of 36 patients in the ice group versus ten out of 32 control patients. We conclude that the application of ice in addition to over-the-counter analgesics does not reduce post-injection pain after corticosteroid injection in the hand or wrist. I Therapeutic Study.

  7. Effectiveness of Telementoring in Surgery Compared With On-site Mentoring: A Systematic Review.

    PubMed

    Bilgic, Elif; Turkdogan, Sena; Watanabe, Yusuke; Madani, Amin; Landry, Tara; Lavigne, Daniel; Feldman, Liane S; Vassiliou, Melina C

    2017-08-01

    Mentorship is important but may not be feasible for distance learning. To bridge this gap, telementoring has emerged. The purpose of this systematic review was to evaluate the effectiveness of telementoring compared with on-site mentoring. A search was done up to March 2015. Studies were included if they used telementoring between surgeons during a clinical encounter and if they compared on-site mentoring and telementoring. A total of 11 studies were included. All reported no difference in complication rates, and 9 (82%) reported similar operative times; 4 (36%) reported technical issues, which was 3% of the total number of cases in the 11 studies. No study reported on higher levels of evidence for effectiveness of telementoring as an educational intervention. Studies reported that telementoring is associated with similar complication rates and operative times compared with on-site mentoring. However, the level of evidence to support the effectiveness of telementoring as a training tool is limited. There is a need for studies that provide evidence for the equivalence of the effectiveness of telementoring as an educational intervention in comparison with on-site mentoring.

  8. Effective degrees of freedom of a random walk on a fractal.

    PubMed

    Balankin, Alexander S

    2015-12-01

    We argue that a non-Markovian random walk on a fractal can be treated as a Markovian process in a fractional dimensional space with a suitable metric. This allows us to define the fractional dimensional space allied to the fractal as the ν-dimensional space F(ν) equipped with the metric induced by the fractal topology. The relation between the number of effective spatial degrees of freedom of walkers on the fractal (ν) and fractal dimensionalities is deduced. The intrinsic time of random walk in F(ν) is inferred. The Laplacian operator in F(ν) is constructed. This allows us to map physical problems on fractals into the corresponding problems in F(ν). In this way, essential features of physics on fractals are revealed. Particularly, subdiffusion on path-connected fractals is elucidated. The Coulomb potential of a point charge on a fractal embedded in the Euclidean space is derived. Intriguing attributes of some types of fractals are highlighted.

  9. Effective degrees of freedom of a random walk on a fractal

    NASA Astrophysics Data System (ADS)

    Balankin, Alexander S.

    2015-12-01

    We argue that a non-Markovian random walk on a fractal can be treated as a Markovian process in a fractional dimensional space with a suitable metric. This allows us to define the fractional dimensional space allied to the fractal as the ν -dimensional space Fν equipped with the metric induced by the fractal topology. The relation between the number of effective spatial degrees of freedom of walkers on the fractal (ν ) and fractal dimensionalities is deduced. The intrinsic time of random walk in Fν is inferred. The Laplacian operator in Fν is constructed. This allows us to map physical problems on fractals into the corresponding problems in Fν. In this way, essential features of physics on fractals are revealed. Particularly, subdiffusion on path-connected fractals is elucidated. The Coulomb potential of a point charge on a fractal embedded in the Euclidean space is derived. Intriguing attributes of some types of fractals are highlighted.

  10. Effectiveness of residual spraying of peridomestic ecotopes with deltamethrin and permethrin on Triatoma infestans in rural western Argentina: a district-wide randomized trial.

    PubMed Central

    Gürtler, Ricardo E.; Canale, Delmi M.; Spillmann, Cynthia; Stariolo, Raúl; Salomón, Oscar D.; Blanco, Sonia; Segura, Elsa L.

    2004-01-01

    OBJECTIVE: To compare the effectiveness of a single residual spraying of pyrethroids on the occurrence and abundance of Triatoma infestans in peridomestic ecotopes in rural La Rioja. METHODS: A total of 667 (32.8%) peridomestic sites positive for T. infestans in May 1999 were randomly assigned to treatment within each village, sprayed in December 1999, and reinspected in December 2000. Treatments included 2.5% suspension concentrate (SC) deltamethrin in water at 25 mg active ingredient (a.i.)/m(2) applied with: (a) manual compression sprayers (standard treatment) or (b) power sprayers; (c) 1.5% emulsifiable concentrate (EC) deltamethrin at 25 mg a.i./m(2); and (d) 10% EC cis-permethrin at 170 mg a.i./m(2). EC pyrethroids were diluted in soybean oil and applied with power sprayers. All habitations were sprayed with the standard treatment. FINDINGS: The prevalence of T. infestans 1-year post-spraying was significantly lower in sites treated with SC deltamethrin applied with manual (24%) or power sprayers (31%) than in sites treated with EC deltamethrin (40%) or EC permethrin (53%). The relative odds of infestation and catch of T. infestans 1-year post-spraying significantly increased with the use of EC pyrethroids, the abundance of bugs per site before spraying, total surface, and host numbers. All insecticides had poor residual effects on wooden posts. CONCLUSION: Most of the infestations probably originated from triatomines that survived exposure to insecticides at each site. Despite the standard treatment proving to be the most effective, the current tactics and procedures fail to eliminate peridomestic populations of T. infestans in semiarid rural areas and need to be revised. PMID:15112008

  11. Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial

    PubMed Central

    Rocca, Corinne H.; Kohn, Julia E.; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J. Joseph; Darney, Philip D.; Harper, Cynthia C.

    2016-01-01

    Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011–2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. PMID:26794168

  12. A mediator effect size in randomized clinical trials.

    PubMed

    Kraemer, Helena Chmura

    2014-12-01

    To understand the process by which a treatment (T) achieves an effect on outcome (O) and thus to improve the effect of T on O, it is vital to detect mediators, to compare the impact of different mediators, and to develop hypotheses about the causal factors (all mediators) linking T and O. An index is needed to facilitate interpretation of the potential clinical importance of a mediator (M) of choice of T on treatment O in randomized clinical trials (RCTs). Ideally such a mediator effect size should (1) be invariant under any rescaling of M and O consistent with the model used, and (2) reflect the difference between the overall observed effect of T on O and what the maximal effect of T on O could be were the association between T and M broken. A mediator effect size is derived first for the traditional linear model, and then more generally for any categorical (ordered or non-ordered) potential mediator. Issues such as the problem of multiple treatments, outcomes and mediators, and of causal inferences, and the correspondence between this approach and earlier ones, are discussed. Illustrations are given of the application of the approach. Copyright © 2014 John Wiley & Sons, Ltd.

  13. Technology diffusion in hospitals: a log odds random effects regression model.

    PubMed

    Blank, Jos L T; Valdmanis, Vivian G

    2015-01-01

    This study identifies the factors that affect the diffusion of hospital innovations. We apply a log odds random effects regression model on hospital micro data. We introduce the concept of clustering innovations and the application of a log odds random effects regression model to describe the diffusion of technologies. We distinguish a number of determinants, such as service, physician, and environmental, financial and organizational characteristics of the 60 Dutch hospitals in our sample. On the basis of this data set on Dutch general hospitals over the period 1995-2002, we conclude that there is a relation between a number of determinants and the diffusion of innovations underlining conclusions from earlier research. Positive effects were found on the basis of the size of the hospitals, competition and a hospital's commitment to innovation. It appears that if a policy is developed to further diffuse innovations, the external effects of demand and market competition need to be examined, which would de facto lead to an efficient use of technology. For the individual hospital, instituting an innovations office appears to be the most prudent course of action. © 2013 The Authors. International Journal of Health Planning and Management published by John Wiley & Sons, Ltd.

  14. Prevalence of Surgical Site Infections Following Orthognathic Surgery: A Double-Blind, Randomized Controlled Trial on a 3-Day Versus 1-Day Postoperative Antibiotic Regimen.

    PubMed

    Davis, Clayton M; Gregoire, Curtis E; Davis, Ian; Steeves, Thomas W

    2017-04-01

    The purpose of this study was to determine the effect of a 3- versus 1-day antibiotic regimen on the rate of surgical site infection (SSI) in patients undergoing orthognathic surgery at a department of oral and maxillofacial surgery in Halifax, Nova Scotia, Canada. A prospective, randomized controlled trial was conducted. All patients received 1 day of intravenous antibiotics after surgery. Then, patients were randomly distributed into groups that received 2 days of additional antibiotics (group A) or placebo (group B). The primary outcome measured was the presence of SSI. The operating surgeon, concomitant extraction of teeth, surgical procedures performed, duration of intermaxillary fixation, and length of hospital stay were analyzed for an effect on SSI. Patients were followed for 1 year after surgery to identify SSIs that might have been diagnosed outside the hospital. The trial started with 288 patients, and 117 patients were lost to follow-up. Statistical analyses were ultimately performed on those 171 patients who were adherent to the study medication regimen. Group A (n = 86) and B (n = 85) SSI rates were 7.0 and 17.6% (number needed to treat = 10; P = .04), respectively. Mandibular bilateral sagittal split osteotomy (BSSO) was involved in 71% of SSIs. Intra- and postoperative surgical variables did not have a relevant effect on the SSI rate. Patients were followed for 1 year after surgery, and group A (n = 46) and group B (n = 44) had SSI rates of 4 and 25% (P < .05), respectively. Three days of postoperative cefazolin and cephalexin markedly decreases SSI rates compared with 1 day. However, the number needed to treat of 10 suggests that the benefits of the extended regimen might not outweigh the risks. The high prevalence of SSIs at the mandibular BSSO incisions might have been caused by contamination, with more saliva and reception of a lower blood supply, than maxillary Le Fort I incisions. Mandibular osteotomies could benefit from an

  15. The blocked-random effect in pictures and words.

    PubMed

    Toglia, M P; Hinman, P J; Dayton, B S; Catalano, J F

    1997-06-01

    Picture and word recall was examined in conjunction with list organization. 60 subjects studied a list of 30 items, either words or their pictorial equivalents. The 30 words/pictures, members of five conceptual categories, each represented by six exemplars, were presented either blocked by category or in a random order. While pictures were recalled better than words and a standard blocked-random effect was observed, the interaction indicated that the recall advantage of a blocked presentation was restricted to the word lists. A similar pattern emerged for clustering. These findings are discussed in terms of limitations upon the pictorial superiority effect.

  16. Low-Level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness at Free Gingival Graft Donor Sites: A Randomized, Controlled Clinical Study.

    PubMed

    Ustaoglu, Gulbahar; Ercan, Esra; Tunali, Mustafa

    2017-04-01

    The aim of this study was to determine the effects of low-level laser therapy (LLLT) on wound healing at free gingival graft (FGG) donor sites. Forty patients requiring FGG were selected for this randomized, controlled, and double-blinded prospective clinical trial. The FGG donor sites were treated with LLLT and compared with an untreated control group. The Wound-Healing Index (WHI), tissue consistency, color match, and H 2 O 2 bubbling test for the evaluation of complete wound epithelialization were recorded on the 3rd, 7th, 14th and 21st days. The pain-burning level, number of analgesics, and bleeding were recorded for 7 days. Donor area soft tissue thickness (TT) was measured at baseline and at the first month. The prevalence of Complete Wound Epithelization was higher in the LLLT group than in the control group on the 14th day (p < 0.001). The bleeding was lower in the test group than in the control group during the first 2 days (p ≤ 0.001). Higher WHI Scores were observed in the test group relative to the control group at all visits (p ≤ 0.001). Color match scores were higher in the test group than in the control group at the first 3 visits (p < 0.05). The TT changed from 4.62 ± 0.79 to 4.71 ± 0.82 mm in the LLLT group and from 4.23 ± 0.62 to 4.01 ± 0.68 mm in the control group. It can be concluded that LLLT enhances FGG donor site wound healing and preserves TT at palatinal donor sites.

  17. A simple and efficient alternative to implementing systematic random sampling in stereological designs without a motorized microscope stage.

    PubMed

    Melvin, Neal R; Poda, Daniel; Sutherland, Robert J

    2007-10-01

    When properly applied, stereology is a very robust and efficient method to quantify a variety of parameters from biological material. A common sampling strategy in stereology is systematic random sampling, which involves choosing a random sampling [corrected] start point outside the structure of interest, and sampling relevant objects at [corrected] sites that are placed at pre-determined, equidistant intervals. This has proven to be a very efficient sampling strategy, and is used widely in stereological designs. At the microscopic level, this is most often achieved through the use of a motorized stage that facilitates the systematic random stepping across the structure of interest. Here, we report a simple, precise and cost-effective software-based alternative to accomplishing systematic random sampling under the microscope. We believe that this approach will facilitate the use of stereological designs that employ systematic random sampling in laboratories that lack the resources to acquire costly, fully automated systems.

  18. Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

    PubMed

    Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

    2010-01-01

    The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  19. The Effects of Surgical Hand Scrubbing Protocols on Skin Integrity and Surgical Site Infection Rates: A Systematic Review.

    PubMed

    Liu, Liang Qin; Mehigan, Sinead

    2016-05-01

    This systematic review aimed to critically appraise and synthesize updated evidence regarding the effect of surgical-scrub techniques on skin integrity and the incidence of surgical site infections. Databases searched include the Cumulative Index to Nursing and Allied Health Literature, MEDLINE, Embase, and Cochrane Central. Our review was limited to eight peer-reviewed, randomized controlled trials and two nonrandomized controlled trials published in English from 1990 to 2015. Comparison models included traditional hand scrubbing with chlorhexidine gluconate or povidone-iodine against alcohol-based hand rubbing, scrubbing with a brush versus without a brush, and detergent-based antiseptics alone versus antiseptics incorporating alcohol solutions. Evidence showed that hand rubbing techniques are as effective as traditional scrubbing and seem to be better tolerated. Hand rubbing appears to cause less skin damage than traditional scrub protocols, and scrub personnel tolerated brushless techniques better than scrubbing using a brush. Copyright © 2016 AORN, Inc. Published by Elsevier Inc. All rights reserved.

  20. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study.

    PubMed

    Guo, Yao-Hong; Kuan, Ta-Shen; Chen, Kuan-Lin; Lien, Wei-Chih; Hsieh, Pei-Chun; Hsieh, I-Chieh; Chiu, Szu-Hao; Lin, Yu-Ching

    2017-01-01

    To compare the effects of 2 different injection sites of low doses of botulinum toxin type A with steroid in treating lateral epicondylalgia. Double-blind, randomized, active drug-controlled trial. Tertiary medical center. Patients with lateral epicondylalgia for >6 months were recruited from a hospital-based outpatient population (N=26). A total of 66 patients were approached, and 40 were excluded. No participant withdrew because of adverse effects. Patients were randomly assigned into 3 groups: (1) botulinum toxin epic group (n=8), who received 20U of botulinum toxin injection into the lateral epicondyle; (2) botulinum toxin tend group (n=7), who received 20U of botulinum toxin injected into tender points of muscles; and (3) steroid group (n=11), who received 40mg of triamcinolone acetonide injected into the lateral epicondyle. A visual analog scale, a dynamometer, and the Patient-Rated Tennis Elbow Evaluation were used to evaluate the perception of pain, maximal grip strength, and functional status, respectively. Outcome measures were assessed before intervention and at 4, 8, 12, and 16 weeks after treatment. The primary outcome measure was a visual analog scale. At 4 weeks after injection, the steroid group was superior to the botulinum toxin tend group in improvement on the visual analog scale (P=.006), grip strength (P=.03), and Patient-Rated Tennis Elbow Evaluation (P=.02). However, these differences were not observed at the 8-, 12-, and 16-week follow-up assessments. There was no significant difference between the steroid and botulinum toxin epic groups. Injections with botulinum toxin and steroid effectively reduced pain and improved upper limb function in patients with lateral epicondylalgia for at least 16 weeks. The onset of effect was earlier in the steroid and botulinum toxin epic groups than in the botulinum toxin tend group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  1. Effects of spatial disturbance on common loon nest site selection and territory success

    USGS Publications Warehouse

    McCarthy, K.P.; DeStefano, S.

    2011-01-01

    The common loon (Gavia immer) breeds during the summer on northern lakes and water bodies that are also often desirable areas for aquatic recreation and human habitation. In northern New England, we assessed how the spatial nature of disturbance affects common loon nest site selection and territory success. We found through classification and regression analysis that distance to and density of disturbance factors can be used to classify observed nest site locations versus random points, suggesting that these factors affect loon nest site selection (model 1: Correct classification = 75%, null = 50%, K = 0.507, P < 0.001; model 2: Correct classification = 78%, null = 50%, K = 0.551, P < 0.001). However, in an exploratory analysis, we were unable to show a relation between spatial disturbance variables and breeding success (P = 0.595, R 2 = 0.436), possibly because breeding success was so low during the breeding seasons of 2007-2008. We suggest that by selecting nest site locations that avoid disturbance factors, loons thereby limit the effect that disturbance will have on their breeding success. Still, disturbance may force loons to use sub-optimal nesting habitat, limiting the available number of territories, and overall productivity. We advise that management efforts focus on limiting disturbance factors to allow breeding pairs access to the best nesting territories, relieving disturbance pressures that may force sub-optimal nest placement. ?? 2011 The Wildlife Society.

  2. Effect of social media in improving knowledge among patients having fixed appliance orthodontic treatment: A single-center randomized controlled trial.

    PubMed

    Al-Silwadi, Fadi M; Gill, Daljit S; Petrie, Aviva; Cunningham, Susan J

    2015-08-01

    Research has shown that orthodontic patients are more likely to retain information presented in an audiovisual format. However, there has been little research on the effectiveness of audiovisual information provided through different routes such as the Internet. This parallel-group randomized controlled trial assessed whether provision of audiovisual information on the YouTube (Google, San Bruno, Calif) Web site to orthodontic patients undergoing fixed appliance treatment results in improved patient knowledge when compared with conventional methods of information provision. The effects of sex and ethnicity were also investigated. Participants were recruited from the Department of Orthodontics of the Eastman Dental Hospital, University College London Hospitals NHS Foundation Trust, United Kingdom. The patients were 13 years of age and over, with no history of orthodontic treatment, and patient and parental (where appropriate) consent were obtained. The participants were randomized into control (n = 34) and intervention (n = 33) groups using a random number table; there was stratification based on age group, with permuted blocks of 10 patients. Both groups were given routine verbal and written patient information related to fixed appliances, and the participants in the intervention group were sent 3 e-mails over 6 weeks requesting that they view a 6-minute YouTube video containing similar information but in audiovisual format. Patient knowledge was measured using identical questionnaires answered on the day of recruitment (baseline) and again 6 to 8 weeks later. The researchers were unaware of group allocations when enrolling patients and scoring questionnaires. Sixty participants (89.55%) completed the study. Those who completed the trial in the intervention group (n = 30) demonstrated significantly greater improvements in knowledge than did those in the control group (n = 30), scoring, on average, almost 1 point more (95% CI for the difference, 0.305-1.602; P = 0

  3. A Framework for Designing Cluster Randomized Trials with Binary Outcomes

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Martinez, Andres

    2011-01-01

    The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

  4. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages.

    PubMed

    Kim, Yoonsang; Choi, Young-Ku; Emery, Sherry

    2013-08-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods' performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages-SAS GLIMMIX Laplace and SuperMix Gaussian quadrature-perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes.

  5. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages

    PubMed Central

    Kim, Yoonsang; Emery, Sherry

    2013-01-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods’ performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages—SAS GLIMMIX Laplace and SuperMix Gaussian quadrature—perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes. PMID:24288415

  6. Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial.

    PubMed

    Marsch, Lisa A; Guarino, Honoria; Grabinski, Michael J; Syckes, Cassandra; Dillingham, Elaine T; Xie, Haiyi; Crosier, Benjamin S

    2015-12-01

    Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers-and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the Web-based therapeutic education system (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this Web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n=72) or the Web-delivered TES intervention (n=69). Intervention effectiveness was assessed by evaluating changes in participants' knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. This study indicates that TES is as effective as HIV/disease prevention delivered by a prevention specialist. Because

  7. A comparison of methods for estimating the random effects distribution of a linear mixed model.

    PubMed

    Ghidey, Wendimagegn; Lesaffre, Emmanuel; Verbeke, Geert

    2010-12-01

    This article reviews various recently suggested approaches to estimate the random effects distribution in a linear mixed model, i.e. (1) the smoothing by roughening approach of Shen and Louis,(1) (2) the semi-non-parametric approach of Zhang and Davidian,(2) (3) the heterogeneity model of Verbeke and Lesaffre( 3) and (4) a flexible approach of Ghidey et al. (4) These four approaches are compared via an extensive simulation study. We conclude that for the considered cases, the approach of Ghidey et al. (4) often shows to have the smallest integrated mean squared error for estimating the random effects distribution. An analysis of a longitudinal dental data set illustrates the performance of the methods in a practical example.

  8. A Randomized Effectiveness Trial of Brief Parent Training: Six-Month Follow-Up

    ERIC Educational Resources Information Center

    Kjøbli, John; Bjørnebekk, Gunnar

    2013-01-01

    Objective: To examine the follow-up effectiveness of brief parent training (BPT) for children with emerging or existing conduct problems. Method: With the use of a randomized controlled trial and parent and teacher reports, this study examined the effectiveness of BPT compared to regular services 6 months after the end of the intervention.…

  9. Run-Reversal Equilibrium for Clinical Trial Randomization

    PubMed Central

    Grant, William C.

    2015-01-01

    In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608

  10. Do Health Reforms to Improve Quality Have Long-Term Effects? Results of a Follow-Up on a Randomized Policy Experiment in the Philippines.

    PubMed

    Quimbo, Stella; Wagner, Natascha; Florentino, Jhiedon; Solon, Orville; Peabody, John

    2016-02-01

    We tracked doctors who had previously participated in a randomized policy experiment in the Philippines. The original experiment involved 30 district hospitals divided equally into one control site and two intervention sites that increased insurance payments (full insurance support for children under 5 years old) or made bonus payments to hospital staff. During the 3 years of the intervention, quality-as measured by clinical performance and value vignettes-improved and was sustained in both intervention sites compared with controls. Five years after the interventions were discontinued, we remeasured the quality of care of the doctors. We found that the intervention sites continued to have significantly higher quality compared with the control sites. The previously documented quality improvement in intervention sites appears to be sustained; moreover, it was subject to a very low (less than 1% per year) rate of decay in quality scores. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Clinical effect of azithromycin as an adjunct to non-surgical treatment of chronic periodontitis: a meta-analysis of randomized controlled clinical trials.

    PubMed

    Zhang, Z; Zheng, Y; Bian, X

    2016-06-01

    The results of recent published studies focusing on the effect of azithromycin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis are inconsistent. We conducted a meta-analysis of randomized controlled clinical trials to examine the effect of azithromycin combined with SRP on periodontal clinical parameters as compared to SRP alone. An electronic search was carried out on Pubmed, Embase and the Cochrane Central Register of Controlled Trials from their earliest records through December 28, 2014 to identify studies that met pre-stated inclusion criteria. Reference lists of retrieved articles were also reviewed. Data were extracted independently by two authors. Either a fixed- or random-effects model was used to calculate the overall effect sizes of azithromycin on probing depth, attachment level (AL) and bleeding on probing (BOP). Heterogeneity was evaluated using the Q test and I(2) statistic. Publication bias was evaluated by Begg's test and Egger's test. A total of 14 trials were included in the meta-analysis. Compared with SRP alone, locally delivered azithromycin plus SRP statistically significantly reduced probing depth by 0.99 mm (95% CI 0.42-1.57) and increased AL by 1.12 mm (95% CI 0.31-1.92). In addition, systemically administered azithromycin plus SRP statistically significantly reduced probing depth by 0.21 mm (95% CI 0.12-0.29), BOP by 4.50% (95% CI 1.45-7.56) and increased AL by 0.23 mm (95% CI 0.07-0.39). Sensitivity analysis yielded similar results. No evidence of publication bias was observed. The additional benefit of systemic azithromycin was shown at the initially deep probing depth sites, but not at shallow or moderate sites. The overall effect sizes of systemic azithromycin showed a tendency to decrease with time, and meta-regression analysis suggested a negative relation between the length of follow-up and net change in probing depth (r = -0.05, p = 0.02). This meta-analysis provides further

  12. Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

    PubMed

    Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

    2017-07-01

    Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

  13. Electroencephalographic response following midazolam-induced general anesthesia: relationship to plasma and effect-site midazolam concentrations.

    PubMed

    Miyake, Wakako; Oda, Yutaka; Ikeda, Yuko; Hagihira, Satoshi; Iwaki, Hiroyoshi; Asada, Akira

    2010-06-01

    To examine the relationships between effect-site concentrations and electroencephalographic parameters after the induction of general anesthesia with midazolam. Twenty-four patients with American Society of Anesthesiologists status I or II were randomly allocated to receive either an intravenous (i.v.) bolus of midazolam 0.2 mg kg(-1) (small-dose group, n = 12) or 0.3 mg kg(-1) (large-dose group, n = 12) for induction of general anesthesia in a double-blind experimental design. The bispectral index (BIS), 95% spectral edge frequency (SEF95), spectral power density, and plasma concentrations of midazolam were measured for 60 min following the induction of general anesthesia. Plasma and simulated effect-site concentrations of midazolam were significantly higher in the large-dose group than in the small-dose group (P = 0.005 and <0.001, respectively). There was a correlation between the relative beta ratio and BIS (r (2) = 0.30, P < 0.001; n = 168); however, effect-site concentrations of midazolam showed no association with BIS, relative beta ratio, or SEF95 (r (2) = 0.07, 0.11 and 0.01, respectively; n = 168). The electroencephalographic spectral power density in the beta-band (>/=13 and <30 Hz) was significantly increased after induction and was significantly larger in the large-dose group than in the small-dose group (P = 0.009). Following the induction of general anesthesia with i.v. midazolam 0.2 or 0.3 mg kg(-1), the BIS was positively correlated with the relative beta ratio. Despite a rapid decrease in the plasma and effect-site concentrations of midazolam, the average BIS remained >60 for 60 min after induction, reflecting an increased power of the electroencephalographic high-frequency band.

  14. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

    PubMed

    McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

    2014-11-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

    2014-01-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

  16. Site characteristics and prey abundance at foraging sites used by Lesser Scaup (Aythya affinis) wintering in Florida

    USGS Publications Warehouse

    Herring, Garth; Collazo, Jaime

    2009-01-01

    We examined site characteristics and prey abundances where wintering Aythya affinis (Lesser Scaup; hereafter scaup) foraged within three regions of the Indian River Lagoon system in central Florida. We observed that scaup concentrated in the Indian and Banana rivers; however, density of prey items did not differ between foraging sites and random sites. We also found that site characteristics were similar between foraging and random sites. Differences in site characteristics between random points across all three regions did not explain the distribution of Foraging scaup (no scaup foraged in the Mosquito Lagoon); however, prey densities were approximately 3 times lower in the Mosquito Lagoon region. Our study suggests that current habitat conditions within the northern Indian River Lagoon system meet the overwintering requirements of scaup; however, prey densities in the Mosquito Lagoon may have been too low to be profitable for foraging scaup during the period of our study.

  17. The genealogy of sequences containing multiple sites subject to strong selection in a subdivided population.

    PubMed Central

    Nordborg, Magnus; Innan, Hideki

    2003-01-01

    A stochastic model for the genealogy of a sample of recombining sequences containing one or more sites subject to selection in a subdivided population is described. Selection is incorporated by dividing the population into allelic classes and then conditioning on the past sizes of these classes. The past allele frequencies at the selected sites are thus treated as parameters rather than as random variables. The purpose of the model is not to investigate the dynamics of selection, but to investigate effects of linkage to the selected sites on the genealogy of the surrounding chromosomal region. This approach is useful for modeling strong selection, when it is natural to parameterize the past allele frequencies at the selected sites. Several models of strong balancing selection are used as examples, and the effects on the pattern of neutral polymorphism in the chromosomal region are discussed. We focus in particular on the statistical power to detect balancing selection when it is present. PMID:12663556

  18. The genealogy of sequences containing multiple sites subject to strong selection in a subdivided population.

    PubMed

    Nordborg, Magnus; Innan, Hideki

    2003-03-01

    A stochastic model for the genealogy of a sample of recombining sequences containing one or more sites subject to selection in a subdivided population is described. Selection is incorporated by dividing the population into allelic classes and then conditioning on the past sizes of these classes. The past allele frequencies at the selected sites are thus treated as parameters rather than as random variables. The purpose of the model is not to investigate the dynamics of selection, but to investigate effects of linkage to the selected sites on the genealogy of the surrounding chromosomal region. This approach is useful for modeling strong selection, when it is natural to parameterize the past allele frequencies at the selected sites. Several models of strong balancing selection are used as examples, and the effects on the pattern of neutral polymorphism in the chromosomal region are discussed. We focus in particular on the statistical power to detect balancing selection when it is present.

  19. Effectiveness of educational outreach in infectious diseases management: a cluster randomized trial in Uganda.

    PubMed

    Mbonye, Martin Kayitale; Burnett, Sarah M; Naikoba, Sarah; Ronald, Allan; Colebunders, Robert; Van Geertruyden, Jean-Pierre; Weaver, Marcia R

    2016-08-04

    Integrated Infectious Diseases Capacity Building Evaluation (IDCAP) teams designed and implemented two health worker in-service training approaches: 1) an off-site classroom-based integrated management of infectious diseases (IMID) course with distance learning aspects, and 2) on-site support (OSS), an educational outreach intervention. We tested the effects of OSS on workload and 12 facility performance indicators for emergency triage assessment and treatment, HIV testing, and malaria and pneumonia case management among outpatients by two subgroups: 1) mid-level practitioners (MLP) who attended IMID training (IMID-MLP) and 2) health workers who did not (No-IMID). Thirty-six health facilities participated in the IDCAP trial, with 18 randomly assigned to Arm A and 18 to Arm B. Two MLP in both arms received IMID. All providers at Arm A facilities received nine monthly OSS visits from April to December 2010 while Arm B did not. From November 2009 to December 2010, 777,667 outpatient visits occurred. We analyzed 669,580 (86.1 %) outpatient visits, where provider cadre was reported. Treatment was provided by 64 IMID-MLP and 1,515 No-IMID providers. The effect of OSS was measured by the difference in pre/post changes across arms after controlling for covariates (adjusted ratio of relative risks = a RRR). The effect of OSS on patients-per-provider-per-day (workload) among IMID-MLP (aRRR = 1.21; p = 0.48) and No-IMID (aRRR = 0.90; p = 0.44) was not statistically significant. Among IMID-MLP, OSS was effective for three indicators: malaria cases receiving an appropriate antimalarial (aRRR = 1.26, 99 % CI = 1.02-1.56), patients with negative malaria test result prescribed an antimalarial (aRRR = 0.49, 99 % CI = 0.26-0.92), and patients with acid-fast bacilli smear negative result receiving empiric treatment for acute respiratory infection (aRRR = 2.04, 99 % CI = 1.06-3.94). Among No-IMID, OSS was effective for two indicators

  20. The conditional power of randomization tests for single-case effect sizes in designs with randomized treatment order: A Monte Carlo simulation study.

    PubMed

    Michiels, Bart; Heyvaert, Mieke; Onghena, Patrick

    2018-04-01

    The conditional power (CP) of the randomization test (RT) was investigated in a simulation study in which three different single-case effect size (ES) measures were used as the test statistics: the mean difference (MD), the percentage of nonoverlapping data (PND), and the nonoverlap of all pairs (NAP). Furthermore, we studied the effect of the experimental design on the RT's CP for three different single-case designs with rapid treatment alternation: the completely randomized design (CRD), the randomized block design (RBD), and the restricted randomized alternation design (RRAD). As a third goal, we evaluated the CP of the RT for three types of simulated data: data generated from a standard normal distribution, data generated from a uniform distribution, and data generated from a first-order autoregressive Gaussian process. The results showed that the MD and NAP perform very similarly in terms of CP, whereas the PND performs substantially worse. Furthermore, the RRAD yielded marginally higher power in the RT, followed by the CRD and then the RBD. Finally, the power of the RT was almost unaffected by the type of the simulated data. On the basis of the results of the simulation study, we recommend at least 20 measurement occasions for single-case designs with a randomized treatment order that are to be evaluated with an RT using a 5% significance level. Furthermore, we do not recommend use of the PND, because of its low power in the RT.

  1. Online gambling's moderators: how effective? Study protocol for a randomized controlled trial.

    PubMed

    Caillon, Julie; Grall-Bronnec, Marie; Hardouin, Jean-Benoit; Venisse, Jean-Luc; Challet-Bouju, Gaelle

    2015-05-30

    Online gambling has been legalized in France in 2010. Licenses are issued to gambling operators who demonstrate their ability to respect the legal framework (security, taxation, consumer protection, etc.). The preventive measures to protect vulnerable gamblers include an obligation to provide online gambling moderators. These moderators should allow gamblers to limit their bets, exclude themselves from the website for 7 days, and consult the balance of the gambler's account at any time. However, there are only a few published reports of empirical research investigating the effectiveness of Internet-based protective measures implemented by French law. Moreover, no empirical research has yet studied the impact of bonuses on gambling behaviors. This research is an experimental randomized controlled trial, risk prevention targeted. The research is divided into four sub-studies depending on the studied moderator: limiting bonuses, self-exclusion, self-limitation and information. The study sample consists of 485 volunteers. For each experimental condition and the control groups, the sample is composed of gamblers equally recruited from gamblers having preferences in each of the three major forms of games (lottery and scratch tickets, sports and horserace betting, and poker). For each form of gambling, the gamblers are recruited in order to obtain as many problem gamblers as non-problem gamblers. According to the randomization, the experimental session begins. The experimental session is a gambling situation on a computer in our research center. The gambler is invited to play on his favorite gambling site as usual, with his own gambler account and his own money. Data collected comprise sociodemographic characteristics, gambling habits, an interview about enjoyment and feeling out of control during the gambling session, moderator impact on gambling practice, statement of gambling parameters and questionnaires (BMIS, GRCS, CPGI, GACS). Moderator efficiency is assessed based

  2. Theory on the mechanism of site-specific DNA-protein interactions in the presence of traps

    NASA Astrophysics Data System (ADS)

    Niranjani, G.; Murugan, R.

    2016-08-01

    The speed of site-specific binding of transcription factor (TFs) proteins with genomic DNA seems to be strongly retarded by the randomly occurring sequence traps. Traps are those DNA sequences sharing significant similarity with the original specific binding sites (SBSs). It is an intriguing question how the naturally occurring TFs and their SBSs are designed to manage the retarding effects of such randomly occurring traps. We develop a simple random walk model on the site-specific binding of TFs with genomic DNA in the presence of sequence traps. Our dynamical model predicts that (a) the retarding effects of traps will be minimum when the traps are arranged around the SBS such that there is a negative correlation between the binding strength of TFs with traps and the distance of traps from the SBS and (b) the retarding effects of sequence traps can be appeased by the condensed conformational state of DNA. Our computational analysis results on the distribution of sequence traps around the putative binding sites of various TFs in mouse and human genome clearly agree well the theoretical predictions. We propose that the distribution of traps can be used as an additional metric to efficiently identify the SBSs of TFs on genomic DNA.

  3. Cross-site randomized control trial of the Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder.

    PubMed

    Brian, Jessica A; Smith, Isabel M; Zwaigenbaum, Lonnie; Bryson, Susan E

    2017-10-01

    To evaluate the efficacy of the Social ABCs parent-mediated intervention for toddlers with suspected or confirmed autism spectrum disorder (ASD), through a cross-site randomized control trial, sixty-three parent-toddler dyads (toddler age: 16-30 months) were randomized into treatment (Social ABCs) or control (service-as-usual) conditions. Video data were obtained at three key time-points: Baseline; Post-training (PT; week 12); and Follow-Up (week 24). Analyses included 62 dyads. Treatment allocation significantly accounted for PT gains, all favouring the Treatment group, in (1) child functional vocal responsiveness to parent prompts (R 2  = 0.43, P < .001), (2) child vocal initiations (R 2  = 0.28, P < .001), (3) parent smiling (R 2  = 0.09, P = .017), and (4) fidelity of implementation (R 2  = 0.71, P < .001). A trend was observed for increased social orienting (R 2  = 0.06, P = 0.054); gains in parent smiling significantly predicted increases in child smiling and social orienting. Parents in the treatment condition reported significant gains in self-efficacy following the intervention (P = 0.009). No differential effects emerged for performance on standardized measures. The Social ABCs is a relatively low-resource, efficacious intervention, with potential to be a cost-effective means of intervening at the first signs of possible ASD. Autism Res 2017, 10: 1700-1711. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. Clinical Trial Title: Social ABCs for Toddlers with Signs of Autism Spectrum Disorder: RCT of a Parent-Mediated Intervention http//ClinicalTrials.gov identifier: NCT02428452. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

  4. The challenge of promoting safe sex at sites where persons meet new sex partners in Jamaica: results of the Kingston PLACE randomized controlled trial.

    PubMed

    Figueroa, J Peter; Weir, Sharon S; Byfield, Lovette; Hall, Alison; Cummings, Stirling M; Suchindran, Chirayath M

    2010-08-01

    To determine whether a site-based Priorities for Local AIDS Control Efforts (PLACE) HIV prevention intervention in Kingston, Jamaica increased condom use among persons with new or multiple sex partners. A total of 147 sites where persons go to meet new sex partners were grouped into 50 geographic clusters and randomized to receive or not receive a multilevel PLACE prevention intervention. Baseline cross-sectional surveys of sites and patrons at sites were conducted in 2005 to determine the nature of social activities at sites to better plan the intervention and to ensure that the two arms of the trial were similar. The intervention was delivered by 50 trained outreach workers between January and June 2006. After the intervention two cross-sectional surveys were conducted to assess the extent of intervention implementation and to estimate the proportion of patrons at sites with recent new or concurrent partnerships and inconsistent condom use. Characteristics of sites and patrons were similar for most variables at intervention and control sites at both baseline and post-intervention. A total of 1535 patrons (723 men, 812 women) were interviewed at intervention sites and 1324 patrons (661 men, 663 women) at control sites 6-9 months after the intervention. There were no significant differences between intervention and control groups in the proportions of men (37.8% and 31.6%) and women (24.6% and 22.6%) who reported new or multiple relationships in the past year and inconsistent condom use. There was no significant difference in the proportion of men or women showing a condom at interview, having a HIV test in the past 12 months or being exposed to the intervention. An intent-to-treat analysis did not show any intervention effect. This was probably because of difficulty in implementing the intervention, the extent of patron mixing among sites, the intensity of national education campaigns, delay in conducting the post-intervention survey and evidence of other

  5. THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON LOWER EXTREMITY MUSCLE PERFORMANCE: A RANDOMIZED CONTROLLED TRIAL.

    PubMed

    MacDonald, Nicole; Baker, Russell; Cheatham, Scott W

    2016-12-01

    Instrument-Assisted Soft Tissue Mobilization (IASTM) is a non-invasive therapeutic technique used to theoretically aid in scar tissue breakdown and absorption, fascial mobilization, and improved tissue healing. Researchers have hypothesized that utilizing IASTM will improve muscular efficiency and performance; yet previous Investigations has been focused on treating injury. The purpose of this investigation was to explore the effects of IASTM on muscle performance to assess if typical treatment application affected measures of muscular performance. A pretest-posttest randomized control design. A convenience sample of 48 physically active adults (mean age 24 ± 4 years), randomly assigned to one of three groups: quadriceps treatment group, triceps surae treatment group, or control group. Participants performed a five-minute warm-up on a Monark bicycle ergometer before performing three countermovement vertical jumps (CMJ). Immediately after, the IASTM treatment was applied by one researcher for three minutes on each leg at the specified site (e.g., quadriceps) for those assigned to the treatment groups, while the control group rested for six minutes. Immediately following treatment, participants performed three additional CMJs. Pre- and post-testing included measures of vertical jump height (JH), peak power (PP) and peak velocity (PV). There were no statistically significant differences found between treatment groups in JH, PP, or PV or across pre- and post-test trials. These preliminary findings suggest that standard treatment times of IASTM do not produce an immediate effect in muscular performance in healthy participants. This may help clinicians determine the optimal sequencing of IASTM when it is part of a pre-performance warm-up program. Future research should be conducted to determine the muscle performance effects of IASTM in individuals with known myofascial restriction and to determine optimal treatment parameters, such as instrument type, amount of

  6. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial.

    PubMed

    Kudsi, Omar Yusef; Castellanos, Andres; Kaza, Srinivas; McCarty, Justin; Dickens, Eugene; Martin, David; Tiesenga, Frederick M; Konstantinidis, Konstantinos; Hirides, Petros; Mehendale, Shilpa; Gonzalez, Anthony

    2017-08-01

    Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique. Prior trials have demonstrated improved cosmesis with the single-incision technique. Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach. This is the first prospective, randomized, controlled study comparing robotic single-site cholecystectomy (RSSC) and multiport laparoscopic cholecystectomy (MPLC) in terms of cosmesis and patient satisfaction. Patients with symptomatic benign gallbladder disease were randomized to RSSC or MPLC. Data included perioperative variables such as operative time, conversion and complications and cosmesis satisfaction, body image perception, quality of life using validated questionnaires, at postoperative visits of 2, 6 weeks and 3 months. One hundred thirty-six patients were randomized to RSSC (N = 83) and MPLC (N = 53) at 8 institutions. Both cohorts were dominated by higher enrollment of females (RSSC = 78%, MPLC = 92%). The RSSC and MPLC cohorts were otherwise statistically matched. Operative time was longer for RSSC (61 min vs. 44 min, P < 0.0001). There were no differences in complication rates. RSSC demonstrated a significant superiority in cosmesis satisfaction and body image perception (P value < 0.05 at every follow-up). There was no statistically significant difference in patient-reported quality of life. Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in cosmesis satisfaction and body image perception with no difference seen in overall quality of life. Results from this trial show that RSSC is associated with improved cosmesis satisfaction and body image perception without a difference in observed complication rate. The uncompromised safety and the improved cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site

  7. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of

  8. Efficacy of abstinence promotion media messages: findings from an online randomized trial.

    PubMed

    Evans, W Douglas; Davis, Kevin C; Ashley, Olivia Silber; Blitstein, Jonathan; Koo, Helen; Zhang, Yun

    2009-10-01

    We conducted an online randomized experiment to evaluate the efficacy of messages from the Parents Speak Up National Campaign (PSUNC) to promote parent-child communication about sex. We randomly assigned a national sample of 1,969 mothers and fathers to treatment (PSUNC exposure) and control (no exposure) conditions. Mothers were further randomized into treatment and booster (additional messages) conditions to evaluate dose-response effects. Participants were surveyed at baseline, 4 weeks postexposure, and 6 months postexposure. We used multivariable logistic regression procedures in our analysis. Treatment fathers were more likely than control fathers to initiate conversations about sex at 4 weeks, and treatment fathers and mothers were more likely than controls at 6 months to recommend that their children wait to have sex. Treatment fathers and mothers were far more likely than controls to use the campaign Web site. There was a dose-response effect for mothers' Web site use. Using new media methods, this study shows that PSUNC messages are efficacious in promoting parent-child communication about sex and abstinence. Future research should evaluate mechanisms and effectiveness in natural settings.

  9. Effectiveness of tai chi as a community-based falls prevention intervention: a randomized controlled trial.

    PubMed

    Taylor, Denise; Hale, Leigh; Schluter, Philip; Waters, Debra L; Binns, Elizabeth E; McCracken, Hamish; McPherson, Kathryn; Wolf, Steven L

    2012-05-01

    To compare the effectiveness of tai chi and low-level exercise in reducing falls in older adults; to determine whether mobility, balance, and lower limb strength improved and whether higher doses of tai chi resulted in greater effect. Randomized controlled trial. Eleven sites throughout New Zealand. Six hundred eighty-four community-residing older adults (mean age 74.5; 73% female) with at least one falls risk factor. Tai chi once a week (TC1) (n = 233); tai chi twice a week (TC2) (n = 220), or a low-level exercise program control group (LLE) (n = 231) for 20 wks. Number of falls was ascertained according to monthly falls calendars. Mobility (Timed-Up-and-Go Test), balance (step test), and lower limb strength (chair stand test) were assessed. The adjusted incident rate ratio (IRR) for falls was not significantly different between the TC1 and LLE groups (IRR = 1.05, 95% confidence interval (CI) = 0.83-1.33, P = .70) or between the TC2 and LLE groups (IRR = 0.88, 95% CI = 0.68-1.16, P = .37). Adjusted multilevel mixed-effects Poisson regression showed a significant reduction in logarithmic mean fall rate of -0.050 (95% CI = -0.064 to -0.037, P < .001) per month for all groups. Multilevel fixed-effects analyses indicated improvements in balance (P < .001 right and left leg) and lower limb strength (P < .001) but not mobility (P = .54) in all groups over time, with no differences between the groups (P = .37 (right leg), P = .66 (left leg), P = .21, and P = .44, respectively). There was no difference in falls rates between the groups, with falls reducing similarly (mean falls rate reduction of 58%) over the 17-month follow-up period. Strength and balance improved similarly in all groups over time. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

  10. Enhancing superconducting critical current by randomness

    NASA Astrophysics Data System (ADS)

    Wang, Y. L.; Thoutam, L. R.; Xiao, Z. L.; Shen, B.; Pearson, J. E.; Divan, R.; Ocola, L. E.; Crabtree, G. W.; Kwok, W. K.

    2016-01-01

    The key ingredient of high critical currents in a type-II superconductor is defect sites that pin vortices. Contrary to earlier understanding on nanopatterned artificial pinning, here we show unequivocally the advantages of a random pinscape over an ordered array in a wide magnetic field range. We reveal that the better performance of a random pinscape is due to the variation of its local density of pinning sites (LDOPS), which mitigates the motion of vortices. This is confirmed by achieving even higher enhancement of the critical current through a conformally mapped random pinscape, where the distribution of the LDOPS is further enlarged. The demonstrated key role of LDOPS in enhancing superconducting critical currents gets at the heart of random versus commensurate pinning. Our findings highlight the importance of random pinscapes in enhancing the superconducting critical currents of applied superconductors.

  11. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation.

    PubMed

    Leung, Joseph; Mann, Surinder; Siao-Salera, Rodelei; Ransibrahmanakul, Kanat; Lim, Brian; Canete, Wilhelmina; Samson, Laramie; Gutierrez, Rebeck; Leung, Felix W

    2011-01-01

    Sedation for colonoscopy discomfort imposes a recovery-time burden on patients. The water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without sedation. On-site and at-home recovery times were not reported. To confirm the beneficial effect of the water method and document the patient recovery-time burden. Randomized, controlled trial, with single-blinded, intent-to-treat analysis. Veterans Affairs outpatient endoscopy unit. This study involved veterans accepting on-demand sedation for screening and surveillance colonoscopy. Air versus water method for colonoscope insertion. Proportion of patients completing colonoscopy without sedation, cecal intubation rate, medication requirement, maximum discomfort (0 = none, 10 = severe), procedure-related and patient-related outcomes. One hundred veterans were randomized to the air (n = 50) or water (n = 50) method. The proportions of patients who could complete colonoscopy without sedation in the water group (78%) and the air group (54%) were significantly different (P = .011, Fisher exact test), but the cecal intubation rate was similar (100% in both groups). Secondary analysis (data as Mean [SD]) shows that the water method produced a reduction in medication requirement: fentanyl, 12.5 (26.8) μg versus 24.0 (30.7) μg; midazolam, 0.5 (1.1) mg versus 0.94 (1.20) mg; maximum discomfort, 2.3 (1.7) versus 4.9 (2.0); recovery time on site, 8.4 (6.8) versus 12.3 (9.4) minutes; and recovery time at home, 4.5 (9.2) versus 10.9 (14.0) hours (P = .049; P = .06; P = .0012; P = .0199; and P = .0048, respectively, t test). Single Veterans Affairs site, predominantly male population, unblinded examiners. This randomized, controlled trial confirms the reported beneficial effects of the water method. The combination of the water method with on-demand sedation minimizes the patient recovery-time burden. ( NCT00920751.). Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by

  12. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial.

    PubMed

    Cui, Xue-Jun; Sun, Yue-Li; You, Sheng-Fu; Mo, Wen; Lu, Sheng; Shi, Qi; Wang, Yong-Jun

    2013-10-07

    Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and

  13. A Randomized, Controlled Study Comparing Two Standardized Closure Methods of Laparoscopic Port Sites

    PubMed Central

    Chen, Kai; Klapper, Allan S.; Voige, Hayley

    2010-01-01

    Objectives: To compare octyl-cyanoacrylate tissue adhesive (OCT) with the standard suture technique for the closure of laparoscopic port sites. Methods: This was a randomized clinical trial of 40 patients. All participants had 2 lower abdominal ports, with one port closed using OCT while the opposite port was closed with 4-0 monocryl suture. An evaluation of the wound was performed 2 weeks to 4 weeks after surgery. The Hollander Wound Evaluation Scale (HWES, including step-off of borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance) was used for cosmetic evaluation. Complications, such as erythema, warmth, tenderness, drainage, and wound infection, were evaluated. Analysis of complications was performed using the chi-square test, and cosmetic evaluation including individual components of the HWES was compared with the t test, P<0.05 considered significant. Results: Eighty wounds were evaluated in 40 patients. The number of patients with complications including erythema (1/40 vs. 16/40), tenderness (1/40 vs. 19/40), and drainage (1/40 vs. 9/40) was lower with OCT than with sutures, respectively (all P<0.001). The ports closed with OCT had higher overall HWES, ie, better cosmetic score (5.92±0.05 vs 5.50±0.13) and lower margin separation (1/40 vs. 10/40) but had higher contour irregularity (6/40 vs. 1/40) (all P<0.05). However, skin contour irregularity was significantly better when OCT was applied using fine tissue forceps (P=0.002). Conclusion: Laparoscopic ports closed with OCT had fewer early complications, such as wound erythema, tenderness, and drainage. Ports closed with OCT had a better cosmetic appearance. PMID:21333194

  14. Effectiveness of Mindfulness-Based Stress Reduction Bibliotherapy: A Preliminary Randomized Controlled Trial.

    PubMed

    Hazlett-Stevens, Holly; Oren, Yelena

    2017-06-01

    This randomized controlled investigation examined the effectiveness of a self-help bibliotherapy format of the evidence-based mindfulness-based stress reduction (MBSR) intervention. College students seeking stress reduction were randomly assigned to a 10-week MBSR bibliotherapy intervention group (n = 47) or a no-treatment control group (n = 45). Self-report measures were collected at baseline and postintervention. A total of 25 bibliotherapy and 43 control group participants provided final data following the intervention period. Compared to the control group, bibliotherapy participants reported increased mindfulness following the intervention. Significant decreases on measures of depression, anxiety, stress, perceived stress, and anxiety sensitivity also were reported postintervention as well as increased quality of life in physical health, psychological, and environmental domains. No statistically significant group effects were found for social relationships quality of life domain, worry, and experiential avoidance measures. This MBSR workbook may provide an acceptable and effective alternative for motivated individuals seeking to reduce stress, at least for a select group of individuals who are willing and able to sustain participation in the intervention. © 2016 Wiley Periodicals, Inc.

  15. Effect of wound infiltration with ropivacaine or bupivacaine analgesia in breast cancer surgery: A meta-analysis of randomized controlled trials.

    PubMed

    Tam, Ka-Wai; Chen, Shin-Yan; Huang, Tsai-Wei; Lin, Chao-Chun; Su, Chih-Ming; Li, Ching-Li; Ho, Yuan-Soon; Wang, Wan-Yu; Wu, Chih-Hsiung

    2015-10-01

    Although not completely painless, breast-conserving surgery is considerably less painful than modified radical mastectomy. Local anesthetics are speculated to reduce postoperative pain when placed at the surgical site. Thus, we conducted a systematic review of randomized controlled trials to evaluate the efficacy of bupivacaine or ropivacaine analgesia for pain relief in breast cancer surgery. PubMed, Embase, the Cochrane Library, Scopus, and the ClinicalTrials.gov registry were searched for studies published up to July 2015. Individual effect sizes were standardized, and a meta-analysis was performed to calculate a pooled effect size by using random effects models. Pain was assessed using a visual analog scale at 1, 2, 12, and 24 h postoperatively. The secondary outcomes included complications and analgesic consumption. We reviewed 13 trials with 1150 patients. We found no difference in postoperative pain reduction at 1, 12, and 24 h after breast cancer surgery between the experimental and control groups. The severity of pain was significantly reduced in the experimental group (weighted mean difference -0.19; 95% confidence interval: -0.39-0.00) at 2 h postoperatively. Moreover, postoperative analgesic consumption did not differ significantly between the groups. No major drug-related complication was observed in any study. Administration of the local anesthetics bupivacaine or ropivacaine during breast cancer surgery decreased pain significantly at only 2 h but did not reduce pain at 12, and 24 h postoperatively. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  16. A simple method for assessing occupational exposure via the one-way random effects model.

    PubMed

    Krishnamoorthy, K; Mathew, Thomas; Peng, Jie

    2016-11-01

    A one-way random effects model is postulated for the log-transformed shift-long personal exposure measurements, where the random effect in the model represents an effect due to the worker. Simple closed-form confidence intervals are proposed for the relevant parameters of interest using the method of variance estimates recovery (MOVER). The performance of the confidence bounds is evaluated and compared with those based on the generalized confidence interval approach. Comparison studies indicate that the proposed MOVER confidence bounds are better than the generalized confidence bounds for the overall mean exposure and an upper percentile of the exposure distribution. The proposed methods are illustrated using a few examples involving industrial hygiene data.

  17. Reduction of randomness in seismic noise as a short-term precursor to a volcanic eruption.

    PubMed

    Glynn, C C; Konstantinou, K I

    2016-11-24

    Ambient seismic noise is characterized by randomness incurred by the random position and strength of the noise sources as well as the heterogeneous properties of the medium through which it propagates. Here we use ambient noise data recorded prior to the 1996 Gjálp eruption in Iceland in order to show that a reduction of noise randomness can be a clear short-term precursor to volcanic activity. The eruption was preceded on 29 September 1996 by a Mw ~5.6 earthquake that occurred in the caldera rim of the Bárdarbunga volcano. A significant reduction of randomness started occurring 8 days before the earthquake and 10 days before the onset of the eruption. This reduction was observed even at stations more than 100 km away from the eruption site. Randomness increased to its previous levels 160 minutes after the Bárdarbunga earthquake, during which time aftershocks migrated from the Bárdarbunga caldera to a site near the Gjálp eruption fissure. We attribute this precursory reduction of randomness to the lack of higher frequencies (>1 Hz) in the noise wavefield caused by high absorption losses as hot magma ascended in the upper crust.

  18. The Random-Effect DINA Model

    ERIC Educational Resources Information Center

    Huang, Hung-Yu; Wang, Wen-Chung

    2014-01-01

    The DINA (deterministic input, noisy, and gate) model has been widely used in cognitive diagnosis tests and in the process of test development. The outcomes known as slip and guess are included in the DINA model function representing the responses to the items. This study aimed to extend the DINA model by using the random-effect approach to allow…

  19. Supplemental Peri-Operative Oxygen and Incision Site Infection after Surgery for Perforated Peptic Ulcer: A Randomized, Double-Blind Monocentric Trial.

    PubMed

    Schietroma, Mario; Cecilia, Emanuela Marina; De Santis, Giuseppe; Carlei, Francesco; Pessia, Beatrice; Amicucci, Gianfranco

    2016-02-01

    The clinical role of hyperoxia for preventing surgical site infection (SSI) remains uncertain because randomized controlled trials on this topic have reported disparate results. One of the principal reasons for this outcome may be that prior trials have entered heterogeneous populations of patients and a variety of procedures. The aim of our study was to assess the influence of hyperoxygenation on SSI using a homogeneous study population. From January 2004 to April 2013, we studied, in a randomized trial, 239 patients, who underwent open surgery for perforated peptic ulcer (PPU). The surgical procedure was performed through an upper abdominal midline incision, and closure of PPU was achieved by suture alone or in combination with an omental patch. Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen (FiO2) of 30% (n = 120) or 80% (n = 119). Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery. The overall incision infection rate was 38.4% (92 of 239): 61 patients (50.8%) had an infection in the 30% FiO2 group and 31 (26%) in the 80% FiO2 group (p < 0.05). The risk of SSI was 48% lower in the 80% FiO2 group (relative risk 0.51; 95% confidence interval [CI] 0.28-1.08) vs 30% FiO2. Supplemental 80% FiO2 during and for 6 h after open surgery for PPU, which reduces post-operative SSI, should be considered part of ongoing quality improvement activities related to surgical care, with few risks to the patient and little associated cost.

  20. Randomized controlled trial of a computer-based module to improve contraceptive method choice.

    PubMed

    Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Ventura, Alicia; Chiasson, Mary Ann

    2012-10-01

    Unintended pregnancy is common in the United States, and interventions are needed to improve contraceptive use among women at higher risk of unintended pregnancy, including Latinas and women with low educational attainment. A three-arm randomized controlled trial was conducted at two family planning sites serving low-income, predominantly Latina populations. The trial tested the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients choosing an effective method of contraception (<10 pregnancies/100 women per year, typical use). Participants were randomized to complete the module and receive tailored health materials, to complete the module and receive generic health materials, or to a control condition. In intent-to-treat analyses adjusted for recruitment site (n=2231), family planning patients who used the module were significantly more likely to choose an effective contraceptive method: 75% among those who received tailored materials [odds ratio (OR)=1.56; 95% confidence interval (CI): 1.23-1.98] and 78% among those who received generic materials (OR=1.74; 95% CI: 1.35-2.25), compared to 65% among control arm participants. The findings support prior research suggesting that patient-centered interventions can positively influence contraceptive method choice. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. Skin antiseptics in venous puncture site disinfection for preventing blood culture contamination: A Bayesian network meta-analysis of randomized controlled trials.

    PubMed

    Liu, Wenjie; Duan, Yuchen; Cui, Wenyao; Li, Li; Wang, Xia; Dai, Heling; You, Chao; Chen, Maojun

    2016-07-01

    To compare the efficacy of several antiseptics in decreasing the blood culture contamination rate. Network meta-analysis. Electronic searches of PubMed and Embase were conducted up to November 2015. Only randomized controlled trials or quasi-randomized controlled trials were eligible. We applied no language restriction. A comprehensive review of articles in the reference lists was also accomplished for possible relevant studies. Relevant studies evaluating efficacy of different antiseptics in venous puncture site for decreasing the blood culture contamination rate were included. The data were extracted from the included randomized controlled trials by two authors independently. The risk of bias was evaluated using Detsky scale by two authors independently. We used WinBUGS1.43 software and statistic model described by Chaimani to perform this network meta-analysis. Then graphs of statistical results of WinBUGS1.43 software were generated using 'networkplot', 'ifplot', 'netfunnel' and 'sucra' procedure by STATA13.0. Odds ratio and 95% confidence intervals were assessed for dichotomous data. A probability of p less than 0.05 was considered to be statistically significant. Compared with ordinary meta-analyses, this network meta-analysis offered hierarchies for the efficacy of different antiseptics in decreasing the blood culture contamination rate. Seven randomized controlled trials involving 34,408 blood samples were eligible for the meta-analysis. No significant difference was found in blood culture contamination rate among different antiseptics. No significant difference was found between non-alcoholic antiseptics and alcoholic antiseptics, alcoholic chlorhexidine and povidone iodine, chlorhexidine and iodine compounds, povidone iodine and iodine tincture in this aspect, respectively. Different antiseptics may not affect the blood culture contamination rate. Different intervals between the skin disinfection and the venous puncture, the different settings (emergency

  2. Site- and bond-percolation thresholds in K_{n,n}-based lattices: Vulnerability of quantum annealers to random qubit and coupler failures on chimera topologies.

    PubMed

    Melchert, O; Katzgraber, Helmut G; Novotny, M A

    2016-04-01

    We estimate the critical thresholds of bond and site percolation on nonplanar, effectively two-dimensional graphs with chimeralike topology. The building blocks of these graphs are complete and symmetric bipartite subgraphs of size 2n, referred to as K_{n,n} graphs. For the numerical simulations we use an efficient union-find-based algorithm and employ a finite-size scaling analysis to obtain the critical properties for both bond and site percolation. We report the respective percolation thresholds for different sizes of the bipartite subgraph and verify that the associated universality class is that of standard two-dimensional percolation. For the canonical chimera graph used in the D-Wave Systems Inc. quantum annealer (n=4), we discuss device failure in terms of network vulnerability, i.e., we determine the critical fraction of qubits and couplers that can be absent due to random failures prior to losing large-scale connectivity throughout the device.

  3. Safety of herpes zoster vaccine in the shingles prevention study: a randomized trial.

    PubMed

    Simberkoff, Michael S; Arbeit, Robert D; Johnson, Gary R; Oxman, Michael N; Boardman, Kathy D; Williams, Heather M; Levin, Myron J; Schmader, Kenneth E; Gelb, Lawrence D; Keay, Susan; Neuzil, Kathleen; Greenberg, Richard N; Griffin, Marie R; Davis, Larry E; Morrison, Vicki A; Annunziato, Paula W

    2010-05-04

    The herpes zoster vaccine is effective in preventing herpes zoster and postherpetic neuralgia in immunocompetent older adults. However, its safety has not been described in depth. To describe local adverse effects and short- and long-term safety profiles of herpes zoster vaccine in immunocompetent older adults. Randomized, placebo-controlled trial with enrollment from November 1998 to September 2001 and follow-up through April 2004 (mean, 3.4 years). A Veterans Affairs Coordinating Center generated the permutated block randomization scheme, which was stratified by site and age. Participants and follow-up study personnel were blinded to treatment assignments. (ClinicalTrials.gov registration number: NCT00007501) 22 U.S. academic centers. 38 546 immunocompetent adults 60 years or older, including 6616 who participated in an adverse events substudy. Single dose of herpes zoster vaccine or placebo. Serious adverse events and rashes in all participants and inoculation-site events in substudy participants during the first 42 days after inoculation. Thereafter, vaccination-related serious adverse events and deaths were monitored in all participants, and hospitalizations were monitored in substudy participants. After inoculation, 255 (1.4%) vaccine recipients and 254 (1.4%) placebo recipients reported serious adverse events. Local inoculation-site side effects were reported by 1604 (48%) vaccine recipients and 539 (16%) placebo recipients in the substudy. A total of 977 (56.6%) of the vaccine recipients reporting local side effects were aged 60 to 69 years, and 627 (39.2%) were older than 70 years. After inoculation, herpes zoster occurred in 7 vaccine recipients versus 24 placebo recipients. Long-term follow-up (mean, 3.39 years) showed that rates of hospitalization or death did not differ between vaccine and placebo recipients. Participants in the substudy were not randomly selected. Confirmation of reported serious adverse events with medical record data was not always

  4. A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

    PubMed

    da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

    2013-08-01

    The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

  5. The Clinical Effectiveness and Cost-Effectiveness of Lamotrigine in Borderline Personality Disorder: A Randomized Placebo-Controlled Trial.

    PubMed

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Cunningham, Gillian; Dale, Oliver; Ganguli, Poushali; Lawrence-Smith, Geoff; Leeson, Verity; Lemonsky, Fenella; Lykomitrou, Georgia; Montgomery, Alan A; Morriss, Richard; Munjiza, Jasna; Paton, Carol; Skorodzien, Iwona; Singh, Vineet; Tan, Wei; Tyrer, Peter; Reilly, Joseph G

    2018-04-06

    The authors examined whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder. This was a multicenter, double-blind, placebo-controlled randomized trial. Between July 2013 and November 2016, the authors recruited 276 people age 18 or over who met diagnostic criteria for borderline personality disorder. Individuals with coexisting bipolar affective disorder or psychosis, those already taking a mood stabilizer, and women at risk of pregnancy were excluded. A web-based randomization service was used to allocate participants randomly in a 1:1 ratio to receive either an inert placebo or up to 400 mg/day of lamotrigine. The primary outcome measure was score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. Secondary outcome measures included depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, and adverse events. A total of 195 (70.6%) participants were followed up at 52 weeks, at which point 49 (36%) of those in the lamotrigine group and 58 (42%) of those in the placebo group were taking study medication. The mean ZAN-BPD score was 11.3 (SD=6.6) among those in the lamotrigine group and 11.5 (SD=7.7) among those in the placebo group (adjusted difference in means=0.1, 95% CI=-1.8, 2.0). There was no evidence of any differences in secondary outcomes. Costs of direct care were similar in the two groups. The results suggest that treating people with borderline personality disorder with lamotrigine is not a clinically effective or cost-effective use of resources.

  6. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials.

    PubMed

    Guo, Jiao; Pan, Ling-Hui; Li, Yun-Xi; Yang, Xiang-Di; Li, Le-Qun; Zhang, Chun-Yan; Zhong, Jian-Hong

    2016-03-01

    Surgical site infection (SSI) is the third most frequent type of nosocomial infections. Triclosan-coated sutures are often used to reduce the risk of SSI, but studies examining this have given conflicting results. Therefore, this meta-analysis was performed to assess the efficacy of triclosan-coated sutures for reducing risk of SSI in adults. PubMed, EMBASE, Google Scholar, and ClinicalTrials.gov were searched to identify randomized clinical trials evaluating triclosan-coated sutures for preventing SSI on patients 18 y or older. Thirteen randomized clinical trials involving 5256 participants were included. Triclosan-coated sutures were associated with lower risk of SSI than uncoated sutures across all surgeries (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.65-0.88, P < 0.001). Similar proportions of patients experienced wound dehiscence with either type of suture (RR 0.97, 95% CI 0.49-1.89, P = 0.92). Subgroup analysis showed lower risk of SSI with triclosan-coated sutures in abdominal surgeries (RR 0.70, 95% CI 0.50-0.99, P = 0.04) and group with prophylactic antibiotic (RR 0.79, 95% CI 0.63-0.99, P = 0.04). However, such risk reduction was not observed in cardiac surgeries, breast surgeries, or group without prophylactic antibiotic. Triclosan-coated sutures can decrease the incidence of SSI in abdominal surgeries and might not interfere with wound healing process. Nevertheless, further studies are needed to examine whether triclosan-coated sutures are effective at preventing SSI in non-abdominal surgeries and to further study the interaction of antibiotic prophylaxis with triclosan-coated sutures. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Effects of spatial disturbance on common loon nest site selection and territory success

    USGS Publications Warehouse

    McCarthy, Kyle P.; DeStefano, Stephen

    2011-01-01

    The common loon (Gavia immer) breeds during the summer on northern lakes and water bodies that are also often desirable areas for aquatic recreation and human habitation. In northern New England, we assessed how the spatial nature of disturbance affects common loon nest site selection and territory success. We found through classification and regression analysis that distance to and density of disturbance factors can be used to classify observed nest site locations versus random points, suggesting that these factors affect loon nest site selection (model 1: Correct classification = 75%, null = 50%, K = 0.507, P < 0.001; model 2: Correct classification = 78%, null = 50%, K = 0.551, P < 0.001). However, in an exploratory analysis, we were unable to show a relation between spatial disturbance variables and breeding success (P = 0.595, R2 = 0.436), possibly because breeding success was so low during the breeding seasons of 2007–2008. We suggest that by selecting nest site locations that avoid disturbance factors, loons thereby limit the effect that disturbance will have on their breeding success. Still, disturbance may force loons to use sub-optimal nesting habitat, limiting the available number of territories, and overall productivity. We advise that management efforts focus on limiting disturbance factors to allow breeding pairs access to the best nesting territories, relieving disturbance pressures that may force sub-optimal nest placement.

  8. Association of Airborne Microorganisms in the Operating Room With Implant Infections: A Randomized Controlled Trial.

    PubMed

    Darouiche, Rabih O; Green, David M; Harrington, Melvyn A; Ehni, Bruce L; Kougias, Panagiotis; Bechara, Carlos F; O'Connor, Daniel P

    2017-01-01

    OBJECTIVE To evaluate the association of airborne colony-forming units (CFU) at incision sites during implantation of prostheses with the incidence of either incisional or prosthesis-related surgical site infections. DESIGN Randomized, controlled trial. SETTING Primary, public institution. PATIENTS Three hundred patients undergoing total hip arthroplasty, instrumented spinal procedures, or vascular bypass graft implantation. METHODS Patients were randomly assigned in a 1:1 ratio to either the intervention group or the control group. A novel device (Air Barrier System), previously shown to reduce airborne CFU at incision sites, was utilized in the intervention group. Procedures assigned to the control group were performed without the device, under routine operating room atmospheric conditions. Patients were followed up for 12 months to determine whether airborne CFU levels at the incision sites predicted the incidence of incisional or prosthesis-related infection. RESULTS Data were available for 294 patients, 148 in the intervention group and 146 in the control group. CFU density at the incision site was significantly lower in the intervention group than in the control group (P<.001). The density of airborne CFU at the incision site during the procedures was significantly related to the incidence of implant infection (P=.021). Airborne CFU densities were 4 times greater in procedures with implant infection versus no implant infection. All 4 of the observed prosthesis infections occurred in the control group. CONCLUSION Reduction of airborne CFU specifically at the incision site during operations may be an effective strategy to reduce prosthesis-related infections. clinicaltrials.gov Identifier: NCT01610271 Infect Control Hosp Epidemiol 2016;1-8.

  9. Comparative effects of precommercial thinning, urea fertilizer, and red alder in a site II, coast Douglas-fir plantation.

    Treesearch

    Richard E. Miller; Edmund L. Obermeyer; Harry W. Anderson

    1999-01-01

    We varied the number of red alder retained with 300 Douglas-fir per acre on a high-quality site in coastal Oregon. Alder densities of 0, 20, 40, and 80 per acre were tested. Our fifth treatment eliminated nitrogen-fixing alder, but substituted nitrogen fertilizer. Treatment 6 had neither thinning nor alder control. Treatments were randomly assigned within each of three...

  10. Effectiveness of 3 methods of anchorage reinforcement for maximum anchorage in adolescents: A 3-arm multicenter randomized clinical trial.

    PubMed

    Sandler, Jonathan; Murray, Alison; Thiruvenkatachari, Badri; Gutierrez, Rodrigo; Speight, Paul; O'Brien, Kevin

    2014-07-01

    The objective of this 3-arm parallel randomized clinical trial was to compare the effectiveness of temporary anchorage devices (TADs), Nance button palatal arches, and headgear for anchorage supplementation in the treatment of patients with malocclusions that required maximum anchorage. This trial was conducted between August 2008 and February 2013 in 2 orthodontic departments in the United Kingdom. The study included 78 patients (ages, 12-18 years; mean age, 14.2 years) who needed maximum anchorage. Eligibility criteria included no active caries, exemplary oral hygiene, and maximum anchorage required. The primary outcome was mesial molar movement during the period in which anchorage supplementation was required. The secondary outcomes were duration of anchorage reinforcement, number of treatment visits, number of casual and failed appointments, total treatment time, dento-occlusal change, and patients' perceptions of the method of anchorage supplementation. Treatment allocation was implemented by contacting via the Internet the randomization center at the University of Nottingham, Clinical Trials Unit. The randomization was based on a computer-generated pseudo-random code with random permuted blocks of randomly varying size. A research assistant who was blinded to the group allocation recorded all data. The patients were randomly allocated to receive anchorage supplementation with TADs, a Nance button on a palatal arch, or headgear. They were all treated with maxillary and mandibular preadjusted edgewise fixed appliances with 0.022-in slot prescription brackets. They were followed until orthodontic treatment was complete. Seventy-eight patients were randomized in a 1:1:1 ratio among the 3 groups. The baseline characteristics were similar in the groups, and they were treated for an average of 27.4 months (SD, 7.1 months); 71 completed orthodontic treatment. The data were analyzed on a per-protocol basis and showed no differences in the effectiveness of anchorage

  11. Effect of Patient Navigation on Breast Cancer Screening Among African American Medicare Beneficiaries: A Randomized Controlled Trial.

    PubMed

    Marshall, Jessie Kimbrough; Mbah, Olive M; Ford, Jean G; Phelan-Emrick, Darcy; Ahmed, Saifuddin; Bone, Lee; Wenzel, Jennifer; Shapiro, Gary R; Howerton, Mollie; Johnson, Lawrence; Brown, Qiana; Ewing, Altovise; Pollack, Craig Evan

    2016-01-01

    There is growing evidence that patient navigation improves breast cancer screening rates; however, there are limited efficacy studies of its effect among African American older adult women. To evaluate the effect of patient navigation on screening mammography among African American female Medicare beneficiaries in Baltimore, MD. The Cancer Prevention and Treatment Demonstration (CPTD), a multi-site study, was a randomized controlled trial conducted from April 2006 through December 2010. Community-based and clinical setting. The CPTD Screening Trial enrolled 1905 community-dwelling African American female Medicare beneficiaries who were ≥65 years of age and resided in Baltimore, MD. Participants were recruited from health clinics, community centers, health fairs, mailings using Medicare rosters, and phone calls. Participants were randomized to either: printed educational materials on cancer screening (control group) or printed educational materials + patient navigation services designed to help participants overcome barriers to cancer screening (intervention group). Self-reported receipt of mammography screening within 2 years of the end of the study. The median follow-up period for participants in this analysis was 17.8 months. In weighted multivariable logistic regression analyses, women in the intervention group had significantly higher odds of being up to date on mammography screening at the end of the follow-up period compared to women in the control group (odds ratio [OR] 2.26, 95 % confidence interval [CI]1.59-3.22). The effect of the intervention was stronger among women who were not up to date with mammography screening at enrollment (OR 3.63, 95 % CI 2.09-6.38). Patient navigation among urban African American Medicare beneficiaries increased self-reported mammography utilization. The results suggest that patient navigation for mammography screening should focus on women who are not up to date on their screening.

  12. Evidence-Based Bundles and Cesarean Delivery Surgical Site Infections: A Systematic Review and Meta-analysis.

    PubMed

    Carter, Ebony B; Temming, Lorene A; Fowler, Susan; Eppes, Catherine; Gross, Gilad; Srinivas, Sindhu K; Macones, George A; Colditz, Graham A; Tuuli, Methodius G

    2017-10-01

    To estimate the association of implementation of evidence-based bundles with surgical site infection rates after cesarean delivery. We searched MEDLINE through PubMed, EMBASE, Scopus, the Cochrane Database of Systematic Reviews, Google Scholar, and ClinicalTrials.gov. We searched electronic databases for randomized controlled trials and observational studies comparing evidence-based infection prevention bundles for cesarean delivery, defined as implementation of three or more processes proven to prevent surgical site infection such as chlorhexidine skin preparation, antibiotic prophylaxis, and hair clipping, with usual care. The primary outcome was overall surgical site infection, defined using Centers for Disease Control and Prevention's National Healthcare Safety Network criteria. Secondary outcomes were superficial or deep surgical site infection and endometritis. Quality of studies and heterogeneity were assessed using validated measures. Pooled relative risks (RRs) with 95% CIs were calculated using random-effects models. Numbers needed to treat were estimated for outcomes with significant reduction. We found no randomized controlled trials. Fourteen preintervention and postintervention studies met inclusion criteria. Eight were full-text articles, and six were published abstracts. Quality of most of the primary studies was adequate with regard to the intervention, but modest in terms of implementation. The rate of surgical site infection was significantly lower after implementing an evidence-based bundle (14 studies: pooled rates 6.2% baseline compared with 2.0% intervention, pooled RR 0.33, 95% CI 0.25-0.43, number needed to treat=24). Evidence-based bundles were also associated with a lower rate of superficial or deep surgical site infection (six studies: pooled rate 5.9% baseline compared with 1.1% intervention, pooled RR 0.19, 95% CI 0.12-0.32, number needed to treat=21). The rate of endometritis was low at baseline and not significantly different after

  13. Randomized evaluation of a web based interview process for urology resident selection.

    PubMed

    Shah, Satyan K; Arora, Sanjeev; Skipper, Betty; Kalishman, Summers; Timm, T Craig; Smith, Anthony Y

    2012-04-01

    We determined whether a web based interview process for resident selection could effectively replace the traditional on-site interview. For the 2010 to 2011 match cycle, applicants to the University of New Mexico urology residency program were randomized to participate in a web based interview process via Skype or a traditional on-site interview process. Both methods included interviews with the faculty, a tour of facilities and the opportunity to ask current residents any questions. To maintain fairness the applicants were then reinterviewed via the opposite process several weeks later. We assessed comparative effectiveness, cost, convenience and satisfaction using anonymous surveys largely scored on a 5-point Likert scale. Of 39 total participants (33 applicants and 6 faculty) 95% completed the surveys. The web based interview was less costly to applicants (mean $171 vs $364, p=0.05) and required less time away from school (10% missing 1 or more days vs 30%, p=0.04) compared to traditional on-site interview. However, applicants perceived the web based interview process as less effective than traditional on-site interview, with a mean 6-item summative effectiveness score of 21.3 vs 25.6 (p=0.003). Applicants and faculty favored continuing the web based interview process in the future as an adjunct to on-site interviews. Residency interviews can be successfully conducted via the Internet. The web based interview process reduced costs and improved convenience. The findings of this study support the use of videoconferencing as an adjunct to traditional interview methods rather than as a replacement. Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  14. Effectiveness of local vancomycin powder to decrease surgical site infections: a meta-analysis.

    PubMed

    Chiang, Hsiu-Yin; Herwaldt, Loreen A; Blevins, Amy E; Cho, Edward; Schweizer, Marin L

    2014-03-01

    Some surgeons use systemic vancomycin to prevent surgical site infections (SSIs), but patients who do not carry methicillin-resistant Staphylococcus aureus have an increased risk of SSIs when given vancomycin alone for intravenous prophylaxis. Applying vancomycin powder to the wound before closure could increase the local tissue vancomycin level without significant systemic levels. However, the effectiveness of local vancomycin powder application for preventing SSIs has not been established. Our objective was to systematically review and evaluate studies on the effectiveness of local vancomycin powder for decreasing SSIs. Meta-analysis. We included observational studies, quasi-experimental studies, and randomized controlled trials of patients undergoing surgical procedures that involved vancomycin powder application to surgical wounds, reported SSI rates, and had a comparison group that did not use local vancomycin powder. The primary outcome was postoperative SSIs. The secondary outcomes included deep incisional SSIs and S. aureus SSIs. We performed systematic literature searches in PubMed, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Cochrane Central Register of Controlled Trials via Wiley, Scopus (including EMBASE abstracts), Web of Science, ClinicalTrials.gov, BMC Proceedings, ProQuest Dissertation, and Thesis in Health and Medicine, and conference abstracts from IDWeek, the Interscience Conference on Antimicrobial Agents and Chemotherapy, the Society for Healthcare Epidemiology of America, and the American Academy of Orthopedic Surgeons annual meetings, and also the Scoliosis Research Society Annual Meeting and Course. We ran the searches from inception on May 9, 2013 with no limits on date or language. After reviewing 373 titles or abstracts and 22 articles in detail, we included 10 independent studies and used a random-effects model when pooling risk estimates to assess the effectiveness of local

  15. Analyzing degradation data with a random effects spline regression model

    DOE PAGES

    Fugate, Michael Lynn; Hamada, Michael Scott; Weaver, Brian Phillip

    2017-03-17

    This study proposes using a random effects spline regression model to analyze degradation data. Spline regression avoids having to specify a parametric function for the true degradation of an item. A distribution for the spline regression coefficients captures the variation of the true degradation curves from item to item. We illustrate the proposed methodology with a real example using a Bayesian approach. The Bayesian approach allows prediction of degradation of a population over time and estimation of reliability is easy to perform.

  16. Analyzing degradation data with a random effects spline regression model

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

    Fugate, Michael Lynn; Hamada, Michael Scott; Weaver, Brian Phillip

    This study proposes using a random effects spline regression model to analyze degradation data. Spline regression avoids having to specify a parametric function for the true degradation of an item. A distribution for the spline regression coefficients captures the variation of the true degradation curves from item to item. We illustrate the proposed methodology with a real example using a Bayesian approach. The Bayesian approach allows prediction of degradation of a population over time and estimation of reliability is easy to perform.

  17. Effect of a toothpaste containing triclosan, cetylpyridinium chloride, and essential oils on gingival status in schoolchildren: a randomized clinical pilot study.

    PubMed

    Cagetti, Maria Grazia; Strohmenger, Laura; Basile, Valentina; Abati, Silvio; Mastroberardino, Stefano; Campus, Guglielmo

    2015-05-01

    This randomized double-blind in vivo pilot study has evaluated the effects of a toothpaste containing fluoride (control) versus toothpaste containing fluoride, triclosan, cetylpyridinium chloride and essential oils (experimental) in controlling supragingival dental plaque and bleeding on probing in a sample of healthy schoolchildren. In total, 48 children (8 to 10 years) were selected and randomly divided into two groups (experimental and control), using the two different toothpastes twice a day for 2 minutes each for a 4-week period. The investigation included an evaluation of plaque quantity, using the Turesky modified Quigley-Hein method, and bleeding on probing that was recorded dichotomously. The unit of analysis was set at the gingival site level. Plaque Index and bleeding on probing were analyzed using distribution tables and chi-square test. A generalized estimating equation was used to estimate the parameters of a generalized linear model with a possible unknown correlation between outcomes. In total, 40 schoolchildren completed the trial. Considering each group separately, a statistically significant difference in plaque scores was recorded for both treatments (z-test = 9.23, P < .01 for the experimental toothpaste; and z-test = 7.47, P < .01 for the control toothpaste). Nevertheless, the effect over time was higher for the experimental toothpaste than for the control one (3.38 vs 1.96). No statistically significant results were observed regarding bleeding on probing. The 4-week use of the experimental toothpaste seems to produce higher plaque reduction compared to fluoridated toothpaste without other antibacterial ingredients. This finding has to be confirmed in a larger study.

  18. Parallel Mitogenome Sequencing Alleviates Random Rooting Effect in Phylogeography.

    PubMed

    Hirase, Shotaro; Takeshima, Hirohiko; Nishida, Mutsumi; Iwasaki, Wataru

    2016-04-28

    Reliably rooted phylogenetic trees play irreplaceable roles in clarifying diversification in the patterns of species and populations. However, such trees are often unavailable in phylogeographic studies, particularly when the focus is on rapidly expanded populations that exhibit star-like trees. A fundamental bottleneck is known as the random rooting effect, where a distant outgroup tends to root an unrooted tree "randomly." We investigated whether parallel mitochondrial genome (mitogenome) sequencing alleviates this effect in phylogeography using a case study on the Sea of Japan lineage of the intertidal goby Chaenogobius annularis Eighty-three C. annularis individuals were collected and their mitogenomes were determined by high-throughput and low-cost parallel sequencing. Phylogenetic analysis of these mitogenome sequences was conducted to root the Sea of Japan lineage, which has a star-like phylogeny and had not been reliably rooted. The topologies of the bootstrap trees were investigated to determine whether the use of mitogenomes alleviated the random rooting effect. The mitogenome data successfully rooted the Sea of Japan lineage by alleviating the effect, which hindered phylogenetic analysis that used specific gene sequences. The reliable rooting of the lineage led to the discovery of a novel, northern lineage that expanded during an interglacial period with high bootstrap support. Furthermore, the finding of this lineage suggested the existence of additional glacial refugia and provided a new recent calibration point that revised the divergence time estimation between the Sea of Japan and Pacific Ocean lineages. This study illustrates the effectiveness of parallel mitogenome sequencing for solving the random rooting problem in phylogeographic studies. © The Author 2016. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  19. Effectiveness of enhanced cognitive behavioral therapy (CBT-E) for eating disorders: study protocol for a randomized controlled trial.

    PubMed

    de Jong, Martie; Korrelboom, Kees; van der Meer, Iris; Deen, Mathijs; Hoek, Hans W; Spinhoven, Philip

    2016-12-03

    While eating disorder not otherwise specified (EDNOS) is the most common eating disorder (ED) diagnosis in routine clinical practice, no specific treatment methods for this diagnosis have yet been developed and studied. Enhanced cognitive behavioral therapy (CBT-E) has been described and put to the test as a transdiagnostic treatment protocol for all EDs, including EDNOS. Initial research in the UK suggests that CBT-E is more effective for EDs, especially bulimia nervosa (BN) and EDNOS, than the earlier version of CBT. These positive results of CBT-E have to be replicated in more detail, preferably by independent researchers in different countries. Being the first Dutch study into CBT-E, the results from this national multicenter study - on three sites specialized in EDs - will deliver important information about the effectiveness of CBT-E in several domains of ED pathology, while providing input for the upcoming update of the Dutch Multidisciplinary Guideline for the Treatment of Eating Disorders. A multicenter randomized controlled trial will be conducted. One hundred and thirty-two adult outpatients (aged 18 years and older) with an ED diagnosis and a Body Mass index (BMI) of between 17.5 and 40 will be randomly allocated to the control or the intervention group. Subjects in the control group will receive Treatment as Usual (standard outpatient treatment provided at the participating sites). Subjects in the intervention group will receive 20 sessions of CBT-E in 20 weeks. The design is a 2 (group) × 5 (time) repeated measures factorial design in which neither therapists nor patients will be blinded for treatment allocation. The primary outcome measure is recovery from the ED. Secondary outcome measures include ED psychopathology, common mental disorders, anxiety and depressive symptoms, health-related quality of life, health care use and productivity loss. Self-esteem, perfectionism and interpersonal problems will be examined as putative predictors and

  20. Ferromagnetic clusters induced by a nonmagnetic random disorder in diluted magnetic semiconductors

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

    Bui, Dinh-Hoi; Physics Department, Hue University’s College of Education, 34 Le Loi, Hue; Phan, Van-Nham, E-mail: phanvannham@dtu.edu.vn

    In this work, we analyze the nonmagnetic random disorder leading to a formation of ferromagnetic clusters in diluted magnetic semiconductors. The nonmagnetic random disorder arises from randomness in the host lattice. Including the disorder to the Kondo lattice model with random distribution of magnetic dopants, the ferromagnetic–paramagnetic transition in the system is investigated in the framework of dynamical mean-field theory. At a certain low temperature one finds a fraction of ferromagnetic sites transiting to the paramagnetic state. Enlarging the nonmagnetic random disorder strength, the paramagnetic regimes expand resulting in the formation of the ferromagnetic clusters.

  1. 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.

  2. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

    PubMed

    Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

    2013-01-01

    To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p < .01). Compared with multi-port surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  3. A Randomized Control Intervention Investigating the Effects of Acute Exercise on Emotional Regulation.

    PubMed

    Edwards, Meghan K; Rhodes, Ryan E; Loprinzi, Paul D

    2017-09-01

    Exercise may help to cope with hectic or demanding events after a stressful situation occurs. Limited research has evaluated whether exercise, prior to a stressor, helps to facilitate subsequent emotional regulation. This pilot study addresses this novel paradigm. We employed a randomized controlled trial evaluating the effects of acute exercise on emotional regulation. Participants were randomly assigned to stretch (control group, N = 10), walk (N = 9), or jog (N = 8) for 15-minutes, after which they were exposed to a film clip intended to elicit a negative emotional response. Participants' emotions were monitored before and during exercise, as well as after the film clip. Emotional responses were evaluated using the Exercise Induced Feeling Inventory and Affective Circumplex Scale. A group x time splitplot interaction effect was significant for anger (p = .046) and anxiousness (p = .038). Follow-up analyses showed that only the stretching group (p = .048) had a significantly increased anger score from baseline to post-film clip, suggesting a protective emotional effect from walking and jogging. Exercise was effective in regulating anger and anxiousness after a stressful event. These findings provide evidence for potential preventive effects of exercise in facilitating emotional regulation.

  4. Group versus individual family planning counseling in Ghana: a randomized, noninferiority trial.

    PubMed

    Schwandt, Hilary M; Creanga, Andreea A; Danso, Kwabena A; Adanu, Richard M K; Agbenyega, Tsiri; Hindin, Michelle J

    2013-08-01

    Group, rather than individual, family planning counseling has the potential to increase family planning knowledge and use through more efficient use of limited human resources. A randomized, noninferiority study design was utilized to identify whether group family planning counseling is as effective as individual family planning counseling in Ghana. Female gynecology patients were enrolled from two teaching hospitals in Ghana in June and July 2008. Patients were randomized to receive either group or individual family planning counseling. The primary outcome in this study was change in modern contraceptive method knowledge. Changes in family planning use intention before and after the intervention and intended method type were also explored. Comparisons between the two study arms suggest that randomization was successful. The difference in change in modern contraceptive methods known from baseline to follow-up between the two study arms (group-individual), adjusted for study site, was -0.21, (95% confidence interval: -0.53 to 0.12) suggesting no difference between the two arms. Group family planning counseling was as effective as individual family planning counseling in increasing modern contraceptive knowledge among female gynecology patients in Ghana. Copyright © 2013 Elsevier Inc. All rights reserved.

  5. Noradrenergic α1 Receptor Antagonist Treatment Attenuates Positive Subjective Effects of Cocaine in Humans: A Randomized Trial

    PubMed Central

    Newton, Thomas F.; De La Garza, Richard; Brown, Gregory; Kosten, Thomas R.; Mahoney, James J.; Haile, Colin N.

    2012-01-01

    Background Preclinical research implicates dopaminergic and noradrenergic mechanisms in mediating the reinforcing effects of drugs of abuse, including cocaine. The objective of this study was to evaluate the impact of treatment with the noradrenergic α1 receptor antagonist doxazosin on the positive subjective effects of cocaine. Methods Thirteen non-treatment seeking, cocaine-dependent volunteers completed this single-site, randomized, placebo-controlled, within-subjects study. In one study phase volunteers received placebo and in the other they received doxazosin, with the order counterbalanced across participants. Study medication was masked by over-encapsulating doxazosin tablets and matched placebo lactose served as the control. Study medication treatment was initiated at 1 mg doxazosin or equivalent number of placebo capsules PO/day and increased every three days by 1 mg. After receiving 4 mg doxazosin or equivalent number of placebo capsules participants received masked doses of 20 and 40 mg cocaine IV in that order with placebo saline randomly interspersed to maintain the blind. Results Doxazosin treatment was well tolerated and doxazosin alone produced minimal changes in heart rate and blood pressure. During treatment with placebo, cocaine produced dose-dependent increases in subjective effect ratings of “high”, “stimulated”, “like cocaine”, “desire cocaine”, “any drug effect”, and “likely to use cocaine if had access” (p<.001). Doxazosin treatment significantly attenuated the effects of 20 mg cocaine on ratings of “stimulated”, “like cocaine”, and “likely to use cocaine if had access” (p<.05). There were trends for doxazosin to reduce ratings of “stimulated”, “desire cocaine”, and “likely to use cocaine if had access” (p<.10). Conclusions Medications that block noradrenergic α1 receptors, such as doxazosin, may be useful as treatments for cocaine dependence, and should be evaluated further. Trial

  6. A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments

    PubMed Central

    Stiell, Ian G.; Clement, Catherine M.; Grimshaw, Jeremy M.; Brison, Robert J.; Rowe, Brian H.; Lee, Jacques S.; Shah, Amit; Brehaut, Jamie; Holroyd, Brian R.; Schull, Michael J.; McKnight, R. Douglas; Eisenhauer, Mary A.; Dreyer, Jonathan; Letovsky, Eric; Rutledge, Tim; MacPhail, Iain; Ross, Scott; Perry, Jeffrey J.; Ip, Urbain; Lesiuk, Howard; Bennett, Carol; Wells, George A.

    2010-01-01

    Background The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments. Methods We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head. Results Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the “before” period (62.8%) to the “after” period (76.2%) (difference +13.3%, 95% CI 9.7%–17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%–10.8%). The change in mean imaging rates from the “before” period to the “after” period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes. Interpretation Our knowledge–translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. (ClinicalTrials.gov trial register no. NCT00993252) PMID:20732978

  7. Effect of hydralazine on duration of soft tissue local anesthesia following dental treatment: a randomized clinical trial.

    PubMed

    Fakheran Esfahani, Omid; Pouraboutaleb, Mohammad Fazel; Khorami, Behnam

    2015-01-01

    Prolonged numbness following routine dental treatments can cause difficulties in speaking and swallowing and may result in inadvertent biting of soft tissues. Local injection of vasodilator agents may represent a solution to this problem. The aim of this study was to evaluate the effect of submucosal injection of hydralazine hydrochloride (HCl) on the duration of oral soft tissue anesthesia after routine dental treatment. This randomized, single-blinded, controlled clinical trial included 50 patients who received inferior alveolar nerve block (2% lidocaine with 1:100,000 epinephrine) for simple restorative treatment. Upon completion of the dental treatment, patients randomly received a hydralazine HCl or sham injection in the same site as the local anesthetic injection. The reversal time to normal sensation of soft tissues (lips, tongue, and perioral skin) was evaluated and reported every 5 minutes by the patients, who followed an assessment protocol that they were taught in advance of treatment. Median recovery times in the hydralazine group and the sham group were 81.4 (SD, 3.6) and 221.8 (SD, 6.3) minutes, respectively. Based on Kaplan-Meier survival analysis, the duration of soft tissue anesthesia in the 2 groups was significantly different (P < 0.0001). By 1 hour after the reversal injection, 76% of subjects receiving hydralazine HCl had returned to normal intraoral and perioral sensation, but none of the subjects in the sham group reported normal sensation. Based on these results, submucosal injection of hydralazine HCl can be considered a safe and effective method to reduce the duration of local anesthetic-induced soft tissue numbness and the related functional problems.

  8. Randomization at the level of primary care practice: use of pre-intervention data and random effects models.

    PubMed

    Nixon, R M; Duffy, S W; Fender, G R; Day, N E; Prevost, T C

    2001-06-30

    The Anglia menorrhagia education study tests the effectiveness of an education package for the treatment of menorrhagia given to doctors at a primary care level. General practices were randomized to receive or not receive the package. It is hoped that this intervention will reduce the proportion of women suffering from menorrhagia that are referred to hospital. Data are available on the treatment and referral of women in the practices in the education and control groups, both pre- and post-intervention. We define and demonstrate a random effects logistic regression model that includes pre-intervention data for calculating the effectiveness of the intervention. Copyright 2001 John Wiley & Sons, Ltd.

  9. A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

    ERIC Educational Resources Information Center

    Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

    2017-01-01

    Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

  10. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    PubMed

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  11. Implementing collaborative care for depression treatment in primary care: A cluster randomized evaluation of a quality improvement practice redesign

    PubMed Central

    2011-01-01

    Background Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. Methods The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM. For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. Results Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low

  12. A comprehensive algorithm for determining whether a run-in strategy will be a cost-effective design modification in a randomized clinical trial.

    PubMed

    Schechtman, K B; Gordon, M E

    1993-01-30

    In randomized clinical trials, poor compliance and treatment intolerance lead to reduced between-group differences, increased sample size requirements, and increased cost. A run-in strategy is intended to reduce these problems. In this paper, we develop a comprehensive set of measures specifically sensitive to the effect of a run-in on cost and sample size requirements, both before and after randomization. Using these measures, we describe a step-by-step algorithm through which one can estimate the cost-effectiveness of a potential run-in. Because the cost-effectiveness of a run-in is partly mediated by its effect on sample size, we begin by discussing the likely impact of a planned run-in on the required number of randomized, eligible, and screened subjects. Run-in strategies are most likely to be cost-effective when: (1) per patient costs during the post-randomization as compared to the screening period are high; (2) poor compliance is associated with a substantial reduction in response to treatment; (3) the number of screened patients needed to identify a single eligible patient is small; (4) the run-in is inexpensive; (5) for most patients, the run-in compliance status is maintained following randomization and, most importantly, (6) many subjects excluded by the run-in are treatment intolerant or non-compliant to the extent that we expect little or no treatment response. Our analysis suggests that conditions for the cost-effectiveness of run-in strategies are stringent. In particular, if the only purpose of a run-in is to exclude ordinary partial compliers, the run-in will frequently add to the cost of the trial. Often, the cost-effectiveness of a run-in requires that one can identify and exclude a substantial number of treatment intolerant or otherwise unresponsive subjects.

  13. Site Matters: Multisite Randomized Trial of Motivational Enhancement Therapy in Community Drug Abuse Clinics

    ERIC Educational Resources Information Center

    Ball, Samuel A.; Martino, Steve; Nich, Charla; Frankforter, Tami L.; Van Horn, Deborah; Crits-Christoph, Paul; Woody, George E.; Obert, Jeanne L.; Farentinos, Christiane; Carroll, Kathleen M.

    2007-01-01

    The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. There were no retention…

  14. Reduction of randomness in seismic noise as a short-term precursor to a volcanic eruption

    PubMed Central

    Glynn, C. C.; Konstantinou, K. I.

    2016-01-01

    Ambient seismic noise is characterized by randomness incurred by the random position and strength of the noise sources as well as the heterogeneous properties of the medium through which it propagates. Here we use ambient noise data recorded prior to the 1996 Gjálp eruption in Iceland in order to show that a reduction of noise randomness can be a clear short-term precursor to volcanic activity. The eruption was preceded on 29 September 1996 by a Mw ~5.6 earthquake that occurred in the caldera rim of the Bárdarbunga volcano. A significant reduction of randomness started occurring 8 days before the earthquake and 10 days before the onset of the eruption. This reduction was observed even at stations more than 100 km away from the eruption site. Randomness increased to its previous levels 160 minutes after the Bárdarbunga earthquake, during which time aftershocks migrated from the Bárdarbunga caldera to a site near the Gjálp eruption fissure. We attribute this precursory reduction of randomness to the lack of higher frequencies (>1 Hz) in the noise wavefield caused by high absorption losses as hot magma ascended in the upper crust. PMID:27883050

  15. Alzheimer random walk

    NASA Astrophysics Data System (ADS)

    Odagaki, Takashi; Kasuya, Keisuke

    2017-09-01

    Using the Monte Carlo simulation, we investigate a memory-impaired self-avoiding walk on a square lattice in which a random walker marks each of sites visited with a given probability p and makes a random walk avoiding the marked sites. Namely, p = 0 and p = 1 correspond to the simple random walk and the self-avoiding walk, respectively. When p> 0, there is a finite probability that the walker is trapped. We show that the trap time distribution can well be fitted by Stacy's Weibull distribution b(a/b){a+1}/{b}[Γ({a+1}/{b})]-1x^a\\exp(-a/bx^b)} where a and b are fitting parameters depending on p. We also find that the mean trap time diverges at p = 0 as p- α with α = 1.89. In order to produce sufficient number of long walks, we exploit the pivot algorithm and obtain the mean square displacement and its Flory exponent ν(p) as functions of p. We find that the exponent determined for 1000 step walks interpolates both limits ν(0) for the simple random walk and ν(1) for the self-avoiding walk as [ ν(p) - ν(0) ] / [ ν(1) - ν(0) ] = pβ with β = 0.388 when p ≪ 0.1 and β = 0.0822 when p ≫ 0.1. Contribution to the Topical Issue "Continuous Time Random Walk Still Trendy: Fifty-year History, Current State and Outlook", edited by Ryszard Kutner and Jaume Masoliver.

  16. Evaluation of Amniotic Membrane Effectiveness in Skin Graft Donor Site Dressing in Burn Patients.

    PubMed

    Salehi, Seyed Hamid; As'adi, Kamran; Mousavi, Seyed Jaber; Shoar, Saeed

    2015-12-01

    Although the recipient site in burn wounds is dressed with universally accepted materials, the ideal management of split-thickness skin donor sites remains controversial. The aim of our study is to compare two methods of wound dressing in donor sites of split-thickness skin graft in patients undergoing burn wound reconstructive surgery. Forty-two consecutive patients with second- and third-degree burns with a total body surface area between 20 and 40 % were enrolled in this randomized clinical trial conducted in Motahari Burn Hospital in Tehran, Iran. In each patient, two anatomic areas with similar features were randomly selected as intervention and control donor sites. The intervention site was dressed with amniotic membrane, whereas the control site was treated with Vaseline-impregnated gauze. Wounds were examined daily by expert surgeons to measure the clinical outcomes including duration of healing, severity of pain, and infection rate. The mean ± SD age of patients was 31.17 ± 13.72 years; furthermore, burn percentage had a mean ± SD of 31.19 ± 10.56. The mean ± SD of patients' cooperation score was 1.6 ± 0.79 in the intervention group compared with 2.93 ± 0.71 in the control group, revealing a statistically significant difference (P < 0.05). Duration of wound healing was significantly shorter (P < 0.05) in the intervention group (17.61 ± 2.56 days) compared with the control group (21.16 ± 3.45 days). However, there was no significant difference in terms of wound infection rate between donor sites in the control and intervention groups (P > 0.05). Amniotic membrane as an alternative for dressing of skin graft donor sites provides significant benefits by increasing patients' comfort via diminishing the number of dressing changes and facilitating the process of wound healing.

  17. Do Prolonged Prophylactic Antibiotics Reduce the Incidence of Surgical-Site Infections in Immediate Prosthetic Breast Reconstruction?

    PubMed

    Wang, Frederick; Chin, Robin; Piper, Merisa; Esserman, Laura; Sbitany, Hani

    2016-12-01

    Approximately 50,000 women in the United States undergo mastectomy and immediate prosthetic breast reconstruction annually, and most receive postoperative prophylactic antibiotics. The effect of these antibiotics on the risk of surgical-site infections remains unclear. The authors searched the Medline, Embase, and Cochrane Library databases for studies that compared less than 24 hours and greater than 24 hours of antibiotics following immediate prosthetic breast reconstruction. Primary outcomes were surgical-site infections and implant loss. Conservative random effects models were used to obtain pooled relative risk estimates. The authors identified 927 studies, but only four cohort studies and one randomized controlled trial met their inclusion criteria. Unadjusted incidences of surgical-site infections were 14 percent with more than 24 hours of antibiotics, 19 percent with less than 24 hours of antibiotics, and 16 percent overall. Unadjusted incidences of implant loss were 8 percent with more than 24 hours of antibiotics, 10 percent with less than 24 hours of antibiotics, and 9 percent overall. The pooled relative risk of implant loss was 1.17 (95 percent CI, 0.39 to 3.6) with less than 24 hours of antibiotics, which was not statistically significant. Prolonged antibiotic use did not have a statistically significant effect on reducing surgical-site infections or implant loss. There was significant heterogeneity between studies, and prolonged antibiotics may have increased the risk of implant loss in the randomized controlled trial. Definitive evidence may only be obtained with data from more prospective randomized controlled trials.

  18. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel.

    PubMed

    Rongetti, Regiane Ladislau; Oliveira e Castro, Paulo de Tarso; Vieira, Renê Aloisio da Costa; Serrano, Sérgio Vicente; Mengatto, Mariana Fabro; Fregnani, José Humberto Tavares Guerreiro

    2014-01-01

    To evaluate the incidence of surgical site infection (SSI) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues. Observer-blind, randomized equivalence clinical trial with two arms (electrocautery versus conventional scalpel) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery. A simple randomization stratified by body mass index (BMI: 30 kg/m(2)) was carried out. Women were evaluated at 14 and 30 days following the operation. A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI. Group arms were balanced for all variables, excepted for surgical time, which was significantly higher in the electrocautery group (mean: 161.1 versus 203.5 min, P = 0.029). The rates of SSI were 7.4% and 9.7%, respectively, for the conventional scalpel and electrocautery groups (P = 0.756). The exploratory multivariate model identified body mass index ≥30 kg/m(2) (OR = 24.2, 95% CI: 2.8-212.1) and transverse surgical incision (OR = 8.1, 95% CI: 1.5-42.6) as independent risk factors for SSI. The type of scalpel used in surgery, when adjusted for these variables and the surgery time, was not a risk factor for SSI. This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different. These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI. NCT01410175 (Clinical Trials - NIH). Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  19. Internet-delivered Treatment for Substance Abuse: A Multi-site Randomized Controlled Clinical Trial

    PubMed Central

    Campbell, Aimee N. C.; Nunes, Edward V.; Matthews, Abigail G.; Stitzer, Maxine; Miele, Gloria M.; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A.; Kyle, Tiffany L.; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E.

    2014-01-01

    Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management. PMID:24700332

  20. Random forests as cumulative effects models: A case study of lakes and rivers in Muskoka, Canada.

    PubMed

    Jones, F Chris; Plewes, Rachel; Murison, Lorna; MacDougall, Mark J; Sinclair, Sarah; Davies, Christie; Bailey, John L; Richardson, Murray; Gunn, John

    2017-10-01

    Cumulative effects assessment (CEA) - a type of environmental appraisal - lacks effective methods for modeling cumulative effects, evaluating indicators of ecosystem condition, and exploring the likely outcomes of development scenarios. Random forests are an extension of classification and regression trees, which model response variables by recursive partitioning. Random forests were used to model a series of candidate ecological indicators that described lakes and rivers from a case study watershed (The Muskoka River Watershed, Canada). Suitability of the candidate indicators for use in cumulative effects assessment and watershed monitoring was assessed according to how well they could be predicted from natural habitat features and how sensitive they were to human land-use. The best models explained 75% of the variation in a multivariate descriptor of lake benthic-macroinvertebrate community structure, and 76% of the variation in the conductivity of river water. Similar results were obtained by cross-validation. Several candidate indicators detected a simulated doubling of urban land-use in their catchments, and a few were able to detect a simulated doubling of agricultural land-use. The paper demonstrates that random forests can be used to describe the combined and singular effects of multiple stressors and natural environmental factors, and furthermore, that random forests can be used to evaluate the performance of monitoring indicators. The numerical methods presented are applicable to any ecosystem and indicator type, and therefore represent a step forward for CEA. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  1. Application of random effects to the study of resource selection by animals

    USGS Publications Warehouse

    Gillies, C.S.; Hebblewhite, M.; Nielsen, S.E.; Krawchuk, M.A.; Aldridge, Cameron L.; Frair, J.L.; Saher, D.J.; Stevens, C.E.; Jerde, C.L.

    2006-01-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence.2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability.3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed.4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects.5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection.6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  2. Application of random effects to the study of resource selection by animals.

    PubMed

    Gillies, Cameron S; Hebblewhite, Mark; Nielsen, Scott E; Krawchuk, Meg A; Aldridge, Cameron L; Frair, Jacqueline L; Saher, D Joanne; Stevens, Cameron E; Jerde, Christopher L

    2006-07-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence. 2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability. 3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed. 4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects. 5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection. 6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  3. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    ERIC Educational Resources Information Center

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  4. Effectiveness of an on-site health clinic at a self-insured university: a cost-benefit analysis.

    PubMed

    McCaskill, Sherrie P; Schwartz, Lisa A; Derouin, Anne L; Pegram, Angela H

    2014-04-01

    This study assessed the impact and cost-effectiveness of an on-site health clinic at a self-insured university. Health care costs and number of claims filed to primary care providers were trended before and after the clinic was established to determine savings. A retrospective chart review of all full-time, insured employees treated for upper respiratory tract infections (URIs) during a 1-year study period was conducted. On-site clinic costs for the treatment of URIs were compared to costs at outside community providers for similar care. Community cost norms for the treatment of URIs were provided by Primary Physicians Care, the administrator of insurance claims for the University. A cost-benefit analysis compared the cost of services on-site versus similar services at an outside community provider. Based on the results of this study, the University's on-site health care services were determined to be more cost-effective than similar off-site health care services for the treatment of URIs. [Workplace Health Saf 2014;62(4):162-169.]. Copyright 2014, SLACK Incorporated.

  5. Rippled graphene in an in-plane magnetic field: effects of a random vector potential.

    PubMed

    Lundeberg, Mark B; Folk, Joshua A

    2010-10-01

    We report measurements of the effects of a random vector potential generated by applying an in-plane magnetic field to a graphene flake. Magnetic flux through the ripples cause orbital effects: Phase-coherent weak localization is suppressed, while quasirandom Lorentz forces lead to anisotropic magnetoresistance. Distinct signatures of these two effects enable the ripple size to be characterized.

  6. Moving a randomized clinical trial into an observational cohort.

    PubMed

    Goodman, Phyllis J; Hartline, Jo Ann; Tangen, Catherine M; Crowley, John J; Minasian, Lori M; Klein, Eric A; Cook, Elise D; Darke, Amy K; Arnold, Kathryn B; Anderson, Karen; Yee, Monica; Meyskens, Frank L; Baker, Laurence H

    2013-02-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute (NCI) and conducted by the Southwest Oncology Group (SWOG). A total of 35,533 men were assigned randomly to one of the four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, and placebo + placebo). The independent Data and Safety Monitoring Committee (DSMC) recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-Up (CFU) study. The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada, and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures

  7. Moving a Randomized Clinical Trial into an Observational Cohort

    PubMed Central

    Goodman, Phyllis J.; Hartline, Jo Ann; Tangen, Catherine M.; Crowley, John J.; Minasian, Lori M.; Klein, Eric A.; Cook, Elise D.; Darke, Amy K.; Arnold, Kathryn B.; Anderson, Karen; Yee, Monica; Meyskens, Frank L.; Baker, Laurence H.

    2013-01-01

    Background The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo. The independent Data and Safety Monitoring Committee recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. Purpose A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-up (CFU) study. Methods The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures

  8. Enhancing outreach for persons with serious mental illness: 12-month results from a cluster randomized trial of an adaptive implementation strategy.

    PubMed

    Kilbourne, Amy M; Almirall, Daniel; Goodrich, David E; Lai, Zongshan; Abraham, Kristen M; Nord, Kristina M; Bowersox, Nicholas W

    2014-12-28

    Few implementation strategies have been empirically tested for their effectiveness in improving uptake of evidence-based treatments or programs. This study compared the effectiveness of an immediate versus delayed enhanced implementation strategy (Enhanced Replicating Effective Programs (REP)) for providers at Veterans Health Administration (VA) outpatient facilities (sites) on improved uptake of an outreach program (Re-Engage) among sites not initially responding to a standard implementation strategy. One mental health provider from each U.S. VA site (N = 158) was initially given a REP-based package and training program in Re-Engage. The Re-Engage program involved giving each site provider a list of patients with serious mental illness who had not been seen at their facility for at least a year, requesting that providers contact these patients, assessing patient clinical status, and where appropriate, facilitating appointments to VA health services. At month 6, sites considered non-responsive (N = 89, total of 3,075 patients), defined as providers updating documentation for less than <80% of patients on their list, were randomized to two adaptive implementation interventions: Enhanced REP (provider coaching; N = 40 sites) for 6 months followed by Standard REP for 6 months; versus continued Standard REP (N = 49 sites) for 6 months followed by 6 months of Enhanced REP for sites still not responding. Outcomes included patient-level Re-Engage implementation and utilization. Patients from sites that were randomized to receive Enhanced REP immediately compared to Standard REP were more likely to have a completed contact (adjusted OR = 2.13; 95% CI: 1.09-4.19, P = 0.02). There were no differences in patient-level utilization between Enhanced and Standard REP sites. Enhanced REP was associated with greater Re-Engage program uptake (completed contacts) among sites not responding to a standard implementation strategy. Further research is needed to

  9. Patellar tendon healing with platelet-rich plasma: a prospective randomized controlled trial.

    PubMed

    de Almeida, Adriano Marques; Demange, Marco Kawamura; Sobrado, Marcel Faraco; Rodrigues, Marcelo Bordalo; Pedrinelli, André; Hernandez, Arnaldo José

    2012-06-01

    The patellar tendon has limited ability to heal after harvesting its central third. Platelet-rich plasma (PRP) could improve patellar tendon healing. Adding PRP to the patellar tendon harvest site would improve donor site healing and improve clinical outcome at 6 months after anterior cruciate ligament (ACL) reconstruction with a patellar tendon graft. Randomized controlled trial; Level of evidence, 1. Twenty-seven patients were randomly divided to receive (n = 12) or not receive (n = 15) PRP in the patellar tendon harvest site during ACL reconstruction. The primary outcome was magnetic resonance imaging (MRI) assessment of patellar tendon healing (gap area) after 6 months. Secondary outcomes were questionnaires and isokinetic testing of ACL reconstruction with a patellar tendon graft comparing both groups. Patellar tendon gap area was significantly smaller in the PRP group (4.9 ± 5.3 mm(2); 95% confidence interval [CI], 1.1-8.8) than in the control group (9.4 ± 4.4 mm(2); 95% CI, 6.6-12.2; P = .046). Visual analog scale score for pain was lower in the PRP group immediately postoperatively (3.8 ± 1.0; 95% CI, 3.18-4.49) than in the control group (5.1 ± 1.4; 95% CI, 4.24-5.90; P = .02). There were no differences after 6 months in questionnaire and isokinetic testing results comparing both groups. We showed that PRP had a positive effect on patellar tendon harvest site healing on MRI after 6 months and also reduced pain in the immediate postoperative period. Questionnaire and isokinetic testing results were not different between the groups at 6 months.

  10. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    PubMed

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  11. Magnet/Hall-Effect Random-Access Memory

    NASA Technical Reports Server (NTRS)

    Wu, Jiin-Chuan; Stadler, Henry L.; Katti, Romney R.

    1991-01-01

    In proposed magnet/Hall-effect random-access memory (MHRAM), bits of data stored magnetically in Perm-alloy (or equivalent)-film memory elements and read out by using Hall-effect sensors to detect magnetization. Value of each bit represented by polarity of magnetization. Retains data for indefinite time or until data rewritten. Speed of Hall-effect sensors in MHRAM results in readout times of about 100 nanoseconds. Other characteristics include high immunity to ionizing radiation and storage densities of order 10(Sup6)bits/cm(Sup 2) or more.

  12. Analog model for quantum gravity effects: phonons in random fluids.

    PubMed

    Krein, G; Menezes, G; Svaiter, N F

    2010-09-24

    We describe an analog model for quantum gravity effects in condensed matter physics. The situation discussed is that of phonons propagating in a fluid with a random velocity wave equation. We consider that there are random fluctuations in the reciprocal of the bulk modulus of the system and study free phonons in the presence of Gaussian colored noise with zero mean. We show that, in this model, after performing the random averages over the noise function a free conventional scalar quantum field theory describing free phonons becomes a self-interacting model.

  13. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

    PubMed

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

  14. Irrigation of Abdomen With Imipenem Solution Decreases Surgical Site Infections in Patients With Perforated Appendicitis: A Randomized Clinical Trial

    PubMed Central

    Hesami, Mohammad Ali; Alipour, Hamid; Nikoupour Daylami, Hamed; Alipour, Bijan; Bazargan-Hejazi, Shahrzad; Ahmadi, Alireza

    2014-01-01

    Background: Perforated appendicitis is one of the most common causes of acute abdomen requiring emergent surgery for immediate appendectomy and peritoneal cavity irrigation; however, the efficacy of irrigation with antibiotic solutions is controversial. Objectives: The aim of this study was to assess the efficacy of imipenem solution irrigation on post-operative surgical site infections (SSIs), hospital length of stay, and hospital costs. We hypothesized that there would be lower rate of SSIs, a shorter hospital stay, and lower hospital cost in patients with perforated appendicitis who received peritoneal cavity irrigation with imipenem solution in comparison to their counterparts who received irrigation with normal saline. Patients and Methods: In this randomized single-blind parallel-group clinical trial, we enrolled 90 patients with perforated appendicitis with 12-50 years of age and randomly allocated them into experimental group (n = 45) and control group (n = 45). The control group received peritoneal irrigation with normal saline (0.9%) and experimental group underwent peritoneal irrigation with imipenem solution (1 mg/mL). All surgical procedures were performed in Imam Reza Hospital of Kermanshah University of Medical Sciences. The study primary outcome was surgical site infections (including wound infection and abdominal abscess) and the secondary outcomes were length of hospital stay and hospital cost. Chi-squared and t-tests were used to analyze the study data. Results: Imipenem solution irrigation was associated with significant clinical improvement at one-month follow-up. The experimental group presented with significantly lower rate of SSIs and shorter length of hospital stay. The experimental group had lower rate of SSIs compared to the control group (4.4% vs. 22.2%, respectively) (p= 0.013). The duration of hospital stay was nearly one day longer in control group (5.84 ± 2.58 days) vs. experimental group (4.91 ± 1.29 days) (P = 0.034), and

  15. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation.

    PubMed

    Lopez, Alexa A; Cobb, Caroline O; Yingst, Jessica M; Veldheer, Susan; Hrabovsky, Shari; Yen, Miao-Shan; Foulds, Jonathan; Eissenberg, Thomas

    2016-03-03

    This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Participants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. TRN: NCT02342795 , registered December 16, 2014.

  16. Effectiveness of Stepped Care for Chronic Fatigue Syndrome: A Randomized Noninferiority Trial

    ERIC Educational Resources Information Center

    Tummers, Marcia; Knoop, Hans; Bleijenberg, Gijs

    2010-01-01

    Objective: In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period.…

  17. Effect of Chlorhexidine Bathing Every Other Day on Prevention of Hospital-Acquired Infections in the Surgical ICU: A Single-Center, Randomized Controlled Trial.

    PubMed

    Swan, Joshua T; Ashton, Carol M; Bui, Lan N; Pham, Vy P; Shirkey, Beverly A; Blackshear, Jolene E; Bersamin, Jimmy B; Pomer, Rubie May L; Johnson, Michael L; Magtoto, Audrey D; Butler, Michelle O; Tran, Shirley K; Sanchez, Leah R; Patel, Jessica G; Ochoa, Robert A; Hai, Shaikh A; Denison, Karen I; Graviss, Edward A; Wray, Nelda P

    2016-10-01

    To test the hypothesis that compared with daily soap and water bathing, 2% chlorhexidine gluconate bathing every other day for up to 28 days decreases the risk of hospital-acquired catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection in surgical ICU patients. This was a single-center, pragmatic, randomized trial. Patients and clinicians were aware of treatment-group assignment; investigators who determined outcomes were blinded. Twenty-four-bed surgical ICU at a quaternary academic medical center. Adults admitted to the surgical ICU from July 2012 to May 2013 with an anticipated surgical ICU stay for 48 hours or more were included. Patients were randomized to bathing with 2% chlorhexidine every other day alternating with soap and water every other day (treatment arm) or to bathing with soap and water daily (control arm). The primary endpoint was a composite outcome of catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection. Of 350 patients randomized, 24 were excluded due to prior enrollment in this trial and one withdrew consent. Therefore, 325 were analyzed (164 soap and water versus 161 chlorhexidine). Patients acquired 53 infections. Compared with soap and water bathing, chlorhexidine bathing every other day decreased the risk of acquiring infections (hazard ratio = 0.555; 95% CI, 0.309-0.997; p = 0.049). For patients bathed with soap and water versus chlorhexidine, counts of incident hospital-acquired infections were 14 versus 7 for catheter-associated urinary tract infection, 13 versus 8 for ventilator-associated pneumonia, 6 versus 3 for incisional surgical site infections, and 2 versus 0 for primary bloodstream infection; the effect was consistent across all infections. The absolute risk reduction for acquiring a hospital-acquired infection was 9.0% (95% CI, 1.5-16.4%; p

  18. The Impact of Five Missing Data Treatments on a Cross-Classified Random Effects Model

    ERIC Educational Resources Information Center

    Hoelzle, Braden R.

    2012-01-01

    The present study compared the performance of five missing data treatment methods within a Cross-Classified Random Effects Model environment under various levels and patterns of missing data given a specified sample size. Prior research has shown the varying effect of missing data treatment options within the context of numerous statistical…

  19. Xenogeneic collagen matrix versus connective tissue graft for buccal soft tissue augmentation at implant site. A randomized, controlled clinical trial.

    PubMed

    Cairo, Francesco; Barbato, Luigi; Tonelli, Paolo; Batalocco, Guido; Pagavino, Gabriella; Nieri, Michele

    2017-07-01

    Peri-implant soft tissue may be critical to prevent inflammation and promote gingival margin stability. The purpose of this randomized clinical trial (RCT) is to compare xenogeneic collagen matrix (XCM) versus connective tissue graft (CTG) to increase buccal soft tissue thickness at implant site. Soft tissue augmentation with XCM (test) or CTG (control) was performed at 60 implants in 60 patients at the time of implant uncovering. Measurements were performed by a blinded examiner at baseline, 3 and 6 months. Outcome measures included buccal soft tissue thickness (GT), apico-coronal keratinized tissue (KT), chair time and post-operative discomfort. Visual Analogue Scale (VAS) was used to evaluate patient satisfaction. After 6 months, the final GT increase was 0.9 ± 0.2 in the XCM group and 1.2 ± 0.3 mm in the CTG group, with a significant difference favouring the control group (0.3 mm; p = .0001). Both procedures resulted in similar final KT amount with no significant difference between treatments. XCM was associated with significant less chair-time (p < .0001), less post-operative pain (p < .0001), painkillers intake (p < .0001) and higher final satisfaction than CTG (p = .0195). CTG was more effective than XCM to increase buccal peri-implant soft tissue thickness. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Random Walks and Effective Optical Depth in Relativistic Flow

    NASA Astrophysics Data System (ADS)

    Shibata, Sanshiro; Tominaga, Nozomu; Tanaka, Masaomi

    2014-05-01

    We investigate the random walk process in relativistic flow. In the relativistic flow, photon propagation is concentrated in the direction of the flow velocity due to the relativistic beaming effect. We show that in the pure scattering case, the number of scatterings is proportional to the size parameter ξ ≡ L/l 0 if the flow velocity β ≡ v/c satisfies β/Γ Gt ξ-1, while it is proportional to ξ2 if β/Γ Lt ξ-1, where L and l 0 are the size of the system in the observer frame and the mean free path in the comoving frame, respectively. We also examine the photon propagation in the scattering and absorptive medium. We find that if the optical depth for absorption τa is considerably smaller than the optical depth for scattering τs (τa/τs Lt 1) and the flow velocity satisfies \\beta \\gg \\sqrt{2\\tau _a/\\tau _s}, then the effective optical depth is approximated by τ* ~= τa(1 + β)/β. Furthermore, we perform Monte Carlo simulations of radiative transfer and compare the results with the analytic expression for the number of scatterings. The analytic expression is consistent with the results of the numerical simulations. The expression derived in this study can be used to estimate the photon production site in relativistic phenomena, e.g., gamma-ray burst and active galactic nuclei.

  1. Telemedicine-based collaborative care for posttraumatic stress disorder: a randomized clinical trial.

    PubMed

    Fortney, John C; Pyne, Jeffrey M; Kimbrell, Timothy A; Hudson, Teresa J; Robinson, Dean E; Schneider, Ronald; Moore, William M; Custer, Paul J; Grubbs, Kathleen M; Schnurr, Paula P

    2015-01-01

    Posttraumatic stress disorder (PTSD) is prevalent, persistent, and disabling. Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials, geographic barriers impede rural veterans from engaging in these evidence-based treatments. To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD. The Telemedicine Outreach for PTSD (TOP) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses. Outpatients were recruited from 11 Department of Veterans Affairs (VA) community-based outpatient clinics serving predominantly rural veterans. Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale. Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia, bipolar disorder, or substance dependence. Two hundred sixty-five veterans were enrolled from November 23, 2009, through September 28, 2011, randomized to usual care (UC) or the TOP intervention, and followed up for 12 months. Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers. Off-site PTSD care teams included telephone nurse care managers, telephone pharmacists, telepsychologists, and telepsychiatrists. Nurses conducted care management activities. Pharmacists reviewed medication histories. Psychologists delivered cognitive processing therapy via interactive video. Psychiatrists supervised the team and conducted interactive video psychiatric consultations. The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale. Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy. During the 12-month follow-up period, 73 of the 133 patients randomized to TOP (54.9%) received cognitive processing therapy

  2. Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials

    PubMed Central

    Troedhan, Angelo; Schlichting, Izabela; Kurrek, Andreas; Wainwright, Marcel

    2014-01-01

    Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation volume. Four different biomaterials were inserted randomly (easy-graft CRYSTAL n = 38, easy-graft CLASSIC n = 41, NanoBone n = 42, BioOss n = 34), 2 ccm in each case. After a mean healing period of 8,92 months uniform tapered screw Q2-implants were inserted and Drill-Torque-Values (DTV) and ITV were recorded and compared to a group of 36 subantral sites without need of sinuslifting. DTV/ITV were processed for statistics by ANOVA-tests. Mean DTV/ITV obtained in Ncm were: Control Group 10,2/22,2, Bio-Oss 12,7/26,2, NanoBone 17,5/33,3, easy-graft CLASSIC 20,3/45,9, easy-graft CRYSTAL 23,8/56,6 Ncm, significance-level of differences throughout p < 0,05. Within the limits of this study the results suggest self-hardening solid-block-like bone-graft-materials to achieve significantly better DTV/ITV than loose granulate biomaterials for its suspected improvement of vascularization and mineralization of the subantral scaffold by full immobilization of the augmentation site towards pressure changes in the human sinus at normal breathing. PMID:25073446

  3. Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials.

    PubMed

    Troedhan, Angelo; Schlichting, Izabela; Kurrek, Andreas; Wainwright, Marcel

    2014-07-30

    Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation volume. Four different biomaterials were inserted randomly (easy-graft CRYSTAL n = 38, easy-graft CLASSIC n = 41, NanoBone n = 42, BioOss n = 34), 2 ccm in each case. After a mean healing period of 8,92 months uniform tapered screw Q2-implants were inserted and Drill-Torque-Values (DTV) and ITV were recorded and compared to a group of 36 subantral sites without need of sinuslifting. DTV/ITV were processed for statistics by ANOVA-tests. Mean DTV/ITV obtained in Ncm were: Control Group 10,2/22,2, Bio-Oss 12,7/26,2, NanoBone 17,5/33,3, easy-graft CLASSIC 20,3/45,9, easy-graft CRYSTAL 23,8/56,6 Ncm, significance-level of differences throughout p < 0,05. Within the limits of this study the results suggest self-hardening solid-block-like bone-graft-materials to achieve significantly better DTV/ITV than loose granulate biomaterials for its suspected improvement of vascularization and mineralization of the subantral scaffold by full immobilization of the augmentation site towards pressure changes in the human sinus at normal breathing.

  4. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial.

    PubMed

    Stacchi, Claudio; Vercellotti, Tomaso; Torelli, Lucio; Furlan, Fabio; Di Lenarda, Roberto

    2013-04-01

    The objective of the present investigation was to longitudinally monitor stability changes of implants inserted using traditional rotary instruments or piezoelectric inserts, and to follow their variations during the first 90 days of healing. A randomized, controlled trial was conducted on 20 patients. Each patient received two identical, adjacent implants in the upper premolar area: the test site was prepared with piezosurgery, and the control site was prepared using twist drills. Resonance frequency analysis measurements were taken by a blinded operator on the day of surgery and after 7, 14, 21, 28, 42, 56, and 90 days. At 90 days, 39 out of 40 implants were osseointegrated (one failure in the control group). Both groups showed an initial decrease in mean implant stability quotient (ISQ) values: a shift in implant stability to increasing ISQ values occurred after 14 days in the test group and after 21 days in the control group. The lowest mean ISQ value was recorded at 14 days for test implants (97.3% of the primary stability) and at 21 days for the control implants (90.8% of the primary stability). ISQ variations with respect to primary stability differed significantly between the two groups during the entire period of observation: from day 14 to day 42, in particular, the differences were extremely significant (p < .0001). All 39 implants were in function successfully at the visit scheduled 1 year after insertion. The findings from this study suggest that ultrasonic implant site preparation results in a limited decrease of ISQ values and in an earlier shifting from a decreasing to an increasing stability pattern, when compared with the traditional drilling technique. From a clinical point of view, implants inserted with the piezoelectric technique demonstrated a short-term clinical success similar to those inserted using twist drills. © 2011 Wiley Periodicals, Inc.

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

    PubMed

    Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

    2013-01-11

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

  6. How random is a random vector?

    NASA Astrophysics Data System (ADS)

    Eliazar, Iddo

    2015-12-01

    Over 80 years ago Samuel Wilks proposed that the "generalized variance" of a random vector is the determinant of its covariance matrix. To date, the notion and use of the generalized variance is confined only to very specific niches in statistics. In this paper we establish that the "Wilks standard deviation" -the square root of the generalized variance-is indeed the standard deviation of a random vector. We further establish that the "uncorrelation index" -a derivative of the Wilks standard deviation-is a measure of the overall correlation between the components of a random vector. Both the Wilks standard deviation and the uncorrelation index are, respectively, special cases of two general notions that we introduce: "randomness measures" and "independence indices" of random vectors. In turn, these general notions give rise to "randomness diagrams"-tangible planar visualizations that answer the question: How random is a random vector? The notion of "independence indices" yields a novel measure of correlation for Lévy laws. In general, the concepts and results presented in this paper are applicable to any field of science and engineering with random-vectors empirical data.

  7. Educational Effects of the Tools of the Mind Curriculum: A Randomized Trial

    ERIC Educational Resources Information Center

    Barnett, W.Steven; Jung, Kwanghee; Yarosz, Donald J.; Thomas, Jessica; Hornbeck, Amy; Stechuk, Robert; Burns, Susan

    2008-01-01

    The effectiveness of the "Tools of the Mind (Tools)" curriculum in improving the education of 3- and 4-year-old children was evaluated by means of a randomized trial. The "Tools" curriculum, based on the work of Vygotsky, focuses on the development of self-regulation at the same time as teaching literacy and mathematics skills…

  8. Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

    PubMed Central

    Harrison, R; Dey, P; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R; Logue, J P; Leidecker, V; Hopwood, P

    2001-01-01

    In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11139305

  9. The effectiveness of dentifrices without and with sodium lauryl sulfate on plaque, gingivitis and gingival abrasion--a randomized clinical trial.

    PubMed

    Sälzer, S; Rosema, N A M; Martin, E C J; Slot, D E; Timmer, C J; Dörfer, C E; van der Weijden, G A

    2016-04-01

    The aim of this study was to compare the efficacy of a dentifrice without sodium lauryl sulfate (SLS) to a dentifrice with SLS in young adults aged 18-34 years on gingivitis. One hundred twenty participants (non-dental students) with a moderate gingival inflammation (bleeding on probing at 40-70 % of test sites) were included in this randomized controlled double blind clinical trial. According to randomization, participants had to brush their teeth either with dentifrice without SLS or with SLS for 8 weeks. The primary outcome was bleeding on marginal probing (BOMP). The secondary outcomes were plaque scores and gingival abrasion scores (GA) as well as a visual analogue scale (VAS) score at exit survey. Baseline and end differences were analysed by univariate analysis of covariance (ANCOVA) test, between group differences by independent t test and within groups by paired sample t test. BOMP improved within groups from on average 0.80 at baseline to 0.60 in the group without SLS and to 0.56 in the group with SLS. No statistical difference for BOMP, plaque and gingival abrasion was found between both groups. VAS scores for taste, freshness and foaming effect were significantly in favour of the SLS-containing dentifrice. The test dentifrice without SLS was as effective as a regular SLS dentifrice on gingival bleeding scores and plaque scores. There was no significant difference in the incidence of gingival abrasion. In patients diagnosed with gingivitis, a dentifrice without SLS seems to be equally effective compared to a dentifrice with SLS and did not demonstrate any significant difference in gingival abrasion. In patient with recurrent aphthous ulcers, the absence of SLS may even be beneficial. However, participants indicate that they appreciate the foaming effect of a dentifrice with SLS more.

  10. Evaluation of the effects of a diabetes educational program: a randomized clinical trial.

    PubMed

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-02-05

    Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). The educational program model developed was effective to improve the glycemic control of the intervention group participants.

  11. Consumer trust to a Web site: moderating effect of attitudes toward online shopping.

    PubMed

    San Martín, Sonia; Camarero, Carmen

    2008-10-01

    In this paper, authors suggest a model that reflects the role played by the Web site characteristics and the previous level of satisfaction as determinant factors of trust in the Web site. Also, authors consider the moderating effects of consumers' motives and inhibitors to purchase online. Results show that satisfaction with previous purchases, the Web site security and privacy policies, and service quality are the main determinants of trust. Also, the motives and inhibitors the individuals perceive when buying online determine the type of signals they consider to trust.

  12. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  13. My Student Body: A High-Risk Drinking Prevention Web Site for College Students

    PubMed Central

    Chiauzzi, Emil; Green, Traci Craig; Lord, Sarah; Thum, Christina; Goldstein, Marion

    2007-01-01

    The authors investigated the efficacy of an interactive Web site, MyStudentBody.com: Alcohol (MSB:Alcohol) that offers a brief, tailored intervention to help heavy drinking college students reduce their alcohol use. They conducted a randomized, controlled clinical trial to compare the intervention with an alcohol education Web site at baseline, postintervention, and 3-month follow-up. Students were assessed on various drinking measures and their readiness to change their drinking habits. The intervention was especially effective for women and persistent binge drinkers. Compared with women who used the control Web site, women who used the intervention significantly reduced their peak and total consumption during special occasions and also reported significantly fewer negative consequences related to drinking. In addition, persistent heavy binge drinkers in the experimental group experienced a more rapid decrease in average consumption and peak consumption compared with those in the control group. The authors judged MSB:Alcohol a useful intervention for reaching important subgroups of college binge drinkers. PMID:15900990

  14. Alternative right ventricular pacing sites.

    PubMed

    Łuciuk, Dariusz; Łuciuk, Marek; Gajek, Jacek

    2015-01-01

    The main adverse effect of chronic stimulation is stimulation-induced heart failure in case of ventricular contraction dyssynchrony. Because of this fact, new techniques of stimulation should be considered to optimize electrotherapy. One of these methods is pacing from alternative right ventricular sites. The purpose of this article is to review currently accumulated data about alternative sites of cardiac pacing. Medline and PubMed bases were used to search English and Polish reports published recently. Recent studies report a deleterious effect of long term apical pacing. It is suggested that permanent apical stimulation, by omitting physiological conduction pattern with His-Purkinie network, may lead to electrical and mechanical dyssynchrony of heart muscle contraction. In the long term this pathological situation can lead to severe heart failure and death. Because of this, scientists began to search for some alternative sites of cardiac pacing to reduce the deleterious effect of stimulation. Based on current accumulated data, it is suggested that the right ventricular outflow tract, right ventricular septum, direct His-bundle or biventricular pacing are better alternatives due to more physiological electrical impulse propagation within the heart and the reduction of the dyssynchrony effect. These methods should preserve a better left ventricular function and prevent the development of heart failure in permanent paced patients. As there is still not enough, long-term, randomized, prospective, cross-over and multicenter studies, further research is required to validate the benefits of using this kind of therapy. The article should pay attention to new sites of cardiac stimulation as a better and safer method of treatment.

  15. Effective pore-scale dispersion upscaling with a correlated continuous time random walk approach

    NASA Astrophysics Data System (ADS)

    Le Borgne, T.; Bolster, D.; Dentz, M.; de Anna, P.; Tartakovsky, A.

    2011-12-01

    We investigate the upscaling of dispersion from a pore-scale analysis of Lagrangian velocities. A key challenge in the upscaling procedure is to relate the temporal evolution of spreading to the pore-scale velocity field properties. We test the hypothesis that one can represent Lagrangian velocities at the pore scale as a Markov process in space. The resulting effective transport model is a continuous time random walk (CTRW) characterized by a correlated random time increment, here denoted as correlated CTRW. We consider a simplified sinusoidal wavy channel model as well as a more complex heterogeneous pore space. For both systems, the predictions of the correlated CTRW model, with parameters defined from the velocity field properties (both distribution and correlation), are found to be in good agreement with results from direct pore-scale simulations over preasymptotic and asymptotic times. In this framework, the nontrivial dependence of dispersion on the pore boundary fluctuations is shown to be related to the competition between distribution and correlation effects. In particular, explicit inclusion of spatial velocity correlation in the effective CTRW model is found to be important to represent incomplete mixing in the pore throats.

  16. Prevalence of skeletal and eye malformations in frogs from north-central United States: estimations based on collections from randomly selected sites.

    PubMed

    Schoff, Patrick K; Johnson, Catherine M; Schotthoefer, Anna M; Murphy, Joseph E; Lieske, Camilla; Cole, Rebecca A; Johnson, Lucinda B; Beasley, Val R

    2003-07-01

    Skeletal malformation rates for several frog species were determined in a set of randomly selected wetlands in the north-central USA over three consecutive years. In 1998, 62 sites yielded 389 metamorphic frogs, nine (2.3%) of which had skeletal or eye malformations. A subset of the original sites was surveyed in the following 2 yr. In 1999, 1,085 metamorphic frogs were collected from 36 sites and 17 (1.6%) had skeletal or eye malformations, while in 2000, examination of 1,131 metamorphs yielded 16 (1.4%) with skeletal or eye malformations. Hindlimb malformations predominated in all three years, but other abnormalities, involving forelimb, eye, and pelvis were also found. Northern leopard frogs (Rana pipiens) constituted the majority of collected metamorphs as well as most of the malformed specimens. However, malformations were also noted in mink frogs (R. septentrionalis), wood frogs (R. sylvatica), and gray tree frogs (Hyla spp.). The malformed specimens were found in clustered sites in all three years but the cluster locations were not the same in any year. The malformation rates reported here are higher than the 0.3% rate determined for metamorphic frogs collected from similar sites in Minnesota in the 1960s, and thus, appear to represent an elevation of an earlier baseline malformation rate.

  17. Prevalence of skeletal and eye malformations in frogs from north-central United States: estimations based on collections from randomly selected sites

    USGS Publications Warehouse

    Schoff, P.K.; Johnson, C.M.; Schotthoefer, A.M.; Murphy, J.E.; Lieske, C.; Cole, Rebecca A.; Johnson, L.B.; Beasley, V.R.

    2003-01-01

    Skeletal malformation rates for several frog species were determined in a set of randomly selected wetlands in the north-central USA over three consecutive years. In 1998, 62 sites yielded 389 metamorphic frogs, nine (2.3%) of which had skeletal or eye malformations. A subset of the original sites was surveyed in the following 2 yr. In 1999, 1,085 metamorphic frogs were collected from 36 sites and 17 (1.6%) had skeletal or eye malformations, while in 2000, examination of 1,131 metamorphs yielded 16 (1.4%) with skeletal or eye malformations. Hindlimb malformations predominated in all three years, but other abnormalities, involving forelimb, eye, and pelvis were also found. Northern leopard frogs (Rana pipiens) constituted the majority of collected metamorphs as well as most of the malformed specimens. However, malformations were also noted in mink frogs (R. septentrionalis), wood frogs (R. sylvatica), and gray tree frogs (Hyla spp.). The malformed specimens were found in clustered sites in all three years but the cluster locations were not the same in any year. The malformation rates reported here are higher than the 0.3% rate determined for metamorphic frogs collected from similar sites in Minnesota in the 1960s, and thus, appear to represent an elevation of an earlier baseline malformation rate.

  18. Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

    PubMed

    Udsen, Flemming Witt; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars Holger

    2014-05-21

    Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone. The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight). There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial. Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

  19. Effects on the immune system associated with living near a pesticide dump site.

    PubMed Central

    Vine, M F; Stein, L; Weigle, K; Schroeder, J; Degnan, D; Tse, C K; Hanchette, C; Backer, L

    2000-01-01

    In this paper, we report results of the second phase of a larger study designed to evaluate the effects on the immune system of living near a Superfund site containing organochlorine pesticides, volatile organic compounds, and metals. Phase II was conducted to determine whether living near the site, consisting of six locations in Aberdeen, North Carolina, is associated with higher plasma organochlorine levels, immune suppression, or DNA damage. Each of 302 residents of Aberdeen and neighboring communities provided a blood specimen, underwent a skin test, and answered a questionnaire. Blood specimens were analyzed for organochlorine pesticides, immune markers, and micronuclei. Of 20 organochlorines tested, only DDE was detected in the blood of participants (except for one individual). Age-adjusted mean plasma DDE levels were 4.05 ppb for Aberdeen residents and 2.95 ppb (p = 0.01) for residents of neighboring communities. Residents of 40-59 years of age who lived within a mile of any site, but particularly the Farm Chemicals site, had higher plasma DDE levels than residents who lived farther away. Residents who lived near the Farm Chemicals site before versus after 1985 also had higher plasma DDE levels. Overall, there were few differences in immune markers between residents of Aberdeen and the neighboring communities. However, residents who lived closer to the dump sites had statistically significantly lower mitogen-induced lymphoproliferative activity than residents who lived farther away (p < 0.05). Residential location was not consistently associated with frequency of micronuclei or skin test responses. Although some statistically significant differences in immune markers were noted in association with residential location, the magnitude of effects are of uncertain clinical importance. PMID:11133390

  20. The effect of statins on erectile dysfunction: a meta-analysis of randomized trials.

    PubMed

    Kostis, John B; Dobrzynski, Jeanne M

    2014-07-01

    Erectile dysfunction (ED) is common in older men, especially those with comorbidities such as diabetes and atherosclerotic disease, conditions where statins are frequently prescribed. To examine the effect of statin therapy on ED using the five-item version of the International Inventory of Erectile Function (IIEF). We performed a random-effects meta-analysis of studies identified by a systematic search of MEDLINE, Web of Knowledge, the Cochrane Database, and ClinicalTrials.gov. Examination of the 186 retrieved citations resulted in the selection of 11 randomized trials for inclusion in the meta-analysis. Change in the IIEF score. IIEF increased by 3.4 points (95% CI 1.7-5.0, P = 0.0001) with statins compared to control. This effect remained statistically significant after multiple sensitivity analyses, including analysis for publication bias, a cumulative meta-analysis, and 11 repeated analyses with each study omitted sequentially. The increase in IIEF with statins was approximately one-third to one-half of that previously reported with phosphodiesterase-5 inhibitors and larger than the effect of lifestyle modification. Metaregression showed an increase in benefit with decreasing lipophilicity. The average age of participants and the degree of LDL cholesterol lowering did not alter the effect on IIEF. Statins cause a clinically relevant improvement of erectile function as measured by the five-item version of the IIEF. © 2014 International Society for Sexual Medicine.

  1. Effects of Price, Information, and Transactions Cost Interventions to Raise Voluntary Enrollment in a Social Health Insurance Scheme: A Randomized Experiment in the Philippines.

    PubMed

    Capuno, Joseph J; Kraft, Aleli D; Quimbo, Stella; Tan, Carlos R; Wagstaff, Adam

    2016-06-01

    A cluster randomized experiment was undertaken testing two sets of interventions encouraging enrollment in the Individually Paying Program (IPP), the voluntary component of the Philippines' social health insurance program. In early 2011, 1037 unenrolled IPP-eligible families in 179 randomly selected intervention municipalities were given an information kit and offered a 50% premium subsidy valid until the end of 2011; 383 IPP-eligible families in 64 control municipalities were not. In February 2012, the 787 families in the intervention sites who were still IPP-eligible but had not enrolled had their vouchers extended, were resent the enrollment kits and received SMS reminders. Half the group also received a 'handholding' intervention: in the endline interview, the enumerator offered to help complete the enrollment form, deliver it to the insurer's office in the provincial capital, and mail the membership cards. The main intervention raised the enrollment rate by 3 percentage points (ppts) (p = 0.11), with an 8 ppt larger effect (p < 0.01) among city-dwellers, consistent with travel time to the insurance office affecting enrollment. The handholding intervention raised enrollment by 29 ppts (p < 0.01), with a smaller effect (p < 0.01) among city-dwellers, likely because of shorter travel times, and higher education levels facilitating unaided completion of the enrollment form. Copyright © The World Bank Health Economics © 2015 John Wiley & Sons, Ltd. Copyright © The World Bank Health Economics © 2015 John Wiley & Sons, Ltd.

  2. Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

    PubMed

    Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

    2017-10-01

    Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

  3. Network meta-analysis of disconnected networks: How dangerous are random baseline treatment effects?

    PubMed

    Béliveau, Audrey; Goring, Sarah; Platt, Robert W; Gustafson, Paul

    2017-12-01

    In network meta-analysis, the use of fixed baseline treatment effects (a priori independent) in a contrast-based approach is regularly preferred to the use of random baseline treatment effects (a priori dependent). That is because, often, there is not a need to model baseline treatment effects, which carry the risk of model misspecification. However, in disconnected networks, fixed baseline treatment effects do not work (unless extra assumptions are made), as there is not enough information in the data to update the prior distribution on the contrasts between disconnected treatments. In this paper, we investigate to what extent the use of random baseline treatment effects is dangerous in disconnected networks. We take 2 publicly available datasets of connected networks and disconnect them in multiple ways. We then compare the results of treatment comparisons obtained from a Bayesian contrast-based analysis of each disconnected network using random normally distributed and exchangeable baseline treatment effects to those obtained from a Bayesian contrast-based analysis of their initial connected network using fixed baseline treatment effects. For the 2 datasets considered, we found that the use of random baseline treatment effects in disconnected networks was appropriate. Because those datasets were not cherry-picked, there should be other disconnected networks that would benefit from being analyzed using random baseline treatment effects. However, there is also a risk for the normality and exchangeability assumption to be inappropriate in other datasets even though we have not observed this situation in our case study. We provide code, so other datasets can be investigated. Copyright © 2017 John Wiley & Sons, Ltd.

  4. A work-site weight control program using financial incentives collected through payroll deduction.

    PubMed

    Forster, J L; Jeffery, R W; Sullivan, S; Snell, M K

    1985-11-01

    In a work-site weight control program using a self-motivational program of financial incentives implemented through payroll deduction, 131 university employees chose weight loss goals (0 to 60 lb) and incentives (+5 to +30) to be deducted from each paycheck for six months. Return of incentive money was contingent on progress toward weight goals. Participants were assigned randomly to one of four protocols, involving group educational sessions v self-instruction only and required v optional attendance at weigh-ins and sessions. Overall, dropout rates (21.4%) and mean weight loss (12.2 lb) were encouraging, especially compared with those of other work-site programs. Weight loss was positively associated with attendance at weigh-ins and educational sessions. However, requiring attendance did not increase program effectiveness and seemed also to discourage enrollment among men. The weight control program was equally effective when offered with professionally led educational sessions or when accompanied by self-instructional materials only.

  5. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial.

    PubMed

    Wedam, Erich F; Bigelow, George E; Johnson, Rolley E; Nuzzo, Paul A; Haigney, Mark C P

    2007-12-10

    Levomethadyl acetate, methadone hydrochloride, and buprenorphine hydrochloride are equally effective treatments for opioid dependence. Each blocks the human ether-a-go-go-related gene (hERG)-associated channel in vitro and represents a risk for QT prolongation. To compare the effects of 3 known hERG-associated channel blockers on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid-addicted subjects. We analyzed 12-lead electrocardiograms collected at baseline and every 4 weeks from 165 opioid-addicted participants in a 17-week randomized double-blind clinical trial of equally effective doses of levomethadyl, methadone, and buprenorphine at a major referral center. Analyses were limited to the 154 patients with a normal baseline QTc = (QT/ radical R-R) who had at least 1 subsequent in-treatment electrocardiogram. Patients were randomized to receive treatment with levomethadyl, methadone, or buprenorphine (hereinafter, levomethadyl, methadone, and buprenorphine groups, respectively). The prespecified end points were a QTc greater than 470 milliseconds in men (or >490 milliseconds in women), or an increase from baseline in QTc greater than 60 milliseconds. Baseline QTc was similar in the 3 groups. The levomethadyl and methadone groups were significantly more likely to manifest a QTc greater than 470 or 490 milliseconds (28% for the levomethadyl group vs 23% for the methadone group vs 0% for the buprenorphine group; P < .001) or an increase from baseline in QTc greater than 60 milliseconds (21% of the levomethadyl group [odds ratio, 15.8; 95% confidence interval, 3.7-67.1] and 12% of the methadone group [odds ratio, 8.4; 95% confidence interval, 1.9-36.4]) compared with the buprenorphine group (2% of subjects; P < .001). In subjects whose dosage of levomethadyl or methadone remained fixed over at least 8 weeks, the QTc continued to increase progressively over time (P = .08 for the levomethadyl group, P = .01 for the methadone group

  6. Resistant hypertension optimal treatment trial: a randomized controlled trial.

    PubMed

    Krieger, Eduardo M; Drager, Luciano F; Giorgi, Dante Marcelo Artigas; Krieger, Jose Eduardo; Pereira, Alexandre Costa; Barreto-Filho, José Augusto Soares; da Rocha Nogueira, Armando; Mill, José Geraldo

    2014-01-01

    The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen. © 2013 Wiley Periodicals, Inc.

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

    PubMed

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

    2014-12-01

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

  8. Height Response to Harvesting Intensity and Site Preparation in Four Young Loblolly Pine Plantations

    Treesearch

    Thomas J. Dean; Ray A. Newbold

    2002-01-01

    A study was conducted to analyze the general effects of harvesting intensity and postharvest treatments on the average, three-year height of loblolly pine (Pinus taeda L.). This was accomplished by analyzing treatment effects across four study sites by treating the locations as random effects in the statistical model. Whole-tree harvesting using...

  9. Effect-site concentration of remifentanil during patient-controlled analgesia in labour.

    PubMed

    Jost, A; Blagus, R; Ban, B; Kamenik, M

    2015-08-01

    Intravenous remifentanil has been described for patient-controlled analgesia in labour. Recently, the application of target-controlled infusion pumps with Minto's pharmacokinetic/pharmacodynamic model has been reported. Hypothetical effect-site remifentanil concentration during patient-controlled analgesia for labour has yet to be examined. The aim of this concept study was to explore characteristics of this parameter. We performed a historical cohort study based on our previous randomised cross-over clinical trial and analysed hypothetical effect-site remifentanil concentration. Values at spontaneous vaginal delivery and Apgar scores were tested for correlation. The association between pain score and the corresponding effect-site remifentanil concentration before and after bolus administration, and their relative difference, was examined with a linear mixed-effects model, adjusted for other variables. A series of 23 parturients with uncomplicated singleton pregnancies were included. On average, effect-site remifentanil concentration was highest during the third quarter throughout our recordings (5.5ng/mL; maximum 15.8ng/mL). The mean (median) {IQR} [range] at spontaneous vaginal delivery (n=14) was 2.52 (1.32) {0.95-4.28} [0.65-6.88] ng/mL, all Apgar scores were >7, and no correlation was confirmed. A negative association between effect-site remifentanil concentration before bolus administration and pain score (scale 0-100) was observed (-3.9, 95% CI -5.16 to -2.61, P <0.01). The residual value of hypothetical effect-site remifentanil concentration before uterine contraction, at the beginning of bolus administration, predicted lower pain scores. Monitoring effect-site remifentanil concentration may be potentially useful when remifentanil is administered for labour analgesia. However, our results need to be confirmed with a pharmacokinetic model optimized for pregnant patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Patient-centered recruitment and retention for a randomized controlled study.

    PubMed

    Chhatre, Sumedha; Jefferson, Ashlie; Cook, Ratna; Meeker, Caitlin R; Kim, Ji Hyun; Hartz, Kayla Marie; Wong, Yu-Ning; Caruso, Adele; Newman, Diane K; Morales, Knashawn H; Jayadevappa, Ravishankar

    2018-03-27

    Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large

  11. Mediating Parent Learning to Promote Social Communication for Toddlers with Autism: Effects from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Schertz, Hannah H.; Odom, Samuel L.; Baggett, Kathleen M.; Sideris, John H.

    2018-01-01

    A randomized controlled trial was conducted to evaluate effects of the Joint Attention Mediated Learning (JAML) intervention. Toddlers with autism spectrum disorders (ASD) aged 16-30 months (n = 144) were randomized to intervention and community control conditions. Parents, who participated in 32 weekly home-based sessions, followed a mediated…

  12. Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

    2017-01-01

    A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

  13. The effects of Web site structure: the role of personal difference.

    PubMed

    Chung, Hwiman; Ahn, Euijin

    2007-12-01

    This study examined the effects of Web site structures in terms of advertising effectiveness- memory, attitude, and behavioral intentions. The primary research question for this study is, What type of Web site (Web ad) structure is most effective? In the pilot study, we tested the difference between two Web site structures, linear and interactive, in terms of traditional advertising effectiveness. Results from the pilot study did not support our research expectations. However, differences in terms of memory were noted between the two structures. After re-creating the Web site based on subjects' comments, in the final experiment, we examined the differences between the two structures and the moderating role of personality difference on the effects of Web site structure. The results confirm that participants' attitude, memory, and behavioral intentions were affected differently by the different Web site structures. However, some research hypotheses were not supported by the current data.

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

    PubMed

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

    2014-05-01

    Neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder (ADHD), mainly attention problems. However, the additional influence of neurofeedback over treatment as usual (TAU) on neurocognitive functioning for adolescents with ADHD remains unclear. By using a multicenter parallel randomized controlled trial (RCT) design, male adolescents with a DSM-IV-TR diagnosis of ADHD (mean age = 16.1 years; range, 12-24) were randomized to receive either a combination of TAU and neurofeedback (n = 45) or TAU (n = 26). Randomization was computer generated and stratified by age group (ages 12 through 15, 16 through 20, and 21 through 24 years). The neurofeedback intervention consisted of approximately 37 sessions over a period of 25 weeks of theta/sensorimotor rhythm training on the vertex (Cz). Primary neurocognitive outcomes included performance parameters derived from the D2 Test of Attention, the Digit Span backward, the Stroop Color-Word Test and the Tower of London, all assessed preintervention and postintervention. Data were collected between December 2009 and July 2012. At postintervention, outcomes of attention and/or motor speed were improved, with faster processing times for both intervention conditions and with medium to large effect sizes (range, ηp2 = .08-.54; P values < .023). In both groups, no improvements for higher executive functions were observed. Results might partly resemble practice effects. Although neurocognitive outcomes improved in all adolescents receiving treatment for ADHD, no additional value for neurofeedback over TAU was observed. Hence, this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to TAU for adolescents with ADHD symptoms. Trialregister.nl identifier: 1759. © Copyright 2014 Physicians Postgraduate Press, Inc.

  15. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

    PubMed

    Platt, Richard; Takvorian, Samuel U; Septimus, Edward; Hickok, Jason; Moody, Julia; Perlin, Jonathan; Jernigan, John A; Kleinman, Ken; Huang, Susan S

    2010-06-01

    The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. All admissions to adult ICUs. The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. Recruitment of hospitals is complete. Data collection will end in Summer 2011. This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

  16. Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial.

    PubMed

    Lee, Myung Kyung; Park, Bu Kyung

    2018-01-01

    This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums.

  17. Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial

    PubMed Central

    Lee, Myung Kyung

    2018-01-01

    Objectives This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. Methods The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Results Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. Conclusions The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums. PMID:29503755

  18. Exploring Mechanisms of Effective Teacher Coaching: A Tale of Two Cohorts From a Randomized Experiment

    ERIC Educational Resources Information Center

    Blazar, David; Kraft, Matthew A.

    2015-01-01

    Although previous research has shown that teacher coaching can improve teaching practices and student achievement, little is known about specific features of effective coaching programs. We estimate the impact of MATCH Teacher Coaching (MTC) on a range of teacher practices using a blocked randomized trial and explore how changes in the coaching…

  19. Psycho-education for substance use and antisocial personality disorder: a randomized trial.

    PubMed

    Thylstrup, Birgitte; Schrøder, Sidsel; Hesse, Morten

    2015-11-14

    Antisocial personality disorder often co-exists with drug and alcohol use disorders. This trial examined the effectiveness of offering psycho-education for antisocial personality disorder in community substance use disorder treatment centers in Denmark. A total of 176 patients were randomly allocated to treatment as usual (TAU, n = 80) or TAU plus a psycho-educative program, Impulsive Lifestyle Counselling (ILC, n = 96) delivered by site clinicians (n = 39). Using follow-up interviews 3 and 9 months after randomization, we examined changes in drug and alcohol use (Addiction Severity Index Composite Scores), percent days abstinent (PDA) within last month, and aggression as measured with the Buss-Perry Aggression Questionnaire-Short Form and the Self-Report of Aggression and Social Behavior Measure. Overall engagement in psychological interventions was modest: 71 (76 %) of participants randomized to psycho-education attended at least one counselling session, and 21 (23 %) attended all six sessions. The Median number of sessions was 2. All patients reduced drug and alcohol problems at 9 months with small within-group effect sizes. Intention-to-treat analyses indicated significant differences between ILC and TAU in mean drugs composite score (p = .018) and in PDA (p = .041) at 3 months. Aggression declined in both groups, but no differences between ILC and TAU were observed in terms of alcohol problems or aggression at any follow-up. Moderate short-term improvements in substance use were associated with randomization to Impulsive Lifestyle Counselling. The findings support the usefulness of providing psycho-education to outpatients with antisocial personality disorder. ISRCTN registry, ISRCTN67266318 , 17/7/2012.

  20. Effectiveness of horticultural therapy: a systematic review of randomized controlled trials.

    PubMed

    Kamioka, Hiroharu; Tsutani, Kiichiro; Yamada, Minoru; Park, Hyuntae; Okuizumi, Hiroyasu; Honda, Takuya; Okada, Shinpei; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Handa, Shuichi; Mutoh, Yoshiteru

    2014-10-01

    To summarize the evidence from randomized controlled trials (RCTs) on the effects of horticultural therapy (HT). Studies were eligible if they were RCTs. Studies included one treatment group in which HT was applied. We searched the following databases from 1990 up to August 20, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi-Web, GHL, WPRIM, and PsyclNFO. We also searched all Cochrane Database and Campbell Systematic Reviews up to September 20, 2013. Four studies met all inclusion criteria. The language of all eligible publications was English and Korean. Target diseases and/or symptoms were dementia, severe mental illness such as schizophrenia, bipolar disorder, and major depression, frail elderly in nursing home, and hemiplegic patients after stroke. These studies showed significant effectiveness in one or more outcomes for mental health and behavior. However, our review especially detected omissions of the following descriptions: method used to generate randomization, concealment, blinding, and intention-to-treat analysis. In addition, the results of this study suggested that the RCTs conducted have been of relatively low quality. Although there was insufficient evidence in the studies of HT due to poor methodological and reporting quality and heterogeneity, HT may be an effective treatment for mental and behavioral disorders such as dementia, schizophrenia, depression, and terminal-care for cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Evaluation of the effects of a diabetes educational program: a randomized clinical trial

    PubMed Central

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-01-01

    ABSTRACT OBJECTIVE Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. METHODS This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. RESULTS After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). CONCLUSIONS The educational program model developed was effective to improve the glycemic control of the intervention group participants. PMID:29412378

  2. A systematic appraisal of allegiance effect in randomized controlled trials of psychotherapy.

    PubMed

    Dragioti, Elena; Dimoliatis, Ioannis; Fountoulakis, Konstantinos N; Evangelou, Evangelos

    2015-01-01

    Experimenter's allegiance (EA) refers to a personal confidence of the superiority of a specific psychotherapy treatment. This factor has been linked with larger treatment effects in favor of the preferred treatment. However, various studies have displayed contradictory results between EA and the pattern of treatment effects. Using a systematic approach followed by meta-analysis, we aimed to evaluate the impact of an allegiance effect on the results of psychotherapeutic studies. We considered the meta-analyses of randomized controlled trials (RCTs) of different types of psychotherapies in the Cochrane Database of Systematic Reviews. Eligible articles included meta-analyses of RCTs with at least one study showing evidence of EA (i.e., allegiant study). Effect sizes in allegiant RCTs were compared with non-allegiant using random and fixed models and a summary relative odds ratio (ROR) were calculated. Heterogeneity was quantified with the I (2) metric. A total of 30 meta-analyses including 240 RCTs were analyzed. The summary ROR was 1.31 [(95 % confidence interval (CI: 1.03-1.66) P = 0.30, I (2) = 53 %] indicating larger effects when allegiance exists. The impact of allegiance did not differ significantly (P > 0.05) when we compared psychiatric versus medical outcomes. Allegiance effect was significant for all forms of psychotherapy except for cognitive behavioral therapy. Moreover, the impact of allegiance was significant only when the treatment integrity of delivered psychotherapy was not assessed. Allegiance effect was even stronger where the experimenter was also both the developer of the preferred treatment and supervised or trained the therapists. No significant differences were found between allegiant and non-allegiant studies in terms of overall quality of studies. Experimenter's allegiance influences the effect sizes of psychotherapy RCTs and can be considered non-financial conflict of interest introducing a form of optimism bias, especially since

  3. Long-Term Effectiveness, under a Mountain Environment, of a Novel Conservation Nanomaterial Applied on Limestone from a Roman Archaeological Site.

    PubMed

    Elhaddad, Farid; Carrascosa, Luis A M; Mosquera, Maria J

    2018-04-28

    A novel alkoxysilane-based product was applied on limestone samples from a Roman archaeological site. The study consisted of an initial phase to evaluate site environmental conditions in order to choose the most suitable product type to be applied. The decay that was produced in the site is mainly caused by natural action, with water being the main vehicle for the decay agents. Thus, the effectiveness of an innovative product with hydrophobic/consolidant properties and two commercial products (consolidant and hydrophobic agent) were evaluated on limestone from Acinipo site, under laboratory conditions. Next, the long-term effectiveness of the three products under study was evaluated by the exposure of limestone samples in the archaeological site for a period of three years. Since the recognized incompatibility between alkoxysilanes and pure carbonate stones, the interaction between the products and the limestones was widely investigated. The results that were obtained allow for it to be concluded that the innovative product presents adequate compatibility and adherence to the limestone under study, producing a long-term effective, homogeneous, and continuous coating with a depth of penetration of up to 10 mm. However, the commercial products produced discontinuous aggregates on the limestone surface, did not penetrate into its porous structure and it did not produce long-lasting effects.

  4. Quantifying the placebo effect in psychological outcomes of exercise training: a meta-analysis of randomized trials.

    PubMed

    Lindheimer, Jacob B; O'Connor, Patrick J; Dishman, Rod K

    2015-05-01

    The placebo effect could account for some or all of the psychological benefits attributed to exercise training. The magnitude of the placebo effect in psychological outcomes of randomized controlled exercise training trials has not been quantified. The aim of this investigation was to estimate the magnitude of the population placebo effect in psychological outcomes from placebo conditions used in exercise training studies and compare it to the observed effect of exercise training. Articles published before 1 July 2013 were located using Google Scholar, MEDLINE, PsycINFO, and The Cochrane Library. To be included in the analysis, studies were required to have (1) a design that randomly assigned participants to exercise training, placebo, and control conditions and (2) an assessment of a subjective (i.e., anxiety, depression, energy, fatigue) or an objective (i.e., cognitive) psychological outcome. Meta-analytic and multi-level modeling techniques were used to analyze effects from nine studies involving 661 participants. Hedges' d effect sizes were calculated, and random effects models were used to estimate the overall magnitude of the placebo and exercise training effects. After adjusting for nesting effects, the placebo mean effect size was 0.20 (95% confidence interval [CI] -0.02, 0.41) and the observed effect of exercise training was 0.37 (95% CI 0.11, 0.63). A small body of research suggests both that (1) the placebo effect is approximately half of the observed psychological benefits of exercise training and (2) there is an urgent need for creative research specifically aimed at better understanding the role of the placebo effect in the mental health consequences of exercise training.

  5. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase.

    PubMed

    Tan, Gabriel; Rintala, Diana H; Jensen, Mark P; Richards, J Scott; Holmes, Sally Ann; Parachuri, Rama; Lashgari-Saegh, Shamsi; Price, Larry R

    2011-01-01

    Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Multi-site, double-blind, sham-controlled study. Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess 'as-needed' CES use. Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal-Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief.

  6. Comparison of Piezosurgery and Conventional Rotary Instruments for Removal of Impacted Mandibular Third Molars: A Randomized Controlled Clinical and Radiographic Trial

    PubMed Central

    Shokry, Mohamed; Aboelsaad, Nayer

    2016-01-01

    The purpose of this study was to test the effect of the surgical removal of impacted mandibular third molars using piezosurgery versus the conventional surgical technique on postoperative sequelae and bone healing. Material and Methods. This study was carried out as a randomized controlled clinical trial: split mouth design. Twenty patients with bilateral mandibular third molar mesioangular impaction class II position B indicated for surgical extraction were treated randomly using either the piezosurgery or the conventional bur technique on each site. Duration of the procedure, postoperative edema, trismus, pain, healing, and bone density and quantity were evaluated up to 6 months postoperatively. Results. Test and control sites were compared using paired t-test. There was statistical significance in reduction of pain and swelling in test sites, where the time of the procedure was statistically increased in test site. For bone quantity and quality, statistical difference was found where test site showed better results. Conclusion. Piezosurgery technique improves quality of patient's life in form of decrease of postoperative pain, trismus, and swelling. Furthermore, it enhances bone quality within the extraction socket and bone quantity along the distal aspect of the mandibular second molar. PMID:27597866

  7. Adherence to treatment with artemether-lumefantrine or amodiaquine-artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial.

    PubMed

    Banek, Kristin; Webb, Emily L; Smith, Samuel Juana; Chandramohan, Daniel; Staedke, Sarah G

    2018-06-04

    Prompt, effective treatment of confirmed malaria cases with artemisinin-based combination therapy (ACT) is a cornerstone of malaria control. Maximizing adherence to ACT medicines is key to ensuring treatment effectiveness. This open-label, randomized trial evaluated caregiver adherence to co-formulated artemether-lumefantrine (AL) and fixed-dose amodiaquine-artesunate (AQAS) in Sierra Leone. Children aged 6-59 months diagnosed with malaria were recruited from two public clinics, randomized to receive AL or AQAS, and visited at home the day after completing treatment. Analyses were stratified by site, due to differences in participant characteristics and outcomes. Of the 784 randomized children, 680 (85.6%) were included in the final per-protocol analysis (340 AL, 340 AQAS). Definite adherence (self-reported adherence plus empty package) was higher for AL than AQAS at both sites (Site 1: 79.4% AL vs 63.4% AQAS, odds ratio [OR] 2.16, compared to probable adherence plus probable or definite non-adherence, 95% confidence interval [CI] 1.34-3.49; p = 0.001; Site 2: 52.1% AL vs 37.5% AQAS, OR 1.53, 95% CI 1.00-2.33, p = 0.049). However, self-reported adherence (ignoring drug package inspection) was higher for both regimens at both sites and there was no strong evidence of variation by treatment (Site 1: 96.6% AL vs 95.9% AQAS, OR 1.19, 95% CI 0.39-3.63, p = 0.753; Site 2: 91.5% AL vs 96.4% AQAS, OR 0.40, 95% CI 0.15-1.07, p = 0.067). In Site 2, correct treatment (correct dose + timing + duration) was lower for AL than AQAS (75.8% vs 88.1%, OR 0.42, 95% CI 0.23-0.76, p = 0.004). In both sites, more caregivers in the AQAS arm reported adverse events (Site 1: 3.4% AL vs 15.7% AQAS, p < 0.001; Site 2: 15.2% AL vs 24.4% AQAS, p = 0.039). Self-reported adherence was high for both AL and AQAS, but varied by site. These results suggest that each regimen has potential disadvantages that might affect adherence; AL was less likely to be taken

  8. Utility and Cost-Effectiveness of Motivational Messaging to Increase Survey Response in Physicians: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chan, Randolph C. H.; Mak, Winnie W. S.; Pang, Ingrid H. Y.; Wong, Samuel Y. S.; Tang, Wai Kwong; Lau, Joseph T. F.; Woo, Jean; Lee, Diana T. F.; Cheung, Fanny M.

    2018-01-01

    The present study examined whether, when, and how motivational messaging can boost the response rate of postal surveys for physicians based on Higgin's regulatory focus theory, accounting for its cost-effectiveness. A three-arm, blinded, randomized controlled design was used. A total of 3,270 doctors were randomly selected from the registration…

  9. Exploration and Trapping of Mortal Random Walkers

    NASA Astrophysics Data System (ADS)

    Yuste, S. B.; Abad, E.; Lindenberg, Katja

    2013-05-01

    Exploration and trapping properties of random walkers that may evanesce at any time as they walk have seen very little treatment in the literature, and yet a finite lifetime is a frequent occurrence, and its effects on a number of random walk properties may be profound. For instance, whereas the average number of distinct sites visited by an immortal walker grows with time without bound, that of a mortal walker may, depending on dimensionality and rate of evanescence, remain finite or keep growing with the passage of time. This number can in turn be used to calculate other classic quantities such as the survival probability of a target surrounded by diffusing traps. If the traps are immortal, the survival probability will vanish with increasing time. However, if the traps are evanescent, the target may be spared a certain death. We analytically calculate a number of basic and broadly used quantities for evanescent random walkers.

  10. The effect of atomoxetine on random and directed exploration in humans.

    PubMed

    Warren, Christopher M; Wilson, Robert C; van der Wee, Nic J; Giltay, Eric J; van Noorden, Martijn S; Cohen, Jonathan D; Nieuwenhuis, Sander

    2017-01-01

    The adaptive regulation of the trade-off between pursuing a known reward (exploitation) and sampling lesser-known options in search of something better (exploration) is critical for optimal performance. Theory and recent empirical work suggest that humans use at least two strategies for solving this dilemma: a directed strategy in which choices are explicitly biased toward information seeking, and a random strategy in which decision noise leads to exploration by chance. Here we examined the hypothesis that random exploration is governed by the neuromodulatory locus coeruleus-norepinephrine system. We administered atomoxetine, a norepinephrine transporter blocker that increases extracellular levels of norepinephrine throughout the cortex, to 22 healthy human participants in a double-blind crossover design. We examined the effect of treatment on performance in a gambling task designed to produce distinct measures of directed exploration and random exploration. In line with our hypothesis we found an effect of atomoxetine on random, but not directed exploration. However, contrary to expectation, atomoxetine reduced rather than increased random exploration. We offer three potential explanations of our findings, involving the non-linear relationship between tonic NE and cognitive performance, the interaction of atomoxetine with other neuromodulators, and the possibility that atomoxetine affected phasic norepinephrine activity more so than tonic norepinephrine activity.

  11. Random versus fixed-site sampling when monitoring relative abundance of fishes in headwater streams of the upper Colorado River basin

    USGS Publications Warehouse

    Quist, M.C.; Gerow, K.G.; Bower, M.R.; Hubert, W.A.

    2006-01-01

    Native fishes of the upper Colorado River basin (UCRB) have declined in distribution and abundance due to habitat degradation and interactions with normative fishes. Consequently, monitoring populations of both native and nonnative fishes is important for conservation of native species. We used data collected from Muddy Creek, Wyoming (2003-2004), to compare sample size estimates using a random and a fixed-site sampling design to monitor changes in catch per unit effort (CPUE) of native bluehead suckers Catostomus discobolus, flannelmouth suckers C. latipinnis, roundtail chub Gila robusta, and speckled dace Rhinichthys osculus, as well as nonnative creek chub Semotilus atromaculatus and white suckers C. commersonii. When one-pass backpack electrofishing was used, detection of 10% or 25% changes in CPUE (fish/100 m) at 60% statistical power required 50-1,000 randomly sampled reaches among species regardless of sampling design. However, use of a fixed-site sampling design with 25-50 reaches greatly enhanced the ability to detect changes in CPUE. The addition of seining did not appreciably reduce required effort. When detection of 25-50% changes in CPUE of native and nonnative fishes is acceptable, we recommend establishment of 25-50 fixed reaches sampled by one-pass electrofishing in Muddy Creek. Because Muddy Creek has habitat and fish assemblages characteristic of other headwater streams in the UCRB, our results are likely to apply to many other streams in the basin. ?? Copyright by the American Fisheries Society 2006.

  12. Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

    PubMed Central

    Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

    2013-01-01

    Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

  13. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    PubMed

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

  14. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

    PubMed

    Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

    2017-04-01

    The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  15. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial.

    PubMed

    Ledford, Christy J W; Womack, Jasmyne J; Rider, Heather A; Seehusen, Angela B; Conner, Stephen J; Lauters, Rebecca A; Hodge, Joshua A

    2018-06-01

    As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing mobile apps with other modalities of patient education and engagement tools. This study was designed to test the effectiveness of a mobile app as a replacement for a spiral notebook guide as a patient education and engagement tool in the prenatal clinical setting. This randomized controlled trial was conducted in the Women's Health Clinic and Family Health Clinic of three hospitals. Repeated-measures analysis of covariance was used to test intervention effects in the study sample of 205 patients. Mothers used a mobile app interface to more frequently record information about their pregnancy; however, across time, mothers using a mobile app reported a significant decrease in patient activation. The unexpected negative effects in the group of patients randomized to the mobile app prompt these authors to recommend that health systems pause before distributing their own version of mobile apps that may decrease patient activation. Mobile apps can be inherently empowering and engaging, but how a system encourages their use may ultimately determine their adoption and success.

  16. A Randomized Controlled Study of Neurofeedback for Chronic PTSD

    PubMed Central

    van der Kolk, Bessel A.; Hodgdon, Hilary; Gapen, Mark; Musicaro, Regina; Suvak, Michael K.; Hamlin, Ed; Spinazzola, Joseph

    2016-01-01

    Introduction Brain/Computer Interaction (BCI) devices are designed to alter neural signals and, thereby, mental activity. This study was a randomized, waitlist (TAU) controlled trial of a BCI, EEG neurofeedback training (NF), in patients with chronic PTSD to explore the capacity of NF to reduce PTSD symptoms and increase affect regulation capacities. Study Design 52 individuals with chronic PTSD were randomized to either NF (n = 28) or waitlist (WL) (n = 24). They completed four evaluations, at baseline (T1), after week 6 (T2), at post-treatment (T3), and at one month follow up (T4). Assessment measures were:1. Traumatic Events Screening Inventory (T1); 2. the Clinician Administered PTSD Scale (CAPS; T1, T3, T4); 3. the Davidson Trauma Scale (DTS; T1-T4) and 4. the Inventory of Altered Self-Capacities (IASC; T1-T4). NF training occurred two times per week for 12 weeks and involved a sequential placement with T4 as the active site, P4 as the reference site. Results Participants had experienced an average of 9.29 (SD = 2.90) different traumatic events. Post-treatment a significantly smaller proportion of NF (6/22, 27.3%) met criteria for PTSD than the WL condition (15/22, 68.2%), χ2 (n = 44, df = 1) = 7.38, p = .007. There was a significant treatment condition x time interaction (b = -10.45, t = -5.10, p< .001). Measures of tension reduction activities, affect dysregulation, and affect instability exhibited a significant Time x Condition interaction. The effect sizes of NF (d = -2.33 within, d = - 1.71 between groups) are comparable to those reported for the most effective evidence based treatments for PTSD. Discussion Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action. PMID:27992435

  17. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials.

    PubMed

    Sheridan, Stacey L; Golin, Carol; Bunton, Audrina; Lykes, John B; Schwartz, Bob; McCormack, Lauren; Driscoll, David; Bangdiwala, Shrikant I; Harris, Russell P

    2012-11-13

    Professional societies recommend shared decision making (SDM) for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1) examine the effects of a prostate cancer screening intervention to promote SDM and 2) determine whether framing prostate information in the context of other clearly beneficial men's health services affects decisions. We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men's health services). For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials). Within each practice site, we randomized men to either 1) a video-based decision aid and researcher-led coaching session or 2) a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. Compared to an attention control, our prostate cancer screening intervention increased men's perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57%) and men's knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%), but had no effect on men's self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference -34%; 95% CI -50% to -18%) and actual screening rates (absolute difference -22%; 95% CI -38 to -7%) with no difference in effect by frame. SDM interventions can

  18. Quantum random walks on congested lattices and the effect of dephasing.

    PubMed

    Motes, Keith R; Gilchrist, Alexei; Rohde, Peter P

    2016-01-27

    We consider quantum random walks on congested lattices and contrast them to classical random walks. Congestion is modelled on lattices that contain static defects which reverse the walker's direction. We implement a dephasing process after each step which allows us to smoothly interpolate between classical and quantum random walks as well as study the effect of dephasing on the quantum walk. Our key results show that a quantum walker escapes a finite boundary dramatically faster than a classical walker and that this advantage remains in the presence of heavily congested lattices.

  19. Quantum random walks on congested lattices and the effect of dephasing

    PubMed Central

    Motes, Keith R.; Gilchrist, Alexei; Rohde, Peter P.

    2016-01-01

    We consider quantum random walks on congested lattices and contrast them to classical random walks. Congestion is modelled on lattices that contain static defects which reverse the walker’s direction. We implement a dephasing process after each step which allows us to smoothly interpolate between classical and quantum random walks as well as study the effect of dephasing on the quantum walk. Our key results show that a quantum walker escapes a finite boundary dramatically faster than a classical walker and that this advantage remains in the presence of heavily congested lattices. PMID:26812924

  20. Effective virtual screening protocol for CYP2C9 ligands using a screening site constructed from flurbiprofen and S-warfarin pockets

    NASA Astrophysics Data System (ADS)

    Polgár, Tímea; Menyhárd, Dóra K.; Keserű, György M.

    2007-09-01

    An effective virtual screening protocol was developed against an extended active site of CYP2C9, which was derived from X-ray structures complexed with flubiprofen and S-warfarin. Virtual screening has been effectively supported by our structure-based pharmacophore model. Importance of hot residues identified by mutation data and structural analysis was first estimated in an enrichment study. Key role of Arg108 and Phe114 in ligand binding was also underlined. Our screening protocol successfully identified 76% of known CYP2C9 ligands in the top 1% of the ranked database resulting 76-fold enrichment relative to random situation. Relevance of the protocol was further confirmed in selectivity studies, when 89% of CYP2C9 ligands were retrieved from a mixture of CYP2C9 and CYP2C8 ligands, while only 22% of CYP2C8 ligands were found applying the structure-based pharmacophore constraints. Moderate discrimination of CYP2C9 ligands from CYP2C18 and CYP2C19 ligands could also be achieved extending the application domain of our virtual screening protocol for the entire CYP2C family. Our findings further demonstrate the existence of an active site comprising of at least two binding pockets and strengthens the need of involvement of protein flexibility in virtual screening.

  1. A Randomized Control Trial of Preoperative Oral Antibiotics as Adjunct Therapy to Systemic Antibiotics for Preventing Surgical Site Infection in Clean Contaminated, Contaminated, and Dirty Type of Colorectal Surgeries.

    PubMed

    Anjum, Nadeem; Ren, Jianan; Wang, Gefei; Li, Guanwei; Wu, Xiuwen; Dong, Hu; Wu, Qin; Li, Jieshou

    2017-12-01

    Preoperative bowel preparation with or without oral antibiotics is controversial in terms of postoperative surgical site infections. This study aimed to evaluate the efficacy of oral antibiotics as adjunct therapy to systemic antibiotics with mechanical bowel preparation for preventing surgical site infections in clean contaminated, contaminated, and dirty colorectal procedures. This was a single-center, prospective randomized study. This study was conducted at the General Surgery Department at Jinling Hospital, Nanjing University, China, from July 15, 2014 to January 20, 2016. Patients aged ≥18 years scheduled for abdominal surgery with clean-contaminated, contaminated, and dirty wounds were selected. Patients were randomly assigned to receive preoperative mechanical bowel preparation or mechanical bowel preparation with oral antibiotics. The primary outcome was the rate of surgical site infections. The secondary outcomes were extra-abdominal complications, duration of postoperative ileus, and readmission rate. Ninety-five patients were allocated to each group. Eight and 26 surgical site infections (8.42% vs 27.3 %, p = 0.004) occurred in the mechanical bowel preparation with oral antibiotics and mechanical bowel preparation groups. Thirteen extra-abdominal complications were reported: 6 in the mechanical bowel preparation with oral antibiotics group and 7 in the mechanical bowel preparation group (6.3% vs 7.3%, p = 0.77). Postoperative ileus duration did not differ between groups (p = 0.23). There were 4 readmissions in the mechanical bowel preparation group and none in the mechanical bowel preparation with oral antibiotics group (p = 0.04). On multivariable analysis, blood loss ≥500 mL (OR, 5.1; 95% CI, 1.27-20.4; p = 0.02), ASA score ≥3 (OR, 3.9; 95% CI, 1.2-12.5; p = 0.01), contaminated types (OR, 3.6; 95% CI, 1.5-8.6; p = 0.01), and administration of preoperative oral antibiotics (OR, 0.20; 95% CI, 0.06-0.60; p = 0.005) independently affected the

  2. Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

    PubMed

    Howie, Amanda J; Malouff, John M

    2014-01-01

    Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

  3. Predicting longitudinal trajectories of health probabilities with random-effects multinomial logit regression.

    PubMed

    Liu, Xian; Engel, Charles C

    2012-12-20

    Researchers often encounter longitudinal health data characterized with three or more ordinal or nominal categories. Random-effects multinomial logit models are generally applied to account for potential lack of independence inherent in such clustered data. When parameter estimates are used to describe longitudinal processes, however, random effects, both between and within individuals, need to be retransformed for correctly predicting outcome probabilities. This study attempts to go beyond existing work by developing a retransformation method that derives longitudinal growth trajectories of unbiased health probabilities. We estimated variances of the predicted probabilities by using the delta method. Additionally, we transformed the covariates' regression coefficients on the multinomial logit function, not substantively meaningful, to the conditional effects on the predicted probabilities. The empirical illustration uses the longitudinal data from the Asset and Health Dynamics among the Oldest Old. Our analysis compared three sets of the predicted probabilities of three health states at six time points, obtained from, respectively, the retransformation method, the best linear unbiased prediction, and the fixed-effects approach. The results demonstrate that neglect of retransforming random errors in the random-effects multinomial logit model results in severely biased longitudinal trajectories of health probabilities as well as overestimated effects of covariates on the probabilities. Copyright © 2012 John Wiley & Sons, Ltd.

  4. A Prospective Randomized Study of Pfannenstiel Versus Expanded Port Site Incision for Intact Specimen Extraction in Laparoscopic Radical Nephrectomy.

    PubMed

    Binsaleh, Saleh; Madbouly, Khaled; Matsumoto, Edward D; Kapoor, Anil

    2015-08-01

    To compare intra- and postoperative outcome of patients undergoing laparoscopic radical nephrectomy with intact specimen extraction through a Pfannenstiel (PFN) transverse suprapubic or expanded port site (EPS) incision in a prospective randomized fashion. Patients undergoing laparoscopic transperitoneal radical nephrectomies for suspected renal tumors were randomized for intact renal specimen extraction via a PFN or EPS incision. Operative, perioperative, 1 week, 6 weeks, and 6 months postoperative parameters were prospectively recorded and analyzed including specimen weight, size in maximum diameter, incision length, total operative time, extraction time, estimated blood loss, length of hospital stay, pain score in the postoperative holding area and on the first post operative day, narcotic consumption, time to fluid intake/full diet intake, unassisted ambulation, cosmesis, and wound-related complications. A postoperative quality-of-life questionnaire was also filled out by all the patients. Our series included 51 patients: 26 in the PFN group and 25 in the EPS group. The two groups were similar in demographic characteristics and intraoperative and postoperative parameters apart from a longer PFN incision (P<0.00). First postoperative day pain score was significantly less in the PFN group than in the EPS group (P=0.023). Complication rate was less in the PFN group, although not statistically significant. Hospital stay was significantly shorter in the PFN than in the EPS group (P=0.01). Mean cosmesis and operative satisfaction scores at week 1, week 6, and 6 month visits were not significantly different between both groups. Compared with the EPS group, PFN group patients significantly will choose the same operation if they would do it again (P=0.004). PFN incision has less morbidity, pain score, and hospital stay compared with EPS incision for intact specimen extraction after transperitoneal laparoscopic radical nephrectomy. Both incisions are associated with high

  5. A Climatology of Surface Cloud Radiative Effects at the ARM Tropical Western Pacific Sites

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

    McFarlane, Sally A.; Long, Charles N.; Flaherty, Julia E.

    Cloud radiative effects on surface downwelling fluxes are investigated using long-term datasets from the three Atmospheric Radiation Measurement (ARM) sites in the Tropical Western Pacific (TWP) region. The Nauru and Darwin sites show significant variability in sky cover, downwelling radiative fluxes, and surface cloud radiative effect (CRE) due to El Niño and the Australian monsoon, respectively, while the Manus site shows little intra-seasonal or interannual variability. Cloud radar measurement of cloud base and top heights are used to define cloud types so that the effect of cloud type on the surface CRE can be examined. Clouds with low bases contributemore » 71-75% of the surface shortwave (SW) CRE and 66-74% of the surface longwave (LW) CRE at the three TWP sites, while clouds with mid-level bases contribute 8-9% of the SW CRE and 12-14% of the LW CRE, and clouds with high bases contribute 16-19% of the SW CRE and 15-21% of the LW CRE.« less

  6. Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty.

    PubMed

    Suen, Kary; Westh, Roger N; Churilov, Leonid; Hardidge, Andrew J

    2017-09-01

    Venous thromboembolism causes significant morbidity and mortality in patients after total joint arthroplasty. Although network meta-analyses have demonstrated a benefit of various thromboprophylactic agents, there remains a concern in the surgical community regarding the resulting wound complications. There is currently no systematic review of the surgical site bleeding complications of thromboprophylactic agents. The aim of this study was to systematically review the surgical site bleeding outcomes of venous thromboembolism prophylaxis in this population. A systematic review and meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials comparing more than one of low-molecular-weight heparin (LMWH), warfarin, rivaroxaban, apixaban, dabigatran, aspirin, or no pharmacologic treatment in patients after total hip or knee arthroplasty were selected for inclusion. Five meta-analyses were performed to compare LMWH with control, warfarin, apixaban, rivaroxaban, and dabigatran. Forty-five randomized controlled trials of 56,730 patients were included. LMWH had a significantly increased relative risk of surgical site bleeding in comparison with control (relative risk, 2.32; 95% confidence interval, 1.40-3.85) and warfarin (1.54; 1.23-1.94). The relative risk of LMWH trended higher than apixaban (1.27; 1.00-1.63) and was similar to rivaroxaban (0.95; 0.74-1.23). Only 1 study reported the risk of surgical site bleeding in LMWH vs dabigatran (5.97; 2.08-17.11). LMWH increased the risk of surgical site bleeding compared with control, warfarin. and dabigatran and trended toward an increased risk compared with apixaban. The risk of surgical site bleeding was similar with LMWH and rivaroxaban. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

    PubMed

    Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

    2013-11-01

    To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

  8. Optimized probability sampling of study sites to improve generalizability in a multisite intervention trial.

    PubMed

    Kraschnewski, Jennifer L; Keyserling, Thomas C; Bangdiwala, Shrikant I; Gizlice, Ziya; Garcia, Beverly A; Johnston, Larry F; Gustafson, Alison; Petrovic, Lindsay; Glasgow, Russell E; Samuel-Hodge, Carmen D

    2010-01-01

    Studies of type 2 translation, the adaption of evidence-based interventions to real-world settings, should include representative study sites and staff to improve external validity. Sites for such studies are, however, often selected by convenience sampling, which limits generalizability. We used an optimized probability sampling protocol to select an unbiased, representative sample of study sites to prepare for a randomized trial of a weight loss intervention. We invited North Carolina health departments within 200 miles of the research center to participate (N = 81). Of the 43 health departments that were eligible, 30 were interested in participating. To select a representative and feasible sample of 6 health departments that met inclusion criteria, we generated all combinations of 6 from the 30 health departments that were eligible and interested. From the subset of combinations that met inclusion criteria, we selected 1 at random. Of 593,775 possible combinations of 6 counties, 15,177 (3%) met inclusion criteria. Sites in the selected subset were similar to all eligible sites in terms of health department characteristics and county demographics. Optimized probability sampling improved generalizability by ensuring an unbiased and representative sample of study sites.

  9. A Randomized Trial Investigating the Effect of a Brief Lifestyle Intervention on Freshman-Year Weight Gain

    ERIC Educational Resources Information Center

    Middleton, Kathryn R.; Perri, Michael G.

    2014-01-01

    Objective: The current study was a randomized controlled trial investigating the effect of an innovative, short-term lifestyle intervention on weight gain in female freshman college students. Participants: Ninety-five freshmen were recruited from a large public university in the United States. Methods: Participants completed baseline assessments…

  10. Cure fraction model with random effects for regional variation in cancer survival.

    PubMed

    Seppä, Karri; Hakulinen, Timo; Kim, Hyon-Jung; Läärä, Esa

    2010-11-30

    Assessing regional differences in the survival of cancer patients is important but difficult when separate regions are small or sparsely populated. In this paper, we apply a mixture cure fraction model with random effects to cause-specific survival data of female breast cancer patients collected by the population-based Finnish Cancer Registry. Two sets of random effects were used to capture the regional variation in the cure fraction and in the survival of the non-cured patients, respectively. This hierarchical model was implemented in a Bayesian framework using a Metropolis-within-Gibbs algorithm. To avoid poor mixing of the Markov chain, when the variance of either set of random effects was close to zero, posterior simulations were based on a parameter-expanded model with tailor-made proposal distributions in Metropolis steps. The random effects allowed the fitting of the cure fraction model to the sparse regional data and the estimation of the regional variation in 10-year cause-specific breast cancer survival with a parsimonious number of parameters. Before 1986, the capital of Finland clearly stood out from the rest, but since then all the 21 hospital districts have achieved approximately the same level of survival. Copyright © 2010 John Wiley & Sons, Ltd.

  11. Alcohol-Specific Parenting within a Cluster-Randomized Effectiveness Trial of a Swedish Primary Prevention Program

    ERIC Educational Resources Information Center

    Strandberg, Anna K.; Bodin, Maria C.

    2011-01-01

    Purpose: Within the framework of an ongoing cluster-randomized effectiveness trial of a parental prevention program, the aim of the present study is to investigate attitudes towards under-age drinking and use of program components, i.e. alcohol-specific parenting behaviors, in parents who did and did not take part in the programme.…

  12. Effect of Subgingivally Delivered 10% Emblica officinalis Gel as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis - A Randomized Placebo-controlled Clinical Trial.

    PubMed

    Grover, Shilpa; Tewari, Shikha; Sharma, Rajinder K; Singh, Gajendra; Yadav, Aparna; Naula, Satish C

    2016-06-01

    Emblica officinalis fruit possesses varied medicinal properties including cytoprotective antimicrobial, antioxidant, antiresorptive and antiinflammatory activity. The present study aimed to investigate the effect of subgingival application of indigenously prepared E. officinalis (Amla) sustained-release gel adjunctive to scaling and root planing (SRP) on chronic periodontitis. Forty-six patients (528 sites) were randomly assigned to control group (23;264): SRP +placebo gel and test group (23;264): SRP + 10% E. officinalis gel application. Periodontal parameters: plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL) and modified sulcus bleeding index (mSBI) were assessed at baseline, 2 and 3-month post-therapy. Forty patients (470 sites) completed the trial. When test and control sites were compared, significantly more reduction in mean PPD, mSBI, number of sites with PPD = 5-6 mm, PPD ≥ 7 mm, CAL ≥ 6 mm and greater CAL gain were achieved in test sites at 2- and 3-month post-therapy (p < 0.05). Locally delivered 10% E. officinalis sustained-release gel used as an adjunct to SRP may be more effective in reducing inflammation and periodontal destruction in patients with chronic periodontitis when compared with SRP alone. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  13. Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence.

    PubMed

    Whitebird, Robin R; Bliss, Donna Zimmaro; Savik, Kay; Lowry, Ann; Jung, Hans-Joachim G

    2010-12-01

    Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). In the Fiber Study, a randomized controlled trial on symptom management for FI, we successfully enrolled 189 community-living adults through collaborations with specialty-based and community-based settings, each employing methods tailored to the organizational characteristics of their site. Results show that using the two settings increased racial and ethnic diversity of the sample and inclusion of informal caregivers. There were no differential effects on enrollment, final eligibility, or completion of protocol by site. Strategic collaborations with complementary sites can achieve sample recruitment goals for clinical trials on topics that are sensitive or known to be underreported. Copyright © 2010 Wiley Periodicals, Inc.

  14. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  15. Mediation and spillover effects in group-randomized trials: a case study of the 4Rs educational intervention

    PubMed Central

    VanderWeele, Tyler J.; Hong, Guanglei; Jones, Stephanie M.; Brown, Joshua L.

    2013-01-01

    Peer influence and social interactions can give rise to spillover effects in which the exposure of one individual may affect outcomes of other individuals. Even if the intervention under study occurs at the group or cluster level as in group-randomized trials, spillover effects can occur when the mediator of interest is measured at a lower level than the treatment. Evaluators who choose groups rather than individuals as experimental units in a randomized trial often anticipate that the desirable changes in targeted social behaviors will be reinforced through interference among individuals in a group exposed to the same treatment. In an empirical evaluation of the effect of a school-wide intervention on reducing individual students’ depressive symptoms, schools in matched pairs were randomly assigned to the 4Rs intervention or the control condition. Class quality was hypothesized as an important mediator assessed at the classroom level. We reason that the quality of one classroom may affect outcomes of children in another classroom because children interact not simply with their classmates but also with those from other classes in the hallways or on the playground. In investigating the role of class quality as a mediator, failure to account for such spillover effects of one classroom on the outcomes of children in other classrooms can potentially result in bias and problems with interpretation. Using a counterfactual conceptualization of direct, indirect and spillover effects, we provide a framework that can accommodate issues of mediation and spillover effects in group randomized trials. We show that the total effect can be decomposed into a natural direct effect, a within-classroom mediated effect and a spillover mediated effect. We give identification conditions for each of the causal effects of interest and provide results on the consequences of ignoring “interference” or “spillover effects” when they are in fact present. Our modeling approach

  16. Effects of a price increase on purchases of sugar sweetened beverages. Results from a randomized controlled trial.

    PubMed

    Waterlander, Wilma Elzeline; Ni Mhurchu, Cliona; Steenhuis, Ingrid H M

    2014-07-01

    Sugar sweetened beverage (SSB) taxes are receiving increased political interest. However, there have been no experimental studies of the effects of price increases on SSBs or the effects on close substitutes such as diet drinks, alcohol or sugary snacks. Therefore, the aim of this study was to examine the effects of a price increase on SSBs on beverage and snack purchases using a randomized controlled design within a three-dimensional web-based supermarket. The trial contained two conditions: experimental condition with a 19% tax on SSBs (to reflect an increase in Dutch value added tax from 6% to 19%); and a control condition with regular prices. N = 102 participants were randomized and purchased groceries on a single occasion at a three-dimensional Virtual Supermarket. Data were analysed using independent t-tests and regression analysis. Results showed that participants in the price increase condition purchased significantly less SSBs than the control group (B = -.90; 95% CI = -1.70 to -.10 L per household per week). There were no significant effects on purchases in other beverage or snack food categories. This means that the higher VAT rate was effective in reducing SSB purchases and had no negative side-effects. Copyright © 2014. Published by Elsevier Ltd.

  17. Heterogeneous Suppression of Sequential Effects in Random Sequence Generation, but Not in Operant Learning.

    PubMed

    Shteingart, Hanan; Loewenstein, Yonatan

    2016-01-01

    There is a long history of experiments in which participants are instructed to generate a long sequence of binary random numbers. The scope of this line of research has shifted over the years from identifying the basic psychological principles and/or the heuristics that lead to deviations from randomness, to one of predicting future choices. In this paper, we used generalized linear regression and the framework of Reinforcement Learning in order to address both points. In particular, we used logistic regression analysis in order to characterize the temporal sequence of participants' choices. Surprisingly, a population analysis indicated that the contribution of the most recent trial has only a weak effect on behavior, compared to more preceding trials, a result that seems irreconcilable with standard sequential effects that decay monotonously with the delay. However, when considering each participant separately, we found that the magnitudes of the sequential effect are a monotonous decreasing function of the delay, yet these individual sequential effects are largely averaged out in a population analysis because of heterogeneity. The substantial behavioral heterogeneity in this task is further demonstrated quantitatively by considering the predictive power of the model. We show that a heterogeneous model of sequential dependencies captures the structure available in random sequence generation. Finally, we show that the results of the logistic regression analysis can be interpreted in the framework of reinforcement learning, allowing us to compare the sequential effects in the random sequence generation task to those in an operant learning task. We show that in contrast to the random sequence generation task, sequential effects in operant learning are far more homogenous across the population. These results suggest that in the random sequence generation task, different participants adopt different cognitive strategies to suppress sequential dependencies when

  18. XenoSite server: a web-available site of metabolism prediction tool.

    PubMed

    Matlock, Matthew K; Hughes, Tyler B; Swamidass, S Joshua

    2015-04-01

    Cytochrome P450 enzymes (P450s) are metabolic enzymes that process the majority of FDA-approved, small-molecule drugs. Understanding how these enzymes modify molecule structure is key to the development of safe, effective drugs. XenoSite server is an online implementation of the XenoSite, a recently published computational model for P450 metabolism. XenoSite predicts which atomic sites of a molecule--sites of metabolism (SOMs)--are modified by P450s. XenoSite server accepts input in common chemical file formats including SDF and SMILES and provides tools for visualizing the likelihood that each atomic site is a site of metabolism for a variety of important P450s, as well as a flat file download of SOM predictions. XenoSite server is available at http://swami.wustl.edu/xenosite. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. A randomized, prospective study of laparoendoscopic single-site plus one-port versus mini laparoscopic technique for live donor nephrectomy.

    PubMed

    Lee, Kyu Won; Choi, Sae Woong; Park, Yong Hyun; Bae, Woong Jin; Choi, Yong Sun; Ha, U-Syn; Hong, Sung-Hoo; Lee, Ji Youl; Kim, Sae Woong; Cho, Hyuk Jin

    2018-04-01

    To compare the clinical outcomes of laparoendoscopic single-site plus one-port donor nephrectomy (LESSOP-DN) and mini laparoscopic donor nephrectomy (MLDN). A prospective randomized controlled trial was conducted from December 2014 to February 2016 in donors scheduled for left donor nephrectomy. Donor and recipient demographics and clinical outcomes including pain scores and questionnaires (BIQ: body image questionnaire, SF-36, patient-reported overall convalescence) were also compared. A total of 121 eligible donors were recruited, of which 99 donors who were scheduled to undergo an operation on their left side were randomized into LESSOP-DN (n = 50) and MLDN (n = 49) groups. There were no significant demographic differences between the two groups. The renal extraction time in the LESS-DN group was shorter than that in the MLDN group (75.89 ± 13.01 vs. 87.31 ± 11.38 min, p < 0.001). Other perioperative parameters and complication rates were comparable between the two groups. The LESSOP-DN group had a smaller incision length than the MLDN group (4.89 ± 0.68 vs. 6.21 ± 1.11 cm, p < 0.001), but cosmetic scores and body image scores were similar in the two groups (p = 0.905, 0.217). Donor quality of life (SF-36) and recovery and satisfaction data were comparable between the two groups. Delayed graft function (DGF) occurred in one recipient undergoing MLDN procedure (2.1%) and progressed to graft failure. There were no differences in cosmetic satisfaction between groups despite the smaller incision size of LESSOP-DN. Safety parameters and subjective measures of postoperative morbidity were similar between the two groups.

  20. Effectiveness of a decision-training aid on referral prioritization capacity: a randomized controlled trial.

    PubMed

    Harries, Priscilla; Tomlinson, Christopher; Notley, Elizabeth; Davies, Miranda; Gilhooly, Kenneth

    2012-01-01

    In the community mental health field, occupational therapy students lack the capacity to prioritize referrals effectively. The purpose of this study was to test the effectiveness of a clinical decision-training aid on referral prioritization capacity. A double-blind, parallel-group, randomized controlled trial was conducted using a judgment analysis approach. Each participant used the World Wide Web to prioritize referral sets at baseline, immediate posttest, and 2-wk follow-up. The intervention group was provided with training after baseline testing; control group was purely given instructions to continue with the task. One hundred sixty-five students were randomly allocated to intervention (n = 87) or control (n = 81). Intervention. Written and graphical descriptions were given of an expert consensus standard explaining how referral information should be used to prioritize referrals. Participants' prioritization ratings were correlated with the experts' ratings of the same referrals at each stage of testing, as well as to examine the effect on mean group scores, regression weights, and the lens model indices. At baseline, no differences were found between control and intervention on rating capacity or demographic characteristics. Comparison of the difference in mean correlation baseline scores of the control and intervention group compared with immediate posttest showed a statistically significant result that was maintained at 2-wk follow-up. The effect size was classified as large. At immediate posttest and follow-up, the intervention group improved rating capacity, whereas the control group's capacity remained poor. The results of this study indicate that the decision-training aid has a positive effect on referral prioritization capacity. This freely available, Web-based decision-training aid will be a valuable adjunct to the education of these novice health professionals internationally.

  1. Effects of transcutaneous electrical nerve stimulation on pain intensity during application of carboxytherapy in patients with cellulite: A randomized placebo-controlled trial.

    PubMed

    Sadala, Adria Y; Machado, Aline F P; Liebano, Richard E

    2018-01-16

    Carboxytherapy may generate local pain that is considered the main limiting factor in clinical practice. Transcutaneous electric nerve stimulation (TENS) is widely used in the control of acute pain; however, the effect of TENS on pain relief during carboxytherapy has not been studied to date. To assess the effect of TENS on pain intensity during carboxytherapy in patients with cellulite in the gluteal region. This randomized clinical trial was conducted with 84 patients, 18-44 years of age, who had moderate cellulite in the gluteal region, according to Cellulite Severity Scale, but never received carboxytherapy. Patients were randomized into 3 groups: active TENS, placebo TENS, and control group. For the intervention, skin depressions with cellulite were outlined, and the gluteal area to be treated was defined. The subcutaneous injection of CO 2 was performed using 0.30 × 13 mm-needles at a 45° angle, with a controlled flow rate of 100 mL/min maintained for 1 minute at each puncture site. The parameters for TENS were as follows: frequency of 100 Hz and pulse duration of 200 μs; TENS intensity was adjusted until the patient reported strong paresthesia. The visual numeric pain rating scale was used to assess pain intensity after each puncture. The active TENS group reported lower pain intensity compared to the placebo TENS (P < .0001) and control (P < .0001) groups. Transcutaneous electric nerve stimulation (TENS) was effective in reducing pain intensity during carboxytherapy in patients with cellulite in the gluteal region. © 2018 Wiley Periodicals, Inc.

  2. A comparison of three random effects approaches to analyze repeated bounded outcome scores with an application in a stroke revalidation study.

    PubMed

    Molas, Marek; Lesaffre, Emmanuel

    2008-12-30

    Discrete bounded outcome scores (BOS), i.e. discrete measurements that are restricted on a finite interval, often occur in practice. Examples are compliance measures, quality of life measures, etc. In this paper we examine three related random effects approaches to analyze longitudinal studies with a BOS as response: (1) a linear mixed effects (LM) model applied to a logistic transformed modified BOS; (2) a model assuming that the discrete BOS is a coarsened version of a latent random variable, which after a logistic-normal transformation, satisfies an LM model; and (3) a random effects probit model. We consider also the extension whereby the variability of the BOS is allowed to depend on covariates. The methods are contrasted using a simulation study and on a longitudinal project, which documents stroke rehabilitation in four European countries using measures of motor and functional recovery. Copyright 2008 John Wiley & Sons, Ltd.

  3. Effects of borrow site preparation and fertilization on natural revegetation

    DOT National Transportation Integrated Search

    1987-01-01

    This study report describes the effects of experimental fertilization and surface conditioning of a gravel borrow site which lacked a topsoil covering. In summary, borrow site revegetation by fireweed may be greatly enhanced by scarifying and fertili...

  4. Validating Components of Teacher Effectiveness: A Random Assignment Study of Value-Added, Observation, and Survey Scores

    ERIC Educational Resources Information Center

    Bacher-Hicks, Andrew; Chin, Mark; Kane, Thomas J.; Staiger, Douglas O.

    2015-01-01

    Policy changes from the past decade have resulted in a growing interest in identifying effective teachers and their characteristics. This study is the third study to use data from a randomized experiment to test the validity of measures of teacher effectiveness. The authors collected effectiveness measures across three school years from three…

  5. Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials.

    PubMed

    Machado, L A C; Kamper, S J; Herbert, R D; Maher, C G; McAuley, J H

    2009-05-01

    Estimates of treatment effects reported in placebo-controlled randomized trials are less subject to bias than those estimates provided by other study designs. The objective of this meta-analysis was to estimate the analgesic effects of treatments for non-specific low back pain reported in placebo-controlled randomized trials. Medline, Embase, Cinahl, PsychInfo and Cochrane Central Register of Controlled Trials databases were searched for eligible trials from earliest records to November 2006. Continuous pain outcomes were converted to a common 0-100 scale and pooled using a random effects model. A total of 76 trials reporting on 34 treatments were included. Fifty percent of the investigated treatments had statistically significant effects, but for most the effects were small or moderate: 47% had point estimates of effects of <10 points on the 100-point scale, 38% had point estimates from 10 to 20 points and 15% had point estimates of >20 points. Treatments reported to have large effects (>20 points) had been investigated only in a single trial. This meta-analysis revealed that the analgesic effects of many treatments for non-specific low back pain are small and that they do not differ in populations with acute or chronic symptoms.

  6. Interim pressure garment therapy (4-6 mmHg) and its effect on donor site healing in burn patients: study protocol for a randomised controlled trial.

    PubMed

    Donovan, Michelle L; Muller, Michael J; Simpson, Claire; Rudd, Michael; Paratz, Jennifer

    2016-04-26

    Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24-40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4-6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient's scar outcomes for donor sites. This study protocol outlines a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months. This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a

  7. Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

    PubMed

    Zhang, Yan; Phy, Jennifer; Scott-Johnson, Chris; Garos, Sheila; Orlando, Jennie; Prien, Samuel; Huang, Jaou-Chen

    2017-04-04

    The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because

  8. Effects of Aerobic Exercise on Overweight Children's Cognitive Functioning: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Davis, Catherine L.; Tomporowski, Phillip D.; Boyle, Colleen A.; Waller, Jennifer L.; Miller, Patricia H.; Naglieri, Jack A.; Gregoski, Mathew

    2007-01-01

    The study tested the effect of aerobic exercise training on executive function in overweight children. Ninety-four sedentary, overweight but otherwise healthy children (mean age = 9.2 years, body mass index [greater than or equal to] 85th percentile) were randomized to a low-dose (20 min/day exercise), high-dose (40 min/day exercise), or control…

  9. Assessing the quality of a non-randomized pragmatic trial for primary prevention of falls among older adults.

    PubMed

    Albert, Steven M; Edelstein, Offer; King, Jennifer; Flatt, Jason; Lin, Chyongchiou J; Boudreau, Robert; Newman, Anne B

    2015-01-01

    Current approaches to falls prevention mostly rely on secondary and tertiary prevention and target individuals at high risk of falls. An alternative is primary prevention, in which all seniors are screened, referred as appropriate, and educated regarding falls risk. Little information is available on research designs that allow investigation of this approach in the setting of aging services delivery, where randomization may not be possible. Healthy Steps for Older Adults, a statewide program of the Pennsylvania (PA) Department of Aging, involves a combination of education about falls and screening for balance problems, with referral to personal physicians and home safety assessments. We developed a non-randomized statewide trial, Falls Free PA, to assess its effectiveness in reducing falls incidence over 12 months. We recruited 814 seniors who completed the program (503 first-time participants, 311 people repeating the program) and 1,020 who did not participate in the program, from the same sites. We assessed the quality of this non-randomized design by examining recruitment, follow-up across study groups, and comparability at baseline. Of older adults approached in senior centers, 90.5 % (n = 2,219) signed informed consent, and 1,834 (82.4 %) completed baseline assessments and were eligible for follow-up. Attrition in the three groups over 12 months was low and non-differential (<10 % for withdrawal and <2 % for other loss to follow-up). Median follow-up, which involved standardized monthly assessment of falls, was 10 months in all study groups. At baseline, the groups did not differ in measures of health or falls risk factors. Comparable status at baseline, recruitment from common sites, and similar experience with retention suggest that the non-randomized design will be effective for assessment of this approach to primary prevention of falls.

  10. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

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

  11. 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.

  12. LETTER TO THE EDITOR: Single-species reactions on a random catalytic chain

    NASA Astrophysics Data System (ADS)

    Oshanin, G.; Burlatsky, S. F.

    2002-11-01

    We present an exact solution for a catalytically activated annihilation A + A → 0 reaction taking place on a one-dimensional chain in which some segments (placed at random, with mean concentration p) possess special, catalytic properties. An annihilation reaction takes place as soon as any two A particles land from the reservoir onto two vacant sites at the extremities of the catalytic segment, or when any A particle lands onto a vacant site on a catalytic segment while the site at the other extremity of this segment is already occupied by another A particle. We find that the disorder-average pressure P(quen) per site of such a chain is given by P(quen) = P(Lan) + β-1F, where P(Lan) = β-1 ln(1 + z) is the Langmuir adsorption pressure, (z being the activity and β-1 the temperature), while β-1F is the reaction-induced contribution, which can be expressed, under appropriate change of notation, as the Lyapunov exponent for the product of 2 × 2 random matrices, obtained exactly by Derrida and Hilhorst (1983 <A article="0305-4470/16/12/013"> J. Phys. A: Math. Gen. 16 2641A>). Explicit asymptotic formulae for the particle mean density and the compressibility are also presented.

  13. Performance of time-varying predictors in multilevel models under an assumption of fixed or random effects.

    PubMed

    Baird, Rachel; Maxwell, Scott E

    2016-06-01

    Time-varying predictors in multilevel models are a useful tool for longitudinal research, whether they are the research variable of interest or they are controlling for variance to allow greater power for other variables. However, standard recommendations to fix the effect of time-varying predictors may make an assumption that is unlikely to hold in reality and may influence results. A simulation study illustrates that treating the time-varying predictor as fixed may allow analyses to converge, but the analyses have poor coverage of the true fixed effect when the time-varying predictor has a random effect in reality. A second simulation study shows that treating the time-varying predictor as random may have poor convergence, except when allowing negative variance estimates. Although negative variance estimates are uninterpretable, results of the simulation show that estimates of the fixed effect of the time-varying predictor are as accurate for these cases as for cases with positive variance estimates, and that treating the time-varying predictor as random and allowing negative variance estimates performs well whether the time-varying predictor is fixed or random in reality. Because of the difficulty of interpreting negative variance estimates, 2 procedures are suggested for selection between fixed-effect and random-effect models: comparing between fixed-effect and constrained random-effect models with a likelihood ratio test or fitting a fixed-effect model when an unconstrained random-effect model produces negative variance estimates. The performance of these 2 procedures is compared. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  14. Associations between urinary biomarkers of oxidative stress and air pollutants observed in a randomized crossover exposure to steel mill emissions.

    PubMed

    Pelletier, Guillaume; Rigden, Marc; Kauri, Lisa Marie; Shutt, Robin; Mahmud, Mamun; Cakmak, Sabit; Kumarathasan, Premkumari; Thomson, Errol M; Vincent, Renaud; Broad, Gayle; Liu, Ling; Dales, Robert

    2017-04-01

    The effects of industrial air pollution on human health have not been as thoroughly investigated as those of urban air pollution which originates mostly from automotive transport. To better assess the health impacts of point sources of industrial air pollution, a randomized crossover exposure study was conducted. Sixty one young and healthy volunteers were randomly assigned to spend five consecutive eight-hour days near a steel mill or at a location five kilometres away. After a nine or sixteen-day washout period, volunteers spent another five consecutive days at the second site. Meteorological conditions and air pollutants were monitored at both exposure sites. On each exposure day, the first morning urine was collected along with a second urine sample obtained immediately before leaving the exposure site at the end of the day. Urinary levels of biomarkers of oxidative stress 8-hydroxy-2'-deoxyguanosine (8-OHdG, a biomarker of oxidative DNA damage), malondialdehyde (MDA, a biomarker of lipid peroxidation), 8-isoprostane (8-IsoP, a bioactive metabolite resulting from the peroxidation of arachidonic acid) and Vascular Endothelial Growth Factor (VEGF, involved in response to oxidative stress) were measured. According to mixed-effects linear regression models, intra-individual variations in 8-OHdG urinary levels were significantly associated with exposure site, but surprisingly, lower levels were observed at the steel mill site. Delayed, temporally-defined associations with specific air pollutants were observed for 8-OHdG, 8-IsoP and VEGF. However, these associations were subtle, presented complex patterns and their biological consequences remain unclear. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  15. Use of Random and Site-Directed Mutagenesis to Probe Protein Structure-Function Relationships: Applied Techniques in the Study of Helicobacter pylori.

    PubMed

    Whitmire, Jeannette M; Merrell, D Scott

    2017-01-01

    Mutagenesis is a valuable tool to examine the structure-function relationships of bacterial proteins. As such, a wide variety of mutagenesis techniques and strategies have been developed. This chapter details a selection of random mutagenesis methods and site-directed mutagenesis procedures that can be applied to an array of bacterial species. Additionally, the direct application of the techniques to study the Helicobacter pylori Ferric Uptake Regulator (Fur) protein is described. The varied approaches illustrated herein allow the robust investigation of the structural-functional relationships within a protein of interest.

  16. The effectiveness of xylitol in a school-based cluster-randomized clinical trial.

    PubMed

    Lee, Wonik; Spiekerman, Charles; Heima, Masahiro; Eggertsson, Hafsteinn; Ferretti, Gerald; Milgrom, Peter; Nelson, Suchitra

    2015-01-01

    The purpose of this double-blind, cluster-randomized clinical trial was to examine the effects of xylitol gummy bear snacks on dental caries progression in primary and permanent teeth of inner-city school children. A total of 562 children aged 5-6 years were recruited from five elementary schools in East Cleveland, Ohio. Children were randomized by classroom to receive xylitol (7.8 g/day) or placebo (inulin fiber 20 g/day) gummy bears. Gummy bears were given three times per day for the 9-month kindergarten year within a supervised school environment. Children in both groups also received oral health education, toothbrush and fluoridated toothpaste, topical fluoride varnish treatment and dental sealants. The numbers of new decayed, missing, and filled surfaces for primary teeth (dmfs) and permanent teeth (DMFS) from baseline to the middle of 2nd grade (exit exam) were compared between the treatment (xylitol/placebo) groups using an optimally-weighted permutation test for cluster-randomized data. The mean new d(3-6)mfs at the exit exam was 5.0 ± 7.6 and 4.0 ± 6.5 for the xylitol and placebo group, respectively. Similarly, the mean new D(3-6)MFS was 0.38 ± 0.88 and 0.48 ± 1.39 for the xylitol and placebo group, respectively. The adjusted mean difference between the two groups was not statistically significant: new d(3-6)mfs: mean 0.4, 95% CI -0.25, 0.8), and new D(3-6)MFS: mean 0.16, 95% CI -0.16, 0.43. Xylitol consumption did not have additional benefit beyond other preventive measures. Caries progression in the permanent teeth of both groups was minimal, suggesting that other simultaneous prevention modalities may have masked the possible beneficial effects of xylitol in this trial. © 2014 S. Karger AG, Basel.

  17. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    ERIC Educational Resources Information Center

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  18. A Paradox-based data collection and management system for multi-center randomized clinical trials.

    PubMed

    Abdellatif, Mazen; Reda, Domenic J

    2004-02-01

    We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.

  19. Housing First Reduces Re-offending among Formerly Homeless Adults with Mental Disorders: Results of a Randomized Controlled Trial

    PubMed Central

    Somers, Julian M.; Rezansoff, Stefanie N.; Moniruzzaman, Akm; Palepu, Anita; Patterson, Michelle

    2013-01-01

    Background Homelessness and mental illness have a strong association with public disorder and criminality. Experimental evidence indicates that Housing First (HF) increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders. HF is also associated with lower residential costs than common alternative approaches. Few studies have examined the effect of HF on criminal behavior. Methods Individuals meeting criteria for homelessness and a current mental disorder were randomized to one of three conditions treatment as usual (reference); scattered site HF; and congregate HF. Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following randomization for up to two years. Results The majority of the sample (67%) was involved with the justice system, with a mean of 8.07 convictions per person in the ten years prior to recruitment. The most common category of crime was “property offences” (mean = 4.09). Following randomization, the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual (Adjusted IRR = 0.29; 95% CI 0.12–0.72). Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual (Adjusted IRR = 0.55; 95% CI: 0.26–1.14). Conclusions This study is the first randomized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime. Our sample was frequently involved with the justice system, with great personal and societal costs. Further implementation of HF is strongly indicated, particularly in the scattered site format. Research examining interdependencies between housing, health, and the justice system is indicated. Trial registration ISRCTN57595077 PMID:24023796

  20. Effectiveness of Antimicrobial Therapy after Extraction of Impacted Mandibular Third Molar: A Randomized Clinical Trial.

    PubMed

    Rabi, A; Maheshwari, Rahul; Srinivasan, Bhuvaneshwari; Warad, Lata P; Suvarna, C C; Tank, Kartik S

    2018-01-01

    The present study was conducted with the aim of evaluating the effectiveness of antimicrobial therapy following extraction of an impacted mandibular third molar. This randomized controlled trial was conducted on a total of 60 patients who were randomly assigned into three groups: Group I individuals were given 625 mg of combined amoxicillin and clavulanic acid tablet; 625 mg of combined amoxicillin and clavulanic acid tablet + 400 mg metronidazole tablet was given to group II individuals; whereas group III individuals were assigned no treatment. All the individuals underwent surgical extraction of impacted mandibular third molars under strict aseptic techniques, with minimal trauma to the surrounding tissues. Mouth opening in millimeters was recorded postoperatively using Vernier calipers on the 1st, 3rd, 5th, and 7th days. A 4-point visual analog scale (VAS) was used for assessing postoperative pain. Patient satisfaction was further assessed in a subjective manner using a graded scale from "very satisfied" to "very unsatisfied". The present study included individuals between the ages of 20 and 35 years. Group II individuals showed slightly better satisfaction than the other group individuals. There was no statistically significant difference between the mean age of groups. It was observed that on day 3, the number of individuals with severe pain was slightly reduced in the group I compared with group III individuals. On day 5, participants with no pain were significantly more in group II followed by group I. Furthermore, there was a statistically significant difference between the study groups with respect to mouth opening on days 3 and 5. It was concluded from this trial that the administration of postoperative antimicrobials showed no significant differences in the degree of postoperative complications that occur following the surgical extraction of impacted mandibular third molars. Antimicrobial drugs are routinely used to reduce the chances of surgical site

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

    NASA Astrophysics Data System (ADS)

    Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

    2018-02-01

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

  2. Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

    PubMed Central

    Morales, Alicia; Gandolfo, Alessandro; Bravo, Joel; Carvajal, Paola; Silva, Nora; Godoy, Claudia; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia; Gamonal, Jorge

    2018-01-01

    ABSTRACT Objective The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP) and were randomly assigned to a probiotic (n=16), antibiotic (n = 16) or placebo (n = 15) group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group. PMID:29364340

  3. Cultured allogeneic keratinocyte sheets accelerate healing compared to Op-site treatment of donor sites in burns.

    PubMed

    Duinslaeger, L A; Verbeken, G; Vanhalle, S; Vanderkelen, A

    1997-01-01

    Donor site treatment is a crucial issue in the treatment of extensive burns. In this single-blind, randomized study treatment of donor sites with a polyurethane dressing, Op-Site (Smith & Nephew, York, U.K.) is compared to treatment with allogeneic cultured keratinocyte sheets. Results show a mean healing time of 6.7 days with use of cultured keratinocyte sheets compared to mean healing time of 13.6 days with Op-Site treatment. Also, improvement in the comfort of patients as the result of less exudate formation and pain attenuation was noted.

  4. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase

    PubMed Central

    Tan, Gabriel; Rintala, Diana H.; Jensen, Mark P.; Richards, J. Scott; Holmes, Sally Ann; Parachuri, Rama; Lashgari-Saegh, Shamsi; Price, Larry R.

    2011-01-01

    Background Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Objective Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Study design Multi-site, double-blind, sham-controlled study. Participants Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Intervention Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess ‘as-needed’ CES use. Outcome measures Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. Results The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal–Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). Conclusions On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief. PMID:21756567

  5. Opposite effects of high- and low-frequency transcranial random noise stimulation probed with visual motion adaptation

    PubMed Central

    Campana, Gianluca; Camilleri, Rebecca; Moret, Beatrice; Ghin, Filippo; Pavan, Andrea

    2016-01-01

    Transcranial random noise stimulation (tRNS) is a recent neuro-modulation technique whose effects at both behavioural and neural level are still debated. Here we employed the well-known phenomenon of motion after-effect (MAE) in order to investigate the effects of high- vs. low-frequency tRNS on motion adaptation and recovery. Participants were asked to estimate the MAE duration following prolonged adaptation (20 s) to a complex moving pattern, while being stimulated with either sham or tRNS across different blocks. Different groups were administered with either high- or low-frequency tRNS. Stimulation sites were either bilateral human MT complex (hMT+) or frontal areas. The results showed that, whereas no effects on MAE duration were induced by stimulating frontal areas, when applied to the bilateral hMT+, high-frequency tRNS caused a significant decrease in MAE duration whereas low-frequency tRNS caused a significant corresponding increase in MAE duration. These findings indicate that high- and low-frequency tRNS have opposed effects on the adaptation-dependent unbalance between neurons tuned to opposite motion directions, and thus on neuronal excitability. PMID:27934947

  6. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    ERIC Educational Resources Information Center

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

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

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

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

  8. Effect of a Cognitive-Behavioral Prevention Program on Depression 6 Years After Implementation Among At-Risk Adolescents: A Randomized Clinical Trial.

    PubMed

    Brent, David A; Brunwasser, Steven M; Hollon, Steven D; Weersing, V Robin; Clarke, Gregory N; Dickerson, John F; Beardslee, William R; Gladstone, Tracy R G; Porta, Giovanna; Lynch, Frances L; Iyengar, Satish; Garber, Judy

    2015-11-01

    Adolescents whose parents have a history of depression are at risk for developing depression and functional impairment. The long-term effects of prevention programs on adolescent depression and functioning are not known. To determine whether a cognitive-behavioral prevention (CBP) program reduced the incidence of depressive episodes, increased depression-free days, and improved developmental competence 6 years after implementation. A 4-site randomized clinical trial compared the effect of CBP plus usual care vs usual care, through follow-up 75 months after the intervention (88% retention), with recruitment from August 2003 through February 2006 at a health maintenance organization, university medical centers, and a community mental health center. A total of 316 participants were 13 to 17 years of age at enrollment and had at least 1 parent with current or prior depressive episodes. Participants could not be in a current depressive episode but had to have subsyndromal depressive symptoms or a prior depressive episode currently in remission. Analysis was conducted between August 2014 and June 2015. The CBP program consisted of 8 weekly 90-minute group sessions followed by 6 monthly continuation sessions. Usual care consisted of any family-initiated mental health treatment. The Depression Symptoms Rating scale was used to assess the primary outcome, new onsets of depressive episodes, and to calculate depression-free days. A modified Status Questionnaire assessed developmental competence (eg, academic or interpersonal) in young adulthood. Over the 75-month follow-up, youths assigned to CBP had a lower incidence of depression, adjusting for current parental depression at enrollment, site, and all interactions (hazard ratio, 0.71 [95% CI, 0.53-0.96]). The CBP program's overall significant effect was driven by a lower incidence of depressive episodes during the first 9 months after enrollment. The CBP program's benefit was seen in youths whose index parent was not

  9. Melatonin for Atypical Antipsychotic-Induced Metabolic Adverse Effects: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Kamath, Ashwin; Rather, Zahoor Ahmad

    2018-01-01

    The objective of our study was to determine the effect of melatonin administration on atypical antipsychotic-induced metabolic adverse effects in patients with psychiatric disorders. A systematic search was performed in PUBMED, Cochrane Library, Scopus, Web of Science, and EBSCOhost electronic databases. Randomized controlled trials studying the effect of melatonin on antipsychotic-induced metabolic adverse effects were identified and subjected to meta-analysis. Four studies were included in the meta-analysis, including 57 patients on melatonin and 61 patients on placebo. Melatonin produced a significant decrease in the diastolic blood pressure compared with placebo (mean difference = -4.44 [95% CI, -7.00 to -1.88]; p = 0.0007; I 2 = 13%), but not the systolic blood pressure (mean difference = -4.23 [95% CI, -8.11 to -0.36]; p = 0.03; I 2 = 0%). Although a decrease in the body mass index was seen in the melatonin group, the difference was not significant in the random-effects analysis model. To conclude, in patients on atypical antipsychotics, melatonin at a dose of up to 5 mg/day for a treatment duration of up to 12 weeks attenuated the rise in diastolic blood pressure compared with placebo but had no significant effects on other metabolic parameters.

  10. Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

    PubMed

    Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

    2017-08-01

    The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a

  11. A theoretical approach to quantify the effect of random cracks on rock deformation in uniaxial compression

    NASA Astrophysics Data System (ADS)

    Zhou, Shuwei; Xia, Caichu; Zhou, Yu

    2018-06-01

    Cracks have a significant effect on the uniaxial compression of rocks. Thus, a theoretically analytical approach was proposed to assess the effects of randomly distributed cracks on the effective Young’s modulus during the uniaxial compression of rocks. Each stage of the rock failure during uniaxial compression was analyzed and classified. The analytical approach for the effective Young’s modulus of a rock with only a single crack was derived while considering the three crack states under stress, namely, opening, closure-sliding, and closure-nonsliding. The rock was then assumed to have many cracks with randomly distributed direction, and the effect of crack shape and number during each stage of the uniaxial compression on the effective Young’s modulus was considered. Thus, the approach for the effective Young’s modulus was used to obtain the whole stress-strain process of uniaxial compression. Afterward, the proposed approach was employed to analyze the effects of related parameters on the whole stress-stain curve. The proposed approach was eventually compared with some existing rock tests to validate its applicability and feasibility. The proposed approach has clear physical meaning and shows favorable agreement with the rock test results.

  12. The Effects of Local Warming on Surgical Site Infection

    PubMed Central

    Dellinger, E. Patchen; Weber, James; Swenson, Ron Edward; Kent, Christopher D.; Swanson, Paul E.; Harmon, Kurt; Perrin, Margot

    2015-01-01

    Abstract Background: Surgical site infections (SSI) account for a major proportion of hospital-acquired infections. They are associated with longer hospital stay, readmissions, increased costs, mortality, and morbidity. Reducing SSI is a goal of the Surgical Care Improvement Project and identifying interventions that reduce SSI effectively is of interest. In a single-blinded randomized controlled trial (RCT) we evaluated the effect of localized warming applied to surgical incisions on SSI development and selected cellular (immune, endothelial) and tissue responses (oxygenation, collagen). Methods: After Institutional Review Board approval and consent, patients having open bariatric, colon, or gynecologic-oncologic related operations were enrolled and randomly assigned to local incision warming (6 post-operative treatments) or non-warming. A prototype surgical bandage was used for all patients. The study protocol included intra-operative warming to maintain core temperature ≥36°C and administration of 0.80 FIO2. Patients were followed for 6 wks for the primary outcome of SSI determined by U.S. Centers for Disease Control (CDC) criteria and ASEPSIS scores (additional treatment; presence of serous discharge, erythema, purulent exudate, and separation of the deep tissues; isolation of bacteria; and duration of inpatient stay). Tissue oxygen (PscO2) and samples for cellular analyses were obtained using subcutaneous polytetrafluoroethylene (ePTFE) tubes and oxygen micro-electrodes implanted adjacent to the incision. Cellular and tissue ePTFE samples were evaluated using flow cytometry, immunohistochemistry, and Sircol™ collagen assay (Biocolor Ltd., Carrickfergus, United Kingdom). Results: One hundred forty-six patients participated (n=73 per group). Study groups were similar on demographic parameters and for intra-operative management factors. The CDC defined rate of SSI was 18%; occurrence of SSI between groups did not differ (p=0.27). At 2 wks, warmed

  13. Effective stochastic generator with site-dependent interactions

    NASA Astrophysics Data System (ADS)

    Khamehchi, Masoumeh; Jafarpour, Farhad H.

    2017-11-01

    It is known that the stochastic generators of effective processes associated with the unconditioned dynamics of rare events might consist of non-local interactions; however, it can be shown that there are special cases for which these generators can include local interactions. In this paper, we investigate this possibility by considering systems of classical particles moving on a one-dimensional lattice with open boundaries. The particles might have hard-core interactions similar to the particles in an exclusion process, or there can be many arbitrary particles at a single site in a zero-range process. Assuming that the interactions in the original process are local and site-independent, we will show that under certain constraints on the microscopic reaction rules, the stochastic generator of an unconditioned process can be local but site-dependent. As two examples, the asymmetric zero-temperature Glauber model and the A-model with diffusion are presented and studied under the above-mentioned constraints.

  14. Cholorhexidine, octenidine or povidone iodine for catheter related infections: A randomized controlled trial.

    PubMed

    Bilir, Ayten; Yelken, Birgül; Erkan, Ayse

    2013-06-01

    Protection of the catheter site by antimicrobial agents is one of the most important factors in the prevention of infection. Povidone iodine and chlorhexidine gluconate are the most common used agents for dressing. The purpose of this study was to compare the effects of povidone iodine, chlorhexidine gluconate and octenidine hydrochloride in preventing catheter related infections. Patients were randomized to receive; 4% chlorhexidine gluconate, 10% povidone iodine or octenidine hydrochlorodine for cutaneous antisepsis. Cultures were taken at the site surrounding catheter insertion and at the catheter hub after removal to help identify the source of microorganisms. Catheter related sepsis was 10.5% in the povidone iodine and octenidine hydrochlorodine groups. Catheter related colonization was 26.3% in povidone iodine group and 21.5% in octenidine hydrochlorodine group. 4% chlorhexidine or octenidine hydrochlorodine for cutaneous disinfection before insertion of an intravascular device and for post-insertion site care can reduce the catheter related colonization.

  15. Cholorhexidine, octenidine or povidone iodine for catheter related infections: A randomized controlled trial

    PubMed Central

    Bilir, Ayten; Yelken, Birgül; Erkan, Ayse

    2013-01-01

    Background: Protection of the catheter site by antimicrobial agents is one of the most important factors in the prevention of infection. Povidone iodine and chlorhexidine gluconate are the most common used agents for dressing. The purpose of this study was to compare the effects of povidone iodine, chlorhexidine gluconate and octenidine hydrochloride in preventing catheter related infections. Materials and Methods: Patients were randomized to receive; 4% chlorhexidine gluconate, 10% povidone iodine or octenidine hydrochlorodine for cutaneous antisepsis. Cultures were taken at the site surrounding catheter insertion and at the catheter hub after removal to help identify the source of microorganisms. Results: Catheter related sepsis was 10.5% in the povidone iodine and octenidine hydrochlorodine groups. Catheter related colonization was 26.3% in povidone iodine group and 21.5% in octenidine hydrochlorodine group. Conclusion: 4% chlorhexidine or octenidine hydrochlorodine for cutaneous disinfection before insertion of an intravascular device and for post-insertion site care can reduce the catheter related colonization. PMID:24250702

  16. A test of various site-effect parameterizations in probabilistic seismic hazard analyses of southern California

    USGS Publications Warehouse

    Field, E.H.; Petersen, M.D.

    2000-01-01

    We evaluate the implications of several attenuation relationships, including three customized for southern California, in terms of accounting for site effects in probabilistic seismic hazard studies. The analysis is carried out at 43 sites along a profile spanning the Los Angeles basin with respect to peak acceleration, and 0.3-, 1.0-, and 3.0-sec response spectral acceleration values that have a 10% chance of being exceeded in 50 years. The variability among currently viable attenuation relationships (espistemic uncertainty) is an approximate factor of 2. Biases between several commonly used attenuation relationships and southern California strong-motion data imply hazard differences that exceed 10%. However, correcting each relationship for the southern California bias does not necessarily bring hazard estimates into better agreement. A detailed subclassification of site types (beyond rock versus soil) is found to be both justified by data and to make important distinctions in terms of hazard levels. A basin depth effect is also shown to be important, implying a difference of up to a factor of 2 in ground motion between the deepest and shallowest parts of the Los Angeles basin. In fact, for peak acceleration, the basin-depth effect is even more influential than the surface site condition. Questions remain, however, whether basin depth is a proxy for some other site attribute such as distance from the basin edge. The reduction in prediction error (sigma) produced by applying detailed site and/or basin-depth corrections does not have an important influence on the hazard. In fact, the sigma reduction is less than epistemic uncertainties on sigma itself. Due to data limitations, it is impossible to determine which attenuation relationship is best. However, our results do indicate which site conditions seem most influential. This information should prove useful to those developing or updating attenuation relationships and to those attempting to make more refined

  17. Effects of lidocaine on random skin flap survival in rats.

    PubMed

    Cao, Bin; Wang, Liren; Lin, Dingsheng; Cai, Leyi; Gao, Weiyang

    2015-01-01

    Use of a random skin flap is common for repairing wounds and for reconstruction. Lidocaine is a traditional local anesthetic that blocks sodium channels and has positive effects on ischemia-reperfusion injury. To investigate the effects of lidocaine on random skin flap survival in rats. McFarlane flaps were established in 20 rats divided into 2 groups. Lidocaine was injected in the lidocaine group, and the same concentration of saline was injected in the control group. The survival area of the flaps was measured on Day 7. Levels of inflammation were evaluated by hematoxylin and eosin (H&E)-stained slices, and superoxide dismutase and malonyldialdehyde contents were examined. The mean survival area of the flaps in the lidocaine group was significantly larger than that in the control group. Superoxide dismutase activity increased significantly in the lidocaine group compared with that in the control group. Malonyldialdehyde level in the lidocaine group was significantly lower than that in the control group. The H&E-stained slices showed that inflammation was clearly inhibited in the lidocaine group. Lidocaine improved the survival of random skin flaps.

  18. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  19. Plastic freezer bags: a cost-effective method to protect extraction sites in laparoscopic colorectal procedures?

    PubMed

    Huynh, Hai P; Musselman, Reilly P; Trottier, Daniel C; Soto, Claudia M; Poulin, Eric C; Mamazza, Joseph; Boushey, Robin P; Auer, Rebecca C; Moloo, Husein

    2013-10-01

    To review surgical-site infection (SSI) and retrieval-site tumor recurrence rates in laparoscopic colorectal procedures when using a plastic freezer bag as a wound protector. Laparoscopic colorectal procedures where a plastic freezer bag used as a wound protector at the extraction site were reviewed between 1991 and 2008 from a prospectively collected database. χ test was used to compare SSI and tumor recurrence rates between groups. Costing data were obtained from the operating room supplies department. A total of 936 cases with 51 (5.45%) surgical-site infections were identified. SSI rates did not differ when comparing groups based on demographic factors, diagnosis, or location of procedure. Retrieval-site tumor recurrence rate was 0.21% (1/474). Cost of plastic freezer bags including sterilization ranged from $0.25 to $3. Plastic freezer bags as wound protectors in laparoscopic colorectal procedures are cost effective and have SSI and retrieval-site tumor recurrence rates that compare favorably to published data.

  20. Effect of Increasing Doses of Saw Palmetto on Lower Urinary Tract Symptoms: A Randomized Trial

    PubMed Central

    Barry, Michael J.; Meleth, Sreelatha; Lee, Jeannette Y.; Kreder, Karl J.; Avins, Andrew L.; Nickel, J. Curtis; Roehrborn, Claus G.; Crawford, E. David; Foster, Harris E.; Kaplan, Steven A.; McCullough, Andrew; Andriole, Gerald L.; Naslund, Michael J.; Williams, O. Dale; Kusek, John W.; Meyers, Catherine M.; Betz, Joseph M.; Cantor, Alan; McVary, Kevin T.

    2012-01-01

    Context Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia. However, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg daily). Objective To determine the effect of a saw palmetto extract at up to three times the standard dose on lower urinary tract symptoms attributed to benign prostatic hyperplasia. Design Multicenter placebo-controlled randomized trial conducted from June, 2008 through October, 2010. Setting Eleven North American clinical sites. Participants Were men at least 45 years old, with a peak urinary flow rate ≥ 4 ml/sec, an AUA Symptom Index (AUASI) score ≥ 8 and ≤ 24, and no exclusions. Interventions One, two, and then three 320 mg daily doses of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. Main Outcome Measures Primary outcome was the difference in AUASI score from baseline to 72 weeks. Secondary outcomes were measures of urinary bother; nocturia; uroflow; postvoid residual; prostate-specific antigen; participants’ global assessments; and indices of sexual function, continence, sleep quality, and prostatitis symptoms. Results From baseline to 72 weeks, mean AUASI scores decreased from 14.4 to 12.2 points with saw palmetto and from 14.7 to 11.7 points with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto and placebo groups was 0.79 points favoring placebo (bound of the 95% confidence interval most favorable to saw palmetto was 1.77 points, one-sided P=0.91). Saw palmetto was no more effective than placebo for any secondary outcome. No attributable side effects were identified. Conclusions Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. (CAMUS study number NCT00603304 http://www.ClinicalTrials.gov) PMID:21954478

  1. Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial.

    PubMed

    Zeng, Juan; Wang, Chun-Ting; Zhang, Fu-Shen; Qi, Feng; Wang, Shi-Fu; Ma, Shuang; Wu, Tie-Jun; Tian, Hui; Tian, Zhao-Tao; Zhang, Shu-Liu; Qu, Yan; Liu, Lu-Yi; Li, Yuan-Zhong; Cui, Song; Zhao, He-Ling; Du, Quan-Sheng; Ma, Zhuang; Li, Chun-Hua; Li, Yun; Si, Min; Chu, Yu-Feng; Meng, Mei; Ren, Hong-Sheng; Zhang, Ji-Cheng; Jiang, Jin-Jiao; Ding, Min; Wang, Yu-Ping

    2016-06-01

    To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia (VAP). This was an open-label, randomized, controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were randomized to receive (1) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis (Medilac-S) 0.5 g three times daily through a nasogastric feeding tube plus standard preventive strategies or (2) standard preventive strategies alone, for a maximum of 14 days. The development of VAP was evaluated daily, and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter. The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients (36.4 vs. 50.4 %, respectively; P = 0.031). The mean time to develop VAP was significantly longer in the probiotics group than in the control group (10.4 vs. 7.5 days, respectively; P = 0.022). The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms (PPMOs) was lower in the probiotics group (24 %) than the control group (44 %) (P = 0.004). However, the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups. The administration of probiotics did not result in any improvement in the incidence of clinically suspected VAP, antimicrobial consumption, duration of mechanical ventilation, mortality and length of hospital stay. Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach.

  2. Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

    PubMed

    Zaragoza, M; Sallés, M; Gomez, J; Bayas, J M; Trilla, A

    1999-06-01

    The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

  3. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    PubMed

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  4. Effects of relationship education on couple communication and satisfaction: A randomized controlled trial with low-income couples.

    PubMed

    Williamson, Hannah C; Altman, Noemi; Hsueh, JoAnn; Bradbury, Thomas N

    2016-02-01

    Although preventive educational interventions for couples have been examined in more than 100 experimental studies, the value of this work is limited by reliance on economically advantaged populations and by an absence of data on proposed mediators and moderators. Data from the Supporting Healthy Marriage Project-a randomized, controlled trial of relationship education for couples living with low incomes-were therefore analyzed to test whether intervention effects on relationship satisfaction would be mediated by observational assessments of relationship communication and whether any such effects would be moderated by couples' pretreatment risk. Within the larger sample of Supporting Healthy Marriage Project couples randomized to a relationship education or no-treatment control condition, the present analyses focus on the 1,034 couples who provided (a) data on sociodemographic risk at baseline, (b) observational data on couple communication 12 months after randomization, and (c) reports of relationship satisfaction 30 months after randomization. Intervention couples reported higher satisfaction at 30 months than control couples, regardless of their level of pretreatment risk. Among higher risk couples, the intervention improved observed communication as well. Contrary to prediction, treatment effects on satisfaction were not mediated by improvements in communication, and improvements in communication did not translate into greater satisfaction. Relationship education programs produce small improvements in relationship satisfaction and communication, particularly for couples at elevated sociodemographic risk. The absence of behavioral effects on satisfaction indicates, however, that the mechanisms by which couples may benefit from relationship education are not yet well understood. (c) 2016 APA, all rights reserved).

  5. Coupling GIS and multivariate approaches to reference site selection for wadeable stream monitoring.

    PubMed

    Collier, Kevin J; Haigh, Andy; Kelly, Johlene

    2007-04-01

    Geographic Information System (GIS) was used to identify potential reference sites for wadeable stream monitoring, and multivariate analyses were applied to test whether invertebrate communities reflected a priori spatial and stream type classifications. We identified potential reference sites in segments with unmodified vegetation cover adjacent to the stream and in >85% of the upstream catchment. We then used various landcover, amenity and environmental impact databases to eliminate sites that had potential anthropogenic influences upstream and that fell into a range of access classes. Each site identified by this process was coded by four dominant stream classes and seven zones, and 119 candidate sites were randomly selected for follow-up assessment. This process yielded 16 sites conforming to reference site criteria using a conditional-probabilistic design, and these were augmented by an additional 14 existing or special interest reference sites. Non-metric multidimensional scaling (NMS) analysis of percent abundance invertebrate data indicated significant differences in community composition among some of the zones and stream classes identified a priori providing qualified support for this framework in reference site selection. NMS analysis of a range standardised condition and diversity metrics derived from the invertebrate data indicated a core set of 26 closely related sites, and four outliers that were considered atypical of reference site conditions and subsequently dropped from the network. Use of GIS linked to stream typology, available spatial databases and aerial photography greatly enhanced the objectivity and efficiency of reference site selection. The multi-metric ordination approach reduced variability among stream types and bias associated with non-random site selection, and provided an effective way to identify representative reference sites.

  6. African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension.

    PubMed

    Houston, Thomas K; Fix, Gemmae M; Shimada, Stephanie L; Long, Judith A; Gordon, Howard S; Pope, Charlene; Volkman, Julie; Allison, Jeroan J; DeLaughter, Kathryn; Orner, Michelle; Bokhour, Barbara G

    2017-09-01

    Disparities in hypertension control persist for African American Veterans. To enhance cultural relevance of hypertension control self-management education, in a multisite, stratified randomized trial, we tested an interactive Veteran-to-Veteran storytelling digital video disk (DVD) intervention created with Veteran partners, versus an education-only DVD comparison. At 3 VA facilities, African American Veterans with uncontrolled hypertension were randomized to storytelling DVD intervention or didactic comparison DVD and followed for 6 months. We hypothesized that follow-up blood pressure (BP) would be lower among Veterans in the intervention group. African American Veterans (N=619) were 92% male, 39% over age 65, most had a high-school education, over 50% of both the intervention and comparison group reported a household income of <$20,000, and 40% had less than adequate health literacy. At baseline, mean intervention and comparison group BPs were 138/80 and 139/81 mm Hg, respectively; at 6 months, mean systolic BP (SBP) increased by 0.1 in the intervention group and by 1.9 for the comparison group; diastolic BP fell by 0.1 in the intervention group and rose by 0.2 in the comparison group. No differences between the intervention and control groups were statistically significant (all P>0.3). Site differences were large; at one, the intervention group improved while the comparison groups deteriorated, resulting in 6.3 and 3.9 mm Hg more improvement for the intervention group in SBP and diastolic BP (P=0.06 and 0.04), respectively; at the other 2 sites, there were positive and negative changes, all small, in the 2 measures, with minimal differences-one site favored the comparison group and the other, the intervention (these comparisons did not approach statistical significance (all P>0.20). In a secondary analysis stratified by baseline BP, there was no intervention effect among those with uncontrolled BP, but intervention patients who were in control at baseline were

  7. Acute changes in lung function associated with proximity to a steel plant: a randomized study.

    PubMed

    Dales, Robert; Kauri, Lisa Marie; Cakmak, Sabit; Mahmud, Mamun; Weichenthal, Scott A; Van Ryswyk, Keith; Kumarathasan, Premkumari; Thomson, Errol; Vincent, Renaud; Broad, Gayle; Liu, Ling

    2013-05-01

    Steel production is a major industry worldwide yet there is relatively little information on the pulmonary effects of air quality near steel manufacturing plants. The aim of this study was to examine how lung function changes acutely when healthy subjects are situated near a steel plant which is adjacent to a residential area. Sixty-one subjects were randomly assigned to spend 5 consecutive, 8-hour days in a residential neighborhood approximately 0.9km from a steel plant, or approximately 4.5km away at a college campus. Subjects crossed-over between sites after a nine-day washout period. Lung function was measured daily at both sites along with air pollutants including SO2, NO2, O3, PM2.5, and ultrafine particles. Diffusion capacity and pulse oximetry were also examined. Compared with the college site, the forced expiratory volume in 1-second/forced vital capacity, forced expiratory flow between 25% and 75% of the FVC, total lung capacity, functional residual capacity, and residual volume were lower near the steel plant by 0.67% (95% CI: 0.28, 1.06),1.62% (95% CI: 0.50, 2.75), 1.54% (95% CI: 0.68, 2.39), 3.54% (95% CI: 1.95, 5.13) and 11.3% (95% CI: 4.92, 17.75), respectively. Diffusion capacity, forced expiratory volume in 1s, and pulse oximetry were also lower near the plant but these effects were not statistically significant. Sulfur dioxide, ultrafine particulates, and oxides of nitrogen were greater near the steel plant site compared to the college site. Spending short periods of time near a steel plant is associated with a decrease in lung function. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  8. The Effects of a Pedometer-Based Intervention on First-Year University Students: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Sharp, Paul; Caperchione, Cristina

    2016-01-01

    Objectives: To assess the effects of a 12-week pedometer-based intervention on the physical activity behavior, health-related quality of life (HRQOL), and psychological well-being of first-year university students. Participants: First-year university students (N = 184) were recruited during September 2012 and randomly assigned to an intervention…

  9. An alternative approach to characterize nonlinear site effects

    USGS Publications Warehouse

    Zhang, R.R.; Hartzell, S.; Liang, J.; Hu, Y.

    2005-01-01

    This paper examines the rationale of a method of nonstationary processing and analysis, referred to as the Hilbert-Huang transform (HHT), for its application to a recording-based approach in quantifying influences of soil nonlinearity in site response. In particular, this paper first summarizes symptoms of soil nonlinearity shown in earthquake recordings, reviews the Fourier-based approach to characterizing nonlinearity, and offers justifications for the HHT in addressing nonlinearity issues. This study then uses the HHT method to analyze synthetic data and recordings from the 1964 Niigata and 2001 Nisqually earthquakes. In doing so, the HHT-based site response is defined as the ratio of marginal Hilbert amplitude spectra, alternative to the Fourier-based response that is the ratio of Fourier amplitude spectra. With the Fourier-based approach in studies of site response as a reference, this study shows that the alternative HHT-based approach is effective in characterizing soil nonlinearity and nonlinear site response.

  10. Randomized trial of the effectiveness of combined behavioral/pharmacological smoking cessation treatment in Syrian primary care clinics.

    PubMed

    Ward, Kenneth D; Asfar, Taghrid; Al Ali, Radwan; Rastam, Samer; Weg, Mark W Vander; Eissenberg, Thomas; Maziak, Wasim

    2013-02-01

    Effectiveness of nicotine replacement therapy (NRT) for smoking cessation has not been evaluated in low income countries, such as Syria, where it is expensive and not widely available. We evaluated whether nicotine patch boosts smoking cessation rates when used in conjunction with behavioral support in primary care clinics in Aleppo, Syria. Two arm, parallel group, randomized, placebo controlled, double-blinded multi-site trial. Four primary care clinics in Aleppo, Syria.  Two hundred and sixty-nine adult primary care patients received behavioral cessation counseling from a trained primary care physician and were randomized to receive six weeks of treatment with nicotine versus placebo patch. Primary end-points were prolonged abstinence (no smoking after a 2-week grace period) at end of treatment, and 6 and 12 months post-quit day, assessed by self-report and exhaled carbon monoxide levels of <10 p.p.m. Treatment adherence was excellent and nicotine patch produced expected reductions in urges to smoke and withdrawal symptoms, but no treatment effect was observed. The proportion of patients in the nicotine and placebo groups with prolonged abstinence was 21.6% and 20.0%, respectively, at end of treatment, 13.4% and 14.1% at 6 months, and 12.7% and 11.9% at 12 months.  Nicotine patches may not be effective in helping smokers in low-income countries to stop when given as an adjunct to behavioural support. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

  11. [Effect of ear point embedding on plasma and effect site concentrations of propofol-remifentanil in elderly patients after target-controlled induction].

    PubMed

    Zheng, Xiaochun; Wan, Liling; Gao, Fei; Chen, Jianghu; Tu, Wenshao

    2017-08-12

    To observe the clinical effect of ear point embedding on plasma and effect site concentrations of propofol-remifentanil in elderly patients who underwent abdominal external hernia surgery at the time of consciousness and pain disappearing by target-controlled infusion (TCI) and bispectral index (BIS). Fifty patients who underwent elective abdominal hernia surgery were randomly assigned into an observation group and a control group, 25 cases in each one. In the observation group, 30 minutes before anesthesia induction, Fugugou (Extra), Gan (CO 12 ), Pizhixia (AT 4 ), and Shenmen (TF 4 ) were embedded by auricular needles until the end of surgery, 10 times of counter press each point. In the control group, the same amount of auricular tape was applied until the end of surgery at the same points without stimulation 30 minutes before anesthesia induction. Patients in the two groups were given total intravenous anesthesia, and BIS was monitored by BIS anesthesia depth monitor. Propofol was infused by TCI at a beginning concentration of 1.5μg/L and increased by 0.3μg/L every 30s until the patients lost their consciousness. After that, remifentanil was infused by TCI at a beginning concentration of 2.0μg/L and increased by 0.3μg/L every 30s until the patients had no body reaction to pain stimulation (orbital reflex). Indices were recorded, including mean arterial pressure (MAP), heart rate (HR) and the BIS values, at the time of T 0 (entering into the operation room), T 1 (losing consciousness) and T 2 (pain relief), the plasma and effect site concentrations of propofol at T 1 , the plasma and effect site concentrations of remifentanil at T 2 . After surgery we recorded the total amounts of propofol and remifentanil, surgery time and anesthesia time. At T 1 and T 2 , MAP and HR of the observation group were higher than those of the control group ( P <0.05, P <0.01). At T 1 , the plasma and effect site concentrations of propofol in the observation group were

  12. Nonemergency PCI at hospitals with or without on-site cardiac surgery.

    PubMed

    Jacobs, Alice K; Normand, Sharon-Lise T; Massaro, Joseph M; Cutlip, Donald E; Carrozza, Joseph P; Marks, Anthony D; Murphy, Nancy; Romm, Iyah K; Biondolillo, Madeleine; Mauri, Laura

    2013-04-18

    Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals

  13. Quantifying Adventitious Error in a Covariance Structure as a Random Effect

    PubMed Central

    Wu, Hao; Browne, Michael W.

    2017-01-01

    We present an approach to quantifying errors in covariance structures in which adventitious error, identified as the process underlying the discrepancy between the population and the structured model, is explicitly modeled as a random effect with a distribution, and the dispersion parameter of this distribution to be estimated gives a measure of misspecification. Analytical properties of the resultant procedure are investigated and the measure of misspecification is found to be related to the RMSEA. An algorithm is developed for numerical implementation of the procedure. The consistency and asymptotic sampling distributions of the estimators are established under a new asymptotic paradigm and an assumption weaker than the standard Pitman drift assumption. Simulations validate the asymptotic sampling distributions and demonstrate the importance of accounting for the variations in the parameter estimates due to adventitious error. Two examples are also given as illustrations. PMID:25813463

  14. Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials.

    PubMed

    Fernández-San-Martín, Maria Isabel; Masa-Font, Roser; Palacios-Soler, Laura; Sancho-Gómez, Pilar; Calbó-Caldentey, Cristina; Flores-Mateo, Gemma

    2010-06-01

    Insomnia is an often seen primary health care problem. Valerian might be an alternative treatment with fewer secondary effects. The aim of this study is to evaluate its effectiveness on insomnia through a meta-analysis of published literature. Search for randomized clinical trials (RCTs) of Valerian preparations compared with a placebo on Medline, the Cochrane Library, Embase and Biosis. sleep-quality improvement (SQ, yes/no), sleep-quality improvement quantified through visual analogical scales (SQS) and the latency time (LT) in minutes until getting to sleep. Three meta-analyses were carried out using inverse-variance weighted random effects models. Heterogeneity was determined with the Q-statistic and was explored through a sub-groups analysis. Publication bias was evaluated using the funnel plot. Eighteen RCTs were selected; eight had a score of 5 on Jadad's scale. The mean differences in LT between the Valerian and placebo treatment groups was 0.70 min (95% CI, -3.44 to 4.83); the standardized mean differences between the groups measured with SQS was -0.02 (95% CI, -0.35 to 0.31); treatment with Valerian showed a relative risk of SQ of 1.37 (95% CI, 1.05-1.78) compared with the placebo group. There was heterogeneity in the three meta-analyses, but it diminished in the sub groups analysis. No publication bias was detected. The qualitative dichotomous results suggest that valerian would be effective for a subjective improvement of insomnia, although its effectiveness has not been demonstrated with quantitative or objective measurements. We recommend future investigations oriented toward improving insomnia with other more promising treatments. Copyright 2010 Elsevier B.V. All rights reserved.

  15. A randomized controlled trial of a pharmacist consultation program for family physicians and their elderly patients

    PubMed Central

    Sellors, John; Kaczorowski, Janusz; Sellors, Connie; Dolovich, Lisa; Woodward, Christel; Willan, Andrew; Goeree, Ron; Cosby, Roxanne; Trim, Kristina; Sebaldt, Rolf; Howard, Michelle; Hardcastle, Linda; Poston, Jeff

    2003-01-01

    Background Pharmacists can improve patient outcomes in institutional and pharmacy settings, but little is known about their effectiveness as consultants to primary care physicians. We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients, as well as costs and health care use. Methods We conducted a randomized controlled trial in family practices in 24 sites in Ontario. We randomly allocated 48 randomly selected family physicians (69.6% participation rate) to the intervention or the control arm, along with 889 (69.5% participation rate) of their randomly selected community-dwelling, elderly patients who were taking 5 or more medications daily. In the intervention group, pharmacists conducted face-to-face medication reviews with the patients and then gave written recommendations to the physicians to resolve any drug-related problems. Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians. Results After 5 months, seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively (p = 0.50). There were no statistically significant differences in health care use or costs between groups. A mean of 2.5 drug-related problems per senior was identified in the intervention arm. Physicians implemented or attempted to implement 72.3% (790/1093) of the recommendations. Interpretation The intervention did not have a significant effect on patient outcomes. However, physicians were receptive to the recommendations to resolve drug-related problems, suggesting that collaboration between physicians and pharmacists is feasible. PMID:12847034

  16. Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

    PubMed

    Nam, I S

    2016-01-01

    Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

  17. Effect of extended-release niacin on plasma lipoprotein(a) levels: A systematic review and meta-analysis of randomized placebo-controlled trials.

    PubMed

    Sahebkar, Amirhosssein; Reiner, Željko; Simental-Mendía, Luis E; Ferretti, Gianna; Cicero, Arrigo F G

    2016-11-01

    Lipoprotein(a) (Lp(a)) is a proatherogenic and prothrombotic lipoprotein. Our aim was to quantify the extended-release nicotinic acid Lp(a) reducing effect with a meta-analysis of the available randomized clinical trials. A meta-analysis and random-effects meta-regression were performed on data pooled from 14 randomized placebo-controlled clinical trials published between 1998 and 2015, comprising 17 treatment arms, which included 9013 subjects, with 5362 in the niacin arm. The impact of ER niacin on plasma Lp(a) concentrations was reported in 17 treatment arms. Meta-analysis suggested a significant reduction of Lp(a) levels following ER niacin treatment (weighted mean difference - WMD: -22.90%, 95% CI: -27.32, -18.48, p<0.001). Results also remained similar when the meta-analysis was repeated with standardized mean difference as summary statistic (WMD: -0.66, 95% CI: -0.82, -0.50, p<0.001). When the studies were categorized according to the administered dose, there was a comparable effect between the subsets of studies with administered doses of <2000mg/day (WMD: -21.85%, 95% CI: -30.61, -13.10, p<0.001) and ≥2000mg/day (WMD: -23.21%, 95% CI: -28.41, -18.01, p<0.001). The results of the random-effects meta-regression did not suggest any significant association between the changes in plasma concentrations of Lp(a) with dose (slope: -0.0001; 95% CI: -0.01, 0.01; p=0.983), treatment duration (slope: -0.40; 95% CI: -0.97, 0.17; p=0.166), and percentage change in plasma HDL-C concentrations (slope: 0.44; 95% CI: -0.48, 1.36; p=0.350). In this meta-analysis of randomized placebo-controlled clinical trials, treatment with nicotinic acid was associated with a significant reduction in Lp(a) levels. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Prospective randomized controlled trial of conventional laparoscopic versus laparoendoscopic single-site radical nephrectomy for localized renal cell carcinoma: a preliminary report regarding quality of life.

    PubMed

    Park, Yong Hyun; Kim, Kwang Taek; Ko, Kyungtae; Kim, Hyeon Hoe

    2015-03-01

    The safety and efficacy of laparoendoscopic single-site surgery (LESS) for renal cell carcinoma (RCC) have not been clearly demonstrated. We aimed to present preliminary data from a prospective randomized controlled trial of LESS versus conventional laparoscopic radical nephrectomy for localized RCC. Patients with cT1-2 RCC were randomized to LESS (n = 17) or conventional laparoscopy (n = 18) group. The short-term outcome measures assessed were perioperative morbidity, postoperative pain, and quality of recovery as determined using QoR-40. No significant differences were observed between the LESS and conventional laparoscopy groups with respect to operative time (143.5 vs. 126.1 min, p = 0.218), blood loss (143.6 vs. 118.2 ml, p = 0.121), hospital stay (3.8 vs. 3.1 day s, p = 0.170), analgesic requirements (63.2 vs. 60.0 mg, p = 0.956), and complication rates (26.7 vs. 22.2 %, p = 0.767). However, postoperative quality of recovery was better in the LESS group (176.4 vs. 152.6, p = 0.005). Furthermore, quality of recovery, as measured using the QoR-40 dimensions of emotional state (39.9 vs. 34.0, p = 0.003), physical comfort (51.9 vs. 46.7, p = 0.034), psychological support (32.2 vs. 25.8, p = 0.003), and physical independence (20.7 vs. 17.5, p = 0.047), but not pain (31.8 vs. 29.6, p = 0.259), was significantly better in the LESS group. The preliminary results from this prospective trial suggest that LESS could be a safe and effective treatment option for localized RCC with equivalent surgical outcomes and improved postoperative quality of recovery compared with conventional laparoscopic surgery.

  19. Effect of botulinum toxin A and nitroglycerin on random skin flap survival in rats.

    PubMed

    Ghanbarzadeh, Kourosh; Tabatabaie, Omid Reza; Salehifar, Ebrahim; Amanlou, Massoud; Khorasani, Ghasemali

    2016-01-01

    A suitable pharmacological substitute for the well-established surgical delay technique for random skin flaps to increase viability has been elusive. To evaluate the effects of nitroglycerin and botulinum toxin type A on random flap survival in a rat model. The present controlled experimental study was performed in the four groups of rats. One week after intervention in each group, the flap was raised and kept in situ, and flap necrosis was evaluated through follow-up. Group 1 received intradermal botulinum toxin type A (BTX-A) and topical nitroglycerin 2%; group 2 received BTX-A and topical Vaseline (Unilever, USA); group 3 received topical nitroglycerin and intradermal normal saline; and group 4 received topical Vaseline and intradermal normal saline. BTX-A reduced the area of necrosis compared with control (24% versus 56% respectively; P<0.001). Nitroglycerin application was associated with a trend toward improved flap viability (42% versus 56%; P=0.059). The combination of topical nitroglycerin and BTX-A, compared with Vaseline and BTX-A, was associated with decreased flap necrosis (16.1% versus 24%, respectively), although it was not statistically significant (P=0.45). BTX-A was effective in reducing distal flap necrosis. The effect of BTX-A was significantly more pronounced than nitroglycerin ointment.

  20. A comparison of observation-level random effect and Beta-Binomial models for modelling overdispersion in Binomial data in ecology & evolution.

    PubMed

    Harrison, Xavier A

    2015-01-01

    Overdispersion is a common feature of models of biological data, but researchers often fail to model the excess variation driving the overdispersion, resulting in biased parameter estimates and standard errors. Quantifying and modeling overdispersion when it is present is therefore critical for robust biological inference. One means to account for overdispersion is to add an observation-level random effect (OLRE) to a model, where each data point receives a unique level of a random effect that can absorb the extra-parametric variation in the data. Although some studies have investigated the utility of OLRE to model overdispersion in Poisson count data, studies doing so for Binomial proportion data are scarce. Here I use a simulation approach to investigate the ability of both OLRE models and Beta-Binomial models to recover unbiased parameter estimates in mixed effects models of Binomial data under various degrees of overdispersion. In addition, as ecologists often fit random intercept terms to models when the random effect sample size is low (<5 levels), I investigate the performance of both model types under a range of random effect sample sizes when overdispersion is present. Simulation results revealed that the efficacy of OLRE depends on the process that generated the overdispersion; OLRE failed to cope with overdispersion generated from a Beta-Binomial mixture model, leading to biased slope and intercept estimates, but performed well for overdispersion generated by adding random noise to the linear predictor. Comparison of parameter estimates from an OLRE model with those from its corresponding Beta-Binomial model readily identified when OLRE were performing poorly due to disagreement between effect sizes, and this strategy should be employed whenever OLRE are used for Binomial data to assess their reliability. Beta-Binomial models performed well across all contexts, but showed a tendency to underestimate effect sizes when modelling non-Beta-Binomial data

  1. Antihypertensive effect of Iranian Crataegus curvisepala Lind.: a randomized, double-blind study.

    PubMed

    Asgary, S; Naderi, G H; Sadeghi, M; Kelishadi, R; Amiri, M

    2004-01-01

    The aim of the present study was to investigate the potential antihypertensive effects of extracts of the flavonoid-rich Iranian flower, Crataegus curvisepala Lind., a member of the Rosaceae family. The hydroalcoholic extract of the leaves and flowers were studied in a double-blind, placebo-controlled clinical trial to determine its effects. A total of 92 men and women with primary mild hypertension, aged 40-60 years, were selected and divided randomly into two groups, receiving either hydroalcoholic extract of C. curvisepala Lind. or placebo three times daily for more than 4 months. Blood pressure (BP) was measured each month. Statistical analysis was carried out using Student's t-test. The results obtained showed a significant decrease in both systolic and diastolic BP after 3 months (p < 0.05). C. curvisepala has a time-dependent antihypertensive effect.

  2. Zero-field random-field effect in diluted triangular lattice antiferromagnet CuFe1-xAlxO2

    NASA Astrophysics Data System (ADS)

    Nakajima, T.; Mitsuda, S.; Kitagawa, K.; Terada, N.; Komiya, T.; Noda, Y.

    2007-04-01

    We performed neutron scattering experiments on a diluted triangular lattice antiferromagnet (TLA), CuFe1-xAlxO2 with x = 0.10. The detailed analysis of the scattering profiles revealed that the scattering function of magnetic reflection is described as the sum of a Lorentzian term and a Lorentzian-squared term with anisotropic width. The Lorentzian-squared term dominating at low temperature is indicative of the domain state in the prototypical random-field Ising model. Taking account of the sinusoidally amplitude-modulated magnetic structure with incommensurate wavenumber in CuFe1-xAlxO2 with x = 0.10, we conclude that the effective random field arises even at zero field, owing to the combination of site-random magnetic vacancies and the sinusoidal structure that is regarded as a partially disordered (PD) structure in a wide sense, as reported in the typical three-sublattice PD phase of a diluted Ising TLA, CsCo0.83Mg0.17Br3 (van Duijn et al 2004 Phys. Rev. Lett. 92 077202). While the previous study revealed the existence of a domain state in CsCo0.83Mg0.17Br3 by detecting magnetic reflections specific to the spin configuration near the domain walls, our present study revealed the existence of a domain state in CuFe1-xAlxO2 (x = 0.10) by determination of the functional form of the scattering function.

  3. A Randomized Effectiveness Trial of Brief Cognitive-Behavioral Therapy for Depressed Adolescents Receiving Antidepressant Medication

    ERIC Educational Resources Information Center

    Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie

    2005-01-01

    Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…

  4. The Effect of Top-Level Domains and Advertisements on Health Web Site Credibility

    PubMed Central

    Wang, Zuoming; Loh, Tracy

    2004-01-01

    Background Concerns over health information on the Internet have generated efforts to enhance credibility markers; yet how users actually assess the credibility of online health information is largely unknown. Objective This study set out to (1) establish a parsimonious and valid questionnaire instrument to measure credibility of Internet health information by drawing on various previous measures of source, news, and other credibility scales; and (2) to identify the effects of Web-site domains and advertising on credibility perceptions. Methods Respondents (N = 156) examined one of 12 Web-site mock-ups and completed credibility scales in a 3 x 2 x 2 between-subjects experimental design. Factor analysis and validity checks were used for item reduction, and analysis of variance was employed for hypothesis testing of Web-site features' effects. Results In an attempt to construct a credibility instrument, three dimensions of credibility (safety, trustworthiness, and dynamism) were retained, reflecting traditional credibility sub-themes, but composed of items from disparate sources. When testing the effect of the presence or absence of advertising on a Web site on credibility, we found that this depends on the site's domain, with a trend for advertisements having deleterious effects on the credibility of sites with .org domain, but positive effects on sites with .com or .edu domains. Conclusions Health-information Web-site providers should select domains purposefully when they can, especially if they must accept on-site advertising. Credibility perceptions may not be invariant or stable, but rather are sensitive to topic and context. Future research may employ these findings in order to compare other forms of health-information delivery to optimal Web-site features. PMID:15471750

  5. The effect of top-level domains and advertisements on health web-site credibility.

    PubMed

    Walther, Joseph B; Wang, Zuoming; Loh, Tracy

    2004-09-03

    Concerns over health information on the Internet have generated efforts to enhance credibility markers; yet how users actually assess the credibility of online health information is largely unknown. This study set out to (1) establish a parsimonious and valid questionnaire instrument to measure credibility of Internet health information by drawing on various previous measures of source, news, and other credibility scales; and (2) to identify the effects of Web-site domains and advertising on credibility perceptions. Respondents (N = 156) examined one of 12 Web-site mock-ups and completed credibility scales in a 3 x 2 x 2 between-subjects experimental design. Factor analysis and validity checks were used for item reduction, and analysis of variance was employed for hypothesis testing of Web-site features' effects. In an attempt to construct a credibility instrument, three dimensions of credibility (safety, trustworthiness, and dynamism) were retained, reflecting traditional credibility sub-themes, but composed of items from disparate sources. When testing the effect of the presence or absence of advertising on a Web site on credibility, we found that this depends on the site's domain, with a trend for advertisements having deleterious effects on the credibility of sites with .org domain, but positive effects on sites with .com or .edu domains. Health-information Web-site providers should select domains purposefully when they can, especially if they must accept on-site advertising. Credibility perceptions may not be invariant or stable, but rather are sensitive to topic and context. Future research may employ these findings in order to compare other forms of health-information delivery to optimal Web-site features.

  6. The effect on teenage risky driving of feedback from a safety monitoring system: a randomized controlled trial.

    PubMed

    Simons-Morton, Bruce G; Bingham, C Raymond; Ouimet, Marie Claude; Pradhan, Anuj K; Chen, Rusan; Barretto, Andrea; Shope, Jean T

    2013-07-01

    Teenage risky driving may be due to teenagers not knowing what is risky, preferring risk, or the lack of consequences. Elevated gravitational-force (g-force) events, caused mainly by hard braking and sharp turns, provide a valid measure of risky driving and are the target of interventions using in-vehicle data recording and feedback devices. The effect of two forms of feedback about risky driving events to teenagers only or to teenagers and their parents was tested in a randomized controlled trial. Ninety parent-teen dyads were randomized to one of two groups: (1) immediate feedback to teens (Lights Only); or (2) immediate feedback to teens plus family access to event videos and ranking of the teen relative to other teenage drivers (Lights Plus). Participants' vehicles were instrumented with data recording devices and events exceeding .5 g were assessed for 2 weeks of baseline and 13 weeks of feedback. Growth curve analysis with random slopes yielded a significant decrease in event rates for the Lights Plus group (slope = -.11, p < .01), but no change for the Lights Only group (slope = .05, p = .67) across the 15 weeks. A large effect size of 1.67 favored the Lights Plus group. Provision of feedback with possible consequences associated with parents being informed reduced risky driving, whereas immediate feedback only to teenagers did not. Published by Elsevier Inc.

  7. A Randomized, Wait-List Controlled Effectiveness Trial Assessing School-Wide Positive Behavior Support in Elementary Schools

    ERIC Educational Resources Information Center

    Horner, Robert H.; Sugai, George; Smolkowski, Keith; Eber, Lucille; Nakasato, Jean; Todd, Anne W.; Esperanza, Jody

    2009-01-01

    We report a randomized, wait-list controlled trial assessing the effects of school-wide positive behavior support (SWPBS). An effectiveness analysis was conducted with elementary schools in Hawaii and Illinois where training and technical assistance in SWPBS was provided by regular state personnel over a 3-year period. Results document that the…

  8. Randomized Trial of Smartphone-Based Evaluation for an Obstetrics and Gynecology Clerkship.

    PubMed

    Sobhani, Nasim C; Fay, Emily E; Schiff, Melissa A; Stephenson-Famy, Alyssa; Debiec, Katherine E

    2017-12-19

    We hypothesized that compared to paper evaluations, a smartphone-based quick response (QR) evaluation tool would improve timeliness of feedback, enhance efficacy of giving and receiving feedback, and be as easy to use. We performed a randomized controlled trial of student and instructor experience with two evaluation tools in the OB/GYN clerkship at University of Washington School of Medicine (UWSOM). Sites were randomized to the QR or paper tool; students at QR sites received individualized QR codes at the beginning of the clerkship. Instructors and students completed postintervention surveys regarding the evaluation tool and associated feedback. We compared responses between groups using chi-squared tests. Participating clerkship sites included primary, tertiary, private practice and institutional settings affiliated with the University of Washington in the Washington, Wyoming, Alaska, Montana and Idaho region. Of the 29 OB/GYN UWSOM clerkship sites, 18 agreed to participate and were randomized. Of 29 eligible instructors, 25 (86%) completed the survey, with n = 18 using QR and n = 7 using paper. Of 161 eligible students, 102 (63%) completed the survey, with n = 54 using QR and n = 48 using paper. Compared to those using paper evaluations, instructors using QR evaluations were significantly more likely to agree that the evaluation tool was easy to understand (100% QR vs 43% paper, p = 0.002), the tool was effective in providing feedback (78% QR vs 29% paper, p = 0.002), and they felt comfortable approaching students with the tool (89% QR vs 43% paper, p = 0.002). Compared to those using paper evaluations, students using QR evaluations were less likely to agree the tool was effective in eliciting feedback (QR 43% vs paper 55%, p = 0.042). Instructors found QR evaluations superior to paper evaluations for providing feedback to medical students, whereas students found QR evaluations less effective for feedback. Copyright © 2017 Association of Program Directors in

  9. Implementing a Measurement Feedback System: A Tale of Two Sites

    PubMed Central

    Douglas, Susan R.; Vides De Andrade, Ana Regina; Tomlinson, Michele; Gleacher, Alissa; Olin, Serene; Hoagwood, Kimberly

    2015-01-01

    A randomized experiment was conducted in two outpatient clinics evaluating a measurement feedback system called contextualized feedback systems. The clinicians of 257 Youth 11–18 received feedback on progress in mental health symptoms and functioning either every 6 months or as soon as the youth’s, clinician’s or caregiver’s data were entered into the system. The ITT analysis showed that only one of the two participating clinics (Clinic R) had an enhanced outcome because of feedback, and only for the clinicians’ ratings of youth symptom severity on the SFSS. A dose–response effect was found only for Clinic R for both the client and clinician ratings. Implementation analyses showed that Clinic R had better implementation of the feedback intervention. Clinicians’ questionnaire completion rate and feedback viewing at Clinic R were 50 % higher than clinicians at Clinic U. The discussion focused on the differences in implementation at each site and how these differences may have contributed to the different outcomes of the experiment. PMID:25876736

  10. Effects of hormone therapy on brain structure: A randomized controlled trial.

    PubMed

    Kantarci, Kejal; Tosakulwong, Nirubol; Lesnick, Timothy G; Zuk, Samantha M; Gunter, Jeffrey L; Gleason, Carey E; Wharton, Whitney; Dowling, N Maritza; Vemuri, Prashanthi; Senjem, Matthew L; Shuster, Lynne T; Bailey, Kent R; Rocca, Walter A; Jack, Clifford R; Asthana, Sanjay; Miller, Virginia M

    2016-08-30

    To investigate the effects of hormone therapy on brain structure in a randomized, double-blinded, placebo-controlled trial in recently postmenopausal women. Participants (aged 42-56 years, within 5-36 months past menopause) in the Kronos Early Estrogen Prevention Study were randomized to (1) 0.45 mg/d oral conjugated equine estrogens (CEE), (2) 50 μg/d transdermal 17β-estradiol, or (3) placebo pills and patch for 48 months. Oral progesterone (200 mg/d) was given to active treatment groups for 12 days each month. MRI and cognitive testing were performed in a subset of participants at baseline, and at 18, 36, and 48 months of randomization (n = 95). Changes in whole brain, ventricular, and white matter hyperintensity volumes, and in global cognitive function, were measured. Higher rates of ventricular expansion were observed in both the CEE and the 17β-estradiol groups compared to placebo; however, the difference was significant only in the CEE group (p = 0.01). Rates of ventricular expansion correlated with rates of decrease in brain volume (r = -0.58; p ≤ 0.001) and with rates of increase in white matter hyperintensity volume (r = 0.27; p = 0.01) after adjusting for age. The changes were not different between the CEE and 17β-estradiol groups for any of the MRI measures. The change in global cognitive function was not different across the groups. Ventricular volumes increased to a greater extent in recently menopausal women who received CEE compared to placebo but without changes in cognitive performance. Because the sample size was small and the follow-up limited to 4 years, the findings should be interpreted with caution and need confirmation. This study provides Class I evidence that brain ventricular volume increased to a greater extent in recently menopausal women who received oral CEE compared to placebo. © 2016 American Academy of Neurology.

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

    PubMed

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

    2016-11-16

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

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

    PubMed

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-11-30

    Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

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

    PubMed Central

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

  14. The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

    PubMed Central

    Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

    2015-01-01

    Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and

  15. Comparative Effectiveness of Cognitive Therapy and Dynamic Psychotherapy for Major Depressive Disorder in a Community Mental Health Setting: A Randomized Clinical Noninferiority Trial.

    PubMed

    Connolly Gibbons, Mary Beth; Gallop, Robert; Thompson, Donald; Luther, Debra; Crits-Christoph, Kathryn; Jacobs, Julie; Yin, Seohyun; Crits-Christoph, Paul

    2016-09-01

    Dynamic psychotherapy (DT) is widely practiced in the community, but few trials have established its effectiveness for specific mental health disorders relative to control conditions or other evidence-based psychotherapies. To determine whether DT is not inferior to cognitive therapy (CT) in the treatment of major depressive disorder (MDD) in a community mental health setting. From October 28, 2010, to July 2, 2014, outpatients with MDD were randomized to treatment delivered by trained therapists. Twenty therapists employed at a community mental health center in Pennsylvania were trained by experts in CT or DT. A total of 237 adult outpatients with MDD seeking services at this site were randomized to 16 sessions of DT or CT delivered across 5 months. Final assessment was completed on December 9, 2014, and data were analyzed from December 10, 2014, to January 14, 2016. Short-term DT or CT. Expert blind evaluations with the 17-item Hamilton Rating Scale for Depression. Among the 237 patients (59 men [24.9%]; 178 women [75.1%]; mean [SD] age, 36.2 [12.1] years) treated by 20 therapists (19 women and 1 man; mean [SD] age, 40.0 [14.6] years), 118 were randomized to DT and 119 to CT. A mean (SD) difference between treatments was found in the change on the Hamilton Rating Scale for Depression of 0.86 (7.73) scale points (95% CI, -0.70 to 2.42; Cohen d, 0.11), indicating that DT was statistically not inferior to CT. A statistically significant main effect was found for time (F1,198 = 75.92; P = .001). No statistically significant differences were found between treatments on patient ratings of treatment credibility. Dynamic psychotherapy and CT were discriminated from each other on competence in supportive techniques (t120 = 2.48; P = .02), competence in expressive techniques (t120 = 4.78; P = .001), adherence to CT techniques (t115 = -7.07; P = .001), and competence in CT (t115 = -7.07; P = .001). This study suggests that DT is not

  16. The Effectiveness of Mandatory-Random Student Drug Testing. NCEE 2010-4025

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric

    2010-01-01

    To help assess the effects of school-based random drug testing programs, the U.S. Department of Education's Institute of Education Sciences (IES) contracted with RMC Research Corporation and Mathematica Policy Research to conduct an experimental evaluation of the Mandatory-Random Student Drug Testing (MRSDT) programs in 36 high schools within…

  17. A Randomized Trial of Longitudinal Effects of Low-Intensity Responsivity Education/Prelinguistic Milieu Teaching

    ERIC Educational Resources Information Center

    Warren, Steven F.; Fey, Marc E.; Finestack, Lizbeth, H.; Brady, Nancy C.; Bredin-Oja, Shelley L.; Fleming, Kandace K.

    2008-01-01

    Purpose: To evaluate the longitudinal effects of a 6-month course of responsivity education (RE)/prelinguistic milieu teaching (PMT) for young children with developmental delay. Method: Fifty-one children, age 24-33 months, with fewer than 10 expressive words were randomly assigned to early-treatment/no-treatment groups. All treatment was added as…

  18. Effect of motivational interviewing on rates of early childhood caries: a randomized trial.

    PubMed

    Harrison, Rosamund; Benton, Tonya; Everson-Stewart, Siobhan; Weinstein, Phil

    2007-01-01

    The purposes of this randomized controlled trial were to: (1) test motivational interviewing (MI) to prevent early childhood caries; and (2) use Poisson regression for data analysis. A total of 240 South Asian children 6 to 18 months old were enrolled and randomly assigned to either the MI or control condition. Children had a dental exam, and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention. Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression. Hazard ratios were produced. Analyses included all participants whenever possible. Poisson regression supported a protective effect of MI (hazard ratio [HR]=0.54 (95%CI=035-0.84)-that is, the M/ group had about a 46% lower rate of dmfs at 2 years than did control children. Similar treatment effect estimates were obtained from models that included, as alternative outcomes, ds, dms, and dmfs, including "white spot lesions." Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had: (1) prechewed their food; (2) been raised in a rural environment; and (3) a higher family income (P<.05). A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries.

  19. Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial.

    PubMed

    Gerami, Hooshang; Saberi, Alia; Nemati, Shadman; Kazemnejad, Ehsan; Aghajanpour, Mohammad

    2012-01-01

    It is still a challenge to find an effective treatment for tinnitus. The aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus. In a randomized double-blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 mg/day), oxcarbazepine (450-900 mg/day) and placebo for 12 weeks. Visual analogue scale (VAS) and tinnitus severity index (TSI) were measured in all subjects in the beginning and at the end of the 8(th) and 12(th) weeks of the trial. Data was analyzed by repeated measure analysis, paired and independent t-test. Among 51 participants who completed the trial course (28 men, 23 women), carbamazepine, oxcarbazepine and placebo decreased tinnitus severity in 56.6%, 46.2% and 38.5% of patients according to VAS, and in 61.1%, 58.8% and 50% of patients according to TSI, respectively. The effects of carbamazepine and oxcarbazepine were better in the first 8 weeks of treatment. However, their effect on tinnitus did not show any statistical difference in comparison with placebo (P = 0.34, P = 0.28). Carbamazepine and oxcarbazepine are not more effective than placebo in decreasing tinnitus severity.

  20. Distortions in Distributions of Impact Estimates in Multi-Site Trials: The Central Limit Theorem Is Not Your Friend

    ERIC Educational Resources Information Center

    May, Henry

    2014-01-01

    Interest in variation in program impacts--How big is it? What might explain it?--has inspired recent work on the analysis of data from multi-site experiments. One critical aspect of this problem involves the use of random or fixed effect estimates to visualize the distribution of impact estimates across a sample of sites. Unfortunately, unless the…