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…

What Works in Gifted Education Mathematics Study: Impact of Pre-Differentiated and Enriched Curricula on General Education Teachers and Their Students. Research Monograph Series. RM13242

ERIC Educational Resources Information Center

Gubbins, E. Jean; McCoach, D. Betsy; Foreman, Jennifer L.; Gilson, Cindy M.; Bruce-Davis, Micah N.; Rubenstein, Lisa DaVia; Savino, Jennifer; Rambo, Karen; Waterman, Craig

2013-01-01

The present study seeks to determine how exposure to pre-differentiated and enriched curricula incorporating educative curriculum materials affects students' achievement as well as teacher and administrator responses to the intervention. A 2-year multi-site cluster randomized control trial study recruited a national sample of 4,530 grade 3…

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2015-02-01

25.0) 9 (47.4) Marital Status Single 12 (30.8) 6 (30.0) 6 (31.6) Married 20 (51.3) 11 (55.0) 9 (47.4) Cohabitating/ Unmarried Partner 1 (2.6) 0 1...inpatient stay, we have not met our recruitment goal. Please see Figure 1 below, which displays the rate of recruitment, projected vs . actual. Page

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…

Sensitivity of the Modified Children's Yale-Brown Obsessive Compulsive Scale to Detect Change: Results from Two Multi-Site Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Sukhodolsky, Denis G.; Anderberg, Emily; Dimitropoulos, Anastasia; Dziura, James; Aman, Michael G.; McCracken, James; Tierney, Elaine; Hallett, Victoria; Katz, Karol; Vitiello, Benedetto; McDougle, Christopher

2016-01-01

Repetitive behavior is a core feature of autism spectrum disorder. We used 8-week data from two federally funded, multi-site, randomized trials with risperidone conducted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate the sensitivity of the Children's Yale-Brown Obsessive Compulsive Scale modified for autism…

Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial.

PubMed

Nunn, Andrew J; Rusen, I D; Van Deun, Armand; Torrea, Gabriela; Phillips, Patrick P J; Chiang, Chen-Yuan; Squire, S Bertel; Madan, Jason; Meredith, Sarah K

2014-09-09

In contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are that patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients with HIV-coinfection. STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion. The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization. Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and, given a 10% margin of non-inferiority, a total of 400 patients are required to be enrolled. Health economics data are being collected on all patients in selected sites. The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging, but for this regimen to be recommended more widely than in a research setting, robust evidence is needed from a randomized clinical trial. Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB. This trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.

Do Parents Know Best? Examining the Relationship Between Parenting Profiles, Prevention Efforts, and Peak Drinking in College Students1

PubMed Central

Mallett, Kimberly A.; Turrisi, Rob; Ray, Anne E.; Stapleton, Jerod; Abar, Caitlin; Mastroleo, Nadine R.; Tollison, Sean; Grossbard, Joel; Larimer, Mary E.

2013-01-01

The study examined parent profiles among high school athletes transitioning to college and their association with high-risk drinking in a multi-site, randomized trial. Students (n = 587) were randomized to a control or combined parent-based and brief motivational intervention condition and completed measures at baseline and at 5- and 10-month follow-ups. Four parent profiles (authoritative, authoritarian, permissive, indifferent) were observed among participants. Findings indicated control participants with authoritarian parenting were at the greatest risk for heavy drinking. Alternately, students exposed to permissive or authoritarian parenting reported lower peak drinking when administered the combined intervention, compared to controls. Findings suggest the combined intervention was efficacious in reducing peak alcohol consumption among high-risk students based on athlete status and parenting profiles. PMID:24109150

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.

Review and meta-analysis of prospective randomized controlled trials (RCTs) comparing laparo-endoscopic single site and multiport laparoscopy in gynecologic operative procedures.

PubMed

Pontis, Alessandro; Sedda, Federica; Mereu, Liliana; Podda, Mauro; Melis, Gian Benedetto; Pisanu, Adolfo; Angioni, Stefano

2016-09-01

To critically appraise published randomized controlled trials (RCTs) comparing laparo-endoscopic single site (LESS) and multi-port laparoscopic (MPL) in gynecologic operative surgery; the aim was to assess feasibility, safety, and potential benefits of LESS in comparison to MPL. A systematic review and meta-analysis of eleven RCTs. Women undergoing operative LESS and MPL gynecologic procedure (hysterectomy, cystectomy, salpingectomy, salpingo-oophorectomy, myomectomy). Outcomes evaluated were as follows: postoperative overall morbidity, postoperative pain evaluation at 6, 12, 24 and 48 h, cosmetic patient satisfaction, conversion rate, body mass index (BMI), operative time, blood loss, hemoglobin drop, postoperative hospital stay. Eleven RCTs comprising 956 women with gynecologic surgical disease randomized to either LESS (477) or MPL procedures (479) were analyzed systematically. The LESS approach is a surgical procedure with longer operative and better cosmetic results time than MPL but without statistical significance. Operative outcomes, postoperative recovery, postoperative morbidity and patient satisfaction are similar in LESS and MPL. LESS may be considered an alternative to MPL with comparable feasibility and safety in gynecologic operative procedures. However, it does not offer the expected advantages in terms of postoperative pain and cosmetic satisfaction.

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2014-02-01

updates on any changes to the IRB or submission process and to answer any questions. Attendance is prioritized to maintain a relationship with the...inclusion, which would assess areas related to social support and integration, use of prescription, drugs , readiness to engage in treatment, and...inclusion/exclusion criteria  (4) TBI, psychosis , cognitive impairment  (90) Ideation without attempt  (6) Not active duty, retired, or veteran  30

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2013-02-01

author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. 1...Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that...required, WRNMMC credentialing office will NOT renew privileges unless a peer review can be conducted. However, as it currently stands, peer review

Estimating Cross-Site Impact Variation in the Presence of Heteroscedasticity

ERIC Educational Resources Information Center

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

2013-01-01

To date, evaluation research and policy analysis have focused mainly on average program impacts and paid little systematic attention to their variation. Recently, the growing number of multi-site randomized trials that are being planned and conducted make it increasingly feasible to study "cross-site" variation in impacts. Important…

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.

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

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

PubMed

Butel, Jean; Braun, Kathryn L; Novotny, Rachel; Acosta, Mark; Castro, Rose; Fleming, Travis; Powers, Julianne; Nigg, Claudio R

2015-12-01

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.

Work-related determinants of multi-site musculoskeletal pain among employees in the health care sector.

PubMed

Neupane, Subas; Nygård, Clas-Håkan; Oakman, Jodi

2016-06-16

Work-related musculoskeletal pain is a major occupational problem. Those with pain in multiple sites usually report worse health outcomes than those with pain in one site. This study explored prevalence and associated predictors of multi-site pain in health care sector employees. Survey responses from 1348 health care sector employees across three organisations (37% response rate) collected data on job satisfaction, work life balance, psychosocial and physical hazards, general health and work ability. Musculoskeletal discomfort was measured across 5 body regions with pain in ≥ 2 sites defined as multi-site pain. Generalized linear models were used to identify relationships between work-related factors and multi-site pain. Over 52% of the employees reported pain in multiple body sites and 19% reported pain in one site. Poor work life balance (PRR = 2.33, 95% CI = 1.06-5.14). physical (PRR = 7.58, 95% CI = 4.89-11.77) and psychosocial (PRR = 1.59, 95% CI = 1.00-2.57) hazard variables were related to multi-site pain (after controlling for age, gender, health and work ability. Older employees and females were more likely to report multi-site pain. Effective risk management of work related multi-site pain must include identification and control of psychosocial and physical hazards.

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

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.

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…

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

PubMed

Laurenssen, Elisabeth M P; Westra, Dieuwertje; Kikkert, Martijn J; Noom, Marc J; Eeren, Hester V; van Broekhuyzen, Anna J; Peen, Jaap; Luyten, Patrick; Busschbach, Jan J V; Dekker, Jack J M

2014-05-22

Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles. Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients. NTR2175.

Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial

PubMed Central

2014-01-01

Background Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. Methods/design The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months’ intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning, attachment, capacity for mentalizing and quality of life. Cost-effectiveness is assessed in terms of the cost per quality-adjusted life year. Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles. Discussion Severe borderline personality disorder is a serious psychological disorder that is associated with high burden. This multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients. Trial registration NTR2175 PMID:24886402

Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis.

PubMed

Gauthier, Lynne V; Kane, Chelsea; Borstad, Alexandra; Strahl, Nancy; Uswatte, Gitendra; Taub, Edward; Morris, David; Hall, Alli; Arakelian, Melissa; Mark, Victor

2017-06-08

Constraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined. This protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL). This multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation. Clinicaltrials.gov, NCT02631850 .

Costs and effectiveness of the fast track intervention for antisocial behavior.

PubMed

Foster, E Michael

2010-09-01

Antisocial behavior is enormously costly to the youth involved, their families, victims, taxpayers and other members of society. These costs are generated by school failure, delinquency and involvement in the juvenile justice system, drug use, health services and other services. For prevention programs to be cost effective, they must reduce these costly behaviors and outcomes. The Fast Track intervention is a 10-year, multi-component prevention program targeting antisocial behavior. The intervention identified children at school entry and provided intervention services over a 10-year period. This study examined the intervention's impact on outcomes affecting societal costs using data through late adolescence. The intervention is being evaluated through a multi-cohort, multi-site, multi-year randomized control trial of program participants and comparable children and youth in similar schools, and that study provides the data for these analyses. Schools within four sites (Durham, NC; Nashville, TN; Seattle, WA; and rural central Pennsylvania) were selected as high-risk based on crime and poverty statistics of the neighborhoods they served. Within each site, schools were divided into multiple sets matched for demographics (size, percentage free/reduced lunch, ethnic composition); one set within each pair was randomly assigned to the intervention and one to the control condition. Within participating schools, high-risk children were identified using a multiple-gating procedure. For each of three annual cohorts, all kindergarteners (9,594 total) in 54 schools were screened for classroom conduct problems by teachers. Those children scoring in the top 40% within cohort and site were then solicited for the next stage of screening for home behavior problems by the parents, and 91% agreed (n = 3,274). The teacher and parent screening scores were then standardized within site and combined into a sum score. These summed scores represented a total severity-of-risk screen score. Children were selected for inclusion into the study based on this screen score, moving from the highest score downward until desired sample sizes were reached within sites, cohorts, and conditions. The intervention lacked both the breadth and depth of effects on costly outcomes to demonstrate cost-effectiveness or even effectiveness. The outcomes examined here reflect effects observed during measurement windows that are not complete for every outcome. Data are lacking on some potential outcomes, such as the use of mental health services before year 7. The most intensive psychosocial intervention ever fielded did not produce meaningful and consistent effects on costly outcomes. The lack of effects through high school suggests that the intervention will not become cost-effective as participants progress through adulthood. Future research should consider alternative approaches to prevention youth violence.

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…

Improving diabetes care: Multi-component CArdiovascular Disease Risk Reduction Strategies for People with Diabetes in South Asia - The CARRS Multi-center Translation Trial

PubMed Central

Shah, Seema; Singh, Kavita; Ali, Mohammed K.; Mohan, V.; Kadir, Muhammad Masood; Unnikrishnan, A.G.; Sahay, Rakesh Kumar; Varthakavi, Premlata; Dharmalingam, Mala; Viswanathan, Vijay; Masood, Qamar; Bantwal, Ganapathi; Khadgawat, Rajesh; Desai, Ankush; Sethi, Bipin Kumar; Shivashankar, Roopa; Ajay, Vamadevan S; Reddy, K. Srinath; Narayan, K.M. Venkat; Prabhakaran, Dorairaj; Tandon, Nikhil

2012-01-01

Aims Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people with diabetes in South Asia. The CARRS translation trial tests the effectiveness, cost-effectiveness, and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan. Methods We randomly assigned 1,146 adults with diabetes recruited from 10 urban clinic sites, to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention. The intervention involves electronic health record management, decision-support prompts to the healthcare team, and the support of a care coordinator to actively facilitate patient and provider adherence to evidence-based guidelines. The primary outcome is a composite of multiple CVD risk factor control (blood glucose and either blood pressure or cholesterol, or all three). Other outcomes include control of the individual CVD risk factors, process and patient-centered measures, cost-effectiveness, and acceptability/feasibility. Conclusion The CARRS translation trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients (clinicaltrials.gov number: NCT01212328). PMID:23084280

Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for patients with osteoarthritis of the knee: a multi-site, randomized, double-blind, placebo-controlled phase II clinical trial.

PubMed

Lao, L; Hochberg, M; Lee, D Y W; Gilpin, A M K; Fong, H H S; Langenberg, P; Chen, K; Li, E K; Tam, L S; Berman, B

2015-12-01

To examine the efficacy and safety of Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine (TCM), in patients with knee osteoarthritis (OA). A multi-site, randomized, double-blind, placebo-controlled phase II dose-escalation clinical trial was conducted. Eligible patients who fulfilled American College of Rheumatology criteria were randomized to receive either HLXL or placebo. Clinical assessments included measurement of knee pain and function with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. A Data and Safety Monitoring Board (DSMB) was established to review the data for ensuring the quality of the trial. In the first stage, 28 participants were randomized to receive either low-dose HLXL-Dan (2400 mg/day) or placebo for 6 weeks. The results showed no statistical difference between the two groups. The study was then re-designed following the recommendation of DSMB. Ninety-two patients were enrolled in the second stage and were randomized to receive either high-dose HLXL-Dan (4000 mg/day for week 1-2, and 5600 mg/day for week 3-8) or placebo for 8 weeks. All outcome assessments showed significant improvements for both groups after 8 weeks but no significant between-group differences. The change (mean ± SD) of WOMAC pain and WOMAC function scores of HLXL and placebo group after 8 weeks were -1.2 ± 1.7 vs -1.4 ± 1.5, and -1.1 ± 1.6 vs -1.3 ± 1.5 respectively. No serious adverse events were reported. Although safe to use, an 8-week treatment of HLXL-Dan was not superior to placebo for reduction in pain or functional improvement in patients with knee OA. Clinicaltrials.gov (NCT00755326). Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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.

A randomized controlled trial comparing mupirocin and polysporin triple ointments in peritoneal dialysis patients: the MP3 Study.

PubMed

McQuillan, Rory F; Chiu, Ernest; Nessim, Sharon; Lok, Charmaine E; Roscoe, Janet M; Tam, Paul; Jassal, Sarbjit Vanita

2012-02-01

Infectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents. This study examined the effectiveness of applying topical Polysporin Triple ointment (P(3)) against mupirocin in a multi-centered, double-blind, randomized controlled trial. PD patients routinely applied either P(3) or mupirocin ointment to their exit site. Patients were followed for 18 months or until death or catheter removal. The primary study outcome was a composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis. Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P(3) (13.2 months; 95% confidence interval, 11.9-14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7-15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P(3) group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P(3) (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05). This study shows that P(3) is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P(3) over mupirocin is not advocated in the prophylaxis of PD-related infections.

A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

PubMed Central

Weissberg-Benchell, Jill; Rausch, Joseph; Iturralde, Esti; Jedraszko, Aneta; Hood, Korey

2016-01-01

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future. PMID:27267154

Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

PubMed Central

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-01-01

Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

PubMed

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-11-01

Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.

Reduced hypothalamic-pituitary-adrenal axis activity in chronic multi-site musculoskeletal pain: partly masked by depressive and anxiety disorders.

PubMed

Generaal, Ellen; Vogelzangs, Nicole; Macfarlane, Gary J; Geenen, Rinie; Smit, Johannes H; Penninx, Brenda W J H; Dekker, Joost

2014-07-09

Studies on hypothalamic-pituitary-adrenal axis (HPA-axis) function amongst patients with chronic pain show equivocal results and well-controlled cohort studies are rare in this field. The goal of our study was to examine whether HPA-axis dysfunction is associated with the presence and the severity of chronic multi-site musculoskeletal pain. Data are from the Netherlands Study of Depression and Anxiety including 1125 subjects with and without lifetime depressive and anxiety disorders. The Chronic Pain Grade questionnaire was used to determine the presence and severity of chronic multi-site musculoskeletal pain. Subjects were categorized into a chronic multi-site musculoskeletal pain group (n = 471) and a control group (n = 654). Salivary cortisol samples were collected to assess HPA-axis function (awakening level, 1-h awakening response, evening level, diurnal slope and post-dexamethasone level). In comparison with the control group, subjects with chronic multi-site musculoskeletal pain showed significantly lower cortisol level at awakening, lower evening level and a blunted diurnal slope. Lower cortisol level at awakening and a blunted diurnal slope appeared to be restricted to those without depressive and/or anxiety disorders, who also showed a lower 1-h awakening response. Our results suggest hypocortisolemia in chronic multi-site musculoskeletal pain. However, if chronic pain is accompanied by a depressive or anxiety disorder, typically related to hypercortisolemia, the association between cortisol levels and chronic multi-site musculoskeletal pain appears to be partly masked. Future studies should take psychopathology into account when examining HPA-axis function in chronic pain.

Reduced hypothalamic-pituitary-adrenal axis activity in chronic multi-site musculoskeletal pain: partly masked by depressive and anxiety disorders

PubMed Central

2014-01-01

Background Studies on hypothalamic-pituitary-adrenal axis (HPA-axis) function amongst patients with chronic pain show equivocal results and well-controlled cohort studies are rare in this field. The goal of our study was to examine whether HPA-axis dysfunction is associated with the presence and the severity of chronic multi-site musculoskeletal pain. Methods Data are from the Netherlands Study of Depression and Anxiety including 1125 subjects with and without lifetime depressive and anxiety disorders. The Chronic Pain Grade questionnaire was used to determine the presence and severity of chronic multi-site musculoskeletal pain. Subjects were categorized into a chronic multi-site musculoskeletal pain group (n = 471) and a control group (n = 654). Salivary cortisol samples were collected to assess HPA-axis function (awakening level, 1-h awakening response, evening level, diurnal slope and post-dexamethasone level). Results In comparison with the control group, subjects with chronic multi-site musculoskeletal pain showed significantly lower cortisol level at awakening, lower evening level and a blunted diurnal slope. Lower cortisol level at awakening and a blunted diurnal slope appeared to be restricted to those without depressive and/or anxiety disorders, who also showed a lower 1-h awakening response. Conclusions Our results suggest hypocortisolemia in chronic multi-site musculoskeletal pain. However, if chronic pain is accompanied by a depressive or anxiety disorder, typically related to hypercortisolemia, the association between cortisol levels and chronic multi-site musculoskeletal pain appears to be partly masked. Future studies should take psychopathology into account when examining HPA-axis function in chronic pain. PMID:25007969

A Randomized Controlled Trial of a Long-Term Professional Mentoring Program for Children at Risk: Outcomes Across the First 5 Years.

PubMed

Eddy, J Mark; Martinez, Charles R; Grossman, Jean Baldwin; Cearley, Jennifer J; Herrera, Danita; Wheeler, Alice C; Rempel, Jeff S; Foney, Dana; Gau, Jeff M; Burraston, Bert O; Harachi, Tracy W; Haggerty, Kevin P; Seeley, John R

2017-11-01

Child outcomes due to a paid professional mentoring program, Friends of the Children (FOTC), were investigated across the first 5 years of an ongoing multi-site randomized controlled trial. Participants were 278 children attending kindergarten or first grade who were identified as "at risk" for adjustment problems during adolescence. The program was delivered through established nonprofit community-based organizations. Mentors were hired to work full time and were provided training, supervision, and support to work individually with small numbers of children. Recruitment took place across a 3-year period. Random assignment to the intervention condition or a services as usual control condition was conducted at the level of the individual, blocking on school and child sex. After the initial assessment, follow-up assessments were conducted every 6 months. Differences in growth curves across the elementary school years were examined in intent-to-treat analyses. Significant effects favoring FOTC were found in terms of caregiver ratings of positive school behavior and less trouble in school, with a trend for higher child behavioral and emotional strengths. Effect sizes were in the range typical in recent trials of youth mentoring.

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 address all the major barriers to eating more F&V (high cost, poor quality, limited access and limited time to shop and cook) and provide a year-round solution to limited access to healthful food in low-income neighborhoods. LWVB is the first randomized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake. If proven efficacious at increasing F&V consumption, LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V. Clinicatrials.gov registration number: NCT02669472 First Received: January 19, 2016.

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 suggest new methods for enhancing outcomes. Australia and New Zealand Clinical Trial Registry: ACTRN12611000136909. Copyright © 2014. Published by Elsevier Ltd.

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…

Improving safety climate through a communication and recognition program for construction: a mixed-methods study

PubMed Central

Sparer, Emily H; Catalano, Paul J; Herrick, Robert F; Dennerlein, Jack T

2016-01-01

Objectives This study aimed to evaluate the efficacy of a safety communication and recognition program (B-SAFE), designed to encourage improvement of physical working conditions and hazard reduction in construction. Methods A matched pair cluster randomized controlled trial was conducted on eight worksites (four received the B-SAFE intervention, four served as control sites) for approximately five months per site. Pre- and post-exposure worker surveys were collected at all sites (N=615, pre-exposure response rate of 74%, post-exposure response rate of 88%). Multi-level mixed-effect regression models evaluated the effect of B-SAFE on safety climate as assessed from surveys. Focus groups (N=6–8 workers/site) were conducted following data collection. Transcripts were coded and analyzed for thematic content using Atlas.ti (version 6). Results The mean safety climate score at intervention sites, as measured on a 0–50 point scale, increased 0.5 points (1%) between pre- and post-B-SAFE exposure, compared to control sites that decreased 0.8 points (1.6%). The intervention effect size was 1.64 (3.28%) (P-value=0.01) when adjusted for month the worker started on-site, total length of time on-site, as well as individual characteristics (trade, title, age, and race/ethnicity). At intervention sites, workers noted increased levels of safety awareness, communication, and teamwork compared to control sites. Conclusions B-SAFE led to many positive changes, including an improvement in safety climate, awareness, teambuilding, and communication. B-SAFE was a simple intervention that engaged workers through effective communication infrastructures and had a significant, positive effect on worksite safety. PMID:27158914

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.

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.

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 appropriate site, whenever colonization risk is considered and not, otherwise, contraindicated. Current evidence on catheter-related bloodstream infection femoral risk, compared with the other sites, is inconclusive.

Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

PubMed Central

Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

2013-01-01

Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. PMID:24028942

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

PubMed

Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

2013-11-01

To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

[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.

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

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. Methods/Design The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. Discussion The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. Trial registration ClinicalTrials.gov: NCT01654341. PMID:24456998

An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial.

PubMed

Rodríguez-Mañas, Leocadio; Bayer, Antony J; Kelly, Mark; Zeyfang, Andrej; Izquierdo, Mikel; Laosa, Olga; Hardman, Timothy C; Sinclair, Alan J; Moreira, Severina; Cook, Justin

2014-01-24

Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. ClinicalTrials.gov: NCT01654341.

Does maintenance CBT contribute to long-term treatment response of panic disorder with or without agoraphobia? A randomized controlled clinical trial.

PubMed

White, Kamila S; Payne, Laura A; Gorman, Jack M; Shear, M Katherine; Woods, Scott W; Saksa, John R; Barlow, David H

2013-02-01

We examined the possibility that maintenance cognitive behavior therapy (M-CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Participants were all patients (N = 379) who first began an open trial of acute-phase CBT. Patients completing and responding to acute-phase treatment were randomized to receive either 9 monthly sessions of M-CBT (n = 79) or assessment only (n = 78) and were then followed for an additional 12 months without treatment. M-CBT produced significantly lower relapse rates (5.2%) and reduced work and social impairment compared to the assessment only condition (18.4%) at a 21-month follow-up. Multivariate Cox proportional hazards models showed that residual symptoms of agoraphobia at the end of acute-phase treatment were independently predictive of time to relapse during 21-month follow-up (hazards ratio = 1.15, p < .01). M-CBT aimed at reinforcing acute treatment gains to prevent relapse and offset disorder recurrence may improve long-term outcome for panic disorder with and without agoraphobia.

Does Maintenance CBT Contribute to Long-Term Treatment Response of Panic Disorder With or Without Agoraphobia? A Randomized Controlled Clinical Trial

PubMed Central

White, Kamila S.; Payne, Laura A.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.; Saksa, John R.; Barlow, David H.

2012-01-01

Objective To examine the possibility that maintenance cognitive behavior therapy (M–CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Method Participants were all patients (N = 379) who first began an open trial of acute-phase CBT. Patients completing and responding to acute-phase treatment were randomized to receive either nine monthly sessions of M-CBT (n = 79) or assessment only (n = 78) and were then followed for an additional 12 months without treatment. Results M–CBT produced significantly lower relapse rates (5.2%) and reduced work and social impairment compared to the assessment only condition (18.4%) at a 21-month follow-up (MFU). Multivariate Cox proportional hazards models showed that residual symptoms of agoraphobia at the end of acute-phase treatment were independently predictive of time to relapse during 21-MFU (HR = 1.15, p < .01). Conclusions M–CBT aimed at reinforcing acute treatment gains to prevent relapse and offset disorder recurrence may improve long-term outcome in PD/A. PMID:23127290

Resilient Multi-Domain Command and Control: Enabling Solutions for 2025 with Virtual Reality

DTIC Science & Technology

2017-04-16

AIR WAR COLLEGE AIR UNIVERSITY RESILIENT MULTI-DOMAIN COMMAND AND CONTROL : ENABLING SOLUTIONS FOR 2025 WITH VIRTUAL REALITY by...monolithic, command and control (C2) sites, such as the theater Air Operation Centers (AOC), at risk. The Multi-Domain Command and Control (MDC2...Air Force respond to the these threats, considering the use of new and existing weapons and concepts, to ensure our ability to command, control and

Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

PubMed Central

Law, Mary; Darrah, Johanna; Pollock, Nancy; Rosenbaum, Peter; Russell, Dianne; Walter, Stephen D; Petrenchik, Theresa; Wilson, Brenda; Wright, Virginia

2007-01-01

Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). Discussion This paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy. Trial registration [clinical trial registration #: NCT00469872] PMID:17900362

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

Targeting Classrooms' Emotional Climate and Preschoolers' Socioemotional Adjustment: Implementation of the Chicago School Readiness Project

PubMed Central

Li-Grining, Christine P.; Raver, C. Cybele; Jones-Lewis, Darlene; Madison-Boyd, Sybil; Lennon, Jaclyn

2015-01-01

Children living in low-income families are more likely to experience less self-regulation, greater behavior problems, and lower academic achievement than higher income children. To help prevent children's later socioemotional and academic difficulties, the Chicago School Readiness Project (CSRP) team implemented a clustered, randomized controlled trial (RCT) in early childhood programs with Head Start funding. Head Start sites were randomly assigned to receive CSRP services, which were offered as part of a multi-component, classroom-based mental health intervention. Here, we provide an overview of the CSRP model, its components, and a descriptive portrait of its implementation. In so doing, we address various aspects of the implementation of three of its components: 1) the training of teachers, 2) MHCs' coaching of teachers, and 3) teachers' behavior management of children. We conclude with a discussion of factors potentially related to the implementation of CSRP and directions for future research. PMID:25321641

Women, Co-occurring Disorders, and Violence Study: evaluation design and study population.

PubMed

McHugo, G J; Kammerer, N; Jackson, E W; Markoff, L S; Gatz, M; Larson, M J; Mazelis, R; Hennigan, K

2005-03-01

The Women, Co-occurring Disorders, and Violence Study (WCDVS) was a multi-site cooperative study to evaluate new service models for women with co-occurring mental health and substance use disorders and a history of physical and/or sexual abuse. Despite common features in the service interventions and evaluation procedures, diversity across the nine sites plus differences introduced by non-random assignment led to numerous methodological challenges. This article describes the design, measurement, and analysis decisions behind the WCDVS and lays the foundation for understanding participant-level outcomes and service costs. This article also describes the study population, as recruited and following attrition at the 6-month follow-up, in order to address the threat of selection bias to inferences drawn from this multi-site study.

Use of multi-opening burrow systems by black-footed ferrets

USGS Publications Warehouse

Biggins, Dean E.

2012-01-01

Multi-opening burrow systems constructed by prairie dogs (Cynomys) ostensibly provide escape routes when prairie dogs are pursued by predators capable of entering the burrows, such as black-footed ferrets (Mustela nigripes), or by predators that can rapidly dig into the tunnels, such as American badgers (Taxidea taxus). Because badgers also prey on ferrets, ferrets might similarly benefit from multi-opening burrow systems. Using an air blower, white-tailed prairie dog (Cynomys leucurus) burrow openings were tested for connectivity on plots occupied by black-footed ferrets and on randomly selected plots in Wyoming. Significantly more connected openings were found on ferret-occupied plots than on random plots. Connected openings might be due to modifications by ferrets in response to plugging by prairie dogs, due to selection by ferrets for complex systems with multiple openings that are already unobstructed, or simply due to ferrets lingering at kill sites that were multi-opening systems selected by their prairie dog prey.

Multi-Site Quality Assurance Project Plan for Wisconsin Public Service Corporation, Peoples Gas Light and Coke Company, and North Shore Gas

EPA Pesticide Factsheets

This Multi-Site QAPP presents the organization, data quality objectives (DQOs), a set of anticipated activities, sample analysis, data handling and specific Quality Assurance/Quality Control (QA/QC) procedures associated with Studies done in EPA Region 5

All optical mode controllable Er-doped random fiber laser with distributed Bragg gratings.

PubMed

Zhang, W L; Ma, R; Tang, C H; Rao, Y J; Zeng, X P; Yang, Z J; Wang, Z N; Gong, Y; Wang, Y S

2015-07-01

An all-optical method to control the lasing modes of Er-doped random fiber lasers (RFLs) is proposed and demonstrated. In the RFL, an Er-doped fiber (EDF) recoded with randomly separated fiber Bragg gratings (FBG) is used as the gain medium and randomly distributed reflectors, as well as the controllable element. By combining random feedback of the FBG array and Fresnel feedback of a cleaved fiber end, multi-mode coherent random lasing is obtained with a threshold of 14 mW and power efficiency of 14.4%. Moreover, a laterally-injected control light is used to induce local gain perturbation, providing additional gain for certain random resonance modes. As a result, active mode selection of the RFL is realized by changing locations of the laser cavity that is exposed to the control light.

Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial.

PubMed

Badaki-Makun, Oluwakemi; Scott, J Paul; Panepinto, Julie A; Casper, T Charles; Hillery, Cheryl A; Dean, J Michael; Brousseau, David C

2014-06-01

Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12 hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8 hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. © 2014 Wiley Periodicals, Inc.

'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 organization, a team-based score on video-assessed team performance and on selected clinical performance. Discussion The perspective is to provide new knowledge on contextual effects of different simulation settings. Trial registration ClincialTrials.gov NCT01792674. PMID:23870501

'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-assessed team performance and on selected clinical performance. The perspective is to provide new knowledge on contextual effects of different simulation settings. ClincialTrials.gov NCT01792674.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

Implementing Telerehabilitation Research for Stroke Rehabilitation with Community Dwelling Veterans: Lessons Learned

PubMed Central

Chumbler, Neale R.; Quigley, Patricia; Sanford, Jon; Griffiths, Patricia; Rose, Dorian; Morey, Miriam; Ely, E. Wesley; Hoenig, Helen

2010-01-01

Telerehabilitation (TR) is the use of telehealth technologies to provide distant support, rehabilitation services, and information exchange between people with disabilities and their clinical providers. This article discusses the barriers experienced when implementing a TR multi-site randomized controlled trial for stroke patients in their homes, and the lessons learned. The barriers are divided into two sections: those specific to TR and those pertinent to the conduct of tele-research. The TR specific barriers included the rapidly changing telecommunications and health care environment and inconsistent equipment functionality. The barriers applicable to tele-research included the need to meet regulations in diverse departments and rapidly changing research regulations. Lessons learned included the need for: telehealth equipment options to allow for functionality within a diverse telecommunications infrastructure; rigorous pilot testing of all equipment in authentic situations; and on-call and on-site biomedical engineering and/or IT staff. PMID:25945169

What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Effectiveness of information and communication technologies interventions to increase mental health literacy: A systematic review.

PubMed

Tay, Jing Ling; Tay, Yi Fen; Klainin-Yobas, Piyanee

2018-06-13

Most mental health conditions affect adolescent and young adults. The onset of many mental disorders occurs in the young age. This is a critical period to implement interventions to enhance mental health literacy (MHL) and to prevent the occurrence of mental health problems. This systematic review examined the effectiveness of information and communication technologies interventions on MHL (recognition of conditions, stigma and help-seeking). The authors searched for both published and unpublished studies. Nineteen studies were included with 9 randomized controlled trials and 10 quasi-experimental studies. Informational interventions were useful to enhance MHL of less-known disorders such as anxiety disorder and anorexia, but not depression. Interventions that were effective in enhancing depression MHL comprised active component such as videos or quizzes. Interventions that successfully elevated MHL also reduced stigma. Elevated MHL levels did not improve help-seeking, and reduction in stigma levels did not enhance help-seeking behaviours. Future good quality, large-scale, multi-sites randomized controlled trials are necessary to evaluate MHL interventions. © 2018 John Wiley & Sons Australia, Ltd.

Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children.

PubMed

Cruz, Theresa H; Davis, Sally M; FitzGerald, Courtney A; Canaca, Glenda F; Keane, Patricia C

2014-06-01

Engagement, recruitment and retention of participants are critical to the success of research studies but specific strategies are rarely elucidated in the literature. The purpose of this paper is to describe the engagement, recruitment and retention process and outcomes in the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, and to describe lessons learned in the process. CHILE is a multi-level, group randomized controlled trial of a childhood obesity prevention intervention in rural American Indian and predominantly Hispanic Head Start (HS) centers in New Mexico. Barriers to engagement, recruitment and retention included distrust of researchers, long travel distances, and different HS and community structures. CHILE employed multiple strategies from the onset including the use of formative assessment, building on previous relationships, developing Memoranda of Agreement, using a community engagement specialist, and gaining support of a community champion. As a result of lessons learned, additional strategies were employed, including more frequent feedback to intervention sites, revised permission forms, telephone reminders, increased site visits and over-scheduling of interviews. These strategies resulted in the recruitment of 16 HS centers, 1,879 children, 655 parents, 7 grocery stores and 14 healthcare providers, meeting or exceeding recruitment goals. By combining principles of community engagement, a variety of recruitment strategies, and lessons learned, this study obtained a high level of recruitment and retention.

Engagement, Recruitment, and Retention in a Trans-Community, Randomized Controlled Trial for the Prevention of Obesity in Rural American Indian and Hispanic Children

PubMed Central

Davis, Sally M.; FitzGerald, Courtney A.; Canaca, Glenda F.; Keane, Patricia C.

2016-01-01

Engagement, recruitment and retention of participants are critical to the success of research studies but specific strategies are rarely elucidated in the literature. The purpose of this paper is to describe the engagement, recruitment and retention process and outcomes in the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, and to describe lessons learned in the process. CHILE is a multi-level, group randomized controlled trial of a childhood obesity prevention intervention in rural American Indian and predominantly Hispanic Head Start (HS) centers in New Mexico. Barriers to engagement, recruitment and retention included distrust of researchers, long travel distances, and different HS and community structures. CHILE employed multiple strategies from the onset including the use of formative assessment, building on previous relationships, developing Memoranda of Agreement, using a community engagement specialist, and gaining support of a community champion. As a result of lessons learned, additional strategies were employed, including more frequent feedback to intervention sites, revised permission forms, telephone reminders, increased site visits and over-scheduling of interviews. These strategies resulted in the recruitment of 16 HS centers, 1,879 children, 655 parents, 7 grocery stores and 14 healthcare providers, meeting or exceeding recruitment goals. By combining principles of community engagement, a variety of recruitment strategies, and lessons learned, this study obtained a high level of recruitment and retention. PMID:24549525

Randomized Multi-site Trial of the Job Seekers’ Workshop in Patients with Substance Use Disorders

PubMed Central

Svikis, Dace S.; Keyser-Marcus, Lori; Stitzer, Maxine; Rieckmann, Traci; Safford, Lauretta; Loeb, Peter; Allen, Tim; Luna-Anderson, Carol; Back, Sudie E.; Cohen, Judith; DeBernardi, Michael A.; Dillard, Bruce; Forcehimes, Alyssa; Jaffee, William; Killeen, Therese; Kolodner, Ken; Levy, Michael; Pallas, Diane; Perl, Harold I.; Potter, Jennifer Sharpe; Provost, Scott; Reese, Karen; Sampson, Royce R.; Sepulveda, Allison; Snead, Ned; Wong, Conrad J.; Zweben, Joan

2012-01-01

Background Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers’ Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. Method Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-hr small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. Results JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program), Specifically, one-fifth of participants at 12 weeks (20.1 – 24.3%) and nearly one-third at 24 weeks (31.4–31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases. Conclusion JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. PMID:21802222

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. Methods/Design The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. Discussion The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. Trial registration Trial registration reference: ISRCTN45433299 PMID:23356861

Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes.

PubMed

Gottlieb, Peter A; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J; Wilson, Darrell M; Rodriguez, Henry; Schatz, Desmond A; Moran, Antoinette M; Lachin, John M; Skyler, Jay S

2010-04-01

This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta-cells in subjects with new-onset type 1 diabetes. A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.

Failure to Preserve β-Cell Function With Mycophenolate Mofetil and Daclizumab Combined Therapy in Patients With New- Onset Type 1 Diabetes

PubMed Central

Gottlieb, Peter A.; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J.; Wilson, Darrell M.; Rodriguez, Henry; Schatz, Desmond A.; Moran, Antoinette M.; Lachin, John M.; Skyler, Jay S.

2010-01-01

OBJECTIVE This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing β-cells in subjects with new-onset type 1 diabetes. RESEARCH DESIGN AND METHODS A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. RESULTS One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. CONCLUSIONS Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process. PMID:20067954

A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer.

PubMed

Robb, Sheri L; Clair, Alicia A; Watanabe, Masayo; Monahan, Patrick O; Azzouz, Faouzi; Stouffer, Janice W; Ebberts, Allison; Darsie, Emily; Whitmer, Courtney; Walker, Joey; Nelson, Kirsten; Hanson-Abromeit, Deanna; Lane, Deforia; Hannan, Ann

2008-07-01

Coping theorists argue that environmental factors affect how children perceive and respond to stressful events such as cancer. However, few studies have investigated how particular interventions can change coping behaviors. The active music engagement (AME) intervention was designed to counter stressful qualities of the in-patient hospital environment by introducing three forms of environmental support. The purpose of this multi-site randomized controlled trial was to determine the efficacy of the AME intervention on three coping-related behaviors (i.e. positive facial affect, active engagement, and initiation). Eighty-three participants, ages 4-7, were randomly assigned to one of three conditions: AME (n = 27), music listening (ML; n = 28), or audio storybooks (ASB; n = 28). Conditions were videotaped to facilitate behavioral data collection using time-sampling procedures. After adjusting for baseline differences, repeated measure analyses indicated that AME participants had a significantly higher frequency of coping-related behaviors compared with ML or ASB. Positive facial affect and active engagement were significantly higher during AME compared with ML and ASB (p<0.0001). Initiation was significantly higher during AME than ASB (p<0.05). This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment. (c) 2007 John Wiley & Sons, Ltd.

Prevalence of drug use during sex amongst MSM in Europe: Results from a multi-site bio-behavioural survey.

PubMed

Rosińska, Magdalena; Gios, Lorenzo; Nöstlinger, Christiana; Vanden Berghe, Wim; Marcus, Ulrich; Schink, Susanne; Sherriff, Nigel; Jones, Anna-Marie; Folch, Cinta; Dias, Sonia; Velicko, Inga; Mirandola, Massimo

2018-05-01

Substance use has been consistently reported to be more prevalent amongst Men who have Sex with Men (MSM) compared to the general population. Substance use, in particular polydrug use, has been found to be influenced by social and contextual factors and to increase the risk of unprotected intercourse among MSM. The objective of this analysis was to investigate the prevalence and predictors of drug use during a sexual encounter and to identify specific prevention needs. A multi-site bio-behavioural cross-sectional survey was implemented in 13 European cities, targeting MSM and using Time-Location Sampling and Respondent-Driven Sampling methods Multivariable multi-level logistic random-intercept model (random effect of study site) was estimated to identify factors associated with the use of alcohol, cannabis, party drugs, sexual performance enhancement drugs and chemsex drugs. Overall, 1261 (30.0%) participants reported drug use, and 436 of 3706 (11.8%) reported the use of two or more drugs during their last sexual encounter. By drug class, 966 (23.0%) reported using sexual performance enhancement drugs, 353 (8.4%) - party drugs, and 142 (3.4%) the use of chemsex drugs. Respondents who reported drug use were more frequently diagnosed with HIV (10.5% vs. 3.9%) before and with other STIs during the 12 months prior to the study (16.7% vs. 9.2%). The use of all the analysed substances was significantly associated with sexual encounter with more than one partner. Substance and polydrug use during sexual encounters occurred amongst sampled MSM across Europe although varying greatly between study sites. Different local social norms within MSM communities may be important contextual drivers of drug use, highlighting the need for innovative and multi-faceted prevention measures to reduce HIV/STI risk in the context of drug use. Copyright © 2018 Elsevier B.V. All rights reserved.

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.

Cooperative Solutions in Multi-Person Quadratic Decision Problems: Finite-Horizon and State-Feedback Cost-Cumulant Control Paradigm

DTIC Science & Technology

2007-01-01

CONTRACT NUMBER Problems: Finite -Horizon and State-Feedback Cost-Cumulant Control Paradigm (PREPRINT) 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER...cooperative cost-cumulant control regime for the class of multi-person single-objective decision problems characterized by quadratic random costs and... finite -horizon integral quadratic cost associated with a linear stochastic system . Since this problem formation is parameterized by the number of cost

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

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Kapczynski, W.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) – hence, reducing dependence on hormone therapy programs. PMID:23675005

Multi-Site Diagnostic Classification of Schizophrenia Using Discriminant Deep Learning with Functional Connectivity MRI.

PubMed

Zeng, Ling-Li; Wang, Huaning; Hu, Panpan; Yang, Bo; Pu, Weidan; Shen, Hui; Chen, Xingui; Liu, Zhening; Yin, Hong; Tan, Qingrong; Wang, Kai; Hu, Dewen

2018-04-01

A lack of a sufficiently large sample at single sites causes poor generalizability in automatic diagnosis classification of heterogeneous psychiatric disorders such as schizophrenia based on brain imaging scans. Advanced deep learning methods may be capable of learning subtle hidden patterns from high dimensional imaging data, overcome potential site-related variation, and achieve reproducible cross-site classification. However, deep learning-based cross-site transfer classification, despite less imaging site-specificity and more generalizability of diagnostic models, has not been investigated in schizophrenia. A large multi-site functional MRI sample (n = 734, including 357 schizophrenic patients from seven imaging resources) was collected, and a deep discriminant autoencoder network, aimed at learning imaging site-shared functional connectivity features, was developed to discriminate schizophrenic individuals from healthy controls. Accuracies of approximately 85·0% and 81·0% were obtained in multi-site pooling classification and leave-site-out transfer classification, respectively. The learned functional connectivity features revealed dysregulation of the cortical-striatal-cerebellar circuit in schizophrenia, and the most discriminating functional connections were primarily located within and across the default, salience, and control networks. The findings imply that dysfunctional integration of the cortical-striatal-cerebellar circuit across the default, salience, and control networks may play an important role in the "disconnectivity" model underlying the pathophysiology of schizophrenia. The proposed discriminant deep learning method may be capable of learning reliable connectome patterns and help in understanding the pathophysiology and achieving accurate prediction of schizophrenia across multiple independent imaging sites. Copyright © 2018 German Center for Neurodegenerative Diseases (DZNE). Published by Elsevier B.V. All rights reserved.

A multi-site controlled trial of a cognitive skills program for mentally disordered offenders.

PubMed

Rees-Jones, Angharad; Gudjonsson, Gisli; Young, Susan

2012-05-18

The effectiveness of offending behaviour programs in forensic mental health settings is not well established. Thus this study aimed to evaluate the Reasoning and Rehabilitation Mental Health program (R&R2 MHP) among a mentally disordered offender (MDO) population. A sample of 121 adult males drawn from 10 forensic mental health sites completed questionnaires at baseline and post-treatment to assess violent attitudes, locus of control, social problem-solving and anger. An informant measure of social and psychological functioning, including disruptive behaviour, was completed by unit staff at the same time. At three month follow-up patients completed again the violent attitudes and locus of control questionnaires. The data of 67 patients who participated in the group condition were compared with 54 waiting-list controls who received treatment as usual. 78% of group participants completed the program. In contrast to controls, significant treatment effects were found at outcome on self-reported measures of violent attitudes, rational problem-solving and anger cognitions. Improvements were endorsed by informant ratings of social and psychological functioning within the establishments. At follow-up significant treatment effects were found for both violent attitudes and locus of control. R&R2 MHP was effective in a sample of MDOs and had a comparatively low drop-out rate. Future research should use a randomized controlled design.

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

PubMed Central

Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

2010-01-01

Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

Maternal Opioid Treatment: Human Experimental Research (MOTHER) – Approach, Issues, and Lessons Learned

PubMed Central

Jones, Hendrée E.; Fischer, Gabriele; Heil, Sarah H.; Kaltenbach, Karol; Martin, Peter R.; Coyle, Mara G.; Selby, Peter; Stine, Susan M.; O’Grady, Kevin E.; Arria, Amelia M.

2015-01-01

Aims The Maternal Opioid Treatment: Human Experimental Research (MOTHER) project, an eight-site randomized, double-blind, double-dummy, flexible-dosing, parallel-group clinical trial is described. This study is the most current – and single most comprehensive – research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine. Methods The MOTHER study design is outlined, and its basic features are presented. Conclusions At least seven important lessons have been learned from the MOTHER study: (1) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (2) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment goals, patient populations, and hospital practices that in turn differentially impact recruitment rates, treatment compliance, and attrition; (3) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (4) staff turnover needs to be addressed with a proactive focus on both hiring and training; (5) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (6) timely tracking of data in a multi-site trial is both demanding and unforgiving; and, (7) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results. PMID:23106924

Control of Pteridium aquilinum: Meta-analysis of a Multi-site Study in the UK

PubMed Central

Stewart, Gavin; Cox, Emma; Le Duc, Mike; Pakeman, Robin; Pullin, Andrew; Marrs, Rob

2008-01-01

Background and Aims A great deal of money is spent controlling invasive weeds as part of international and national policies. It is essential that the funded treatments work across the region in which the policies operate. We argue that experiments across multiple sites are required to validate these programs as results from single sites may be misleading. Here, the control of Pteridium aquilinum (bracken) is used as a test example to address the following four questions. (1) Does the effectiveness of P. aquilinum-control treatments vary across sites? (2) Is the best treatment identified in previous research (cutting twice per year) consistent at all sites, and if not why not? (3) Is treatment performance related to P. aquilinum rhizome mass, litter cover or litter depth at the various sites? (4) Does successful P. aquilinum control influence species richness? Methods Pteridium aquilinum‐control treatments were monitored for 10 years using six replicated experiments and analysed using meta-analysis. Meta-regressions were used to explore heterogeneity between sites. Key Results The effectiveness of treatments varied between sites depending on the measure used to assess P. aquilinum performance. In general, cutting twice per year was the most successful treatment but on some sites other, less expensive treatments were as good. The effectiveness of treatments at different sites was not related to rhizome mass, but the effectiveness of most applied treatments were inversely related to post-control litter. Effective treatment was also associated with high species richness. Conclusions It is concluded that successful development of national weed control programs requires multi-site experimental approaches. Here, meta-analyses demonstrate that variation in effectiveness between sites could be explained in part by pre-specified variables. Reliance on data from a single site for policy formulation is therefore clearly dangerous. PMID:18337356

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related ED Visits

PubMed Central

Paulozzi, Leonard J.; Howell, Donelle; McPherson, Sterling; Murphy, Sean M.; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, Jon

2017-01-01

Background Increasing prescription overdose deaths have demonstrated the need for safer ED prescribing practices for patients who are frequent ED users. Objectives We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. Methods We conducted a multi-site randomized controlled trial (RCT) across all EDs in a metropolitan area. 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. Results The intervention arm experienced a 34% decrease (IRR = 0.66, p < 0.001; 95% CI: 0.57 – 0.78) in ED visits and an 80% decrease (OR = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers. Conclusion This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. PMID:27624507

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

PubMed

Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

2016-07-19

The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

Osteoporosis prevention using soy: the OPUS study

USDA-ARS?s Scientific Manuscript database

Soy isoflavones are believed to have anti-osteoporotic properties. To evaluate the effect of soy isoflavones on bone loss, 403 early postmenopausal women (54.0+/-4.0 y) were enrolled in an intent-to-treat, multi-site, 2-year follow-up, randomized, double-blind study with 1/3 on placebo, 1/3 on 80 mg...

Psychiatric Syndromes in Adolescents with Marijuana Abuse and Dependency in Outpatient Treatment

ERIC Educational Resources Information Center

Diamond, Guy; Panichelli-Mindel, Susan M.; Shera, David; Dennis, Mike; Tims, Frank; Ungemack, Jane

2006-01-01

Objective: The purpose of the current study to assist in understanding the prevalence and clinical correlates of psychiatric distress in adolescents seeking outpatient services for marijuana abuse or dependency. Methods: In a multi-site randomized clinical trial, 600 adolescents and their parents were assessed at intake using the Global Appraisals…

Avoiding Boundary Estimates in Hierarchical Linear Models through Weakly Informative Priors

ERIC Educational Resources Information Center

Chung, Yeojin; Rabe-Hesketh, Sophia; Gelman, Andrew; Dorie, Vincent; Liu, Jinchen

2012-01-01

Hierarchical or multilevel linear models are widely used for longitudinal or cross-sectional data on students nested in classes and schools, and are particularly important for estimating treatment effects in cluster-randomized trials, multi-site trials, and meta-analyses. The models can allow for variation in treatment effects, as well as…

Efficacy and Safety of Atomoxetine in Childhood Attention-Deficit/Hyperactivity Disorder with Comorbid Oppositional Defiant Disorder

ERIC Educational Resources Information Center

Kaplan, S.; Heiligenstein, J.; West, S.; Busner, J.; Harder, D.; Dittmann, R.; Casat, C.; Wernicke, J. F.

2004-01-01

Objective: To compare the safety and efficacy of atomoxetine, a selective inhibitor of the norepinephrine transporter, versus placebo in Attention-Deficit/Hyperactivity Disorder (ADHD) patients with comorbid Oppositional Defiant Disorder (ODD). Methods: A subset analysis of 98 children from two identical, multi-site, double-blind, randomized,…

Multi-scale habitat selection in highly territorial bird species: Exploring the contribution of nest, territory and landscape levels to site choice in breeding rallids (Aves: Rallidae)

NASA Astrophysics Data System (ADS)

Jedlikowski, Jan; Chibowski, Piotr; Karasek, Tomasz; Brambilla, Mattia

2016-05-01

Habitat selection often involves choices made at different spatial scales, but the underlying mechanisms are still poorly understood, and studies that investigate the relative importance of individual scales are rare. We investigated the effect of three spatial scales (landscape, territory, nest-site) on the occurrence pattern of little crake Zapornia parva and water rail Rallus aquaticus at 74 ponds in the Masurian Lakeland, Poland. Habitat structure, food abundance and water chemical parameters were measured at nests and random points within landscape plots (from 300-m to 50-m radius), territory (14-m) and nest-site plots (3-m). Regression analyses suggested that the most relevant scale was territory level, followed by landscape, and finally by nest-site for both species. Variation partitioning confirmed this pattern for water rail, but also highlighted the importance of nest-site (the level explaining the highest share of unique variation) for little crake. The most important variables determining the occurrence of both species were water body fragmentation (landscape), vegetation density (territory) and water depth (at territory level for little crake, and at nest-site level for water rail). Finally, for both species multi-scale models including factors from different levels were more parsimonious than single-scale ones, i.e. habitat selection was likely a multi-scale process. The importance of particular spatial scales seemed more related to life-history traits than to the extent of the scales considered. In the case of our study species, the territory level was highly important likely because both rallids have to obtain all the resources they need (nest site, food and mates) in relatively small areas, the multi-purpose territories they defend.

Uncoordinated MAC for Adaptive Multi Beam Directional Networks: Analysis and Evaluation

DTIC Science & Technology

2016-08-01

control (MAC) policies for emerging systems that are equipped with fully digital antenna arrays which are capable of adaptive multi-beam directional...Adaptive Beam- forming, Multibeam, Directional Networking, Random Access, Smart Antennas I. INTRODUCTION Fully digital beamforming antenna arrays that...are capable of adaptive multi-beam communications are quickly becoming a reality. These antenna arrays allow users to form multiple simultaneous

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.

Efficacy, Safety and Cost of Insecticide Treated Wall Lining, Insecticide Treated Bed Nets and Indoor Wall Wash with Lime for Visceral Leishmaniasis Vector Control in the Indian Sub-continent: A Multi-country Cluster Randomized Controlled Trial

PubMed Central

Das, Pradeep; Ghosh, Debashis; Priyanka, Jyoti; Matlashewski, Greg; Kroeger, Axel; Upfill-Brown, Alexander

2016-01-01

Background We investigated the efficacy, safety and cost of lime wash of household walls plus treatment of sand fly breeding places with bleach (i.e. environmental management or EM), insecticide impregnated durable wall lining (DWL), and bed net impregnation with slow release insecticide (ITN) for sand fly control in the Indian sub-continent. Methods This multi-country cluster randomized controlled trial had 24 clusters in each three sites with eight clusters per high, medium or low sand fly density stratum. Every cluster included 45–50 households. Five households from each cluster were randomly selected for entomological measurements including sand fly density and mortality at one, three, nine and twelve months post intervention. Household interviews were conducted for socioeconomic information and intervention acceptability assessment. Cost for each intervention was calculated. There was a control group without intervention. Findings Sand fly mortality [mean and 95%CI] ranged from 84% (81%-87%) at one month to 74% (71%-78%) at 12 months for DWL, 75% (71%-79%) at one month to 49% (43%-55%) at twelve months for ITN, and 44% (34%-53%) at one month to 22% (14%-29%) at twelve months for EM. Adjusted intervention effect on sand fly density measured by incidence rate ratio ranged from 0.28 (0.23–0.34) at one month to 0.62 (0.51–0.75) at 12 months for DWL; 0.72 (0.62–0.85) at one month to 1.02 (0.86–1.22) at 12 months for ITN; and 0.89 (0.76–1.03) at one months to 1.49 (1.26–1.74) at 12 months for EM. Household acceptance of EM was 74% compared to 94% for both DWL and ITN. Operational cost per household in USD was about 5, 8, and 2 for EM, DWL and ITN, respectively. Minimal adverse reactions were reported for EM and ITN while 36% of households with DWL reported transient itching. Interpretation DWL is the most effective, durable and acceptable control method followed by ITN. The Visceral Leishmaniasis (VL) Elimination Program in the Indian sub-continent should consider DWL and ITN for sand fly control in addition to IRS. PMID:27533097

A Randomized Controlled Trial of the Social Tools and Rules for Teens (START) Program: An Immersive Socialization Intervention for Adolescents with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Vernon, Ty W.; Miller, Amber R.; Ko, Jordan A.; Barrett, Amy C.; McGarry, Elizabeth S.

2018-01-01

Adolescents with ASD face numerous personal and contextual barriers that impede the development of social motivation and core competencies, warranting the need for targeted intervention. A randomized controlled trial was conducted with 40 adolescents to evaluate the merits of a multi-component socialization intervention that places emphasis on…

Preschool Teachers Can Use a PBS KIDS Transmedia Curriculum Supplement to Support Young Children's Mathematics Learning: Results of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Llorente, Carlin; Pasnik, Shelley; Moorthy, Savitha; Hupert, Naomi; Rosenfeld, Deborah; Gerard, Sarah

2015-01-01

The current study, a randomized controlled trial, explores how technology and educational transmedia resources can enhance prekindergarten math teaching and learning in preschools, especially those serving children who may be at risk for academic difficulties due to economic and social disadvantages. This research is part of a multi-year summative…

A randomized, controlled phase I/II study to evaluate the safety and efficacy of MGV354 for ocular hypertension or glaucoma.

PubMed

Stacy, Rebecca; Huttner, Kenneth; Watts, Jen; Peace, James; Wirta, David; Walters, Tom; Sall, Kenneth; Seaman, John; Ni, Xiao; Prasanna, Ganesh; Mogi, Muneto; Adams, Christopher; Yan, Jing-He; Wald, Michael; He, Yunsheng; Newton, Ronald; Kolega, Randall; Grosskreutz, Cynthia

2018-05-23

To assess the clinical safety, tolerability, and efficacy of topically administered MGV354, a soluble guanylate cyclase (sGC) activator, in patients with ocular hypertension (OH) or glaucoma DESIGN: Double-masked, randomized, and vehicle-controlled study METHODS: Parts 1 and 2 evaluated safety and tolerability to identify the maximum tolerated dose (MTD) of once daily MGV354 in 32 healthy volunteers (Part 1) and 16 patients with OH or glaucoma (Part 2) at a single clinical site. Part 3 was a multi-site trial that evaluated IOP-lowering efficacy of the MTD administered nightly for one week in 50 patients with minimum IOP of 24mm Hg at 8 AM, with a main outcome measure of mean diurnal IOP at Day 8 compared to baseline (ClinicalTrials.gov NCT02743780). There was no difference in favor of MGV354 for IOP lowering; change from Baseline to Day 8 in mean diurnal IOP was -0.6 mmHg for MGV354-treated patients and -1.1 mmHg for Vehicle-treated patients in Part 3, with a confidence interval of -0.7 to 1.7. The most common adverse events reported after MGV354 administration were conjunctival and ocular hyperemia. Overall, MGV354 0.1% demonstrated no statistically significant effect compared to Vehicle in lowering IOP based upon the study's main outcome measure. MGV354 produced ocular hyperemia consistent with its pharmacology. Copyright © 2018 Elsevier Inc. All rights reserved.

CONCEPTUAL AND METHODOLOGICAL ISSUES IN DESIGNING A RANDOMIZED CONTROLLED TREATMENT TRIAL FOR GERIATRIC BIPOLAR DISORDER: GERI-BD

PubMed Central

Young, Robert C.; Schulberg, Herbert C.; Gildengers, Ariel G.; Sajatovic, Martha; Mulsant, Benoit H.; Gyulai, Laszlo; Beyer, John; Marangell, Lauren; Kunik, Mark; Have, Thomas Ten; Bruce, Martha L.; Gur, Ruben; Marino, Patricia; Evans, Jovier D.; Reynolds, Charles F.; Alexopoulos, George S.

2010-01-01

Aim This report considers the conceptual and methodological concerns confronting clinical investigators seeking to generate knowledge regarding the tolerability and benefits of pharmacotherapy in geriatric bipolar (BP) patients. Method There is continuing need for evidence-based guidelines derived from randomized controlled trials that will enhance drug treatment of geriatric BP patients. We, therefore, present the complex conceptual and methodological choices encountered in designing a multi-site clinical trial and the decisions reached by the investigators with the intention that study findings are pertinent to, and can facilitate, routine treatment decisions. Results Guided by a literature review and input from peers, the tolerability and anti-manic effect of lithium and valproate were judged to be the key mood stabilizers to investigate with regard to treating BP I manic, mixed and hypomanic states. The patient selection criteria are intended to generate a sample that experiences common treatment needs but which also represents the variety of older patients seen in university-based clinical settings. The clinical protocol guides titratation of lithium and valproate to target serum concentrations, with lower levels allowed when necessitated by limited tolerability. The protocol emphasizes initial monotherapy. However, augmentation with risperidone is permitted after three weeks when indicated by operational criteria. Conclusions A randomized controlled trial that both investigates commonly prescribed mood stabilizers and maximizes patient participation can meaningfully address high priority clinical concerns directly relevant to the routine pharmacologic treatment of geriatric BP patients. PMID:20148867

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Building capacity for rigorous controlled trials in autism: the importance of measuring treatment adherence.

PubMed

McConachie, H; Fletcher-Watson, S

2015-03-01

Research groups across Europe have been networking to share information and ideas about research on preschool children with autism. The paper describes preliminary work to develop capacity for future multi-site randomized controlled trials of early intervention, with a specific focus on the need to measure treatment adherence where parents deliver therapy. The paper includes a review of randomized and controlled studies of parent-mediated early intervention from two sources, a recent Cochrane Collaboration review and a mapping of European early intervention studies in autism published since 2002. The data extracted focused on methods for describing parent adherence, that is, how and to what extent parents carry out the strategies taught them by therapists. Less than half of the 32 studies reviewed included any measure of parent adherence. Only seven included a direct assessment method. The challenges of developing pan-European early intervention evaluation studies are discussed, including choice of intervention model and of important outcomes, the need for translation of measurement tools and achievement of joint training to reliability of assessors. Measurement of parent-child interaction style and of adherence to strategies taught need further study. © 2014 The Authors. Child: Care, Health and Development published by John Wiley & Sons Ltd.

A method for multi-codon scanning mutagenesis of proteins based on asymmetric transposons.

PubMed

Liu, Jia; Cropp, T Ashton

2012-02-01

Random mutagenesis followed by selection or screening is a commonly used strategy to improve protein function. Despite many available methods for random mutagenesis, nearly all generate mutations at the nucleotide level. An ideal mutagenesis method would allow for the generation of 'codon mutations' to change protein sequence with defined or mixed amino acids of choice. Herein we report a method that allows for mutations of one, two or three consecutive codons. Key to this method is the development of a Mu transposon variant with asymmetric terminal sequences. As a demonstration of the method, we performed multi-codon scanning on the gene encoding superfolder GFP (sfGFP). Characterization of 50 randomly chosen clones from each library showed that more than 40% of the mutants in these three libraries contained seamless, in-frame mutations with low site preference. By screening only 500 colonies from each library, we successfully identified several spectra-shift mutations, including a S205D variant that was found to bear a single excitation peak in the UV region.

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

Effect of local drug delivery in chronic periodontitis patients: A meta-analysis

PubMed Central

Kalsi, Rupali; Vandana, K. L.; Prakash, Shobha

2011-01-01

Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. Thus, an essential component of therapy is to eliminate or control these pathogens. This has been traditionally accomplished through mechanical means (scaling and root planing (SRP)), which is time-consuming, difficult, and, sometimes, ineffective. From about the past 30 years, locally delivered, anti-infective pharmacological agents, most recently employing sustained-release vehicles, have been introduced to achieve this goal. This systematic review is an effort to determine the efficacy of the currently available anti-infective agents, with and without concurrent SRP, in controlling chronic periodontitis. Four studies were included, which were all randomized controlled trials, incorporating a total patient population of 80, with 97 control sites and 111 test sites. A meta-analysis completed on these four studies including SRP and local sustained-release agents compared with SRP alone indicated significant adjunctive probing depth (PD) reduction for 10% Doxycycline hycylate (ATRIDOX), minocycline hydrochloride (ARESTIN), tetracycline hydrochloride (PERIODONTAL PLUS AB), and chlorhexidine gluconate (PERIOCHIP). Essentially, all studies reported substantial reductions in gingival inflammation, plaque scores, and bleeding indices, which were similar in both the control and the experimental groups. Use of antimicrobial sustained-release systems as an adjunct to SRP does not result in significant patient-centered adverse events. Local drug delivery combined with SRP appears to provide additional benefits in PD reduction compared with SRP alone. PMID:22368351

Multi-Species Genome Comparison Sheds New Light on Evolutionary Processes, Cancer Mutations

ERIC Educational Resources Information Center

Journal of College Science Teaching, 2005

2005-01-01

An international team that includes researchers from the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH), has discovered that mammalian chromosomes have evolved by breaking at specific sites rather than randomly as long thought--and that many of the breakage hot spots are also involved in human…

Evaluation of a nurse practitioner disease management model for chronic heart failure: a multi-site implementation study.

PubMed

Lowery, Julie; Hopp, Faith; Subramanian, Usha; Wiitala, Wyndy; Welsh, Deborah E; Larkin, Angela; Stemmer, Karen; Zak, Cassandra; Vaitkevicius, Peter

2012-01-01

While disease management appears to be effective in selected, small groups of CHF patients from randomized controlled trials, its effectiveness in a broader CHF patient population is not known. This prospective, quasi-experimental study compared patient outcomes under a nurse practitioner-led disease management model (intervention group) with outcomes under usual care (control group) in both primary and tertiary medical centers. The study included 969 veterans (458 intervention, 511 control) treated for CHF at six VA medical centers. Intervention patients had significantly fewer (p<0.05) CHF and all-cause admissions at one-year follow-up, and lower mortality at both one- and two-year follow-up. These data provide support for the potential effectiveness of the intervention, and suggest that the evidence from RCTs of disease management models for CHF can be translated into clinical practice, even without the benefits of a selected patient population and dedicated resources often found in RCTs. © 2011 Wiley Periodicals, Inc.

77 FR 3284 - Comment Request for Information Collection for the H-1B Technical Skills Training (H-1B) and the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-23

... participants at the time they are randomly assigned to a treatment or control group, ensure that random... assignment of participants into treatment and control groups. A Web- based PTS will execute the random... grantee sites and the services available to control group members. This qualitative information will...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

PubMed

Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel

2016-09-02

Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.

Using Mahalanobis Distance Scores for Matched Pairing of Schools in a Randomized Controlled Trial Study of Leadership and Assistance for Science Education Reform (LASER)

ERIC Educational Resources Information Center

Zoblotsky, Todd; Ransford-Kaldon, Carolyn; Morrison, Donald M.

2011-01-01

The present paper describes the recruitment and site selection process that has been underway since January 2011, with particular emphasis on the use of Mahalanobis distance score to determine matched pairs of sites prior to randomization to treatment and control groups. Through a systematic winnowing process, the authors found that they could…

Computerized Multi-Media Instructional Television. COMIT. Proceedings of a Symposium.

ERIC Educational Resources Information Center

Andrews, Gordon C., Ed.; Knapper, Christopher K., Ed.

A joint research project in educational techniques, which was conducted by the University of Waterloo and the IBM Corporation, explored the use of color television with random-access videotape under computer control. At the end of the three-year project, papers were solicited from all COMIT (Computerized Multi-Media Instructional Television)…

School gardens and physical activity: a randomized controlled trial of low-income elementary schools.

PubMed

Wells, Nancy M; Myers, Beth M; Henderson, Charles R

2014-12-01

This study examines effects of a school garden intervention on elementary school children's physical activity (PA). Twelve schools in New York were randomly assigned to receive the school garden intervention (n=6) or to the waitlist control group that later received gardens (n=6). PA was measured by self-report survey (Girls Health Enrichment Multi-site Study Activity Questionnaire) (N=227) and accelerometry (N=124, 8 schools) at baseline (Fall 2011) and follow-up (Spring 2012, Fall 2012, Spring 2013). Direct observation (N=117, 4 schools) was employed to compare indoor (classroom) and outdoor (garden) PA. Analysis was by general linear mixed models. Survey data indicate garden intervention children's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children's (Δ=-.19, p=.001). Accelerometry data reveal that during the school day, children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children (Δ=+.58, p=.010; Δ=+1.0, p=.044). Direct observation within-group comparison of children at schools with gardens revealed that children move more and sit less during an outdoor garden-based lesson than during an indoor, classroom-based lesson. School gardens show some promise to promote children's PA. clinicaltrials.gov # NCT02148315. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

A multi-center, randomized, double blind placebo-controlled trial of estrogens to prevent Alzheimer’s disease and loss of memory in women: design and baseline characteristics

PubMed Central

Sano, Mary; Jacobs, Diane; Andrews, Howard; Bell, Karen; Graff-Radford, Neill; Lucas, John; Rabins, Peter; Bolla, Karen; Tsai, Wei-Yan; Cross, Peter; Andrews, Karen; Costa, Rosann; Luo, Xiaodong

2012-01-01

Background Observational studies and small clinical trials suggested that hormone replacement therapy (HRT) decreases risk of cognitive loss and Alzheimer’s disease (AD) in postmenopausal women and may have value in primary prevention. Purpose A clinical trial was designed to determine if HRT delays AD or memory loss. This report describes the rationale and original design of the trial and details extensive modifications that were required to respond to unanticipated findings that emerged from other studies during the course of the trial. Methods The trial was designed as a multi-center, placebo-controlled primary prevention trial for women 65 years of age or older with a family history of dementia. Recruitment from local sites was supplemented by centralized efforts to use names of Medicare beneficiaries. Inclusion criteria included good general health and intact memory functioning. Participants were randomized to HRT or placebo in a 1:1 ratio. Assignment was stratified by hysterectomy status and site. The primary outcomes were incident AD and memory decline on neuropsychological testing. Results Enrollment began in March 1998. In response to the Women’s Health Initiative (WHI) May 2002 report of increased incidence of heart disease, stroke, pulmonary embolism, and breast cancer among women randomized to HRT, participants were re-consented with a revised consent form. Procedural modifications, including discontinuation of study medication and a modification of the planned primary outcome based on a final enrollment below the target enrollment (N = 477), were enacted in response to the subsequent WHI Memory Study report of increased risk of dementia and poorer cognitive function with HRT. The mean length of treatment exposure prior to discontinuation was 2.14 years. Participants’ mean age at baseline was 72.8; mean education was 14.2 years. Minority participation was 19% and 34% had a hysterectomy. The study continues to follow these participants for a total of 5 years blind to the original medication assignment. Limitations Results reported from the WHI during the course of this study mandated extensive procedural modifications, including discontinuing recruitment before completion and halting study medication. Alternative strategies for study redesign that were considered are discussed. PMID:18827045

[Multi-central controlled study on three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen].

PubMed

Zhou, Yun-feng; Wei, Yu-long; Zhang, Pu-lin; Gao, Shan; Ning, Guo-li; Zhang, Zhen-qiang; Hu, Bin; Wang, Dan-yi; Yan, Mei-rong; Liu, Wen-jun

2006-06-01

To make multi-central clinical evaluation for three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen. One hundred and sixty-six cases were randomly divided into a test group (n = 84) and a control group (n = 82). Multi-central, randomized and controlled methods were adopted. The test group were treated by the three-part massage therapy, i. e. acupoints at the head, abdomen and back were massaged, once each day; and the control group by oral administration of Guipi Pills [symbol: see text], 8 pills each time, thrice daily. The treatment was given for 15 consecutive days and then the therapeutic effects were observed. Sixty-seven cases were cured, 11 markedly effective, 3 effective, and 3 ineffective in the test group, and the corresponding figures were 10, 21, 29 and 22 in the control group with a very significant difference between the two groups (P< 0.001). The test group was superior to the control group in improvement for Pittsburgh Sleep Quality Index (PSQI), Sleepless Anxiety Scale (SAS) and Sleepless Depression Scale (SDS) (P < 0.001). The three-part massage therapy has definite therapeutic effect on insomnia of deficiency of both the heart and spleen with safety.

Multi-dimensional water quality assessment of an urban drinking water source elucidated by high resolution underwater towed vehicle mapping.

PubMed

Lock, Alan; Spiers, Graeme; Hostetler, Blair; Ray, James; Wallschläger, Dirk

2016-04-15

Spatial surveys of Ramsey Lake, Sudbury, Ontario water quality were conducted using an innovative underwater towed vehicle (UTV) equipped with a multi-parameter probe providing real-time water quality data. The UTV revealed underwater vent sites through high resolution monitoring of different spatial chemical characteristics using common sensors (turbidity, chloride, dissolved oxygen, and oxidation/reduction sensors) that would not be feasible with traditional water sampling methods. Multi-parameter probe vent site identification is supported by elevated alkalinity and silica concentrations at these sites. The identified groundwater vent sites appear to be controlled by bedrock fractures that transport water from different sources with different contaminants of concern. Elevated contaminants, such as, arsenic and nickel and/or nutrient concentrations are evident at the vent sites, illustrating the potential of these sources to degrade water quality. Copyright © 2016 Elsevier Ltd. All rights reserved.

Multi-Label Learning via Random Label Selection for Protein Subcellular Multi-Locations Prediction.

PubMed

Wang, Xiao; Li, Guo-Zheng

2013-03-12

Prediction of protein subcellular localization is an important but challenging problem, particularly when proteins may simultaneously exist at, or move between, two or more different subcellular location sites. Most of the existing protein subcellular localization methods are only used to deal with the single-location proteins. In the past few years, only a few methods have been proposed to tackle proteins with multiple locations. However, they only adopt a simple strategy, that is, transforming the multi-location proteins to multiple proteins with single location, which doesn't take correlations among different subcellular locations into account. In this paper, a novel method named RALS (multi-label learning via RAndom Label Selection), is proposed to learn from multi-location proteins in an effective and efficient way. Through five-fold cross validation test on a benchmark dataset, we demonstrate our proposed method with consideration of label correlations obviously outperforms the baseline BR method without consideration of label correlations, indicating correlations among different subcellular locations really exist and contribute to improvement of prediction performance. Experimental results on two benchmark datasets also show that our proposed methods achieve significantly higher performance than some other state-of-the-art methods in predicting subcellular multi-locations of proteins. The prediction web server is available at http://levis.tongji.edu.cn:8080/bioinfo/MLPred-Euk/ for the public usage.

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

Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).

PubMed

Towfighi, Amytis; Cheng, Eric M; Ayala-Rivera, Monica; McCreath, Heather; Sanossian, Nerses; Dutta, Tara; Mehta, Bijal; Bryg, Robert; Rao, Neal; Song, Shlee; Razmara, Ali; Ramirez, Magaly; Sivers-Teixeira, Theresa; Tran, Jamie; Mojarro-Huang, Elizabeth; Montoya, Ana; Corrales, Marilyn; Martinez, Beatrice; Willis, Phyllis; Macias, Mireya; Ibrahim, Nancy; Wu, Shinyi; Wacksman, Jeremy; Haber, Hilary; Richards, Adam; Barry, Frances; Hill, Valerie; Mittman, Brian; Cunningham, William; Liu, Honghu; Ganz, David A; Factor, Diane; Vickrey, Barbara G

2017-02-06

Recurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population. In this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care. If this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings. ClinicalTrials.gov Identifier NCT01763203 .

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.

Multi-component access to a commercially available weight loss program: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

This study examined weight loss between a community-based, intensive behavioral counseling program (Weight Watchers PointsPlus that included three treatment access modes and a self-help condition. A total of 292 participants were randomized to a Weight Watchers (WW; n=147) or a self-help condition (...

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

PubMed

Feig, Denice S; Asztalos, Elizabeth; Corcoy, Rosa; De Leiva, Alberto; Donovan, Lois; Hod, Moshe; Jovanovic, Lois; Keely, Erin; Kollman, Craig; McManus, Ruth; Murphy, Kellie; Ruedy, Katrina; Sanchez, J Johanna; Tomlinson, George; Murphy, Helen R

2016-07-18

Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012.

Brief Report: Social Disability in Autism Spectrum Disorder--Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials

ERIC Educational Resources Information Center

Scahill, Lawrence; Hallett, Victoria; Aman, Michael G.; McDougle, Christopher J.; Arnold, L. Eugene; McCracken, James T.; Tierney, Elaine; Deng, Yanhong; Dziura, James; Vitiello, Benedetto

2013-01-01

There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to…

The Friendly Schools Friendly Families Programme: Three-Year Bullying Behaviour Outcomes in Primary School Children

ERIC Educational Resources Information Center

Cross, Donna; Waters, Stacey; Pearce, Natasha; Shaw, Therese; Hall, Margaret; Erceg, Erin; Burns, Sharyn; Roberts, Clare; Hamilton, Greg

2012-01-01

Purpose: This three-year group randomized controlled trial assessed whether a multi-age, multi-level bullying prevention and intervention with staff capacity building, can reduce bullying among primary school children. Methods: This study comprised two intervention and one comparison conditions. Student self-report data were collected from 2552…

Transitioning Together: A Multi-Family Group Psychoeducation Program for Adolescents with ASD and Their Parents

ERIC Educational Resources Information Center

DaWalt, Leann Smith; Greenberg, Jan S.; Mailick, Marsha R.

2018-01-01

Currently there are few evidence-based programs available for families of individuals with ASD during the transition to adulthood. The present study provided a preliminary evaluation of a multi-family group psychoeducation intervention using a randomized waitlist control design (n = 41). Families in the intervention condition participated in…

Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

PubMed Central

Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

2014-01-01

Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

Cluster Randomized Trial of a Toolkit and Early Vaccine Delivery to Improve Childhood Influenza Vaccination Rates in Primary Care

PubMed Central

Zimmerman, Richard K.; Nowalk, Mary Patricia; Lin, Chyongchiou Jeng; Hannibal, Kristin; Moehling, Krissy K.; Huang, Hsin-Hui; Matambanadzo, Annamore; Troy, Judith; Allred, Norma J.; Gallik, Greg; Reis, Evelyn C.

2014-01-01

Purpose To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a randomized cluster trial. Methods Twenty primary care practices treating children (range for n=536-8,183) were randomly assigned to Intervention and Control arms to test the effectiveness of an evidence-based practice improvement toolkit (4 Pillars Toolkit) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months-18 years. Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm. Rates for the 2010-2011 and 2011-2012 influenza seasons were compared. Two-level generalized linear mixed modeling was used to evaluate outcomes. Results Overall increases in influenza vaccination rates were significantly greater in the Intervention arm (7.9 percentage points) compared with the Control arm (4.4 percentage points; P<0.034). These rate changes represent 4522 additional doses in the Intervention arm vs. 1,390 additional doses in the Control arm. This effect of the intervention was observed despite the fact that rates increased significantly in both arms - 8/10 Intervention (P<0.001) and 7/10 Control sites (P-values 0.04 to <0.001). Rates in two Intervention sites with pre-intervention vaccination rates >58% did not significantly increase. In regression analyses, a child's likelihood of being vaccinated was significantly higher with: younger age, white race (Odds ratio [OR]=1.29; 95% confidence interval [CI]=1.23-1.34), having commercial insurance (OR=1.30; 95%CI=1.25-1.35), higher pre-intervention practice vaccination rate (OR=1.25; 95%CI=1.16-1.34), and being in the Intervention arm (OR=1.23; 95%CI=1.01-1.50). Early delivery of influenza vaccine was rated by Intervention practices as an effective strategy for raising rates. Conclusions Implementation of a multi-strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practices but the effect may be less pronounced in practices with moderate to high existing vaccination rates. PMID:24793941

A robust multi-frequency mixing algorithm for suppression of rivet signal in GMR inspection of riveted structures

NASA Astrophysics Data System (ADS)

Safdernejad, Morteza S.; Karpenko, Oleksii; Ye, Chaofeng; Udpa, Lalita; Udpa, Satish

2016-02-01

The advent of Giant Magneto-Resistive (GMR) technology permits development of novel highly sensitive array probes for Eddy Current (EC) inspection of multi-layer riveted structures. Multi-frequency GMR measurements with different EC pene-tration depths show promise for detection of bottom layer notches at fastener sites. However, the distortion of the induced magnetic field due to flaws is dominated by the strong fastener signal, which makes defect detection and classification a challenging prob-lem. This issue is more pronounced for ferromagnetic fasteners that concentrate most of the magnetic flux. In the present work, a novel multi-frequency mixing algorithm is proposed to suppress rivet signal response and enhance defect detection capability of the GMR array probe. The algorithm is baseline-free and does not require any assumptions about the sample geometry being inspected. Fastener signal suppression is based upon the random sample consensus (RANSAC) method, which iteratively estimates parameters of a mathematical model from a set of observed data with outliers. Bottom layer defects at fastener site are simulated as EDM notches of different length. Performance of the proposed multi-frequency mixing approach is evaluated on finite element data and experimental GMR measurements obtained with unidirectional planar current excitation. Initial results are promising demonstrating the feasibility of the approach.

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

PubMed

Firouzi, Somayyeh; Majid, Hazreen Abdul; Ismail, Amin; Kamaruddin, Nor Azmi; Barakatun-Nisak, Mohd-Yusof

2017-06-01

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. A randomized, double-blind, parallel-group, controlled clinical trial. Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

MDC-Analyzer: a novel degenerate primer design tool for the construction of intelligent mutagenesis libraries with contiguous sites.

PubMed

Tang, Lixia; Wang, Xiong; Ru, Beibei; Sun, Hengfei; Huang, Jian; Gao, Hui

2014-06-01

Recent computational and bioinformatics advances have enabled the efficient creation of novel biocatalysts by reducing amino acid variability at hot spot regions. To further expand the utility of this strategy, we present here a tool called Multi-site Degenerate Codon Analyzer (MDC-Analyzer) for the automated design of intelligent mutagenesis libraries that can completely cover user-defined randomized sequences, especially when multiple contiguous and/or adjacent sites are targeted. By initially defining an objective function, the possible optimal degenerate PCR primer profiles could be automatically explored using the heuristic approach of Greedy Best-First-Search. Compared to the previously developed DC-Analyzer, MDC-Analyzer allows for the existence of a small amount of undesired sequences as a tradeoff between the number of degenerate primers and the encoded library size while still providing all the benefits of DC-Analyzer with the ability to randomize multiple contiguous sites. MDC-Analyzer was validated using a series of randomly generated mutation schemes and experimental case studies on the evolution of halohydrin dehalogenase, which proved that the MDC methodology is more efficient than other methods and is particularly well-suited to exploring the sequence space of proteins using data-driven protein engineering strategies.

Systematic review and meta-analysis: Multi-strain probiotics as adjunct therapy for Helicobacter pylori eradication and prevention of adverse events

PubMed Central

Huang, Ying; Wang, Lin; Malfertheiner, Peter

2015-01-01

Background Eradication rates with triple therapy for Helicobacter pylori infections have currently declined to unacceptable levels worldwide. Newer quadruple therapies are burdened with a high rate of adverse events. Whether multi-strain probiotics can improve eradication rates or diminish adverse events remains uncertain. Methods Relevant publications in which patients with H. pylori infections were randomized to a multi-strain probiotic or control were identified in PubMed, Cochrane Databases, and other sources from 1 January 1960–3 June 2015. Primary outcomes included eradication rates, incidence of any adverse event and the incidence of antibiotic-associated diarrhea. As probiotic efficacy is strain-specific, pooled relative risks and 95% confidence intervals were calculated using meta-analysis stratified by similar multi-strain probiotic mixtures. Results A total of 19 randomized controlled trials (20 treatment arms, n = 2730) assessing one of six mixtures of strains of probiotics were included. Four multi-strain probiotics significantly improved H. pylori eradication rates, five significantly prevented any adverse reactions and three significantly reduced antibiotic-associated diarrhea. Only two probiotic mixtures (Lactobacillus acidophilus/Bifidobacterium animalis and an eight-strain mixture) had significant efficacy for all three outcomes. Conclusions Our meta-analysis found adjunctive use of some multi-strain probiotics may improve H. pylori eradication rates and prevent the development of adverse events and antibiotic-associated diarrhea, but not all mixtures were effective. PMID:27536365

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.

Telomere formation on macronuclear chromosomes of Oxytricha trifallax and O. fallax: alternatively processed regions have multiple telomere addition sites

PubMed Central

Williams, Kevin R; Doak, Thomas G; Herrick, Glenn

2002-01-01

Background Ciliates employ massive chromatid breakage and de novo telomere formation during generation of the somatic macronucleus. Positions flanking the 81-MAC locus are reproducibly cut. But those flanking the Common Region are proposed to often escape cutting, generating three nested macronuclear chromosomes, two retaining "arms" still appended to the Common Region. Arm-distal positions must differ (in cis) from the Common Region flanks. Results The Common-Region-flanking positions also differ from the arm-distal positions in that they are "multi-TAS" regions: anchored PCR shows heterogeneous patterns of telomere addition sites, but arm-distal sites do not. The multi-TAS patterns are reproducible, but are sensitive to the sequence of the allele being processed. Thus, random degradation following chromatid cutting does not create this heterogeneity; these telomere addition sites also must be dictated by cis-acting sequences. Conclusions Most ciliates show such micro-heterogeneity in the precise positions of telomere addition sites. Telomerase is believed to be tightly associated with, and act in concert with, the chromatid-cutting nuclease: heterogeneity must be the result of intervening erosion activity. Our "weak-sites" hypothesis explains the correlation between alternative chromatid cutting at the Common Region boundaries and their multi-TAS character: when the chromatid-breakage machine encounters either a weak binding site or a weak cut site at these regions, then telomerase dissociates prematurely, leaving the new end subject to erosion by an exonuclease, which pauses at cis-acting sequences; telomerase eventually heals these resected termini. Finally, we observe TAS positioning influenced by trans-allelic interactions, reminiscent of transvection. PMID:12199911

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

Generalizability of findings from randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

PubMed

Susukida, Ryoko; Crum, Rosa M; Ebnesajjad, Cyrus; Stuart, Elizabeth A; Mojtabai, Ramin

2017-07-01

To compare randomized controlled trial (RCT) sample treatment effects with the population effects of substance use disorder (SUD) treatment. Statistical weighting was used to re-compute the effects from 10 RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Multi-site RCTs and usual SUD treatment settings in the United States. A total of 3592 patients in 10 RCTs and 1 602 226 patients from usual SUD treatment settings between 2001 and 2009. Three outcomes of SUD treatment were examined: retention, urine toxicology and abstinence. We weighted the RCT sample treatment effects using propensity scores representing the conditional probability of participating in RCTs. Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology and one trial for abstinence); also, non-significant effects became significantly positive (one trial for abstinence) and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results. The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not reflect adequately the target populations and there is treatment effect heterogeneity across patient subgroups. © 2017 Society for the Study of Addiction.

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.

Growing Right Onto Wellness (GROW): A Family-Centered, Community-Based Obesity Prevention Randomized Controlled Trial for Preschool Child-Parent Pairs

PubMed Central

Po’e, Eli K.; Heerman, William J.; Mistry, Rishi S.; Barkin, Shari L.

2013-01-01

Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., built-environment) and micro (i.e., genetics) level systems that contribute to the childhood obesity epidemic. Six hundred parent-child pairs will be randomized to a 3-year healthy lifestyle intervention or a 3-year school readiness program. Eligible children are enrolled between ages 3 and 5, are from minority communities, and are not obese. The principal site for the GROW intervention is local community recreation centers and libraries. The primary outcome is childhood Body Mass Index (BMI) trajectory at the end of the three-year study period. In addition to other anthropometric measurements, mediators and moderators of growth are considered, including genetics, accelerometry, and diet recall. GROW is a staged intensity intervention, consisting of intensive, maintenance, and sustainability phases. Throughout the study, parents build skills in nutrition, physical activity, and parenting, concurrently forming new social networks. Participants are taught goal-setting, self-monitoring, and problem solving techniques to facilitate sustainable behavior change. The GROW curriculum uses low health literacy communication and social media to communicate key health messages. The control arm is administered to both control and intervention participants. By conducting this trial in public community centers, and by implementing a family-centered approach to sustainable healthy childhood growth, we aim to develop an exportable community-based intervention to address the expanding public health crisis of pediatric obesity. PMID:24012890

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.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial.

PubMed

Günter, Christina Irene; Bader, Augustinus; Dornseifer, Ulf; Egert, Silvia; Dunda, Sebastian; Grieb, Gerrit; Wolter, Thomas; Pallua, Norbert; von Wild, Tobias; Siemers, Frank; Mailänder, Peter; Thamm, Oliver; Ernert, Carsten; Steen, Michael; Sievers, Reiner; Reichert, Bert; Rahmanian-Schwarz, Afshin; Schaller, Hans; Hartmann, Bernd; Otte, Max; Kehl, Victoria; Ohmann, Christian; Jelkmann, Wolfgang; Machens, Hans-Günther

2013-05-03

Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.

Umbilical Cord Blood Use for Admission Blood Tests of VLBW (Very Low Birth Weight) Preterm Neonates: A Multi-center Randomized Clinical Trial

DTIC Science & Technology

2016-09-12

agents (erythropoietin and darbepoetin alfa ), and limiting phlebotomy via use of point-of-care testing devices, benchtop laboratory analyzers, and...Manual, 2014. 18: p. 571-592. 6. Ohls, R.K., et al., A randomized, masked, placebo-controlled study of darbepoetin alfa in preterm infants. Pediatrics

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.

Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial.

PubMed

Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena

2012-03-01

Connective tissue graft (CTG) plus coronally advanced flap (CAF) is the reference therapy for root coverage. The aim of the present study is to evaluate the use of a porcine collagen matrix (PCM) plus CAF as an alternative to CTG+CAF for the treatment of gingival recessions (REC), in a prospective randomized, controlled clinical trial. Eighteen adult patients participated in this study. The patients presented 22 single Miller's Class I or II REC, randomly assigned to the test (PCM+CAF) or control (CTG+CAF) group. REC, probing depth, clinical attachment level (CAL), and width of keratinized tissue (KG) were evaluated at 12 months. In addition, the gingival thickness (GT) was measured 1mm apical to the bottom of the sulcus. At 12 months, mean REC was 0.23 mm for test sites and 0.09 mm for control sites (P <0.01), whereas percentage of root coverage was 94.32% and 96.97%, respectively. CAL gain was 2.41 mm in test sites and 2.95 mm in control sites (P <0.01). KG gain was 1.23 mm in the test group and 1.27 mm in the control group (P <0.01). In test sites, GT changed from 0.82 to 1.82 mm, and in control sites, from 0.86 to 2.09 mm (P <0.01). Within the limits of the study, both treatment procedures resulted in significant reduction in REC at 12 months. No statistically significant differences were found between PCM+CAF and CTG+CAF with regard to any clinical parameter. The collagen matrix represents a possible alternative to CTG.

Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial.

PubMed

Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

2017-01-01

S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p < 0.001). The incidence of drug-related AEs at the application site was 9.5% (32 AEs, 29 mild and 3 moderate) in SFPP and 1.6% in FP patch (p < 0.001). Withdrawals due to AE were five in SFPP and one in FP patch. The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.

Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients.

PubMed

Bech, Rune D; Ovesen, Ole; Lindholm, Peter; Overgaard, Søren

2014-04-01

To our knowledge, there is no evidence to support the use of local infiltration analgesia (LIA) for postoperative pain relief after periacetabular osteotomy (PAO). We investigated the effect of wound infiltration with a long-acting local anesthetic (ropivacaine) for postoperative analgesia after PAO. We performed a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site. 26 patients received ropivacaine and 27 received saline. The intervention period was 2 days and the observational period was 4 days. All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose. Pain was assessed at specific postoperative time points and the daily opioid usage was registered. Infiltration with 75 mL (150 mg) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days. The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable, and we are planning further studies to explore the potential of LIA in larger volume-and also a multimodal regimen-to treat pain in this category of patients.

Effect of Multi Modal Representations on the Critical Thinking Skills of the Fifth Grade Students

ERIC Educational Resources Information Center

Öz, Muhittin; Memis, Esra Kabatas

2018-01-01

The purpose of this study was to explore the effects of multi modal representations within writing to learn activities on students' critical thinking. Mixed method was used. The participants included 32 students 5th grade from elementary school. The groups were randomly selected as a control group and the other class was selected as the…

Involving Community Stakeholders to Increase Park Use and Physical Activity

PubMed Central

Marsh, Terry; Mariscal, Mark; Pina-Cortez, Sophia; Cohen, Deborah A.

2014-01-01

Objective To describe implementation of a randomized controlled trial of community-based participatory research (CBPR) approaches to increase park use and physical activity across 33 diverse neighborhoods in Los Angeles. Methods Fifty parks were randomly assigned based on park size, facilities and programs, and neighborhood socio-demographic characteristics to: park director (PD, 17 parks); PD and park advisory board of interested community members (PD+PAB, 16 parks); and no-intervention control (17 parks) arms. Between 2007 and 2012, PDs and PABs from the 33 intervention parks participated in community engagement, baseline assessment, marketing training, intervention design and implementation, and follow-up assessment. Results Intervention parks (PD and PD+PAB) invested in new and diversified signage, promotional items, outreach or support for group activities like fitness classes and walking clubs, and various marketing strategies. Scaling up CBPR methods across parks in 33 diverse neighborhoods was challenging. Working with departmental management and established structures for community input (PABs) and park policy (PDs) facilitated implementation and sustainability. Conclusion Scaling up CBPR methods across diverse communities involved tradeoffs. CBPR is useful for tailoring research and enhancing community impact and sustainability, but more work is needed to understand how to conduct multi-site trials across diverse settings using CBPR. PMID:24674853

Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa.

PubMed

Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

2015-12-01

To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc.

Involving community stakeholders to increase park use and physical activity.

PubMed

Derose, Kathryn Pitkin; Marsh, Terry; Mariscal, Mark; Pina-Cortez, Sophia; Cohen, Deborah A

2014-07-01

The aim of this study is to describe implementation of a randomized controlled trial of community-based participatory research (CBPR) approaches to increase park use and physical activity across 33 diverse neighborhoods in Los Angeles. Fifty parks were randomly assigned based on park size, facilities and programs, and neighborhood socio-demographic characteristics to: park director (PD, 17 parks); PD and park advisory board of interested community members (PD+PAB, 16 parks); and no-intervention control (17 parks) arms. Between 2007 and 2012, PDs and PABs from the 33 intervention parks participated in community engagement, baseline assessment, marketing training, intervention design and implementation, and follow-up assessment. Intervention parks (PD and PD+PAB) invested in new and diversified signage, promotional items, outreach or support for group activities like fitness classes and walking clubs, and various marketing strategies. Scaling up CBPR methods across parks in 33 diverse neighborhoods was challenging. Working with departmental management and established structures for community input (PABs) and park policy (PDs) facilitated implementation and sustainability. Scaling up CBPR methods across diverse communities involved tradeoffs. CBPR is useful for tailoring research and enhancing community impact and sustainability, but more work is needed to understand how to conduct multi-site trials across diverse settings using CBPR. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants.

PubMed

Standley, Jayne M; Cassidy, Jane; Grant, Roy; Cevasco, Andrea; Szuch, Catherine; Nguyen, Judy; Walworth, Darcy; Procelli, Danielle; Jarred, Jennifer; Adams, Kristen

2010-01-01

In this randomized, controlled multi-site study, the pacifier-activated-lullaby system (PAL) was used with 68 premature infants. Dependent variables were (a) total number of days prior to nipple feeding, (b) days of nipple feeding, (c) discharge weight, and (d) overall weight gain. Independent variables included contingent music reinforcement for non-nutritive sucking for PAL intervention at 32 vs. 34 vs. 36 weeks adjusted gestational age (AGA), with each age group subdivided into three trial conditions: control consisting of no PAL used vs. one 15-minute PAL trial vs. three 15-minute PAL trials. At 34 weeks, PAL trials significantly shortened gavage feeding length, and three trials were significantly better than one trial. At 32 weeks, PAL trials lengthened gavage feeding. Female infants learned to nipple feed significantly faster than male infants. It was noted that PAL babies went home sooner after beginning to nipple feed, a trend that was not statistically significant.

Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial.

PubMed

Robb, Sheri L; Burns, Debra S; Docherty, Sharron L; Haase, Joan E

2011-11-01

The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children's Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11-24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the National Institutes of Health (NIH) Behavior Change Consortium Treatment Fidelity Workgroup (BCC) recommendations and provide a successful working model for treatment fidelity implementation in a large, multi-site behavioral intervention study. In this paper, we summarize 20 specific treatment fidelity strategies used in the SMART trial and how these strategies correspond with NIH BCC recommendations in five specific areas: (1) study design, (2) training providers, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment skills. Increased use and reporting of treatment fidelity procedures is essential in advancing the reliability and validity of behavioral intervention research. The SMART trial provides a strong model for the application of fidelity strategies to improve scientific findings and addresses the absence of published literature, illustrating the application of BCC recommendations in behavioral intervention studies. Copyright © 2010 John Wiley & Sons, Ltd.

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.

Impact of smoking reduced nicotine content cigarettes on sensitivity to cigarette price: further results from a multi-site clinical trial.

PubMed

Smith, Tracy T; Cassidy, Rachel N; Tidey, Jennifer W; Luo, Xianghua; Le, Chap T; Hatsukami, Dorothy K; Donny, Eric C

2017-02-01

To assess the impact of a reduction in the nicotine content of cigarettes on estimated consumption of reduced nicotine cigarettes and usual brand cigarettes at a variety of hypothetical prices. Double-blind study with participants assigned randomly to receive cigarettes for 6 weeks that were either usual brand or an investigational cigarette with one of five nicotine contents. Ten sites across the United States. A total of 839 eligible adult smokers randomized from 2013 to 2014. Participants received their usual brand or an investigational cigarette with one of five nicotine contents: 15.8 (primary control), 5.2, 2.4, 1.3, or 0.4 mg/g. The Cigarette Purchase Task was completed at baseline and at the week 6 post-randomization visit. Compared with normal nicotine content controls, the lowest nicotine content (0.4 mg/g) reduced the number of study cigarettes participants estimated they would smoke at a range of prices [mean reduction relative to 15.8 mg/g at a price of $4.00/pack: 9.50, 95% confidence interval (CI) = 6.81,12.19]. The lowest nicotine content also reduced the maximum amount of money allocated to study cigarettes and the price at which participants reported they would stop buying study cigarettes [median reduction relative to 15.8 mg/g, 95% CI = $8.21 (4.27,12.15) per day and $0.44 (0.17,0.71) per cigarette, respectively]. A reduction in nicotine content to the lowest level also reduced the maximum amount of money allocated to usual brand cigarettes (median reduction relative to 15.8 mg/g: $4.39 per day, 95% CI = 1.88,6.90). In current smokers, a reduction in nicotine content may reduce cigarette consumption, reduce the reinforcement value of cigarettes and increase cessation if reduced nicotine content cigarettes were the only cigarette available for purchase. © 2016 Society for the Study of Addiction.

Randomized Clinical Trial of Therapeutic Music Video Intervention for Resilience Outcomes in Adolescents/Young Adults Undergoing Hematopoietic Stem Cell Transplant: A Report from the Children’s Oncology Group

PubMed Central

Robb, Sheri L.; Burns, Debra S.; Stegenga, Kristin A.; Haut, Paul R.; Monahan, Patrick O.; Meza, Jane; Stump, Timothy E.; Cherven, Brooke O.; Docherty, Sharron L.; Hendricks-Ferguson, Verna L.; Kintner, Eileen K.; Haight, Ann E.; Wall, Donna A.; Haase, Joan E.

2013-01-01

Background To reduce the risk of adjustment problems associated with Hematopoietic Stem Cell Transplant (HSCT) for adolescents/young adults (AYA), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: (a) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; (b) decrease risk factors of illness-related distress and defensive coping; and (c) increase outcomes of self-transcendence and resilience. Methods A multi-site, randomized controlled trial (COG-ANUR0631) conducted at 8 Children’s Oncology Group sites involving 113 AYA aged 11–24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase’s Resilience in Illness Model. Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning and resilience at baseline (T1), post-intervention (T2), and 100-days post-transplant (T3). Results At T2, the TMV group reported significantly better courageous coping (ES=0.505; P=0.030). At T3, the TMV group reported significantly better social integration (ES=0.543; P=.028) and family environment (ES=0.663; P=0.008), as well as moderate non-significant effect sizes for spiritual perspective (E=0.450; P=0.071) and self-transcendence (ES=0.424; P=0.088). Conclusion The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high risk cancer treatment. We recommend the TMV be examined in a broader population of AYA with high risk cancers. PMID:24469862

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

Multi-Cellular Logistics of Collective Cell Migration

PubMed Central

Yamao, Masataka; Naoki, Honda; Ishii, Shin

2011-01-01

During development, the formation of biological networks (such as organs and neuronal networks) is controlled by multicellular transportation phenomena based on cell migration. In multi-cellular systems, cellular locomotion is restricted by physical interactions with other cells in a crowded space, similar to passengers pushing others out of their way on a packed train. The motion of individual cells is intrinsically stochastic and may be viewed as a type of random walk. However, this walk takes place in a noisy environment because the cell interacts with its randomly moving neighbors. Despite this randomness and complexity, development is highly orchestrated and precisely regulated, following genetic (and even epigenetic) blueprints. Although individual cell migration has long been studied, the manner in which stochasticity affects multi-cellular transportation within the precisely controlled process of development remains largely unknown. To explore the general principles underlying multicellular migration, we focus on the migration of neural crest cells, which migrate collectively and form streams. We introduce a mechanical model of multi-cellular migration. Simulations based on the model show that the migration mode depends on the relative strengths of the noise from migratory and non-migratory cells. Strong noise from migratory cells and weak noise from surrounding cells causes “collective migration,” whereas strong noise from non-migratory cells causes “dispersive migration.” Moreover, our theoretical analyses reveal that migratory cells attract each other over long distances, even without direct mechanical contacts. This effective interaction depends on the stochasticity of the migratory and non-migratory cells. On the basis of these findings, we propose that stochastic behavior at the single-cell level works effectively and precisely to achieve collective migration in multi-cellular systems. PMID:22205934

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

2017-03-01

To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. Multicentre, open, cluster randomised controlled trial. Obstetric units in the Netherlands. Women with a singleton pregnancy beyond 24 weeks of gestation. Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training. Intention-to-treat analyses were performed at the cluster level, including a measurement 1 year prior to the intervention. Primary outcome was a composite outcome of obstetric complications during the first year post-intervention, including low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischaemic encephalopathy. Maternal and perinatal mortality were also registered. Each study group included 12 units with a median unit size of 1224 women, combining for a total of 28 657 women. In total, 471 medical professionals received the training course. The composite outcome of obstetric complications did not differ between study groups [odds ratio (OR) 1.0, 95% confidence interval (CI) 0.80-1.3]. Team training reduced trauma due to shoulder dystocia (OR 0.50, 95% CI 0.25-0.99) and increased invasive treatment for severe postpartum haemorrhage (OR 2.2, 95% CI 1.2-3.9) compared with no intervention. Other outcomes did not differ between study groups. A 1-day, off-site, simulation-based team training, focusing on teamwork skills, did not reduce a composite of obstetric complications. 1-day, off-site, simulation-based team training did not reduce a composite of obstetric complications. © 2016 Royal College of Obstetricians and Gynaecologists.

Population-Level Cost-Effectiveness of Implementing Evidence-Based Practices into Routine Care

PubMed Central

Fortney, John C; Pyne, Jeffrey M; Burgess, James F

2014-01-01

Objective The objective of this research was to apply a new methodology (population-level cost-effectiveness analysis) to determine the value of implementing an evidence-based practice in routine care. Data Sources/Study Setting Data are from sequentially conducted studies: a randomized controlled trial and an implementation trial of collaborative care for depression. Both trials were conducted in the same practice setting and population (primary care patients prescribed antidepressants). Study Design The study combined results from a randomized controlled trial and a pre-post-quasi-experimental implementation trial. Data Collection/Extraction Methods The randomized controlled trial collected quality-adjusted life years (QALYs) from survey and medication possession ratios (MPRs) from administrative data. The implementation trial collected MPRs and intervention costs from administrative data and implementation costs from survey. Principal Findings In the randomized controlled trial, MPRs were significantly correlated with QALYs (p = .03). In the implementation trial, patients at implementation sites had significantly higher MPRs (p = .01) than patients at control sites, and by extrapolation higher QALYs (0.00188). Total costs (implementation, intervention) were nonsignificantly higher ($63.76) at implementation sites. The incremental population-level cost-effectiveness ratio was $33,905.92/QALY (bootstrap interquartile range −$45,343.10/QALY to $99,260.90/QALY). Conclusions The methodology was feasible to operationalize and gave reasonable estimates of implementation value. PMID:25328029

Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

2014-12-10

Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM.

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.

PubMed

Pasha, Omrana; McClure, Elizabeth M; Wright, Linda L; Saleem, Sarah; Goudar, Shivaprasad S; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A; Derman, Richard J; Hibberd, Patricia L; Liechty, Edward K; Krebs, Nancy; Hambidge, K Michael; Buekens, Pierre; Moore, Janet; Jobe, Alan H; Koso-Thomas, Marion; Wallace, Dennis D; Stalls, Suzanne; Goldenberg, Robert L

2013-10-03

Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be. ClinicalTrials.gov NCT01073488.

Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study.

PubMed

Boccia, Ralph V; Gordan, Lucio N; Clark, Gemma; Howell, Julian D; Grunberg, Steven M

2011-10-01

A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV). Six hundred forty-one patients were randomized to oral (2 mg/day, 3-5 days) or transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The prespecified non-inferiority margin was 15%. Five hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3). Both treatments were well tolerated, the most common adverse event being constipation. The GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7 days that is as effective as oral granisetron.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial.

PubMed

Imam, Bita; Miller, William C; Finlayson, Heather C; Eng, Janice J; Payne, Michael Wc; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-12-22

The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed "Wii.n.Walk", an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants' homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks' duration. The primary outcome measure will be the "Two-Minute Walk Test" to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).

Compensation of temporal and spatial dispersion for multiphoton acousto-optic laser-scanning microscopy

NASA Astrophysics Data System (ADS)

Iyer, Vijay; Saggau, Peter

2003-10-01

In laser-scanning microscopy, acousto-optic (AO) deflection provides a means to quickly position a laser beam to random locations throughout the field-of-view. Compared to conventional laser-scanning using galvanometer-driven mirrors, this approach increases the frame rate and signal-to-noise ratio, and reduces time spent illuminating sites of no interest. However, random-access AO scanning has not yet been combined with multi-photon microscopy, primarily because the femtosecond laser pulses employed are subject to significant amounts of both spatial and temporal dispersion upon propagation through common AO materials. Left uncompensated, spatial dispersion reduces the microscope"s spatial resolution while temporal dispersion reduces the multi-photon excitation efficacy. In previous work, we have demonstrated, 1) the efficacy of a single diffraction grating scheme which reduces the spatial dispersion at least 3-fold throughout the field-of-view, and 2) the use of a novel stacked-prism pre-chirper for compensating the temporal dispersion of a pair of AODs using a shorter mechanical path length (2-4X) than standard prism-pair arrangements. In this work, we demonstrate for the first time the use of these compensation approaches with a custom-made large-area slow-shear TeO2 AOD specifically suited for the development of a high-resolution 2-D random-access AO scanning multi-photon laser-scanning microscope (AO-MPLSM).

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…

Applying the Brakes to Multi-Site SR Protein Phosphorylation: Substrate-Induced Effects on the Splicing Kinase SRPK1†

PubMed Central

Aubol, Brandon E.; Adams, Joseph A.

2011-01-01

To investigate how a protein kinase interacts with its protein substrate during extended, multi-site phosphorylation, the kinetic mechanism of a protein kinase involved in mRNA splicing control was investigated using rapid quench flow techniques. The protein kinase SRPK1 phosphorylates approximately 10 serines in the arginine-serine-rich domain (RS domain) of the SR protein SRSF1 in a C-to-N-terminal direction, a modification that directs this essential splicing factor from the cytoplasm to the nucleus. Transient-state kinetic experiments illustrate that the first phosphate is added rapidly onto the RS domain of SRSF1 (t1/2 = 0.1 sec) followed by slower, multi-site phosphorylation at the remaining serines (t1/2 = 15 sec). Mutagenesis experiments suggest that efficient phosphorylation rates are maintained by an extensive hydrogen bonding and electrostatic network between the RS domain of the SR protein and the active site and docking groove of the kinase. Catalytic trapping and viscosometric experiments demonstrate that while the phosphoryl transfer step is fast, ADP release limits multi-site phosphorylation. By studying phosphate incorporation into selectively pre-phosphorylated forms of the enzyme-substrate complex, the kinetic mechanism for site-specific phosphorylation along the reaction coordinate was assessed. The binding affinity of the SR protein, the phosphoryl transfer rate and ADP exchange rate were found to decline significantly as a function of progressive phosphorylation in the RS domain. These findings indicate that the protein substrate actively modulates initiation, extension and termination events associated with prolonged, multi-site phosphorylation. PMID:21728354

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.

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial

PubMed Central

Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-01-01

Background Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. Objective The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. Methods A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association–recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators’ monitoring of patients’ adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A1c levels, weight, and the usability of the connected system. Results An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) PMID:29610111

77 FR 40889 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

... evaluation study will be conducted using a group-randomized controlled trial multi-time series design. Four... their time. Estimated Annualized Burden Hours Number of Average burden Respondents Number of responses...

Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of a smart server.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

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.

Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomized placebo-controlled trial

PubMed Central

Lenze, Eric J.; Mulsant, Benoit H.; Blumberger, Daniel M.; Karp, Jordan F.; Newcomer, John W.; Anderson, Stewart J.; Dew, Mary Amanda; Butters, Meryl A.; Stack, Jacqueline A.; Begley, Amy E.; Reynolds, Charles F.

2015-01-01

Summary Background Treatment-resistant major depressive disorder is common and potentially life-threatening in older persons, in whom little is known about the benefits and risks of augmentation pharmacotherapy. Methods We conducted a multi-site, placebo-controlled, randomized clinical trial to test the efficacy and safety of aripiprazole augmentation for older adults with treatment-resistant depression. We treated 468 participants aged 60 and older with current major depressive episode with venlafaxine extended-release (ER); 96 (20.5%) did not complete this open phase, 191 (40.8%) remitted, and 181 (38.7%) did not remit and were randomized to 12 weeks of double-blind augmentation with aripiprazole or placebo. The computer-generated randomization was done in blocks and stratified by site. The primary endpoint was remission, defined as Montgomery-Asberg Depression Rating Scale scores ≤10 (and at least two points below the score at the start of the randomized phase) at both of the final two consecutive visits. We also assessed resolution of suicidal ideation, and safety and tolerability with cardiometabolic and neurological measures. Analyses were conducted according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT00892047. Findings Older adults on aripiprazole had a higher remission rate than those on placebo (44% versus 29%; odds ratio [OR]=2.0, 95% CI 1.1–3.7, p=0.03; number needed to treat [NNT]=6.6 [95% CI 3.5–81.8]). Overall, remission was stable during 12 additional weeks of continuation treatment. The resolution of suicidal ideation was more marked with aripiprazole than with placebo. Akathisia was the most common adverse effect (27% of participants on aripiprazole). Compared to placebo, aripiprazole was also associated with more Parkinsonism but not with treatment-emergent suicidal ideation, QTc prolongation, or increases in adiposity, glucose, insulin, or lipids. Interpretation In older adults who fail to achieve remission from depression with a first-line antidepressant, the addition of aripiprazole is effective in achieving and sustaining remission. Tolerability concerns include potential for akathisia and Parkinsonism. Funding National Institute of Mental Health, UPMC Endowment in Geriatric Psychiatry, Taylor Family Institute for Innovative Psychiatric Research, National Center for Advancing Translational Sciences, and the Campbell Family Mental Health Research Institute. PMID:26423182

The influence of social networking sites on health behavior change: a systematic review and meta-analysis

PubMed Central

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Objective Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Materials and methods Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's ‘risk of bias’ tool. Randomized controlled trials were pooled in a meta-analysis. Results The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges’ g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I2 = 84.0%; T2 = 0.058) and no evidence of publication bias. Discussion To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used ‘network alteration’, showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Conclusions Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. PMID:25005606

Nutrition Education among Low-Income Older Adults: A Randomized Intervention Trial in Congregate Nutrition Sites

ERIC Educational Resources Information Center

Mitchell, Roger E.; Ash, Sarah L.; McClelland, Jacquelyn W.

2006-01-01

Nutritional well-being among older adults is critical for maintaining health, increasing longevity, and decreasing the impact of chronic illness. However, few well-controlled studies have examined nutritional behavior change among low-income older adults. A prospective, controlled, randomized design examined a five session nutrition education…

Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

ERIC Educational Resources Information Center

Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

2010-01-01

Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

Randomized, Controlled Trial of Atomoxetine for Attention-Deficit/Hyperactivity Disorder in Adolescents with Substance Use Disorder

ERIC Educational Resources Information Center

Thurstone, Christian; Riggs, Paula D.; Salomonsen-Sautel, Stacy; Mikulich-Gilbertson, Susan K.

2010-01-01

Objective: To evaluate the effect of atomoxetine hydrochloride versus placebo on attention-deficit/hyperactivity disorder (ADHD) and substance use disorder (SUD) in adolescents receiving motivational interviewing/cognitive behavioral therapy (MI/CBT) for SUD. Method: This single-site, randomized, controlled trial was conducted between December…

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.

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.

Multi-muscle FES force control of the human arm for arbitrary goals.

PubMed

Schearer, Eric M; Liao, Yu-Wei; Perreault, Eric J; Tresch, Matthew C; Memberg, William D; Kirsch, Robert F; Lynch, Kevin M

2014-05-01

We present a method for controlling a neuroprosthesis for a paralyzed human arm using functional electrical stimulation (FES) and characterize the errors of the controller. The subject has surgically implanted electrodes for stimulating muscles in her shoulder and arm. Using input/output data, a model mapping muscle stimulations to isometric endpoint forces measured at the subject's hand was identified. We inverted the model of this redundant and coupled multiple-input multiple-output system by minimizing muscle activations and used this inverse for feedforward control. The magnitude of the total root mean square error over a grid in the volume of achievable isometric endpoint force targets was 11% of the total range of achievable forces. Major sources of error were random error due to trial-to-trial variability and model bias due to nonstationary system properties. Because the muscles working collectively are the actuators of the skeletal system, the quantification of errors in force control guides designs of motion controllers for multi-joint, multi-muscle FES systems that can achieve arbitrary goals.

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial)

PubMed Central

Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

2018-01-01

PURPOSE: To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. DESIGN: The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. SUBJECTS AND SETTING: The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. METHODS: Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. RESULTS: Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: −1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were “very satisfied” with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups. CONCLUSIONS: The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes. PMID:29300287

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

PubMed

Colwell, Janice C; Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups. The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines.

PubMed

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-08-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4-10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child's health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2013; all rights reserved.

Educational Web-Based Intervention for High School Students to Increase Knowledge and Promote Positive Attitudes toward Organ Donation

ERIC Educational Resources Information Center

Vinokur, Amiram D.; Merion, Robert M.; Couper, Mick P.; Jones, Eleanor G.; Dong, Yihui

2006-01-01

A sample of 490 high school students from 81 schools in Michigan participated in an experiment in which they were randomly assigned to either a control or an experimental Web site. The experimental Web site provided exposure to educational material about the process of organ donation and organ transplantation. The control Web site provided…

Altered visual sensory fusion in children with reading difficulties.

PubMed

González-Castro, P; Rodríguez, C; Núñez, J C; Vallejo, G; González-Pienda, J A

2014-12-01

Reading is a multi-sensory and multi-cognitive task, and its difficulties (e.g., dyslexia) are not a unitary disorder. There are probably a variety of manifestations that relate to the actual site of impairment. A randomized, pre-test/post-test nonequivalent-groups design was conducted over 4 months with three groups aged between 6 and 8 years. One group comprised 76 participants (34 boys, 42 girls) with reading difficulties and altered sensory fusion (RD+ASF), a second group was made up of 123 students (59 boys, 64 girls) with reading difficulties but without altered sensory fusion (RD), and a third group comprised 81 participants (39 boys, 42 girls) who were young readers (RL) without reading delay, paired with the RD group on reading level. The experimental groups received intervention in the skills of control, stimulus recognition, and phonological awareness during a 4-month period. Both pre-test and post-test measures of errors in reading mechanics and reading routes (word and pseudo-word) were obtained. Poorer results in mechanics and reading routes of the RD+ASF group suggest that the effectiveness of the intervention depended on the characteristics of the groups and on the presence of sensory fusion deficits in the RD students.

Monitoring environmental impact in the Upper Sonoran Lifestyle: a new tool for rapid ecological assessment.

PubMed

Allen, Casey D

2009-02-01

Characterized by expensive housing, high socioeconomic status, and topographic relief, Upper Sonoran Lifestyle communities are found primarily along the Wildland-Urban Interface (WUI) in the Phoenix, Arizona metro area. Communities like these sprawl into the wildlands in the United States Southwest, creating a distinct urban fringe. This article, through locational comparison, introduces and evaluates a new field assessment tool for monitoring anthropogenic impact on soil-vegetation interactions along the well-maintained multi-use recreational trails in Upper Sonoran Lifestyle region. Comparing data from randomly selected transects along other multi-use trails with data from a control site revealed three key indicators of anthropogenic disturbances on soil-vegetation interactions: soil disturbance, vegetation disturbance, and vegetation density. Soil and vegetation disturbance displayed an average distance decay exponent factor of -0.60, while vegetation density displayed a reverse decay average of 0.60. Other important indicators of disturbance included vegetation type, biological soil crusts, and soil bulk density. The predictive ability of this new field tool enhances its applicability, offering a powerful rapid ecological assessment method for monitoring long-term anthropogenic impact in the Upper Sonoran Lifestyle, and other sprawling cities along the WUI.

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

PubMed

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

Healthy Children, Strong Families 2: a randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches

PubMed Central

Tomayko, Emily J; Prince, Ronald J; Cronin, Kate A; Parker, Tassy; Kim, KyungMann; Grant, Vernon M; Sheche, Judith N; Adams, Alexandra K

2017-01-01

Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 (HCSF2) is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of an RCT have been described. Methods HCSF2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two lesser-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyles intervention (Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group (Safety Journey) for one year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities’ request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons Learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities’ request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a two-year study. Conclusions This multi-site intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. HCSF2’s innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and lesser-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families. PMID:28064525

Effect of pre-operative octenidine nasal ointment and showering on surgical site infections in patients undergoing cardiac surgery.

PubMed

Reiser, M; Scherag, A; Forstner, C; Brunkhorst, F M; Harbarth, S; Doenst, T; Pletz, M W; Hagel, S

2017-02-01

To evaluate the effect of pre-operative octenidine (OCT) decolonization on surgical site infection (SSI) rates. Before-and-after cohort study. Patients undergoing an elective isolated coronary artery bypass graft (CABG) procedure: control group (1 st January to 31 st December 2013), N=475; intervention group (1 st January to 31 st December 2014), N=428. The intervention consisted of nasal application of OCT ointment three times daily, beginning on the day before surgery, and showering the night before and on the day of surgery with OCT soap. A median sternotomy was performed in 805 (89.1%) patients and a minimally invasive direct coronary artery bypass procedure was performed in 98 (10.9%) patients. Overall, there was no difference in SSI rates between the control and intervention groups (15.4% vs 13.3%, P=0.39). The rate of harvest site SSIs was significantly lower in patients in the intervention group (2.5% vs 0.5%, P=0.01). Patients who had undergone a median sternotomy in the intervention group had a significantly lower rate of organ/space sternal SSIs (1.9% vs 0.3%, P=0.04). However, there was a trend towards an increased rate of deep incisional sternal SSIs (1.2% vs 2.9%, P=0.08). Multi-variate analysis did not identify a significant protective effect of the intervention (odds ratio 0.79, 95% confidence interval 0.53-1.15, P=0.27). Pre-operative decolonization with OCT did not reduce overall SSI rates in patients undergoing an elective isolated CABG procedure, but significantly decreased harvest site and organ/space sternal SSIs. Randomized controlled trials, including controlled patient adherence to the intervention, are required to confirm these observations and to determine the clinical utility of OCT in pre-operative decolonization. Copyright © 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis.

PubMed

Tupasi, Thelma; Gupta, Rajesh; Danilovits, Manfred; Cirule, Andra; Sanchez-Garavito, Epifanio; Xiao, Heping; Cabrera-Rivero, Jose L; Vargas-Vasquez, Dante E; Gao, Mengqiu; Awad, Mohamed; Gentry, Leesa M; Geiter, Lawrence J; Wells, Charles D

2016-02-01

New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials. Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services. Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.

Effectiveness of multi-drug regimen chemotherapy treatment in osteosarcoma patients: a network meta-analysis of randomized controlled trials.

PubMed

Wang, Xiaojie; Zheng, Hong; Shou, Tao; Tang, Chunming; Miao, Kun; Wang, Ping

2017-03-29

Osteosarcoma is the most common malignant bone tumour. Due to the high metastasis rate and drug resistance of this disease, multi-drug regimens are necessary to control tumour cells at various stages of the cell cycle, eliminate local or distant micrometastases, and reduce the emergence of drug-resistant cells. Many adjuvant chemotherapy protocols have shown different efficacies and controversial results. Therefore, we classified the types of drugs used for adjuvant chemotherapy and evaluated the differences between single- and multi-drug chemotherapy regimens using network meta-analysis. We searched electronic databases, including PubMed (MEDLINE), EmBase, and the Cochrane Library, through November 2016 using the keywords "osteosarcoma", "osteogenic sarcoma", "chemotherapy", and "random*" without language restrictions. The major outcome in the present analysis was progression-free survival (PFS), and the secondary outcome was overall survival (OS). We used a random effect network meta-analysis for mixed multiple treatment comparisons. We included 23 articles assessing a total of 5742 patients in the present systematic review. The analysis of PFS indicated that the T12 protocol (including adriamycin, bleomycin, cyclophosphamide, dactinomycin, methotrexate, cisplatin) plays a more critical role in osteosarcoma treatment (surface under the cumulative ranking (SUCRA) probability 76.9%), with a better effect on prolonging the PFS of patients when combined with ifosfamide (94.1%) or vincristine (81.9%). For the analysis of OS, we separated the regimens to two groups, reflecting the disconnection. The T12 protocol plus vincristine (94.7%) or the removal of cisplatinum (89.4%) is most likely the best regimen. We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients, and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients, particularly in combination with ifosfamide or vincristine. The OS analysis showed that the T12 protocol plus vincristine or the T12 protocol with the removal of cisplatinum might be a better regimen for improving the OS of patients. However, well-designed randomized controlled trials of chemotherapeutic protocols are still necessary.

The investigation of social networks based on multi-component random graphs

NASA Astrophysics Data System (ADS)

Zadorozhnyi, V. N.; Yudin, E. B.

2018-01-01

The methods of non-homogeneous random graphs calibration are developed for social networks simulation. The graphs are calibrated by the degree distributions of the vertices and the edges. The mathematical foundation of the methods is formed by the theory of random graphs with the nonlinear preferential attachment rule and the theory of Erdôs-Rényi random graphs. In fact, well-calibrated network graph models and computer experiments with these models would help developers (owners) of the networks to predict their development correctly and to choose effective strategies for controlling network projects.

Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

PubMed

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

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. Web-based technical assistance with online training and resources may be a good investment when future funding is not ensured.

SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer.

PubMed

van Hazel, Guy A; Heinemann, Volker; Sharma, Navesh K; Findlay, Michael P N; Ricke, Jens; Peeters, Marc; Perez, David; Robinson, Bridget A; Strickland, Andrew H; Ferguson, Tom; Rodríguez, Javier; Kröning, Hendrik; Wolf, Ido; Ganju, Vinod; Walpole, Euan; Boucher, Eveline; Tichler, Thomas; Shacham-Shmueli, Einat; Powell, Alex; Eliadis, Paul; Isaacs, Richard; Price, David; Moeslein, Fred; Taieb, Julien; Bower, Geoff; Gebski, Val; Van Buskirk, Mark; Cade, David N; Thurston, Kenneth; Gibbs, Peter

2016-05-20

SIRFLOX was a randomized, multicenter trial designed to assess the efficacy and safety of adding selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres to standard fluorouracil, leucovorin, and oxaliplatin (FOLFOX)-based chemotherapy in patients with previously untreated metastatic colorectal cancer. Chemotherapy-naïve patients with liver metastases plus or minus limited extrahepatic metastases were randomly assigned to receive either modified FOLFOX (mFOLFOX6; control) or mFOLFOX6 plus SIRT (SIRT) plus or minus bevacizumab. The primary end point was progression-free survival (PFS) at any site as assessed by independent centralized radiology review blinded to study arm. Between October 2006 and April 2013, 530 patients were randomly assigned to treatment (control, 263; SIRT, 267). Median PFS at any site was 10.2 v 10.7 months in control versus SIRT (hazard ratio, 0.93; 95% CI, 0.77 to 1.12; P = .43). Median PFS in the liver by competing risk analysis was 12.6 v 20.5 months in control versus SIRT (hazard ratio, 0.69; 95% CI, 0.55 to 0.90; P = .002). Objective response rates (ORRs) at any site were similar (68.1% v 76.4% in control v SIRT; P = .113). ORR in the liver was improved with the addition of SIRT (68.8% v 78.7% in control v SIRT; P = .042). Grade ≥ 3 adverse events, including recognized SIRT-related effects, were reported in 73.4% and 85.4% of patients in control versus SIRT. The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liver-only metastatic colorectal cancer did not improve PFS at any site but significantly delayed disease progression in the liver. The safety profile was as expected and was consistent with previous studies. © 2016 by American Society of Clinical Oncology.

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.

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

PubMed

Montero-Odasso, Manuel; Almeida, Quincy J; Burhan, Amer M; Camicioli, Richard; Doyon, Julien; Fraser, Sarah; Li, Karen; Liu-Ambrose, Teresa; Middleton, Laura; Muir-Hunter, Susan; McIlroy, William; Morais, José A; Pieruccini-Faria, Frederico; Shoemaker, Kevin; Speechley, Mark; Vasudev, Akshya; Zou, G Y; Berryman, Nicolas; Lussier, Maxime; Vanderhaeghe, Leanne; Bherer, Louis

2018-04-16

Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study.

PubMed

Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Jones, Rachel A; Warren, Janet M; Cliff, Dylan P; Burrows, Tracy L; Colyvas, Kim; Steele, Julie R; Baur, Louise A

2010-09-01

To evaluate whether a child-centered physical activity program, combined with a parent-centered dietary program, was more efficacious than each treatment alone, in preventing unhealthy weight-gain in overweight children. An assessor-blinded randomized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children. Participants were randomly assigned to 1 of 3 interventions: a parent-centered dietary program (Diet); a child-centered physical activity program (Activity); or a combination of both (Diet+Activity). All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls. Analysis was by intention-to-treat. The primary outcome was change in body mass index z-score at 6 and 12 months (n=114 and 106, respectively). Body mass index z-scores were reduced at 12-months in all groups, with the Diet (mean [95% confidence interval]) (-0.39 [-0.51 to 0.27]) and Diet + Activity (-0.32, [-0.36, -0.23]) groups showing a greater reduction than the Activity group (-0.17 [-0.28, -0.06]) (P=.02). Changes in other outcomes (waist circumference and metabolic profile) were not statistically significant among groups. Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program, a parent-centered dietary program, or both. The greatest effect was achieved when a parent-centered dietary component was included. Copyright (c) 2010 Mosby, Inc. All rights reserved.

The Citicoline Brain Injury Treatment (COBRIT) Trial: Design and Methods

PubMed Central

Zafonte, Ross; Lee, Shing M.; Levin, Bruce; Diaz-Arrastia, Ramon; Ansel, Beth; Eisenberg, Howard; Timmons, Shelly D.; Temkin, Nancy; Novack, Thomas; Ricker, Joseph; Merchant, Randall; Jallo, Jack

2009-01-01

Abstract Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000 mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery. PMID:19803786

Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans.

PubMed

Lukach, Alexis J; Jedrziewski, M Kathryn; Grove, George A; Mechanic-Hamilton, Dawn J; Williams, Shardae S; Wollam, Mariegold E; Erickson, Kirk I

2016-05-01

The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65-75years) African Americans. Participants (n=80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. Copyright © 2016 Elsevier Inc. All rights reserved.

Rhythm experience and Africana culture trial (REACT!): A culturally salient intervention to promote neurocognitive health, mood, and well-being in older African Americans

PubMed Central

Lukach, Alexis J.; Jedrziewski, M. Kathryn; Grove, George A.; Mechanic-Hamilton, Dawn J.; Williams, Shardae S.; Wollam, Mariegold E.; Erickson, Kirk I.

2017-01-01

The Rhythm Experience and Africana Culture Trial (REACT!) is a multi-site randomized controlled intervention study designed to examine the efficacy of using African Dance as a form of moderate-intensity physical activity to improve cognitive function in older African Americans. African Americans are almost two times more likely than Caucasians to experience cognitive impairment in late adulthood. This increased risk may be attributed to lower level and quality of education, lower socioeconomic status, and higher prevalence of vascular diseases, type 2 diabetes, hypertension, and obesity, all of which are recognized as risk factors for dementia. Fortunately, interventions targeting cardiovascular health (i.e., physical activity) are associated with improved neurocognitive function and a reduced risk for dementia, so African Americans may be particularly suited for interventions targeting cardiovascular health and cognitive function. Here, we describe a randomized intervention protocol for increasing physical activity in older (65–75 years) African Americans. Participants (n = 80) at two study locations will be randomized into one of two groups. The treatment group will participate in African Dance three times per week for six months and the control group will receive educational training on Africana history and culture, as well as information about health behaviors, three times per week for six months. If successful, the REACT! study may transform community interventions and serve as a platform and model for testing other populations, age groups, and health outcomes, potentially identifying novel and creative methods for reducing or eliminating health disparities. PMID:27033674

A Randomized Trial Comparing Live and Telemedicine Delivery of an Imagery-based Behavioral Intervention for Breast Cancer Survivors: Reducing Symptoms and Barriers to Care

PubMed Central

Freeman, Lyn W.; White, Rebecca; Ratcliff, Chelsea G.; Sutton, Sue; Stewart, Mary; Palmer, J. Lynn; Link, Judith; Cohen, Lorenzo

2015-01-01

Objective This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled “Envision the Rhythms of Life” (ERL). Methods Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-hour group sessions at a community center with therapist present (live-delivery; LD, n=48); therapist streamed via telemedicine (telemedicine-delivery; TD, n=23); or to a waitlist control group (WL, n=47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1 and 3 months post-treatment including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. Results The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. LMM analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared to WL across the follow-up (p’s <0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. Conclusions Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared to a waitlist control. Further, there were no significant differences between live- and telemedicine-delivery, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. PMID:25146413

Classical Coset Hamiltonian for the Electronic Motion and its Application to Anderson Localization and Hammett Equation

NASA Astrophysics Data System (ADS)

Xing, Guan; Wu, Guo-Zhen

2001-02-01

A classical coset Hamiltonian is introduced for the system of one electron in multi-sites. By this Hamiltonian, the dynamical behaviour of the electronic motion can be readily simulated. The simulation reproduces the retardation of the electron density decay in a lattice with site energies randomly distributed - an analogy with Anderson localization. This algorithm is also applied to reproduce the Hammett equation which relates the reaction rate with the property of the substitutions in the organic chemical reactions. The advantages and shortcomings of this algorithm, as contrasted with traditional quantum methods such as the molecular orbital theory, are also discussed.

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…

Reading Profiles in Multi-Site Data With Missingness.

PubMed

Eckert, Mark A; Vaden, Kenneth I; Gebregziabher, Mulugeta

2018-01-01

Children with reading disability exhibit varied deficits in reading and cognitive abilities that contribute to their reading comprehension problems. Some children exhibit primary deficits in phonological processing, while others can exhibit deficits in oral language and executive functions that affect comprehension. This behavioral heterogeneity is problematic when missing data prevent the characterization of different reading profiles, which often occurs in retrospective data sharing initiatives without coordinated data collection. Here we show that reading profiles can be reliably identified based on Random Forest classification of incomplete behavioral datasets, after the missForest method is used to multiply impute missing values. Results from simulation analyses showed that reading profiles could be accurately classified across degrees of missingness (e.g., ∼5% classification error for 30% missingness across the sample). The application of missForest to a real multi-site dataset with missingness ( n = 924) showed that reading disability profiles significantly and consistently differed in reading and cognitive abilities for cases with and without missing data. The results of validation analyses indicated that the reading profiles (cases with and without missing data) exhibited significant differences for an independent set of behavioral variables that were not used to classify reading profiles. Together, the results show how multiple imputation can be applied to the classification of cases with missing data and can increase the integrity of results from multi-site open access datasets.

Sampled-Data Consensus of Linear Multi-agent Systems With Packet Losses.

PubMed

Zhang, Wenbing; Tang, Yang; Huang, Tingwen; Kurths, Jurgen

In this paper, the consensus problem is studied for a class of multi-agent systems with sampled data and packet losses, where random and deterministic packet losses are considered, respectively. For random packet losses, a Bernoulli-distributed white sequence is used to describe packet dropouts among agents in a stochastic way. For deterministic packet losses, a switched system with stable and unstable subsystems is employed to model packet dropouts in a deterministic way. The purpose of this paper is to derive consensus criteria, such that linear multi-agent systems with sampled-data and packet losses can reach consensus. By means of the Lyapunov function approach and the decomposition method, the design problem of a distributed controller is solved in terms of convex optimization. The interplay among the allowable bound of the sampling interval, the probability of random packet losses, and the rate of deterministic packet losses are explicitly derived to characterize consensus conditions. The obtained criteria are closely related to the maximum eigenvalue of the Laplacian matrix versus the second minimum eigenvalue of the Laplacian matrix, which reveals the intrinsic effect of communication topologies on consensus performance. Finally, simulations are given to show the effectiveness of the proposed results.In this paper, the consensus problem is studied for a class of multi-agent systems with sampled data and packet losses, where random and deterministic packet losses are considered, respectively. For random packet losses, a Bernoulli-distributed white sequence is used to describe packet dropouts among agents in a stochastic way. For deterministic packet losses, a switched system with stable and unstable subsystems is employed to model packet dropouts in a deterministic way. The purpose of this paper is to derive consensus criteria, such that linear multi-agent systems with sampled-data and packet losses can reach consensus. By means of the Lyapunov function approach and the decomposition method, the design problem of a distributed controller is solved in terms of convex optimization. The interplay among the allowable bound of the sampling interval, the probability of random packet losses, and the rate of deterministic packet losses are explicitly derived to characterize consensus conditions. The obtained criteria are closely related to the maximum eigenvalue of the Laplacian matrix versus the second minimum eigenvalue of the Laplacian matrix, which reveals the intrinsic effect of communication topologies on consensus performance. Finally, simulations are given to show the effectiveness of the proposed results.

Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs)

PubMed Central

Kernan, W N.; Viscoli, C M.; DeMarco, D; Mendes, B; Shrauger, K; Schindler, J L.; McVeety, J C.; Sicklick, A; Moalli, D; Greco, P; Bravata, D M.; Eisen, S; Resor, L; Sena, K; Story, D; Brass, L M.; Furie, K L.; Gutmann, L; Hinnau, E; Gorman, M; Lovejoy, A M.; Inzucchi, S E.; Young, L H.; Horwitz, R I.

2009-01-01

Objective: Our purpose was to develop a geographically localized, multi-institution strategy for improving enrolment in a trial of secondary stroke prevention. Methods: We invited 11 Connecticut hospitals to participate in a project named the Local Identification and Outreach Network (LION). Each hospital provided the names of patients with stroke or TIA, identified from electronic admission or discharge logs, to researchers at a central coordinating center. After obtaining permission from personal physicians, researchers contacted each patient to describe the study, screen for eligibility, and set up a home visit for consent. Researchers traveled throughout the state to enroll and follow participants. Outside the LION, investigators identified trial participants using conventional recruitment strategies. We compared recruitment success for the LION and other sites using data from January 1, 2005, through June 30, 2007. Results: The average monthly randomization rate from the LION was 4.0 participants, compared with 0.46 at 104 other Insulin Resistance Intervention after Stroke (IRIS) sites. The LION randomized on average 1.52/1,000 beds/month, compared with 0.76/1,000 beds/month at other IRIS sites (p = 0.03). The average cost to randomize and follow one participant was $8,697 for the LION, compared with $7,198 for other sites. Conclusion: A geographically based network of institutions, served by a central coordinating center, randomized substantially more patients per month compared with sites outside of the network. The high enrollment rate was a result of surveillance at multiple institutions and greater productivity at each institution. Although the cost per patient was higher for the network, compared with nonnetwork sites, cost savings could result from more rapid completion of research. GLOSSARY BMI = body mass index; HIPAA = Health Insurance Portability and Accountability Act; HOMA = homeostastis model assessment of insulin resistance; ICD-9 = International Classification of Diseases, 9th Revision; IRB = institutional review board; IRIS = Insulin Resistance Intervention after Stroke; LION = Local Identification and Outreach Network. PMID:19365056

Efficacy of a single late-dormant application of mineral oil plus chlorothalonil for control of peach scab, caused by Venturia carpophila

USDA-ARS?s Scientific Manuscript database

Peach scab, caused by Venturia carpophila, is a major disease of peach across the southeastern United States. In multi-year, multi-site field trials, mineral oil plus chlorothalonil late-dormant treatments suppressed both scab incidence and severity, as previously reported for almond scab in Califor...

Comparison of applying particulate demineralized bone matrix (DBM), putty DBM and open flap debridement in periodontal horizontal bone defects. A 12-month longitudinal, multi-centre, triple-blind, split-mouth, randomized, controlled clinical study. Part 2 - evaluation of the interdental soft tissue.

PubMed

Kaya, Y; Yalim, M; Bahçecitapar, M; Baloş, K

2009-07-01

To date, there have been many studies clinically evaluating periodontal regenerative procedures by the help of routinely used hard and soft tissue parameters; however, these parameters are not capable of assessing interdental soft tissue located above the regenerative periodontal surgery area. The purpose of this study was to assess interproximal soft tissue changes following application of (i) particulate form demineralized bone matrix (DBM), (ii) putty form DBM and (ii) open flap debridement (OFD, control), using modified curtain technique in the treatment of interproximal suprabony (horizontal) defects located in anterior maxillary region, as previously reported. Twenty-five chronic periodontitis patients with 125 interproximal surgery sites (radiologically >or=4 mm horizontal bone defect) were also participate in this second stage of the triple-blind, split mouth, randomized, controlled clinical trial. Surgery sites were assessed by (i) plaque index (PI), (ii) gingival index (GI), (iii) the presence of interdental soft tissue clefts or craters and (iv) the loss of interdental papilla height by using papilla presence index (PPI), during the healing period. At the baseline and 3, 6, 9 and 12 months after the operations, these measurements were repeated. In all groups, there is a significant increase in the prevalence of soft tissue cleft and crater formation (P < 0.01), with increase in PI and GI scores at interdental soft tissue defect areas (P < 0.001), 3 months after the operations. There was also an increase in PPI scores after the operations in all treatment groups (P < 0.01). Three procedures affected the interproximal soft tissues similarly. There was no significant difference among groups in terms of all parameters (P > 0.05). Particulate DBM, putty DBM and OFD demostrated similar interproximal soft tissue changes especially increasing interproximal PI and GI scores in 3 months follow-up.

A Conductometric Indium Oxide Semiconducting Nanoparticle Enzymatic Biosensor Array

PubMed Central

Lee, Dongjin; Ondrake, Janet; Cui, Tianhong

2011-01-01

We report a conductometric nanoparticle biosensor array to address the significant variation of electrical property in nanomaterial biosensors due to the random network nature of nanoparticle thin-film. Indium oxide and silica nanoparticles (SNP) are assembled selectively on the multi-site channel area of the resistors using layer-by-layer self-assembly. To demonstrate enzymatic biosensing capability, glucose oxidase is immobilized on the SNP layer for glucose detection. The packaged sensor chip onto a ceramic pin grid array is tested using syringe pump driven feed and multi-channel I–V measurement system. It is successfully demonstrated that glucose is detected in many different sensing sites within a chip, leading to concentration dependent currents. The sensitivity has been found to be dependent on the channel length of the resistor, 4–12 nA/mM for channel lengths of 5–20 μm, while the apparent Michaelis-Menten constant is 20 mM. By using sensor array, analytical data could be obtained with a single step of sample solution feeding. This work sheds light on the applicability of the developed nanoparticle microsensor array to multi-analyte sensors, novel bioassay platforms, and sensing components in a lab-on-a-chip. PMID:22163696

Designing minimal space telerobotics systems for maximum performance

NASA Technical Reports Server (NTRS)

Backes, Paul G.; Long, Mark K.; Steele, Robert D.

1992-01-01

The design of the remote site of a local-remote telerobot control system is described which addresses the constraints of limited computational power available at the remote site control system while providing a large range of control capabilities. The Modular Telerobot Task Execution System (MOTES) provides supervised autonomous control, shared control and teleoperation for a redundant manipulator. The system is capable of nominal task execution as well as monitoring and reflex motion. The MOTES system is minimized while providing a large capability by limiting its functionality to only that which is necessary at the remote site and by utilizing a unified multi-sensor based impedance control scheme. A command interpreter similar to one used on robotic spacecraft is used to interpret commands received from the local site. The system is written in Ada and runs in a VME environment on 68020 processors and initially controls a Robotics Research K1207 7 degree of freedom manipulator.

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.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.

PubMed

Gareen, Ilana F; Sicks, JoRean D; Jain, Amanda Adams; Moline, Denise; Coffman-Kadish, Nancy

2013-01-01

In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. Copyright © 2012 Elsevier Inc. All rights reserved.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: The model used by the American College of Radiology arm of the National Lung Screening Trial

PubMed Central

Gareen, Ilana F.; Sicks, JoRean; Adams, Amanda; Moline, Denise; Coffman-Kadish, Nancy

2012-01-01

Background In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. Methods The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Results Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. Conclusions We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. PMID:22982342

Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

PubMed

Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

2015-07-10

CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards. Using an occupational health and safety risk assessment and control framework, Sun Safety at Work Canada will support workplaces to assess their exposure risks, implement control strategies that build on their existing programs, and embed the controls into their existing occupational health and safety system.

MultiBLUP: improved SNP-based prediction for complex traits.

PubMed

Speed, Doug; Balding, David J

2014-09-01

BLUP (best linear unbiased prediction) is widely used to predict complex traits in plant and animal breeding, and increasingly in human genetics. The BLUP mathematical model, which consists of a single random effect term, was adequate when kinships were measured from pedigrees. However, when genome-wide SNPs are used to measure kinships, the BLUP model implicitly assumes that all SNPs have the same effect-size distribution, which is a severe and unnecessary limitation. We propose MultiBLUP, which extends the BLUP model to include multiple random effects, allowing greatly improved prediction when the random effects correspond to classes of SNPs with distinct effect-size variances. The SNP classes can be specified in advance, for example, based on SNP functional annotations, and we also provide an adaptive procedure for determining a suitable partition of SNPs. We apply MultiBLUP to genome-wide association data from the Wellcome Trust Case Control Consortium (seven diseases), and from much larger studies of celiac disease and inflammatory bowel disease, finding that it consistently provides better prediction than alternative methods. Moreover, MultiBLUP is computationally very efficient; for the largest data set, which includes 12,678 individuals and 1.5 M SNPs, the total analysis can be run on a single desktop PC in less than a day and can be parallelized to run even faster. Tools to perform MultiBLUP are freely available in our software LDAK. © 2014 Speed and Balding; Published by Cold Spring Harbor Laboratory Press.

75 FR 58395 - Agency Information Collection Activities: Proposed Collection: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-24

... Technology Planning Grants, Electronic Health Record Implementation Health Center Controlled Networks, Health... Records Implementation for Health Center Controlled Networks and Large Multi Site Health Centers. In order... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency...

Resolving controversies in hip fracture care: the need for large collaborative trials in hip fractures.

PubMed

Bhandari, Mohit; Sprague, Sheila; Schemitsch, Emil H

2009-07-01

Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicate the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip fractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Opportunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

Managing salinity in Upper Colorado River Basin streams: Selecting catchments for sediment control efforts using watershed characteristics and random forests models

USGS Publications Warehouse

Tillman, Fred; Anning, David W.; Heilman, Julian A.; Buto, Susan G.; Miller, Matthew P.

2018-01-01

Elevated concentrations of dissolved-solids (salinity) including calcium, sodium, sulfate, and chloride, among others, in the Colorado River cause substantial problems for its water users. Previous efforts to reduce dissolved solids in upper Colorado River basin (UCRB) streams often focused on reducing suspended-sediment transport to streams, but few studies have investigated the relationship between suspended sediment and salinity, or evaluated which watershed characteristics might be associated with this relationship. Are there catchment properties that may help in identifying areas where control of suspended sediment will also reduce salinity transport to streams? A random forests classification analysis was performed on topographic, climate, land cover, geology, rock chemistry, soil, and hydrologic information in 163 UCRB catchments. Two random forests models were developed in this study: one for exploring stream and catchment characteristics associated with stream sites where dissolved solids increase with increasing suspended-sediment concentration, and the other for predicting where these sites are located in unmonitored reaches. Results of variable importance from the exploratory random forests models indicate that no simple source, geochemical process, or transport mechanism can easily explain the relationship between dissolved solids and suspended sediment concentrations at UCRB monitoring sites. Among the most important watershed characteristics in both models were measures of soil hydraulic conductivity, soil erodibility, minimum catchment elevation, catchment area, and the silt component of soil in the catchment. Predictions at key locations in the basin were combined with observations from selected monitoring sites, and presented in map-form to give a complete understanding of where catchment sediment control practices would also benefit control of dissolved solids in streams.

Balance training with multi-task exercises improves fall-related self-efficacy, gait, balance performance and physical function in older adults with osteoporosis: a randomized controlled trial.

PubMed

Halvarsson, Alexandra; Franzén, Erika; Ståhle, Agneta

2015-04-01

To evaluate the effects of a balance training program including dual- and multi-task exercises on fall-related self-efficacy, fear of falling, gait and balance performance, and physical function in older adults with osteoporosis with an increased risk of falling and to evaluate whether additional physical activity would further improve the effects. Randomized controlled trial, including three groups: two intervention groups (Training, or Training+Physical activity) and one Control group, with a 12-week follow-up. Stockholm County, Sweden. Ninety-six older adults, aged 66-87, with verified osteoporosis. A specific and progressive balance training program including dual- and multi-task three times/week for 12 weeks, and physical activity for 30 minutes, three times/week. Fall-related self-efficacy (Falls Efficacy Scale-International), fear of falling (single-item question - 'In general, are you afraid of falling?'), gait speed with and without a cognitive dual-task at preferred pace and fast walking (GAITRite®), balance performance tests (one-leg stance, and modified figure of eight), and physical function (Late-Life Function and Disability Instrument). Both intervention groups significantly improved their fall-related self-efficacy as compared to the controls (p ≤ 0.034, 4 points) and improved their balance performance. Significant differences over time and between groups in favour of the intervention groups were found for walking speed with a dual-task (p=0.003), at fast walking speed (p=0.008), and for advanced lower extremity physical function (p=0.034). This balance training program, including dual- and multi-task, improves fall-related self-efficacy, gait speed, balance performance, and physical function in older adults with osteoporosis. © The Author(s) 2014.

MRIQC: Advancing the automatic prediction of image quality in MRI from unseen sites

PubMed Central

2017-01-01

Quality control of MRI is essential for excluding problematic acquisitions and avoiding bias in subsequent image processing and analysis. Visual inspection is subjective and impractical for large scale datasets. Although automated quality assessments have been demonstrated on single-site datasets, it is unclear that solutions can generalize to unseen data acquired at new sites. Here, we introduce the MRI Quality Control tool (MRIQC), a tool for extracting quality measures and fitting a binary (accept/exclude) classifier. Our tool can be run both locally and as a free online service via the OpenNeuro.org portal. The classifier is trained on a publicly available, multi-site dataset (17 sites, N = 1102). We perform model selection evaluating different normalization and feature exclusion approaches aimed at maximizing across-site generalization and estimate an accuracy of 76%±13% on new sites, using leave-one-site-out cross-validation. We confirm that result on a held-out dataset (2 sites, N = 265) also obtaining a 76% accuracy. Even though the performance of the trained classifier is statistically above chance, we show that it is susceptible to site effects and unable to account for artifacts specific to new sites. MRIQC performs with high accuracy in intra-site prediction, but performance on unseen sites leaves space for improvement which might require more labeled data and new approaches to the between-site variability. Overcoming these limitations is crucial for a more objective quality assessment of neuroimaging data, and to enable the analysis of extremely large and multi-site samples. PMID:28945803

Multi-step resistive switching behavior of Li-doped ZnO resistance random access memory device controlled by compliance current

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

Lin, Chun-Cheng; Department of Mathematic and Physical Sciences, R.O.C. Air Force Academy, Kaohsiung 820, Taiwan; Tang, Jian-Fu

2016-06-28

The multi-step resistive switching (RS) behavior of a unipolar Pt/Li{sub 0.06}Zn{sub 0.94}O/Pt resistive random access memory (RRAM) device is investigated. It is found that the RRAM device exhibits normal, 2-, 3-, and 4-step RESET behaviors under different compliance currents. The transport mechanism within the device is investigated by means of current-voltage curves, in-situ transmission electron microscopy, and electrochemical impedance spectroscopy. It is shown that the ion transport mechanism is dominated by Ohmic behavior under low electric fields and the Poole-Frenkel emission effect (normal RS behavior) or Li{sup +} ion diffusion (2-, 3-, and 4-step RESET behaviors) under high electric fields.

Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10-School Randomized Controlled Trial.

PubMed

Ockene, Judith K; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Jolicoeur, Denise G; Murray, David M; Shoben, Abigail B; David, Sean P; Ferguson, Kristi J; Huggett, Kathryn N; Adams, Michael; Okuliar, Catherine A; Gross, Robin L; Bass, Pat F; Greenberg, Ruth B; Leone, Frank T; Okuyemi, Kola S; Rudy, David W; Waugh, Jonathan B; Geller, Alan C

2016-02-01

Early in medical education, physicians must develop competencies needed for tobacco dependence treatment. To assess the effect of a multi-modal tobacco dependence treatment curriculum on medical students' counseling skills. A group-randomized controlled trial (2010-2014) included ten U.S. medical schools that were randomized to receive either multi-modal tobacco treatment education (MME) or traditional tobacco treatment education (TE). Students from the classes of 2012 and 2014 at ten medical schools participated. Students from the class of 2012 (N = 1345) completed objective structured clinical examinations (OSCEs), and 50 % (N = 660) were randomly selected for pre-intervention evaluation. A total of 72.9 % of eligible students (N = 1096) from the class of 2014 completed an OSCE and 69.7 % (N = 1047) completed pre and post surveys. The MME included a Web-based course, a role-play classroom demonstration, and a clerkship booster session. Clerkship preceptors in MME schools participated in an academic detailing module and were encouraged to be role models for third-year students. The primary outcome was student tobacco treatment skills using the 5As measured by an objective structured clinical examination (OSCE) scored on a 33-item behavior checklist. Secondary outcomes were student self-reported skills for performing 5As and pharmacotherapy counseling. Although the difference was not statistically significant, MME students completed more tobacco counseling behaviors on the OSCE checklist (mean 8.7 [SE 0.6] vs. mean 8.0 [SE 0.6], p = 0.52) than TE students. Several of the individual Assist and Arrange items were significantly more likely to have been completed by MME students, including suggesting behavioral strategies (11.8 % vs. 4.5 %, p < 0.001) and providing information regarding quitline (21.0 % vs. 3.8 %, p < 0.001). MME students reported higher self-efficacy for Assist, Arrange, and Pharmacotherapy counseling items (ps ≤0.05). Inclusion of only ten schools limits generalizability. Subsequent interventions should incorporate lessons learned from this first randomized controlled trial of a multi-modal longitudinal tobacco treatment curriculum in multiple U.S. medical schools. NIH Trial Registry Number: NCT01905618.

System architecture for asynchronous multi-processor robotic control system

NASA Technical Reports Server (NTRS)

Steele, Robert D.; Long, Mark; Backes, Paul

1993-01-01

The architecture for the Modular Telerobot Task Execution System (MOTES) as implemented in the Supervisory Telerobotics (STELER) Laboratory is described. MOTES is the software component of the remote site of a local-remote telerobotic system which is being developed for NASA for space applications, in particular Space Station Freedom applications. The system is being developed to provide control and supervised autonomous control to support both space based operation and ground-remote control with time delay. The local-remote architecture places task planning responsibilities at the local site and task execution responsibilities at the remote site. This separation allows the remote site to be designed to optimize task execution capability within a limited computational environment such as is expected in flight systems. The local site task planning system could be placed on the ground where few computational limitations are expected. MOTES is written in the Ada programming language for a multiprocessor environment.

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut.

PubMed

Ciesinski, Lisa; Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9-30.2% multi-resistant E. coli compared to 5.8-14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters.

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut

PubMed Central

Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H.

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9–30.2% multi-resistant E. coli compared to 5.8–14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters. PMID:29373597

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

PubMed

Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

2014-11-01

Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Interpersonal art psychotherapy for the treatment of aggression in people with learning disabilities in secure care: a protocol for a randomised controlled feasibility study.

PubMed

Hackett, Simon S; Taylor, John L; Freeston, Mark; Jahoda, Andrew; McColl, Elaine; Pennington, Lindsay; Kaner, Eileen

2017-01-01

Art psychotherapy has greater potential for use with adults with mild to moderate learning disabilities as it places less of a burden on verbal interaction to achieve positive therapeutic, psychological, and behavioural goals. The feasibility study objectives include testing procedures, outcomes, validated tools, recruitment and attrition rates, acceptability, and treatment fidelity for manualised interpersonal art psychotherapy. Adult males and females with mild to moderate learning disabilities will be recruited from four NHS secure hospitals. Twenty patients will be recruited and randomly assigned to one of two treatment groups: fifteen 1-h individual sessions of manualised interpersonal art psychotherapy, or a treatment as usual waiting list control group. The Modified Overt Aggression Scale will be administered to both treatment arms. Four patients will be recruited to a single-case design component of the study exploring the acceptability of an attentional condition. This multi-site study will assist in future trial planning and inform feasibility including, procedures, treatment acceptability, therapist adherence, and estimation of samples size for a definitive RCT.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial

PubMed Central

Imam, Bita; Finlayson, Heather C; Eng, Janice J; Payne, Michael WC; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-01-01

Background The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed “Wii.n.Walk”, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants’ homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks’ duration. The primary outcome measure will be the “Two-Minute Walk Test” to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). PMID:25533902

Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial.

PubMed

Wang, Jing; Coleman, Deidra Carroll; Kanter, Justin; Ummer, Brad; Siminerio, Linda

2018-04-02

Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association-recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A 1c levels, weight, and the usability of the connected system. An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5). ©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.

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 .

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia.

PubMed

Vallila-Rohter, Sofia; Kiran, Swathi

2015-08-01

Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive-linguistic assessments. Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities.

Efficacy of the oral pentavalent rotavirus vaccine in Mali.

PubMed

Sow, Samba O; Tapia, Milagritos; Haidara, Fadima C; Ciarlet, Max; Diallo, Fatoumata; Kodio, Mamoudou; Doumbia, Moussa; Dembélé, Rokiatou D; Traoré, Oumou; Onwuchekwa, Uma U; Lewis, Kristen D C; Victor, John C; Steele, A Duncan; Neuzil, Kathleen M; Kotloff, Karen L; Levine, Myron M

2012-04-27

The oral, pentavalent rotavirus vaccine (PRV), RotaTeq was assessed for prevention of severe rotavirus gastroenteritis (RVGE) in young children in two multi-site, randomized, placebo-controlled field trials; one in Asia (Vietnam and Bangladesh) and the other in sub-Saharan Africa (Ghana, Kenya and Mali). The efficacy results for the Mali site of the multi-country trial are presented here. We randomly assigned infants in a 1:1 ratio to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age. Gastroenteritis episodes were captured passively at the local health centers and by home visits. The primary study outcome was severe RVGE, as defined by a score of ≥ 11 using the Vesikari Clinical Scoring System occurring ≥ 14 days after the third dose until the end of the study. Other efficacy analyses included efficacy against severe RVGE through the first year and during the second years of life, as well as efficacy after receiving at least one dose of vaccine. In total, 1960 infants were enrolled in the trial at the Mali site and sera were collected on a subset of infants (approximately 150) for immunogenicity testing. In the first year of follow-up, largely due to cultural practices to visit traditional healers as the first point of care, the point estimate of efficacy was unreliable: the per protocol vaccine efficacy against severe RVGE was 1% (95% confidence interval [CI]: -431.7, 81.6); the intention-to-treat vaccine efficacy was 42.9% (95% CI: -125.7, 87.7). During the second year of follow-up, after the surveillance system was modified to adapt to local customs and health care seeking practices, the point estimate of per-protocol vaccine efficacy was 19.2% (95% CI: -23.1,47.3%). 82.5% of Malian infants (95% CI: 70.1,91.3%) who received PRV mounted a seroresponse (≥ 3-fold rise from baseline (prevaccination) to post-dose 3 vaccination) of anti-rotavirus immunoglobulin A antibody, with a post third-dose geometric mean titer (GMT) of 31.3 units/mL. By contrast, only 20.0% of placebo recipients (95% CI: 10.0, 33.7%) developed a seroresponse and the post-third dose GMT was 3.2 units/mL. None of the serious clinical adverse events observed were considered to be vaccine-related. Copyright © 2011 Elsevier Ltd. All rights reserved.

Human intrabony defect regeneration with micro-grafts containing dental pulp stem cells: A randomized controlled clinical trial.

PubMed

Ferrarotti, Francesco; Romano, Federica; Gamba, Mara Noemi; Quirico, Andrea; Giraudi, Marta; Audagna, Martina; Aimetti, Mario

2018-05-19

The goal of this study was to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration. In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively. Test sites exhibited significantly more PD reduction (4.9 mm versus 3.4 mm), CAL gain (4.5 versus 2.9 mm) and bone defect fill (3.9 versus 1.6 mm) than controls. Moreover, residual PD < 5 mm (93% versus 50%) and CAL gain ≥ 4 mm (73% versus 29%) was significantly more frequent in the test group. Application of DPSCs significantly improved clinical parameters of periodontal regeneration one year after treatment. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A multi-landing pad DNA integration platform for mammalian cell engineering

PubMed Central

Gaidukov, Leonid; Wroblewska, Liliana; Teague, Brian; Nelson, Tom; Zhang, Xin; Liu, Yan; Jagtap, Kalpana; Mamo, Selamawit; Tseng, Wen Allen; Lowe, Alexis; Das, Jishnu; Bandara, Kalpanie; Baijuraj, Swetha; Summers, Nevin M; Zhang, Lin; Weiss, Ron

2018-01-01

Abstract Engineering mammalian cell lines that stably express many transgenes requires the precise insertion of large amounts of heterologous DNA into well-characterized genomic loci, but current methods are limited. To facilitate reliable large-scale engineering of CHO cells, we identified 21 novel genomic sites that supported stable long-term expression of transgenes, and then constructed cell lines containing one, two or three ‘landing pad’ recombination sites at selected loci. By using a highly efficient BxB1 recombinase along with different selection markers at each site, we directed recombinase-mediated insertion of heterologous DNA to selected sites, including targeting all three with a single transfection. We used this method to controllably integrate up to nine copies of a monoclonal antibody, representing about 100 kb of heterologous DNA in 21 transcriptional units. Because the integration was targeted to pre-validated loci, recombinant protein expression remained stable for weeks and additional copies of the antibody cassette in the integrated payload resulted in a linear increase in antibody expression. Overall, this multi-copy site-specific integration platform allows for controllable and reproducible insertion of large amounts of DNA into stable genomic sites, which has broad applications for mammalian synthetic biology, recombinant protein production and biomanufacturing. PMID:29617873

Overweight is a risk factor for surgical site infection following distal gastrectomy for gastric cancer.

PubMed

Hirao, Motohiro; Tsujinaka, Toshimasa; Imamura, Hiroshi; Kurokawa, Yukinori; Inoue, Kentaro; Kimura, Yutaka; Shimokawa, Toshio; Furukawa, Hiroshi

2013-04-01

Our objective was to assess the risk factors for surgical site infections (SSIs) in gastric surgery using the results of the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) 0501 phase 3 trial. The OGSG 0501 trial was conducted to compare standard prophylactic antibiotic administration versus extended prophylactic antibiotic administration in 355 patients who underwent open distal gastrectomy for gastric cancer. Various risk factors associated with the incidence of SSI following gastrectomy were analyzed from the results of this multi-institutional randomized controlled trial. Among the 355 patients, there were 24 SSIs, for an overall SSI rate of 7 %. Multivariate analysis using eight baseline factors (administration of antibiotics, age, sex, body mass index [BMI], prognostic nutritional index, tumor stage, lymph node dissection, reconstructive method) identified that BMI ≥ 25 kg/m(2) was an independent risk factor for the occurrence of SSI (odds ratio 2.82; 95 % confidence interval [CI] 1.05-7.52; P = 0.049). BMI also showed significant relationships with the volume of blood loss and the operation time (P = 0.001 and P < 0.001, respectively). Compared with patients of normal weight, overweight patients had a significantly higher risk of SSI after distal gastrectomy for cancer.

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

PubMed

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled Trials ISRCTN19287682 , 21 December 2012.

Utilization of Herbicide Concentration/Exposure Time Relationships for Controlling Submersed Invasive Plants on Lake Gaston, Virginia/North Carolina

DTIC Science & Technology

2011-06-01

of efficacy in controlling invasive plant species, and are verified in aquatic and wetland field sites throughout the US. This multi-tiered...localized treatment sites, moving or still water. Chlorosis of stems and leaves with plant death in 7-10 days. 2,4-D 3 DMA liquid, BEE salt...with Eurasian watermilfoil. Formulations include a liquid dimethyl amine (DMA) and a granular clay butoxyethanol ester ( BEE ). Current Evaluations

Effect of randomness on multi-frequency aeroelastic responses resolved by Unsteady Adaptive Stochastic Finite Elements

NASA Astrophysics Data System (ADS)

Witteveen, Jeroen A. S.; Bijl, Hester

2009-10-01

The Unsteady Adaptive Stochastic Finite Elements (UASFE) method resolves the effect of randomness in numerical simulations of single-mode aeroelastic responses with a constant accuracy in time for a constant number of samples. In this paper, the UASFE framework is extended to multi-frequency responses and continuous structures by employing a wavelet decomposition pre-processing step to decompose the sampled multi-frequency signals into single-frequency components. The effect of the randomness on the multi-frequency response is then obtained by summing the results of the UASFE interpolation at constant phase for the different frequency components. Results for multi-frequency responses and continuous structures show a three orders of magnitude reduction of computational costs compared to crude Monte Carlo simulations in a harmonically forced oscillator, a flutter panel problem, and the three-dimensional transonic AGARD 445.6 wing aeroelastic benchmark subject to random fields and random parameters with various probability distributions.

How Can Multi-Site Evaluations Be Participatory?

ERIC Educational Resources Information Center

Lawrenz, Frances; Huffman, Douglas

2003-01-01

Multi-site evaluations are becoming increasingly common in federal funding portfolios. Although much thought has been given to multi-site evaluation, there has been little emphasis on how it might interact with participatory evaluation. Therefore, this paper reviews several National Science Foundation educational, multi-site evaluations for the…

Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries.

PubMed

Shen, Ye; King, Charles H; Binder, Sue; Zhang, Feng; Whalen, Christopher C; Evan Secor, W; Montgomery, Susan P; Mwinzi, Pauline N M; Olsen, Annette; Magnussen, Pascal; Kinung'hi, Safari; Phillips, Anna E; Nalá, Rassul; Ferro, Josefo; Aurelio, H Osvaldo; Fleming, Fiona; Garba, Amadou; Hamidou, Amina; Fenwick, Alan; Campbell, Carl H; Colley, Daniel G

2017-09-29

The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) focus is on randomized trials of different approaches to mass drug administration (MDA) in endemic countries in Africa. Because their studies provided an opportunity to evaluate the effects of mass treatment on Schistosoma-associated morbidity, nested cohort studies were developed within SCORE's intervention trials to monitor changes in a suite of schistosomiasis disease outcomes. This paper describes the process SCORE used to select markers for prospective monitoring and the baseline prevalence of these morbidities in four parallel cohort studies. In July 2009, SCORE hosted a discussion of the potential impact of MDA on morbidities due to Schistosoma infection that might be measured in the context of multi-year control. Candidate markers were reviewed and selected for study implementation. Baseline data were then collected from cohorts of children in four country studies: two in high endemic S. mansoni sites (Kenya and Tanzania), and two in high endemic S. haematobium sites (Niger and Mozambique), these cohorts to be followed prospectively over 5 years. At baseline, 62% of children in the S. mansoni sites had detectable eggs in their stool, and 10% had heavy infections (≥ 400 eggs/g feces). Heavy S. mansoni infections were found to be associated with increased baseline risk of anemia, although children with moderate or heavy intensity infections had lower risk of physical wasting. Prevalence of egg-positive infection in the combined S. haematobium cohorts was 27%, with 5% of individuals having heavy infection (≥50 eggs/10 mL urine). At baseline, light intensity S. haematobium infection was associated with anemia and with lower scores in the social domain of health-related quality-of-life (HRQoL) assessed by Pediatric Quality of Life Inventory. Our consensus on practical markers of Schistosoma-associated morbidity indicated that height, weight, hemoglobin, exercise tolerance, HRQoL, and ultrasound abnormalities could be used as reference points for gauging treatment impact. Data collected over five years of program implementation will provide guidance for future evaluation of morbidity control in areas endemic for schistosomiasis. These cohort studies are registered and performed in conjunction with the International Standard Randomised Controlled Trial Registry trials ISRCTN16755535 , ISRCTN14117624 , ISRCTN95819193 , and ISRCTN32045736 .

Hybrid Solution of Stochastic Optimal Control Problems Using Gauss Pseudospectral Method and Generalized Polynomial Chaos Algorithms

DTIC Science & Technology

2012-03-01

0-486-41183-4. 15. Brown , Robert G. and Patrick Y. C. Hwang . Introduction to Random Signals and Applied Kalman Filtering. Wiley, New York, 1996. ISBN...stability and perfor- mance criteria. In the 1960’s, Kalman introduced the Linear Quadratic Regulator (LQR) method using an integral performance index...feedback of the state variables and was able to apply this method to time-varying and Multi-Input Multi-Output (MIMO) systems. Kalman further showed

Development of a Multi-Target Contingency Management Intervention for HIV Positive Substance Users.

PubMed

Stitzer, Maxine; Calsyn, Donald; Matheson, Timothy; Sorensen, James; Gooden, Lauren; Metsch, Lisa

2017-01-01

Contingency management (CM) interventions generally target a single behavior such as attendance or drug use. However, disease outcomes are mediated by complex chains of both healthy and interfering behaviors enacted over extended periods of time. This paper describes a novel multi-target contingency management (CM) program developed for use with HIV positive substance users enrolled in a CTN multi-site study (0049 Project HOPE). Participants were randomly assigned to usual care (referral to health care and SUD treatment) or 6-months strength-based patient navigation interventions with (PN+CM) or without (PN only) the CM program. Primary outcome of the trial was viral load suppression at 12-months post-randomization. Up to $1160 could be earned over 6 months under escalating schedules of reinforcement. Earnings were divided among eight CM targets; two PN-related (PN visits; paperwork completion; 26% of possible earnings), four health-related (HIV care visits, lab blood draw visits, medication check, viral load suppression; 47% of possible earnings) and two drug-use abatement (treatment entry; submission of drug negative UAs; 27% of earnings). The paper describes rationale for selection of targets, pay amounts and pay schedules. The CM program was compatible with and fully integrated into the PN intervention. The study design will allow comparison of behavioral and health outcomes for participants receiving PN with and without CM; results will inform future multi-target CM development. Copyright © 2016 Elsevier Inc. All rights reserved.

A randomized comparative prospective study of platelet-rich plasma, platelet-rich fibrin, and hydroxyapatite as a graft material for mandibular third molar extraction socket healing.

PubMed

Dutta, Shubha Ranjan; Passi, Deepak; Singh, Purnima; Sharma, Sarang; Singh, Mahinder; Srivastava, Dhirendra

2016-01-01

The purpose of this study was to compare the efficacy of platelet-rich plasma (PRP), platelet-rich fibrin (PRF), and hydroxyapatite (HA) for reduction of pain and swelling, absence of dry socket, soft tissue healing, and bone regeneration after mandibular third molar extraction in human patients. Forty patients requiring extraction of mandibular third molars were randomly grouped as control, PRP, PRF, and HA-treated. The patients were assessed for postoperative pain, swelling, dry socket, and soft tissue healing on the 3 rd , 7 th , and 14 th day of postoperative periods depending on the standard methods. Radiological assessment of the extraction site was done at 1, 2, and 6 months interval to compare the change in bone density in the sockets in control and treated patients. Pain and swelling were less on PRP and PRF site when compared to HA and control site. PRP and PRF site showed better soft tissue healing when compared to HA and control site. Radiographic assessment showed comparatively lesser bone density values in PRP, PRF, and control site at 1, 2, and 6 months than HA site. Our study showed that PRP and PRF are better graft materials than HA regarding pain, swelling, dry socket, and soft tissue healing. Bone regeneration is induced promptly by HA as compared to other graft materials. However, a more elaborate study with a larger number of clinical cases is very much essential to be more conclusive regarding the efficacy of the graft materials.

A randomized comparative prospective study of platelet-rich plasma, platelet-rich fibrin, and hydroxyapatite as a graft material for mandibular third molar extraction socket healing

PubMed Central

Dutta, Shubha Ranjan; Passi, Deepak; Singh, Purnima; Sharma, Sarang; Singh, Mahinder; Srivastava, Dhirendra

2016-01-01

Aim: The purpose of this study was to compare the efficacy of platelet-rich plasma (PRP), platelet-rich fibrin (PRF), and hydroxyapatite (HA) for reduction of pain and swelling, absence of dry socket, soft tissue healing, and bone regeneration after mandibular third molar extraction in human patients. Materials and Methods: Forty patients requiring extraction of mandibular third molars were randomly grouped as control, PRP, PRF, and HA-treated. The patients were assessed for postoperative pain, swelling, dry socket, and soft tissue healing on the 3rd, 7th, and 14th day of postoperative periods depending on the standard methods. Radiological assessment of the extraction site was done at 1, 2, and 6 months interval to compare the change in bone density in the sockets in control and treated patients. Results: Pain and swelling were less on PRP and PRF site when compared to HA and control site. PRP and PRF site showed better soft tissue healing when compared to HA and control site. Radiographic assessment showed comparatively lesser bone density values in PRP, PRF, and control site at 1, 2, and 6 months than HA site. Conclusion: Our study showed that PRP and PRF are better graft materials than HA regarding pain, swelling, dry socket, and soft tissue healing. Bone regeneration is induced promptly by HA as compared to other graft materials. However, a more elaborate study with a larger number of clinical cases is very much essential to be more conclusive regarding the efficacy of the graft materials. PMID:28163478

Multi-finger synergies and the muscular apparatus of the hand.

PubMed

Cuadra, Cristian; Bartsch, Angelo; Tiemann, Paula; Reschechtko, Sasha; Latash, Mark L

2018-05-01

We explored whether the synergic control of the hand during multi-finger force production tasks depends on the hand muscles involved. Healthy subjects performed accurate force production tasks and targeted force pulses while pressing against loops positioned at the level of fingertips, middle phalanges, and proximal phalanges. This varied the involvement of the extrinsic and intrinsic finger flexors. The framework of the uncontrolled manifold (UCM) hypothesis was used to analyze the structure of inter-trial variance, motor equivalence, and anticipatory synergy adjustments prior to the force pulse in the spaces of finger forces and finger modes (hypothetical finger-specific control signals). Subjects showed larger maximal force magnitudes at the proximal site of force production. There were synergies stabilizing total force during steady-state phases across all three sites of force production; no differences were seen across the sites in indices of structure of variance, motor equivalence, or anticipatory synergy adjustments. Indices of variance, which did not affect the task (within the UCM), correlated with motor equivalent motion between the steady states prior to and after the force pulse; in contrast, variance affecting task performance did not correlate with non-motor equivalent motion. The observations are discussed within the framework of hierarchical control with referent coordinates for salient effectors at each level. The findings suggest that multi-finger synergies are defined at the level of abundant transformation between the low-dimensional hand level and higher dimensional finger level while being relatively immune to transformations between the finger level and muscle level. The results also support the scheme of control with two classes of neural variables that define referent coordinates and gains in back-coupling loops between hierarchical control levels.

On multi-site damage identification using single-site training data

NASA Astrophysics Data System (ADS)

Barthorpe, R. J.; Manson, G.; Worden, K.

2017-11-01

This paper proposes a methodology for developing multi-site damage location systems for engineering structures that can be trained using single-site damaged state data only. The methodology involves training a sequence of binary classifiers based upon single-site damage data and combining the developed classifiers into a robust multi-class damage locator. In this way, the multi-site damage identification problem may be decomposed into a sequence of binary decisions. In this paper Support Vector Classifiers are adopted as the means of making these binary decisions. The proposed methodology represents an advancement on the state of the art in the field of multi-site damage identification which require either: (1) full damaged state data from single- and multi-site damage cases or (2) the development of a physics-based model to make multi-site model predictions. The potential benefit of the proposed methodology is that a significantly reduced number of recorded damage states may be required in order to train a multi-site damage locator without recourse to physics-based model predictions. In this paper it is first demonstrated that Support Vector Classification represents an appropriate approach to the multi-site damage location problem, with methods for combining binary classifiers discussed. Next, the proposed methodology is demonstrated and evaluated through application to a real engineering structure - a Piper Tomahawk trainer aircraft wing - with its performance compared to classifiers trained using the full damaged-state dataset.

A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study.

PubMed

Becan, Jennifer E; Bartkowski, John P; Knight, Danica K; Wiley, Tisha R A; DiClemente, Ralph; Ducharme, Lori; Welsh, Wayne N; Bowser, Diana; McCollister, Kathryn; Hiller, Matthew; Spaulding, Anne C; Flynn, Patrick M; Swartzendruber, Andrea; Dickson, Megan F; Fisher, Jacqueline Horan; Aarons, Gregory A

2018-04-13

This paper describes the means by which a United States National Institute on Drug Abuse (NIDA)-funded cooperative, Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS), utilized an established implementation science framework in conducting a multi-site, multi-research center implementation intervention initiative. The initiative aimed to bolster the ability of juvenile justice agencies to address unmet client needs related to substance use while enhancing inter-organizational relationships between juvenile justice and local behavioral health partners. The EPIS (Exploration, Preparation, Implementation, Sustainment) framework was selected and utilized as the guiding model from inception through project completion; including the mapping of implementation strategies to EPIS stages, articulation of research questions, and selection, content, and timing of measurement protocols. Among other key developments, the project led to a reconceptualization of its governing implementation science framework into cyclical form as the EPIS Wheel. The EPIS Wheel is more consistent with rapid-cycle testing principles and permits researchers to track both progressive and recursive movement through EPIS. Moreover, because this randomized controlled trial was predicated on a bundled strategy method, JJ-TRIALS was designed to rigorously test progress through the EPIS stages as promoted by facilitation of data-driven decision making principles. The project extended EPIS by (1) elucidating the role and nature of recursive activity in promoting change (yielding the circular EPIS Wheel), (2) by expanding the applicability of the EPIS framework beyond a single evidence-based practice (EBP) to address varying process improvement efforts (representing varying EBPs), and (3) by disentangling outcome measures of progression through EPIS stages from the a priori established study timeline. The utilization of EPIS in JJ-TRIALS provides a model for practical and applied use of implementation frameworks in real-world settings that span outer service system and inner organizational contexts in improving care for vulnerable populations. NCT02672150 . Retrospectively registered on 22 January 2016.

A Prospective Randomized Trial of the Efficacy of Fibrin Glue, Triamcinolone Acetonide, and Quilting Sutures in Seroma Prevention after Latissimus Dorsi Breast Reconstruction.

PubMed

Hart, Alexandra M; Duggal, Clarie; Pinell-White, Ximena; Losken, Albert

2017-04-01

Donor-site seroma is the most common complication following latissimus dorsi flap breast reconstruction. Various agents and techniques have attempted to minimize seroma formation. The purpose of this study was to compare the efficacy of different products and quilting sutures at seroma prevention. This is a single-center, double-blinded, randomized, controlled trial of a consecutive series of breast cancer patients (n = 96) undergoing latissimus dorsi flap reconstruction performed by a single surgeon. Patients were randomized to receive (1) fibrin glue (Tisseel) (n = 23), (2) triamcinolone acetonide (n = 26), or (3) normal saline (control) (n = 27) sprayed into the donor site. The fourth arm included donor-site quilting sutures (n = 20). Outcomes included seroma, drain output, and days to last drain removal. Drain removal was standardized at less than 30 cc/day. All groups were matched evenly without differences in risk, procedures, or complications. The overall seroma rate was 31.3 percent (n = 30). The quilting group had significantly less drainage for weeks 1 (p = 0.006) and 2 (p = 0.050) postoperatively. Quilting statistically reduced the incidence of seromas to 5.0 percent (n = 1; p = 0.038) compared with other groups (control, 34.5 percent; fibrin, 27.6 percent; and triamcinolone, 37.6 percent). Drains were removed 10 days earlier with quilting (control, 35.5 days; fibrin, 39.5 days; triamcinolone, 37.4 days; and quilting, 25.8 days; p = 0.001). The incidence of all other complications was similar between groups. The use of quilting donor sites significantly decreases the incidence of donor-site seromas and leads to earlier drain removal following latissimus dorsi flap reconstruction and maintains a low complication profile. Therapeutic, II.

Project Connect Online: Randomized Trial of an Internet-Based Program to Chronicle the Cancer Experience and Facilitate Communication

PubMed Central

Stanton, Annette L.; Thompson, Elizabeth H.; Crespi, Catherine M.; Link, John S.; Waisman, James R.

2013-01-01

Purpose Evidence suggests that expressing emotions related to cancer and receiving interpersonal support can promote psychological and physical health in women diagnosed with breast cancer. However, adaptive expression of feelings and communication with one's social network can pose challenges for patients with cancer. We report on a randomized controlled trial of an intervention, Project Connect Online, for patients with breast cancer to create personal Web sites to chronicle their experience and communicate with their social network. Patients and Methods Women (N = 88) diagnosed with breast cancer (any stage, any interval since diagnosis) were randomly assigned to participate in a 3-hour workshop for hands-on creation of personal Web sites with a follow-up call to facilitate Web site use, or to a waiting-list control. Assessed before randomization and 6 months after the intervention, dependent variables included depressive symptoms, positive and negative mood, cancer-related intrusive thoughts, and perceived cancer-related benefits in life appreciation and strengthened relationships. Results Relative to control participants, women randomly assigned to Project Connect Online evidenced significant benefit 6 months later on depressive symptoms, positive mood, and life appreciation, but not negative mood, perceived strengthened relationships, or intrusive thoughts. Treatment status moderated the intervention effects, such that women currently undergoing medical treatment for cancer benefitted significantly more from the intervention on depressive symptoms and positive mood than did women not receiving treatment. Conclusion Findings suggest the promise of an intervention to facilitate the ability of women diagnosed with breast cancer to chronicle their experience and communicate with their social network via the Internet. PMID:23940228

Project connect online: randomized trial of an internet-based program to chronicle the cancer experience and facilitate communication.

PubMed

Stanton, Annette L; Thompson, Elizabeth H; Crespi, Catherine M; Link, John S; Waisman, James R

2013-09-20

Evidence suggests that expressing emotions related to cancer and receiving interpersonal support can promote psychological and physical health in women diagnosed with breast cancer. However, adaptive expression of feelings and communication with one's social network can pose challenges for patients with cancer. We report on a randomized controlled trial of an intervention, Project Connect Online, for patients with breast cancer to create personal Web sites to chronicle their experience and communicate with their social network. Women (N = 88) diagnosed with breast cancer (any stage, any interval since diagnosis) were randomly assigned to participate in a 3-hour workshop for hands-on creation of personal Web sites with a follow-up call to facilitate Web site use, or to a waiting-list control. Assessed before randomization and 6 months after the intervention, dependent variables included depressive symptoms, positive and negative mood, cancer-related intrusive thoughts, and perceived cancer-related benefits in life appreciation and strengthened relationships. Relative to control participants, women randomly assigned to Project Connect Online evidenced significant benefit 6 months later on depressive symptoms, positive mood, and life appreciation, but not negative mood, perceived strengthened relationships, or intrusive thoughts. Treatment status moderated the intervention effects, such that women currently undergoing medical treatment for cancer benefitted significantly more from the intervention on depressive symptoms and positive mood than did women not receiving treatment. Findings suggest the promise of an intervention to facilitate the ability of women diagnosed with breast cancer to chronicle their experience and communicate with their social network via the Internet.

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

PubMed

Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

2015-11-06

'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

PS2-06: Best Practices for Advancing Multi-site Chart Abstraction Research

PubMed Central

Blick, Noelle; Cole, Deanna; King, Colleen; Riordan, Rick; Von Worley, Ann; Yarbro, Patty

2012-01-01

Background/Aims Multi-site chart abstraction studies are becoming increasingly common within the HMORN. Differences in systems among HMORN sites can pose significant obstacles to the success of these studies. It is therefore crucial to standardize abstraction activities by following best practices for multi-site chart abstraction, as consistency of processes across sites will increase efficiencies and enhance data quality. Methods Over the past few months the authors have been meeting to identify obstacles to multi-site chart abstraction and to address ways in which multi-site chart abstraction processes can be systemized and standardized. The aim of this workgroup is to create a best practice guide for multi-site chart abstraction studies. Focus areas include: abstractor training, format for chart abstraction (database, paper, etc), data quality, redaction, mechanism for transferring data, site specific access to medical records, IRB/HIPAA concerns, and budgetary issues. Results The results of the workgroup’s efforts (the best practice guide) will be presented by a panel of experts at the 2012 HMORN conference. The presentation format will also focus on discussion among attendees to elicit further input and to identify areas that need to be further addressed. Subsequently, the best practice guide will be posted on the HMORN website. Discussion The best practice guide for multi-site chart abstraction studies will establish sound guidelines and serve as an aid to researchers embarking on multi-site chart abstraction studies. Efficiencies and data quality will be further enhanced with standardized multi-site chart abstraction practices.

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial.

PubMed

DeWalt, Darren A; Broucksou, Kimberly A; Hawk, Victoria; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kirsten; Holmes, Mark; Weinberger, Morris; Macabasco-O'Connell, Aurelia; Pignone, Michael

2009-06-11

Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months. Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. ClinicalTrials.gov (http://www.clinicaltrials.gov/) NCT00378950.

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

PubMed Central

DeWalt, Darren A; Broucksou, Kimberly A; Hawk, Victoria; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kirsten; Holmes, Mark; Weinberger, Morris; Macabasco-O'Connell, Aurelia; Pignone, Michael

2009-01-01

Background Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects. Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011. Trial Registration ClinicalTrials.gov NCT00378950 PMID:19519904

DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

PubMed Central

Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

2009-01-01

OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

Increasing the response rate of text messaging data collection: a delayed randomized controlled trial

PubMed Central

Li, Ye; Wang, Wei; Wu, Qiong; van Velthoven, Michelle Helena; Chen, Li; Du, Xiaozhen; Zhang, Yanfeng; Rudan, Igor; Car, Josip

2015-01-01

Objective To test the effectiveness of multiple interventions on increasing the response rate of text messaging for longitudinal data collection. Methods Our cohort included 283 caregivers of children aged 6–12 months who were participating in an anemia program in rural China. Using text messages to collect data on anemia medication adherence, we conducted a delayed randomized controlled trial to test multiple interventions (an additional four reminders; a ¥5.0 (US$0.79) credit reward for replying; and a feedback text message). After a 6-week pilot study with week 7 as the baseline measurement, we randomly allocated all participants into two groups: group 1 (n = 142) and group 2 (n = 141). During weeks 8–11, we introduced the interventions to group 1, and in weeks 12–15 the intervention was introduced to both groups. We compared the response rates between groups and explored factors affecting the response rate. Results During weeks 8–11, the response rates in group 1 increased and were significantly higher than in group 2 (p<0.05). During weeks 12–15, the response rate increased significantly in group 2 (p>0.05) and slightly decreased in group 1. Younger participants or participants who had children with lower hemoglobin concentration were more likely to reply (p = 0.02). Sending four reminders on the second day contributed to only 286 (11.7%) extra text messages. Discussion Our study showed that multiple interventions were effective in increasing response rate of text messaging data collection in rural China. Conclusions Larger multi-site studies are needed to find the most effective way of using these interventions to allow usage of text messaging data collection for health research. PMID:25332355

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study.

PubMed

Pepin, Stephanie; Szymanski, Henryk; Rochín Kobashi, Ilya Angélica; Villagomez Martinez, Sandra; González Zamora, José Francisco; Brzostek, Jerzy; Huang, Li-Min; Chiu, Cheng-Hsun; Chen, Po-Yen; Ahonen, Anitta; Forstén, Aino; Seppä, Ilkka; Quiroz, René Farfán; Korhonen, Tiina; Rivas, Enrique; Monfredo, Celine; Hutagalung, Yanee; Menezes, Josemund; Vesikari, Timo

2016-12-01

A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomized, double-blind, active-controlled, multi-center study to examine the immunogenicity and safety of IIV4 in children 3-8 y of age (EudraCT no. 2011-005374-33). Participants were randomized 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received 2 doses of vaccine 28 d apart; all others received a single dose. 1242 children were included. For all 4 strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 d after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3-8 y who received one dose or 2 doses 28 d apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.

A randomized trial of diet and physical activity in women treated for stage II—IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study☆,☆☆

PubMed Central

Thomson, Cynthia A.; Crane, Tracy E.; Miller, Austin; Garcia, David O.; Basen-Engquist, Karen; Alberts, David S.

2016-01-01

Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24 month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24 months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors. PMID:27394382

PTMscape: an open source tool to predict generic post-translational modifications and map modification crosstalk in protein domains and biological processes.

PubMed

Li, Ginny X H; Vogel, Christine; Choi, Hyungwon

2018-06-07

While tandem mass spectrometry can detect post-translational modifications (PTM) at the proteome scale, reported PTM sites are often incomplete and include false positives. Computational approaches can complement these datasets by additional predictions, but most available tools use prediction models pre-trained for single PTM type by the developers and it remains a difficult task to perform large-scale batch prediction for multiple PTMs with flexible user control, including the choice of training data. We developed an R package called PTMscape which predicts PTM sites across the proteome based on a unified and comprehensive set of descriptors of the physico-chemical microenvironment of modified sites, with additional downstream analysis modules to test enrichment of individual or pairs of PTMs in protein domains. PTMscape is flexible in the ability to process any major modifications, such as phosphorylation and ubiquitination, while achieving the sensitivity and specificity comparable to single-PTM methods and outperforming other multi-PTM tools. Applying this framework, we expanded proteome-wide coverage of five major PTMs affecting different residues by prediction, especially for lysine and arginine modifications. Using a combination of experimentally acquired sites (PSP) and newly predicted sites, we discovered that the crosstalk among multiple PTMs occur more frequently than by random chance in key protein domains such as histone, protein kinase, and RNA recognition motifs, spanning various biological processes such as RNA processing, DNA damage response, signal transduction, and regulation of cell cycle. These results provide a proteome-scale analysis of crosstalk among major PTMs and can be easily extended to other types of PTM.

Food security among individuals experiencing homelessness and mental illness in the At Home/Chez Soi Trial.

PubMed

O'Campo, Patricia; Hwang, Stephen W; Gozdzik, Agnes; Schuler, Andrée; Kaufman-Shriqui, Vered; Poremski, Daniel; Lazgare, Luis Ivan Palma; Distasio, Jino; Belbraouet, Slimane; Addorisio, Sindi

2017-08-01

Individuals experiencing homelessness are particularly vulnerable to food insecurity. The At Home/Chez Soi study provides a unique opportunity to first examine baseline levels of food security among homeless individuals with mental illness and second to evaluate the effect of a Housing First (HF) intervention on food security in this population. At Home/Chez Soi was a 2-year randomized controlled trial comparing the effectiveness of HF compared with usual care among homeless adults with mental illness, stratified by level of need for mental health services (high or moderate). Logistic regressions tested baseline associations between food security (US Food Security Survey Module), study site, sociodemographic variables, duration of homelessness, alcohol/substance use, physical health and service utilization. Negative binomial regression determined the impact of the HF intervention on achieving levels of high or marginal food security over an 18-month follow-up period (6 to 24 months). Community settings at five Canadian sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver). Homeless adults with mental illness (n 2148). Approximately 41 % of our sample reported high or marginal food security at baseline, but this figure varied with gender, age, mental health issues and substance use problems. High need participants who received HF were more likely to achieve marginal or high food security than those receiving usual care, but only at the Toronto and Moncton sites. Our large multi-site study demonstrated low levels of food security among homeless experiencing mental illness. HF showed promise for improving food security among participants with high levels of need for mental health services, with notable site differences.

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.

PubMed

Brendryen, Håvar; Kraft, Pål

2008-03-01

To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.

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.

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 elucidate its mechanism of action. Prospective randomized controlled study, Level I.

Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.

PubMed

Williams, Grant R; Nyrop, Kirsten A; Deal, Allison M; Muss, Hyman B; Sanoff, Hanna K

2015-05-01

Colorectal cancer (CRC) diagnosis and treatment can have substantial detrimental impacts on health related quality of life (HRQOL) and physical function. This is especially true for older CRC patients and is of paramount concern in chemotherapy treatment decision making; yet, few studies to date have focused on understanding and managing fatigue in older CRC patients. We present the design of a study to evaluate the feasibility and impact of a home-based, self-directed physical activity intervention on fatigue in older CRC patients receiving adjuvant chemotherapy treatment. Secondary aims pertain to intervention impact on HRQOL, physical function, and self-efficacy for managing fatigue. Multi-site, randomized controlled trial of physical activity intervention compared to usual care in a sample of older adults undergoing adjuvant chemotherapy for CRC. Forty CRC patients will be recruited and study questionnaires/assessments will be performed at baseline, 3 months, and after completion of adjuvant chemotherapy. The primary outcome is a comparison of the change in fatigue from baseline to 3 months between Intervention and Control arms. We will also compare changes in engagement in physical activity, HRQOL, physical function, and self-efficacy. Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). If positive, findings from this pilot study would suggest the potential for improving the care of older persons with CRC undergoing adjuvant chemotherapy through a home-based physical activity intervention to manage fatigue, HRQOL, and physical function. NCT02191969. Copyright © 2015 Elsevier Inc. All rights reserved.

Rationale, design and methods of the HEALTHY study behavior intervention component

USDA-ARS?s Scientific Manuscript database

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

A randomized controlled trial of a commercially available weight loss program

USDA-ARS?s Scientific Manuscript database

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians refer obese adults for intensive, multi-component behavioral counseling, yet most obese Americans choose a self-help approach to lose weight. The current study examined weight loss between a community-based, intensive behavi...

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.

PubMed

Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, Michele

2014-12-01

Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes. We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling. Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM. Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

PubMed Central

2012-01-01

Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080 PMID:23153188

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

DTIC Science & Technology

2010-01-01

to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

Low-order black-box models for control system design in large power systems

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

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1996-02-01

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting from the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

Low-order black-box models for control system design in large power systems

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

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1995-12-31

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting form the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

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 interventions at some control sites.

The effects of workplace health promotion on absenteeism and employment costs in a large industrial population.

PubMed Central

Bertera, R L

1990-01-01

We evaluated the impact of a comprehensive workplace health promotion program on absences among full-time employees in a large, multi-location, diversified industrial company. A pretest-posttest control group design was used to study 41 intervention sites and 19 control sites with 29,315 and 14,573 hourly employees, respectively. Blue-collar employees at intervention sites experienced an 14.0 percent decline in disability days over two years versus a 5.8 percent decline at control sites. This resulted in a net difference of 11,726 fewer disability days over two years at program sites compared with non-program sites. Savings due to lower disability costs at intervention sites offset program costs in the first year, and provided a return of $2.05 for every dollar invested in the program by the end of the second year. These results suggest that comprehensive workplace health promotion programs can reduce disability days among blue collar employees and provide a good return on investment. PMID:2382748

Evaluation of complex community-based childhood obesity prevention interventions.

PubMed

Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial.

PubMed

Antonini, A; Bauer, L; Dohin, E; Oertel, W H; Rascol, O; Reichmann, H; Schmid, M; Singh, P; Tolosa, E; Chaudhuri, K Ray

2015-10-01

Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD. In this double-blind trial (NCT01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1-7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale (UPDRS) III (motor) and the 39-item Parkinson's Disease Questionnaire (PDQ-39). In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the 'mood/apathy' and 'miscellaneous' NMSS domains (P < 0.05). Treatment differences in UPDRS III (-2.60; -4.27, -0.92; P = 0.002) and PDQ-39 (-2.79; -5.21, -0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache. Rotigotine improvement in the multi-domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings. © 2015 EAN.

A randomized, double-blind, placebo-controlled study of the effect of ezetimibe on glucose metabolism in subjects with type 2 diabetes mellitus and hypercholesterolemia.

PubMed

Saito, Itori; Azuma, Kyoichi; Kakikawa, Taro; Oshima, Nobuyuki; Hanson, Mary E; Tershakovec, Andrew M

2015-05-01

Recent evidence points to an increased incidence of new-onset diabetes and a negative impact on glucose parameters with statin use. This study examined the safety of ezetimibe vs placebo for change from baseline to week 24 in HbA1c (primary endpoint), glycoalbumin, and fasting plasma glucose (secondary endpoints) in Japanese subjects with type 2 diabetes and hypercholesterolemia. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-site trial. Adults with type 2 diabetes and hypercholesterolemia whose LDL-C measured <140 mg/dl (subjects receiving lipid-lowering drugs) or <160 mg/dl (subjects not receiving lipid-lowering drugs) at the start of the screening phase, were randomized after a 5-week wash-out period to ezetimibe 10 mg or placebo (1:1) for 24 weeks. Changes in HbA1c, glycoalbumin and fasting plasma glucose from baseline to week 24 were evaluated. The non-inferiority margin was set at 0.5% for HbA1c. Overall, 152 subjects were randomized (75 to ezetimibe and 77 to placebo). From baseline to 24 weeks, HbA1c significantly increased in both the ezetimibe and placebo groups (between-treatment difference 0.08 [95% CI: -0.07 to 0.23]). Ezetimibe was statistically non-inferior to placebo. At 24 weeks, the mean change from baseline in glycoalbumin levels (between-treatment differences 0.00 [95% CI: -0.47, 0.47]) and fasting plasma glucose (between-treatment differences -4.8 [95% CI: -12.1, 2.1]) were similar in both treatment groups. These results suggest that ezetimibe 10 mg does not result in dysregulation of glucose metabolism in Japanese patients with type 2 diabetes and hypercholesterolemia over 24 weeks of treatment. ClinicalTrials.gov identifier NCT01611883 .

Porcine small intestine submucosal grafts improve remucosalization and progenitor cell recruitment to sites of upper airway tissue remodeling.

PubMed

Nayak, Jayakar V; Rathor, Aakanksha; Grayson, Jessica W; Bravo, Dawn T; Velasquez, Nathalia; Noel, Julia; Beswick, Daniel M; Riley, Kristen O; Patel, Zara M; Cho, Do-Yeon; Dodd, Robert L; Thamboo, Andrew; Choby, Garret W; Walgama, Evan; Harsh, Griffith R; Hwang, Peter H; Clemons, Lisa; Lowman, Deborah; Richman, Joshua S; Woodworth, Bradford A

2018-06-01

To better understand upper airway tissue regeneration, the exposed cartilage and bone at donor sites of tissue flaps may serve as in vivo "Petri dishes" for active wound healing. The pedicled nasoseptal flap (NSF) for skull-base reconstruction creates an exposed donor site within the nasal airway. The objective of this study is to evaluate whether grafting the donor site with a sinonasal repair cover graft is effective in promoting wound healing. In this multicenter, prospective trial, subjects were randomized to intervention (graft) or control (no graft) intraoperatively after NSF elevation. Individuals were evaluated at 2, 6, and 12 weeks postintervention with endoscopic recordings. Videos were graded (Likert scale) by 3 otolaryngologists blinded to intervention on remucosalization, crusting, and edema. Scores were analyzed for interrater reliability and cohorts compared. Biopsy and immunohistochemistry at the leading edge of wound healing was performed in select cases. Twenty-one patients were randomized to intervention and 26 to control. Subjects receiving the graft had significantly greater overall remucosalization (p = 0.01) than controls over 12 weeks. Although crusting was less in the small intestine submucosa (SIS) group, this was not statistically significant (p = 0.08). There was no overall effect on nasal edema (p = 0.2). Immunohistochemistry demonstrated abundant upper airway basal cell progenitors in 2 intervention samples, suggesting that covering grafts may facilitate tissue proliferation via progenitor cell expansion. This prospective, randomized, controlled trial indicates that a porcine SIS graft placed on exposed cartilage and bone within the upper airway confers improved remucosalization compared to current practice standards. © 2018 ARS-AAOA, LLC.

Effectiveness of contact-based education for reducing mental illness-related stigma in pharmacy students.

PubMed

Patten, Scott B; Remillard, Alfred; Phillips, Leslie; Modgill, Geeta; Szeto, Andrew Ch; Kassam, Aliya; Gardner, David M

2012-12-05

A strategy for reducing mental illness-related stigma in health-profession students is to include contact-based sessions in their educational curricula. In such sessions students are able to interact socially with a person that has a mental illness. We sought to evaluate the effectiveness of this strategy in a multi-centre study of pharmacy students. The study was a randomized controlled trial conducted at three sites. Because it was necessary that all students receive the contact-based sessions, the students were randomized either to an early or late intervention, with the late intervention group not having participated in the contact-based education at the time when the primary outcome was assessed. The primary outcome, stigma, was assessed using an attitudes scale called the Opening Minds Survey for Health Care Providers (OMS-HC). We initially confirmed that outcomes were homogeneous across study centres, centre by group interaction, p = 0.76. The results were pooled across the three study centres. A significant reduction in stigma was observed in association with the contact-based sessions (mean change 4.3 versus 1.5, t=2.1, p=0.04). The effect size (Cohen's d) was 0.45. A similar reduction was seen in the control group when they later received the intervention. Contact-based education is an effective method of reducing stigma during pharmacy education. These results add to a growing literature confirming the effectiveness of contact-based strategies for stigma reduction in health profession trainees.

Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial.

PubMed

Huang, Beatrice; Willard-Grace, Rachel; De Vore, Denise; Wolf, Jessica; Chirinos, Chris; Tsao, Stephanie; Hessler, Danielle; Su, George; Thom, David H

2017-06-09

Chronic obstructive pulmonary disease (COPD) severely hinders quality of life for those affected and is costly to the health care system. Care gaps in areas such as pharmacotherapy, inhaler technique, and knowledge of disease are prevalent, particularly for vulnerable populations served by community clinics. Non-professionally licensed health coaches have been shown to be an effective and cost-efficient solution in bridging care gaps and facilitating self-management for patients with other chronic diseases, but no research to date has explored their efficacy in improving care for people living with COPD. This is multi-site, single blinded, randomized controlled trial evaluates the efficacy of health coaches to facilitate patient self-management of disease and improve quality of life for patients with moderate to severe COPD. Spirometry, survey, and an exercise capacity test are conducted at baseline and at 9 months. A short survey is administered by phone at 3 and 6 months post-enrollment. The nine month health coaching intervention focuses on enhancing disease understanding and symptom awareness, improving use of inhalers; making personalized plans to increase physical activity, smoking cessation, or otherwise improve disease management; and facilitating care coordination. The results of this study will provide evidence regarding the efficacy and feasibility of health coaching to improve self-management and quality of life for urban underserved patients with moderate to severe COPD. ClinicalTrials.gov identifier NCT02234284 . Registered 12 August 2014.

Methods to Limit Attrition in Longitudinal Comparative Effectiveness Trials: Lessons from the Lithium Use for Bipolar Disorder (LiTMUS) Study

PubMed Central

Sylvia, Louisa G.; Reilly-Harrington, Noreen A.; Leon, Andrew C.; Kansky, Christine I.; Ketter, Terence A.; Calabrese, Joseph R.; Thase, Michael E.; Bowden, Charles L.; Friedman, Edward S.; Ostacher, Michael J.; Iosifescu, Dan V.; Severe, Joanne; Nierenberg, Andrew A.

2013-01-01

Background High attrition rates which occur frequently in longitudinal clinical trials of interventions for bipolar disorder limit the interpretation of results. Purpose The aim of this article is to present design approaches that limited attrition in the Lithium Use for Bipolar Disorder (LiTMUS) Study. Methods LiTMUS was a 6-month randomized, longitudinal multi-site comparative effectiveness trial that examined bipolar participants who were at least mildly ill. Participants were randomized to either low to moderate doses of lithium or no lithium, in addition to other treatments needed for mood stabilization administered in a guideline-informed, empirically supported, and personalized fashion (N=283). Results Components of the study design that may have contributed to the low attrition rate of the study included use of: (1) an intent-to-treat design; (2) a randomized adjunctive single-blind design; (3) participant reimbursement; (4) intent-to-attend the next study visit (includes a discussion of attendance obstacles when intention is low); (5) quality care with limited participant burden; and (6) target windows for study visits. Limitations Site differences and the effectiveness and tolerability data have not been analyzed yet. Conclusions These components of the LiTMUS study design may have reduced the probability of attrition which would inform the design of future randomized clinical effectiveness trials. PMID:22076437

Assessment of Antarctic moss health from multi-sensor UAS imagery with Random Forest Modelling

NASA Astrophysics Data System (ADS)

Turner, Darren; Lucieer, Arko; Malenovský, Zbyněk; King, Diana; Robinson, Sharon A.

2018-06-01

Moss beds are one of very few terrestrial vegetation types that can be found on the Antarctic continent and as such mapping their extent and monitoring their health is important to environmental managers. Across Antarctica, moss beds are experiencing changes in health as their environment changes. As Antarctic moss beds are spatially fragmented with relatively small extent they require very high resolution remotely sensed imagery to monitor their distribution and dynamics. This study demonstrates that multi-sensor imagery collected by an Unmanned Aircraft System (UAS) provides a novel data source for assessment of moss health. In this study, we train a Random Forest Regression Model (RFM) with long-term field quadrats at a study site in the Windmill Islands, East Antarctica and apply it to UAS RGB and 6-band multispectral imagery, derived vegetation indices, 3D topographic data, and thermal imagery to predict moss health. Our results suggest that moss health, expressed as a percentage between 0 and 100% healthy, can be estimated with a root mean squared error (RMSE) between 7 and 12%. The RFM also quantifies the importance of input variables for moss health estimation showing the multispectral sensor data was important for accurate health prediction, such information being essential for planning future field investigations. The RFM was applied to the entire moss bed, providing an extrapolation of the health assessment across a larger spatial area. With further validation the resulting maps could be used for change detection of moss health across multiple sites and seasons.

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

Biphasic responses in multi-site phosphorylation systems.

PubMed

Suwanmajo, Thapanar; Krishnan, J

2013-12-06

Multi-site phosphorylation systems are repeatedly encountered in cellular biology and multi-site modification is a basic building block of post-translational modification. In this paper, we demonstrate how distributive multi-site modification mechanisms by a single kinase/phosphatase pair can lead to biphasic/partial biphasic dose-response characteristics for the maximally phosphorylated substrate at steady state. We use simulations and analysis to uncover a hidden competing effect which is responsible for this and analyse how it may be accentuated. We build on this to analyse different variants of multi-site phosphorylation mechanisms showing that some mechanisms are intrinsically not capable of displaying this behaviour. This provides both a consolidated understanding of how and under what conditions biphasic responses are obtained in multi-site phosphorylation and a basis for discriminating between different mechanisms based on this. We also demonstrate how this behaviour may be combined with other behaviour such as threshold and bistable responses, demonstrating the capacity of multi-site phosphorylation systems to act as complex molecular signal processors.

The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial.

PubMed

Park, Dae-Myung; Kim, Seok-Hwan; Park, Yang-Chun; Kang, Wee-Chang; Lee, Sang-Ryong; Jung, In-Chul

2014-12-02

Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders. The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations. Multicenter, randomized, double-blinded, placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010. They were given Gamisoyo-San individual extract mixture (extraction done for each crude materia medica separately) or Gamisoyo-San multi-compound extract (extraction done for whole materia medica at once) or controlled medication. Hamilton Rating Scale for Anxiety (HAM-A), Korean State-Trait Anxiety Inventory (K-STAI), Penn State Worry Questionnaire (PSWQ), Korean Beck Depression Inventroy (K-BDI), Symptom Checklist-90-Revised (SCL-90-R), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were evaluated. We also applied Pattern Identification tool for 'JingJi and ZhengChong (, Traditional Korean Medicine term which correlates with generalized anxiety disorder)' to patients to evaluate different responses among 9 patterns. HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group, but the difference was insignificant. WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group. In Heart blood deficiency pattern, the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group. Gamisoyo-San did not improve anxiety level of GAD patients. However, it can be useful to improve quality of life, and reduce depressive, obsessive-compulsive, somatic symptoms of generalized anxiety disorder. Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture, especially in Heart blood deficiency pattern. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Responses of cavity-nesting birds to stand-replacement fire and salvage logging in ponderosa pine/Douglas-fir forests of southwestern Idaho

Treesearch

Victoria A. Saab; Jonathan G. Dudley

1998-01-01

From 1994 to 1996, researchers monitored 695 nests of nine cavity-nesting bird species and measured vegetation at nest sites and at 90 randomly located sites in burned ponderosa pine forests of southwestern Idaho. Site treatments included two types of salvage logging, and unlogged controls. All bird species selected nest sites with higher tree densities, larger...

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

PubMed Central

2011-01-01

Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. Trial registration German Clinical Trial Register Number: DRKS00000040 PMID:21303515

Train the trainer? A randomized controlled trial of a multi-tiered oral health education programme in community-based residential services for adults with intellectual disability.

PubMed

Mac Giolla Phadraig, Caoimhin; Guerin, Suzanne; Nunn, June

2013-04-01

To assess the impact of a multi-tiered oral health education programme on care staff caring for people with intellectual disability (ID). Postal questionnaires were sent to all care staff of a community-based residential care service for adults, randomly assigned to control and intervention groups. A specifically developed training programme was delivered to residential staff nominees, who then trained all staff within the intervention group. The control group received no training. Post-test questionnaires were sent to both groups. Paired-samples t-test was used to compare oral health-related knowledge (K) and behaviour, attitude and self-efficacy (BAS) scores. Of the initial 219 respondents, 154 (response rate between 40% and 35.8%, with attrition rate of 29.7% from baseline to repeat) returned completed questionnaires at post-test (M=8.5 months, range=6.5-11 months). Control and intervention groups were comparable for general training, employment and demographic variables. In the intervention group, mean Knowledge Index score rose from K=7.2 to K=7.9 (P<0.001) and mean BAS scale score rose from BAS=4.7 to BAS=5.4 (P<0.001). There was no statistically significant increase in mean scores from test (K=7.0, BAS=4.7) to post-test (K=7.2, BAS=4.9) for the control group. Mean scores regarding knowledge, attitude, self-efficacy and reported behaviour increased significantly at 8.5 months in staff where training was provided. The results indicate that a multi-tiered training programme improved knowledge, attitude, self-efficacy and reported behaviour amongst staff caring for people with ID. © 2012 John Wiley & Sons A/S.

A multi-model approach to nucleic acid-based drug development.

PubMed

Gautherot, Isabelle; Sodoyer, Regís

2004-01-01

With the advent of functional genomics and the shift of interest towards sequence-based therapeutics, the past decades have witnessed intense research efforts on nucleic acid-mediated gene regulation technologies. Today, RNA interference is emerging as a groundbreaking discovery, holding promise for development of genetic modulators of unprecedented potency. Twenty-five years after the discovery of antisense RNA and ribozymes, gene control therapeutics are still facing developmental difficulties, with only one US FDA-approved antisense drug currently available in the clinic. Limited predictability of target site selection models is recognized as one major stumbling block that is shared by all of the so-called complementary technologies, slowing the progress towards a commercial product. Currently employed in vitro systems for target site selection include RNAse H-based mapping, antisense oligonucleotide microarrays, and functional screening approaches using libraries of catalysts with randomized target-binding arms to identify optimal ribozyme/DNAzyme cleavage sites. Individually, each strategy has its drawbacks from a drug development perspective. Utilization of message-modulating sequences as therapeutic agents requires that their action on a given target transcript meets criteria of potency and selectivity in the natural physiological environment. In addition to sequence-dependent characteristics, other factors will influence annealing reactions and duplex stability, as well as nucleic acid-mediated catalysis. Parallel consideration of physiological selection systems thus appears essential for screening for nucleic acid compounds proposed for therapeutic applications. Cellular message-targeting studies face issues relating to efficient nucleic acid delivery and appropriate analysis of response. For reliability and simplicity, prokaryotic systems can provide a rapid and cost-effective means of studying message targeting under pseudo-cellular conditions, but such approaches also have limitations. To streamline nucleic acid drug discovery, we propose a multi-model strategy integrating high-throughput-adapted bacterial screening, followed by reporter-based and/or natural cellular models and potentially also in vitro assays for characterization of the most promising candidate sequences, before final in vivo testing.

Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

PubMed

Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

2013-08-01

Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

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.

Motivational Interviewing or Reminders for Glaucoma Medication Adherence? Results of a Multi-Site Randomized Controlled Trial

PubMed Central

Schmiege, Sarah J.; Mansberger, Steven L.; Sheppler, Christina; Kammer, Jeffrey; Fitzgerald, Timothy; Kahook, Malik Y.

2017-01-01

Objective Nonadherence reduces glaucoma treatment efficacy. Motivational interviewing (MI) is a well-studied adherence intervention, but has not been tested in glaucoma. Reminder interventions also may improve adherence. Design 201 patients with glaucoma or ocular hypertension were urn-randomized to receive MI delivered by an ophthalmic technician (OT), usual care, or a minimal behavioral intervention (reminder calls). Main Outcome Measures Outcomes included electronic monitoring with Medication Event Monitoring System (MEMS) bottles, two self-report adherence measures, patient satisfaction, and clinical outcomes. Multilevel modeling was used to test differences in MEMS results by group over time; ANCOVA was used to compare groups on other measures. Results Reminder calls increased adherence compared to usual care based on MEMS, p = .005, and self-report, p = .04. MI had a nonsignificant effect but produced higher satisfaction than reminder calls, p = .007. Treatment fidelity was high on most measures, with observable differences in behavior between groups. All groups had high baseline adherence that limited opportunities for change. Conclusion Reminder calls, but not MI, led to better adherence than usual care. Although a large literature supports MI, reminder calls might be a cost-effective intervention for patients with high baseline adherence. Replication is needed with less adherent participants. PMID:27701902

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

PubMed

Zhang, Zhe; Zhang, Fan; Wang, Yang; Du, Yi; Zhang, Huiyong; Kong, Dezhao; Liu, Yue; Yang, Guanlin

2014-10-30

Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris. This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed. The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology. ChiCTR-TRC-13003608, registered 18 June 2013.

Simple-MSSM: a simple and efficient method for simultaneous multi-site saturation mutagenesis.

PubMed

Cheng, Feng; Xu, Jian-Miao; Xiang, Chao; Liu, Zhi-Qiang; Zhao, Li-Qing; Zheng, Yu-Guo

2017-04-01

To develop a practically simple and robust multi-site saturation mutagenesis (MSSM) method that enables simultaneously recombination of amino acid positions for focused mutant library generation. A general restriction enzyme-free and ligase-free MSSM method (Simple-MSSM) based on prolonged overlap extension PCR (POE-PCR) and Simple Cloning techniques. As a proof of principle of Simple-MSSM, the gene of eGFP (enhanced green fluorescent protein) was used as a template gene for simultaneous mutagenesis of five codons. Forty-eight randomly selected clones were sequenced. Sequencing revealed that all the 48 clones showed at least one mutant codon (mutation efficiency = 100%), and 46 out of the 48 clones had mutations at all the five codons. The obtained diversities at these five codons are 27, 24, 26, 26 and 22, respectively, which correspond to 84, 75, 81, 81, 69% of the theoretical diversity offered by NNK-degeneration (32 codons; NNK, K = T or G). The enzyme-free Simple-MSSM method can simultaneously and efficiently saturate five codons within one day, and therefore avoid missing interactions between residues in interacting amino acid networks.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia

PubMed Central

Kiran, Swathi

2015-01-01

Purpose Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Method Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive–linguistic assessments. Results Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Conclusions Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities. PMID:25908438

Testing Maternal Depression and Attachment Style as Moderators of Early Head Start's Effects on Parenting

PubMed Central

Berlin, Lisa J.; Whiteside-Mansell, Leanne; Roggman, Lori A.; Green, Beth L.; Robinson, JoAnn; Spieker, Susan

2010-01-01

This study examined maternal depression, attachment avoidance, and attachment anxiety as moderators of Early Head Start's effects on four parenting outcomes assessed at age 3. Participants (N = 947) were drawn from six sites of the Early Head Start National Research and Evaluation Project, a multi-site randomized trial. Findings suggest more positive program effects for mothers with less initial attachment avoidance or attachment anxiety. First, baseline attachment avoidance moderated EHS program effects on observed maternal supportiveness, such that program mothers with lower baseline attachment avoidance were rated as more supportive of their 3-year-olds than program mothers with higher baseline attachment avoidance. Second, program effects on spanking varied depending on mothers’ baseline attachment anxiety. PMID:21240694

Testing maternal depression and attachment style as moderators of Early Head Start's effects on parenting.

PubMed

Berlin, Lisa J; Whiteside-Mansell, Leanne; Roggman, Lori A; Green, Beth L; Robinson, JoAnn; Spieker, Susan

2011-01-01

This study examined maternal depression, attachment avoidance, and attachment anxiety as moderators of Early Head Start's effects on four parenting outcomes assessed at age three. Participants (N = 947) were drawn from six sites of the Early Head Start National Research and Evaluation Project, a multi-site randomized trial. Findings suggest more positive program effects for mothers with less initial attachment avoidance or attachment anxiety. First, baseline attachment avoidance moderated Early Head Start program effects on observed maternal supportiveness, such that program mothers with lower baseline attachment avoidance were rated as more supportive of their three-year-olds than program mothers with higher baseline attachment avoidance. Second, program effects on spanking varied depending on mothers' baseline attachment anxiety.

An i2b2-based, generalizable, open source, self-scaling chronic disease registry

PubMed Central

Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

2013-01-01

Objective Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Materials and methods Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. Results The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. Discussion We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. Conclusions The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases. PMID:22733975

An i2b2-based, generalizable, open source, self-scaling chronic disease registry.

PubMed

Natter, Marc D; Quan, Justin; Ortiz, David M; Bousvaros, Athos; Ilowite, Norman T; Inman, Christi J; Marsolo, Keith; McMurry, Andrew J; Sandborg, Christy I; Schanberg, Laura E; Wallace, Carol A; Warren, Robert W; Weber, Griffin M; Mandl, Kenneth D

2013-01-01

Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases.

Gait ataxia in humans: vestibular and cerebellar control of dynamic stability.

PubMed

Schniepp, Roman; Möhwald, Ken; Wuehr, Max

2017-10-01

During human locomotion, vestibular feedback control is fundamental for maintaining dynamic stability and adapting the gait pattern to external circumstances. Within the supraspinal locomotor network, the cerebellum represents the key site for the integration of vestibular feedback information. The cerebellum is further important for the fine-tuning and coordination of limb movements during walking. The aim of this review article is to highlight the shared structural and functional sensorimotor principles in vestibular and cerebellar locomotion control. Vestibular feedback for the maintenance of dynamic stability is integrated into the locomotor pattern via midline, caudal cerebellar structures (vermis, flocculonodular lobe). Hemispheric regions of the cerebellum facilitate feed-forward control of multi-joint coordination and higher locomotor functions. Characteristic features of the gait disorder in patients with vestibular deficits or cerebellar ataxia are increased levels of spatiotemporal gait variability in the fore-aft and the medio-lateral gait dimension. In the fore-aft dimension, pathologic increases of gait fluctuations critically depend on the locomotion speed and predominantly manifest during slow walking velocities. This feature is associated with an increased risk of falls in both patients with vestibular hypofunction as well as patients with cerebellar ataxia. Pharmacological approaches for the treatment of vestibular or cerebellar gait ataxia are currently not available. However, new promising options are currently tested in randomized, controlled trials (fampridine/FACEG; acetyl-DL-leucine/ALCAT).

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.

The influence of social networking sites on health behavior change: a systematic review and meta-analysis.

PubMed

Laranjo, Liliana; Arguel, Amaël; Neves, Ana L; Gallagher, Aideen M; Kaplan, Ruth; Mortimer, Nathan; Mendes, Guilherme A; Lau, Annie Y S

2015-01-01

Our aim was to evaluate the use and effectiveness of interventions using social networking sites (SNSs) to change health behaviors. Five databases were scanned using a predefined search strategy. Studies were included if they focused on patients/consumers, involved an SNS intervention, had an outcome related to health behavior change, and were prospective. Studies were screened by independent investigators, and assessed using Cochrane's 'risk of bias' tool. Randomized controlled trials were pooled in a meta-analysis. The database search retrieved 4656 citations; 12 studies (7411 participants) met the inclusion criteria. Facebook was the most utilized SNS, followed by health-specific SNSs, and Twitter. Eight randomized controlled trials were combined in a meta-analysis. A positive effect of SNS interventions on health behavior outcomes was found (Hedges' g 0.24; 95% CI 0.04 to 0.43). There was considerable heterogeneity (I(2) = 84.0%; T(2) = 0.058) and no evidence of publication bias. To the best of our knowledge, this is the first meta-analysis evaluating the effectiveness of SNS interventions in changing health-related behaviors. Most studies evaluated multi-component interventions, posing problems in isolating the specific effect of the SNS. Health behavior change theories were seldom mentioned in the included articles, but two particularly innovative studies used 'network alteration', showing a positive effect. Overall, SNS interventions appeared to be effective in promoting changes in health-related behaviors, and further research regarding the application of these promising tools is warranted. Our study showed a positive effect of SNS interventions on health behavior-related outcomes, but there was considerable heterogeneity. Protocol registration The protocol for this systematic review is registered at http://www.crd.york.ac.uk/PROSPERO with the number CRD42013004140. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.comFor numbered affiliations see end of article.

A second generation experiment in fault-tolerant software

NASA Technical Reports Server (NTRS)

Knight, J. C.

1986-01-01

Information was collected on the efficacy of fault-tolerant software by conducting two large-scale controlled experiments. In the first, an empirical study of multi-version software (MVS) was conducted. The second experiment is an empirical evaluation of self testing as a method of error detection (STED). The purpose ot the MVS experiment was to obtain empirical measurement of the performance of multi-version systems. Twenty versions of a program were prepared at four different sites under reasonably realistic development conditions from the same specifications. The purpose of the STED experiment was to obtain empirical measurements of the performance of assertions in error detection. Eight versions of a program were modified to include assertions at two different sites under controlled conditions. The overall structure of the testing environment for the MVS experiment and its status are described. Work to date in the STED experiment is also presented.

Syndemic vulnerability, sexual and injection risk behaviors, and HIV continuum of care outcomes in HIV-positive injection drug users

PubMed Central

Mizuno, Yuko; Purcell, David W.; Knowlton, Amy R.; Wilkinson, James D.; Gourevitch, Marc N.; Knight, Kelly R.

2015-01-01

Limited investigations have been conducted on syndemics and HIV continuum of care outcomes. Using baseline data from a multi-site, randomized controlled study of HIV-positive injection drug users (n=1052), we examined whether psychosocial factors co-occurred, and whether these factors were additively associated with behavioral and HIV continuum of care outcomes. Experiencing one type of psychosocial problem was significantly (p<0.05) associated with an increased odds of experiencing another type of problem. Persons with 3 or more psychosocial problems were significantly more likely to report sexual and injection risk behaviors and were less likely to be adherent to HIV medications. Persons with 4 or more problems were less likely to be virally suppressed. Reporting any problems was associated with not currently taking HIV medications. Our findings highlight the association of syndemics not only with risk behaviors, but also with outcomes related to the continuum of care for HIV-positive persons. PMID:25249392

Preventing neuronal damage and inflammation in vivo during cortical microelectrode implantation through the use of Poloxamer P-188

NASA Astrophysics Data System (ADS)

Misra, A.; Kondaveeti, P.; Nissanov, J.; Barbee, K.; Shewokis, P.; Rioux, L.; Moxon, K. A.

2013-02-01

Objective. The aim of this study was to test the efficacy of Poloxamer P188 to reduce cell death and immune response associated with mechanical trauma to cells during implantation of a chronic recording electrode. Approach. Ceramic multi-site recording electrodes were implanted bilaterally into 15 adult male Long-Evans rats. One of each pair was randomly assigned to receive a coating of Poloxamer while the other was treated with saline. The extent of neuron loss, and glial cell recruitment were characterized at 2, 4 and 6 weeks post-implantation by stereologic analysis. Main results. At 2 and 4 weeks post-implantation, Poloxamer-coated implants showed significantly fewer glial cells and more neurons in the peri-electrode space than controls; however, this significance was lost by 6 weeks. Significance. These findings are the first to suggest that Poloxamer has neuroprotective effects in vivo; however, at a fixed loading dose, these effects are limited to approximately 1 month post-implantation.

Smoking, drinking, and depression: comorbidity in head and neck cancer patients undergoing radiotherapy.

PubMed

McCarter, Kristen; Baker, Amanda L; Britton, Benjamin; Wolfenden, Luke; Wratten, Chris; Bauer, Judith; Halpin, Sean A; Carter, Gregory; Beck, Alison K; Leigh, Lucy; Oldmeadow, Christopher

2018-04-19

We aimed to determine the prevalence and co-occurrence of tobacco smoking, alcohol consumption, and depressive symptoms among a sample of head and neck cancer (HNC) patients undergoing radiotherapy. A total of 307 HNC patients participated in a multi-site stepped-wedge randomized controlled trial (RCT) evaluating the effectiveness of a dietitian-delivered health behavior intervention in patients with HNC undergoing radiotherapy. During week one of radiotherapy patients completed measures of smoking, alcohol consumption, and level of depression. Approximately one-fifth (21%) of patients had two or more co-occurring problems: current smoking, hazardous alcohol use, and/or likely presence of a major depressive episode (MDE). Approximately one-third (34%) of the sample were current smokers, one-third (31%) were drinking hazardously and almost one-fifth (19%) had likely cases of depression. Comorbidity of smoking, hazardous alcohol use, and MDE is high in HNC patients, and interventions need to address this cluster of cancer risk factors. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Site systems engineering fiscal year 1999 multi-year work plan (MYWP) update for WBS 1.8.2.2

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

GRYGIEL, M.L.

1998-10-08

Manage the Site Systems Engineering process to provide a traceable integrated requirements-driven, and technically defensible baseline. Through the Site Integration Group(SIG), Systems Engineering ensures integration of technical activities across all site projects. Systems Engineering's primary interfaces are with the RL Project Managers, the Project Direction Office and with the Project Major Subcontractors, as well as with the Site Planning organization. Systems Implementation: (1) Develops, maintains, and controls the site integrated technical baseline, ensures the Systems Engineering interfaces between projects are documented, and maintain the Site Environmental Management Specification. (2) Develops and uses dynamic simulation models for verification of the baselinemore » and analysis of alternatives. (3) Performs and documents fictional and requirements analyses. (4) Works with projects, technology management, and the SIG to identify and resolve technical issues. (5) Supports technical baseline information for the planning and budgeting of the Accelerated Cleanup Plan, Multi-Year Work Plans, Project Baseline Summaries as well as performance measure reporting. (6) Works with projects to ensure the quality of data in the technical baseline. (7) Develops, maintains and implements the site configuration management system.« less

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.

Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial.

PubMed

Andrews, Jeannette O; Mueller, Martina; Dooley, Mary; Newman, Susan D; Magwood, Gayenell S; Tingen, Martha S

2016-09-01

To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority. Copyright © 2016 Elsevier Inc. All rights reserved.

Multi-site pain and working conditions as predictors of work ability in a 4-year follow-up among food industry employees.

PubMed

Neupane, S; Virtanen, P; Leino-Arjas, P; Miranda, H; Siukola, A; Nygård, C-H

2013-03-01

We investigated the separate and joint effects of multi-site musculoskeletal pain and physical and psychosocial exposures at work on future work ability. A survey was conducted among employees of a Finnish food industry company in 2005 (n = 1201) and a follow-up survey in 2009 (n = 734). Information on self-assessed work ability (current work ability on a scale from 0 to 10; 7 = poor work ability), multi-site musculoskeletal pain (pain in at least two anatomical areas of four), leisure-time physical activity, body mass index and physical and psychosocial exposures was obtained by questionnaire. The separate and joint effects of multi-site pain and work exposures on work ability at follow-up, among subjects with good work ability at baseline, were assessed by logistic regression, and p-values for the interaction derived. Compared with subjects with neither multi-site pain nor adverse work exposure, multi-site pain at baseline increased the risk of poor work ability at follow-up, allowing for age, gender, occupational class, body mass index and leisure-time physical activity. The separate effects of the work exposures on work ability were somewhat smaller than those of multi-site pain. Multi-site pain had an interactive effect with work environment and awkward postures, such that no association of multi-site pain with poor work ability was seen when work environment was poor or awkward postures present. The decline in work ability connected with multi-site pain was not increased by exposure to adverse physical or psychosocial factors at work. © 2012 European Federation of International Association for the Study of Pain Chapters.

Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers.

PubMed

Rich, Porchia; Aarons, Gregory A; Takemoto, Michelle; Cardenas, Veronica; Crist, Katie; Bolling, Khalisa; Lewars, Brittany; Sweet, Cynthia Castro; Natarajan, Loki; Shi, Yuyan; Full, Kelsie M; Johnson, Eileen; Rosenberg, Dori E; Whitt-Glover, Melicia; Marcus, Bess; Kerr, Jacqueline

2017-07-18

As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. The Peer Empowerment Program 4 Physical Activity' (PEP4PA) is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA) intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit), adoption & penetration (reach), fidelity (quantity & quality of intervention delivered), acceptability (satisfaction), costs, and sustainability. Using a peer led implementation strategy to deliver a multi-level community based PA program can enhance program adoption, implementation, and sustainment. ClinicalTrials.gov, USA ( NCT02405325 ). Date of registration, March 20, 2015. This website also contains all items from the World Health Organization Trial Registration Data Set.

Hybrid time-variant reliability estimation for active control structures under aleatory and epistemic uncertainties

NASA Astrophysics Data System (ADS)

Wang, Lei; Xiong, Chuang; Wang, Xiaojun; Li, Yunlong; Xu, Menghui

2018-04-01

Considering that multi-source uncertainties from inherent nature as well as the external environment are unavoidable and severely affect the controller performance, the dynamic safety assessment with high confidence is of great significance for scientists and engineers. In view of this, the uncertainty quantification analysis and time-variant reliability estimation corresponding to the closed-loop control problems are conducted in this study under a mixture of random, interval, and convex uncertainties. By combining the state-space transformation and the natural set expansion, the boundary laws of controlled response histories are first confirmed with specific implementation of random items. For nonlinear cases, the collocation set methodology and fourth Rounge-Kutta algorithm are introduced as well. Enlightened by the first-passage model in random process theory as well as by the static probabilistic reliability ideas, a new definition of the hybrid time-variant reliability measurement is provided for the vibration control systems and the related solution details are further expounded. Two engineering examples are eventually presented to demonstrate the validity and applicability of the methodology developed.

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

PubMed

Foster, J D; Ewings, P; Falk, S; Cooper, E J; Roach, H; West, N P; Williams-Yesson, B A; Hanna, G B; Francis, N K

2016-10-01

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

Bidirectional and Multi-User Telerehabilitation System: Clinical Effect on Balance, Functional Activity, and Satisfaction in Patients with Chronic Stroke Living in Long-Term Care Facilities

PubMed Central

Lin, Kwan-Hwa; Chen, Chin-Hsing; Chen, You-Yin; Huang, Wen-Tzeng; Lai, Jin-Shin; Yu, Shang-Ming; Chang, Yuan-Jen

2014-01-01

Background The application of internet technology for telerehabilitation in patients with stroke has developed rapidly. Objective The current study aimed to evaluate the effect of a bidirectional and multi-user telerehabilitation system on balance and satisfaction in patients with chronic stroke living in long-term care facilities (LTCFs). Method This pilot study used a multi-site, blocked randomization design. Twenty-four participants from three LTCFs were recruited, and the participants were randomly assigned into the telerehabilitation (Tele) and conventional therapy (Conv) groups within each LTCF. Tele group received telerehabilitation but the Conv group received conventional therapy with two persons in each group for three sessions per week and for four weeks. The outcome measures included Berg Balance Scale (BBS), Barthel Index (BI), and the telerehabilitation satisfaction of the participants. Setting A telerehabilitation system included “therapist end” in a laboratory, and the “client end” in LTCFs. The conventional therapy was conducted in LTCFs. Results Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI. No significant difference between groups could be demonstrated. The satisfaction of participants between the Tele and the Conv groups also did not show significant difference. Conclusions This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs. PMID:25019632

Vector nature of multi-soliton patterns in a passively mode-locked figure-eight fiber laser.

PubMed

Ning, Qiu-Yi; Liu, Hao; Zheng, Xu-Wu; Yu, Wei; Luo, Ai-Ping; Huang, Xu-Guang; Luo, Zhi-Chao; Xu, Wen-Cheng; Xu, Shan-Hui; Yang, Zhong-Min

2014-05-19

The vector nature of multi-soliton dynamic patterns was investigated in a passively mode-locked figure-eight fiber laser based on the nonlinear amplifying loop mirror (NALM). By properly adjusting the cavity parameters such as the pump power level and intra-cavity polarization controllers (PCs), in addition to the fundamental vector soliton, various vector multi-soliton regimes were observed, such as the random static distribution of vector multiple solitons, vector soliton cluster, vector soliton flow, and the state of vector multiple solitons occupying the whole cavity. Both the polarization-locked vector solitons (PLVSs) and the polarization-rotating vector solitons (PRVSs) were observed for fundamental soliton and each type of multi-soliton patterns. The obtained results further reveal the fundamental physics of multi-soliton patterns and demonstrate that the figure-eight fiber lasers are indeed a good platform for investigating the vector nature of different soliton types.

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.

Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

PubMed

Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

2018-01-01

Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

PubMed

Kevany, Sebastian; Khumalo-Sakutukwa, Gertrude; Singh, Basant; Chingono, Alfred; Morin, Stephen

2016-01-01

Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites ensures consistent and high quality delivery of all intervention components, in keeping with the goals of the study protocol, while also providing a forum for corrective feedback, additional supervision and retraining of staff. QAC ensures staff fidelity to study procedures and is critical to the successful delivery of multi-site HIV prevention interventions, as well as the delivery of services scaled up in programmatic situations.

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.

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

PubMed

Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

2008-01-01

African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre-adolescent African-American girls.

School-based programmes for preventing smoking.

PubMed

Thomas, R; Perera, R

2006-07-19

Smoking rates in adolescents are rising in some countries. Helping young people to avoid starting smoking is a widely endorsed goal of public health, but there is uncertainty about how to do this. Schools provide a route for communicating with a large proportion of young people, and school-based programmes for smoking prevention have been widely developed and evaluated. To review all randomized controlled trials of behavioural interventions in schools to prevent children (aged 5 to12) and adolescents (aged 13 to18) starting smoking. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Tobacco Addiction Group's Specialized Register, MEDLINE, EMBASE, PsyclNFO, ERIC, CINAHL, Health Star, Dissertation Abstracts and studies identified in the bibliographies of articles. Individual MEDLINE searches were made for 133 authors who had undertaken randomized controlled trials in this area. Types of studies: those in which individual students, classes, schools, or school districts were randomized to the intervention or control groups and followed for at least six months. Children (aged 5 to12) or adolescents (aged 13 to18) in school settings. Types of interventions: Classroom programmes or curricula, including those with associated family and community interventions, intended to deter use of tobacco. We included programmes or curricula that provided information, those that used social influences approaches, those that taught generic social competence, and those that included interventions beyond the school into the community. We included programmes with a drug or alcohol focus if outcomes for tobacco use were reported. Types of outcome measures: Prevalence of non-smoking at follow up among those not smoking at baseline. We did not require biochemical validation of self-reported tobacco use for study inclusion. We assessed whether identified citations were randomized controlled trials. We assessed the quality of design and execution, and abstracted outcome data. Because of the marked heterogeneity of design and outcomes, we computed pooled estimates only for those trials that could be analyzed together and for which statistical data were available. We predominantly synthesized the data using narrative systematic review. We grouped studies by intervention method (information; social competence; social influences; combined social influences/social competence; multi-modal programmes). Within each group, we placed them into three categories (low, medium and high risk of bias) according to validity using quality criteria for reported study design. Of the 94 randomized controlled trials identified, we classified 23 as category one (most valid). There was one category one study of information-giving and two of teaching social comeptence. There were thirteen category one studies of social influences interventions. Of these, nine found some positive effect of intervention on smoking prevalence, and four failed to detect an effect on smoking prevalence. The largest and most rigorous study, the Hutchinson Smoking Prevention Project, found no long-term effect of an intensive eight-year programme on smoking behaviour. There were three category one RCTs of combined social influences and social competence interventions: one provided significant results and one only for instruction by health educators compared to self-instruction. There was a lack of high quality evidence about the effectiveness of combinations of social influences and social competence approaches. There was one category one study providing data on social influences compared with information giving. There were four category one studies of multi-modal approaches but they provided limited evidence about the effectiveness of multi-modal approaches including community initiatives. There is one rigorous test of the effects of information-giving about smoking. There are well-conducted randomized controlled trials to test the effects of social influences interventions: in half of the group of best quality studies those in the intervention group smoke less than those in the control, but many studies failed to detect an effect of the intervention. There are only three high quality RCTs which test the effectiveness of combinations of social influences and social competence interventions, and four which test multi-modal interventions; half showed significant positive results.

A Randomized Controlled Trial of the Child Anxiety Multi-Day Program (CAMP) for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich-May, Jill

2013-01-01

While the efficacy of cognitive behavior therapy for childhood anxiety disorders, including separation anxiety disorder (SAD), has been established, tailoring such treatments to particular interests and needs may enhance uptake of evidence-based interventions. The current investigation evaluates the feasibility and preliminary efficacy of an…

A Randomized Controlled Trial of a Multi-Dose Bystander Intervention Program Using Peer Education Theater

ERIC Educational Resources Information Center

McMahon, Sarah; Winter, Samantha C.; Palmer, Jane E.; Postmus, Judy L.; Peterson, N. Andrew; Zucker, Sharon; Koenick, RuthAnne

2015-01-01

This article reports findings from a longitudinal, experimental evaluation of a peer education theater program, Students Challenging Realities and Educating Against Myths (SCREAM) Theater. This study examines the impact of SCREAM Theater on a range of bystander-related outcomes (i.e. bystander intentions, bystander efficacy, perception of friend…

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.

Comparative efficacy of diclazuril (Vecoxan®) and toltrazuril (Baycox bovis®) against natural infections of Eimeria bovis and Eimeria zuernii in French calves.

PubMed

Philippe, P; Alzieu, J P; Taylor, M A; Dorchies, Ph

2014-12-15

A blinded, randomized, controlled, multi-centric field study was conducted on French dairy farms (n = 9) to evaluate the long term efficacy of metaphylactic, single oral treatments with either 1 mg/kg body weight (BW) of diclazuril (Vecoxan®), or 15 mg/kg BW of toltrazuril (Baycox®) against natural infections with Eimeria zuernii and/or Eimeria bovis, compared to untreated control animals. A total of 199 calves from nine commercial farms aged between 21 and 55 days old at the start of study were included and randomly allocated to one of three groups. Calves on all farms were observed for a period of 78 days post treatment, using both parasitological (oocyst excretion), and clinical parameters (faecal score and body weight). The assessment of efficacy was based on both control of oocyst excretion, and on the average daily weight gains throughout the study. During the whole study period, the mean number of days with diarrhoea (≥ 2) was similar (0.7 days) between treated groups. Excretion in the untreated group peaked at 21 days after treatment. In both the diclazuril and toltrazuril-treated groups, mean oocyst excretion decreased dramatically in the five days following treatment. Thereafter, particularly towards the end of the study period, oocyst counts and percentage levels of E. zuernii were highest in the toltrazuril-treated group. In pooled data from all trial sites, the average daily weight gain was significantly (p = 0.01) higher (+ 0.057 kg/day) in the diclazuril group when compared to the toltrazuril group, and the average body weight gain of the diclazuril treated group was 4.4 kg higher than the toltrazuril group. On eight of the nine trial sites, the average daily gain was greater in the diclazuril group than in the toltrazuril group. This study demonstrates that, over an extended observation period of 78 days, metaphylactic treatment with both diclazuril and toltrazuril reduces the impact of coccidiosis, but greater performance benefits based on average daily weight gains, were achieved following the use of diclazuril. Copyright © 2014 Elsevier B.V. All rights reserved.

A multi target approach to control chemical reactions in their inhomogeneous solvent environment

NASA Astrophysics Data System (ADS)

Keefer, Daniel; Thallmair, Sebastian; Zauleck, Julius P. P.; de Vivie-Riedle, Regina

2015-12-01

Shaped laser pulses offer a powerful tool to manipulate molecular quantum systems. Their application to chemical reactions in solution is a promising concept to redesign chemical synthesis. Along this road, theoretical developments to include the solvent surrounding are necessary. An appropriate theoretical treatment is helpful to understand the underlying mechanisms. In our approach we simulate the solvent by randomly selected snapshots from molecular dynamics trajectories. We use multi target optimal control theory to optimize pulses for the various arrangements of explicit solvent molecules simultaneously. This constitutes a major challenge for the control algorithm, as the solvent configurations introduce a large inhomogeneity to the potential surfaces. We investigate how the algorithm handles the new challenges and how well the controllability of the system is preserved with increasing complexity. Additionally, we introduce a way to statistically estimate the efficiency of the optimized laser pulses in the complete thermodynamical ensemble.

Six weeks of multi-station program on the knee proprioception and performance of futsal players.

PubMed

Pérez-Silvestre, Ángel; Albert-Lucena, Daniel; Gómez-Chiguano, Guido F; Plaza-Manzano, Gustavo; Pecos-Martín, Daniel; Gallego-Izquierdo, Tomás; Martín-Casas, Patricia; Romero-Franco, Natalia

2018-03-27

Proprioception and vertical jump are important parameters in the performance and prevention of injuries in futsal. However, very few studies have analyzed the role of multi-station exercises to improve these variables. The purpose of this study was to assess the effects of a six-week multi-station exercise program on knee joint position sense (JPS) and countermovement jump (CMJ) of futsal players. Thirty-four male futsal players randomly classified into experimental (n = 17) or control group (n = 17). The experimental group included a multi-station exercise protocol to their training routines (2 times/week - 6 weeks); the control group continued their training routines. All the players completed similar training routines outside of the multi-station exercises. Before (baseline), just after the intervention (Post6Wk) and four weeks later (Post10Wk), CMJ and knee JPS (absolute, relative and variable angular error: AAE, RAE and VAE, respectively) were evaluated. ANOVA showed that the experimental group significantly decreased VAE at Post10Wk compared to baseline, suggestive of greater proprioceptive precision, while the control group significantly increased AAE, RAE and VAE at Post10Wk compared to baseline. The experimental group exhibited lower and thus, better AAE and VAE than the control group at Post10Wk, although no significant differences were found at Post6Wk. No significant differences was found in the CMJ. A six weeks of multi-station program may help improve proprioceptive precision of futsal players, even one month after finishing the 6-wk multi-station training program. However, this is not long enough to improve proprioceptive acuity and maximum vertical jump. Therefore, the meaningful of these results in term of performance are unclear.

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.

Effects of cooking using multi-ply cookware on absorption of potassium and vitamins: a randomized double-blind placebo control study

PubMed Central

Mori, Mari; Hamada, Atsumi; Mori, Hideki; Yamori, Yukio; Tsuda, Kinsuke

2012-01-01

This 2-week interventional study involved a randomized allocation of subjects into three groups: Group A (daily ingestion of 350 g vegetables cooked without water using multi-ply [multilayer-structured] cookware), Group B (daily ingestion of 350g vegetables; ordinary cookware) and Group C (routine living). Before and after intervention, each subject underwent health examination with 24-h urine sampling. Blood vitamin C significantly increased after intervention from the baseline in Group A (P < 0.01) and Group B (P < 0.05). β-Carotene levels also increased significantly after intervention in Group A (P < 0.01) and Group B (P < 0.01). Oxidized low-density lipoprotein decreased significantly after intervention in Group A (P < 0.01). In Group A, 24-h urinary potassium excretion increased significantly (P < 0.01) and 24-h urinary sodium (Na)/K ratio improved significantly (P < 0.05) after intervention. In conclusion, a cooking method modification with multi-ply cookware improved absorption of nutrients from vegetables and enhanced effective utilization of the antioxidant potentials of vegetable nutrients. PMID:22229802

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).

Pre-Visit Prioritization for Complex Patients with Diabetes: Randomized Trial Design and Implementation within an Integrated Health Care System

PubMed Central

Grant, Richard W; Uratsu, Connie S; Hansen, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-01-01

Background/Aims Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. Methods We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. Results This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015 – 6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) Navigating research vs. quality improvement requirements; (2) Addressing informed consent considerations; and (3) Introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for “self-learning health system” research. Conclusions By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. PMID:26820612

Flaxseed Supplementation (not Dietary Fat Restriction) Reduces Prostate Cancer Proliferation Rates in Men Presurgery

PubMed Central

Demark-Wahnefried, Wendy; Polascik, Thomas J.; George, Stephen L.; Switzer, Boyd R.; Madden, John F.; Ruffin, Mack T.; Snyder, Denise C.; Owzar, Kouros; Hars, Vera; Albala, David M.; Walther, Philip J.; Robertson, Cary N.; Moul, Judd W.; Dunn, Barbara K.; Brenner, Dean; Minasian, Lori; Stella, Philip; Vollmer, Robin T.

2009-01-01

Background Prostate cancer affects one-out-of-six men during their lifetime. Dietary factors are postulated to influence the development and progression of prostate cancer. Low-fat diets and flaxseed supplementation may offer potentially protective strategies. Methods We undertook a multi-site, randomized controlled trial to test the effects of low-fat and/or flaxseed-supplemented diets on the biology of the prostate and other biomarkers. Prostate cancer patients (n=161) scheduled at least 21 days before prostatectomy were randomly assigned to one of the following arms: 1) control (usual diet); 2) flaxseed-supplemented diet (30 g/day); 2) low-fat diet (<20% total energy); or 4) flaxseed-supplemented, low-fat diet. Blood was drawn at baseline and prior to surgery and analyzed for prostate specific antigen (PSA), sex hormone binding globulin, testosterone, insulin-like growth factor-1 and binding protein-3, c-reactive protein, and total and low density lipoprotein cholesterol. Tumors were assessed for proliferation (Ki-67, the primary endpoint) and apoptosis. Results Men were on protocol an average of 30 days. Proliferation rates were significantly lower (P < 0.002) among men assigned to the flaxseed arms. Median Ki-67 positive cells/total nuclei ratios (x100) were 1.66 (flaxseed-supplemented diet) and 1.50 (flaxseed-supplemented, low-fat diet) vs. 3.23 (control) and 2.56 (low-fat diet). No differences were observed between arms with regard to side effects, apoptosis, and most serological endpoints; however, men on low-fat diets experienced significant decreases in serum cholesterol (P=0.048). Conclusions Findings suggest that flaxseed is safe, and associated with biologic alterations that may be protective for prostate cancer. Data also further support low-fat diets to manage serum cholesterol. PMID:19064574

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

PubMed

Grant, Richard W; Uratsu, Connie S; Estacio, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-03-01

Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. Copyright © 2016 Elsevier Inc. All rights reserved.

Brief telephone-delivered cognitive-behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial

PubMed Central

Levy, Rona L.; Langer, Shelby L.; van Tilburg, Miranda A.L.; Romano, Joan M.; Murphy, Tasha B.; Walker, Lynn S.; Mancl, Lloyd A.; Claar, Robyn L.; DuPen, Melissa M.; Whitehead, William E.; Abdullah, Bisher; Swanson, Kimberly S.; Baker, Melissa D.; Stoner, Susan A.; Christie, Dennis L.; Feld, Andrew D.

2017-01-01

Pediatric functional abdominal pain disorders (FAPD) are associated with increased healthcare utilization, school absences, and poor quality of life (QoL). Cost-effective and accessible interventions are needed. This multi-site study tested the effects of a 3-session cognitive-behavioral intervention delivered to parents, in person or remotely, on the primary outcome of pain severity and secondary outcomes (process measures) of parental solicitousness, pain beliefs, catastrophizing, and child-reported coping. Additional outcomes hypothesized a priori and assessed included functional disability, quality of life, pain behavior, school absences, healthcare utilization, and gastrointestinal symptoms. The study was prospective and longitudinal (baseline, 3 and 6 months follow-up) with three randomized conditions: social learning and cognitive-behavioral therapy in-person (SLCBT) or by phone (SLCBT-R) and education/support condition by phone (ES-R). Participants were children aged 7–12 with FAPD and their parents (N = 316 dyads). While no significant treatment effect for pain severity was found, the SLCBT groups showed significantly greater improvements compared to controls on process measures of parental solicitousness, pain beliefs and catastrophizing, and additional outcomes of parent-reported functional disability, pain behaviors, child healthcare visits for abdominal pain, and (remote condition only) quality of life and missed school days. No effects were found for parent and child-reported gastrointestinal symptoms, or child-reported quality of life or coping. These findings suggest that for children with FAPD, a brief phone SLCBT for parents can be similarly effective as in-person SLCBT in changing parent responses and improving outcomes, if not reported pain and symptom report, compared to a control condition. PMID:28301859

Evaluation of postoperative antibiotic prophylaxis after liver resection: a randomized controlled trial.

PubMed

Hirokawa, Fumitoshi; Hayashi, Michihiro; Miyamoto, Yoshiharu; Asakuma, Mitsuhiro; Shimizu, Tetsunosuke; Komeda, Koji; Inoue, Yoshihiro; Uchiyama, Kazuhisa; Nishimura, Yasuichiro

2013-07-01

Antibiotic prophylaxis is frequently administered after liver resection to prevent postoperative infections. However, very few studies have examined the usefulness of antibiotic prophylaxis after liver resection. A randomized controlled trial was conducted to evaluate the postoperative antibiotic prophylaxis in patients after liver resection. A total of 241 patients scheduled to undergo liver resection were randomly assigned to the non-postoperative antibiotic group (n = 95) or the antibiotic group (n = 95). The antibiotic group was given flomoxef sodium every 12 hours for 3 days after the operation. The end point was signs of infection, surgical site infection, or infectious complications. There were no significant differences between the 2 groups in signs of infection (21.3% vs 25.5%, P = .606), the incidence of systemic inflammatory response syndrome (11.7% vs 17.0%, P = .406), infectious complications (7.5% vs 17.0%, P = .073), surgical site infection (10.6% vs 13.8%, P = .657), and remote site infection (2.1% vs 8.5%, P = .100). Postoperative antibiotic prophylaxis cannot prevent postoperative infections after liver resection, and it is thought that antibiotic prophylaxis is unnecessary and costly. Copyright © 2013 Elsevier Inc. All rights reserved.

Exergaming and older adult cognition: a cluster randomized clinical trial.

PubMed

Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

2012-02-01

Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain.

PubMed

Khadilkar, A; Milne, S; Brosseau, L; Robinson, V; Saginur, M; Shea, B; Tugwell, P; Wells, G

2005-07-20

Chronic low-back pain (LBP) affects a significant proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an adjunct to the pharmacological management of pain. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. The aim of this systematic review was to determine the effectiveness of TENS in the management of chronic LBP. We searched the Cochrane Central Register of Controlled Trials (Issue 2, 2005), MEDLINE, EMBASE and PEDro up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. The only two RCTs (175 patients) meeting eligibility criteria differed in study design, methodological quality, inclusion and exclusion criteria, type and method of TENS application, treatment schedule, co-interventions and final outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Pre-planned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations and baseline patient characteristics were not possible due to the small number of included trials. There is inconsistent evidence to support the use of TENS as a single treatment in the management of chronic LBP. Larger, multi-center, randomized controlled trials are needed to better assess the true effectiveness of TENS. Special attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low-back pain.

The effect of images of Michelle Obama's face on trick-or-treaters' dietary choices: A randomized control trial.

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

Enhancing the photon-extraction efficiency of site-controlled quantum dots by deterministically fabricated microlenses

NASA Astrophysics Data System (ADS)

Kaganskiy, Arsenty; Fischbach, Sarah; Strittmatter, André; Rodt, Sven; Heindel, Tobias; Reitzenstein, Stephan

2018-04-01

We report on the realization of scalable single-photon sources (SPSs) based on single site-controlled quantum dots (SCQDs) and deterministically fabricated microlenses. The fabrication process comprises the buried-stressor growth technique complemented with low-temperature in-situ electron-beam lithography for the integration of SCQDs into microlens structures with high yield and high alignment accuracy. The microlens-approach leads to a broadband enhancement of the photon-extraction efficiency of up to (21 ± 2)% and a high suppression of multi-photon events with g (2)(τ = 0) < 0.06 without background subtraction. The demonstrated combination of site-controlled growth of QDs and in-situ electron-beam lithography is relevant for arrays of efficient SPSs which, can be applied in photonic quantum circuits and advanced quantum computation schemes.

Secure web-based access to radiology: forms and databases for fast queries

NASA Astrophysics Data System (ADS)

McColl, Roderick W.; Lane, Thomas J.

2002-05-01

Currently, Web-based access to mini-PACS or similar databases commonly utilizes either JavaScript, Java applets or ActiveX controls. Many sites do not permit applets or controls or other binary objects for fear of viruses or worms sent by malicious users. In addition, the typical CGI query mechanism requires several parameters to be sent with the http GET/POST request, which may identify the patient in some way; this in unacceptable for privacy protection. Also unacceptable are pages produced by server-side scripts which can be cached by the browser, since these may also contain sensitive information. We propose a simple mechanism for access to patient information, including images, which guarantees security of information, makes it impossible to bookmark the page, or to return to the page after some defined length of time. In addition, this mechanism is simple, therefore permitting rapid access without the need to initially download an interface such as an applet or control. In addition to image display, the design of the site allows the user to view and save movies of multi-phasic data, or to construct multi-frame datasets from entire series. These capabilities make the site attractive for research purposes such as teaching file preparation.

LapTrain: multi-modality training curriculum for laparoscopic cholecystectomy-results of a randomized controlled trial.

PubMed

Kowalewski, K F; Garrow, C R; Proctor, T; Preukschas, A A; Friedrich, M; Müller, P C; Kenngott, H G; Fischer, L; Müller-Stich, B P; Nickel, F

2018-02-12

Multiple training modalities for laparoscopy have different advantages, but little research has been conducted on the benefit of a training program that includes multiple different training methods compared to one method only. This study aimed to evaluate benefits of a combined multi-modality training program for surgical residents. Laparoscopic cholecystectomy (LC) was performed on a porcine liver as the pre-test. Randomization was stratified for experience to the multi-modality Training group (12 h of training on Virtual Reality (VR) and box trainer) or Control group (no training). The post-test consisted of a VR LC and porcine LC. Performance was rated with the Global Operative Assessment of Laparoscopic Skills (GOALS) score by blinded experts. Training (n = 33) and Control (n = 31) were similar in the pre-test (GOALS: 13.7 ± 3.4 vs. 14.7 ± 2.6; p = 0.198; operation time 57.0 ± 18.1 vs. 63.4 ± 17.5 min; p = 0.191). In the post-test porcine LC, Training had improved GOALS scores (+ 2.84 ± 2.85 points, p < 0.001), while Control did not (+ 0.55 ± 2.34 points, p = 0.154). Operation time in the post-test was shorter for Training vs. Control (40.0 ± 17.0 vs. 55.0 ± 22.2 min; p = 0.012). Junior residents improved GOALS scores to the level of senior residents (pre-test: 13.7 ± 2.7 vs. 18.3 ± 2.9; p = 0.010; post-test: 15.5 ± 3.4 vs. 18.8 ± 3.8; p = 0.120) but senior residents remained faster (50.1 ± 20.6 vs. 25.0 ± 1.9 min; p < 0.001). No differences were found between groups on the post-test VR trainer. Structured multi-modality training is beneficial for novices to improve basics and overcome the initial learning curve in laparoscopy as well as to decrease operation time for LCs in different stages of experience. Future studies should evaluate multi-modality training in comparison with single modalities. German Clinical Trials Register DRKS00011040.

A multi-stage drop-the-losers design for multi-arm clinical trials.

PubMed

Wason, James; Stallard, Nigel; Bowden, Jack; Jennison, Christopher

2017-02-01

Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cause problems when applying for funding as the cost will also be generally highly variable. This motivates a type of design that provides the efficiency advantages of a group-sequential multi-arm multi-stage design, but has a fixed sample size. One such design is the two-stage drop-the-losers design, in which a number of experimental treatments, and a control treatment, are assessed at a prescheduled interim analysis. The best-performing experimental treatment and the control treatment then continue to a second stage. In this paper, we discuss extending this design to have more than two stages, which is shown to considerably reduce the sample size required. We also compare the resulting sample size requirements to the sample size distribution of analogous group-sequential multi-arm multi-stage designs. The sample size required for a multi-stage drop-the-losers design is usually higher than, but close to, the median sample size of a group-sequential multi-arm multi-stage trial. In many practical scenarios, the disadvantage of a slight loss in average efficiency would be overcome by the huge advantage of a fixed sample size. We assess the impact of delay between recruitment and assessment as well as unknown variance on the drop-the-losers designs.

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

PubMed

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

2017-02-01

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

Optimizing Constrained Single Period Problem under Random Fuzzy Demand

NASA Astrophysics Data System (ADS)

Taleizadeh, Ata Allah; Shavandi, Hassan; Riazi, Afshin

2008-09-01

In this paper, we consider the multi-product multi-constraint newsboy problem with random fuzzy demands and total discount. The demand of the products is often stochastic in the real word but the estimation of the parameters of distribution function may be done by fuzzy manner. So an appropriate option to modeling the demand of products is using the random fuzzy variable. The objective function of proposed model is to maximize the expected profit of newsboy. We consider the constraints such as warehouse space and restriction on quantity order for products, and restriction on budget. We also consider the batch size for products order. Finally we introduce a random fuzzy multi-product multi-constraint newsboy problem (RFM-PM-CNP) and it is changed to a multi-objective mixed integer nonlinear programming model. Furthermore, a hybrid intelligent algorithm based on genetic algorithm, Pareto and TOPSIS is presented for the developed model. Finally an illustrative example is presented to show the performance of the developed model and algorithm.

The effect of time on CPR and automated external defibrillator skills in the Public Access Defibrillation Trial

PubMed Central

Christenson, Jim; Nafziger, Sarah; Compton, Scott; Vijayaraghavan, Kris; Slater, Brian; Ledingham, Robert; Powell, Judy; McBurnie, Mary Ann

2009-01-01

Background The time to skill deterioration between primary training/retraining and further retraining in Cardiopulmonary resuscitation (CPR) and automated external defibrillation (AED) for lay-persons is unclear. The Public Access Defibrillation (PAD) Trial was a multi-center randomized controlled trial evaluating survival after CPR-only vs. CPR+AED delivered by onsite non-medical volunteer responders in out-of-hospital cardiac arrest. Aims This sub-study evaluated the relationship of time between primary training/retraining and further retraining on volunteer performance during pretest AED and CPR skill evaluation. Methods Volunteers at 1260 facilities in 24 North American regions underwent training/retraining according to facility randomization, which included an initial session and a refresher session at approximately 6 months. Before the next retraining, a CPR and AED skill test was completed for 2729 volunteers. Primary outcome for the study was assessment of global competence of CPR or AED performance (adequate vs not adequate) using Chi-square tests for trends by time interval (3, 6, 9, and 12 months). Confirmatory (GEE) logistic regression analysis, adjusted for site and potential confounders. Results The proportion of volunteers judged to be competent did not diminish by interval (3,6,9,12 months) for either CPR or AED skills. After adjusting for site and potential confounders, longer intervals before to further retraining was associated with a slightly lower likelihood of performing adequate CPR but not with AED scores. Conclusions After primary training/retraining, the CPR skills of targeted lay responders deteriorate nominally but 80% remain competent up to one year. AED skills do not significantly deteriorate and 90% of volunteers remain competent up to one year. PMID:17303309

Visual scoring of non-cavitated caries lesions and clinical trial efficiency, testing xylitol in caries active adults

PubMed Central

Brown, JP; Amaechi, BT; Bader, JD; Gilbert, GH; Makhija, SK; Lozano-Pineda, J; Leo, MC; Chuhe, C; Vollmer, WM

2013-01-01

Objectives To better understand the effectiveness of xylitol in caries prevention in adults, and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X-ACT), non-cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 grams/day of xylitol, consumed by dissolving in the mouth five 1 gram lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21–80, with complete data for four dental examinations were selected from the 691 randomized into the three year trial, conducted at three sites. Acceptable inter and intra examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized non-cavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically non-significant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non-cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non-cavitated lesion assessment in this full scale, placebo controlled, multi site, randomized, double blinded clinical trial in adults experiencing dental caries, did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration ClinicalTrials.Gov NCT00393055 PMID:24205951

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

PubMed

Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

2015-07-10

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

multi-dice: r package for comparative population genomic inference under hierarchical co-demographic models of independent single-population size changes.

PubMed

Xue, Alexander T; Hickerson, Michael J

2017-11-01

Population genetic data from multiple taxa can address comparative phylogeographic questions about community-scale response to environmental shifts, and a useful strategy to this end is to employ hierarchical co-demographic models that directly test multi-taxa hypotheses within a single, unified analysis. This approach has been applied to classical phylogeographic data sets such as mitochondrial barcodes as well as reduced-genome polymorphism data sets that can yield 10,000s of SNPs, produced by emergent technologies such as RAD-seq and GBS. A strategy for the latter had been accomplished by adapting the site frequency spectrum to a novel summarization of population genomic data across multiple taxa called the aggregate site frequency spectrum (aSFS), which potentially can be deployed under various inferential frameworks including approximate Bayesian computation, random forest and composite likelihood optimization. Here, we introduce the r package multi-dice, a wrapper program that exploits existing simulation software for flexible execution of hierarchical model-based inference using the aSFS, which is derived from reduced genome data, as well as mitochondrial data. We validate several novel software features such as applying alternative inferential frameworks, enforcing a minimal threshold of time surrounding co-demographic pulses and specifying flexible hyperprior distributions. In sum, multi-dice provides comparative analysis within the familiar R environment while allowing a high degree of user customization, and will thus serve as a tool for comparative phylogeography and population genomics. © 2017 The Authors. Molecular Ecology Resources Published by John Wiley & Sons Ltd.

Effectiveness of Activity-Based Therapy in Comparison with Surface Spinal Stimulation in People with Traumatic Incomplete Spinal Cord Injury for Activation of Central Pattern Generator for Locomotion: Study Protocol for a 24-Week Randomized Controlled Trial.

PubMed

Bedi, Parneet Kaur; Arumugam, Narkeesh; Chhabra, Harvinder Singh

2018-06-01

A multi-centric randomized controlled trial to be conducted at two sites, department of phyhysiotherapypy, Punjabi University, Patiala and rehabilitation department, Indian Spinal Injury Centre, New Delhi, India. To determine the effectiveness of activity-based therapy in comparison with surface spinal stimulation (SSS) in traumatic incomplete spinal cord injury (SCI) with special reference to locomotion-a central pattern generator controlled function. A major goal for many patients after SCI is to regain the function of locomotion. It is crucial that rehabilitation strives to maximize locomotor ability and functional recovery after SCI. Experimental evidence of improvement in stepping and motor control after activity-based training in animal models and human SCI has been translated into clinical neuro-rehabilitation. Control group participants will undertake an intensive 24-week duration thrice weekly program of activity-based therapy. In addition to this the participants in experimental group will also receive a session of 45 minutes of SSS on thrice weekly basis. The primary analysis for our study will be at 24 weeks. Linear regression will be used to determine the mean between-group differences and 95% confidence interval for all continuous outcomes using baseline scores and group allocation as covariates. The primary outcome measure is improvement in the level of walking index for SCI-II. The secondary outcome measures are modified Ashworth scale, Penn spasm frequency score, spinal cord independence measure-III, SCI functional ambulation inventory, Hoffman's reflex, somatosensory evoked potential, and American Spinal Injury Association Impairment Scale scores. An insight into training-induced mechanisms will be of great importance to fine tune such combined treatments and vindicate their efficacy in restoration of locomotion and functional activities in individuals with SCI.

Signaling networks in TMPRSS2-ERG positive prostate cancers: Do we need a Pied Piper or sharpshooter to deal with "at large" fused oncoprotein.

PubMed

Lin, X; Qureshi, M Z; Romero, M A; Yaylim, I; Arif, S; Ucak, I; Fayyaz, S; Farooqi, A A; Mansoor, Q; Ismail, M

2017-02-28

Overwhelmingly increasing scientific evidence has provided near complete resolution of prostate cancer landscape and it is now more understandable that wide ranging factors underlies its development and progression. Increasingly it is being realized that genetic/epigenetic factors, Intra-tumoral and inter-tumoral heterogeneity, loss of apoptosis, dysregulations of spatio-temporally controlled signaling cascades, Darwinian evolution in response to therapeutic pressures play instrumental role in prostate carcinogenesis. Moreover, multi-directional patterns of spread between primary tumors and metastatic sites have also been studied extensively in prostate cancer. Research over the years has gradually and systematically revealed closer association between tumor phenotype and type of gene fusion. Latest developments in deep sequencing technologies have shown that gene fusions originate in a non-random, cell type dependent manner and are much more frequent than previously surmised. These findings enabled sub-classification and categorization of seemingly identical diseases. Furthermore, research methodologies have shown that many gene fusions inform us about risk stratification and many chimeric proteins encoded by the fused genes are being studied as drug target/s. We partition this multi-component review into the molecular basis of formation of fusion transcripts, how protein network is regulated in fusion positive prostate cancer cells and therapeutic strategies which are currently being investigated to efficiently target fusion transcript and its protein product.

Optimum random and age replacement policies for customer-demand multi-state system reliability under imperfect maintenance

NASA Astrophysics Data System (ADS)

Chen, Yen-Luan; Chang, Chin-Chih; Sheu, Dwan-Fang

2016-04-01

This paper proposes the generalised random and age replacement policies for a multi-state system composed of multi-state elements. The degradation of the multi-state element is assumed to follow the non-homogeneous continuous time Markov process which is a continuous time and discrete state process. A recursive approach is presented to efficiently compute the time-dependent state probability distribution of the multi-state element. The state and performance distribution of the entire multi-state system is evaluated via the combination of the stochastic process and the Lz-transform method. The concept of customer-centred reliability measure is developed based on the system performance and the customer demand. We develop the random and age replacement policies for an aging multi-state system subject to imperfect maintenance in a failure (or unacceptable) state. For each policy, the optimum replacement schedule which minimises the mean cost rate is derived analytically and discussed numerically.

Application of Deep Learning of Multi-Temporal SENTINEL-1 Images for the Classification of Coastal Vegetation Zone of the Danube Delta

NASA Astrophysics Data System (ADS)

Niculescu, S.; Ienco, D.; Hanganu, J.

2018-04-01

Land cover is a fundamental variable for regional planning, as well as for the study and understanding of the environment. This work propose a multi-temporal approach relying on a fusion of radar multi-sensor data and information collected by the latest sensor (Sentinel-1) with a view to obtaining better results than traditional image processing techniques. The Danube Delta is the site for this work. The spatial approach relies on new spatial analysis technologies and methodologies: Deep Learning of multi-temporal Sentinel-1. We propose a deep learning network for image classification which exploits the multi-temporal characteristic of Sentinel-1 data. The model we employ is a Gated Recurrent Unit (GRU) Network, a recurrent neural network that explicitly takes into account the time dimension via a gated mechanism to perform the final prediction. The main quality of the GRU network is its ability to consider only the important part of the information coming from the temporal data discarding the irrelevant information via a forgetting mechanism. We propose to use such network structure to classify a series of images Sentinel-1 (20 Sentinel-1 images acquired between 9.10.2014 and 01.04.2016). The results are compared with results of the classification of Random Forest.

77 FR 27460 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-10

... combined. Individuals will be randomly assigned to a treatment or control group at each site. Data for the..., and 36 months. The 6-month survey is intended to gather information from treatment and control group.... Respondents: Study participants in the treatment and control groups will respond to the baseline and follow-up...

Parent satisfaction in a multi-site acute trial of risperidone in children with autism: a social validity study.

PubMed

Tierney, Elaine; Aman, Michael; Stout, David; Pappas, Krista; Arnold, L Eugene; Vitiello, Benedetto; Scahill, Lawrence; McDougle, Christopher; McCracken, James; Wheeler, Courtney; Martin, Andres; Posey, David; Shah, Bhavik

2007-03-01

Subjects who view experimental procedures as worthwhile are more likely to participate in clinical trials and comply with study procedures. Designing studies that consider the consumer's perspective will help to forge a better alliance between participants and researchers. Participant satisfaction is seldom assessed in pharmacological research. In this paper, we report on parent satisfaction in a randomized clinical trial in children with autistic disorder and severely disruptive behavior. Parents of 101 children with autism who had participated in a multi-site 8-week double-blind clinical trial of risperidone were given a questionnaire at the end to elicit their perceptions of the appropriateness and acceptability of clinical trial procedures. Ninety-six (95.0%) parents returned the questionnaire. Of these, 80.0 to 96.8%, depending on the question, expressed satisfaction with their child's research participation regardless of treatment outcome or assignment to active drug or placebo. In all, 90.5% of parents indicated that they would "definitely" recommend the clinical trial to other families with similar children. A total of 92.7% indicated that they would rejoin the clinical trial if they had to do it all over again. Ethnic minority subjects were more satisfied than white participants with the use of "learning tests". Parents of children participating in this trial were highly satisfied and supportive of the clinical trial procedures. Random assignment to drug or placebo and the clinical response of their children did not appear to influence their views. Further satisfaction studies of this sort are encouraged.

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.

Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks.

PubMed

Rosas, Scott R; Cope, Marie T; Villa, Christie; Motevalli, Mahnaz; Utech, Jill; Schouten, Jeffrey T

2014-04-01

Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks. A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units. Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms. The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings. © 2013 John Wiley & Sons Ltd.

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.

Effective techniques for the identification and accommodation of disturbances

NASA Technical Reports Server (NTRS)

Johnson, C. D.

1989-01-01

The successful control of dynamic systems such as space stations, or launch vehicles, requires a controller design methodology that acknowledges and addresses the disruptive effects caused by external and internal disturbances that inevitably act on such systems. These disturbances, technically defined as uncontrollable inputs, typically vary with time in an uncertain manner and usually cannot be directly measured in real time. A relatively new non-statistical technique for modeling, and (on-line) identification, of those complex uncertain disturbances that are not as erratic and capricious as random noise is described. This technique applies to multi-input cases and to many of the practical disturbances associated with the control of space stations, or launch vehicles. Then, a collection of smart controller design techniques that allow controlled dynamic systems, with possible multi-input controls, to accommodate (cope with) such disturbances with extraordinary effectiveness are associated. These new smart controllers are designed by non-statistical techniques and typically turn out to be unconventional forms of dynamic linear controllers (compensators) with constant coefficients. The simplicity and reliability of linear, constant coefficient controllers is well-known in the aerospace field.

What is the benefit of driving a hydrological model with data from a multi-site weather generator compared to data from a simple delta change approach?"

NASA Astrophysics Data System (ADS)

Rössler, Ole; Keller, Denise; Fischer, Andreas

2016-04-01

In 2011 the Swiss national consortium C2SM providednew climate change scenarios were released in Switzerland that came with a comprehensive data set of temperature and precipitation changes under climate change conditions for every a large network of meteorological stations, and for aggregated as well as regions in across Switzerland. These climate change signals were generated for three emission scenarios and three different future time-periods and designed to be used asbased on a delta change factors approach. This data set proved to be very successful in Switzerland as many different users, researchers, private companies, and societal users were able to use and interpret the climate data set. Thus, a range of applications that are all based on the same climate data set enabled a comparable view on climate change impact in several disciplines. The main limitation and criticism to this data set was the usage of the delta change approach for downscaling as it comes with severe limitations such as underestimatinges changes in extreme values and neglecting changes in variability and changes in temporal sequencesneglecting changes in variability, be it year-to-year or day-to-day, and changes in temporal sequences . lacks a change in the day-to-day-variability. One way to overcome this the latter limitation is the usage of stochastic weather generators in a downscaling context. Weather generators are known to be one suitable downscaling technique, but A common limitation of most weather generators is the absence of spatial consistency rrelation in the generated daily time-series, resulting in an underestimation of areal means over several stations that are often low-biased. refer to one point scale (single-site) and lacks the spatial representation of weather. The latter A realistic representation of the inter-station correlation in the downscaled time-series This is of high particular importance in some impact studies, especially infor any hydrological impact studiesy. Recently, a multi-site weather generator was developed and tested for downscaling purposes over Switzerland. The weather generator is of type Richardson, that is run with spatially correlated random number streams to ensure spatial consistency. As a downside, multi-site weather generators are much more complex to develop, but they are a very promising alternative downscaling technique. A new multi-site-weather generator was developed for Switzerland in a previous study (Keller et al. 2014). In this study, we tested this new multi-site-weather generator against the "standard" delta change derived data in a hydrological impact assessment study that focused on runoff in the meso-scale catchment of the river Thur catchment. Two hydrological models of different complexity were run with the data sets under present (1980-2009) and under future conditions (2070-2099), assuming the SRES A1B emission2070-2100 scenario conditions. Eight meteorological stations were used to interpolate a meteorological field that served as input to calibrate and validate the two hydrological models against runoff. The downscaling intercomparison was done for We applied 10 GCM-RCM combinations simulations of the ENSEMBLES. In case of the weather generator, that allows for multiple synthetic realizations, we generated for which change factors for each station (delta change approach) were available and generated 25 realizations of multi-site weather. with each climate model projection. Results show that the delta change driven data constitutes only one appropriate representation compared to theof a bandwidth of runoff projections yielded by the multi-site weather generator data. Especially oOn average, differences between both the two approaches are small. Low and high runoff Runoff values to both extremes are however better reproduced with the weather generator driven data set. The stochastic representation of multiday rainfall events are considered as the main reason. Hence, tThere is a clear yet small added value to the delta change approach that in turn performs rather well. Although these small but considerable differences might questioning the need to construct a multi-site-weather generator with a huge effort, the potential and possibilities to further develop the multi-site weather generator is undoubted.

Development of quality control and instrumentation performance metrics for diffuse optical spectroscopic imaging instruments in the multi-center clinical environment

NASA Astrophysics Data System (ADS)

Keene, Samuel T.; Cerussi, Albert E.; Warren, Robert V.; Hill, Brian; Roblyer, Darren; Leproux, AnaÑ--s.; Durkin, Amanda F.; O'Sullivan, Thomas D.; Haghany, Hosain; Mantulin, William W.; Tromberg, Bruce J.

2013-03-01

Instrument equivalence and quality control are critical elements of multi-center clinical trials. We currently have five identical Diffuse Optical Spectroscopic Imaging (DOSI) instruments enrolled in the American College of Radiology Imaging Network (ACRIN, #6691) trial located at five academic clinical research sites in the US. The goal of the study is to predict the response of breast tumors to neoadjuvant chemotherapy in 60 patients. In order to reliably compare DOSI measurements across different instruments, operators and sites, we must be confident that the data quality is comparable. We require objective and reliable methods for identifying, correcting, and rejecting low quality data. To achieve this goal, we developed and tested an automated quality control algorithm that rejects data points below the instrument noise floor, improves tissue optical property recovery, and outputs a detailed data quality report. Using a new protocol for obtaining dark-noise data, we applied the algorithm to ACRIN patient data and successfully improved the quality of recovered physiological data in some cases.

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 intervention (six studies: pooled rate 1.3% baseline compared with 0.9% intervention, pooled RR 0.57, 95% CI 0.31-1.06). Evidence-based bundles are associated with a significant reduction in surgical site infection after cesarean delivery.

Sensorimotor Assessment and Rehabilitative Apparatus

DTIC Science & Technology

2016-10-01

Support: Title: Tinnitus Retraining Treatment Trial Data Coordinating Center (TRTT) (GRANT RECENTLY ENDED) Grant Number/PI: U01 DC007422 (Scherer...Description of project’s goals: The Tinnitus Retraining Therapy Trial is a multi-center randomized controlled trial testing the efficacy of tinnitus ...retraining therapy versus usual care as a treatment for severe debilitating tinnitus in patients with functionally normal hearing. Title

75 FR 6033 - Agency Information Collection Request; 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Initial Telephone Screen........ Active Control 2400 1 20 minutes 800 hours Group (ACG)/ Experimental Group (EG) In-person interview EG 1200 1 1.25 hours 1,500 hours Jump start phone call EG 1200 1 30... care insurance who are age 75 and over using a multi- tiered random experimental research design to...

75 FR 19976 - Agency Information Collection Request; 30-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

...) hours Initial Telephone Screen...... Experimental 240 1 20/60 80 Group. In-person interview 240 1 80/60... Telephone Screen...... Active Control 240 1 20/60 80 Group. Quarterly phone calls......... 240 4 10/60 160... private long-term care insurance who are age 75 and over using a multi- tiered random experimental...

Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non obese humans

USDA-ARS?s Scientific Manuscript database

Calorie restriction (CR) inhibits inflammation and slows aging in many animal species, but in rodents housed in pathogen-free facilities, CR impairs immunity against certain pathogens. However, little is known about the effects of long-term moderate CR on immune function in humans. In this multi-cen...

Using multi-trait and random regression models to identify genetic variation in tolerance of pigs to Porcine Reproductive and Respiratory Syndrome virus

USDA-ARS?s Scientific Manuscript database

Background A host can adopt two response strategies to infection: resistance (reduce pathogen load) and tolerance (minimize impact of infection on performance). Both strategies may be under genetic control and could thus be targeted for genetic improvement. Although there is evidence in support of a...

Making Healthy Eating and Physical Activity Policy Practice: Process Evaluation of a Group Randomized Controlled Intervention in Afterschool Programs

ERIC Educational Resources Information Center

Weaver, R. Glenn; Beets, Michael W.; Hutto, Brent; Saunders, Ruth P.; Moore, Justin B.; Turner-McGrievy, Gabrielle; Huberty, Jennifer L.; Ward, Dianne S.; Pate, Russell R.; Beighle, Aaron; Freedman, Darcy

2015-01-01

This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying…

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

PubMed

Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

2017-01-01

We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

Immersive telepresence system using high-resolution omnidirectional movies and a locomotion interface

NASA Astrophysics Data System (ADS)

Ikeda, Sei; Sato, Tomokazu; Kanbara, Masayuki; Yokoya, Naokazu

2004-05-01

Technology that enables users to experience a remote site virtually is called telepresence. A telepresence system using real environment images is expected to be used in the field of entertainment, medicine, education and so on. This paper describes a novel telepresence system which enables users to walk through a photorealistic virtualized environment by actual walking. To realize such a system, a wide-angle high-resolution movie is projected on an immersive multi-screen display to present users the virtualized environments and a treadmill is controlled according to detected user's locomotion. In this study, we use an omnidirectional multi-camera system to acquire images real outdoor scene. The proposed system provides users with rich sense of walking in a remote site.

Real-time simultaneous and proportional myoelectric control using intramuscular EMG

PubMed Central

Kuiken, Todd A; Hargrove, Levi J

2014-01-01

Objective Myoelectric prostheses use electromyographic (EMG) signals to control movement of prosthetic joints. Clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom (DOFs); however, the use of implantable devices that record intramuscular EMG signals could overcome this constraint. The objective of this study was to evaluate the real-time simultaneous control of three DOFs (wrist rotation, wrist flexion/extension, and hand open/close) using intramuscular EMG. Approach We evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire EMG: (i) parallel dual-site differential control, which enabled simultaneous control of three DOFs and (ii) pattern recognition control, which required sequential control of DOFs. Main Results Over the course of the experiment, subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a Fitts' Law test. By the end of the experiment, performance using parallel dual-site control was significantly better (up to a 25% increase in throughput) than when using sequential pattern recognition control for tasks requiring multiple DOFs. The learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible. Subjects occasionally experienced difficulty in performing isolated single-DOF movements with parallel dual-site control but were able to accomplish related Fitts' Law tasks with high levels of path efficiency. Significance These results suggest that intramuscular EMG, used in a parallel dual-site configuration, can provide simultaneous control of a multi-DOF prosthetic wrist and hand and may outperform current methods that enforce sequential control. PMID:25394366

Real-time simultaneous and proportional myoelectric control using intramuscular EMG

NASA Astrophysics Data System (ADS)

Smith, Lauren H.; Kuiken, Todd A.; Hargrove, Levi J.

2014-12-01

Objective. Myoelectric prostheses use electromyographic (EMG) signals to control movement of prosthetic joints. Clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom (DOFs); however, the use of implantable devices that record intramuscular EMG signals could overcome this constraint. The objective of this study was to evaluate the real-time simultaneous control of three DOFs (wrist rotation, wrist flexion/extension, and hand open/close) using intramuscular EMG. Approach. We evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire EMG: (i) parallel dual-site differential control, which enabled simultaneous control of three DOFs and (ii) pattern recognition control, which required sequential control of DOFs. Main results. Over the course of the experiment, subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a Fitts’ Law test. By the end of the experiment, performance using parallel dual-site control was significantly better (up to a 25% increase in throughput) than when using sequential pattern recognition control for tasks requiring multiple DOFs. The learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible. Subjects occasionally experienced difficulty in performing isolated single-DOF movements with parallel dual-site control but were able to accomplish related Fitts’ Law tasks with high levels of path efficiency. Significance. These results suggest that intramuscular EMG, used in a parallel dual-site configuration, can provide simultaneous control of a multi-DOF prosthetic wrist and hand and may outperform current methods that enforce sequential control.

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

[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 surgical site infections.

Smart Care Based on Telemonitoring and Telemedicine for Type 2 Diabetes Care: Multi-center Randomized Controlled Trial.

PubMed

Jeong, Ji Yun; Jeon, Jae-Han; Bae, Kwi-Hyun; Choi, Yeon-Kyung; Park, Keun-Gyu; Kim, Jung-Guk; Won, Kyu Chang; Cha, Bong Soo; Ahn, Chul Woo; Kim, Dong Won; Lee, Chang Hee; Lee, In-Kyu

2018-01-17

This study was performed to determine the effectiveness of the Smart Care service on glucose control based on telemedicine and telemonitoring compared with conventional treatment in patients with type 2 diabetes. This 24-week prospective multi-center randomized controlled trial involved 338 adult patients with type 2 diabetes at four university hospitals in South Korea. The patients were randomly assigned to a control group (group A, n = 113), a telemonitoring group (group B, n = 113), or a telemedicine group (group C, n = 112). Patients in the telemonitoring group visited the outpatient clinic regularly, accompanied by an additional telemonitoring service that included remote glucose monitoring with automated patient decision support by text. Remote glucose monitoring was identical in the telemedicine group, but assessment by outpatient visits was replaced by video conferencing with an endocrinologist. The adjusted net reductions in HbA1c concentration after 24 weeks were similar in the conventional, telemonitoring, and telemedicine groups (-0.66% ± 1.03% vs. -0.66% ± 1.09% vs. -0.81% ± 1.05%; p > 0.05 for each pairwise comparison). Fasting glucose concentrations were lower in the telemonitoring and telemedicine groups than in the conventional group. Rates of hypoglycemia were lower in the telemedicine group than in the other two groups, and compliance with medication was better in the telemonitoring and telemedicine than in the conventional group. No serious adverse events were associated with telemedicine. Telehealthcare was as effective as conventional care at improving glycemia in patients with type 2 diabetes without serious adverse effects.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

PubMed

Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

2018-02-01

Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

Insight into Best Variables for COPD Case Identification: A Random Forests Analysis.

PubMed

Leidy, Nancy K; Malley, Karen G; Steenrod, Anna W; Mannino, David M; Make, Barry J; Bowler, Russ P; Thomashow, Byron M; Barr, R G; Rennard, Stephen I; Houfek, Julia F; Yawn, Barbara P; Han, Meilan K; Meldrum, Catherine A; Bacci, Elizabeth D; Walsh, John W; Martinez, Fernando

This study is part of a larger, multi-method project to develop a questionnaire for identifying undiagnosed cases of chronic obstructive pulmonary disease (COPD) in primary care settings, with specific interest in the detection of patients with moderate to severe airway obstruction or risk of exacerbation. To examine 3 existing datasets for insight into key features of COPD that could be useful in the identification of undiagnosed COPD. Random forests analyses were applied to the following databases: COPD Foundation Peak Flow Study Cohort (N=5761), Burden of Obstructive Lung Disease (BOLD) Kentucky site (N=508), and COPDGene® (N=10,214). Four scenarios were examined to find the best, smallest sets of variables that distinguished cases and controls:(1) moderate to severe COPD (forced expiratory volume in 1 second [FEV 1 ] <50% predicted) versus no COPD; (2) undiagnosed versus diagnosed COPD; (3) COPD with and without exacerbation history; and (4) clinically significant COPD (FEV 1 <60% predicted or history of acute exacerbation) versus all others. From 4 to 8 variables were able to differentiate cases from controls, with sensitivity ≥73 (range: 73-90) and specificity >68 (range: 68-93). Across scenarios, the best models included age, smoking status or history, symptoms (cough, wheeze, phlegm), general or breathing-related activity limitation, episodes of acute bronchitis, and/or missed work days and non-work activities due to breathing or health. Results provide insight into variables that should be considered during the development of candidate items for a new questionnaire to identify undiagnosed cases of clinically significant COPD.

A Systematic Review of Randomized Controlled Trials Examining the Effectiveness of Saffron (Crocus sativus L.) on Psychological and Behavioral Outcomes

PubMed Central

Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

2017-01-01

Introduction Throughout the past three decades, increased scientific attention has been given to examining saffron’s (Crocus sativus L.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. Saffron has been shown to improve numerous health-related physiological to psychological outcomes. The purpose of this systematic review is to examine and categorize the current state of scientific evidence from randomized controlled trials (RCTs) regarding the efficacy of saffron on psychological and behavioral outcomes. Methods Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)”. Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. Results Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes with respect to the following health conditions: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efficacy of saffron in improving: depressive symptoms, premenstrual symptoms, sexual function, and satiety. Conclusion Findings from initial clinical trials suggest that saffron can improve the symptoms and effects of depression, premenstrual syndrome, sexual dysfunction and infertility, and excessive snacking behaviors. Larger multi-site clinical trials are needed to extend these preliminary findings. PMID:26165367

The Use of Mentoring Programs to Improve Energy Balance Behaviors in High Risk Children

PubMed Central

Haire-Joshu, Debra; Nanney, Marilyn S.; Elliott, Michael; Davey, Cynthia; Caito, Nicole; Loman, Deborah; Brownson, Ross; Kreuter, Matthew

2013-01-01

Introduction This study tested the impact of “Partners of all Ages Reading About Diet and Exercise” (PARADE), an energy balance intervention incorporated into child mentoring programs. Methods We used a group randomized nested cohort design which randomized mentoring program sites (n=112) and children (N = 296; age=8.5 years) to intervention or usual care conditions. PARADE mentors delivered 8 lesson plans, 8 child-focused computer-tailored storybooks, and 8 parent action support newsletters addressing positive diet and activity behavior patterns. Results When compared to the control group, PARADE children were more knowledgeable of diet and activity guidelines (p<0.01), challenged themselves more to eat 5 fruits and vegetables per day (p=0.04) and to be active one hour daily (p=0.02). Calories from high fat foods decreased in overweight/obese children (p=0.05) but not for normal weight children. There were no significant differences in percent time being active. Among parents there were no significant differences between PARADE and control groups. PARADE parents did report an increase in minutes of walking (p=.13) and modeling activity behaviors to their child (p=.12). Discussion PARADE motivated high needs children to develop healthy energy balance patterns. Children need to be supported by stronger parental involvement and behavior change in providing a positive food and activity environment. Conclusion PARADE provides evidence for the use of multi-component, community-based approaches to reach high risk children and their parents as a routine component of their mentoring experience. PMID:20107465

Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial.

PubMed

Renner, Regina-Maria; Edelman, Alison B; Nichols, Mark D; Jensen, Jeffrey T; Lim, Jeong Y; Bednarek, Paula H

2016-11-01

Our objective was to evaluate two different aspects of the paracervical block (PCB) technique for first trimester surgical abortion, to compare a 3-min wait prior to cervical dilation to no wait and to compare four-site with two-site injection. We conducted two consecutive randomized, single-blinded noninferiority trials. In the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with either a 3-min wait between PCB injection and dilation or no wait. In the second trial, we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at additional time points, anxiety, satisfaction and adverse events. Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD, 32mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68 mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because the confidence interval of the mean pain score difference between groups included the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed the four-site PCB to be superior to the two-site PCB. It remained inconclusive whether a 3-min wait time between PCB and cervical dilation provides noninferior pain control for first trimester surgical abortion. However, a four-site PCB appeared to be superior to a two-site PCB. It remained inconclusive whether a 3-min wait time between PCB and cervical dilation or using a two-site instead of a four-site PCB provided noninferior pain control for first trimester surgical abortion. This study did not assess whether the combination of the two separate factors provides additive benefit. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. Via the inhibition of inflammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesis and growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin contains EPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healing in thermally injured patients. Methods/Design This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. Discussion We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. Trial registration EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824. PMID:23782555

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

The At Home/Chez Soi trial protocol: a pragmatic, multi-site, randomised controlled trial of a Housing First intervention for homeless individuals with mental illness in five Canadian cities

PubMed Central

Streiner, David L; Adair, Carol; Aubry, Tim; Barker, Jayne; Distasio, Jino; Hwang, Stephen W; Komaroff, Janina; Latimer, Eric; Somers, Julian; Zabkiewicz, Denise M

2011-01-01

Introduction Housing First is a complex housing and support intervention for homeless individuals with mental health problems. It has a sufficient knowledge base and interest to warrant a test of wide-scale implementation in various settings. This protocol describes the quantitative design of a Canadian five city, $110 million demonstration project and provides the rationale for key scientific decisions. Methods A pragmatic, mixed methods, multi-site field trial of the effectiveness of Housing First in Vancouver, Winnipeg, Toronto, Montreal and Moncton, is randomising approximately 2500 participants, stratified by high and moderate need levels, into intervention and treatment as usual groups. Quantitative outcome measures are being collected over a 2-year period and a qualitative process evaluation is being completed. Primary outcomes are housing stability, social functioning and, for the economic analyses, quality of life. Hierarchical linear modelling is the primary data analytic strategy. Ethics and dissemination Research ethics board approval has been obtained from 11 institutions and a safety and adverse events committee is in place. The results of the multi-site analyses of outcomes at 12 months and 2 years will be reported in a series of core scientific journal papers. Extensive knowledge exchange activities with non-academic audiences will occur throughout the duration of the project. Trial registration number This study has been registered with the International Standard Randomised Control Trial Number Register and assigned ISRCTN42520374. PMID:22102645

Multi-parameter fiber optic sensors based on fiber random grating

NASA Astrophysics Data System (ADS)

Xu, Yanping; Zhang, Mingjiang; Lu, Ping; Mihailov, Stephen; Bao, Xiaoyi

2017-04-01

Two novel configurations of multi-parameter fiber-optic sensing systems based on the fiber random grating are reported. The fiber random grating is fabricated through femtosecond laser induced refractive index modification over a 10cm standard telecom single mode fiber. In one configuration, the reflective spectrum of the fiber random grating is directly detected and a wavelength-division spectral cross-correlation algorithm is adopted to extract the spectral shifts for simultaneous measurement of temperature, axial strain, and surrounding refractive index. In the other configuration, a random fiber ring laser is constructed by incorporating the random feedback from the random grating. Numerous polarization-dependent spectral filters are formed along the random grating and superimposed to provide multiple lasing lines with high signal-to-noise ratio up to 40dB, which enables a high-fidelity multi-parameter sensing scheme by monitoring the spectral shifts of the lasing lines. Without the need of phase mask for fabrication and with the high physical strength, the random grating based sensors are much simpler and more compact, which could be potentially an excellent alternative for liquid medical sample sensing in biomedical and biochemical applications.

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

A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries.

PubMed

Humeniuk, Rachel; Ali, Robert; Babor, Thomas; Souza-Formigoni, Maria Lucia O; de Lacerda, Roseli Boerngen; Ling, Walter; McRee, Bonnie; Newcombe, David; Pal, Hemraj; Poznyak, Vladimir; Simon, Sara; Vendetti, Janice

2012-05-01

This study evaluated the effectiveness of a brief intervention (BI) for illicit drugs (cannabis, cocaine, amphetamine-type stimulants and opioids) linked to the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The ASSIST screens for problem or risky use of 10 psychoactive substances, producing a score for each substance that falls into either a low-, moderate- or high-risk category. Prospective, randomized controlled trial in which participants were either assigned to a 3-month waiting-list control condition or received brief motivational counselling lasting an average of 13.8 minutes for the drug receiving the highest ASSIST score. Primary health-care settings in four countries: Australia, Brazil, India and the United States. A total of 731 males and females scoring within the moderate-risk range of the ASSIST for cannabis, cocaine, amphetamine-type stimulants or opioids. ASSIST-specific substance involvement scores for cannabis, stimulants or opioids and ASSIST total illicit substance involvement score at baseline and 3 months post-randomization. Omnibus analyses indicated that those receiving the BI had significantly reduced scores for all measures, compared with control participants. Country-specific analyses showed that, with the exception of the site in the United States, BI participants had significantly lower ASSIST total illicit substance involvement scores at follow-up compared with the control participants. The sites in India and Brazil demonstrated a very strong brief intervention effect for cannabis scores (P < 0.005 for both sites), as did the sites in Australia (P < 0.005) and Brazil (P < 0.01) for stimulant scores and the Indian site for opioid scores (P < 0.01). The Alcohol, Smoking and Substance Involvement Screening Test-linked brief intervention aimed at reducing illicit substance use and related risks is effective, at least in the short term, and the effect generalizes across countries. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Probability-based constrained MPC for structured uncertain systems with state and random input delays

NASA Astrophysics Data System (ADS)

Lu, Jianbo; Li, Dewei; Xi, Yugeng

2013-07-01

This article is concerned with probability-based constrained model predictive control (MPC) for systems with both structured uncertainties and time delays, where a random input delay and multiple fixed state delays are included. The process of input delay is governed by a discrete-time finite-state Markov chain. By invoking an appropriate augmented state, the system is transformed into a standard structured uncertain time-delay Markov jump linear system (MJLS). For the resulting system, a multi-step feedback control law is utilised to minimise an upper bound on the expected value of performance objective. The proposed design has been proved to stabilise the closed-loop system in the mean square sense and to guarantee constraints on control inputs and system states. Finally, a numerical example is given to illustrate the proposed results.

A comparison of single- and multi-site calibration and validation: a case study of SWAT in the Miyun Reservoir watershed, China

NASA Astrophysics Data System (ADS)

Bai, Jianwen; Shen, Zhenyao; Yan, Tiezhu

2017-09-01

An essential task in evaluating global water resource and pollution problems is to obtain the optimum set of parameters in hydrological models through calibration and validation. For a large-scale watershed, single-site calibration and validation may ignore spatial heterogeneity and may not meet the needs of the entire watershed. The goal of this study is to apply a multi-site calibration and validation of the Soil andWater Assessment Tool (SWAT), using the observed flow data at three monitoring sites within the Baihe watershed of the Miyun Reservoir watershed, China. Our results indicate that the multi-site calibration parameter values are more reasonable than those obtained from single-site calibrations. These results are mainly due to significant differences in the topographic factors over the large-scale area, human activities and climate variability. The multi-site method involves the division of the large watershed into smaller watersheds, and applying the calibrated parameters of the multi-site calibration to the entire watershed. It was anticipated that this case study could provide experience of multi-site calibration in a large-scale basin, and provide a good foundation for the simulation of other pollutants in followup work in the Miyun Reservoir watershed and other similar large areas.

HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention.

PubMed

Linde, Jennifer A; Nygaard, Katherine E; MacLehose, Richard F; Mitchell, Nathan R; Harnack, Lisa J; Cousins, Julie M; Graham, Daniel J; Jeffery, Robert W

2012-02-16

U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1) measured height and weight; 2) online surveys of individual dietary intake and physical activity behaviors; and 3) detailed worksite environment assessment. Mean participant age was 42.9 years (range 18-75), 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m(2) (range 16.9-61.2 kg/m(2)). A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36). Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. ClinicalTrials.gov: NCT00708461.

Multi-compartment medication devices and patient compliance.

PubMed

McGraw, Caroline

2004-07-01

Multi-compartment medication compliance devices are widely used in primary care. The aim of this review is to reveal whether they are effective in promoting adherence among non-adherent adults living at home. Searches were undertaken using two electronic databases (Medline (1966-2003) and International Pharmaceutical Abstracts (1970-2002)). Only randomized controlled trials (including crossover studies) were included in the review. Participants had to be non-institutionalized adults receiving one or more prescription medicines each day and displaying problems with adherence. Studies had to compare multi-compartment medication compliance devices to standard packaging and outcome measures and to include either pill counts, biological assays and/or clinical response. Articles were selected if they described a follow up period of at least three months and demonstrated that over 80% of participants had completed the trial. Two studies were identified that met the criteria, reporting data on a total of 148 patients. The findings from the first study found diabetic patients receiving medication in a compliance device demonstrated better glucose control than patients receiving medication in standard packaging. The second study found compliance devices had no impact on blood pressure control in hypertensive patients. Further research needs to be conducted to assess the effectiveness of multi-compartment medication compliance devices in promoting adherence among non-adherent adults living at home.

Ultrasound enhanced thrombolysis: Clinical evidence

NASA Astrophysics Data System (ADS)

Alexandrov, Andrei V.

2005-04-01

Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

PubMed

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation.

PubMed

McGuire, Michael K; Scheyer, E Todd

2014-10-01

The standard of care for increasing keratinized tissue (KT) and vestibular area is an autogenous free gingival graft (FGG) and vestibuloplasty; however, there is morbidity associated with the harvest of autogenous tissue, and supply is limited. The purpose of this study is to determine if a xenogeneic collagen matrix (CM) might be as effective as FGG. This study is a single-masked, randomized, controlled, split-mouth study of 30 patients with insufficient zones of KT (<2 mm). It uses a within-patient treatment-comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was change in KT width (∆KT) from surgery to 6 months post-surgery. Secondary endpoints included traditional periodontal measures, such as clinical attachment level, recession, and bleeding on probing. Patient-reported pain, discomfort, and esthetic satisfaction were also recorded. Biopsies were obtained at 6 months. Surgery and postoperative sequelae were uneventful, with normal healing observed at both test and control sites. The primary outcome, ∆KT width at 6 months, did not establish non-inferiority of CM compared to FGG (P = 0.9992), with the FGG sites averaging 1.5 mm more KT width than CM sites. However, the amount of new KT generated for both therapies averaged ≥2 mm. Secondary outcomes were not significantly different between test and control sites. All site biopsies appeared as normal mucoperiosteum with keratinized epithelium. CM sites achieved better texture and color matches, and more than two-thirds of patients preferred the appearance of their CM sites. With the proviso of sufficient KT (≈2 mm in width) and study goals of lower morbidity, unlimited supply, and patient satisfaction, CM appears to be a suitable substitute for FGG in vestibuloplasty procedures designed to increase KT around teeth.

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.

Multi-Sited Global Ethnography and Travel: Gendered Journeys in Three Registers

ERIC Educational Resources Information Center

Epstein, Debbie; Fahey, Johannah; Kenway, Jane

2013-01-01

This paper joins a barely begun conversation about multi-sited and global ethnography in educational research; a conversation that is likely to intensify along with growing interest in the links between education, globalisation, internationalisation and transnationalism. Drawing on an ongoing multi-sited global ethnography of elite schools and…

Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial.

PubMed

Khan, Fakhar Z; Virdee, Mumohan S; Palmer, Christopher R; Pugh, Peter J; O'Halloran, Denis; Elsik, Maros; Read, Philip A; Begley, David; Fynn, Simon P; Dutka, David P

2012-04-24

This study sought to assess the impact of targeted left ventricular (LV) lead placement on outcomes of cardiac resynchronization therapy (CRT). Placement of the LV lead to the latest sites of contraction and away from the scar confers the best response to CRT. We conducted a randomized, controlled trial to compare a targeted approach to LV lead placement with usual care. A total of 220 patients scheduled for CRT underwent baseline echocardiographic speckle-tracking 2-dimensional radial strain imaging and were then randomized 1:1 into 2 groups. In group 1 (TARGET [Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy]), the LV lead was positioned at the latest site of peak contraction with an amplitude of >10% to signify freedom from scar. In group 2 (control) patients underwent standard unguided CRT. Patients were classified by the relationship of the LV lead to the optimal site as concordant (at optimal site), adjacent (within 1 segment), or remote (≥2 segments away). The primary endpoint was a ≥15% reduction in LV end-systolic volume at 6 months. Secondary endpoints were clinical response (≥1 improvement in New York Heart Association functional class), all-cause mortality, and combined all-cause mortality and heart failure-related hospitalization. The groups were balanced at randomization. In the TARGET group, there was a greater proportion of responders at 6 months (70% vs. 55%, p = 0.031), giving an absolute difference in the primary endpoint of 15% (95% confidence interval: 2% to 28%). Compared with controls, TARGET patients had a higher clinical response (83% vs. 65%, p = 0.003) and lower rates of the combined endpoint (log-rank test, p = 0.031). Compared with standard CRT treatment, the use of speckle-tracking echocardiography to the target LV lead placement yields significantly improved response and clinical status and lower rates of combined death and heart failure-related hospitalization. (Targeted Left Ventricular Lead Placement to Guide Cardiac Resynchronization Therapy [TARGET] study); ISRCTN19717943). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A multi-site evaluation of innovative approaches to increase tuberculosis case notification: summary results.

PubMed

Creswell, Jacob; Sahu, Suvanand; Blok, Lucie; Bakker, Mirjam I; Stevens, Robert; Ditiu, Lucica

2014-01-01

Globally, TB notifications have stagnated since 2007, and sputum smear positive notifications have been declining despite policies to improve case detection. We evaluate results of 28 interventions focused on improving TB case detection. We measured additional sputum smear positive cases treated, defined as the intervention area's increase in case notification during the project compared to the previous year. Projects were encouraged to select control areas and collect historical notification data. We used time series negative binomial regression for over-dispersed cross-sectional data accounting for fixed and random effects to test the individual projects' effects on TB notification while controlling for trend and control populations. Twenty-eight projects, 19 with control populations, completed at least four quarters of case finding activities, covering a population of 89.2 million. Among all projects sputum smear positive (SS+) TB notifications increased 24.9% and annualized notification rates increased from 69.1 to 86.2/100,000 (p = 0.0209) during interventions. Among the 19 projects with control populations, SS+TB case notifications increased 36.9% increase while in the control populations a 3.6% decrease was observed. Fourteen (74%) of the 19 projects' SS+TB notification rates in intervention areas increased from the baseline to intervention period when controlling for historical trends and notifications in control areas. Interventions were associated with large increases in TB notifications across many settings, using an array of interventions. Many people with TB are not reached using current approaches. Different methods and interventions tailored to local realities are urgently needed.

Three-Dimensional Bayesian Geostatistical Aquifer Characterization at the Hanford 300 Area using Tracer Test Data

NASA Astrophysics Data System (ADS)

Chen, X.; Murakami, H.; Hahn, M. S.; Hammond, G. E.; Rockhold, M. L.; Rubin, Y.

2010-12-01

Tracer testing under natural or forced gradient flow provides useful information for characterizing subsurface properties, by monitoring and modeling the tracer plume migration in a heterogeneous aquifer. At the Hanford 300 Area, non-reactive tracer experiments, in addition to constant-rate injection tests and electromagnetic borehole flowmeter (EBF) profiling, were conducted to characterize the heterogeneous hydraulic conductivity field. A Bayesian data assimilation technique, method of anchored distributions (MAD), is applied to assimilate the experimental tracer test data and to infer the three-dimensional heterogeneous structure of the hydraulic conductivity in the saturated zone of the Hanford formation. In this study, the prior information of the underlying random hydraulic conductivity field was obtained from previous field characterization efforts using the constant-rate injection tests and the EBF data. The posterior distribution of the random field is obtained by further conditioning the field on the temporal moments of tracer breakthrough curves at various observation wells. The parallel three-dimensional flow and transport code PFLOTRAN is implemented to cope with the highly transient flow boundary conditions at the site and to meet the computational demand of the proposed method. The validation results show that the field conditioned on the tracer test data better reproduces the tracer transport behavior compared to the field characterized previously without the tracer test data. A synthetic study proves that the proposed method can effectively assimilate tracer test data to capture the essential spatial heterogeneity of the three-dimensional hydraulic conductivity field. These characterization results will improve conceptual models developed for the site, including reactive transport models. The study successfully demonstrates the capability of MAD to assimilate multi-scale multi-type field data within a consistent Bayesian framework. The MAD framework can potentially be applied to combine geophysical data with other types of data in site characterization.

Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

PubMed

Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

2016-03-15

Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

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

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.

Optimizing Multi-Product Multi-Constraint Inventory Control Systems with Stochastic Replenishments

NASA Astrophysics Data System (ADS)

Allah Taleizadeh, Ata; Aryanezhad, Mir-Bahador; Niaki, Seyed Taghi Akhavan

Multi-periodic inventory control problems are mainly studied employing two assumptions. The first is the continuous review, where depending on the inventory level orders can happen at any time and the other is the periodic review, where orders can only happen at the beginning of each period. In this study, we relax these assumptions and assume that the periodic replenishments are stochastic in nature. Furthermore, we assume that the periods between two replenishments are independent and identically random variables. For the problem at hand, the decision variables are of integer-type and there are two kinds of space and service level constraints for each product. We develop a model of the problem in which a combination of back-order and lost-sales are considered for the shortages. Then, we show that the model is of an integer-nonlinear-programming type and in order to solve it, a search algorithm can be utilized. We employ a simulated annealing approach and provide a numerical example to demonstrate the applicability of the proposed methodology.

Breeding value accuracy estimates for growth traits using random regression and multi-trait models in Nelore cattle.

PubMed

Boligon, A A; Baldi, F; Mercadante, M E Z; Lobo, R B; Pereira, R J; Albuquerque, L G

2011-06-28

We quantified the potential increase in accuracy of expected breeding value for weights of Nelore cattle, from birth to mature age, using multi-trait and random regression models on Legendre polynomials and B-spline functions. A total of 87,712 weight records from 8144 females were used, recorded every three months from birth to mature age from the Nelore Brazil Program. For random regression analyses, all female weight records from birth to eight years of age (data set I) were considered. From this general data set, a subset was created (data set II), which included only nine weight records: at birth, weaning, 365 and 550 days of age, and 2, 3, 4, 5, and 6 years of age. Data set II was analyzed using random regression and multi-trait models. The model of analysis included the contemporary group as fixed effects and age of dam as a linear and quadratic covariable. In the random regression analyses, average growth trends were modeled using a cubic regression on orthogonal polynomials of age. Residual variances were modeled by a step function with five classes. Legendre polynomials of fourth and sixth order were utilized to model the direct genetic and animal permanent environmental effects, respectively, while third-order Legendre polynomials were considered for maternal genetic and maternal permanent environmental effects. Quadratic polynomials were applied to model all random effects in random regression models on B-spline functions. Direct genetic and animal permanent environmental effects were modeled using three segments or five coefficients, and genetic maternal and maternal permanent environmental effects were modeled with one segment or three coefficients in the random regression models on B-spline functions. For both data sets (I and II), animals ranked differently according to expected breeding value obtained by random regression or multi-trait models. With random regression models, the highest gains in accuracy were obtained at ages with a low number of weight records. The results indicate that random regression models provide more accurate expected breeding values than the traditionally finite multi-trait models. Thus, higher genetic responses are expected for beef cattle growth traits by replacing a multi-trait model with random regression models for genetic evaluation. B-spline functions could be applied as an alternative to Legendre polynomials to model covariance functions for weights from birth to mature age.

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.

[METHODS OF EVALUATION OF MUSCLE MASS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS].

PubMed

Moreira, Osvaldo Costa; de Oliveira, Cláudia Eliza Patrocínio; Candia-Luján, Ramón; Romero-Pérez, Ena Monserrat; de Paz Fernandez, José Antonio

2015-09-01

in recent years, research about muscle mass has gained popularity for their relationship to health. Thus precise measurement of muscle mass may have clinical application once may interfere with the diagnosis and prescription drug or drug treatment. to conduct a systematic review of the methods most used for evaluation of muscle mass in randomized controlled trials, with its advantages and disadvantages. we conducted a search of the data bases Pub- Med, Web of Science and Scopus, with words "muscle mass", "measurement", "assessment" and "evaluation", combined in this way: "muscle mass" AND (assessment OR measurement OR evaluation). 23 studies were recovered and analyzed, all in English. 69.56% only used a method for quantification of muscle mass; 69.57% used dual X-ray absorptiometry (DXA); in 45.46% the type of measure used was the body lean mass; and 51.61% chose the whole body as a site of measurement. in the randomized controlled trials analyzed the majority used just one method of assessment, with the DXA being the method most used, the body lean mass the measurement type most used and total body the most common site of measure. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

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 autograft BPTB ACL reconstruction. Registration: NCT01765712 ( ClinicalTrials.gov identifier).

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.

A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.

PubMed

Shepperd, Sasha; Cradduck-Bamford, Andrea; Butler, Chris; Ellis, Graham; Godfrey, Mary; Gray, Alastair; Hemsley, Anthony; Khanna, Pradeep; Langhorne, Peter; McCaffrey, Patricia; Mirza, Lubena; Pushpangadan, Maj; Ramsay, Scott; Schiff, Rebekah; Stott, David; Young, John; Yu, Ly-Mee

2017-10-23

There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. We are conducting a multi-site randomised open trial of geriatrician-led admission avoidance hospital at home, compared with admission to hospital. We are recruiting older people with markers of frailty or prior dependence who have been referred to admission avoidance hospital at home for an acute medical event. This includes patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. Participants are randomised using a computerised random number generator to geriatrician-led admission avoidance hospital at home or a control group of inpatient admission in a 2:1 ratio in favour of the intervention. The primary endpoint 'living at home' (the inverse of death or living in a residential care setting) is measured at 6 months follow-up, and we also collect data on this outcome at 12 months. Secondary outcomes include the incidence of delirium, mortality, new long-term residential care, cognitive impairment, activities of daily living, quality of life and quality-adjusted survival, length of stay, readmission or transfer to hospital. We will conduct a parallel economic evaluation, and a process evaluation that includes an interview study to explore the experiences of patients and carers. Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will provide evidence on alternative models of healthcare for older people who require hospital admission. ISRCTN60477865 : Registered on 10 March 2014. Trial Sponsor: University of Oxford. Version 3.1, 14/06/2016.

Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

PubMed

Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C

2018-06-01

US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention. Copyright © 2018 Elsevier Inc. All rights reserved.

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 American Heart Association, Inc.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

75 FR 67376 - Proposed Information Collection Activity; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-02

... sites were randomly assigned either to the program group (allowed to enroll in EHS), or to the control group (precluded from enrolling in EHS, although they could receive other services in the community... information on the parents' perception of the children's status. Respondents: Treatment and control group...

76 FR 1436 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-10

... children and families in 17 sites were randomly assigned either to the program group (allowed to enroll in EHS), or to the control group (precluded from enrolling in EHS, although they could receive other... or guardians in the spring of 2011. Respondents: Treatment and control group members in the Early...

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

Housing First Improves Adherence to Antipsychotic Medication Among Formerly Homeless Adults With Schizophrenia: Results of a Randomized Controlled Trial

PubMed Central

Moniruzzaman, Akm; Fazel, Seena; McCandless, Lawrence; Procyshyn, Ric; Somers, Julian M.

2017-01-01

Abstract Adherence to antipsychotic medication is a significant challenge among homeless patients. No experimental trials have investigated the impact of Housing First on adherence among patients with schizophrenia. We investigated whether Housing First in congregate and scattered-site configurations resulted in superior adherence compared to usual care. Adult participants (n = 165) met criteria for homelessness, schizophrenia, and initiation of antipsychotic pharmacotherapy prior to recruitment to an unblinded, 3-arm randomized controlled trial in Vancouver, Canada. Randomization arms were: congregate Housing First (CHF) with on-site supports (including physician and pharmacy services); scattered-site Housing First (SHF) with Assertive Community Treatment; or treatment as usual (TAU) consisting of existing services. Participants were followed for an average of 2.6 years. Adherence to antipsychotic medication was measured using the medication possession ratio (MPR), and 1-way ANOVA was used to compare outcomes between the 3 conditions. Data were drawn from comprehensive pharmacy records. Prior to randomization, mean MPR among participants was very low (0.44–0.48). Mean MPR in the follow-up period was significantly different between study arms (P < .001) and approached the guideline threshold of 0.80 in SHF. Compared to TAU, antipsychotic adherence was significantly higher in SHF but not in CHF. The results demonstrate that further implementation of SHF is indicated among homeless people with schizophrenia, and that urgent action is needed to address very low levels of antipsychotic adherence in this population (trial registration: ISRCTN57595077). PMID:27665002

Multi-aged Forest: an Optimal Management Strategy for Carbon Sequestration

NASA Astrophysics Data System (ADS)

Yao, L.; Tang, X.; Ma, M.

2017-12-01

Disturbances and climatic changes significantly affect forest ecosystem productivity, water use efficiency (WUE) and carbon (C) flux dynamics. A deep understanding of terrestrial feedbacks to such effects and recovery mechanisms in forests across contrasting climatic regimes is essential to predict future regional/global C and water budgets, which are also closely related to the potential forest management decisions. However, the resilience of multi-aged and even-aged forests to disturbances has been debated for more than 60 years because of technical measurement constraints. Here we evaluated 62 site-years of eddy covariance measurements of net ecosystem production (NEP), evapotranspiration (ET), the estimates of gross primary productivity (GPP), ecosystem respiration (Re) and ecosystem-level WUE, as well as the relationships with environmental controls in three chronosequences of multi- and even-aged coniferous forests covering the Mediterranean, temperate and boreal regions. Age-specific dynamics in multi-year mean annual NEP and WUE revealed that forest age is a key variable that determines the sign and magnitude of recovering forest C source-sink strength from disturbances. However, the trends of annual NEP and WUE across succession stages between two stand structures differed substantially. The successional patterns of NEP exhibited an inverted-U trend with age at the two even-aged chronosequences, whereas NEP of the multi-aged chronosequence increased steadily through time. Meanwhile, site-level WUE of even-aged forests decreased gradually from young to mature, whereas an apparent increase occurred for the same forest age in multi-aged stands. Compared with even-aged forests, multi-aged forests sequestered more CO2 with forest age and maintained a relatively higher WUE in the later succession periods. With regard to the available flux measurements in this study, these behaviors are independent of tree species, stand ages and climate conditions . We also found that distinctly different environmental factors controlled forest C and water fluxes under three climatic regimes.These findings will provide important implications for forest management strategies to mitigate global climate change.

Multi-site precipitation downscaling using a stochastic weather generator

NASA Astrophysics Data System (ADS)

Chen, Jie; Chen, Hua; Guo, Shenglian

2018-03-01

Statistical downscaling is an efficient way to solve the spatiotemporal mismatch between climate model outputs and the data requirements of hydrological models. However, the most commonly-used downscaling method only produces climate change scenarios for a specific site or watershed average, which is unable to drive distributed hydrological models to study the spatial variability of climate change impacts. By coupling a single-site downscaling method and a multi-site weather generator, this study proposes a multi-site downscaling approach for hydrological climate change impact studies. Multi-site downscaling is done in two stages. The first stage involves spatially downscaling climate model-simulated monthly precipitation from grid scale to a specific site using a quantile mapping method, and the second stage involves the temporal disaggregating of monthly precipitation to daily values by adjusting the parameters of a multi-site weather generator. The inter-station correlation is specifically considered using a distribution-free approach along with an iterative algorithm. The performance of the downscaling approach is illustrated using a 10-station watershed as an example. The precipitation time series derived from the National Centers for Environment Prediction (NCEP) reanalysis dataset is used as the climate model simulation. The precipitation time series of each station is divided into 30 odd years for calibration and 29 even years for validation. Several metrics, including the frequencies of wet and dry spells and statistics of the daily, monthly and annual precipitation are used as criteria to evaluate the multi-site downscaling approach. The results show that the frequencies of wet and dry spells are well reproduced for all stations. In addition, the multi-site downscaling approach performs well with respect to reproducing precipitation statistics, especially at monthly and annual timescales. The remaining biases mainly result from the non-stationarity of NCEP precipitation. Overall, the proposed approach is efficient for generating multi-site climate change scenarios that can be used to investigate the spatial variability of climate change impacts on hydrology.

Shared worlds: multi-sited ethnography and nursing research.

PubMed

Molloy, Luke; Walker, Kim; Lakeman, Richard

2017-03-22

Background Ethnography, originally developed for the study of supposedly small-scale societies, is now faced with an increasingly mobile, changing and globalised world. Cultural identities can exist without reference to a specific location and extend beyond regional and national boundaries. It is therefore no longer imperative that the sole object of the ethnographer's practice should be a geographically bounded site. Aim To present a critical methodological review of multi-sited ethnography. Discussion Understanding that it can no longer be taken with any certainty that location alone determines culture, multi-sited ethnography provides a method of contextualising multi-sited social phenomena. The method enables researchers to examine social phenomena that are simultaneously produced in different locations. It has been used to undertake cultural analysis of diverse areas such as organ trafficking, global organisations, technologies and anorexia. Conclusion The authors contend that multi-sited ethnography is particularly suited to nursing research as it provides researchers with an ethnographic method that is more relevant to the interconnected world of health and healthcare services. Implications for practice Multi-sited ethnography provides nurse researchers with an approach to cultural analysis in areas such as the social determinants of health, healthcare services and the effects of health policies across multiple locations.

Interference Drop Scheme: Enhancing QoS Provision in Multi-Hop Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Luo, Chang-Yi; Komuro, Nobuyoshi; Takahashi, Kiyoshi; Kasai, Hiroyuki; Ueda, Hiromi; Tsuboi, Toshinori

Ad hoc networking uses wireless technologies to construct networks with no physical infrastructure and so are expected to provide instant networking in areas such as disaster recovery sites and inter-vehicle communication. Unlike conventional wired networks services, services in ad hoc networks are easily disrupted by the frequent changes in traffic and topology. Therefore, solutions to assure the Quality of Services (QoS) in ad hoc networks are different from the conventional ones used in wired networks. In this paper, we propose a new queue management scheme, Interference Drop Scheme (IDS) for ad hoc networks. In the conventional queue management approaches such as FIFO (First-in First-out) and RED (Random Early Detection), a queue is usually managed by a queue length limit. FIFO discards packets according to the queue limit, and RED discards packets in an early and random fashion. IDS, on the other hand, manages the queue according to wireless interference time, which increases as the number of contentions in the MAC layer increases. When there are many MAC contentions, IDS discards TCP data packets. By observing the interference time and discarding TCP data packets, our simulation results show that IDS improves TCP performance and reduces QoS violations in UDP in ad hoc networks with chain, grid, and random topologies. Our simulation results also demonstrate that wireless interference time is a better metric than queue length limit for queue management in multi-hop ad hoc networks.

Improvement of microcirculation and wound healing in vertical ridge augmentation after pre-treatment with self-inflating soft tissue expanders - a randomized study in dogs.

PubMed

Kaner, Dogan; Zhao, Han; Terheyden, Hendrik; Friedmann, Anton

2015-06-01

We investigated the effect of soft tissue expansion (STE) on vertical ridge augmentation with regard to the incidence of wound dehiscences and the impairment of microcirculation in dogs, and the applicability of laser Doppler flowmetry (LDF) to explore the relation between microcirculation and wound healing. Bone defects were created on both mandibular sides in ten beagle dogs by extraction of premolars and removal of bone. Six weeks later, self-filling tissue expanders were implanted in randomly assigned test sites. After 5 weeks of expansion, vertical augmentation was carried out in test and control sites using calvarial onlay grafts side by side with granular biphasic calcium phosphate covered with a resorbable polyethylene glycol membrane. Microcirculation was evaluated with laser Doppler flowmetry (LDF). The incidence of wound dehiscences was evaluated after 2 weeks. The validity of LDF to predict dehiscences was evaluated by construction of receiver operating characteristic (ROC) curves. After augmentation, test sites showed significantly better perfusion than control sites without preceding STE (P = 0.012). Three days after surgery, perfusion was still significantly decreased in control sites (P = 0.005), while microcirculation in test sites had returned to pre-surgical levels. After 2 weeks, healing in test sites was good, whereas eight dehiscences were found in control sites (P = 0.002). ROC curves showed that microcirculation levels immediately after augmentation surgery significantly predicted subsequent wound dehiscences (AUC = 0.799, CI 0.642-0.955, P = 0.006). Laser Doppler flowmetry is suitable for evaluation of soft tissue microcirculation after ridge augmentation. STE reduced the impairment of microcirculation caused by vertical ridge augmentation and decreased the incidence of wound dehiscences in the investigated animal model. © 2014 The Authors. Clinical Oral Implants Research Published by John Wiley & Sons Ltd.

Multi-Exciter Vibroacoustic Simulation of Hypersonic Flight Vibration

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

GREGORY,DANNY LYNN; CAP,JEROME S.; TOGAMI,THOMAS C.

1999-11-11

Many aerospace structures must survive severe high frequency, hypersonic, random vibration during their flights. The random vibrations are generated by the turbulent boundary layer developed along the exterior of the structures during flight. These environments have not been simulated very well in the past using a fixed-based, single exciter input with an upper frequency range of 2 kHz. This study investigates the possibility of using acoustic ardor independently controlled multiple exciters to more accurately simulate hypersonic flight vibration. The test configuration, equipment, and methodology are described. Comparisons with actual flight measurements and previous single exciter simulations are also presented.

A multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention in nursing homes: a two-armed randomized controlled trial.

PubMed

Beeckman, Dimitri; Clays, Els; Van Hecke, Ann; Vanderwee, Katrien; Schoonhoven, Lisette; Verhaeghe, Sofie

2013-04-01

Frail older people admitted to nursing homes are at risk of a range of adverse outcomes, including pressure ulcers. Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals. To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes. Two-armed randomized controlled trial in a nursing home setting in Belgium. The trial consisted of a 16-week implementation intervention between February and June 2010, including one baseline, four intermediate, and one post-testing measurement. Primary outcome was the adherence to guideline-based care recommendations (in terms of allocating adequate pressure ulcer prevention in residents at risk). Secondary outcomes were the change in resident outcomes (pressure ulcer prevalence) and intermediate outcomes (knowledge and attitudes of healthcare professionals). Random sample of 11 wards (6 experimental; 5 control) in a convenience sample of 4 nursing homes in Belgium. In total, 464 nursing home residents and 118 healthcare professionals participated. The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system, including interactive education, reminders, monitoring, feedback and leadership. The control arm received a hard-copy of the pressure ulcer prevention protocol, supported by standardized 30 min group lecture. Patients in the intervention arm were significantly more likely to receive fully adequate pressure ulcer prevention when seated in a chair (F=16.4, P=0.003). No significant improvement was observed on pressure ulcer prevalence and knowledge of the professionals. While baseline attitude scores were comparable between both groups [exp. 74.3% vs. contr. 74.5% (P=0.92)], the mean score after the intervention was 83.5% in the experimental group vs. 72.1% in the control group (F=15.12, P<0.001). The intervention was only partially successful to improve the primary outcome. Attitudes improved significantly while the knowledge of the healthcare workers remained unsatisfactorily low. Further research should focus on the underlying reasons for these findings. Copyright © 2012 Elsevier Ltd. All rights reserved.

Multi-Disciplinary Knowledge Synthesis for Human Health Assessment on Earth and in Space

NASA Astrophysics Data System (ADS)

Christakos, G.

We discuss methodological developments in multi-disciplinary knowledge synthesis (KS) of human health assessment. A theoretical KS framework can provide the rational means for the assimilation of various information bases (general, site-specific etc.) that are relevant to the life system of interest. KS-based techniques produce a realistic representation of the system, provide a rigorous assessment of the uncertainty sources, and generate informative health state predictions across space-time. The underlying epistemic cognition methodology is based on teleologic criteria and stochastic logic principles. The mathematics of KS involves a powerful and versatile spatiotemporal random field model that accounts rigorously for the uncertainty features of the life system and imposes no restriction on the shape of the probability distributions or the form of the predictors. KS theory is instrumental in understanding natural heterogeneities, assessing crucial human exposure correlations and laws of physical change, and explaining toxicokinetic mechanisms and dependencies in a spatiotemporal life system domain. It is hoped that a better understanding of KS fundamentals would generate multi-disciplinary models that are useful for the maintenance of human health on Earth and in Space.

Does Patient Time Spent Viewing Computer-Tailored Colorectal Cancer Screening Materials Predict Patient-Reported Discussion of Screening with Providers?

ERIC Educational Resources Information Center

Sanders, Mechelle; Fiscella, Kevin; Veazie, Peter; Dolan, James G.; Jerant, Anthony

2016-01-01

The main aim is to examine whether patients' viewing time on information about colorectal cancer (CRC) screening before a primary care physician (PCP) visit is associated with discussion of screening options during the visit. We analyzed data from a multi-center randomized controlled trial of a tailored interactive multimedia computer program…

Personality Disorder Patients' Perspectives on the Introduction of Imagery within Schema Therapy: A Qualitative Study of Patients' Experiences

ERIC Educational Resources Information Center

ten Napel-Schutz, Marieke C.; Abma, Tineke A.; Bamelis, Lotte; Arntz, Arnoud

2011-01-01

A qualitative study was done on patients' perspectives on the first phases of imagery work in the context of schema therapy (ST) for personality disorders. Patients participated in a multi-center randomized controlled study of the effectiveness of ST. Patients' experiences and opinions were collected with semistructured in-depth interviews at the…

Estimating Treatment Effects from Contaminated Multi-Period Education Experiments: The Dynamic Impacts of Class Size Reductions. NBER Working Paper No. 15200

ERIC Educational Resources Information Center

Ding, Weili; Lehrer, Steven F.

2009-01-01

This paper introduces an empirical strategy to estimate dynamic treatment effects in randomized trials that provide treatment in multiple stages and in which various noncompliance problems arise such as attrition and selective transitions between treatment and control groups. Our approach is applied to the highly influential four year randomized…

Mediating Factors of a School-Based Multi-Component Smoking Prevention Intervention: The LdP Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Carreras, G.; Bosi, S.; Angelini, P.; Gorini, G.

2016-01-01

The aim of this study was to investigate factors mediating the effects of Luoghi di Prevenzione (LdP) smoking prevention intervention based on social competence and social influence approaches, and characterized by peer-led school-based interventions, out-of-school workshops, school lessons, and by enforcing the school anti-smoking policy.…

Structural Brain Changes after Traditional and Robot-Assisted Multi-Domain Cognitive Training in Community-Dwelling Healthy Elderly

PubMed Central

Kim, Geon Ha; Jeon, Seun; Im, Kiho; Kwon, Hunki; Lee, Byung Hwa; Kim, Ga Young; Jeong, Hana; Han, Noh Eul; Seo, Sang Won; Cho, Hanna; Noh, Young; Park, Sang Eon; Kim, Hojeong; Hwang, Jung Won; Yoon, Cindy W.; Kim, Hee Jin; Ye, Byoung Seok; Chin, Ju Hee; Kim, Jung-Hyun; Suh, Mee Kyung; Lee, Jong Min; Kim, Sung Tae; Choi, Mun-Taek; Kim, Mun Sang; Heilman, Kenneth M; Jeong, Jee Hyang; Na, Duk L.

2015-01-01

The purpose of this study was to investigate if multi-domain cognitive training, especially robot-assisted training, alters cortical thickness in the brains of elderly participants. A controlled trial was conducted with 85 volunteers without cognitive impairment who were 60 years old or older. Participants were first randomized into two groups. One group consisted of 48 participants who would receive cognitive training and 37 who would not receive training. The cognitive training group was randomly divided into two groups, 24 who received traditional cognitive training and 24 who received robot-assisted cognitive training. The training for both groups consisted of daily 90-min-session, five days a week for a total of 12 weeks. The primary outcome was the changes in cortical thickness. When compared to the control group, both groups who underwent cognitive training demonstrated attenuation of age related cortical thinning in the frontotemporal association cortices. When the robot and the traditional interventions were directly compared, the robot group showed less cortical thinning in the anterior cingulate cortices. Our results suggest that cognitive training can mitigate age-associated structural brain changes in the elderly. Trial Registration ClnicalTrials.gov NCT01596205 PMID:25898367

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background One of the major risk variables for surgical site infection is wound management. Understanding infection risk factors for breast operations is essential in order to develop infection-prevention strategies and improve surgical outcomes. The aim of this trial is to assess the influence of dressing wear time on surgical site infection rates and skin colonization. Patients’ perception at self-assessment will also be analyzed. Methods/Design This is a two-arm randomized controlled trial. Two hundred breast cancer patients undergoing immediate or delayed breast reconstruction will be prospectively enrolled. Patients will be randomly allocated to group I (dressing removed on postoperative day one) or group II (dressing removed on postoperative day six). Surgical site infections will be defined by standard criteria from the Centers for Disease Control and Prevention (CDC). Skin colonization will be assessed by culture of samples collected at predefined time points. Patients will score dressing wear time with regard to safety, comfort and convenience. Discussion The evidence to support dressing standards for breast surgery wounds is empiric and scarce. CDC recommends protecting, with a sterile dressing for 24 to 48 hours postoperatively, a primarily closed incision, but there is no recommendation to cover this kind of incision beyond 48 hours, or on the appropriate time to shower or bathe with an uncovered incision. The results of the ongoing trial may support standard recommendations regarding dressing wear time after breast reconstruction. Trial registration ClinicalTrials.gov identifier: http://NCT01148823. PMID:23432779

Quality assurance of research protocols conducted in the community: the National Institute on Drug Abuse Clinical Trials Network experience.

PubMed

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-04-01

Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. : QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed.

Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

PubMed Central

Rosa, Carmen; Campbell, Aimee; Kleppinger, Cynthia; Sampson, Royce; Tyson, Clare; Mamay-Gentilin, Stephanie

2009-01-01

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials. Purpose: This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Methods: The authors reviewed internal records maintained by the sponsor, a coordinating site (Lead Nodes), and a local site detailing procedural development, training sessions, protocol violation monitoring, and site visit reporting. Results: Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6560 participants randomized across the sites. During this time 1937 QA site visits were reported across the three tiers of monitoring and the cost depended on the location of the sites and the salaries of the staff involved. One study reported 109 protocol violations (M = 15.6). Examples are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. Limitations: QA data from the entire network were not easily available for review as much of the data were not electronically accessible. The authors reviewed and discussed a representative sample of internal data from the studies and participating sites. Conclusions: The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. The CTN model can work for sponsors overseeing studies at sites with limited research experience that require more frequent, in-depth monitoring. We recommend that sponsors not develop a rigid monitoring approach, but work with the study principal investigators to determine the intensity of monitoring needed depending on trial complexity, the risks of the intervention(s), and the experience of the staff with clinical research. After careful evaluation, sponsors should then determine the best approach to site monitoring and what resources will be needed. PMID:19342468

Effects of cooking using multi-ply cookware on absorption of potassium and vitamins: a randomized double-blind placebo control study.

PubMed

Mori, Mari; Hamada, Atsumi; Mori, Hideki; Yamori, Yukio; Tsuda, Kinsuke

2012-08-01

This 2-week interventional study involved a randomized allocation of subjects into three groups: Group A (daily ingestion of 350 g vegetables cooked without water using multi-ply [multilayer-structured] cookware), Group B (daily ingestion of 350 g vegetables; ordinary cookware) and Group C (routine living). Before and after intervention, each subject underwent health examination with 24-h urine sampling. Blood vitamin C significantly increased after intervention from the baseline in Group A (P < 0.01) and Group B (P < 0.05). β-Carotene levels also increased significantly after intervention in Group A (P < 0.01) and Group B (P < 0.01). Oxidized low-density lipoprotein decreased significantly after intervention in Group A (P < 0.01). In Group A, 24-h urinary potassium excretion increased significantly (P < 0.01) and 24-h urinary sodium (Na)/K ratio improved significantly (P < 0.05) after intervention. In conclusion, a cooking method modification with multi-ply cookware improved absorption of nutrients from vegetables and enhanced effective utilization of the antioxidant potentials of vegetable nutrients.

A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS.

PubMed

Robinson, Thomas N; Matheson, Donna M; Kraemer, Helena C; Wilson, Darrell M; Obarzanek, Eva; Thompson, Nikko S; Alhassan, Sofiya; Spencer, Tirzah R; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; Killen, Joel D

2010-11-01

To test a 2-year community- and family-based obesity prevention program for low-income African American girls: Stanford GEMS (Girls' health Enrichment Multi-site Studies). Randomized controlled trial with follow-up measures scheduled at 6, 12, 18, and 24 months. Low-income areas of Oakland, California. African American girls aged 8 to 10 years (N=261) and their parents or guardians. Families were randomized to one of two 2-year, culturally tailored interventions: (1) after-school hip-hop, African, and step dance classes and a home/family-based intervention to reduce screen media use or (2) information-based health education. Changes in body mass index (BMI). Changes in BMI did not differ between groups (adjusted mean difference [95% confidence interval] = 0.04 [-0.18 to 0.27] per year). Among secondary outcomes, fasting total cholesterol level (adjusted mean difference, -3.49 [95% confidence interval, -5.28 to -1.70] mg/dL per year), low-density lipoprotein cholesterol level (-3.02 [-4.74 to -1.31] mg/dL per year), incidence of hyperinsulinemia (relative risk, 0.35 [0.13 to 0.93]), and depressive symptoms (-0.21 [-0.42 to -0.001] per year) decreased more among girls in the dance and screen time reduction intervention. In exploratory moderator analysis, the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline (P = .02) and/or those whose parents or guardians were unmarried (P = .01). A culturally tailored after-school dance and screen time reduction intervention for low-income, preadolescent African American girls did not significantly reduce BMI gain compared with health education but did produce potentially clinically important reductions in lipid levels, hyperinsulinemia, and depressive symptoms. There was also evidence for greater effectiveness in high-risk subgroups of girls.

Consensus pursuit of heterogeneous multi-agent systems under a directed acyclic graph

NASA Astrophysics Data System (ADS)

Yan, Jing; Guan, Xin-Ping; Luo, Xiao-Yuan

2011-04-01

This paper is concerned with the cooperative target pursuit problem by multiple agents based on directed acyclic graph. The target appears at a random location and moves only when sensed by the agents, and agents will pursue the target once they detect its existence. Since the ability of each agent may be different, we consider the heterogeneous multi-agent systems. According to the topology of the multi-agent systems, a novel consensus-based control law is proposed, where the target and agents are modeled as a leader and followers, respectively. Based on Mason's rule and signal flow graph analysis, the convergence conditions are provided to show that the agents can catch the target in a finite time. Finally, simulation studies are provided to verify the effectiveness of the proposed approach.

[Development of multi-channels cardiac electrophysiological polygraph with LabVIEW as software platform and its clinical application].

PubMed

Fan, Shounian; Jiang, Yi; Jiang, Chenxi; Yang, Tianhe; Zhang, Chengyun; Liu, Junshi; Wu, Qiang; Zheng, Yaxi; Liu, Xiaoqiao

2004-10-01

Polygraph has become a necessary instrument in interventional cardiology and fundamental research of medicine up to the present. In this study, a LabView development system (DS) (developed by NI in U.S.) used as software platform, a DAQ data acquisition module and universal computer used as hardware platform, were creatively coupled with our self-made low noise multi-channels preamplifier to develop Multi-channels electrocardiograph. The device possessed the functions such as real time display of physiological process, digit highpass and lowpass, 50Hz filtered and gain adjustment, instant storing, random playback and printing, and process control stimulation. Besides, it was small-sized, economically practical and easy to operate. It could advance the spread of cardiac intervention treatment in hospitals.

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

A. Alfonsi; C. Rabiti; D. Mandelli

The Reactor Analysis and Virtual control ENviroment (RAVEN) code is a software tool that acts as the control logic driver and post-processing engine for the newly developed Thermal-Hydraulic code RELAP-7. RAVEN is now a multi-purpose Probabilistic Risk Assessment (PRA) software framework that allows dispatching different functionalities: Derive and actuate the control logic required to simulate the plant control system and operator actions (guided procedures), allowing on-line monitoring/controlling in the Phase Space Perform both Monte-Carlo sampling of random distributed events and Dynamic Event Tree based analysis Facilitate the input/output handling through a Graphical User Interface (GUI) and a post-processing data miningmore » module« less

Treating pain on skin graft donor sites: Review and clinical recommendations.

PubMed

Sinha, Sarthak; Schreiner, Amanda J; Biernaskie, Jeff; Nickerson, Duncan; Gabriel, Vincent A

2017-11-01

Split-thickness skin grafting is the most common reconstructive procedure in managing burn injuries. Harvesting split-thickness skin creates a new partial thickness wound referred to as the donor site. Pain at the donor site is reported to be one of the most distressing symptoms during the early postoperative period. Here, we (a) identify strategies for managing donor site pain, (b) assess the quality of individual studies, and (c) formulate evidence-based recommendations based on the amount and consistency of evidence. Our analysis revealed five distinct approaches to minimize donor site pain. These include: continuous subcutaneous local anesthetic infusion (three studies), subcutaneous anesthetic injection (five studies), topical agents (six studies), nonpharmacological interventions (three studies), and wound dressings (18 studies). Available randomized control trials typically evaluated pain on standardized scales (i.e. Visual Analog Scale, Numerical Rating Scale), and compared the experimental group with standard care. Recommended treatments include: (a) subcutaneous anesthetic injection of adrenaline-lidocaine; (b) ice application; (c) topical agents, such as lidocaine and bupivacaine; and (d) hydrocolloid- and polyurethane-based wound dressings accompanied with fibrin sealant. Methodologically sound randomized control trials examining the efficacy of modified tumescent solution, ropivacaine, plasma therapy, noncontact ultrasound, and morphine gels are lacking and should be a priority for future research.

Tuning resistance states by thickness control in an electroforming-free nanometallic complementary resistance random access memory

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

Yang, Xiang; Lu, Yang; Lee, Jongho

2016-01-04

Tuning low resistance state is crucial for resistance random access memory (RRAM) that aims to achieve optimal read margin and design flexibility. By back-to-back stacking two nanometallic bipolar RRAMs with different thickness into a complementary structure, we have found that its low resistance can be reliably tuned over several orders of magnitude. Such high tunability originates from the exponential thickness dependence of the high resistance state of nanometallic RRAM, in which electron wave localization in a random network gives rise to the unique scaling behavior. The complementary nanometallic RRAM provides electroforming-free, multi-resistance-state, sub-100 ns switching capability with advantageous characteristics formore » memory arrays.« less

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial.

PubMed

Abdullah, Kawsari; Thorpe, Kevin E; Mamak, Eva; Maguire, Jonathon L; Birken, Catherine S; Fehlings, Darcy; Hanley, Anthony J; Macarthur, Colin; Zlotkin, Stanley H; Parkin, Patricia C

2015-04-02

Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy. Early stages of iron deficiency, termed non-anemic iron deficiency (NAID), provide an opportunity for early detection and treatment before progression to IDA. There is little research regarding NAID, which may be associated with delayed development in young children. The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study. From a screening cohort, those identified with NAID (hemoglobin ≥110 g/L and serum ferritin <14 μg/L) are invited to participate in a pragmatic, multi-site, placebo controlled, blinded, parallel group, superiority randomized trial. Participating physicians are part of a primary healthcare research network called TARGet Kids! Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice, or placebo plus dietary advice (75 per group). The primary outcome, child developmental score, is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization. Secondary outcomes include an age appropriate behavior measure (Children's Behavior Questionnaire) and two laboratory measures (hemoglobin and serum ferritin levels). Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method). This trial will provide evidence regarding the association between child development and NAID, and the effectiveness of oral iron to improve developmental outcomes in children with NAID. The sample size of the trial will be recalculated using estimates taken from an internal pilot study. This trial was registered with Clinicaltrials.gov (identifier: NCT01481766 ) on 22 November 2011.

A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial

PubMed Central

2017-01-01

Background Acute pain frequently transitions to chronic pain after major lower extremity trauma (ET). Several modifiable psychological risk and protective factors have been found to contribute to, or prevent, chronic pain development. Some empirical evidence has shown that interventions, including cognitive and behavioral strategies that promote pain self-management, could prevent chronic pain. However, the efficacy of such interventions has never been demonstrated in ET patients. We have designed a self-management intervention to prevent acute to chronic pain transition after major lower extremity trauma (iPACT-E-Trauma). Objective This pilot randomized controlled trial (RCT) aims to evaluate the feasibility and research methods of the intervention, as well as the potential effects of iPACT-E-Trauma, on pain intensity and pain interference with daily activities. Methods A 2-arm single-blind pilot RCT will be conducted. Participants will receive the iPACT-E-Trauma intervention (experimental group) or an educational pamphlet (control group) combined with usual care. Data will be collected at baseline, during iPACT-E-Trauma delivery, as well as at 3 and 6 months post-injury. Primary outcomes are pain intensity and pain interference with daily living activities at 6 months post-injury. Secondary outcomes are pain self-efficacy, pain acceptance, pain catastrophizing, pain-related fear, anxiety and depression symptoms, health care service utilization, and return to work. Results Fifty-three patients were recruited at the time of manuscript preparation. Comprehensive data analyses will be initiated in July 2017. Study results are expected to be available in 2018. Conclusions Chronic pain is an important problem after major lower ET. However, no preventive intervention has yet been successfully proven in these patients. This study will focus on developing a feasible intervention to prevent acute to chronic pain transition in the context of ET. Findings will allow for the refinement of iPACT-E-Trauma and methodological parameters in prevision of a full-scale multi-site RCT. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91987302; http://www.controlled-trials.com/ISRCTN91987302 (Archived by WebCite at http://www.webcitation.org/6rR8G2vMs) PMID:28652226

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

PubMed

McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI = -18.14 to -1.70). ICBT patients had better therapy continuation versus IAC (P<0.001). There were no unexpected or study-related adverse events. Integrated cognitive behavioral therapy may improve drug-related outcomes in post-traumatic stress disorder sufferers with substance use disorder more than drug-focused counseling, but probably not by reducing post-traumatic stress disorder symptoms to a greater extent. © 2015 Society for the Study of Addiction.

A Randomized Controlled ERP Study on the Effects of Multi-Domain Cognitive Training and Task Difficulty on Task Switching Performance in Older Adults.

PubMed

Küper, Kristina; Gajewski, Patrick D; Frieg, Claudia; Falkenstein, Michael

2017-01-01

Executive functions are subject to a marked age-related decline, but have been shown to benefit from cognitive training interventions. As of yet, it is, however, still relatively unclear which neural mechanism can mediate training-related performance gains. In the present electrophysiological study, we examined the effects of multi-domain cognitive training on performance in an untrained cue-based task switch paradigm featuring Stroop color words: participants either had to indicate the word meaning of Stroop stimuli (word task) or perform the more difficult task of color naming (color task). One-hundred and three older adults (>65 years old) were randomly assigned to a training group receiving a 4-month multi-domain cognitive training, a passive no-contact control group or an active (social) control group receiving a 4-month relaxation training. For all groups, we recorded performance and EEG measures before and after the intervention. For the cognitive training group, but not for the two control groups, we observed an increase in response accuracy at posttest, irrespective of task and trial type. No training-related effects on reaction times were found. Cognitive training was also associated with an overall increase in N2 amplitude and a decrease of P2 latency on single trials. Training-related performance gains were thus likely mediated by an enhancement of response selection and improved access to relevant stimulus-response mappings. Additionally, cognitive training was associated with an amplitude decrease in the time window of the target-locked P3 at fronto-central electrodes. An increase in the switch positivity during advance task preparation emerged after both cognitive and relaxation training. Training-related behavioral and event-related potential (ERP) effects were not modulated by task difficulty. The data suggest that cognitive training increased slow negative potentials during target processing which enhanced the N2 and reduced a subsequent P3-like component on both switch and non-switch trials and irrespective of task difficulty. Our findings further corroborate the effectiveness of multi-domain cognitive training in older adults and indicate that ERPs can be instrumental in uncovering the neural processes underlying training-related performance gains.

Getting a Job Is Only Half the Battle: Maternal Job Loss and Child Classroom Behavior in Low-Income Families

ERIC Educational Resources Information Center

Hill, Heather D.; Morris, Pamela A.; Castells, Nina; Walker, Jessica Thornton

2011-01-01

This study uses data from an experimental employment program and instrumental variables (IV) estimation to examine the effects of maternal job loss on child classroom behavior. Random assignment to the treatment at one of three program sites is an exogenous predictor of employment patterns. Cross-site variation in treatment-control differences is…

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.

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.

Performance analysis of two-degree of freedom fractional order PID controllers for robotic manipulator with payload.

PubMed

Sharma, Richa; Gaur, Prerna; Mittal, A P

2015-09-01

The robotic manipulators are multi-input multi-output (MIMO), coupled and highly nonlinear systems. The presence of external disturbances and time-varying parameters adversely affects the performance of these systems. Therefore, the controller designed for these systems should effectively deal with such complexities, and it is an intriguing task for control engineers. This paper presents two-degree of freedom fractional order proportional-integral-derivative (2-DOF FOPID) controller scheme for a two-link planar rigid robotic manipulator with payload for trajectory tracking task. The tuning of all controller parameters is done using cuckoo search algorithm (CSA). The performance of proposed 2-DOF FOPID controllers is compared with those of their integer order designs, i.e., 2-DOF PID controllers, and with the traditional PID controllers. In order to show effectiveness of proposed scheme, the robustness testing is carried out for model uncertainties, payload variations with time, external disturbance and random noise. Numerical simulation results indicate that the 2-DOF FOPID controllers are superior to their integer order counterparts and the traditional PID controllers. Copyright © 2015 ISA. Published by Elsevier Ltd. All rights reserved.

Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment.

PubMed

Li, Siying; Koch, Gary G; Preisser, John S; Lam, Diana; Sanchez-Kam, Matilde

2017-01-01

Dichotomous endpoints in clinical trials have only two possible outcomes, either directly or via categorization of an ordinal or continuous observation. It is common to have missing data for one or more visits during a multi-visit study. This paper presents a closed form method for sensitivity analysis of a randomized multi-visit clinical trial that possibly has missing not at random (MNAR) dichotomous data. Counts of missing data are redistributed to the favorable and unfavorable outcomes mathematically to address possibly informative missing data. Adjusted proportion estimates and their closed form covariance matrix estimates are provided. Treatment comparisons over time are addressed with Mantel-Haenszel adjustment for a stratification factor and/or randomization-based adjustment for baseline covariables. The application of such sensitivity analyses is illustrated with an example. An appendix outlines an extension of the methodology to ordinal endpoints.

PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

PubMed Central

Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

2014-01-01

Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial.

PubMed

Mansfield, Avril; Peters, Amy L; Liu, Barbara A; Maki, Brian E

2010-04-01

Compensatory stepping and grasping reactions are prevalent responses to sudden loss of balance and play a critical role in preventing falls. The ability to execute these reactions effectively is impaired in older adults. The purpose of this study was to evaluate a perturbation-based balance training program designed to target specific age-related impairments in compensatory stepping and grasping balance recovery reactions. This was a double-blind randomized controlled trial. The study was conducted at research laboratories in a large urban hospital. Thirty community-dwelling older adults (aged 64-80 years) with a recent history of falls or self-reported instability participated in the study. Participants were randomly assigned to receive either a 6-week perturbation-based (motion platform) balance training program or a 6-week control program involving flexibility and relaxation training. Features of balance reactions targeted by the perturbation-based program were: (1) multi-step reactions, (2) extra lateral steps following anteroposterior perturbations, (3) foot collisions following lateral perturbations, and (4) time to complete grasping reactions. The reactions were evoked during testing by highly unpredictable surface translation and cable pull perturbations, both of which differed from the perturbations used during training. /b> Compared with the control program, the perturbation-based training led to greater reductions in frequency of multi-step reactions and foot collisions that were statistically significant for surface translations but not cable pulls. The perturbation group also showed significantly greater reduction in handrail contact time compared with the control group for cable pulls and a possible trend in this direction for surface translations. Further work is needed to determine whether a maintenance program is needed to retain the training benefits and to assess whether these benefits reduce fall risk in daily life. Perturbation-based training shows promise as an effective intervention to improve the ability of older adults to prevent themselves from falling when they lose their balance.

The effect of integration of HIV care and treatment into antenatal care clinics on mother-to-child HIV transmission and maternal outcomes in Nyanza, Kenya: results from the SHAIP cluster randomized controlled trial

PubMed Central

Washington, Sierra; Owuor, Kevin; Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Shade, Starley B.; Bukusi, Elizabeth A.; Ackers, Marta L.; Cohen, Craig R.

2015-01-01

Background Many HIV-infected pregnant women identified during antenatal care do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. Methods We performed a cluster-randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, PMTCT, and HIV care delivered in the ANC clinic; n=6 intervention facilities), or standard ANC services (including PMTCT and referral to a separate clinic for HIV care; n=6 control facilities). Results There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was twelve month follow up data for 256/611 (41.8%) women, and postpartum data for only 325/1172 (28%) women. By 9 months of age, 382/568 (67.3%) infants at intervention sites and 338/594 (57.0%) at control sites had tested for HIV (OR 1.45, 95% CI 0.71-2.82); 7.3% of infants tested HIV-positive at intervention sites compared to 8.0% of infants at control sites (OR 0.89, 95% CI 0.56-1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1 %, OR 0.83, 95% CI 0.41 - 1.68). Conclusions Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk HIV transmission to infants and did not appear to affect short-term maternal health outcomes. PMID:25886930

Impact of Multi-Micronutrient Fortified Rice on Hemoglobin, Iron and Vitamin A Status of Cambodian Schoolchildren: a Double-Blind Cluster-Randomized Controlled Trial.

PubMed

Perignon, Marlène; Fiorentino, Marion; Kuong, Khov; Dijkhuizen, Marjoleine A; Burja, Kurt; Parker, Megan; Chamnan, Chhoun; Berger, Jacques; Wieringa, Frank T

2016-01-07

In Cambodia, micronutrient deficiencies remain a critical public health problem. Our objective was to evaluate the impact of multi-micronutrient fortified rice (MMFR) formulations, distributed through a World Food Program school-meals program (WFP-SMP), on the hemoglobin concentrations and iron and vitamin A (VA) status of Cambodian schoolchildren. The FORISCA-UltraRice+NutriRice study was a double-blind, cluster-randomized, placebo-controlled trial. Sixteen schools participating in WFP-SMP were randomly assigned to receive extrusion-fortified rice (UltraRice Original, UltraRice New (URN), or NutriRice) or unfortified rice (placebo) six days a week for six months. Four additional schools not participating in WFP-SMP were randomly selected as controls. A total of 2440 schoolchildren (6-16 years old) participated in the biochemical study. Hemoglobin, iron status, estimated using inflammation-adjusted ferritin and transferrin receptors concentrations, and VA status, assessed using inflammation-adjusted retinol-binding protein concentration, were measured at the baseline, as well as at three and six months. Baseline prevalence of anemia, depleted iron stores, tissue iron deficiency, marginal VA status and VA deficiency were 15.6%, 1.4%, 51.0%, 7.9%, and 0.7%, respectively. The strongest risk factors for anemia were hemoglobinopathy, VA deficiency, and depleted iron stores (all p < 0.01). After six months, children receiving NutriRice and URN had 4 and 5 times less risk of low VA status, respectively, in comparison to the placebo group. Hemoglobin significantly increased (+0.8 g/L) after three months for the URN group in comparison to the placebo group; however, this difference was no longer significant after six months, except for children without inflammation. MMFR containing VA effectively improved the VA status of schoolchildren. The impact on hemoglobin and iron status was limited, partly by sub-clinical inflammation. MMFR combined with non-nutritional approaches addressing anemia and inflammation should be further investigated.

Preliminary design package for solar heating and hot water system

NASA Technical Reports Server (NTRS)

1977-01-01

The preliminary design review on the development of a multi-family solar heating and domestic hot water prototype system is presented. The report contains the necessary information to evaluate the system. The system consists of the following subsystems: collector, storage, transport, control and Government-furnished site data acquisition.

[Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial].

PubMed

Zhou, Q; Zuo, M H; Li, Q W; Tian, Y T; Xie, Y B; Wang, Y B; Yang, G Y; Ye, Y J; Guo, P; Liu, J P; Liu, Z L; An, C; Zhou, T; Tian, Z; Liu, C B; Hu, Y; Chi, X Y; Shen, Y; Xia, Y; Hu, K W

2017-12-23

Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group ( P =0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group ( P =0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups ( P =0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer. Trial registration: International Standard Randomized Controlled Trial Number Register, ISRCTN18291857.

The use of leucocyte and platelet-rich fibrin in socket management and ridge preservation: a split-mouth, randomized, controlled clinical trial.

PubMed

Temmerman, Andy; Vandessel, Jeroen; Castro, Ana; Jacobs, Reinhilde; Teughels, Wim; Pinto, Nelson; Quirynen, Marc

2016-11-01

To investigate the influence of the use L-PRF as a socket filling material and its ridge preservation properties. Twenty-two patients in need of single bilateral and closely symmetrical tooth extractions in the maxilla or mandible were included in a split-mouth RCT. Treatments were randomly assigned (L-PRF socket filling versus natural healing). CBCT scans were obtained after tooth extraction and three months. Scans were evaluated by superimposition using the original DICOM data. Mean ridge width differences between timepoints were measured at three levels below the crest on both the buccal and lingual sides (crest -1 mm (primary outcome variable), -3 mm and -5 mm). Mean vertical height changes at the buccal were -1.5 mm (±1.3) for control sites and 0.5 mm (±2.3) for test sites (p < 0.005). At the buccal side, control sites values were, respectively, -2.1 (±2.5), -0.3 mm (±0.3) (p < 0.005) and -0.1 mm (±0.0), and test sites values were, respectively, -0.6 mm (±2.2) (p < 0.005), -0.1 mm (±0.3) and 0.0 mm (±0.1). Significant differences (p < 0.005) were found for total width reduction between test (-22.84%) and control sites (-51.92%) at 1 mm below crest level. Significant differences were found for socket fill (visible mineralized bone) between test (94.7%) and control sites (63.3%). The use of L-PRF as a socket filling material to achieve preservation of horizontal and vertical ridge dimension at three  months after tooth extraction is beneficial. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Multi-site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology

PubMed Central

Weiss, Roger D.; Potter, Jennifer Sharpe; Provost, Scott E.; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

2010-01-01

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. PMID:20116457

A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): rationale, design, and methodology.

PubMed

Weiss, Roger D; Potter, Jennifer Sharpe; Provost, Scott E; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

2010-03-01

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age > or =18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. Copyright 2010 Elsevier Inc. All rights reserved.

Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

PubMed Central

Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

2015-01-01

Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

High prevalence of daily and multi-site pain – a cross-sectional population-based study among 3000 Danish adolescents

PubMed Central

2013-01-01

Background Daily pain and multi-site pain are both associated with reduction in work ability and health-related quality of life (HRQoL) among adults. However, no population-based studies have yet investigated the prevalence of daily and multi-site pain among adolescents and how these are associated with respondent characteristics. The purpose of this study was to investigate the prevalence of self-reported daily and multi-site pain among adolescents aged 12–19 years and associations of almost daily pain and multi-site pain with respondent characteristics (sex, age, body mass index, HRQoL and sports participation). Methods A population-based cross-sectional study was conducted among 4,007 adolescents aged 12–19 years in Denmark. Adolescents answered an online questionnaire during physical education lessons. The questionnaire contained a mannequin divided into 12 regions on which the respondents indicated their current pain sites and pain frequency (rarely, monthly, weekly, more than once per week, almost daily pain), characteristics, sports participation and HRQoL measured by the EuroQoL 5D. Multivariate regression was used to calculate the odds ratio for the association between almost daily pain, multi-site pain and respondent characteristics. Results The response rate was 73.7%. A total of 2,953 adolescents (62% females) answered the questionnaire. 33.3% reported multi-site pain (pain in >1 region) while 19.8% reported almost daily pain. 61% reported current pain in at least one region with knee and back pain being the most common sites. Female sex (OR: 1.35-1.44) and a high level of sports participation (OR: 1.51-2.09) were associated with increased odds of having almost daily pain and multi-site pain. Better EQ-5D score was associated with decreased odds of having almost daily pain or multi-site pain (OR: 0.92-0.94). Conclusion In this population-based cohort of school-attending Danish adolescents, nearly two out of three reported current pain and, on average, one out of three reported pain in more than one body region. Female sex, and high level of sports participation were associated with increased odds of having almost daily pain and multi-site pain. The study highlights an important health issue that calls for investigations to improve our understanding of adolescent pain and our capacity to prevent and treat this condition. PMID:24252440

Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial

PubMed Central

Hayes, Rashelle B.; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M.; Shoben, Abigail; David, Sean P.; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K.

2014-01-01

INTRODUCTION Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment are cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. METHODS/DESIGN 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. DISCUSSION MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students’ tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. PMID:24486635

Multi-level stressor analysis from the DNA/biochemical level to community levels in an urban stream and integrative health response (IHR) assessments.

PubMed

Lee, Jae Hoon; Kim, Joon Ha; Oh, Hee-Mock; An, Kwang-Guk

2013-01-01

The objectives of this study were to identify multi-level stressors at the DNA/biochemical level to the community level in fish in an urban stream and to develop an integrative health response (IHR) model for ecological health diagnosis. A pristine control site (S (c) ) and an impacted site (S (i) ) were selected from among seven pre-screened sites studied over seven years. Various chemical analyses indicated that nutrient enrichment (Nitrogen, Phosphorus) and organic pollution were significantly greater (t > 8.783, p < 0.01) at the S (i) site compared to the S (c) site. Single-cell gel electrophoresis (comet assays) of DNA-level impairment indicated significantly (t = 5.678, p < 0.01) greater tail intensity, expressed as % tail-DNA, at the S (i) site and genotoxic responses were detected in the downstream reach. Ethoxyresorufin-O-deethylase (EROD) assays, as a physiological bioindicator, were 2.8-fold higher (p < 0.05, NK-test after ANOVA) at the S (i) site. Tissue analysis using a necropsy-based health assessment index (NHAI) showed distinct internal organ disorders in three tissues, i.e., liver, kidney, and gill, at the S (i) site. Population-level analysis using the sentinel species Zacco platypus showed that the regression coefficient (b) was 3.012 for the S (i) site and 2.915 for the S (c) site, indicating population skewness in the downstream reach. Community-level health was impaired at the S (i) site based on an index of biological integrity (IBI), and physical habitat modifications were identified by a qualitative habitat evaluation index (QHEI). Overall, the model values for the integrative health response (IHR), developed using the star plot approach, were 3.22 (80.5%) at the S (c) site and 0.74 (18.5%) at the S (i) site, indicating that, overall, ecological health impairments were evident in the urban reach. Our study was based on multi-level approaches using biological organization and the results suggest that there is a pivotal point of linkage between mechanistic understanding and real ecological consequences of environmental stressors.

Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)

EPA Pesticide Factsheets

The Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) provides detailed guidance on how to demonstrate that a site is in compliance with a radiation dose- or risk-based regulation.