Concordance of Race or Ethnicity of Interventionists and Caregivers of Dementia Patients: Relationship to Attrition and Treatment Outcomes in the REACH Study

ERIC Educational Resources Information Center

McGinnis, Kathleen A.; Schulz, Richard; Stone, Roslyn A.; Klinger, Julie; Mercurio, Rocco

2006-01-01

Purpose: We assess the effects of racial or ethnic concordance between caregivers and interventionists on caregiver attrition, change in depression, and change in burden in a multisite randomized clinical trial. Design and Methods: Family caregivers of patients with Alzheimer's disease were randomized to intervention or control groups at six sites…

Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

ERIC Educational Resources Information Center

Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

2013-01-01

The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

A Multisite Cluster Randomized Field Trial of Open Court Reading

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

2008-01-01

In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

Supervision of Facilitators in a Multisite Study: Goals, Process, and Outcomes

PubMed Central

2010-01-01

Objective To describe the aims, implementation, and desired outcomes of facilitator supervision for both interventions (treatment and control) in Project Eban and to present the Eban Theoretical Framework for Supervision that guided the facilitators’ supervision. The qualifications and training of supervisors and facilitators are also described. Design This article provides a detailed description of supervision in a multisite behavioral intervention trial. The Eban Theoretical Framework for Supervision is guided by 3 theories: cognitive behavior therapy, the Life-long Model of Supervision, and “Empowering supervisees to empower others: a culturally responsive supervision model.” Methods Supervision is based on the Eban Theoretical Framework for Supervision, which provides guidelines for implementing both interventions using goals, process, and outcomes. Results Because of effective supervision, the interventions were implemented with fidelity to the protocol and were standard across the multiple sites. Conclusions Supervision of facilitators is a crucial aspect of multisite intervention research quality assurance. It provides them with expert advice, optimizes the effectiveness of facilitators, and increases adherence to the protocol across multiple sites. Based on the experience in this trial, some of the challenges that arise when conducting a multisite randomized control trial and how they can be handled by implementing the Eban Theoretical Framework for Supervision are described. PMID:18724192

WWC Review of the Report "Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Randomized Experiment." What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2015

2015-01-01

For the 2013 study, "Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Randomized Experiment," researchers examined the impact of the Talent Transfer Initiative (TTI) on students' reading and mathematics achievement in 10 school districts. The TTI enabled principals of low-performing schools to provide…

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

ERIC Educational Resources Information Center

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

2017-01-01

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

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.

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

PubMed

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

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

PubMed

Johnson, Miriam J; Booth, Sara; Currow, David C; Lam, Lawrence T; Phillips, Jane L

2016-05-01

The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom. To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures. This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion. Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome. A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Challenges and lessons learned in conducting comparative-effectiveness trials.

PubMed

Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

2012-05-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

Challenges and Lessons Learned in Conducting Comparative-Effectiveness Trials

PubMed Central

Herrick, Linda M.; Locke, G. Richard; Zinsmeister, Alan R.; Talley, Nicholas J.

2014-01-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication. PMID:22552235

The Effects of Collaborative Strategic Reading Instruction on the Reading Comprehension of Middle School Students: Year 2 Replication

ERIC Educational Resources Information Center

Swanson, Elizabeth; Mohammed, Sarojani S.; Boardman, Alison Gould; Vaughn, Sharon; Klingner, Janette; Roberts, Greg; Leroux, Audrey; Solis, Michael

2011-01-01

The current study is the second in a series of multi-site, multi-year randomized control trials designed to test the efficacy of a fully developed intervention, Collaborative Strategic Reading (CSR), with adolescent readers. In year 1, the research questions were: (1) Does CSR improve reading comprehension for adolescent readers attending…

Examining the Impact of ABRACADABRA on Early Literacy in Northern Australia: An Implementation Fidelity Analysis

ERIC Educational Resources Information Center

Wolgemuth, Jennifer R.; Abrami, Philip C.; Helmer, Janet; Savage, Robert; Harper, Helen; Lea, Tess

2014-01-01

To address students' poor literacy outcomes, an intervention using a computer-based literacy tool, ABRACADABRA, was implemented in 6 Northern Australia primary schools. A pretest, posttest parallel group, single blind multisite randomized controlled trial was conducted with 308 students between the ages of 4 and 8 years old (M age = 5.8 years, SD…

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

PubMed

McMurran, Mary; Day, Florence; Reilly, Joseph; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Moran, Paul; Crawford, Mike J

2017-12-01

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.

Learning "about" and "from" Variation in Program Impacts Using Multisite Trials. MDRC Working Papers on Research Methodology

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present paper, which is intended for a diverse audience of evaluation researchers, applied social scientists, and research funders, provides a broad overview of the conceptual and statistical issues involved in using multisite randomized trials to learn "about" and "from" variation in program effects across…

Learning about and from a Distribution of Program Impacts Using Multisite Trials

ERIC Educational Resources Information Center

Raudenbush, Stephen W.; Bloom, Howard S.

2015-01-01

The present article provides a synthesis of the conceptual and statistical issues involved in using multisite randomized trials to learn about and from a distribution of heterogeneous program impacts across individuals and/or program sites. Learning "about" such a distribution involves estimating its mean value, detecting and quantifying…

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

PubMed

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

2017-10-01

Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, η p 2 =0.04), peak power output (F(2150)=8.16, p<0.01, η p 2 =0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, η p 2 =0.05), but not gait outcomes, for those who underwent the intervention compared with those who underwent the control condition. This RCT provides novel, preliminary evidence that multimodal exercise training may improve endurance walking performance and cognitive processing speed, perhaps based on improvements in cardiorespiratory capacity, in persons with MS with substantial mobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension.

PubMed

Houston, Thomas K; Fix, Gemmae M; Shimada, Stephanie L; Long, Judith A; Gordon, Howard S; Pope, Charlene; Volkman, Julie; Allison, Jeroan J; DeLaughter, Kathryn; Orner, Michelle; Bokhour, Barbara G

2017-09-01

Disparities in hypertension control persist for African American Veterans. To enhance cultural relevance of hypertension control self-management education, in a multisite, stratified randomized trial, we tested an interactive Veteran-to-Veteran storytelling digital video disk (DVD) intervention created with Veteran partners, versus an education-only DVD comparison. At 3 VA facilities, African American Veterans with uncontrolled hypertension were randomized to storytelling DVD intervention or didactic comparison DVD and followed for 6 months. We hypothesized that follow-up blood pressure (BP) would be lower among Veterans in the intervention group. African American Veterans (N=619) were 92% male, 39% over age 65, most had a high-school education, over 50% of both the intervention and comparison group reported a household income of <$20,000, and 40% had less than adequate health literacy. At baseline, mean intervention and comparison group BPs were 138/80 and 139/81 mm Hg, respectively; at 6 months, mean systolic BP (SBP) increased by 0.1 in the intervention group and by 1.9 for the comparison group; diastolic BP fell by 0.1 in the intervention group and rose by 0.2 in the comparison group. No differences between the intervention and control groups were statistically significant (all P>0.3). Site differences were large; at one, the intervention group improved while the comparison groups deteriorated, resulting in 6.3 and 3.9 mm Hg more improvement for the intervention group in SBP and diastolic BP (P=0.06 and 0.04), respectively; at the other 2 sites, there were positive and negative changes, all small, in the 2 measures, with minimal differences-one site favored the comparison group and the other, the intervention (these comparisons did not approach statistical significance (all P>0.20). In a secondary analysis stratified by baseline BP, there was no intervention effect among those with uncontrolled BP, but intervention patients who were in control at baseline were more likely to stay in control, compared with comparison [SBP increase by 6.3 mm Hg (SD=14.4) among intervention, and by 10.9 mm Hg (SD=16.9) in comparison, P=0.02]. In this multisite trial, we did not find a significant overall storytelling intervention effect (Clinicaltrials.gov Reg. #NCT01276197).

Finding Efficiency in the Design of Large Multisite Evaluations: Estimating Variances for Science Achievement Studies

ERIC Educational Resources Information Center

Westine, Carl D.

2016-01-01

Little is known empirically about intraclass correlations (ICCs) for multisite cluster randomized trial (MSCRT) designs, particularly in science education. In this study, ICCs suitable for science achievement studies using a three-level (students in schools in districts) MSCRT design that block on district are estimated and examined. Estimates of…

Lessons Learned in Evaluating a Multisite, Comprehensive Teen Dating Violence Prevention Strategy: Design and Challenges of the Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships.

PubMed

Niolon, Phyllis Holditch; Taylor, Bruce G; Latzman, Natasha E; Vivolo-Kantor, Alana M; Valle, Linda Anne; Tharp, Andra T

2016-03-01

This paper describes the multisite, longitudinal cluster randomized controlled trial (RCT) design of the evaluation of the Dating Matters: Strategies to Promote Healthy Relationships initiative, and discusses challenges faced in conducting this evaluation. Health departments in 4 communities are partnering with middle schools in high-risk, urban communities to implement 2 models of teen dating violence (TDV) prevention over 4 years. Schools were randomized to receive either the Dating Matters comprehensive strategy or the "standard of care" strategy (an existing, evidence-based TDV prevention curriculum). Our design permits comparison of the relative effectiveness of the comprehensive and standard of care strategies. Multiple cohorts of students from 46 middle schools are surveyed in middle school and high school, and parents and educators from participating schools are also surveyed. Challenges discussed in conducting a multisite RCT include site variability, separation of implementation and evaluation responsibilities, school retention, parent engagement in research activities, and working within the context of high-risk urban schools and communities. We discuss the strengths and weaknesses of our approaches to these challenges in the hopes of informing future research. Despite multiple challenges, the design of the Dating Matters evaluation remains strong. We hope this paper provides researchers who are conducting complex evaluations of behavioral interventions with thoughtful discussion of the challenges we have faced and potential solutions to such challenges.

Lessons Learned in Evaluating a Multisite, Comprehensive Teen Dating Violence Prevention Strategy: Design and Challenges of the Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships

PubMed Central

Niolon, Phyllis Holditch; Taylor, Bruce G.; Latzman, Natasha E.; Vivolo-Kantor, Alana M.; Valle, Linda Anne; Tharp, Andra T.

2018-01-01

Objective This paper describes the multisite, longitudinal cluster randomized controlled trial (RCT) design of the evaluation of the Dating Matters: Strategies to Promote Healthy Relationships initiative, and discusses challenges faced in conducting this evaluation. Method Health departments in 4 communities are partnering with middle schools in high-risk, urban communities to implement 2 models of teen dating violence (TDV) prevention over 4 years. Schools were randomized to receive either the Dating Matters comprehensive strategy or the “standard of care” strategy (an existing, evidence-based TDV prevention curriculum). Our design permits comparison of the relative effectiveness of the comprehensive and standard of care strategies. Multiple cohorts of students from 46 middle schools are surveyed in middle school and high school, and parents and educators from participating schools are also surveyed. Results Challenges discussed in conducting a multisite RCT include site variability, separation of implementation and evaluation responsibilities, school retention, parent engagement in research activities, and working within the context of high-risk urban schools and communities. We discuss the strengths and weaknesses of our approaches to these challenges in the hopes of informing future research. Conclusions Despite multiple challenges, the design of the Dating Matters evaluation remains strong. We hope this paper provides researchers who are conducting complex evaluations of behavioral interventions with thoughtful discussion of the challenges we have faced and potential solutions to such challenges. PMID:29607239

The study designed by a committee: design of the Multisite Violence Prevention Project.

PubMed

Henry, David B; Farrell, Albert D

2004-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 x 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8-12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed.

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…

Bias and Bias Correction in Multisite Instrumental Variables Analysis of Heterogeneous Mediator Effects

ERIC Educational Resources Information Center

Reardon, Sean F.; Unlu, Fatih; Zhu, Pei; Bloom, Howard S.

2014-01-01

We explore the use of instrumental variables (IV) analysis with a multisite 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, an assumption known in the IV literature as the exclusion restriction.…

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…

Treatment of chronically depressed patients: A multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depressions versus usual secondary care

PubMed Central

Wiersma, Jenneke E; van Schaik, Digna JF; van Oppen, Patricia; McCullough, James P; Schoevers, Robert A; Dekker, Jack J; Blom, Marc BJ; Maas, Kristel; Smit, Johannes H; Penninx, Brenda WJH; Beekman, Aartjan TF

2008-01-01

Background 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) is a form of psychotherapy specifically developed for patients with chronic depression. In a study in the U.S., remarkable favorable effects of CBASP have been demonstrated. However, no other studies have as yet replicated these findings and CBASP has not been tested outside the United States. This protocol describes a randomized controlled trial on the effectiveness of CBASP in the Netherlands. Methods/Design The purpose of the present paper is to report the study protocol of a multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depression in the Netherlands. In this study, CBASP in combination with medication, will be tested versus usual secondary care in combination with medication. The aim is to recruit 160 patients from three mental health care organizations. Depressive symptoms will be assessed at baseline, after 8 weeks, 16 weeks, 32 weeks and 52 weeks, using the 28-item Inventory for Depressive Symptomatology (IDS). Effect modification by co morbid anxiety, alcohol consumption, general and social functioning and working alliance will be tested. GEE analyses of covariance, controlling for baseline value and center will be used to estimate the overall treatment effectiveness (difference in IDS score) at post-treatment and follow up. The primary analysis will be by 'intention to treat' using double sided tests. An economic analysis will compare the two groups in terms of mean costs and cost-effectiveness from a societal perspective. Discussion The study will provide an answer to the question whether the favorable effects of CBASP can be replicated outside the US. Trial Registration The Dutch Cochrane Center, NTR1090. PMID:18366729

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…

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

Sources of Site Differences in the Efficacy of a Multisite Clinical Trial: The Treatment of SSRI-Resistant Depression in Adolescents

ERIC Educational Resources Information Center

Spirito, Anthony; Abebe, Kaleab Z.; Iyengar, Satish; Brent, David; Vitiello, Benedetto; Clarke, Gregory; Wagner, Karen Dineen; Asarnow, Joan; Emslie, Graham; Keller, Martin

2009-01-01

Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a…

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…

Effect Sizes in Cluster-Randomized Designs

ERIC Educational Resources Information Center

Hedges, Larry V.

2007-01-01

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

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

Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention using Dosed Exercise (STRIDE) trial.

PubMed

Walker, Robrina; Morris, David W; Greer, Tracy L; Trivedi, Madhukar H

2014-01-01

Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (STimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants for STRIDE. Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study. Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all research assistants demonstrated ability to correctly and reliably administer the measures throughout the study. Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.

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 randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Coll, Joseph R; Schoen, Sarah A

2007-01-01

A pilot randomized controlled trial (RCT) of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) was conducted with children who had sensory modulation disorders (SMDs). This study evaluated the effectiveness of three treatment groups. In addition, sample size estimates for a large scale, multisite RCT were calculated. Twenty-four children with SMD were randomly assigned to one of three treatment conditions; OT-SI, Activity Protocol, and No Treatment. Pretest and posttest measures of behavior, sensory and adaptive functioning, and physiology were administered. The OT-SI group, compared to the other two groups, made significant gains on goal attainment scaling and on the Attention subtest and the Cognitive/Social composite of the Leiter International Performance Scale-Revised. Compared to the control groups, OT-SI improvement trends on the Short Sensory Profile, Child Behavior Checklist, and electrodermal reactivity were in the hypothesized direction. Findings suggest that OT-SI may be effective in ameliorating difficulties of children with SMD.

Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial.

PubMed

Syrjala, Karen L; Abrams, Janet R; Polissar, Nayak L; Hansberry, Jennifer; Robison, Jeanne; DuPen, Stuart; Stillman, Mark; Fredrickson, Marvin; Rivkin, Saul; Feldman, Eric; Gralow, Julie; Rieke, John W; Raish, Robert J; Lee, Douglas J; Cleeland, Charles S; DuPen, Anna

2008-03-01

Standard guidelines for cancer pain treatment routinely recommend training patients to reduce barriers to pain relief, use medications appropriately, and communicate their pain-related needs. Methods are needed to reduce professional time required while achieving sustained intervention effectiveness. In a multisite, randomized controlled trial, this study tested a pain training method versus a nutrition control. At six oncology clinics, physicians (N=22) and nurses (N=23) enrolled patients (N=93) who were over 18 years of age, with cancer diagnoses, pain, and a life expectancy of at least 6 months. Pain training and control interventions were matched for materials and method. Patients watched a video followed by about 20 min of manual-standardized training with an oncology nurse focused on reviewing the printed material and adapted to individual concerns of patients. A follow-up phone call after 72 h addressed individualized treatment content and pain communication. Assessments at baseline, one, three, and 6 months included barriers, the Brief Pain Inventory, opioid use, and physician and nurse ratings of their patients' pain. Trained versus control patients reported reduced barriers to pain relief (P<.001), lower usual pain (P=.03), and greater opioid use (P<.001). No pain training patients reported severe pain (>6 on a 0-10 scale) at 1-month outcomes (P=.03). Physician and nurse ratings were closer to patients' ratings of pain for trained versus nutrition groups (P=.04 and <.001, respectively). Training efficacy was not modified by patient characteristics. Using video and print materials, with brief individualized training, effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups.

Multisite Phosphorylation Modulates the T Cell Receptor ζ-Chain Potency but not the Switchlike Response.

PubMed

Mukhopadhyay, Himadri; de Wet, Ben; Clemens, Lara; Maini, Philip K; Allard, Jun; van der Merwe, P Anton; Dushek, Omer

2016-04-26

Multisite phosphorylation is ubiquitous in cellular signaling and is thought to provide signaling proteins with additional regulatory mechanisms. Indeed, mathematical models have revealed a large number of mechanisms by which multisite phosphorylation can produce switchlike responses. The T cell antigen receptor (TCR) is a multisubunit receptor on the surface of T cells that is a prototypical multisite substrate as it contains 20 sites that are distributed on 10 conserved immunoreceptor tyrosine-based activation motifs (ITAMs). The TCR ζ-chain is a homodimer subunit that contains six ITAMs (12 sites) and exhibits a number of properties that are predicted to be sufficient for a switchlike response. We have used cellular reconstitution to systematically study multisite phosphorylation of the TCR ζ-chain. We find that multisite phosphorylation proceeds by a nonsequential random mechanism, and find no evidence that multiple ITAMs modulate a switchlike response but do find that they alter receptor potency and maximum phosphorylation. Modulation of receptor potency can be explained by a reduction in molecular entropy of the disordered ζ-chain upon phosphorylation. We further find that the tyrosine kinase ZAP-70 increases receptor potency but does not modulate the switchlike response. In contrast to other multisite proteins, where phosphorylations act in strong concert to modulate protein function, we suggest that the multiple ITAMs on the TCR function mainly to amplify subsequent signaling. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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

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

PubMed

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

2010-06-01

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

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Trial registration Clinical Trials NCT01740635. PMID:24156396

Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection

PubMed Central

Kreimer, Aimée R.; Schiffman, Mark; Herrero, Rolando; Wacholder, Sholom; Rodriguez, Ana Cecilia; Lowy, Douglas R.; Porras, Carolina; Schiller, John T.; Quint, Wim; Jimenez, Silvia; Safaeian, Mahboobeh; Struijk, Linda; Schussler, John; Hildesheim, Allan; Gonzalez, Paula

2016-01-01

Background: Previous Costa Rica Vaccine Trial (CVT) reports separately demonstrated vaccine efficacy against HPV16 and HPV18 (HPV16/18) infections at the cervical, anal, and oral regions; however, the combined overall multisite efficacy (protection at all three sites) and vaccine efficacy among women infected with HPV16 or HPV18 prior to vaccination are less known. Methods: Women age 18 to 25 years from the CVT were randomly assigned to the HPV16/18 vaccine (Cervarix) or a hepatitis A vaccine. Cervical, oral, and anal specimens were collected at the four-year follow-up visit from 4186 women. Multisite and single-site vaccine efficacies (VEs) and 95% confidence intervals (CIs) were computed for one-time detection of point prevalent HPV16/18 in the cervical, anal, and oral regions four years after vaccination. All statistical tests were two-sided. Results: The multisite woman-level vaccine efficacy was highest among “naïve” women (HPV16/18 seronegative and cervical HPV high-risk DNA negative at vaccination) (vaccine efficacy = 83.5%, 95% CI = 72.1% to 90.8%). Multisite woman-level vaccine efficacy was also demonstrated among women with evidence of a pre-enrollment HPV16 or HPV18 infection (seropositive for HPV16 and/or HPV18 but cervical HPV16/18 DNA negative at vaccination) (vaccine efficacy = 57.8%, 95% CI = 34.4% to 73.4%), but not in those with cervical HPV16 and/or HPV18 DNA at vaccination (anal/oral HPV16/18 VE = 25.3%, 95% CI = -40.4% to 61.1%). Concordant HPV16/18 infections at two or three sites were also less common in HPV16/18-infected women in the HPV vaccine vs control arm (7.4% vs 30.4%, P < .001). Conclusions: This study found high multisite vaccine efficacy among “naïve” women and also suggests the vaccine may provide protection against HPV16/18 infections at one or more anatomic sites among some women infected with these types prior to HPV16/18 vaccination. PMID:26467666

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

ERIC Educational Resources Information Center

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

2014-01-01

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

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.

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

Orthopaedic resident preparedness for closed reduction and pinning of pediatric supracondylar fractures is improved by e-learning: a multisite randomized controlled study.

PubMed

Hearty, Thomas; Maizels, Max; Pring, Maya; Mazur, John; Liu, Raymond; Sarwark, John; Janicki, Joseph

2013-09-04

There is a need to provide more efficient surgical training methods for orthopaedic residents. E-learning could possibly increase resident surgical preparedness, confidence, and comfort for surgery. Using closed reduction and pinning of pediatric supracondylar humeral fractures as the index case, we hypothesized that e-learning could increase resident knowledge acquisition for case preparation in the operating room. An e-learning surgical training module was created on the Computer Enhanced Visual Learning platform. The module provides a detailed and focused road map of the procedure utilizing a multimedia format. A multisite prospective randomized controlled study design compared residents who used a textbook for case preparation (control group) with residents who used the same textbook plus completed the e-learning module (test group). All subjects completed a sixty-question test on the theory and methods of the case. After completion of the test, the control group then completed the module as well. All subjects were surveyed on their opinion regarding the effectiveness of the module after performing an actual surgical case. Twenty-eight subjects with no previous experience in this surgery were enrolled at four academic centers. Subjects were randomized into two equal groups. The test group scored significantly better (p < 0.001) and demonstrated competence on the test compared with the control group; the mean correct test score (and standard deviation) was 90.9% ± 6.8% for the test group and 73.5% ± 6.4% for the control group. All residents surveyed (n = 27) agreed that the module is a useful supplement to traditional methods for case preparation and twenty-two of twenty-seven residents agreed that it reduced their anxiety during the case and improved their attention to surgical detail. E-learning using the Computer Enhanced Visual Learning platform significantly improved preparedness, confidence, and comfort with percutaneous closed reduction and pinning of a pediatric supracondylar humeral fracture. We believe that adapting such methods into residency training programs will improve efficiency in surgical training.

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…

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

ERIC Educational Resources Information Center

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

2009-01-01

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

Multisite effectiveness trials of treatments for substance abuse and co-occurring problems: have we chosen the best designs?

PubMed

Nunes, Edward V; Ball, Samuel; Booth, Robert; Brigham, Gregory; Calsyn, Donald A; Carroll, Kathleen; Feaster, Daniel J; Hien, Denise; Hubbard, Robert L; Ling, Walter; Petry, Nancy M; Rotrosen, John; Selzer, Jeffrey; Stitzer, Maxine; Tross, Susan; Wakim, Paul; Winhusen, Theresa; Woody, George

2010-06-01

Multisite effectiveness trials such as those carried out in the National Drug Abuse Treatment Clinical Trials Network (CTN) are a critical step in the development and dissemination of evidence-based treatments because they address how such treatments perform in real-world clinical settings. As Brigham et al. summarized in a recent article (G. S. Brigham, D. J. Feaster, P. G. Wakim, & C. L. Dempsey C. L., 2009), several possible experimental designs may be chosen for such effectiveness trials. These include (a) a new treatment intervention (Tx) is compared to an existing mode of community based treatment as usual (TAU): Tx versus TAU; (b) a new intervention is added to TAU and compared to TAU alone: Tx + TAU versus TAU; or (c) a new intervention is added to TAU and compared to a control condition added to TAU: Tx + TAU versus control + TAU. Each of these designs addresses a different question and has different potential strengths and weaknesses. As of December 2009, the primary outcome paper had been published for 16 of the multisite randomized clinical trials conducted in the CTN, testing various treatments for drug abuse, HIV risk behavior, or related problems. This paper systematically examines, for each of the completed trials, the experimental design type chosen and its original rationale, the main findings of the trial, and the strengths and weaknesses of the design in hindsight. Based on this review, recommendations are generated to inform the design of future effectiveness trials on treatments for substance abuse, HIV risk, and other behavioral health problems.

A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

ERIC Educational Resources Information Center

Kerson, Cynthia

2013-01-01

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders.

PubMed

Harbourne, Regina T; Dusing, Stacey C; Lobo, Michele A; Westcott-McCoy, Sarah; Bovaird, James; Sheridan, Susan; Galloway, James C; Chang, Hui-Ju; Hsu, Lin-Ya; Koziol, Natalie; Marcinowski, Emily C; Babik, Iryna

2018-06-01

There is limited research examining the efficacy of early physical therapy on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the clear association between motor activity and cognition during infancy. The aim of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to advance global development in infants with motor delays or neuromotor dysfunction. This study is a longitudinal multisite randomized controlled trial. Infants in the START-Play group are compared to infants receiving usual care in early intervention (EI). The research takes place in homes in Pennsylvania, Delaware, Washington, and Virginia. There will be 140 infants with neuromotor dysfunction participating, beginning between 7 to 16 months of age. Infants will have motor delays and emerging sitting skill. START-Play provides individualized twice-weekly home intervention for 12 weeks with families to enhance cognition through sitting, reaching, and problem-solving activities for infants. Ten interventionists provide the intervention, with each child assigned 1 therapist. The primary outcome measure is the Bayley III Scales of Infant Development. Secondary measures include change in the Early Problem Solving Indicator, change in the Gross Motor Function Measure, and change in the type and duration of toy contacts during reaching. Additional measures include sitting posture control and parent-child interaction. Limitations include variability in usual EI care and the lack of blinding for interventionists and families. This study describes usual care in EI across 4 US regions and compares outcomes of the START-Play intervention to usual care.

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.

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.

Strategies to Support Recruitment of Patients with Life-limiting illness for Research: The Palliative Care Research Cooperative Group

PubMed Central

Hanson, Laura C.; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E.; Kutner, Jean S.; Aziz, Noreen M.; Abernethy, Amy

2014-01-01

Context The Palliative Care Research Cooperative group (PCRC) is the first clinical trials cooperative for palliative care in the United States. Objectives To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. Methods The parent study was a multi-site randomized controlled trial enrolling adults with life expectancy anticipated to be 1–6 months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semi-structured interviews with 18 site Principal Investigators (PI) and Clinical Research Coordinators (CRC), and reviewed recruitment rates. Interviews covered 3 topics – 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. Results All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of n=381 patients. Site enrollment ranged from 1–109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients’ needs, support from clinical champions, and the additional resources of a trials cooperative group. Conclusion The recruitment experience from the multi-site PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. PMID:24863152

Multisite Randomized Trial of Behavioral Interventions for Women with Co-Occurring PTSD and Substance Use Disorders

ERIC Educational Resources Information Center

Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.

2009-01-01

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353…

Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Randomized Experiment. NCEE 2014-4004

ERIC Educational Resources Information Center

Glazerman, Steven; Protik, Ali; Teh, Bing-ru; Bruch, Julie; Max, Jeffrey

2013-01-01

One way to improve struggling schools' access to effective teachers is to use selective transfer incentives. Such incentives offer bonuses for the highest-performing teachers to move into schools serving the most disadvantaged students. In this report, we provide evidence from a randomized experiment that tested whether such a policy intervention…

Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

ERIC Educational Resources Information Center

Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

2011-01-01

Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

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

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial.

PubMed

Kron, Frederick W; Fetters, Michael D; Scerbo, Mark W; White, Casey B; Lypson, Monica L; Padilla, Miguel A; Gliva-McConvey, Gayle A; Belfore, Lee A; West, Temple; Wallace, Amelia M; Guetterman, Timothy C; Schleicher, Lauren S; Kennedy, Rebecca A; Mangrulkar, Rajesh S; Cleary, James F; Marsella, Stacy C; Becker, Daniel M

2017-04-01

To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group's experiences and learning preferences. A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR's intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. MPathic-VR's virtual human simulation offers an effective and engaging means of advanced communication training. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Using a computer simulation for teaching communication skills: A blinded multisite mixed methods randomized controlled trial

PubMed Central

Kron, Frederick W.; Fetters, Michael D.; Scerbo, Mark W.; White, Casey B.; Lypson, Monica L.; Padilla, Miguel A.; Gliva-McConvey, Gayle A.; Belfore, Lee A.; West, Temple; Wallace, Amelia M.; Guetterman, Timothy C.; Schleicher, Lauren S.; Kennedy, Rebecca A.; Mangrulkar, Rajesh S.; Cleary, James F.; Marsella, Stacy C.; Becker, Daniel M.

2016-01-01

Objectives To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group’s experiences and learning preferences. Methods A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N=210) to computer-based learning (N=211). Primary outcomes: communication scores during repeat interactions with MPathic-VR’s intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. Secondary outcomes: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. Results MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. Conclusions MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. Practice Implications MPathic-VR’s virtual human simulation offers an effective and engaging means of advanced communication training. PMID:27939846

Voxel-based morphometric multisite collaborative study on schizophrenia.

PubMed

Segall, Judith M; Turner, Jessica A; van Erp, Theo G M; White, Tonya; Bockholt, H Jeremy; Gollub, Randy L; Ho, Beng C; Magnotta, Vince; Jung, Rex E; McCarley, Robert W; Schulz, S Charles; Lauriello, John; Clark, Vince P; Voyvodic, James T; Diaz, Michele T; Calhoun, Vince D

2009-01-01

Regional gray matter (GM) abnormalities are well known to exist in patients with chronic schizophrenia. Voxel-based morphometry (VBM) has been previously used on structural magnetic resonance images (MRI) data to characterize these abnormalities. Two multisite schizophrenia studies, the Functional Biomedical Informatics Research Network and the Mind Clinical Imaging Consortium, which include 9 data collection sites, are evaluating the efficacy of pooling structural imaging data across imaging centers. Such a pooling of data could yield the increased statistical power needed to elucidate effects that may not be seen with smaller samples. VBM analyses were performed to evaluate the consistency of patient versus control gray matter concentration (GMC) differences across the study sites, as well as the effects of combining multisite data. Integration of data from both studies yielded a large sample of 503 subjects, including 266 controls and 237 patients diagnosed with schizophrenia, schizoaffective or schizophreniform disorder. The data were analyzed using the combined sample, as well as analyzing each of the 2 multisite studies separately. A consistent pattern of reduced relative GMC in schizophrenia patients compared with controls was found across all study sites. Imaging center-specific effects were evaluated using a region of interest analysis. Overall, the findings support the use of VBM in combined multisite studies. This analysis of schizophrenics and controls from around the United States provides continued supporting evidence for GM deficits in the temporal lobes, anterior cingulate, and frontal regions in patients with schizophrenia spectrum disorders.

Issues in the design of multisite clinical trials of psychotherapy: VA Cooperative Study No. 494 as an example.

PubMed

Schnurr, Paula P; Friedman, Matthew J; Engel, Charles C; Foa, Edna B; Shea, M Tracie; Resick, Patricia M; James, Kenneth E; Chow, Bruce K

2005-12-01

This article describes issues in the design of an ongoing multisite randomized clinical trial of psychotherapy for treating posttraumatic stress disorder (PTSD) in female veterans and active duty personnel. Research aimed at testing treatments for PTSD in women who have served in the military is especially important due to the high prevalence of PTSD in this population. VA Cooperative Study 494 was designed to enroll 384 participants across 12 sites. Participants are randomly assigned to receive 10 weekly sessions of individual psychotherapy: Prolonged Exposure, a specific cognitive-behavioral therapy protocol for PTSD, or present-centered therapy, a comparison treatment that addresses current interpersonal problems but avoids a trauma focus. PTSD is the primary outcome. Additional outcomes are comorbid problems such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and service utilization. Follow-up assessments are conducted at the end of treatment and then 3 and 6 months after treatment. Both treatments are delivered according to a manual. Videotapes of therapy sessions are viewed by experts who provide feedback to therapists throughout the trial to ensure adherence to the treatment manual. Discussion includes issues encountered in multisite psychotherapy trials along with the rationale for our decisions about how we addressed these issues in CSP #494.

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

PubMed

Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

2017-05-01

To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001). Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

Process evaluation of the Hunter Illawarra Kids Challenge Using Parent Support study: a multisite randomized controlled trial for the management of child obesity.

PubMed

Jones, Rachel A; Warren, Janet M; Okely, Anthony D; Collins, Clare E; Morgan, Philip J; Cliff, Dylan P; Burrows, Tracy; Cleary, Jane; Baur, Louise A

2010-11-01

The purposes of this article are to (a) outline findings from secondary or process outcome data of the Hunter Illawarra Kids Challenge Using Parent Support (HIKCUPS) study and (b) inform the design and development of future research interventions and practice in the management of child obesity. Data were collected by means of facilitator evaluations, independent session observation, attendance records, and parent questionnaires. Internal validity and reliability of the program delivery were high. All parents reported positive changes in their children as a result of the physical activity program, the dietary modification program, or both. Most participants completed the home activities, but more than half reported that finding time to do them was problematic. Facilitator review indicated that future programs should specifically cater to children of similar age or same sex, allow adequate time for explanation of complex nutritional concepts, and use intrinsic motivators for participants. Recommendations for future interventions, specifically the implementation of subsequent HIKCUPS or other multisite effectiveness studies, are detailed.

A Design Principle for an Autonomous Post-translational Pattern Formation.

PubMed

Sugai, Shuhei S; Ode, Koji L; Ueda, Hiroki R

2017-04-25

Previous autonomous pattern-formation models often assumed complex molecular and cellular networks. This theoretical study, however, shows that a system composed of one substrate with multisite phosphorylation and a pair of kinase and phosphatase can generate autonomous spatial information, including complex stripe patterns. All (de-)phosphorylation reactions are described with a generic Michaelis-Menten scheme, and all species freely diffuse without pre-existing gradients. Computational simulation upon >23,000,000 randomly generated parameter sets revealed the design motifs of cyclic reaction and enzyme sequestration by slow-diffusing substrates. These motifs constitute short-range positive and long-range negative feedback loops to induce Turing instability. The width and height of spatial patterns can be controlled independently by distinct reaction-diffusion processes. Therefore, multisite reversible post-translational modification can be a ubiquitous source for various patterns without requiring other complex regulations such as autocatalytic regulation of enzymes and is applicable to molecular mechanisms for inducing subcellular localization of proteins driven by post-translational modifications. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2007-08-01

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

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.

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…

Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Randomized Experiment. Executive Summary. NCEE 2014-4004

ERIC Educational Resources Information Center

Glazerman, Steven; Protik, Ali; Teh, Bing-ru; Bruch, Julie; Max, Jeffrey

2013-01-01

One way to improve struggling schools' access to effective teachers is to use selective transfer incentives. Such incentives offer bonuses for the highest-performing teachers to move into schools serving the most disadvantaged students. In this report, we provide evidence from a randomized experiment that tested whether such a policy intervention…

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

ERIC Educational Resources Information Center

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

2009-01-01

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

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

ERIC Educational Resources Information Center

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

2017-01-01

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

The added value of auditory cortex transcranial random noise stimulation (tRNS) after bifrontal transcranial direct current stimulation (tDCS) for tinnitus.

PubMed

To, Wing Ting; Ost, Jan; Hart, John; De Ridder, Dirk; Vanneste, Sven

2017-01-01

Tinnitus is the perception of a sound in the absence of a corresponding external sound source. Research has suggested that functional abnormalities in tinnitus patients involve auditory as well as non-auditory brain areas. Transcranial electrical stimulation (tES), such as transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex and transcranial random noise stimulation (tRNS) to the auditory cortex, has demonstrated modulation of brain activity to transiently suppress tinnitus symptoms. Targeting two core regions of the tinnitus network by tES might establish a promising strategy to enhance treatment effects. This proof-of-concept study aims to investigate the effect of a multisite tES treatment protocol on tinnitus intensity and distress. A total of 40 tinnitus patients were enrolled in this study and received either bifrontal tDCS or the multisite treatment of bifrontal tDCS before bilateral auditory cortex tRNS. Both groups were treated on eight sessions (two times a week for 4 weeks). Our results show that a multisite treatment protocol resulted in more pronounced effects when compared with the bifrontal tDCS protocol or the waiting list group, suggesting an added value of auditory cortex tRNS to the bifrontal tDCS protocol for tinnitus patients. These findings support the involvement of the auditory as well as non-auditory brain areas in the pathophysiology of tinnitus and demonstrate the idea of the efficacy of network stimulation in the treatment of neurological disorders. This multisite tES treatment protocol proved to be save and feasible for clinical routine in tinnitus patients.

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.

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.

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial [Formula: see text].

PubMed

McCullough, Amy; Ruehrdanz, Ashleigh; Jenkins, Molly A; Gilmer, Mary Jo; Olson, Janice; Pawar, Anjali; Holley, Leslie; Sierra-Rivera, Shirley; Linder, Deborah E; Pichette, Danielle; Grossman, Neil J; Hellman, Cynthia; Guérin, Noémi A; O'Haire, Marguerite E

2018-05-01

This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child's treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

PubMed Central

2011-01-01

Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial registration ClinicalTrials.gov (NCT00970437). PMID:21849054

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group.

PubMed

Hanson, Laura C; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E; Kutner, Jean S; Aziz, Noreen M; Abernethy, Amy

2014-12-01

The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S. To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group. The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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.

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

Treesearch

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

2006-01-01

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

Cost-Effectiveness of an Internet-Delivered Treatment for Substance Abuse: Data from a Multisite Randomized Controlled Trial

PubMed Central

Murphy, Sean M.; Campbell, Aimee N. C.; Ghitza, Udi E.; Kyle, Tiffany L.; Bailey, Genie L.; Nunes, Edward V.; Polsky, Daniel

2016-01-01

Background Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Methods Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). Results From the provider’s perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. Conclusions With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Clinical trial registration NCT01104805. PMID:26880594

Cost-effectiveness of an internet-delivered treatment for substance abuse: Data from a multisite randomized controlled trial.

PubMed

Murphy, Sean M; Campbell, Aimee N C; Ghitza, Udi E; Kyle, Tiffany L; Bailey, Genie L; Nunes, Edward V; Polsky, Daniel

2016-04-01

Substance misuse and excessive alcohol consumption are major public health issues. Internet-based interventions for substance use disorders (SUDs) are a relatively new method for addressing barriers to access and supplementing existing care. This study examines cost-effectiveness in a multisite, randomized trial of an internet-based version of the community reinforcement approach (CRA) with contingency management (CM) known as the Therapeutic Education System (TES). Economic evaluation of the 12-week trial with follow-up at 24 and 36 weeks. 507 individuals who were seeking therapy for alcohol or other substance use disorders at 10 outpatient community-based treatment programs were recruited and randomized to either treatment as usual (TAU) or TES+TAU. Sub-analyses were completed on participants with a poorer prognosis (i.e., those not abstinent at study entry). From the provider's perspective, TES+TAU as it was implemented in this study costs $278 (SE=87) more than TAU alone after 12 weeks. The quality-adjusted life years gained by TES+TAU and TAU were similar; however, TES+TAU has at least a 95% chance of being considered cost-effective for providers and payers with willingness-to-pay thresholds as low as $20,000 per abstinent year. Findings for the subgroup not abstinent at study entry are slightly more favorable. With regard to the clinical outcome of abstinence, our cost-effectiveness findings of TES+TAU compare favorably to those found elsewhere in the CM literature. The analyses performed here serve as an initial economic framework for future studies integrating technology into SUD therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

Identifying Depressed Older Adults in Primary Care: A Secondary Analysis of a Multisite Randomized Controlled Trial

PubMed Central

Voils, Corrine I.; Olsen, Maren K.; Williams, John W.; for the IMPACT Study Investigators

2008-01-01

Objective: To determine whether a subset of depressive symptoms could be identified to facilitate diagnosis of depression in older adults in primary care. Method: Secondary analysis was conducted on 898 participants aged 60 years or older with major depressive disorder and/or dysthymic disorder (according to DSM-IV criteria) who participated in the Improving Mood–Promoting Access to Collaborative Treatment (IMPACT) study, a multisite, randomized trial of collaborative care for depression (recruitment from July 1999 to August 2001). Linear regression was used to identify a core subset of depressive symptoms associated with decreased social, physical, and mental functioning. The sensitivity and specificity, adjusting for selection bias, were evaluated for these symptoms. The sensitivity and specificity of a second subset of 4 depressive symptoms previously validated in a midlife sample was also evaluated. Results: Psychomotor changes, fatigue, and suicidal ideation were associated with decreased functioning and served as the core set of symptoms. Adjusting for selection bias, the sensitivity of these 3 symptoms was 0.012 and specificity 0.994. The sensitivity of the 4 symptoms previously validated in a midlife sample was 0.019 and specificity was 0.997. Conclusion: We identified 3 depression symptoms that were highly specific for major depressive disorder in older adults. However, these symptoms and a previously identified subset were too insensitive for accurate diagnosis. Therefore, we recommend a full assessment of DSM-IV depression criteria for accurate diagnosis. PMID:18311416

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

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org.

PubMed

Lindquist, Lee A; Ramirez-Zohfeld, Vanessa; Sunkara, Priya D; Forcucci, Chris; Campbell, Dianne S; Mitzen, Phyllis; Ciolino, Jody D; Kricke, Gayle; Seltzer, Anne; Ramirez, Ana V; Cameron, Kenzie A

2017-11-01

Investigate the effect of PlanYourLifespan.org (PYL) on knowledge of posthospital discharge options. Multisite randomized controlled trial. Nonhospitalized adults, aged =65 years, living in urban, suburban, and rural areas of Texas, Illinois, and Indiana. PYL is a national, publicly available tool that provides education on posthospital therapy choices and local home-based resources. Participants completed an in-person baseline survey, followed by exposure to intervention or attention control (AC) websites, then 1-month and 3-month telephone surveys. The primary knowledge outcome was measured with 6 items (possible 0-6 points) pertaining to hospital discharge needs. Among 385 participants randomized, mean age was 71.9 years (standard deviation 5.6) and 79.5% of participants were female. At 1 month, the intervention group had a 0.6 point change (standard deviation = 1.6) versus the AC group who had a -0.1 point change in knowledge score. Linear mixed modeling results suggest sex, health literacy level, level of education, income, and history of high blood pressure/kidney disease were significant predictors of knowledge over time. Controlling for these variables, treatment effect remained significant (P < 0.0001). Seniors who used PYL demonstrated an increased understanding of posthospitalization and home services compared to the control group. © 2017 Society of Hospital Medicine

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

PubMed Central

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

2007-01-01

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

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

A Multisite, Randomized Clinical Trial of Virtual Reality and Prolonged Exposure Therapy for Active Duty Soldiers with PTSD

DTIC Science & Technology

2015-02-01

Department of Defense, Washington Headquarters Services , Directorate for Information Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite...1204, Arlington, VA 22202- 4302. Respondents should be aware that notwithstanding any other provision of law , no person shall be subject to any...conducted for both treatments. Service members were assessed before randomization, after 5 sessions, at posttreatment, and 3- and 6-months posttreatment

Using Growth Curves To Determine the Timing of the Booster Sessions.

ERIC Educational Resources Information Center

Hennessy, Michael; Bolan, Gail A.; Hoxworth, Tamara; Iatesta, Michael; Rhodes, Fen; Zenilman, Jonathan M.

1999-01-01

Demonstrates an application of a method for using growth curves to determine the timing of booster sessions to reinforce the cognitive messages or behavior changes of interventions. Uses data from a multisite randomized experiment that compared three counseling and testing methods for preventing sexual disease transmission. Presents…

Assessment in Multisite Randomized Clinical Trials of Patients with Autistic Disorder: The Autism RUPP Network.

ERIC Educational Resources Information Center

Arnold, L. Eugene; Aman, Michael G.; Martin, Andres; Collier-Crespin, Angie; Vitiello, Benedetto; Tierney, Elaine; Asarnow, Robert; Bell-Bradshaw, Felicia; Freeman, Betty Jo; Gates-Ulanet, Patricia; Klin, Ami; McCracken, James T.; McDougle, Christopher J.; McGough, James J.; Posey, David J.; Scahill, Lawrence; Swiezy, Naomi B.; Ritz, Louise; Volkmar, Fred

2000-01-01

This paper explains how the Autism Research Units on Pediatric Psychopharmacology (RUPP Autism Network) resolved common assessment problems including communication problems compromising use of the patient as informant, broad subject heterogeneity, difficulties in assessing low-end IQs, scarcity of autism-adapted cognitive and neuropsychological…

Coherent Power Analysis in Multilevel Studies Using Parameters from Surveys

ERIC Educational Resources Information Center

Rhoads, Christopher

2017-01-01

Researchers designing multisite and cluster randomized trials of educational interventions will usually conduct a power analysis in the planning stage of the study. To conduct the power analysis, researchers often use estimates of intracluster correlation coefficients and effect sizes derived from an analysis of survey data. When there is…

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…

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

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 Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity.

PubMed

Erickson, Zachary D; Kwan, Crystal L; Gelberg, Hollie A; Arnold, Irina Y; Chamberlin, Valery; Rosen, Jennifer A; Shah, Chandresh; Nguyen, Charles T; Hellemann, Gerhard; Aragaki, Dixie R; Kunkel, Charles F; Lewis, Melissa M; Sachinvala, Neena; Sonza, Patrick A; Pierre, Joseph M; Ames, Donna

2017-04-01

Weight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits. We investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System. We conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups. Veterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy. One group received "Lifestyle Balance" (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive "Usual Care" (UC) consisting of weight monitoring and provision of self-help. Participants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly. Participants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001). Behavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. "Lifestyle Balance" integrates well with VA healthcare's patient-centered "Whole Health" approach. ClinicalTrials.gov identifier NCT01052714.

Effects of an Organizational Linkage Intervention on Inter-Organizational Service Coordination Between Probation/Parole Agencies and Community Treatment Providers.

PubMed

Welsh, Wayne N; Knudsen, Hannah K; Knight, Kevin; Ducharme, Lori; Pankow, Jennifer; Urbine, Terry; Lindsey, Adrienne; Abdel-Salam, Sami; Wood, Jennifer; Monico, Laura; Link, Nathan; Albizu-Garcia, Carmen; Friedmann, Peter D

2016-01-01

Weak coordination between community correctional agencies and community-based treatment providers is a major barrier to diffusion of medication-assisted treatment (MAT)--the inclusion of medications (e.g., methadone and buprenorphine) in combination with traditional counseling and behavioral therapies to treat substance use disorders. In a multisite cluster randomized trial, experimental sites (j = 10) received a 3-h MAT training plus a 12-month linkage intervention; control sites (j = 10) received the 3-h training alone. Hierarchical linear models showed that the intervention resulted in significant improvements in perceptions of interagency coordination among treatment providers, but not probation/parole agents. Implications for policy and practice are discussed.

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

PubMed

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

2016-08-31

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

The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial.

PubMed

Forrester, David Anthony Tony; Doyle-Munoz, Janet; McTigue, Toni; D'Andrea, Stephanie; Natale-Ryan, Angela

2014-01-01

The purpose of this prospective, attention-controlled, randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention. Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study. Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings. Subjects were randomized to 3 groups: (1) standard postoperative care (n = 18); (2) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control (n = 16); and (3) standard care and gum chewing (n = 13). Standard postoperative care included removal of the nasogastric tube, early ambulation, nothing by mouth with ice chips only until the first passage of flatus, and then advancement of diet until tolerance of solid food. No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured: (1) first passage of flatus; (2) first bowel movement; (3) return of hunger; and (4) ability to tolerate solid food for one meal. Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms, length of stay, or complications among patients following open/laparoscopic sigmoid colectomy.

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.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

PubMed

El-Bassel, Nabila; Jemmott, John B; Bellamy, Scarlett L; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Landis, J Richard; Remien, Robert H

2016-06-01

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

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.

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

A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

PubMed

Gomar, Jesús J; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J; Ovejero, María R; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J

2015-11-01

The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

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…

Designing Large-Scale Multisite and Cluster-Randomized Studies of Professional Development

ERIC Educational Resources Information Center

Kelcey, Ben; Spybrook, Jessaca; Phelps, Geoffrey; Jones, Nathan; Zhang, Jiaqi

2017-01-01

We develop a theoretical and empirical basis for the design of teacher professional development studies. We build on previous work by (a) developing estimates of intraclass correlation coefficients for teacher outcomes using two- and three-level data structures, (b) developing estimates of the variance explained by covariates, and (c) modifying…

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,…

Efficacy of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP) Primary Version

ERIC Educational Resources Information Center

DiPerna, James Clyde; Lei, Puiwa; Bellinger, Jillian; Cheng, Weiyi

2015-01-01

A multisite cluster randomized trial was conducted to examine the effects of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007) on students' classroom social behavior. The final sample included 432 students across 38 second grade classrooms. Social skills and problem behaviors were measured…

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…

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

ERIC Educational Resources Information Center

Qin, Xu; Hong, Guanglei

2017-01-01

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

Functioning and Quality of Life in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Vitiello, Benedetto; Rohde, Paul; Silva, Susan; Wells, Karen; Casat, Charles; Waslick, Bruce; Simons, Anne; Reinecke, Mark; Weller, Elizabeth; Kratochvil, Christopher; Walkup, John; Pathak, Sanjeev; Robins, Michele; March, John

2006-01-01

Obective: To test whether 12-week treatment of major depression improved the level of functioning, global health, and quality of life of adolescents. Method: The Treatment for Adolescents With Depression Study was a multisite, randomized clinical trial of fluoxetine, cognitive-behavioral therapy (CBT), their combination (COMB), or clinical…

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

Results of a multisite randomized trial of supported employment interventions for individuals with severe mental illness.

PubMed

Cook, Judith A; Leff, H Stephen; Blyler, Crystal R; Gold, Paul B; Goldberg, Richard W; Mueser, Kim T; Toprac, Marcia G; McFarlane, William R; Shafer, Michael S; Blankertz, Laura E; Dudek, Ken; Razzano, Lisa A; Grey, Dennis D; Burke-Miller, Jane

2005-05-01

National probability surveys indicate that most individuals with schizophrenia and other severe mental illnesses are not employed. This multisite study tested the effectiveness of supported employment (SE) models combining clinical and vocational rehabilitation services to establish competitive employment. We randomly assigned 1273 outpatients with severe mental illness from 7 states in the United States to an experimental SE program or to a comparison or a services-as-usual condition, with follow-up for 24 months. Participants were interviewed semiannually, paid employment was tracked weekly, and vocational and clinical services were measured monthly. Mixed-effects random regression analysis was used to predict the likelihood of competitive employment, working 40 or more hours in a given month, and monthly earnings. Cumulative results during 24 months show that experimental group participants (359/648 [55%]) were more likely than those in the comparison programs (210/625 [34%]) to achieve competitive employment (chi(2) = 61.17; P<.001). Similarly, patients in experimental group programs (330/648 [51%]) were more likely than those in comparison programs (245/625 [39%]) to work 40 or more hours in a given month (chi(2) = 17.66; P<.001). Finally, participants in experimental group programs had significantly higher monthly earnings than those in the comparison programs (mean, US 122 dollars/mo [n=639] vs US 99 dollars/mo [n=622]); t(1259) = -2.04; P<.05). In the multivariate longitudinal analysis, experimental condition subjects were more likely than comparison group subjects to be competitively employed, work 40 or more hours in a given month, and have higher earnings, despite controlling for demographic, clinical, work history, disability beneficiary status, and study site confounders. Moreover, the advantage of experimental over comparison group participants increased during the 24-month study period. The SE models tailored by integrating clinical and vocational services were more effective than services as usual or unenhanced services.

Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network.

PubMed

Donovan, Dennis M; Daley, Dennis C; Brigham, Gregory S; Hodgkins, Candace C; Perl, Harold I; Garrett, Sharon B; Doyle, Suzanne R; Floyd, Anthony S; Knox, Patricia C; Botero, Christopher; Kelly, Thomas M; Killeen, Therese K; Hayes, Carole; Kau'i Baumhofer, Nicole; Kau'ibaumhofer, Nicole; Seamans, Cindy; Zammarelli, Lucy

2013-01-01

The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). Intensive outpatient substance treatment programs. Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. Urinalysis and self-reports of substance use and 12-step attendance and activities. Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

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.

A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students.

PubMed

Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi

2009-07-01

The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.

A Randomized Clinical Trial Evaluating a Combined Alcohol Intervention for High-Risk College Students*

PubMed Central

Turrisi, Rob; Larimer, Mary E.; Mallett, Kimberly A.; Kilmer, Jason R.; Ray, Anne E.; Mastroleo, Nadine R.; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W.; Montoya, Heidi

2009-01-01

Objective: The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Method: Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. Results: The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. Conclusions: The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session. PMID:19515296

Screening for asymptomatic bacteriuria in adults: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement.

PubMed

Lin, Kenneth; Fajardo, Kevin

2008-07-01

Asymptomatic bacteriuria is common, and screening for this condition in pregnant women is a well-established, evidence-based standard of current medical practice. Screening other groups of adults has not been shown to improve outcomes. To review new and substantial evidence on screening for asymptomatic bacteriuria, to support the work of the U.S. Preventive Services Task Force. English-language studies of adults (age >18 years) indexed in PubMed and the Cochrane Library and published from 1 January 2002 through 30 April 2007. For benefits of screening or treatment for screened populations, systematic reviews; meta-analyses; and randomized, controlled trials were included. For harms of screening, systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case-control studies; and case series of large multisite databases were included. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion. Two reviewers extracted data from studies on benefits of screening and treatment (including decreases in the incidence of adverse maternal and fetal outcomes, symptomatic urinary tract infections, hypertension, and renal function decline). An updated Cochrane systematic review of 14 randomized, controlled trials of treatment supports screening for asymptomatic bacteriuria in pregnant women. A randomized, controlled trial and a prospective cohort study show that screening nonpregnant women with diabetes for asymptomatic bacteriuria is unlikely to produce benefits. No new evidence on screening men for asymptomatic bacteriuria or on harms of screening was found. The focused search strategy may have missed some smaller studies on the benefits and harms of screening for asymptomatic bacteriuria. The available evidence continues to support screening for asymptomatic bacteriuria in pregnant women, but not in other groups of adults.

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

Evaluation of Intervention Fidelity in a Multisite Clinical Trial in Persons With Multiple Sclerosis.

PubMed

Morrison, Janet D; Becker, Heather; Stuifbergen, Alexa K

2017-12-01

Careful consideration of intervention fidelity is critical to establishing the validity and reliability of research findings, yet such reports are often lacking in the research literature. It is imperative that intervention fidelity be methodically evaluated and reported to promote the translation of effective interventions into sound evidence-based practice. The purpose of this article is to explore strategies used to promote intervention fidelity, incorporating examples from a multisite clinical trial, that illustrate the National Institutes of Health Behavior Change Consortium's 5 domains for recommended treatment practices: (1) study design, (2) facilitator training, (3) intervention delivery, (4) intervention receipt, and (5) intervention enactment. A multisite randomized clinical trial testing the efficacy of a computer-assisted cognitive rehabilitation intervention for adults with multiple sclerosis is used to illustrate strategies promoting intervention fidelity. Data derived from audiotapes of intervention classes, audits of computer exercises completed by participants, participant class attendance, and goal attainment scaling suggested relatively high fidelity to the intervention protocol. This study illustrates how to report intervention fidelity in the literature guided by best practice strategies, which may serve to promote fidelity monitoring and reporting in future studies.

Effect of a Mobile Web App on Kidney Transplant Candidates' Knowledge About Increased Risk Donor Kidneys: A Randomized Controlled Trial.

PubMed

Gordon, Elisa J; Sohn, Min-Woong; Chang, Chih-Hung; McNatt, Gwen; Vera, Karina; Beauvais, Nicole; Warren, Emily; Mannon, Roslyn B; Ison, Michael G

2017-06-01

Kidney transplant candidates (KTCs) must provide informed consent to accept kidneys from increased risk donors (IRD), but poorly understand them. We conducted a multisite, randomized controlled trial to evaluate the efficacy of a mobile Web application, Inform Me, for increasing knowledge about IRDs. Kidney transplant candidates undergoing transplant evaluation at 2 transplant centers were randomized to use Inform Me after routine transplant education (intervention) or routine transplant education alone (control). Computer adaptive learning method reinforced learning by embedding educational material, and initial (test 1) and additional test questions (test 2) into each chapter. Knowledge (primary outcome) was assessed in person after education (tests 1 and 2), and 1 week later by telephone (test 3). Controls did not receive test 2. Willingness to accept an IRD kidney (secondary outcome) was assessed after tests 1 and 3. Linear regression test 1 knowledge scores were used to test the significance of Inform Me exposure after controlling for covariates. Multiple imputation was used for intention-to-treat analysis. Two hundred eighty-eight KTCs participated. Intervention participants had higher test 1 knowledge scores (mean difference, 6.61; 95% confidence interval [95% CI], 5.37-7.86) than control participants, representing a 44% higher score than control participants' scores. Intervention participants' knowledge scores increased with educational reinforcement (test 2) compared with control arm test 1 scores (mean difference, 9.50; 95% CI, 8.27-10.73). After 1 week, intervention participants' knowledge remained greater than controls' knowledge (mean difference, 3.63; 95% CI, 2.49-4.78) (test 3). Willingness to accept an IRD kidney did not differ between study arms at tests 1 and 3. Inform Me use was associated with greater KTC knowledge about IRD kidneys above routine transplant education alone.

Early Implementation Experiences of the 2010 Teacher Incentive Fund Grantees. NCEE Study Snapshot. NCEE 2014-4021

ERIC Educational Resources Information Center

National Center for Education Evaluation and Regional Assistance, 2014

2014-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Bridging the Gap between Science and Practice: The Effective Nationwide Transport of MST Programs in Norway

ERIC Educational Resources Information Center

Ogden, Terje; Christensen, Bernadette; Sheidow, Ashli J.; Holth, Per

2008-01-01

The successful nationwide transport and evaluation of Multisystemic Therapy (MST) programs in Norway is described. This description is provided within the context of the nation's movement towards the adoption of evidence-based practices (EBPs) during the past decade, the conduct of a multisite randomized clinical trial to examine the effectiveness…

Remission and Residual Symptoms after Short-Term Treatment in the Treatment of Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Kennard, Betsy; Silva, Susan; Vitiello, Benedetto; Curry, John; Kratochvil, Christopher; Simons, Anne; Hughes, Jennifer; Feeny, Norah; Weller, Elizabeth; Sweeney, Michael; Reinecke, Mark; Pathak, Sanjeev; Ginsburg, Golda; Emslie, Graham; March, John

2006-01-01

Objective: To ascertain remission rates in depressed youth participating in the Treatment for Adolescents With Depression Study (TADS), a multisite clinical trial that randomized 439 adolescents with major depressive disorder (MDD) to a 12-week treatment of fluoxetine (FLX), cognitive-behavioral therapy (CBT), their combination (COMB), or clinical…

Remission after Acute Treatment in Children and Adolescents with Anxiety Disorders: Findings from the CAMS

ERIC Educational Resources Information Center

Ginsburg, Golda S.; Kendall, Philip C.; Sakolsky, Dara; Compton, Scott N.; Piacentini, John; Albano, Anne Marie; Walkup, John T.; Sherrill, Joel; Coffey, Kimberly A.; Rynn, Moira A.; Keeton, Courtney P.; McCracken, James T.; Bergman, Lindsey; Iyengar, Satish; Birmaher, Boris; March, John

2011-01-01

Objective: To report on remission rates in anxious youth who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). The CAMS, a multisite clinical trial, randomized 488 children and adolescents (ages 7-17 years; 79% Caucasian; 50% female) with separation, social, and/or generalized anxiety disorder to a 12-week treatment of…

Perceived sleep deficit is a strong predictor of RLS in multisite pain - A population based study in middle aged females.

PubMed

Stehlik, Romana; Ulfberg, Jan; Zou, Ding; Hedner, Jan; Grote, Ludger

2017-10-01

Chronic pain conditions as well as Restless Legs Syndrome (RLS) are known to be associated with subjectively and objectively disturbed sleep. RLS has been recently described as highly prevalent in multisite pain and the role of sleep as a modifying factor in this RLS phenotype is unknown. This study aimed to investigate if perceived sleep deficit and other sleep related parameters predict RLS in subjects with multisite pain. We have recently demonstrated a strong association between Restless Legs Syndrome (RLS) and number of pain locations. In the current analysis we hypothesized that impaired sleep predicts RLS in subjects with multisite pain. Questionnaire-based data from 2727 randomly selected women aged 18-64 years were used to analyze RLS symptoms, self-reported sleep quality, and the degree of daytime sleepiness (Epworth Sleepiness Scale (ESS)) in relation to type, degree and localization of body pain. Potential confounders including anthropometrics, pain localization, co-morbidities, and medication were adjusted for in the Generalized Linear Models (GLM). Perceived sleep deficit ≥90min (OR 2.4 (1.5-3.8), p<0.001) and frequent nocturnal awakenings (OR 2.3 (1.4-3.6), p<0.001) were the strongest sleep related predictors for RLS in subjects with multisite pain. Additional factors include prolonged sleep latency (≥30min, OR 1.8 (1.1-2.8), p=0.01) and daytime symptoms like elevated daytime sleepiness (ESS score ≥9, OR 1.8 (1.2-2.7), p=0.005). Accordingly, RLS diagnosis was associated with impaired sleep quality (TST (Total Sleep Time) -8.2min, sleep latency +8.0min, and number of awakenings from sleep +0.4, p<0.01). ESS score increased with RLS diagnosis (+0.74, p<0.01) and number of pain locations (0.5, 1.7, and 1.8 for 1, 3, and 5 pain areas, p<0.001). In addition, confounders like pain severity, the history of psychiatric disease, and current smoking were associated with impaired sleep quality in this group of females. Perceived sleep deficit and sleep fragmentation are the strongest sleep related predictors of RLS in multisite pain. Potential implication of our results are that clinical management programmes of RLS in subjects with multisite pain need to consider both sleep quality and sleep quantity for individually tailored treatment regimes. RLS, pain, and sleep disorders are highly interrelated. Our study strongly suggests that clinical management of RLS in patients with multisite pain needs to consider sleep quality as an independent risk factor. Copyright © 2017 Scandinavian Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

A Paradox-based data collection and management system for multi-center randomized clinical trials.

PubMed

Abdellatif, Mazen; Reda, Domenic J

2004-02-01

We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.

Improving Quality of Life and Depression After Stroke Through Telerehabilitation

PubMed Central

Linder, Susan M.; Rosenfeldt, Anson B.; Bay, R. Curtis; Sahu, Komal; Wolf, Steven L.

2015-01-01

OBJECTIVE. The aim of this study was to determine the effects of home-based robot-assisted rehabilitation coupled with a home exercise program compared with a home exercise program alone on depression and quality of life in people after stroke. METHOD. A multisite randomized controlled clinical trial was completed with 99 people <6 mo after stroke who had limited access to formal therapy. Participants were randomized into one of two groups, (1) a home exercise program or (2) a robot-assisted therapy + home exercise program, and participated in an 8-wk home intervention. RESULTS. We observed statistically significant changes in all but one domain on the Stroke Impact Scale and the Center for Epidemiologic Studies Depression Scale for both groups. CONCLUSION. A robot-assisted intervention coupled with a home exercise program and a home exercise program alone administered using a telerehabilitation model may be valuable approaches to improving quality of life and depression in people after stroke. PMID:26122686

Improving Quality of Life and Depression After Stroke Through Telerehabilitation.

PubMed

Linder, Susan M; Rosenfeldt, Anson B; Bay, R Curtis; Sahu, Komal; Wolf, Steven L; Alberts, Jay L

2015-01-01

The aim of this study was to determine the effects of home-based robot-assisted rehabilitation coupled with a home exercise program compared with a home exercise program alone on depression and quality of life in people after stroke. A multisite randomized controlled clinical trial was completed with 99 people<6 mo after stroke who had limited access to formal therapy. Participants were randomized into one of two groups, (1) a home exercise program or (2) a robot-assisted therapy+home exercise program, and participated in an 8-wk home intervention. We observed statistically significant changes in all but one domain on the Stroke Impact Scale and the Center for Epidemiologic Studies Depression Scale for both groups. A robot-assisted intervention coupled with a home exercise program and a home exercise program alone administered using a telerehabilitation model may be valuable approaches to improving quality of life and depression in people after stroke. Copyright © 2015 by the American Occupational Therapy Association, Inc.

Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

PubMed

Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

2012-06-01

Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

PubMed

Saunders, Gabrielle H; Biswas, Kousick; Serpi, Tracey; McGovern, Stephanie; Groer, Shirley; Stock, Eileen M; Magruder, Kathryn M; Storzbach, Daniel; Skelton, Kelly; Abrams, Thad; McCranie, Mark; Richerson, Joan; Dorn, Patricia A; Huang, Grant D; Fallon, Michael T

2017-11-01

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD. Published by Elsevier Inc.

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

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

PubMed

Neven, Darin; Paulozzi, Leonard; Howell, Donelle; McPherson, Sterling; Murphy, Sean M; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, John

2016-11-01

Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users. 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. We conducted a multisite 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. The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 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, respectively. This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

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

Predictors of Abstinence: National Institute of Drug Abuse Multisite Buprenorphine/Naloxone Treatment Trial in Opioid-Dependent Youth

ERIC Educational Resources Information Center

Subramaniam, Geetha A.; Warden, Diane; Minhajuddin, Abu; Fishman, Marc J.; Stitzer, Maxine L.; Adinoff, Bryon; Trivedi, Madhukar; Weiss, Roger; Potter, Jennifer; Poole, Sabrina A.; Woody, George E.

2011-01-01

Objective: To examine predictors of opioid abstinence in buprenorphine/naloxone (Bup/Nal)-assisted psychosocial treatment for opioid-dependent youth. Method: Secondary analyses were performed of data from 152 youth (15-21 years old) randomly assigned to 12 weeks of extended Bup/Nal therapy or up to 2 weeks of Bup/Nal detoxification with weekly…

Energy contents of frequently ordered restaurant meals and comparison with human energy requirements and US Department of Agriculture database information: a multisite randomized study

USDA-ARS?s Scientific Manuscript database

BACKGROUND: Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ~50% of US restaurants are individual or small-chain (non-chain) establishments that do not provide nutrition information. OBJECTIVE: To measure the energy content of frequently o...

Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. NCEE 2014-4019

ERIC Educational Resources Information Center

Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

2014-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Implementation and Impacts of Pay-for-Performance after Two Years. NCEE 2015-4020

ERIC Educational Resources Information Center

Chiang, Hanley; Wellington, Alison; Hallgren, Kristin; Speroni, Cecilia; Herrmann, Mariesa; Glazerman, Steven; Constantine, Jill

2015-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

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…

A Marine Protein-based Dietary Supplement for Subclinical Hair Thinning/Loss: Results of a Multisite, Double-blind, Placebo-controlled Clinical Trial

PubMed Central

Rizer, Ronald L; Stephens, Thomas J; Herndon, James H; Sperber, Brian R; Murphy, James; Ablon, Glynis R

2015-01-01

Introduction: Since skin and hair quality are potent vitality signals, and hair growth deficiency can cause significant psychological morbidity. In addition to clearly-defined hair loss disorders, milder forms of hair thinning or hair loss appear to be increasingly common, with a suggestion that sub-optimal diets and stressful lifestyles may be involved. Methods: Here we assess the value of a dietary marine-extract based dietary supplement in premenopausal women with subclinical hair thinning or hair loss conditions. This multi-site, randomized double-blind, placebo-controlled clinical trial was conducted with impact on hair shedding rate and hair fiber diameter (assessed by phototrichogram) as primary end points upon consumption of the oral supplement compared to a placebo. A total of 96 eligible female subjects were enrolled aged 21–55 years of age from Asian, Caucasian, and Hispanic ethnic backgrounds. Results: This study showed that hair shedding was significantly reduced in the first 3–6 months of daily consumption of the oral supplement. Moreover, phototrichogram image analysis revealed a statistically significant increase in the mean vellus-like hair diameter after 6 months of supplement consumption, when compared to the mean vellus-like hair diameters measured at baseline. Discussion: These results support the view that a nutritional supplement approach may be useful for women in this age group to deal with subclinical hair thinning or hair loss conditions, and those components of this marine extract-based oral supplement may be a useful adjunct. PMID:26903744

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.

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.

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

PubMed Central

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

2016-01-01

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

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 .

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

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

PubMed

Bekelman, David B; Allen, Larry A; McBryde, Connor F; Hattler, Brack; Fairclough, Diane L; Havranek, Edward P; Turvey, Carolyn; Meek, Paula M

2018-04-01

Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52). This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved. clinicaltrials.gov Identifier: NCT01739686.

Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

PubMed

Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

2017-03-01

To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

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.

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.

Efficacy of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP) primary version.

PubMed

DiPerna, James Clyde; Lei, Puiwa; Bellinger, Jillian; Cheng, Weiyi

2015-03-01

A multisite cluster randomized trial was conducted to examine the effects of the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007) on students' classroom social behavior. The final sample included 432 students across 38 second grade classrooms. Social skills and problem behaviors were measured via the SSIS rating scale for all participants, and direct observations were completed for a subsample of participants within each classroom. Results indicated that the SSIS-CIP demonstrated positive effects on teacher ratings of participants' social skills and internalizing behaviors, with the greatest changes occurring in classrooms with students who exhibited lower skill proficiency prior to implementation. Statistically significant differences were not observed between treatment and control participants on teacher ratings of externalizing problem behaviors or direct observation.

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 and Impacts of Pay-for-Performance: The 2010 Teacher Incentive Fund (TIF) Grantees after Two Years. NCEE Study Snapshot. NCEE 2015-4022

ERIC Educational Resources Information Center

National Center for Education Evaluation and Regional Assistance, 2015

2015-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years: Executive Summary. NCEE 2018-4005

ERIC Educational Resources Information Center

Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

2017-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years. NCEE 2018-4004

ERIC Educational Resources Information Center

Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

2017-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. Executive Summary. NCEE 2014-4020

ERIC Educational Resources Information Center

Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

2014-01-01

The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

Applying probabilistic temporal and multisite data quality control methods to a public health mortality registry in Spain: a systematic approach to quality control of repositories.

PubMed

Sáez, Carlos; Zurriaga, Oscar; Pérez-Panadés, Jordi; Melchor, Inma; Robles, Montserrat; García-Gómez, Juan M

2016-11-01

To assess the variability in data distributions among data sources and over time through a case study of a large multisite repository as a systematic approach to data quality (DQ). Novel probabilistic DQ control methods based on information theory and geometry are applied to the Public Health Mortality Registry of the Region of Valencia, Spain, with 512 143 entries from 2000 to 2012, disaggregated into 24 health departments. The methods provide DQ metrics and exploratory visualizations for (1) assessing the variability among multiple sources and (2) monitoring and exploring changes with time. The methods are suited to big data and multitype, multivariate, and multimodal data. The repository was partitioned into 2 probabilistically separated temporal subgroups following a change in the Spanish National Death Certificate in 2009. Punctual temporal anomalies were noticed due to a punctual increment in the missing data, along with outlying and clustered health departments due to differences in populations or in practices. Changes in protocols, differences in populations, biased practices, or other systematic DQ problems affected data variability. Even if semantic and integration aspects are addressed in data sharing infrastructures, probabilistic variability may still be present. Solutions include fixing or excluding data and analyzing different sites or time periods separately. A systematic approach to assessing temporal and multisite variability is proposed. Multisite and temporal variability in data distributions affects DQ, hindering data reuse, and an assessment of such variability should be a part of systematic DQ procedures. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

The Impact of Parent-Delivered Intervention on Parents of Very Young Children with Autism

ERIC Educational Resources Information Center

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2014-01-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n = 49) with community intervention (n = 49) for children aged 12 and 24 months. The P-ESDM group reported no…

Quantifying Variation in Head Start Effects on Young Children's Cognitive and Socio-Emotional Skills Using Data from the National Head Start Impact Study

ERIC Educational Resources Information Center

Bloom, Howard S.; Weiland, Christina

2015-01-01

This paper uses data from the Head Start Impact Study (HSIS), a nationally representative multisite randomized trial, to quantify variation in effects of Head Start during 2002-2003 on children's cognitive and socio-emotional outcomes relative to the effects of other local alternatives, including parent care. We find that (1) treatment and control…

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…

Acculturation level and caregiver outcomes from a randomized intervention trial to enhance caregivers' health: evidence from REACH II.

PubMed

Meyer, Oanh L; Liu, Xiaoyan Lucia; Tancredi, Daniel; Ramirez, A Susana; Schulz, Richard; Hinton, Ladson

2018-06-01

Latinos comprise a growing segment of the caregiver population and vary widely in acculturation, yet little is known regarding how acculturation might affect caregiver stress or intervention outcomes. This study examined the relationship between acculturation and burden, bother, and depression in Latino dementia caregivers at baseline and following an intervention. This was a secondary data analysis of 211 Latino caregivers of older adults with dementia from Resources for Enhancing Alzheimer's Caregiver Health (REACH) II, a multisite randomized trial of caregiver interventions. Baseline and follow-up data were used to run mixed-effects models examining the main and moderating effect of acculturation on caregiver stress. No significant main effect of acculturation was found for any of the outcome measures, controlling for demographic covariates. Acculturation moderated the effect of the intervention on caregiver burden: those who were more acculturated benefited more from the intervention. Differential acculturation for Latino caregivers was not directly associated with caregiver burden, bother, or depression, but was associated with reducing burden from the intervention. Future research should explore by what mechanism acculturation influences caregiver burden following an intervention.

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.

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.

A multisite randomized trial of social norms marketing campaigns to reduce college student drinking.

PubMed

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

2006-11-01

An 18-site randomized trial was conducted to determine the effectiveness of social norms marketing (SNM) campaigns in reducing college student drinking. The SNM campaigns are intended to correct misperceptions of subjective drinking norms and thereby drive down alcohol consumption. Institutions of higher education were randomly assigned to treatment and control groups. At the treatment group institutions, SNM campaigns delivered school-specific, data-driven messages through a mix of campus media venues. Cross-sectional student surveys were conducted by mail at baseline (n = 2,771) and at posttest 3 years later (n = 2,939). Hierarchical linear modeling was applied to examine multiple drinking outcomes, taking intraclass correlation into account. Controlling for other predictors, having an SNM campaign was significantly associated with lower perceptions of student drinking levels and lower alcohol consumption, as measured by a composite drinking scale, recent maximum consumption, blood alcohol concentration for recent maximum consumption, drinks consumed when partying, and drinks consumed per week. A moderate mediating effect of normative perceptions on student drinking was demonstrated by an attenuation of the Experimental Group x Time interaction, ranging from 16.4% to 39.5% across measures. Additional models that took into account the intensity of SNM campaign activity at the treatment institutions suggested that there was a dose-response relationship. This study is the most rigorous evaluation of SNM campaigns conducted to date. Analysis revealed that students attending institutions that implemented an SNM campaign had a lower relative risk of alcohol consumption than students attending control group institutions.

Feasibility and acceptability of a child sexual abuse prevention program for childcare professionals: comparison of a web-based and in-person training.

PubMed

Rheingold, Alyssa A; Zajac, Kristyn; Patton, Meghan

2012-01-01

Recent prevention research has established the efficacy of some child sexual abuse prevention programs targeting adults; however, less is known about the feasibility of implementing such programs. The current study examines the feasibility and acceptability of a child sexual abuse prevention program for child care professionals provided in two different formats: in person and Web based. The sample consisted of 188 child care professionals from a large-scale, multisite, randomized controlled trial. Findings indicate that both in-person and online training formats are feasible to implement and acceptable to professionals. When comparing formats, the in-person format was favored in terms of comfort level and likelihood of sharing information with others. These findings have significant implications for dissemination of child sexual abuse prevention programs for child care professionals.

The Study Designed by a Committee

PubMed Central

Henry, David B.; Farrell, Albert D.

2009-01-01

This article describes the research design of the Multisite Violence Prevention Project (MVPP), organized and funded by the National Center for Injury Prevention and Control (NCIPC) at the Centers for Disease Control and Prevention (CDC). CDC's objectives, refined in the course of collaboration among investigators, were to evaluate the efficacy of universal and targeted interventions designed to produce change at the school level. The project's design was developed collaboratively, and is a 2 × 2 cluster-randomized true experimental design in which schools within four separate sites were assigned randomly to four conditions: (1) no-intervention control group, (2) universal intervention, (3) targeted intervention, and (4) combined universal and targeted interventions. A total of 37 schools are participating in this study with 8–12 schools per site. The impact of the interventions on two successive cohorts of sixth-grade students will be assessed based on multiple waves of data from multiple sources of information, including teachers, students, parents, and archival data. The nesting of students within teachers, families, schools and sites created a number of challenges for designing and implementing the study. The final design represents both resolution and compromise on a number of creative tensions existing in large-scale prevention trials, including tensions between cost and statistical power, and between internal and external validity. Strengths and limitations of the final design are discussed. PMID:14732183

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.

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.

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.

Conducting a Multisite Education Research Project: Strategies to Overcome the Barriers to Achieve the Benefits.

PubMed

Beischel, Kelly P; Hart, Julie; Turkelson, Sandra L

2016-01-01

Multisite education research projects have many benefits as well as perceived barriers. In this article, we share our experiences with a multisite education research project and the barriers we overcame to reap the benefits. The outcome of our research resulted in increased rigor, role-modeling professional collaboration, and promotion of future multisite education studies. The strategies presented in this article will help alleviate perceived barriers and ameliorate the process of conducting multisite education research studies.

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

Patient Acceptance of Sexual Orientation and Gender Identity Questions on Intake Forms in Outpatient Clinics: A Pragmatic Randomized Multisite Trial.

PubMed

Rullo, Jordan E; Foxen, Jilian L; Griffin, Joan M; Geske, Jennifer R; Gonzalez, Cesar A; Faubion, Stephanie S; van Ryn, Michelle

2018-03-09

To (1) test whether patient attitudes toward intake forms at three Midwestern outpatient clinics are significantly more negative among those who are asked to complete SOGI questions versus those who are not; and (2) gain an in-depth understanding of patient concerns about SOGI questions. Data were collected between 6/29/2015 and 2/29/2016 from new patients (N = 491) who presented at three outpatient clinics in a large academic medical center. This study was originally a quality improvement project, and later, institutional review board approval was obtained for secondary data analysis. Two-stage mixed-methods study. (1) Experimental: New patients at three sites were randomly assigned to complete either routine intake forms (control) or routine intake forms with SOGI questions (experimental); and (2) qualitative: interviews with patients who responded negatively to SOGI questions. There were no significant differences in patient attitudes between experimental and control groups (p > .05). Of those who received SOGI questions, only 3 percent reported being distressed, upset, or offended by the SOGI questions. Collection of SOGI data as a part of the routine clinical patient intake process is not distressing to 97 percent of patients who are heterosexual, cisgender, and older than 50 years. © Health Research and Educational Trust.

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.

Does improvement of cognitive functioning by cognitive remediation therapy effect work outcomes in severe mental illness? A secondary analysis of a randomized controlled trial.

PubMed

Ikebuchi, Emi; Sato, Sayaka; Yamaguchi, Sosei; Shimodaira, Michiyo; Taneda, Ayano; Hatsuse, Norifumi; Watanabe, Yukako; Sakata, Masuhiro; Satake, Naoko; Nishio, Masaaki; Ito, Jun-Ichiro

2017-05-01

The aim of this study was to clarify whether improvement of cognitive functioning by cognitive remediation therapy can improve work outcome in schizophrenia and other severe mental illnesses when combined with supported employment. The subjects of this study were persons with severe mental illness diagnosed with schizophrenia, major depression, or bipolar disorder (ICD-10) and cognitive dysfunction who participated in both cognitive remediation using the Thinking Skills for Work program and a supported employment program in a multisite, randomized controlled study. Logistic and multiple linear regression analyses were performed to clarify the influence of cognitive functioning on vocational outcomes, adjusting for demographic and clinical variables. Improvement of cognitive functioning with cognitive remediation significantly contributed to the total days employed and total earnings of competitive employment in supported employment service during the study period. Any baseline demographic and clinical variables did not significantly contribute to the work-related outcomes. A cognitive remediation program transferring learning skills into the real world is useful to increase the quality of working life in supported employment services for persons with severe mental illness and cognitive dysfunction who want to work competitively. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

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

PubMed Central

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

2014-01-01

Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight. This trial was registered at clinicaltrails.gov as NCT01781780. PMID:24898236

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

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

A multicenter study of the effect of dietary supplementation with fish oil omega-3 fatty acids on carprofen dosage in dogs with osteoarthritis.

PubMed

Fritsch, Dale A; Allen, Timothy A; Dodd, Chadwick E; Jewell, Dennis E; Sixby, Kristin A; Leventhal, Phillip S; Brejda, John; Hahn, Kevin A

2010-03-01

To determine the effects of feeding a diet supplemented with fish oil omega-3 fatty acids on carprofen dosage in dogs with osteoarthritis. Randomized, controlled, multisite clinical trial. 131 client-owned dogs with stable chronic osteoarthritis examined at 33 privately owned veterinary hospitals in the United States. In all dogs, the dosage of carprofen was standardized over a 3-week period to approximately 4.4 mg/kg/d (2 mg/lb/d), PO. Dogs were then randomly assigned to receive a food supplemented with fish oil omega-3 fatty acids or a control food with low omega-3 fatty acid content, and 3, 6, 9, and 12 weeks later, investigators made decisions regarding increasing or decreasing the carprofen dosage on the basis of investigator assessments of 5 clinical signs and owner assessments of 15 signs. Linear regression analysis indicated that over the 12-week study period, carprofen dosage decreased significantly faster among dogs fed the supplemented diet than among dogs fed the control diet. The distribution of changes in carprofen dosage for dogs in the control group was significantly different from the distribution of changes in carprofen dosage for dogs in the test group. Results suggested that in dogs with chronic osteoarthritis receiving carprofen because of signs of pain, feeding a diet supplemented with fish oil omega-3 fatty acids may allow for a reduction in carprofen dosage.

Empirically Derived Subtypes of Adolescent Depression: Latent Profile Analysis of Co-Occurring Symptoms in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Herman, Keith C.; Ostrander, Rick; Walkup, John T.; Silva, Susan G.; March, John S.

2007-01-01

A latent profile analysis was conducted on the co-occurring symptoms of 423 adolescents diagnosed with major depressive disorder as part of the Treatment for Adolescents with Depression Study (TADS), a multisite, randomized treatment trial. The participants had a mean (SD) age of 14.6 (1.5) years; of the sample, 45.6% was male and 73.8% was white.…

Towards a Neurobehavioral Profile of Fetal Alcohol Spectrum Disorders

PubMed Central

Mattson, Sarah N.; Roesch, Scott C.; Fagerlund, Åse; Autti-Rämö, Ilona; Jones, Kenneth Lyons; May, Philip A.; Adnams, Colleen M.; Konovalova, Valentina; Riley, Edward P.

2010-01-01

Background A primary goal of recent research is the development of neurobehavioral profiles that specifically define fetal alcohol spectrum disorders (FASD), which may assist differential diagnosis or improve treatment. In the current study we define a preliminary profile using neuropsychological data from a multisite study. Methods Data were collected using a broad neurobehavioral protocol from two sites of a multisite study of FASD. Subjects were children with heavy prenatal alcohol exposure and unexposed controls. The alcohol-exposed group included children with and with out fetal alcohol syndrome (FAS). From 547 neuropsychological, 22 variables were selected for analysis based on their ability to distinguish children with heavy prenatal alcohol exposure from nonexposed controls. These data were analyzed using latent profile analysis (LPA). Results The results indicated that a 2-class model best fit the data. The resulting profile was successful at distinguishing subjects with FAS from nonexposed controls without FAS with 92% overall accuracy; 87.8% of FAS cases and 95.7% of controls were correctly classified. The same analysis was repeated with children with heavy prenatal alcohol exposure but without FAS and non-exposed controls with similar results. The overall accuracy was 84.7%; 68.4% of alcohol-exposed cases and 95% of controls were correctly classified. In both analyses, the profile based on neuropsychological variables was more successful at distinguishing the groups than was IQ alone. Conclusions We used data from two sites of a multisite study and a broad neuropsychological test battery to determine a profile that could be used to accurately identify children affected by prenatal alcohol exposure. Results indicated that measures of executive function and spatial processing are especially sensitive to prenatal alcohol exposure. PMID:20569243

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.

Transmission Heterogeneity and Autoinoculation in a Multisite Infection Model of HPV

PubMed Central

Brouwer, Andrew F.; Meza, Rafael; Eisenberg, Marisa C.

2015-01-01

The human papillomavirus (HPV) is sexually transmitted and can infect oral, genital, and anal sites in the human epithelium. Here, we develop a multisite transmission model that includes autoinoculation, to study HPV and other multisite diseases. Under a homogeneous-contacts assumption, we analyze the basic reproduction number R0, as well as type and target reproduction numbers, for a two-site model. In particular, we find that R0 occupies a space between taking the maximum of next generation matrix terms for same site transmission and taking the geometric average of cross-site transmission terms in such a way that heterogeneity in the same-site transmission rates increases R0 while heterogeneity in the cross-site transmission decreases it. Additionally, autoinoculation adds considerable complexity to the form of R0. We extend this analysis to a heterosexual population, which additionally yields dynamics analogous to those of vector–host models. We also examine how these issues of heterogeneity may affect disease control, using type and target reproduction numbers. PMID:26518265

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.

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.

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

Improving health outcomes for youth living with the human immunodeficiency virus: a multisite randomized trial of a motivational intervention targeting multiple risk behaviors.

PubMed

Naar-King, Sylvie; Parsons, Jeffrey T; Murphy, Debra A; Chen, Xinguang; Harris, D Robert; Belzer, Marvin E

2009-12-01

To determine if Healthy Choices, a motivational interviewing intervention targeting multiple risk behaviors, improved human immunodeficiency virus (HIV) viral load. A randomized, 2-group repeated measures design with analysis of data from baseline and 6- and 9-month follow-up collected from 2005 to 2007. Five US adolescent medicine HIV clinics. A convenience sample with at least 1 of 3 risk behaviors (nonadherence to HIV medications, substance abuse, and unprotected sex) was enrolled. The sample was aged 16 to 24 years and primarily African American. Of the 205 enrolled, 19 did not complete baseline data collections, for a final sample size of 186. Young people living with HIV were randomized to the intervention plus specialty care (n = 94) or specialty care alone (n = 92). The 3- and 6-month follow-up rates, respectively, were 86% and 82% for the intervention group and 81% and 73% for controls. Intervention Healthy Choices was a 4-session individual clinic-based motivational interviewing intervention delivered during a 10-week period. Motivational interviewing is a method of communication designed to elicit and reinforce intrinsic motivation for change. Outcome Measure Plasma viral load. Youth randomized to Healthy Choices showed a significant decline in viral load at 6 months postintervention compared with youth in the control condition (beta = -0.36, t = -2.15, P = .03), with those prescribed antiretroviral medications showing the lowest viral loads. Differences were no longer significant at 9 months. A motivational interviewing intervention targeting multiple risk behaviors resulted in short-term improvements in viral load for youth living with HIV. Trial Registration clinicaltrials.gov Identifier: NCT00103532.

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

Benefit-cost analysis of SBIRT interventions for substance using patients in emergency departments.

PubMed

Horn, Brady P; Crandall, Cameron; Forcehimes, Alyssa; French, Michael T; Bogenschutz, Michael

2017-08-01

Screening, brief intervention, and referral to treatment (SBIRT) has been widely implemented as a method to address substance use disorders in general medical settings, and some evidence suggests that its use is associated with decreased societal costs. In this paper, we investigated the economic impact of SBIRT using data from Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), a multisite, randomized controlled trial. Utilizing self-reported information on medical status, health services utilization, employment, and crime, we conduct a benefit-cost analysis. Findings indicate that neither of the SMART-ED interventions resulted in any significant changes to the main economic outcomes, nor had any significant impact on total economic benefit. Thus, while SBIRT interventions for substance abuse in Emergency Departments may be appealing from a clinical perspective, evidence from this economic study suggests resources could be better utilized supporting other health interventions. Copyright © 2017 Elsevier Inc. 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.

Can augmented physiotherapy input enhance recovery of mobility after stroke? A randomized controlled trial.

PubMed

2004-08-01

To discover if the provision of additional inpatient physiotherapy after stroke speeds the recovery of mobility. A multisite single-blind randomized controlled trial (RCT) comparing the effects of augmented physiotherapy input with normal input on the recovery of mobility after stroke. Three rehabilitation hospitals in North Glasgow, Scotland. Patients admitted to hospital with a clinical diagnosis of stroke, who were able to tolerate and benefit from mobility rehabilitation. We aimed to provide double the amount of physiotherapy to the augmented group. Primary outcomes were mobility milestones (ability to stand, step and walk), Rivermead Mobility Index (RMI) and walking speed. Seventy patients were recruited. The augmented therapy group received more direct contact with a physiotherapist (62 versus 35 minutes per weekday) and were more active (8.0% versus 4.8% time standing or walking) than normal therapy controls. The augmented group tended to achieve independent walking earlier (hazard ratio 1.48, 95% confidence interval 0.90-2.43; p=0.12) and had higher Rivermead Mobility Index scores at three months (mean difference 1.6; -0.1 to 3.3; p=0.068) but these differences did not reach statistical significance. There was no significant difference in any other outcome. A modest augmented physiotherapy programme resulted in patients having more direct physiotherapy time and being more active. The inability to show statistically significant changes in outcome measures could indicate either that this intervention is ineffective or that our study could not detect modest changes.

Effects of a Flexibility/Support Intervention on Work Performance: Evidence From the Work, Family, and Health Network.

PubMed

Bray, Jeremy W; Hinde, Jesse M; Kaiser, David J; Mills, Michael J; Karuntzos, Georgia T; Genadek, Katie R; Kelly, Erin L; Kossek, Ellen E; Hurtado, David A

2018-05-01

To estimate the effects of a workplace initiative to reduce work-family conflict on employee performance. A group-randomized multisite controlled experimental study with longitudinal follow-up. An information technology firm. Employees randomized to the intervention (n = 348) and control condition (n = 345). An intervention, "Start. Transform. Achieve. Results." to enhance employees' control over their work time, to increase supervisors' support for this change, and to increase employees' and supervisors' focus on results. We estimated the effect of the intervention on 9 self-reported employee performance measures using a difference-in-differences approach with generalized linear mixed models. Performance measures included actual and expected hours worked, absenteeism, and presenteeism. This study found little evidence that an intervention targeting work-family conflict affected employee performance. The only significant effect of the intervention was an approximately 1-hour reduction in expected work hours. After Bonferroni correction, the intervention effect is marginally insignificant at 6 months and marginally significant at 12 and 18 months. The intervention reduced expected working time by 1 hour per week; effects on most other employee self-reported performance measures were statistically insignificant. When coupled with the other positive wellness and firm outcomes, this intervention may be useful for improving employee perceptions of increased access to personal time or personal wellness without sacrificing performance. The null effects on performance provide countervailing evidence to recent negative press on work-family and flex work initiatives.

Efficacy of tilmicosin in the control of experimentally induced Actinobacillus pleuropneumoniae infection in swine

PubMed Central

2004-01-01

Abstract The efficacy of tilmicosin administered in the feed to control Actinobacillus pleuropneumoniae infections in pigs was evaluated through a multisite, multitrial study. For each of 6 trials, 48 pigs (stratified by weight and sex) were randomly assigned to 6 to 8 pens. Medicated feed containing tilmicosin (200 g/t) and unmedicated feed were randomly assigned at the pen level and were provided ad libitum from day −7 to trial termination (day 14). Seeder pigs (inoculated intranasally with A. pleuropneumoniae serotype 1 and showing signs of clinical disease) were introduced to each pen on day 0. Rates of death, gross lesions, and culture of A. pleuropneumoniae at necropsy, clinical scores, average daily gain in weight, and average body temperature were compared between the medicated and unmedicated pigs. Compared with the unmedicated pigs, significantly fewer (P < 0.05) pigs given tilmicosin had lesions typical of A. pleuropneumoniae or had A. pleuropneumoniae isolated from their tissues at necropsy. Together with a significant reduction (P < 0.05) in the average percentage of pneumonic lung involvement (both visually and by weight), there were reductions in the numbers of pigs with moderate and severe pneumonic lung lesions and with A. pleuropneumoniae associated mortality. With tilmicosin treatment, the average daily weight gain, daily temperature, abdominal appearance, attitude, and respiration were also significantly better (P < 0.05). The results of this study demonstrate the in vivo effectiveness of tilmicosin (200 g/t) in controlling pleuropneumonia among swine experimentally infected with A. pleuropneumoniae. PMID:14979429

Efficacy of tilmicosin in the control of experimentally induced Actinobacillus pleuropneumoniae infection in swine.

PubMed

Paradis, Marie-Anne; Vessie, Gordon H; Merrill, John K; Dick, C Paul; Moore, Camille; Charbonneau, George; Gottschalk, M; MacInnes, Janet I; Higgins, Robert; Mittal, K R; Girard, C; Aramini, Jeffery J; Wilson, Jeffrey B

2004-01-01

The efficacy of tilmicosin administered in the feed to control Actinobacillus pleuropneumoniae infections in pigs was evaluated through a multisite, multitrial study. For each of 6 trials, 48 pigs (stratified by weight and sex) were randomly assigned to 6 to 8 pens. Medicated feed containing tilmicosin (200 g/t) and unmedicated feed were randomly assigned at the pen level and were provided ad libitum from day -7 to trial termination (day 14). Seeder pigs (inoculated intranasally with A. pleuropneumoniae serotype 1 and showing signs of clinical disease) were introduced to each pen on day 0. Rates of death, gross lesions, and culture of A. pleuropneumoniae at necropsy, clinical scores, average daily gain in weight, and average body temperature were compared between the medicated and unmedicated pigs. Compared with the unmedicated pigs, significantly fewer (P < 0.05) pigs given tilmicosin had lesions typical of A. pleuropneumoniae or had A. pleuropneumoniae isolated from their tissues at necropsy. Together with a significant reduction (P < 0.05) in the average percentage of pneumonic lung involvement (both visually and by weight), there were reductions in the numbers of pigs with moderate and severe pneumonic lung lesions and with A. pleuropneumoniae associated mortality. With tilmicosin treatment, the average daily weight gain, daily temperature, abdominal appearance, attitude, and respiration were also significantly better (P < 0.05). The results of this study demonstrate the in vivo effectiveness of tilmicosin (200 g/t) in controlling pleuropneumonia among swine experimentally infected with A. pleuropneumoniae.

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

PubMed

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly greater self-efficacy in managing conflict (p=0.025; Cohen d=0.61) and more able to cooperate with grandparents in childcare (p=0.046; Cohen d=0.59) than the control group. The intervention was effective in reducing stress and enhancing happiness among new mothers, particularly those with higher EPDS scores. Postnatal follow-up contacts as booster interventions may be needed to achieve lasting effects of the intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

Diode probes for spatiotemporal optical control of multiple neurons in freely moving animals

PubMed Central

Koos, Tibor; Buzsáki, György

2012-01-01

Neuronal control with high temporal precision is possible with optogenetics, yet currently available methods do not enable to control independently multiple locations in the brains of freely moving animals. Here, we describe a diode-probe system that allows real-time and location-specific control of neuronal activity at multiple sites. Manipulation of neuronal activity in arbitrary spatiotemporal patterns is achieved by means of an optoelectronic array, manufactured by attaching multiple diode-fiber assemblies to high-density silicon probes or wire tetrodes and implanted into the brains of animals that are expressing light-responsive opsins. Each diode can be controlled separately, allowing localized light stimulation of neuronal activators and silencers in any temporal configuration and concurrent recording of the stimulated neurons. Because the only connections to the animals are via a highly flexible wire cable, unimpeded behavior is allowed for circuit monitoring and multisite perturbations in the intact brain. The capacity of the system to generate unique neural activity patterns facilitates multisite manipulation of neural circuits in a closed-loop manner and opens the door to addressing novel questions. PMID:22496529

Effectiveness of Immersive Virtual Reality in Surgical Training-A Randomized Control Trial.

PubMed

Pulijala, Yeshwanth; Ma, Minhua; Pears, Matthew; Peebles, David; Ayoub, Ashraf

2018-05-01

Surgical training methods are evolving with the technological advancements, including the application of virtual reality (VR) and augmented reality. However, 28 to 40% of novice residents are not confident in performing a major surgical procedure. VR surgery, an immersive VR (iVR) experience, was developed using Oculus Rift and Leap Motion devices (Leap Motion, Inc, San Francisco, CA) to address this challenge. Our iVR is a multisensory, holistic surgical training application that demonstrates a maxillofacial surgical technique, the Le Fort I osteotomy. The main objective of the present study was to evaluate the effect of using VR surgery on the self-confidence and knowledge of surgical residents. A multisite, single-blind, parallel, randomized controlled trial (RCT) was performed. The participants were novice surgical residents with limited experience in performing the Le Fort I osteotomy. The primary outcome measures were the self-assessment scores of trainee confidence using a Likert scale and an objective assessment of the cognitive skills. Ninety-five residents from 7 dental schools were included in the RCT. The participants were randomly divided into a study group of 51 residents and a control group of 44. Participants in the study group used the VR surgery application on an Oculus Rift with Leap Motion device. The control group participants used similar content in a standard PowerPoint presentation on a laptop. Repeated measures multivariate analysis of variance was applied to the data to assess the overall effect of the intervention on the confidence of the residents. The study group participants showed significantly greater perceived self-confidence levels compared with those in the control group (P = .034; α = 0.05). Novices in the first year of their training showed the greatest improvement in their confidence compared with those in their second and third year. iVR experiences improve the knowledge and self-confidence of the surgical residents. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

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.

Preventing adolescent drug use: long-term results of a junior high program.

PubMed Central

Ellickson, P L; Bell, R M; McGuigan, K

1993-01-01

OBJECTIVES. Although several studies have reported short-term gains for drug-use prevention programs targeted at young adolescents, few have assessed the long-term effects of such programs. Such information is essential for judging how long prevention benefits last. This paper reports results over a 6-year period for a multisite randomized trial that achieved reductions in drug use during the junior high school years. METHODS. The 11-lesson curriculum, which was tested in 30 schools in eight highly diverse West Coast communities, focused on helping 7th and 8th grade students develop the motivation and skills to resist drugs. Schools were randomly assigned to treatment and control conditions. About 4000 students were assessed in grade 7 and six times thereafter through grade 12. Program effects were adjusted for pretest covariates and school effects. RESULTS. Once the lessons stopped, the program's effects on drug use stopped. Effects on cognitive risk factors persisted for a longer time (many through grade 10), but were not sufficient to produce corresponding reductions in use. CONCLUSIONS. It is unlikely that early prevention gains can be maintained without additional prevention efforts during high school. Future research is needed to develop and test such efforts. PMID:8498624

One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities.

PubMed

Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula

2015-05-01

Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (p<.001, odds ratio=6.35, covariate adjusted difference=42%, 95% confidence interval [CI]=36%-48%). Improvement in overall quality of life was significantly greater among Housing First participants compared with treatment-as-usual participants (p<.001, d=.31, CI=.16-.46). Housing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.

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.

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

Costs of a work-family intervention: evidence from the work, family, and health network.

PubMed

Barbosa, Carolina; Bray, Jeremy W; Brockwood, Krista; Reeves, Daniel

2014-01-01

To estimate the cost to the workplace of implementing initiatives to reduce work-family conflict. Prospective cost analysis conducted alongside a group-randomized multisite controlled experimental study, using a microcosting approach. An information technology firm. Employees (n = 1004) and managers (n = 141) randomized to the intervention arm. STAR (Start. Transform. Achieve. Results.) to enhance employees' control over their work time, increase supervisor support for employees to manage work and family responsibilities, and reorient the culture toward results. A taxonomy of activities related to customization, start-up, and implementation was developed. Resource use and unit costs were estimated for each activity, excluding research-related activities. Economic costing approach (accounting and opportunity costs). Sensitivity analyses on intervention costs. The total cost of STAR was $709,654, of which $389,717 was labor costs and $319,937 nonlabor costs (including $313,877 for intervention contract). The cost per employee participation in the intervention was $340 (95% confidence interval: $330-$351); $597 ($561-$634) for managers and $300 ($292-$308) for other employees (2011 prices). A detailed activity costing approach allows for more accurate cost estimates and identifies key drivers of cost. The key cost driver was employees' time spent on receiving the intervention. Ignoring this cost, which is usual in studies that cost workplace interventions, would seriously underestimate the cost of a workplace initiative.

What is Taught on Firearm Safety in Undergraduate, Graduate, and Continuing Medical Education? A Review of Educational Programs.

PubMed

Puttagunta, R; Coverdale, T R; Coverdale, J

2016-10-01

Because there have been no published formal reviews on teaching of firearm safety, we set out to systematically locate and review the literature on curricula that educated physicians and other health care providers, residents across specialties, and medical students on how to counsel on firearm safety. We searched for all papers with outcomes that described firearm safety training programs for healthcare providers and trainees. Studies were identified through PubMed, Scopus, Google Scholar, PsychInfo, EMBASE, and MedEdPortal databases and electronically searched using combinations of words from general topic areas of firearms, learners, and education. We found four programs that met inclusion criteria. These targeted a narrow range of learners including medical students, pediatric residents, practicing pediatricians, and nurse practitioners. Teaching methods included lectures, case-based learning, group discussions, and audiotape training. There were two randomized controlled trials, one cohort design, and one posttest design. One of the randomized controlled trials was an office-based high quality multisite national study, although the focus of teaching was not on firearm safety alone. All studies used different outcomes, and only one study validated the outcome measures. There were no studies targeting psychiatrists or psychiatry residents. These results underscore a priority for developing firearm safety education programs in undergraduate, graduate, and continuing medical education settings.

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial.

PubMed

Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

2016-06-01

This multisite, randomized controlled trial assigned 75 adult cancer patients prescribed an oral anticancer agent to either an experimental group that received daily text messages for adherence for 21 days plus usual care or a control group that received usual care. Measures were administered at baseline, weekly (Weeks 1-8), and at exit (Week 9). A satisfaction survey was conducted following the intervention. Acceptability, feasibility, and satisfaction were examined. Primary outcomes were adherence and symptoms. Secondary outcomes were depressive symptoms, self-efficacy, cognition, physical function, and social support. Mixed or general linear models were used for the analyses comparing trial groups. Effect sizes (ES) were estimated to gauge clinical significance. Regarding acceptability, 57.2% (83 of 145) of eligible patients consented, 88% (n = 37 of 42) receiving text messages read them most or all of the time, and 90% (n = 38) were satisfied. The differences between experimental and control groups' ES were 0.29 for adherence, 0.21 for symptom severity, and 0.21 for symptom interference, and differences were not statistically significant. Furthermore, perceived social support was higher (p = 0.04; ES = 0.54) in the experimental group. Proof of concept and preliminary efficacy of a mobile health intervention using text messages to promote adherence for patients prescribed oral anticancer agents were demonstrated. Patients accepted and had high satisfaction with the intervention, and adherence improved after the intervention. Text messages show promise. Additional research is needed prior to use in practice.

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.

An Integrative, Multilevel, and Transdisciplinary Research Approach to Challenges of Work, Family, and Health

PubMed Central

Bray, Jeremy W.; Kelly, Erin L.; Hammer, Leslie B.; Almeida, David M.; Dearing, James W.; King, Rosalind B.; Buxton, Orfeu M.

2013-01-01

Recognizing a need for rigorous, experimental research to support the efforts of workplaces and policymakers in improving the health and wellbeing of employees and their families, the National Institutes of Health and the Centers for Disease Control and Prevention formed the Work, Family & Health Network (WFHN). The WFHN is implementing an innovative multisite study with a rigorous experimental design (adaptive randomization, control groups), comprehensive multilevel measures, a novel and theoretically based intervention targeting the psychosocial work environment, and translational activities. This paper describes challenges and benefits of designing a multilevel and transdisciplinary research network that includes an effectiveness study to assess intervention effects on employees, families, and managers; a daily diary study to examine effects on family functioning and daily stress; a process study to understand intervention implementation; and translational research to understand and inform diffusion of innovation. Challenges were both conceptual and logistical, spanning all aspects of study design and implementation. In dealing with these challenges, however, the WFHN developed innovative, transdisciplinary, multi-method approaches to conducting workplace research that will benefit both the research and business communities. PMID:24618878

The Study to Explore Early Development (SEED): A Multisite Epidemiologic Study of Autism by the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network

PubMed Central

Schendel, Diana; DiGuiseppi, Carolyn; Croen, Lisa; Fallin, M Danielle; Reed, Philip L.; Schieve, Laura; Wiggins, Lisa; Daniels, Julie; Grether, Judith; Levy, Susan; Miller, Lisa; Newschaffer, Craig; Pinto-Martin, Jennifer; Robinson, Cordelia; Windham, Gayle; Alexander, Aimee; Aylsworth, Arthur; Bernal, Pilar; Bonner, Joseph D.; Blaskey, Lisa; Bradley, Chyrise; Collins, Jack; Ferretti, Casara; Farzadegan, Homayoon; Giarelli, Ellen; Harvey, Marques; Hepburn, Susan; Herr, Matthew; Kaparich, Kristina; Landa, Rebecca; Lee, Li-Ching; Levenseller, Brooke; Meyerer, Stacey; Rahbar, Mohammad H.; Ratchford, Andria; Reynolds, Ann; Rosenberg, Steve; Rusyniak, Julie; Shapira, Stuart K.; Smith, Karen; Souders, Margaret; AaronThompson, Patrick; Young, Lisa; Yeargin-Allsopp, Marshalyn

2015-01-01

The Study to Explore Early Development (SEED), a multisite investigation addressing knowledge gaps in autism phenotype and etiology, aims to: (1) characterize the autism behavioral phenotype and associated developmental, medical, and behavioral conditions and (2) investigate genetic and environmental risks with emphasis on immunologic, hormonal, gastrointestinal, and sociodemographic characteristics. SEED uses a case–control design with population-based ascertainment of children aged 2–5 years with an autism spectrum disorder (ASD) and children in two control groups—one from the general population and one with non-ASD developmental problems. Data from parent-completed questionnaires, interviews, clinical evaluations, biospecimen sampling, and medical record abstraction focus on the prenatal and early postnatal periods. SEED is a valuable resource for testing hypotheses regarding ASD characteristics and causes. PMID:22350336

History of chickenpox in glioma risk: a report from the glioma international case-control study (GICC).

PubMed

Amirian, E Susan; Scheurer, Michael E; Zhou, Renke; Wrensch, Margaret R; Armstrong, Georgina N; Lachance, Daniel; Olson, Sara H; Lau, Ching C; Claus, Elizabeth B; Barnholtz-Sloan, Jill S; Il'yasova, Dora; Schildkraut, Joellen; Ali-Osman, Francis; Sadetzki, Siegal; Jenkins, Robert B; Bernstein, Jonine L; Merrell, Ryan T; Davis, Faith G; Lai, Rose; Shete, Sanjay; Amos, Christopher I; Melin, Beatrice S; Bondy, Melissa L

2016-06-01

Varicella zoster virus (VZV) is a neurotropic α-herpesvirus that causes chickenpox and establishes life-long latency in the cranial nerve and dorsal root ganglia of the host. To date, VZV is the only virus consistently reported to have an inverse association with glioma. The Glioma International Case-Control Study (GICC) is a large, multisite consortium with data on 4533 cases and 4171 controls collected across five countries. Here, we utilized the GICC data to confirm the previously reported associations between history of chickenpox and glioma risk in one of the largest studies to date on this topic. Using two-stage random-effects restricted maximum likelihood modeling, we found that a positive history of chickenpox was associated with a 21% lower glioma risk, adjusting for age and sex (95% confidence intervals (CI): 0.65-0.96). Furthermore, the protective effect of chickenpox was stronger for high-grade gliomas. Our study provides additional evidence that the observed protective effect of chickenpox against glioma is unlikely to be coincidental. Future studies, including meta-analyses of the literature and investigations of the potential biological mechanism, are warranted. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

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.

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.

The Role of Involvement and Use in Multisite Evaluations

ERIC Educational Resources Information Center

Lawrenz, Frances; King, Jean A.; Ooms, Ann

2011-01-01

A cross-case analysis of four National Science Foundation (NSF) case studies identified both unique details and common themes related to promoting the use and influence of multisite evaluations. The analysis provided evidence of diverse evaluation use by stakeholders and suggested that people taking part in the multisite evaluations perceived…

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…

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

Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care.

PubMed

Moore, Katherine N; Hunter, Kathleen F; McGinnis, Rosemary; Bacsu, Chasta; Fader, Mandy; Gray, Mikel; Getliffe, Kathy; Chobanuk, Janice; Puttagunta, Lakshmi; Voaklander, Donald C

2009-01-01

Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage. A multisite randomized controlled trial. Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK). At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type. One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change. At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes.

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.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

PubMed

Brenner, Alison T; Getrich, Christina M; Pignone, Michael; Rhyne, Robert L; Hoffman, Richard M; McWilliams, Andrew; de Hernandez, Brisa Urquieta; Weaver, Mark A; Tapp, Hazel; Harbi, Khalil; Reuland, Daniel

2014-07-08

Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. ClinicalTrials.gov NCT02054598.

A Mixed Methods Sampling Methodology for a Multisite Case Study

ERIC Educational Resources Information Center

Sharp, Julia L.; Mobley, Catherine; Hammond, Cathy; Withington, Cairen; Drew, Sam; Stringfield, Sam; Stipanovic, Natalie

2012-01-01

The flexibility of mixed methods research strategies makes such approaches especially suitable for multisite case studies. Yet the utilization of mixed methods to select sites for these studies is rarely reported. The authors describe their pragmatic mixed methods approach to select a sample for their multisite mixed methods case study of a…

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.

PubMed

Frank, Fabian; Wilk, Juliette; Kriston, Levente; Meister, Ramona; Shimodera, Shinji; Hesse, Klaus; Bitzer, Eva-Maria; Berger, Mathias; Hölzel, Lars P

2015-10-23

Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.

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.

Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study.

PubMed

Karhuvaara, Sakari; Simojoki, Kaarlo; Virta, Antti; Rosberg, Markus; Löyttyniemi, Eliisa; Nurminen, Tommi; Kallio, Antero; Mäkelä, Rauno

2007-07-01

Clinical studies with opioid antagonists for treatment of problem drinking have mainly been conducted in specialized alcohol treatment centers, included structured psychosocial treatment, and have focused on maintaining abstinence after a period of abstinence from alcohol. This multisite, randomized double-blind study investigated targeted nalmefene in reducing heavy drinking. Specialized alcohol treatment centers and private general practices enrolled 403 subjects (328 men, 75 women). Subjects were instructed to take nalmefene 10 to 40 mg (n=242) or placebo (n=161) when they believed drinking to be imminent. After 28 weeks, 57 subjects from the nalmefene group continued into a 24-week randomized withdrawal extension. Concomitant psychosocial intervention was minimal and no treatment goals were imposed. Alcohol consumption was recorded using the time-line follow-back method. Biochemical indicators of alcohol use were also measured. The mean monthly number of heavy drinking days (HDDs) during the 12-week period before inclusion was 15.5 (SD 6.9) in the nalmefene group and 16.2 (SD 6.9) in the placebo group. During treatment, the mean numbers of HDDs were 8.6 to 9.3 in the nalmefene group and 10.6 to 12.0 in the placebo group (p=0.0065). The levels of serum alanine aminotransferase and gamma-glutamyl transferase decreased in the nalmefene group compared with the placebo group (p=0.0088 and 0.0023). During the randomized withdrawal period, subjects randomized to placebo apparently returned to heavier drinking. Subjects receiving nalmefene reported more nausea, insomnia, fatigue, dizziness, and malaise than subjects on placebo. Nalmefene appears to be effective and safe in reducing heavy drinking, even when accompanied by minimal psychosocial support.

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

Behavior management for children and adolescents with acquired brain injury.

PubMed

Slifer, Keith J; Amari, Adrianna

2009-01-01

Behavioral problems such as disinhibition, irritability, restlessness, distractibility, and aggression are common after acquired brain injury (ABI). The persistence and severity of these problems impair the brain-injured individual's reintegration into family, school, and community life. Since the early 1980s, behavior analysis and therapy have been used to address the behavioral sequelae of ABI. These interventions are based on principles of learning and behavior that have been robustly successful when applied across a broad range of other clinical populations. Most of the research on behavioral treatment after ABI has involved clinical case studies or studies employing single-subject experimental designs across a series of cases. The literature supports the effectiveness of these interventions across ages, injury severities, and stages of recovery after ABI. Recommended guidelines for behavior management include: direct behavioral observations, systematic assessment of environmental and within-patient variables associated with aberrant behavior, antecedent management to minimize the probability of aberrant behavior, provision of functionally equivalent alternative means of controlling the environment, and differential reinforcement to shape positive behavior and coping strategies while not inadvertently shaping emergent, disruptive sequelae. This package of interventions requires direction by a highly skilled behavioral psychologist or therapist who systematically monitors target behavior to evaluate progress and guide treatment decisions. A coordinated multisite effort is needed to design intervention protocols that can be studied prospectively in randomized controlled trials. However, there will continue to be an important role for single subject experimental design for studying the results of individualized interventions and obtaining pilot data to guide subsequent randomized controlled trails. (c) 2009 Wiley-Liss, Inc.

How Accurately Do Consecutive Cohort Audits Predict Phase III Multisite Clinical Trial Recruitment in Palliative Care?

PubMed

McCaffrey, Nikki; Fazekas, Belinda; Cutri, Natalie; Currow, David C

2016-04-01

Audits have been proposed for estimating possible recruitment rates to randomized controlled trials (RCTs), but few studies have compared audit data with subsequent recruitment rates. To compare the accuracy of estimates of potential recruitment from a retrospective consecutive cohort audit of actual participating sites and recruitment to four Phase III multisite clinical RCTs. The proportion of potentially eligible study participants estimated from an inpatient chart review of people with life-limiting illnesses referred to six Australian specialist palliative care services was compared with recruitment data extracted from study prescreening information from three sites that participated fully in four Palliative Care Clinical Studies Collaborative RCTs. The predominant reasons for ineligibility in the audit and RCTs were analyzed. The audit overestimated the proportion of people referred to the palliative care services who could participate in the RCTs (pain 17.7% vs. 1.2%, delirium 5.8% vs. 0.6%, anorexia 5.1% vs. 0.8%, and bowel obstruction 2.8% vs. 0.5%). Approximately 2% of the referral base was potentially eligible for these effectiveness studies. Ineligibility for general criteria (language, cognition, and geographic proximity) varied between studies, whereas the reasons for exclusion were similar between the audit and pain and anorexia studies but not for delirium or bowel obstruction. The retrospective consecutive case note audit in participating sites did not predict realistic recruitment rates, mostly underestimating the impact of study-specific inclusion criteria. These findings have implications for the applicability of the results of RCTs. Prospective pilot studies are more likely to predict actual recruitment. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

How Institutional and University Counselor Policies Effectively Respond to Victims of Cyber Violent Acts: A Multisite Case Study

ERIC Educational Resources Information Center

Richards, Gretchen M.

2012-01-01

This multisite case study examined how institutional and university counselor policies effectively respond to cyber violent acts. Stake's (2006) multisite case study methodology was used to identify seven themes from current literature. Two sites with four participants were selected. The participants included two counseling directors and the…

Paper Tape Prevents Foot Blisters: A Randomized Prevention Trial Assessing Paper Tape in Endurance Distances II (Pre-TAPED II).

PubMed

Lipman, Grant S; Sharp, Louis J; Christensen, Mark; Phillips, Caleb; DiTullio, Alexandra; Dalton, Andrew; Ng, Pearlly; Shangkuan, Jennifer; Shea, Katherine; Krabak, Brian J

2016-09-01

To determine whether paper tape prevents foot blisters in multistage ultramarathon runners. Multisite prospective randomized trial. The 2014 250-km (155-mile) 6-stage RacingThePlanet ultramarathons in Jordan, Gobi, Madagascar, and Atacama Deserts. One hundred twenty-eight participants were enrolled: 19 (15%) from the Jordan, 35 (27%) from Gobi, 21 (16%) from Madagascar, and 53 (41%) from the Atacama Desert. The mean age was 39.3 years (22-63) and body mass index was 24.2 kg/m (17.4-35.1), with 31 (22.5%) females. Paper tape was applied to a randomly selected foot before the race, either to participants' blister-prone areas or randomly selected location if there was no blister history, with untaped areas of the same foot used as the control. Development of a blister anywhere on the study foot. One hundred six (83%) participants developed 117 blisters, with treatment success in 98 (77%) runners. Paper tape reduced blisters by 40% (P < 0.01, 95% confidence interval, 28-52) with a number needed to treat of 1.31. Most of the study participants had 1 blister (78%), with most common locations on the toes (n = 58, 50%) and heel (n = 27, 23%), with 94 (80%) blisters occurring by the end of stage 2. Treatment success was associated with earlier stages [odds ratio (OR), 74.9, P < 0.01] and time spent running (OR, 0.66, P = 0.01). Paper tape was found to prevent both the incidence and frequency of foot blisters in runners.

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.

Biological stress systems, adverse life events and the onset of chronic multisite musculoskeletal pain: a 6-year cohort study.

PubMed

Generaal, Ellen; Vogelzangs, Nicole; Macfarlane, Gary J; Geenen, Rinie; Smit, Johannes H; de Geus, Eco J C N; Penninx, Brenda W J H; Dekker, Joost

2016-05-01

Dysregulated biological stress systems and adverse life events, independently and in interaction, have been hypothesised to initiate chronic pain. We examine whether (1) function of biological stress systems, (2) adverse life events, and (3) their combination predict the onset of chronic multisite musculoskeletal pain. Subjects (n=2039) of the Netherlands Study of Depression and Anxiety, free from chronic multisite musculoskeletal pain at baseline, were identified using the Chronic Pain Grade Questionnaire and followed up for the onset of chronic multisite musculoskeletal pain over 6 years. Baseline assessment of biological stress systems comprised function of the hypothalamic-pituitary-adrenal axis (1-h cortisol awakening response, evening levels, postdexamethasone levels), the immune system (basal and lipopolysaccharide-stimulated inflammation) and the autonomic nervous system (heart rate, pre-ejection period, SD of the normal-to-normal interval, respiratory sinus arrhythmia). The number of recent adverse life events was assessed at baseline using the List of Threatening Events Questionnaire. Hypothalamic-pituitary-adrenal axis, immune system and autonomic nervous system functioning was not associated with onset of chronic multisite musculoskeletal pain, either by itself or in interaction with adverse life events. Adverse life events did predict onset of chronic multisite musculoskeletal pain (HR per event=1.14, 95% CI 1.04 to 1.24, p=0.005). This longitudinal study could not confirm that dysregulated biological stress systems increase the risk of developing chronic multisite musculoskeletal pain. Adverse life events were a risk factor for the onset of chronic multisite musculoskeletal pain, suggesting that psychosocial factors play a role in triggering the development of this condition. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

A multisite randomized controlled trial on time to self-support among sickness absence beneficiaries. The Danish national return-to-work programme.

PubMed

Nielsen, Maj Britt D; Vinsløv Hansen, Jørgen; Aust, Birgit; Tverborgvik, Torill; Thomsen, Birthe L; Bue Bjorner, Jakob; Steen Mortensen, Ole; Rugulies, Reiner; Winzor, Glen; Ørbæk, Palle; Helverskov, Trine; Kristensen, Nicolai; Melchior Poulsen, Otto

2015-02-01

In 2010, the Danish Government launched the Danish national return-to-work (RTW) programme to reduce sickness absence and promote labour market attainment. Multidisciplinary teams delivered the RTW programme, which comprised a coordinated, tailored and multidisciplinary effort (CTM) for sickness absence beneficiaries at high risk for exclusion from the labour market. The aim of this article was to evaluate the effectiveness of the RTW programme on self-support. Beneficiaries from three municipalities (denoted M1, M2 and M3) participated in a randomized controlled trial. We randomly assigned beneficiaries to CTM (M1: n = 598; M2: n = 459; M3: n = 331) or to ordinary sickness absence management (OSM) (M1: n = 393; M2: n = 324; M3: n = 95). We used the Cox proportional hazards model to estimate hazard ratios (HR) comparing rates of becoming self-supporting between beneficiaries receiving CTM and OSM. In M2, beneficiaries from employment receiving CTM became self-supporting faster compared with beneficiaries receiving OSM (HR = 1.32, 95% CI: 1.08-1.61). In M3, beneficiaries receiving CTM became self-supporting slower than beneficiaries receiving OSM (HR = 0.72, 95% CI: 0.54-0.95). In M1, we found no difference between the two groups (HR = 0.99, 95% CI: 0.84-1.17). The effect of the CTM programme on return to self-support differed substantially across the three participating municipalities. Thus, generalizing the study results to other Danish municipalities is not warranted. ISRCTN43004323. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

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.

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

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

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

2014-03-15

To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs 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 (RIM). 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), postintervention (T2), and 100 days posttransplant (T3). At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). 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 AYAs with high-risk cancers. © 2013 American Cancer Society.

Exploiting Multisite Gateway and pENFRUIT plasmid collection for fruit genetic engineering.

PubMed

Estornell, Leandro H; Granell, Antonio; Orzaez, Diego

2012-01-01

MultiSite Gateway cloning techniques based on homologous recombination facilitate the combinatorial assembly of basic genetic pieces (i.e., promoters, CDS, and terminators) into gene expression or gene silencing cassettes. pENFRUIT is a collection of MultiSite Triple Gateway Entry vectors dedicated to genetic engineering in fruits. It comprises a number of fruit-operating promoters as well as C-terminal tags adapted to the Gateway standard. In this way, flanking regulatory/labeling sequences can be easily Gateway-assembled with a given gene of interest for its ectopic expression or silencing in fruits. The resulting gene constructs can be analyzed in stable transgenic plants or in transient expression assays, the latter allowing fast testing of the increasing number of combinations arising from MultiSite methodology. A detailed description of the use of MultiSite cloning methodology for the assembly of pENFRUIT elements is presented.

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.

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial

PubMed Central

Broderick, Joan E.; Keefe, Francis J.; Bruckenthal, Patricia; Junghaenel, Doerte U.; Schneider, Stefan; Schwartz, Joseph E.; Kaell, Alan T.; Caldwell, David S.; McKee, Daphne; Reed, Shelby; Gould, Elaine

2014-01-01

A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients’ doctors’ offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain. PMID:24865795

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

Does physical or psychosocial workload modify the effect of musculoskeletal pain on sickness absence? A prospective study among the Finnish population.

PubMed

Neupane, Subas; Pensola, Tiina; Haukka, Eija; Ojajärvi, Anneli; Leino-Arjas, Päivi

2016-07-01

Previously, among food industry workers, multisite pain predicted sickness absence (SA) only in those with low biomechanical workload. Here we studied among a wide range of occupations whether the relationship of pain with SA was modified by the level of physical or psychosocial workload. A nationally representative sample (Health 2000 Survey) comprised 3420 occupationally active Finns aged 30-55 years. Baseline data on musculoskeletal pain during the preceding month, strenuous work history, current physical workload, job demands, job control, support at work, lifestyle, and chronic diseases were obtained in 2000/2001 by questionnaire, interview, and clinical examination. Musculoskeletal pain in 18 body locations was combined into four sites (neck, upper limbs, low back, and lower limbs) and classified as no pain, single-site pain, and multisite pain (2-4 sites). The data were linked with information from national registers on annual SA periods lasting ≥10 workdays for 2002-2008. Negative binomial regression analysis was used. At baseline, one-third of the study sample reported single-site and one-third multisite pain. Allowing for gender and age, the employees with multisite pain in strata with high physical workload and high job demands tended to have the highest risk of SA, but no statistically significant interactive effects between work factors and pain were observed. Further adjustment for health-related lifestyle and chronic diseases decreased the risk estimates in all strata. We did not find evidence for significant modification by physical or psychosocial workload of the relationship between musculoskeletal pain and SA periods lasting ≥10 workdays.

Risk and direct protective factors for youth violence: results from the Centers for Disease Control and Prevention's Multisite Violence Prevention Project.

PubMed

Henry, David B; Tolan, Patrick H; Gorman-Smith, Deborah; Schoeny, Michael E

2012-08-01

This study was conducted as part of a multisite effort to examine risk and direct protective factors for youth violence. The goal was to identify those factors in the lives of young people that increase or decrease the risk of violence. These analyses fill an important gap in the literature, as few studies have examined risk and direct protective factors for youth violence across multiple studies. Data on 4432 middle-school youth, from the CDC Multisite Violence Prevention Project were used. Evaluations were made of effects of variables coded as risk and direct protective factors in the fall of 6th grade on violence measured in spring of 7th and 8th grades. Factors tested included depression, delinquency, alcohol and drug involvement, involvement in family activities, academic achievement, attitudes toward school, truancy, and peer deviance. Most variables were coded with two sets of dummy variables indicating risk and protective directions of effects. Results showed that higher teacher-rated study skills were associated with lower subsequent violence across genders and ethnic groups. Affiliation with deviant peers was significantly associated with increased subsequent violence among youth reporting their race/ethnicity as white or other, marginally associated with increased violence among African-American youth, and unrelated among Latino youth. This study identified some factors than should be areas of interest for effective prevention programs. Some ethnic differences also should be considered in planning of prevention. The CDC Multisite Violence Prevention Project completed enrollment prior to July 2005. Copyright © 2012. Published by Elsevier Inc.

Further Validation of the Pathways Housing First Fidelity Scale.

PubMed

Goering, Paula; Veldhuizen, Scott; Nelson, Geoffrey B; Stefancic, Ana; Tsemberis, Sam; Adair, Carol E; Distasio, Jino; Aubry, Tim; Stergiopoulos, Vicky; Streiner, David L

2016-01-01

This study examined whether Housing First fidelity ratings correspond to program operation descriptions from administrative data and predict client outcomes. A multisite, randomized controlled trial (At Home/Chez Soi) in five Canadian cities included two assessments of 12 programs over two years. Outcomes for 1,158 clients were measured every six months. Associations between fidelity ratings and administrative data (Spearman correlations) and participant outcomes (mixed-effects modeling) were examined. Fidelity ratings were generally good (mean ± SD=136.6 ± 10.3 out of a possible range of 38-152; 87% of maximum value). Fidelity was significantly associated with three of four measures of program operation, with correlations between .55 and .60. Greater program fidelity was associated with improvement in housing stability, community functioning, and quality of life. Variation in program fidelity was associated with operations and outcomes, supporting scale validity and intervention effectiveness. These findings reinforced the value of using fidelity monitoring to conduct quality assurance and technical assistance activities.

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.

Best-Practice Physical Activity Programs for Older Adults: Findings From the National Impact Study

PubMed Central

Seymour, Rachel B.; Campbell, Richard T.; Whitelaw, Nancy; Bazzarre, Terry

2009-01-01

Objectives. We assessed the impact of existing best-practice physical activity programs for older adults on physical activity participation and health-related outcomes. Methods. We used a multisite, randomized trial with 544 older adults (mean age 66 years) and measures at baseline, 5, and 10 months to test the impact of a multiple-component physical activity program compared with results for a control group that did not participate in such a program. Results. For adults who participated in a multiple-component physical activity program, we found statistically significant benefits at 5 and 10 months with regard to self-efficacy for exercise adherence over time (P < .001), adherence in the face of barriers (P = .01), increased upper- and lower-body strength (P = .02, P = .01), and exercise participation (P = .01). Conclusions. Best-practice community-based physical activity programs can measurably improve aspects of functioning that are risk factors for disability among older adults. US public policy should encourage these inexpensive health promotion programs. PMID:19059858

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.

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.

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.

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.

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

Motivational tools to improve probationer treatment outcomes.

PubMed

Taxman, Faye S; Walters, Scott T; Sloas, Lincoln B; Lerch, Jennifer; Rodriguez, Mayra

2015-07-01

Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational interviewing (MI), a motivational computer program (MC), and supervision as usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. NCT01891656. Copyright © 2015. Published by Elsevier Inc.

Feasibility and Acceptability of Internet-delivered Cognitive Behavioral Therapy for Chronic Pain in Adolescents With Sickle Cell Disease and Their Parents.

PubMed

Palermo, Tonya M; Dudeney, Joanne; Santanelli, James P; Carletti, Alexie; Zempsky, William T

2018-03-01

Pain is a clinical hallmark of sickle cell disease (SCD), and is rarely optimally managed. Cognitive-behavioral therapy (CBT) for pain has been effectively delivered through the Internet in other pediatric populations. We tested feasibility and acceptability of an Internet-delivered CBT intervention in 25 adolescents with SCD (64% female, mean age=14.8 y) and their parents randomized to Internet CBT (n=15) or Internet Pain Education (n=10). Participants completed pretreatment/posttreatment measures. Eight dyads completed semistructured interviews to evaluate treatment acceptability. Feasibility indicators included recruitment and participation rates, engagement and adherence to intervention, and completion of outcome measures. In total, 87 referrals were received from 9 study sites; our recruitment rate was 60% from those families approached for screening. Among participants, high levels of initial intervention engagement (>90%), and adherence (>70%) were demonstrated. Most participants completed posttreatment outcome and diary measures (>75%). Retention at posttreatment was 80%. High treatment acceptability was reported in interviews. Our findings suggest that Internet-delivered CBT for SCD pain is feasible and acceptable to adolescents with SCD and their parents. Engagement and adherence were good. Next steps are to modify recruitment plans to enhance enrollment and determine efficacy of Internet CBT for SCD pain in a large multisite randomized controlled trial.

A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone.

PubMed

Christensen, Kurt D; Uhlmann, Wendy R; Roberts, J Scott; Linnenbringer, Erin; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cupples, L Adrienne; Butson, Melissa B; Fasaye, Grace-Ann; Hiraki, Susan; Chen, Clara A; Siebert, Uwe; Cook-Deegan, Robert; Green, Robert C

2018-01-01

PurposeTelephone disclosure of genetic test results can improve access to services. To date, studies of its impact have focused on return of Mendelian risk information, principally hereditary cancer syndromes.MethodsIn a multisite trial of Alzheimer disease genetic risk disclosure, asymptomatic adults were randomized to receive test results in person or via telephone. Primary analyses examined patient outcomes 12 months after disclosure.ResultsData from 257 participants showed that telephone disclosure occurred 7.4 days sooner and was 30% shorter, on average, than in-person disclosure (both P < 0.001). Anxiety and depression scores were well below cutoffs for clinical concern across protocols. Comparing telephone and in-person disclosure protocols, 99% confidence intervals of mean differences were within noninferiority margins on scales assessing anxiety, depression, and test-related distress, but inconclusive about positive impact. No differences were observed on measures of recall and subjective impact. Subanalyses supported noninferiority on all outcomes among apolipoprotein E (APOE) ɛ4-negative participants. Subanalyses were inconclusive for APOE ɛ4-positive participants, although mean anxiety and depression scores were still well below cutoffs for clinical concern.ConclusionTelephone disclosure of APOE results and risk for Alzheimer disease is generally safe and helps providers meet demands for services, even when results identify an increased risk for disease.

Ultrasensitivity and sharp threshold theorems for multisite systems

NASA Astrophysics Data System (ADS)

Dougoud, M.; Mazza, C.; Vinckenbosch, L.

2017-02-01

This work studies the ultrasensitivity of multisite binding processes where ligand molecules can bind to several binding sites. It considers more particularly recent models involving complex chemical reactions in allosteric phosphorylation processes and for transcription factors and nucleosomes competing for binding on DNA. New statistics-based formulas for the Hill coefficient and the effective Hill coefficient are provided and necessary conditions for a system to be ultrasensitive are exhibited. It is first shown that the ultrasensitivity of binding processes can be approached using sharp-threshold theorems which have been developed in applied probability theory and statistical mechanics for studying sharp threshold phenomena in reliability theory, random graph theory and percolation theory. Special classes of binding process are then introduced and are described as density dependent birth and death process. New precise large deviation results for the steady state distribution of the process are obtained, which permits to show that switch-like ultrasensitive responses are strongly related to the multi-modality of the steady state distribution. Ultrasensitivity occurs if and only if the entropy of the dynamical system has more than one global minimum for some critical ligand concentration. In this case, the Hill coefficient is proportional to the number of binding sites, and the system is highly ultrasensitive. The classical effective Hill coefficient I is extended to a new cooperativity index I q , for which we recommend the computation of a broad range of values of q instead of just the standard one I  =  I 0.9 corresponding to the 10%-90% variation in the dose-response. It is shown that this single choice can sometimes mislead the conclusion by not detecting ultrasensitivity. This new approach allows a better understanding of multisite ultrasensitive systems and provides new tools for the design of such systems.

Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

PubMed Central

2010-01-01

Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). Conclusions The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples based clinical trials in HIV/STD risk reduction and can be generalized to other couples based behavioral interventions. PMID:18724188

Preconception maternal nutrition: a multi-site randomized controlled trial

PubMed Central

2014-01-01

Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age. Trial registration ClinicalTrials.gov NCT01883193. PMID:24650219

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 .

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.

Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial.

PubMed

Czaja, Sara J; Boot, Walter R; Charness, Neil; Rogers, Wendy A; Sharit, Joseph

2018-05-08

Information and communication technology holds promise in terms of providing support and reducing isolation among older adults. We evaluated the impact of a specially designed computer system for older adults, the Personal Reminder Information and Social Management (PRISM) system. The trial was a multisite randomized field trial conducted at 3 sites. PRISM was compared to a Binder condition wherein participants received a notebook that contained paper content similar to that contained in PRISM. The sample included 300 older adults at risk for social isolation who lived independently in the community (Mage = 76.15 years). Primary outcome measures included indices of social isolation, social support, loneliness, and well-being. Secondary outcome measures included indices of computer proficiency and attitudes toward technology. Data were collected at baseline and at 6 and 12 months post-randomization. The PRISM group reported significantly less loneliness and increased perceived social support and well-being at 6 months. There was a trend indicating a decline in social isolation. Group differences were not maintained at 12 months, but those in the PRISM condition still showed improvements from baseline. There was also an increase in computer self-efficacy, proficiency, and comfort with computers for PRISM participants at 6 and 12 months. The findings suggest that access to technology applications such as PRISM may enhance social connectivity and reduce loneliness among older adults and has the potential to change attitudes toward technology and increase technology self-efficacy.

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.

Distinctive Trajectories of Opioid Use Over an Extended Follow-up of Patients in a Multisite Trial on Buprenorphine + Naloxone and Methadone.

PubMed

Hser, Yih-Ing; Huang, David; Saxon, Andrew J; Woody, George; Moskowitz, Andrew L; Matthews, Abigail G; Ling, Walter

Uncovering heterogeneities in longitudinal patterns (trajectories) of opioid use among individuals with opioid use disorder can increase our understanding of disease progression and treatment responses to improve care. The present study aims to identify distinctive opioid use trajectories and factors associated with these patterns among participants randomized to treatment with methadone (MET) or buprenorphine + naloxone (BUP). Growth mixture modeling was applied to identify distinctive opioid use trajectories among 795 opioid users after their enrollment in a multisite trial during 2006 to 2009, with follow-up interviews conducted during 2011 to 2014. Four distinctive trajectories were identified based on opioid use over the follow-up period: low use (42.0%), high use (22.3%), increasing use (17.1%), and decreasing use (18.6%). Greater odds of being in the high use group (relative to low use) was associated with Hispanics (relative to African American, odds ratio [OR] 3.21), injection drug use (OR 2.12), higher mental health functioning at baseline (OR 1.23), location on the West Coast (vs East Coast, OR 2.15), and randomization to BUP (relative to MET, OR 1.53). High use and increasing use groups had greater severity in problems related to drug, employment, legal, and social/family relationships, and worsened mental health functioning at follow-up. Participation in treatment significantly accounted for both within and between-group differences in opioid use. Continued treatment is necessary to reduce risk for opioid use and related adverse consequences, particularly among individuals (eg, injecting drug) at risk for consistently high level of opioid use.

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

PubMed Central

2010-01-01

Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. Trial registration ClinicalTrials.gov NCT00052078. PMID:20051130

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios

2016-02-16

The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).

Behavioral Outcome Effects of Serious Gaming as an Adjunct to Treatment for Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

PubMed Central

2016-01-01

Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052

A novel environmental chamber for neuronal network multisite recordings.

PubMed

Biffi, E; Regalia, G; Ghezzi, D; De Ceglia, R; Menegon, A; Ferrigno, G; Fiore, G B; Pedrocchi, A

2012-10-01

Environmental stability is a critical issue for neuronal networks in vitro. Hence, the ability to control the physical and chemical environment of cell cultures during electrophysiological measurements is an important requirement in the experimental design. In this work, we describe the development and the experimental verification of a closed chamber for multisite electrophysiology and optical monitoring. The chamber provides stable temperature, pH and humidity and guarantees cell viability comparable to standard incubators. Besides, it integrates the electronics for long-term neuronal activity recording. The system is portable and adaptable for multiple network housings, which allows performing parallel experiments in the same environment. Our results show that this device can be a solution for long-term electrophysiology, for dual network experiments and for coupled optical and electrical measurements. Copyright © 2012 Wiley Periodicals, Inc.

Psychosocial stress and multi-site musculoskeletal pain: a cross-sectional survey of patient care workers.

PubMed

Sembajwe, Grace; Tveito, Torill Helene; Hopcia, Karen; Kenwood, Christopher; O'Day, Elizabeth Tucker; Stoddard, Anne M; Dennerlein, Jack T; Hashimoto, Dean; Sorensen, Glorian

2013-03-01

The aim of this study was to assess the relationship between psychosocial factors at work and multi-site musculoskeletal pain among patient care workers. In a survey of 1,572 workers from two hospitals, occupational psychosocial factors and health outcomes of workers with single and multi-site pain were evaluated using items from the Job Content Questionnaire that was designed to measure psychological demands, decision latitude, and social support. An adapted Nordic Questionnaire provided data on the musculoskeletal pain outcome. Covariates included body mass index, age, gender, and occupation. The analyses revealed statistically significant associations between psychosocial demands and multi-site musculoskeletal pain among patient care associates, nurses, and administrative personnel, both men and women. Supervisor support played a significant role for nurses and women. These results remained statistically significant after adjusting for covariates. These results highlight the associations between workplace psychosocial strain and multi-site musculoskeletal pain, setting the stage for future longitudinal explorations. Copyright 2013, SLACK Incorporated.

Pathways curriculum and family interventions to promote healthful eating and physical activity in American Indian schoolchildren

PubMed Central

Davis, Sally M.; Clay, Theresa; Smyth, Mary; Gittelsohn, Joel; Arviso, Vivian; Flint-Wagner, Hilary; Rock, Bonnie Holy; Brice, Richard A.; Metcalfe, Lauve; Stewart, Dawn; Vu, Maihan; Stone, Elaine J.

2016-01-01

Background Pathways, a multisite school-based study aimed at promoting healthful eating and increasing physical activity, was a randomized field trial including 1704 American Indian third to fifth grade students from 41 schools (21 intervention, 20 controls) in seven American Indian communities. Methods The intervention schools received four integrated components: a classroom curriculum, food service, physical activity, and family modules. The curriculum and family components were based on Social Learning Theory, American Indian concepts, and results from formative research. Process evaluation data were collected from teachers (n = 235), students (n = 585), and families. Knowledge, Attitudes, and Behavior Questionnaire data were collected from 1150 students including both intervention and controls. Results There were significant increases in knowledge and cultural identity in children in intervention compared to control schools with a significant retention of knowledge over the 3 years, based on the results of repeating the third and fourth grade test items in the fifth grade. Family members participated in Family Events and take-home activities, with fewer participating each year. Conclusion A culturally appropriate school intervention can promote positive changes in knowledge, cultural identity, and self-reported healthful eating and physical activity in American Indian children and environmental change in school food service. PMID:14636806

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.

ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol.

PubMed

Allary, C; Bourmaud, A; Tinquaut, F; Oriol, M; Kalecinski, J; Dutertre, V; Lechopier, N; Pommier, M; Benoist, Y; Rousseau, S; Regnier, V; Buthion, V; Chauvin, F

2016-07-07

The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis. The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months. The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases. NCT02369757.

Peer effects on self-regulation in adolescence depend on the nature and quality of the peer interaction.

PubMed

King, Kevin M; McLaughlin, Katie A; Silk, Jennifer; Monahan, Kathryn C

2017-11-21

Adolescence is a critical period for the development of self-regulation, and peer interactions are thought to strongly influence regulation ability. Simple exposure to peers has been found to alter decisions about risky behaviors and increase sensitivity to rewards. The link between peer exposure and self-regulation is likely to vary as a function of the type and quality of peer interaction (e.g., rejection or acceptance). Little is known about how the nature of interactions with peers influences different dimensions of self-regulation. We examined how randomization to acceptance or rejection by online "virtual" peers influenced multiple dimensions of self-regulation in a multisite community sample of 273 adolescents aged 16-17 years. Compared to a neutral condition, exposure to peers produced increases in cold cognitive control, but decreased hot cognitive control. Relative to peer acceptance, peer rejection reduced distress tolerance and increased sensitivity to losses. These findings suggest that different dimensions of adolescent self-regulation are influenced by the nature of the peer context: basic cognitive functions are altered by mere exposure to peers, whereas more complex decision making and emotion regulation processes are influenced primarily by the quality of that exposure.

Collateral benefits of the Family Check-Up on early childhood school readiness: indirect effects of parents' positive behavior support.

PubMed

Lunkenheimer, Erika S; Dishion, Thomas J; Shaw, Daniel S; Connell, Arin M; Gardner, Frances; Wilson, Melvin N; Skuban, Emily M

2008-11-01

The authors examined the longitudinal effects of the Family Check-Up (FCU) on parents' positive behavior support and children's school readiness competencies in early childhood. It was hypothesized that the FCU would promote language skills and inhibitory control in children at risk for behavior problems as an indirect outcome associated with targeted improvements in parents' positive behavior support. High-risk families in the Women, Infants, and Children Nutrition Program participated in a multisite preventive intervention study (N = 731) with 3 yearly assessments beginning at child age 2 years. Positive behavior support was measured using 4 indicators derived from at-home observations of parent-child interaction during semistructured tasks. Longitudinal structural equation models revealed that parents in families randomly assigned to the FCU showed improvements in positive behavior support from child age 2 to 3, which in turn promoted children's inhibitory control and language development from age 3 to 4, accounting for child gender, ethnicity, and parental education. Findings suggest that a brief, ecological preventive intervention supporting positive parenting practices can indirectly foster key facets of school readiness in children at risk.

Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health.

PubMed

Hallfors, Denise; Cho, Hyunsan; Sanchez, Victoria; Khatapoush, Shereen; Kim, Hyung Min; Bauer, Daniel

2006-12-01

The US Department of Education requires schools to choose substance abuse and violence prevention programs that meet standards of effectiveness. The Substance Abuse and Mental Health Services Agency certifies "model" programs that meet this standard. We compared findings from a large, multisite effectiveness trial of 1 model program to its efficacy trial findings, upon which the certification was based. 1370 high-risk youths were randomized to experimental or control groups across 9 high schools in 2 large urban school districts. We used intent-to-treat and on-treatment approaches to examine baseline equivalence, attrition, and group differences in outcomes at the end of the program and at a 6-month follow-up. Positive efficacy trial findings were not replicated in the effectiveness trial. All main effects were either null or worse for the experimental than for the control group. These findings suggest that small efficacy trials conducted by developers provide insufficient evidence of effectiveness. Federal agencies and public health scientists must work together to raise the standards of evidence and ensure that data from new trials are incorporated into ongoing assessments of program effects.

Collateral Benefits of the Family Check-Up on Early Childhood School Readiness: Indirect Effects of Parents’ Positive Behavior Support

PubMed Central

Lunkenheimer, Erika S.; Dishion, Thomas J.; Shaw, Daniel S.; Connell, Arin M.; Gardner, Frances; Wilson, Melvin N.; Skuban, Emily M.

2009-01-01

The authors examined the longitudinal effects of the Family Check-Up (FCU) on parents’ positive behavior support and children’s school readiness competencies in early childhood. It was hypothesized that the FCU would promote language skills and inhibitory control in children at risk for behavior problems as an indirect outcome associated with targeted improvements in parents’ positive behavior support. High-risk families in the Women, Infants, and Children Nutrition Program participated in a multisite preventive intervention study (N = 731) with 3 yearly assessments beginning at child age 2 years. Positive behavior support was measured using 4 indicators derived from at-home observations of parent–child interaction during semistructured tasks. Longitudinal structural equation models revealed that parents in families randomly assigned to the FCU showed improvements in positive behavior support from child age 2 to 3, which in turn promoted children’s inhibitory control and language development from age 3 to 4, accounting for child gender, ethnicity, and parental education. Findings suggest that a brief, ecological preventive intervention supporting positive parenting practices can indirectly foster key facets of school readiness in children at risk. PMID:18999335

Increasing the ranks of academic researchers in mental health: a multisite approach to postdoctoral fellowship training.

PubMed

O'Hara, Ruth; Cassidy-Eagle, Erin L; Beaudreau, Sherry A; Eyler, Lisa T; Gray, Heather L; Giese-Davis, Janine; Hubbard, Jeffrey; Yesavage, Jerome A

2010-01-01

This report highlights the use of multisite training for psychiatry and psychology postdoctoral fellows developing careers in academic clinical research in the field of mental health. The objective is to describe a model of training for young investigators to establish independent academic clinical research careers, including (1) program structure and eligibility, (2) program goals and development of a multisite curriculum, (3) use of technology for implementing the program across multiple sites, and (4) advantages and challenges of this multisite approach. In 2000, in collaboration with the Veterans Affairs (VA) Mental Illness Research, Education and Clinical Centers (MIRECCs), the VA Office of Academic Affiliations launched the Special Fellowship Program in Advanced Psychiatry and Psychology. Each of the 10 currently participating VA sites across the United States is affiliated with a MIRECC and an academic medical institution. In the first five years of this fellowship program, 83 fellows (34 psychiatrists and 49 psychologists) have participated. The success of this multisite approach is evidenced by the 58 fellows who have already graduated from the program: 70% have entered academic clinical research positions, and over 25 have obtained independent extramural grant support from the VA or the National Institutes of Health. Multisite training results in a greater transfer of knowledge and capitalizes on the nationwide availability of experts, creating unique networking and learning opportunities for trainees. The VA's multisite fellowship program plays a valuable role in preparing substantial numbers of psychiatry and psychology trainees for a range of academic clinical research and leadership positions in the field of mental health.

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.

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

Reliability of an fMRI Paradigm for Emotional Processing in a Multisite Longitudinal Study

PubMed Central

Gee, Dylan G.; McEwen, Sarah C.; Forsyth, Jennifer K.; Haut, Kristen M.; Bearden, Carrie E.; Addington, Jean; Goodyear, Bradley; Cadenhead, Kristin S.; Mirzakhanian, Heline; Cornblatt, Barbara A.; Olvet, Doreen; Mathalon, Daniel H.; McGlashan, Thomas H.; Perkins, Diana O.; Belger, Aysenil; Seidman, Larry J.; Thermenos, Heidi; Tsuang, Ming T.; van Erp, Theo G.M.; Walker, Elaine F.; Hamann, Stephan; Woods, Scott W.; Constable, Todd; Cannon, Tyrone D.

2015-01-01

Multisite neuroimaging studies can facilitate the investigation of brain-related changes in many contexts, including patient groups that are relatively rare in the general population. Though multisite studies have characterized the reliability of brain activation during working memory and motor functional magnetic resonance imaging tasks, emotion processing tasks, pertinent to many clinical populations, remain less explored. A traveling participants study was conducted with eight healthy volunteers scanned twice on consecutive days at each of the eight North American Longitudinal Prodrome Study sites. Tests derived from generalizability theory showed excellent reliability in the amygdala (Eρ2=0.82), inferior frontal gyrus (IFG;Eρ2=0.83), anterior cingulate cortex (ACC;Eρ2=0.76), insula (Eρ2=0.85), and fusiform gyrus (Eρ2=0.91) for maximum activation and fair to excellent reliability in the amygdala (Eρ2=0.44), IFG (Eρ2=0.48), ACC (Eρ2=0.55), insula (Eρ2=0.42), and fusiform gyrus (Eρ2=0.83) for mean activation across sites and test days. For the amygdala, habituation (Eρ2=0.71) was more stable than mean activation. In a second investigation, data from 111 healthy individuals across sites were aggregated in a voxelwise, quantitative meta-analysis. When compared with a mixed effects model controlling for site, both approaches identified robust activation in regions consistent with expected results based on prior single-site research. Overall, regions central to emotion processing showed strong reliability in the traveling participants study and robust activation in the aggregation study. These results support the reliability of blood oxygen level-dependent signal in emotion processing areas across different sites and scanners and may inform future efforts to increase efficiency and enhance knowledge of rare conditions in the population through multisite neuroimaging paradigms. PMID:25821147

Multisite musculoskeletal pain in adolescence and later mental health disorders: a population-based registry study of Norwegian youth: the NAAHS cohort study

PubMed Central

Eckhoff, Christian; Straume, Bjørn; Kvernmo, Siv

2017-01-01

Objectives To examine the association between multisite musculoskeletal pain in adolescence and mental health disorders in young adulthood. Design and setting Data were obtained from a linkage between the Norwegian Patient Registry (2008–2012) and the Norwegian Arctic Adolescent Health Study, a school-based survey conducted among 10th grade students in North Norway (2003–2005). Participants In total, 3987 (68%) of all 5877 invited participants consented to the registry linkage. Outcome measures Mental healthcare use and disorders from age 18–20 to 23–25 years (5 years). Methods Musculoskeletal pain was measured by the number of musculoskeletal pain sites. Multivariable logistic regression was used to explore the association with later mental healthcare use and disorders. Results Multisite adolescent musculoskeletal pain was significantly associated with an increase in mental healthcare use and mental health disorders in young adulthood. The relationship was stronger for anxiety and mood disorders, in both genders. Overall, the association between musculoskeletal pain and later mental health problems was attenuated after controlling for adolescent psychosocial and mental health problems, not by physical or sedentary activity. This could be due to confounding or mediation. However, when examining different mental health disorders, we found musculoskeletal pain to be significantly associated with anxiety disorders, and showing a strong trend in mood disorders, when adjusted for the adolescent factors. Conclusions Physicians should be aware that multisite adolescent pain is associated with mental health problems in adolescence, and that these adolescents are at increased risk of mental health disorders in young adulthood. As youth troubled by mental health problems commonly present physical symptoms it is important to examine for psychosocial problems in order to offer early interventions. PMID:28188150

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

PubMed

Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J

2016-04-01

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.

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.

Solid anthropomorphic infant whole body DXA phantom: Design, evaluation, and multisite testing

USDA-ARS?s Scientific Manuscript database

Dual energy X-ray absorptiometry (DXA) requires phantoms for quality control and cross-calibration. No commercially available phantoms are designed specifically for infant whole-body scanning. We fabricated a phantom closely matching a 7-kg human infant in body habitus using PVC, nylon-mix, and poly...

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

A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol.

PubMed

Williams, Kristine; Blyler, Diane; Vidoni, Eric D; Shaw, Clarissa; Wurth, JoEllen; Seabold, Denise; Perkhounkova, Yelena; Van Sciver, Angela

2018-06-01

The number of persons with dementia (PWD) in the United States is expected to reach 16 million by 2050. Due to the behavioral and psychological symptoms of dementia, caregivers face challenging in-home care situations that lead to a range of negative health outcomes such as anxiety and depression for the caregivers and nursing home placement for PWD. Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) is a multisite randomized controlled trial evaluating the effects of a telehealth intervention on caregiver well-being and PWD behavioral symptoms. The FamTechCare intervention provides individualized dementia-care strategies to in-home caregivers based on video recordings that the caregiver creates of challenging care situations. A team of dementia care experts review videos submitted by caregivers and provide interventions to improve care weekly for the experimental group. Caregivers in the control group receive feedback for improving care based on a weekly phone call with the interventionist and receive feedback on their videos at the end of the 3-month study. Using linear mixed modeling, we will compare experimental and control group outcomes (PWD behavioral symptoms and caregiver burden) after 1 and 3 months. An exploratory descriptive design will identify a typology of interventions for telehealth support for in-home dementia caregivers. Finally, the cost for FamTechCare will be determined and examined in relation to hypothesized effects on PWD behavioral symptoms, placement rates, and caregiver burden. This research will provide the foundation for future research for telehealth interventions with this population, especially for families in rural or remote locations. © 2018 Wiley Periodicals, Inc.

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

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

PubMed

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

2017-04-01

Pediatric functional abdominal pain disorders (FAPDs) are associated with increased health care utilization, school absences, and poor quality of life (QoL). Cost-effective and accessible interventions are needed. This multisite 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, QoL, pain behavior, school absences, health care utilization, and gastrointestinal symptoms. The study was prospective and longitudinal (baseline and 3 and 6 months' follow-up) with 3 randomized conditions: social learning and cognitive behavioral therapy in-person (SLCBT) or by phone (SLCBT-R) and education and support condition by phone (ES-R). Participants were children aged 7 to 12 years with FAPD and their parents (N = 316 dyads). Although no significant treatment effect for pain severity was found, the SLCBT groups showed significantly greater improvements compared with controls on process measures of parental solicitousness, pain beliefs, and catastrophizing, and additional outcomes of parent-reported functional disability, pain behaviors, child health care visits for abdominal pain, and (remote condition only) QoL and missed school days. No effects were found for parent and child-reported gastrointestinal symptoms, or child-reported QoL 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 with a control condition.

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.

Physical Activity Self-Management and Coaching Compared to Social Interaction in Huntington Disease: Results From the ENGAGE-HD Randomized, Controlled Pilot Feasibility Trial

PubMed Central

Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; Rosser, Anne; Hood, Kerenza

2017-01-01

Abstract Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention compared with social contact in Huntington disease (HD) to inform the design of a future full-scale trial. Design. Assessor blind, multisite, randomized pilot feasibility trial. Setting. Participants were recruited and assessed at baseline, 16 weeks following randomization, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention. People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements. Eligibility, recruitment, retention, and intervention participation were determined at 16 weeks. Other outcomes of interest included measures of mobility, self-efficacy, physical activity, and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results. Forty percent (n = 46) of eligible patients were enrolled; 22 were randomized to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92%, respectively. Minimum participation criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between-group treatment effects on function; however, increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lend support to our predefined intervention logic model. Limitations. The use of self-report measures may have introduced bias. Conclusions. An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation. PMID:28371942

Partnership-driven Resources to Improve and Enhance Research (PRIMER): a survey of community-engaged researchers and creation of an online toolkit.

PubMed

Dolor, Rowena J; Greene, Sarah M; Thompson, Ella; Baldwin, Laura-Mae; Neale, Anne Victoria

2011-08-01

This project aimed to develop an open-access website providing adaptable resources to facilitate best practices for multisite research from initiation to closeout. methods: A web-based assessment was sent to the leadership of the Clinical and Translational Science Award (CTSA) Community Engagement Key Functions Committee (n= 38) and the CTSA-affiliated Primary Care Practice-based Research Networks (PBRN, n= 55). Respondents rated the benefits and barriers of multisite research, the utility of available resources, and indicated their level of interest in unavailable resources. Then, existing research resources were evaluated for relevance to multisite research, adaptability to other projects, and source credibility. Fifty-five (59%) of invited participants completed the survey. Top perceived benefits of multisite research were the ability to conduct community-relevant research through academic-community partnerships (34%) and accelerating translation of research into practice (31%). Top perceived barriers were lack of research infrastructure to support PBRNs and community partners (31%) and inadequate funding to support multisite collaborations (26%). Over 200 resources were evaluated, of which 120 unique resources were included in the website. The PRIMER Research Toolkit (http://www.researchtoolkit.org) provides an array of peer-reviewed resources to facilitate translational research for the conduct of multisite studies within PBRNs and community-based organizations. © 2011 Wiley Periodicals, Inc.

Partnership‐Driven Resources to Improve and Enhance Research (PRIMER): A Survey of Community‐Engaged Researchers and Creation of an Online Toolkit

PubMed Central

Dolor, Rowena J.; Greene, Sarah M.; Thompson, Ella; Baldwin, Laura‐Mae; Neale, Anne Victoria

2011-01-01

Abstract Objective: This project aimed to develop an open‐access website providing adaptable resources to facilitate best practices for multisite research from initiation to closeout. Methods: A web‐based assessment was sent to the leadership of the Clinical and Translational Science Award (CTSA) Community Engagement Key Functions Committee (n= 38) and the CTSA‐affiliated Primary Care Practice‐based Research Networks (PBRN, n= 55). Respondents rated the benefits and barriers of multisite research, the utility of available resources, and indicated their level of interest in unavailable resources. Then, existing research resources were evaluated for relevance to multisite research, adaptability to other projects, and source credibility. Results: Fifty‐five (59%) of invited participants completed the survey. Top perceived benefits of multisite research were the ability to conduct community‐relevant research through academic–community partnerships (34%) and accelerating translation of research into practice (31%). Top perceived barriers were lack of research infrastructure to support PBRNs and community partners (31%) and inadequate funding to support multisite collaborations (26%). Over 200 resources were evaluated, of which 120 unique resources were included in the website. Conclusion: The PRIMER Research Toolkit (http://www.researchtoolkit.org) provides an array of peer‐reviewed resources to facilitate translational research for the conduct of multisite studies within PBRNs and community‐based organizations. Clin Trans Sci 2011; Volume 4: 259–265 PMID:21884512

Processes for design, construction and utilisation of arrays of light-emitting diodes and light-emitting diode-coupled optical fibres for multi-site brain light delivery

PubMed Central

Bernstein, Jacob G.; Allen, Brian D.; Guerra, Alexander A.; Boyden, Edward S.

2016-01-01

Optogenetics enables light to be used to control the activity of genetically targeted cells in the living brain. Optical fibers can be used to deliver light to deep targets, and LEDs can be spatially arranged to enable patterned light delivery. In combination, arrays of LED-coupled optical fibers can enable patterned light delivery to deep targets in the brain. Here we describe the process flow for making LED arrays and LED-coupled optical fiber arrays, explaining key optical, electrical, thermal, and mechanical design principles to enable the manufacturing, assembly, and testing of such multi-site targetable optical devices. We also explore accessory strategies such as surgical automation approaches as well as innovations to enable low-noise concurrent electrophysiology. PMID:26798482

Brain white matter changes associated with urological chronic pelvic pain syndrome: multisite neuroimaging from a MAPP case-control study.

PubMed

Huang, Lejian; Kutch, Jason J; Ellingson, Benjamin M; Martucci, Katherine T; Harris, Richard E; Clauw, Daniel J; Mackey, Sean; Mayer, Emeran A; Schaeffer, Anthony J; Apkarian, A Vania; Farmer, Melissa A

2016-12-01

Clinical phenotyping of urological chronic pelvic pain syndromes (UCPPSs) in men and women have focused on end organ abnormalities to identify putative clinical subtypes. Initial evidence of abnormal brain function and structure in male pelvic pain has necessitated large-scale, multisite investigations into potential UCPPS brain biomarkers. We present the first evidence of regional white matter (axonal) abnormalities in men and women with UCPPS, compared with positive (irritable bowel syndrome, IBS) and healthy controls. Epidemiological and neuroimaging data were collected from participants with UCPPS (n = 52), IBS (n = 39), and healthy sex- and age-matched controls (n = 61). White matter microstructure, measured as fractional anisotropy (FA), was examined by diffusion tensor imaging. Group differences in regional FA positively correlated with pain severity, including segments of the right corticospinal tract and right anterior thalamic radiation. Increased corticospinal FA was specific and sensitive to UCPPS, positively correlated with pain severity, and reflected sensory (not affective) features of pain. Reduced anterior thalamic radiation FA distinguished patients with IBS from those with UCPPS and controls, suggesting greater microstructural divergence from normal tract organization. Findings confirm that regional white matter abnormalities characterize UCPPS and can distinguish between visceral diagnoses, suggesting that regional axonal microstructure is either altered with ongoing pain or predisposes its development.

Brain white matter changes associated with urological chronic pelvic pain syndrome: Multi-site neuroimaging from a MAPP case-control study

PubMed Central

Huang, Lejian; Kutch, Jason J.; Ellingson, Benjamin M.; Martucci, Katherine T.; Harris, Richard E.; Clauw, Daniel J.; Mackey, Sean; Mayer, Emeran A.; Schaeffer, Anthony J.; Apkarian, A. Vania; Farmer, Melissa A.

2016-01-01

Clinical phenotyping of urological chronic pelvic pain syndromes (UCPPS) in men and women has focused on end-organ abnormalities to identify putative clinical subtypes. Initial evidence of abnormal brain function and structure in male pelvic pain has necessitated large-scale, multi-site investigations into potential UCPPS brain biomarkers. We present the first evidence of regional white matter (axonal) abnormalities in men and women with UCPPS, compared to positive (irritable bowel syndrome, IBS) and healthy controls. Epidemiological and neuroimaging data was collected from participants with UCPPS (n=52), IBS (n=39), and healthy, sex- and age-matched controls (n=61). White matter microstructure, measured as fractional anisotropy (FA), was examined with diffusion tensor imaging (DTI). Group differences in regional FA positively correlated with pain severity, including segments of the right corticospinal tract and right anterior thalamic radiation. Increased corticospinal FA was specific and sensitive to UCPPS, positively correlated with pain severity, and reflected sensory (not affective) features of pain. Reduced anterior thalamic radiation FA distinguished IBS from UCPPS patients and controls, suggesting greater microstructural divergence from normal tract organization. Findings confirm that regional white matter abnormalities characterize UCPPS and can distinguish between visceral diagnoses, suggesting that regional axonal microstructure is either altered with ongoing pain or predisposes its development. PMID:27842046

A Randomized Control Trial: Supplementing Hearing Aid Use with Listening and Communication Enhancement (LACE) Auditory Training.

PubMed

Saunders, Gabrielle H; Smith, Sherri L; Chisolm, Theresa H; Frederick, Melissa T; McArdle, Rachel A; Wilson, Richard H

2016-01-01

To examine the effectiveness of the Listening and Communication Enhancement (LACE) program as a supplement to standard-of-care hearing aid intervention in a Veteran population. A multisite randomized controlled trial was conducted to compare outcomes following standard-of-care hearing aid intervention supplemented with (1) LACE training using the 10-session DVD format, (2) LACE training using the 20-session computer-based format, (3) placebo auditory training (AT) consisting of actively listening to 10 hr of digitized books on a computer, and (4) educational counseling-the control group. The study involved 3 VA sites and enrolled 279 veterans. Both new and experienced hearing aid users participated to determine if outcomes differed as a function of hearing aid user status. Data for five behavioral and two self-report measures were collected during three research visits: baseline, immediately following the intervention period, and at 6 months postintervention. The five behavioral measures were selected to determine whether the perceptual and cognitive skills targeted in LACE training generalized to untrained tasks that required similar underlying skills. The two self-report measures were completed to determine whether the training resulted in a lessening of activity limitations and participation restrictions. Outcomes were obtained from 263 participants immediately following the intervention period and from 243 participants 6 months postintervention. Analyses of covariance comparing performance on each outcome measure separately were conducted using intervention and hearing aid user status as between-subject factors, visit as a within-subject factor, and baseline performance as a covariate. No statistically significant main effects or interactions were found for the use of LACE on any outcome measure. Findings from this randomized controlled trial show that LACE training does not result in improved outcomes over standard-of-care hearing aid intervention alone. Potential benefits of AT may be different than those assessed by the performance and self-report measures utilized here. Individual differences not assessed in this study should be examined to evaluate whether AT with LACE has any benefits for particular individuals. Clinically, these findings suggest that audiologists may want to temper the expectations of their patients who embark on LACE training.

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation.

PubMed

Wolf, Steven L; Sahu, Komal; Bay, R Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

2015-01-01

Geographical location, socioeconomic status, and logistics surrounding transportation impede access of poststroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP) was incorporated within a home exercise program (HEP) to improve upper-extremity (UE) functional capabilities poststroke. To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months poststroke and characterized as underserved. In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to UE rehabilitation were randomized to either (1) the experimental group, which received combined HEP and HMP for 3 h/d ×5 days ×8 weeks, or (2) the control group, which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions. Both groups demonstrated improvement across all UE outcomes. Robotic + HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time. Additional research is necessary to determine the appropriate dosage of HMP and HEP. © The Author(s) 2015.

The HAAPI (Home Arm Assistance Progression Initiative) Trial: - A Novel Robotics Delivery Approach in Stroke Rehabilitation

PubMed Central

Wolf, Steven L.; Sahu, Komal; Bay, R. Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

2015-01-01

Background Geographical location, socioeconomic status and logistics surrounding transportation impede access of post-stroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing for the remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP), was incorporated within a home exercise program (HEP) to improve upper extremity functional capabilities post-stroke. Objective To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months post-stroke and characterized as underserved. Methods In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to upper extremity rehabilitation were randomized to the: 1) experimental group which received combined HEP and HMP for 3 hrs/day x 5 days x 8 weeks; or 2) control group which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl Meyer Assessment (upper extremity) were primary and secondary outcome measures respectively, undertaken before and after the interventions. Results Both groups demonstrated improvement across all upper extremity outcomes. Conclusions Robotic+HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time, additional research is necessary to determine appropriate dosage of HMP and HEP. PMID:25782693

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 efficacy of an opportunistic cognitive behavioral intervention package (OCB) on substance use and comorbid suicide risk: a multisite randomized controlled trial.

PubMed

Morley, Kirsten C; Sitharthan, Gomathi; Haber, Paul S; Tucker, Peter; Sitharthan, Thiagarajan

2014-02-01

People with substance use disorders who present with suicidal behavior are at high risk of subsequent suicide. There are few effective treatments specifically tailored for this population that diminish this risk. We aimed to assess the impact of an opportunistic cognitive behavioral intervention package (OCB) among adult outpatients with a substance use and comorbid suicide risk. A randomized controlled trial was conducted across 2 sites in which 185 patients presenting with suicide risk and concurrent substance use received either OCB (8 sessions plus group therapy) or treatment as usual (TAU) over a 6-month period. Primary outcomes were suicidal behavior (suicide attempts, suicidal intent and presence of suicide ideation) and level of drug and alcohol consumption. Secondary outcomes were changes in psychological measures of suicide ideation, depression, anxiety, and self-efficacy. There were no completed suicides, and only 2 participants reported suicide attempts at follow-up. Suicide ideation, alcohol consumption, and cannabis use fell over time but no significant Treatment × Time differences were found. There were also no differences between OCB and TAU over time on psychological measures of depression, anxiety, or self-efficacy. Suicide ideation at 6-month follow-up was predicted by cannabis use and higher scores on the Brief Psychiatric Rating Scale at baseline. The opportunistic cognitive behavioral intervention package did not appear to be beneficial in reducing suicide ideation, drug and alcohol consumption, or depression relative to treatment as usual. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure.

PubMed

El-Jawahri, Areej; Paasche-Orlow, Michael K; Matlock, Dan; Stevenson, Lynne Warner; Lewis, Eldrin F; Stewart, Garrick; Semigran, Marc; Chang, Yuchiao; Parks, Kimberly; Walker-Corkery, Elizabeth S; Temel, Jennifer S; Bohossian, Hacho; Ooi, Henry; Mann, Eileen; Volandes, Angelo E

2016-07-05

Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure. This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test; range, 0-6) after intervention. In the intervention group, 27 (22%) chose life-prolonging care, 31 (25%) chose limited care, 63 (51%) selected comfort care, and 2 (2%) were uncertain. In the control group, 50 (41%) chose life-prolonging care, 27 (22%) selected limited care, 37 (30%) chose comfort care, and 8 (7%) were uncertain (P<0.001). Intervention participants (compared with control subjects) were more likely to forgo CPR (68% versus 35%; P<0.001) and intubation (77% versus 48%; P<0.001) and had higher mean knowledge scores (4.1 versus 3.0; P<0.001). Patients with heart failure who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared with patients receiving verbal information only. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01589120. © 2016 American Heart Association, Inc.

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.

The Relations among Measurements of Informant Discrepancies within a Multisite Trial of Treatments for Childhood Social Phobia

ERIC Educational Resources Information Center

De Los Reyes, Andres; Alfano, Candice A.; Beidel, Deborah C.

2010-01-01

Discrepancies between informants' reports of children's behavior are robustly observed in clinical child research and have important implications for interpreting the outcomes of controlled treatment trials. However, little is known about the basic psychometric properties of these discrepancies. This study examined the relation between…

Effects of Comprehensive School Reform on Student Achievement and School Change: A Longitudinal Multi-Site Study

ERIC Educational Resources Information Center

Sterbinsky, Allan; Ross, Steven M.; Redfield, Doris

2006-01-01

The longitudinal impacts on school change and student achievement of implementing varied Comprehensive School Reform (CSR) models was investigated in 12 elementary schools in diverse geographic locations. Each school was individually matched and compared to a demographically similar control school on measures of school climate, teacher…

Laterality defects in the national birth defects prevention study 1998-2007 birth prevalence and descriptive epidemiology

USDA-ARS?s Scientific Manuscript database

Little is known epidemiologically about laterality defects. Using data from the National Birth Defects Prevention Study (NBDPS), a large multi-site case-control study of birth defects, we analyzed prevalence and selected characteristics in children born with laterality defects born from 1998 to 2007...

Levels and Growth of Specific and General Norms for Nonviolence among Middle School Students

ERIC Educational Resources Information Center

Dymnicki, Allison B.; Antonio, Tiago; Henry, David B.

2011-01-01

This study examined the levels and growth of specific and general normative beliefs about nonviolence (called norms for nonviolence). The sample consisted of 1254 middle school students from four metropolitan areas who participated in the control condition of the Multisite Violence Prevention Project. We predicted that the association and…

A Multisite Investigation of Binge Eating Behaviors in Children and Adolescents

ERIC Educational Resources Information Center

Tanofsky-Kraff, Marian; Goossens, Lien; Eddy, Kamryn T.; Ringham, Rebecca; Goldschmidt, Andrea; Yanovski, Susan Z.; Braet, Caroline; Marcus, Marsha D.; Wilfley, Denise E.; Olsen, Cara; Yanovski, Jack A.

2007-01-01

The phenomenology of childhood and adolescent loss of control (LOC) eating is unknown. The authors interviewed 445 youths to assess aspects of aberrant eating. LOC was associated with eating forbidden food before the episode; eating when not hungry; eating alone; and experiencing secrecy, negative emotions, and a sense of "numbing" while eating…

Improved Prevention Counseling by HIV Care Providers in a Multisite, Clinic-Based Intervention: Positive STEPs

ERIC Educational Resources Information Center

Thrun, Mark; Cook, Paul F.; Bradley-Springer, Lucy A.; Gardner, Lytt; Marks, Gary; Wright, Julie; Wilson, Tracey E.; Quinlivan, E. Byrd; O'Daniels, Christine; Raffanti, Stephen; Thompson, Melanie; Golin, Carol

2009-01-01

The Centers for Disease Control and Prevention have recommended that HIV care clinics incorporate prevention into clinical practice. This report summarizes HIV care providers' attitudes and counseling practices before and after they received training to deliver a counseling intervention to patients. Providers at seven HIV clinics received training…

The Impact of Tutoring on Early Reading Achievement for Children with and without Attention Problems

ERIC Educational Resources Information Center

Rabiner, David L.; Malone, Patrick S.

2004-01-01

This study examined whether the benefits of reading tutoring in first grade were moderated by children's level of attention problems. Participants were 581 children from the intervention and control samples of Fast Track, a longitudinal multisite investigation of the development and prevention of conduct problems. Standardized reading achievement…

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

PubMed

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

2017-04-01

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 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 a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention ( Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group ( Safety Journey) for 1 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 2-year study. Conclusion This multisite intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. Healthy Children, Strong Families 2's innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and less-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.

Project STYLE: a multisite RCT for HIV prevention among youths in mental health treatment.

PubMed

Brown, Larry K; Hadley, Wendy; Donenberg, Geri R; DiClemente, Ralph J; Lescano, Celia; Lang, Delia M; Crosby, Richard; Barker, David; Oster, Danielle

2014-03-01

The study examined the efficacy of family-based and adolescent-only HIV prevention programs in decreasing HIV risk and improving parental monitoring and sexual communication among youths in mental health treatment. A randomized controlled trial (RCT) with 721 adolescents (ages 13-18 years) and their caregivers from mental health settings in three U.S. cities were randomly assigned to one of three theory-based, structured group interventions: family-based HIV prevention, adolescent-only HIV prevention, and adolescent-only health promotion. Interventions were delivered during an all-day workshop. Assessments were completed at baseline and three months postintervention. Compared with those in the health intervention, adolescents in the HIV prevention interventions reported fewer unsafe sex acts (adjusted rate ratio=.49, p=.01), greater condom use (adjusted relative change=59%, p=.01), and greater likelihood of avoiding sex (adjusted odds ratio=1.44, p=.05). They also showed improved HIV knowledge (p<.01) and self-efficacy (p<.05). The family-based intervention, compared with the other interventions, produced significant improvements in parent-teen sexual communication (p<.01), parental monitoring (p<.01), and parental permissiveness (p=.05). This RCT found that the HIV prevention interventions reduced sexual risk behavior over three months in a large, diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex. These interventions show promise.

A Randomized Controlled Trial of Disclosing Genetic Risk Information for Alzheimer’s Disease via Telephone

PubMed Central

Christensen, Kurt D.; Uhlmann, Wendy R.; Roberts, J. Scott; Linnenbringer, Erin; Whitehouse, Peter J.; Royal, Charmaine D. M.; Obisesan, Thomas O.; Cupples, L. Adrienne; Butson, Melissa B.; Fasaye, Grace-Ann; Hiraki, Susan; Chen, Clara A.; Siebert, Uwe; Cook-Deegan, Robert; Green, Robert C.

2018-01-01

Purpose Telephone disclosure of genetic test results can improve access to services. To date, studies of its impact have focused on return of Mendelian risk information, principally hereditary cancer syndromes. Methods In a multisite trial of Alzheimer’s disease genetic risk disclosure, asymptomatic adults were randomized to receive test results in-person or via telephone. Primary analyses examined patient outcomes 12 months after disclosure. Results Data from 257 participants showed that telephone disclosure occurred 7.4 days sooner and were 30% shorter, on average, than in-person disclosure (both p<0.001). Anxiety and depression scores were well below cutoffs for clinical concern across protocols. Comparing telephone and in-person disclosure protocols, 99% CIs of mean differences were within non-inferiority margins on scales assessing anxiety, depression, and test-related distress, but inconclusive about positive impact. No differences were observed on measures of recall and subjective impact. Sub-analyses supported non-inferiority on all outcomes among APOE ε4-negative participants. Sub-analyses were inconclusive for APOE ε4-positive participants, although mean anxiety and depression scores were still well below cutoffs for clinical concern. Conclusion Telephone disclosure of APOE results and risk for Alzheimer’s disease is generally safe and helps providers meet demands for services, even when results identify an increased risk for disease. PMID:28726810

Comparison of gray mineral trioxide aggregate and diluted formocresol in pulpotomized primary molars: a 6- to 24-month observation.

PubMed

Sushynski, John M; Zealand, Cameron M; Botero, Tatiana M; Boynton, James R; Majewski, Robert F; Shelburne, Charles E; Hu, Jan Chingchun

2012-01-01

The purpose of this multisite, multioperator, prospective, randomized, controlled clinical trial was to evaluate 2-year outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) as pulpotomy medicaments. Following the standard pulpotomy procedure, the pulp stumps of 252 primary molars in 168 healthy children were randomly covered with GMTA or DFC. Pulp chambers were filled with Intermediate Restorative Material (IRM(®)) and teeth were restored with stainless steel crowns. At each follow-up appointment, the clinical status of the treated tooth was assessed and radiographs were taken. A total of 694 clinical and radiographic evaluations were analyzed. Gender, study site, arch type, and tooth type did not influence treatment outcome. At the combined 6- to 24-month follow-up, clinical success in the DFC group was no different than for the GMTA group. Radiographically, a significantly lower success rate was found in the DFC group vs the MTA group at all time points (P<.01). Dentin bridge formation was observed at a significantly higher frequency among the GMTA group (P<.01), while internal root resorption was observed at a higher frequency in the DFC group (P<.01). At the combined 6- to 24-month follow-up, gray mineral trioxide aggregate demonstrated significantly better radiographic outcomes vs diluted formocresol as pulpotomy medicaments.

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.

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 .

Preliminary findings on the association between clients' perceived helpfulness of substance abuse treatment and outcomes: does race matter?

PubMed

Montgomery, LaTrice; Sanning, Blair; Litvak, Nicole; Peters, Erica N

2014-06-01

Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients' perspective. The current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 Black and White adults participating in a multisite randomized clinical trial (RCT) of Motivational Enhancement Therapy. Throughout the 16-week RCT, participants self-reported substance use. Upon completion of treatment, participants completed a self-report measure assessing the perceived helpfulness of treatment components. Black participants rated 9 out of 12 treatment components (e.g., "learning skills that will help me cope with my problems") as being more helpful than their White counterparts, even after controlling for age, gender, employment status, primary drug type, and treatment assignment. However, perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants. Clients' perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment, especially for Black adults. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Preliminary Findings on the Association Between Clients’ Perceived Helpfulness of Substance Abuse Treatment and Outcomes: Does Race Matter?

PubMed Central

Montgomery, LaTrice; Sanning, Blair; Litvak, Nicole; Peters, Erica N.

2015-01-01

BACKGROUND Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients’ perspective. METHODS The current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 Black and White adults participating in a multisite randomized clinical trial (RCT) of Motivational Enhancement Therapy. Throughout the 16-week RCT, participants self-reported substance use. Upon completion of treatment, participants completed a self-report measure assessing the perceived helpfulness of treatment components. RESULTS Black participants rated 9 out of 12 treatment components (e.g., “learning skills that will help me cope with my problems”) as being more helpful than their White counterparts, even after controlling for age, gender, employment status, primary drug type, and treatment assignment. However, perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants. CONCLUSIONS Clients’ perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment, especially for Black adults. PMID:24767892

Tools and Methods for Risk Management in Multi-Site Engineering Projects

NASA Astrophysics Data System (ADS)

Zhou, Mingwei; Nemes, Laszlo; Reidsema, Carl; Ahmed, Ammar; Kayis, Berman

In today's highly global business environment, engineering and manufacturing projects often involve two or more geographically dispersed units or departments, research centers or companies. This paper attempts to identify the requirements for risk management in a multi-site engineering project environment, and presents a review of the state-of-the-art tools and methods that can be used to manage risks in multi-site engineering projects. This leads to the development of a risk management roadmap, which will underpin the design and implementation of an intelligent risk mapping system.

Psychopharmacological strategies in the management of posttraumatic stress disorder (PTSD): what have we learned?

PubMed

Bernardy, Nancy C; Friedman, Matthew J

2015-04-01

There have been significant advancements in the pharmacologic management of posttraumatic stress disorder (PTSD) in the past two decades. Multisite randomized clinical trials (RCTs) have noted the efficacy of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNR Is) for PTSD treatment. Unfortunately, there have been no new medications approved to treat PTSD in the past 10 years. Although there have been exciting new findings in our knowledge of the neurobiology of PTSD, clinical trials testing new medications have lagged. This review summarizes recent research that builds on the unique pathophysiology of PTSD and suggests ways to move the field forward.

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.

Biological Stress Systems, Adverse Life Events, and the Improvement of Chronic Multisite Musculoskeletal Pain Across a 6-Year Follow-Up.

PubMed

Generaal, Ellen; Vogelzangs, Nicole; Macfarlane, Gary J; Geenen, Rinie; Smit, Johannes H; de Geus, Eco J C N; Dekker, Joost; Penninx, Brenda W J H

2017-02-01

Dysfunction of biological stress systems and adverse life events, independently and in interaction, have been hypothesized to predict chronic pain persistence. Conversely, these factors may hamper the improvement of chronic pain. Longitudinal evidence is currently lacking. We examined whether: 1) function of biological stress systems, 2) adverse life events, and 3) their combination predict the improvement of chronic multisite musculoskeletal pain. Subjects of the Netherlands Study of Depression and Anxiety (NESDA) with chronic multisite musculoskeletal pain at baseline (N = 665) were followed-up 2, 4, and 6 years later. The Chronic Pain Grade Questionnaire was used to determine improvement (not meeting the criteria) of chronic multisite musculoskeletal pain at follow-up. Baseline assessment of biological stress systems included function of hypothalamic-pituitary-adrenal axis (1-hour cortisol awakening response, evening level, and post dexamethasone level), the immune system (basal and lipopolysaccharide-stimulated inflammatory markers), the autonomic nervous system (heart rate, pre-ejection period, SD of the normal-to-normal interval, and respiratory sinus arrhythmia). The number of adverse life events were assessed at baseline and 2-year follow-up using the List of Threatening Events Questionnaire. We showed that hypothalamic-pituitary-adrenal axis, immune system, and autonomic nervous system functioning and adverse life events were not associated with the improvement of chronic multisite musculoskeletal pain, either as a main effect or in interaction. This longitudinal study could not confirm that biological stress system dysfunction and adverse life events affect the course of chronic multisite musculoskeletal pain. Biological stress systems and adverse life events are not associated with the improvement of chronic multisite musculoskeletal pain over 6 years of follow-up. Other determinants should thus be considered in future research to identify in which persons pain symptoms will improve. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

Multisite occupation of divalent dopants in barium and strontium titanates

NASA Astrophysics Data System (ADS)

Zulueta, Yohandys A.; Nguyen, Minh Tho

2018-10-01

Based on recent experimental and theoretical proofs of calcium multisite occupation in barium titanate, we investigated a mixed incorporation mechanism for divalent dopants in barium and strontium titanates (BaTiO3 and SrTiO3). Our present theoretical results demonstrated the multisite occupation of divalent dopants in both perovskite structures. We determined the dependences of the solution, binding energies, and final solution energies with respect to the ionic radii of the dopants. Calculated results obtained based on classical simulations showed that the divalent dopants can occupy both A- and Ti- cation sites in ATiO3 perovskite structures. Such a multisite occupation has direct implications for other experimental findings regarding BaTiO3, such as non-stabilization of the tetragonal phase, shifts in the Curie temperature, intensification of the diffuse phase transition, and shifts in the absorption of ultraviolet light to the visible range in photocatalytic applications related to solar cells for producing energy.

A Virtual Reality Curriculum for Pediatric Residents Decreases Rates of Influenza Vaccine Refusal.

PubMed

Real, Francis J; DeBlasio, Dominick; Beck, Andrew F; Ollberding, Nicholas J; Davis, David; Cruse, Bradley; Samaan, Zeina; McLinden, Daniel; Klein, Melissa D

Influenza vaccine hesitancy is common in the primary care setting. Though physicians can affect caregivers' attitudes toward vaccination, physicians report uneasiness discussing vaccine hesitancy. Few studies have targeted physician-patient communication training as a means to decrease vaccination refusal. An immersive virtual reality (VR) curriculum was created to teach pediatric residents communication skills when discussing influenza vaccine hesitancy. This pilot curriculum consisted of 3 VR simulations during which residents counseled graphical character representatives (avatars) who expressed vaccine hesitancy. Participants were randomized to the intervention (n = 24) or control (n = 21) group. Only residents in the intervention group underwent the VR curriculum. Impact of the curriculum was assessed through difference in influenza vaccine refusal rates between the intervention and control groups in the 3 months after the VR curriculum. Participants included postgraduate level (PL) 2 and PL3 pediatric residents. All eligible residents (n = 45) participated; the survey response rate was 100%. In patients aged 6 to 59 months, residents in the intervention group had a decreased rate of influenza vaccination refusal in the postcurriculum period compared to the control group (27.8% vs 37.1%; P = .03). Immersive VR may be an effective modality to teach communication skills to medical trainees. Next steps include evaluation of the curriculum in a larger, multisite trial. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Criminal Victimisation in People with Severe Mental Illness: A Multi-Site Prevalence and Incidence Survey in the Netherlands

PubMed Central

Kamperman, Astrid M.; Henrichs, Jens; Bogaerts, Stefan; Lesaffre, Emmanuel M. E. H.; Wierdsma, André I.; Ghauharali, Razia R. R.; Swildens, Wilma; Nijssen, Yolanda; van der Gaag, Mark; Theunissen, Jan R.; Delespaul, Philippe A.; van Weeghel, Jaap; van Busschbach, Jooske T.; Kroon, Hans; Teplin, Linda A.; van de Mheen, Dike; Mulder, Cornelis L.

2014-01-01

Background Although crime victimisation is as prevalent in psychiatric patients as crime perpetration (and possibly more so), few European figures for it are available. We therefore assessed its one-year prevalence and incident rates in Dutch severely mentally ill outpatients, and compared the results with victimisation rates in the general population. Method This multisite epidemiological survey included a random sample of 956 adult severely mentally ill outpatients. Data on victimisation were obtained using the victimisation scale of the Dutch Crime and Victimisation Survey, which assesses crime victimisation over the preceding 12 months. Comparison data were derived from the nationwide survey on safety and victimisation in the Netherlands. Prevalence and incident rates were weighted for sex, age, ethnicity and socioeconomic status, and compared with a general population sample matched by region (N = 38,227). Results In the past year, almost half of the severely mentally ill outpatients (47%) had been victim of a crime. After control for demographic differences, prevalence rates of overall and specific victimisation measures were significantly higher in severely mentally ill outpatients than in the general population. The relative rates were especially high for personal crimes such as violent threats (RR = 2.12, 95% CI: 1.72–2.61), physical assaults (RR = 4.85, 95% CI: 3.69–6.39) and sexual harassment and assaults (RR = 3.94, 95% CI: 3.05–5.09). In concordance, severely mentally ill outpatients reported almost 14 times more personal crime incidents than persons from the general population (IRR = 13.68, 95% CI: 12.85–14.56). Conclusion Crime victimisation is a serious problem in Dutch severely mentally ill outpatients. Mental-healthcare institutions and clinicians should become aware of their patients’ victimisation risk, and should implement structural measures to detect and prevent (re-)victimisation. PMID:24609108

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.

Children With Medical Complexity: A Web-Based Multimedia Curriculum Assessing Pediatric Residents Across North America.

PubMed

Shah, Neha H; Bhansali, Priti; Barber, Aisha; Toner, Keri; Kahn, Michael; MacLean, Meaghan; Kadden, Micah; Sestokas, Jeffrey; Agrawal, Dewesh

No standardized curricula exist for training residents in the special needs of children with medical complexity. We assessed resident satisfaction, knowledge, and behavior after implementing a novel online curriculum composed of multimedia modules on care of children with medical complexity utilizing virtual simulation. We conducted a randomized controlled trial of residents across North America. A Web-based curriculum of 6 self-paced, interactive, multimedia modules was developed. Readings for each topic served as the control curriculum. Residents were randomized to 1 of 2 groups, each completing 3 modules and 3 sets of readings that were mutually exclusive. Outcomes included resident scores on satisfaction, knowledge-based assessments, and virtual simulation activities. Four hundred forty-two residents from 56 training programs enrolled in the curriculum, 229 of whom completed it and were included in the analysis. Subjects were more likely to report comfort with all topics if they reviewed modules compared to readings (P ≤ .01 for all 6 topics). Posttest knowledge scores were significantly higher than pretest scores overall (mean increase in score 17.7%; 95% confidence interval 16.0, 19.4), and the mean pre-post score increase for modules was significantly higher than readings (20.9% vs 15.4%, P < .001). Mean scores on the verbal handoff virtual simulation increased by 1.1 points (95% confidence interval 0.2, 2.0, P = .02). There were no significant differences found in pre-post performance for the device-related emergency virtual simulation. There was high satisfaction, significant knowledge acquisition, and specific behavior change after participating in this innovative online curriculum. This is the first multisite, randomized trial assessing satisfaction, knowledge impact, and behavior change in a virtually simulated environment with pediatric trainees. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

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.

The Effect of Telephone-Based Cognitive-Behavioral Therapy on Postnatal Depression: A Randomized Controlled Trial.

PubMed

Ngai, Fei-Wan; Wong, Paul Wai-Ching; Leung, Kwok-Yin; Chau, Pui-Hing; Chung, Ka-Fai

2015-01-01

Cognitive-behavioral therapy (CBT) is one of the most effective interventions for postnatal depression. However, few studies have evaluated the effect of CBT delivered via telephone for newborn mothers. The purpose of this study was to evaluate the efficacy of telephone-based CBT for postnatal depression at 6 weeks and 6 months postpartum. A multisite randomized controlled trial was conducted in the postnatal units at 3 regional hospitals in Hong Kong. A total of 397 women with an Edinburgh Postnatal Depression Scale (EPDS) score ≥10 on the second or third day postpartum were randomized to receive telephone-based CBT (n = 197) or standard care (n = 200). Primary outcome was the total EPDS score. A cutoff score of 9/10 on the EPDS was used to define women at risk of postnatal depression. Telephone-based CBT was associated with significantly lower depressive symptoms compared with standard care, when assessed at 6 weeks postpartum in the subgroups of mothers with minor depression (EPDS 10-12; difference = 1.90, 95% CI: 0.72-3.08; p = 0.002) and major depression (EPDS ≥13; difference = 5.00, 95% CI: 3.12-6.88; p < 0.001). The effect was sustained at 6 months postpartum in the subgroup with minor depression (difference = 1.20, 95% CI: 0.09-2.32; p = 0.034) but not significant in the subgroup with major depression (difference = 1.69, 95% CI: -0.10-3.47; p = 0.064). The proportion of women who satisfied our definition of postnatal depression was significantly lower in the intervention group at 6 weeks (difference = 23.3%, 95% CI: 13.7-33.0%; p < 0.001) and 6 months postpartum (difference = 11.4%, 95% CI: 1.9-20.8%; p = 0.019). Telephone-based CBT produced a significantly greater reduction in depressive symptoms than standard care during the postpartum period. © 2015 S. Karger AG, Basel.

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.

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

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...

Striving for Effectiveness in the Treatment of Adolescent Depression: Cognitive Behavior Therapy for Multisite Community Intervention

ERIC Educational Resources Information Center

Curry, John F.; Wells, Karen C.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) was designed to compare the relative and combined effectiveness of cognitive behavior therapy (CBT) and fluoxetine, each of which had demonstrated efficacy in carefully controlled single-site studies. Models of CBT from these efficacy studies served as the foundation for the TADS…

Nurse case management for pregnant women experiencing or at risk for abuse.

PubMed

Curry, Mary Ann; Durham, Laurel; Bullock, Linda; Bloom, Tina; Davis, Jan

2006-01-01

To determine whether individualized nursing case management can decrease stress among pregnant women at risk for or in abusive relationships. A multisite randomized controlled trial. Two prenatal clinics in the Pacific Northwest and rural Midwest. 1,000 women who spoke English and were 13 to 23 weeks pregnant at time of recruitment. All intervention group women (N = 499) were offered an abuse video and had access to a nurse case manager 24/7. Additionally, participants at risk for or in abusive relationships received individualized nursing care management throughout the pregnancy. The most frequent nursing care management activities were providing support (38%) and assessing needs (32%). The nursing care management group received an average of 22 contacts, most (80%) by telephone and had a significant reduction in stress scores as measured by the Prenatal Psychosocial Profile. Compared to the control group, the differences were in the predicted direction, but not statistically different. A major finding was the choice by abused women to focus on basic needs and their pregnancies rather than the abuse, although all received safety planning. Pregnant women at risk for or in abusive relationships experience very stressful and complex lives. Nurses need to focus on the needs they identify, which may not be the abusive relationship.

The combination of two training approaches to improve older adults' driving safety.

PubMed

Bédard, Michel; Porter, Michelle M; Marshall, Shawn; Isherwood, Ivy; Riendeau, Julie; Weaver, Bruce; Tuokko, Holly; Molnar, Frank; Miller-Polgar, Jan

2008-03-01

An increasing number of older adults rely on the automobile for transportation. Educational approaches based on the specific needs of older drivers may help to optimize safe driving. We examined if the combination of an in-class education program with on-road education would lead to improvements in older drivers' knowledge of safe driving practices and on-road driving evaluations. We used a multisite, randomized controlled trial approach. Participants in the intervention group received the in-class and on-road education; those in the control group waited and were offered the education afterwards. We measured knowledge of safe driving practices before and after the in-class component of the program and on-road driving skills before and after the whole program. Participants' knowledge improved from 61% of correct answers before the in-class education component to 81% after (p < .001). The on-road evaluation results suggested improvements on some aspects of safe driving (e.g., moving in roadway, p < .05) but not on others. The results of this study demonstrate that education programs focused on the needs of older drivers may help improve their knowledge of safe driving practices and actual driving performance. Further research is required to determine if these changes will affect other variables such as driver confidence and crash rates.

Reduced-complexity multi-site rainfall generation: one million years over night using the model TripleM

NASA Astrophysics Data System (ADS)

Breinl, Korbinian; Di Baldassarre, Giuliano; Girons Lopez, Marc

2017-04-01

We assess uncertainties of multi-site rainfall generation across spatial scales and different climatic conditions. Many research subjects in earth sciences such as floods, droughts or water balance simulations require the generation of long rainfall time series. In large study areas the simulation at multiple sites becomes indispensable to account for the spatial rainfall variability, but becomes more complex compared to a single site due to the intermittent nature of rainfall. Weather generators can be used for extrapolating rainfall time series, and various models have been presented in the literature. Even though the large majority of multi-site rainfall generators is based on similar methods, such as resampling techniques or Markovian processes, they often become too complex. We think that this complexity has been a limit for the application of such tools. Furthermore, the majority of multi-site rainfall generators found in the literature are either not publicly available or intended for being applied at small geographical scales, often only in temperate climates. Here we present a revised, and now publicly available, version of a multi-site rainfall generation code first applied in 2014 in Austria and France, which we call TripleM (Multisite Markov Model). We test this fast and robust code with daily rainfall observations from the United States, in a subtropical, tropical and temperate climate, using rain gauge networks with a maximum site distance above 1,000km, thereby generating one million years of synthetic time series. The modelling of these one million years takes one night on a recent desktop computer. In this research, we first start the simulations with a small station network of three sites and progressively increase the number of sites and the spatial extent, and analyze the changing uncertainties for multiple statistical metrics such as dry and wet spells, rainfall autocorrelation, lagged cross correlations and the inter-annual rainfall variability. Our study contributes to the scientific community of earth sciences and the ongoing debate on extreme precipitation in a changing climate by making a stable, and very easily applicable, multi-site rainfall generation code available to the research community and providing a better understanding of the performance of multi-site rainfall generation depending on spatial scales and climatic conditions.

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.

Analysis Concerning the Inspection Threshold for Multi-Site Damage.

DOT National Transportation Integrated Search

1993-12-01

Periodic inspections, at a prescribed interval, for Multi-Site Damage (MS) in longitudinal fuselage lap-joints start when the aircraft has accumulated a certain number of flights, the inspection threshold. The work reported here was an attempt to obt...

Multisite tumor sampling enhances the detection of intratumor heterogeneity at all different temporal stages of tumor evolution.

PubMed

Erramuzpe, Asier; Cortés, Jesús M; López, José I

2018-02-01

Intratumor heterogeneity (ITH) is an inherent process of tumor development that has received much attention in previous years, as it has become a major obstacle for the success of targeted therapies. ITH is also temporally unpredictable across tumor evolution, which makes its precise characterization even more problematic since detection success depends on the precise temporal snapshot at which ITH is analyzed. New and more efficient strategies for tumor sampling are needed to overcome these difficulties which currently rely entirely on the pathologist's interpretation. Recently, we showed that a new strategy, the multisite tumor sampling, works better than the routine sampling protocol for the ITH detection when the tumor time evolution was not taken into consideration. Here, we extend this work and compare the ITH detections of multisite tumor sampling and routine sampling protocols across tumor time evolution, and in particular, we provide in silico analyses of both strategies at early and late temporal stages for four different models of tumor evolution (linear, branched, neutral, and punctuated). Our results indicate that multisite tumor sampling outperforms routine protocols in detecting ITH at all different temporal stages of tumor evolution. We conclude that multisite tumor sampling is more advantageous than routine protocols in detecting intratumor heterogeneity.

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

Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and US Department of Agriculture Database Information: A Multisite Randomized Study

PubMed Central

Urban, Lorien E.; Weber, Judith L.; Heyman, Melvin B.; Schichtl, Rachel L.; Verstraete, Sofia; Lowery, Nina S.; Das, Sai Krupa; Schleicher, Molly M.; Rogers, Gail; Economos, Christina; Masters, William A.; Roberts, Susan B.

2017-01-01

Background Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ~50% of US restaurants are individual or small-chain (non–chain) establishments that do not provide nutrition information. Objective To measure the energy content of frequently ordered meals in non–chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. Design A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non–chain restaurants, together with equivalent meals from large-chain restaurants. Setting Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Main outcome measures Meal energy content determined by bomb calorimetry. Statistical analysis performed Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non–chain and chain meals, human energy requirements, and food database values. Results Meals from non–chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non–chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Conclusions Non–chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized for providing excess energy. Restaurants in general, rather than specific categories of restaurant, expose patrons to excessive portions that induce overeating through established biological mechanisms. PMID:26803805

Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and U.S. Department of Agriculture Database Information: A Multisite Randomized Study.

PubMed

Urban, Lorien E; Weber, Judith L; Heyman, Melvin B; Schichtl, Rachel L; Verstraete, Sofia; Lowery, Nina S; Das, Sai Krupa; Schleicher, Molly M; Rogers, Gail; Economos, Christina; Masters, William A; Roberts, Susan B

2016-04-01

Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ∼50% of US restaurants are individual or small-chain (non-chain) establishments that do not provide nutrition information. To measure the energy content of frequently ordered meals in non-chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non-chain restaurants, together with equivalent meals from large-chain restaurants. Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Meal energy content determined by bomb calorimetry. Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non-chain and chain meals, human energy requirements, and food database values. Meals from non-chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non-chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Non-chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized for providing excess energy. Restaurants in general, rather than specific categories of restaurant, expose patrons to excessive portions that induce overeating through established biological mechanisms. Copyright © 2016 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

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.

Culture and Influence in Multisite Evaluation

ERIC Educational Resources Information Center

Kirkhart, Karen E.

2011-01-01

Understanding the influence of multisite evaluation requires careful consideration of cultural context. The author illustrates dimensions of influence and culture with excerpts from four National Science Foundation evaluation case studies and summarizes what influence teaches everyone about culture and what culture teaches everyone about…

Sex-specific impact of early-life adversity on chronic pain: a large population-based study in Japan.

PubMed

Yamada, Keiko; Matsudaira, Ko; Tanaka, Eizaburo; Oka, Hiroyuki; Katsuhira, Junji; Iso, Hiroyasu

2017-01-01

Responses to early-life adversity may differ by sex. We investigated the sex-specific impact of early-life adversity on chronic pain, chronic multisite pain, and somatizing tendency with chronic pain. We examined 4229 respondents aged 20-79 years who participated in the Pain Associated Cross-Sectional Epidemiological Survey in Japan. Outcomes were: 1) chronic pain prevalence, 2) multisite pain (≥3 sites) prevalence, and 3) multiple somatic symptoms (≥3 symptoms) among respondents with chronic pain related to the presence or absence of early-life adversity. Multivariable-adjusted odds ratios (ORs) were calculated with 95% confidence intervals using a logistic regression model including age, smoking status, exercise routine, sleep time, body mass index, household expenditure, and the full distribution of scores on the Mental Health Inventory-5. We further adjusted for pain intensity when we analyzed the data for respondents with chronic pain. The prevalence of chronic pain was higher among respondents reporting the presence of early-life adversity compared with those reporting its absence, with multivariable ORs of 1.62 (1.22-2.15, p <0.01) in men and 1.47 (1.13-1.90, p <0.01) in women. Among women with chronic pain, early-life adversity was associated with multisite pain and multiple somatic symptoms; multivariable ORs were 1.78 (1.22-2.60, p <0.01) for multisite pain and 1.89 (1.27-2.83, p <0.01) for ≥3 somatic symptoms. No associations were observed between early-life adversity and chronic multisite pain or multiple somatic symptoms among men with chronic pain. Early-life adversity may be linked to a higher prevalence of chronic pain among both sexes and to multisite pain and somatizing tendency among women with chronic pain.

Randomized Controlled Trial of Osmotic-Release Methylphenidate with CBT in Adolescents with ADHD and Substance Use Disorders

PubMed Central

Riggs, Paula D.; Winhusen, Theresa; Davies, Robert D.; Leimberger, Jeffrey D.; Mikulich-Gilbertson, Susan; Klein, Constance; Macdonald, Marilyn; Lohman, Michelle; Bailey, Genie L.; Haynes, Louise; Jaffee, William B.; Hodgkins, Candace; Whitmore, Elizabeth; Trello-Rishel, Kathlene; Tamm, Leanne; Acosta, Michelle C.; Royer-Malvestuto, Charlotte; Subramaniam, Geetha; Fishman, Marc; Holmes, Beverly W.; Kaye, Mary Elyse; Vargo, Mark A.; Woody, George E.; Nunes, Edward V.; Liu, David

2011-01-01

Objective To evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared to placebo for attention deficit hyperactivity disorder (ADHD) and impact on substance treatment outcomes in adolescents concurrently receiving cognitive behavioral therapy (CBT) for substance use disorders (SUD). Method 16-week randomized controlled multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13-18), meeting DSM-IV diagnostic criteria for ADHD and SUD. Primary outcomes: (1) ADHD- clinician-administered ADHD Rating Scale (ADHD-RS), adolescent informant; (2) Substance- adolescent reported days of use in the past 28 days. Secondary outcome measures included parent ADHD-RS and weekly urine drug screens (UDS). Results There were no group differences on reduction in ADHD-RS scores (OROS-MPH: −19.2, 95% confidence interval [CI], −17.1 to −21.2; placebo,−21.2, 95% CI, −19.1 to −23.2) or reduction in days of substance use (OROS-MPH: −5.7 days, 95% CI, 4.0-7.4; placebo: −5.2 days, 95% CI, 3.5-7.0). Some secondary outcomes favored OROS-MPH including lower parent ADHD-RS scores at 8 (mean difference [md]=4.4, 95% CI, 0.8-7.9) and 16 weeks (md=6.9; 95% CI, 2.9-10.9) and more negative UDS in OROS-MPH (mean=3.8) compared to placebo (mean=2.8; P=0.04). Conclusions OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD. However, OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures. PMID:21871372

A Randomized Controlled Trial to Compare Computer-assisted Motivational Intervention with Didactic Educational Counseling to Reduce Unprotected Sex in Female Adolescents.

PubMed

Gold, Melanie A; Tzilos, Golfo K; Stein, L A R; Anderson, Bradley J; Stein, Michael D; Ryan, Christopher M; Zuckoff, Allan; DiClemente, Carlo

2016-02-01

To examine a computer-assisted, counselor-guided motivational intervention (CAMI) aimed at reducing the risk of unprotected sexual intercourse. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: We conducted a 9-month, longitudinal randomized controlled trial with a multisite recruitment strategy including clinic, university, and social referrals, and compared the CAMI with didactic educational counseling in 572 female adolescents with a mean age of 17 years (SD = 2.2 years; range = 13-21 years; 59% African American) who were at risk for pregnancy and sexually transmitted diseases. The primary outcome was the acceptability of the CAMI according to self-reported rating scales. The secondary outcome was the reduction of pregnancy and sexually transmitted disease risk using a 9-month, self-report timeline follow-back calendar of unprotected sex. The CAMI was rated easy to use. Compared with the didactic educational counseling, there was a significant effect of the intervention which suggested that the CAMI helped reduce unprotected sex among participants who completed the study. However, because of the high attrition rate, the intent to treat analysis did not demonstrate a significant effect of the CAMI on reducing the rate of unprotected sex. Among those who completed the intervention, the CAMI reduced unprotected sex among an at-risk, predominantly minority sample of female adolescents. Modification of the CAMI to address methodological issues that contributed to a high drop-out rate are needed to make the intervention more acceptable and feasible for use among sexually active predominantly minority, at-risk, female adolescents. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Teen Online Problem Solving for Teens With Traumatic Brain Injury: Rationale, Methods, and Preliminary Feasibility of a Teen Only Intervention

PubMed Central

Wade, Shari L.; Narad, Megan E.; Kingery, Kathleen M.; Taylor, H. Gerry; Stancin, Terry; Kirkwood, Michael W.; Yeates, Keith O.

2017-01-01

Purpose/Objective To describe the Teen Online Problem Solving—Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving—Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11–18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Results Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). Conclusions/Implications TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. PMID:28836809

Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial.

PubMed

Korte, J; Bohlmeijer, E T; Cappeliez, P; Smit, F; Westerhof, G J

2012-06-01

BACKGROUND. Although there is substantial evidence for the efficacy of life review therapy as an early treatment of depression in later life, its effectiveness in natural settings has not been studied. The present study evaluates an intervention based on life review and narrative therapy in a large multi-site, pragmatic randomized controlled trial(RCT). METHOD. Life review therapy was compared with care as usual. The primary outcome was depressive symptoms;secondary outcomes were anxiety symptoms, positive mental health, quality of life, and current major depressive episode (MDE). To identify groups for whom the intervention was particularly effective, moderator analyses were carried out (on sociodemographic variables, personality traits, reminiscence functions, clinically relevant depressive and anxiety symptoms, and past MDEs). RESULTS. Compared with care as usual (n=102), life review therapy (n=100) was effective in reducing depressive symptoms, at post-treatment (d=0.60, B= -5.3, p<0.001), at 3-month follow-up (d=0.50, B= -5.0, p<0.001) and for the intervention also at 9-month follow-up (t=5.7, p<0.001). The likelihood of a clinically significant change in depressive symptoms was significantly higher [odds ratio (OR) 3.77, p<0.001 at post-treatment ; OR 3.76, p<0.001 at the 3-month follow-up]. Small significant effects were found for symptoms of anxiety and positive mental health.Moderator analyses showed only two significant moderators, the personality trait of extraversion and the reminiscence function of boredom reduction. CONCLUSIONS. This study shows the effectiveness of life review therapy as an early intervention for depression in an ecologically valid context, supporting its applicability to a broad target group. The intervention is also effective in reducing anxiety symptoms and strengthening positive mental health.

Moclobemide is effective and well tolerated in the long-term pharmacotherapy of social anxiety disorder with or without comorbid anxiety disorder.

PubMed

Stein, D J; Cameron, A; Amrein, R; Montgomery, S A

2002-07-01

Social phobia (social anxiety disorder) is a highly prevalent and chronic disorder that is associated with significant comorbidity and disability. Despite recent advances in the pharmacotherapy of the disorder, there is a paucity of randomized controlled trials on patients with comorbid disorders and on maintenance treatment. A randomized placebo-controlled, double-blind multi-site trial of moclobemide, a reversible inhibitor of monoamine oxidase A, was undertaken with 390 subjects. After an initial 12 weeks, there was the option of continuing for an additional 6 months of treatment. The primary efficacy parameter chosen was responder status as defined by the Clinical Global Impression scale change item. From week 4 onwards, there was a significantly higher response rate on moclobemide than on placebo. Superiority of medication over placebo was similar in patients with comorbid anxiety disorders (33% of subjects) and without, as well as in patients with different subtypes of social anxiety disorder; indeed, treatment with moclobemide rather than placebo was the strongest predictor of response. Adverse events were similar across treatment groups, and were typically mild and transient. In the extension phase, response rates remained higher in the moclobemide group, and ratings of tolerability were equally high in both groups. Thus, in a large sample of social anxiety disorder patients with and without comorbid anxiety disorders, moclobemide was both effective and well-tolerated in the short as well as long-term. These data confirm and extend previous findings on the value of moclobemide in the treatment of social anxiety disorder, and strengthen the range of therapeutic options for managing this important disorder.

A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis.

PubMed

Rausch-Derra, L; Huebner, M; Wofford, J; Rhodes, L

2016-05-01

This study evaluated the effectiveness and safety of grapiprant for treatment of pain in dogs with osteoarthritis (OA). Grapiprant will relieve pain as measured by the owner's and veterinarian's evaluation of pain in dogs with OA. Another objective was evaluation of the safety of grapiprant. Two hundred and eighty-five client-owned dogs with OA were enrolled and treated with grapiprant or placebo with 262 cases (N = 131 in each group) evaluable for the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study dogs were treated daily with grapiprant (2 mg/kg) per OS or placebo. Owners completed an evaluation using the Canine Brief Pain Inventory (CBPI) on days 0, 7, 14, 21, and 28. Success was defined as improvement in the CBPI. Veterinary assessments were made on screening and days 14 and 28. Safety was evaluated by physical examination, evaluation of clinical pathology results, and owner observations. Grapiprant treatment improved pain compared to placebo on day 28 (48.1 and 31.3% treatment successes respectively; P = .0315). The pain interference score (PIS) and pain severity score (PSS) improved in the grapiprant group compared to placebo (P = .0029 and 0.0022, respectively). Veterinary assessments were significantly better in the grapiprant-treated dogs (P = .0086). Grapiprant generally was well tolerated, but a higher percentage of treated dogs (17.02%) had occasional vomiting as compared to the placebo group (6.25%). Grapiprant is an effective treatment for alleviation of pain in dogs with OA, and represents a modality of treatment that may be better tolerated than current options. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Rasagiline for mild cognitive impairment in Parkinson's disease: A placebo-controlled trial.

PubMed

Weintraub, Daniel; Hauser, Robert A; Elm, Jordan J; Pagan, Fernando; Davis, Matthew D; Choudhry, Azhar

2016-05-01

This study's aims were to determine the efficacy and tolerability of rasagiline, a selective monoamine oxidase inhibitor B, for PD patients with mild cognitive impairment. Patients on stable dopaminergic therapy were randomized to adjunct rasagiline 1 mg/day or placebo in this 24-week, double-blind, placebo-controlled, multisite study. The primary endpoint was mean change from baseline to week 24 on the Scales for Outcomes of Parkinson's Disease-Cognition total score. Key secondary measures included changes in cognition, activities of daily living, motor scores, and Clinical Global Impression of Change, as well as safety and tolerability measures. Of the 170 patients randomized, 151 (88.2%) completed the study. Change in Scales for Outcomes of Parkinson's Disease-Cognition scores were not significantly different in the rasagiline and placebo groups (adjusted mean: 1.6 [standard error {SE} = 0.5] vs. 0.8 [SE = 0.5] points; LS means difference = 0.8; 95% confidence interval: -0.48, 2.05; P = 0.22). There were no between-group differences in change in the MoCA (p=0.84) or Penn Daily Activities Questionnaire (P = 0.48) scores or in the distribution of Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change modified for mild cognitive impairment (P = 0.1). Changes in motor (UPDRS part III; P = 0.02) and activities of daily living (UPDRS part II; P < 0.001) scores favored rasagiline. Rasagiline was well tolerated; the most common adverse events in both groups were falls and dizziness. Rasagiline treatment in PD patients with mild cognitive impairment was not associated with cognitive improvement. Rasagiline did not worsen cognition, improved motor symptoms and activities of daily living, and was well tolerated in elderly cognitively impaired patients. © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention.

PubMed

Wade, Shari L; Narad, Megan E; Kingery, Kathleen M; Taylor, H Gerry; Stancin, Terry; Kirkwood, Michael W; Yeates, Keith O

2017-08-01

To describe the Teen Online Problem Solving-Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving-Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design: This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11-18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Psychometric Study of the Aberrant Behavior Checklist in Fragile X Syndrome and Implications for Targeted Treatment

ERIC Educational Resources Information Center

Sansone, Stephanie M.; Widaman, Keith F.; Hall, Scott S.; Reiss, Allan L.; Lightbody, Amy; Kaufmann, Walter E.; Berry-Kravis, Elizabeth; Lachiewicz, Ave; Brown, Elaine C.; Hessl, David

2012-01-01

Animal studies elucidating the neurobiology of fragile X syndrome (FXS) have led to multiple controlled trials in humans, with the Aberrant Behavior Checklist-Community (ABC-C) commonly adopted as a primary outcome measure. A multi-site collaboration examined the psychometric properties of the ABC-C in 630 individuals (ages 3-25) with FXS using…

Using Standardized Diagnostic Instruments to Classify Children with Autism in the Study to Explore Early Development

ERIC Educational Resources Information Center

Wiggins, Lisa D.; Reynolds, Ann; Rice, Catherine E.; Moody, Eric J.; Bernal, Pilar; Blaskey, Lisa; Rosenberg, Steven A.; Lee, Li-Ching; Levy, Susan E.

2015-01-01

The Study to Explore Early Development (SEED) is a multi-site case-control study designed to explore the relationship between autism spectrum disorder (ASD) phenotypes and etiologies. The goals of this paper are to (1) describe the SEED algorithm that uses the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule…

MultiSite Gateway-Compatible Cell Type-Specific Gene-Inducible System for Plants1[OPEN

PubMed Central

Siligato, Riccardo; Wang, Xin; Yadav, Shri Ram; Lehesranta, Satu; Ma, Guojie; Ursache, Robertas; Sevilem, Iris; Zhang, Jing; Gorte, Maartje; Prasad, Kalika; Heidstra, Renze

2016-01-01

A powerful method to study gene function is expression or overexpression in an inducible, cell type-specific system followed by observation of consequent phenotypic changes and visualization of linked reporters in the target tissue. Multiple inducible gene overexpression systems have been developed for plants, but very few of these combine plant selection markers, control of expression domains, access to multiple promoters and protein fusion reporters, chemical induction, and high-throughput cloning capabilities. Here, we introduce a MultiSite Gateway-compatible inducible system for Arabidopsis (Arabidopsis thaliana) plants that provides the capability to generate such constructs in a single cloning step. The system is based on the tightly controlled, estrogen-inducible XVE system. We demonstrate that the transformants generated with this system exhibit the expected cell type-specific expression, similar to what is observed with constitutively expressed native promoters. With this new system, cloning of inducible constructs is no longer limited to a few special cases but can be used as a standard approach when gene function is studied. In addition, we present a set of entry clones consisting of histochemical and fluorescent reporter variants designed for gene and promoter expression studies. PMID:26644504

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial

PubMed Central

2013-01-01

Background There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users’ readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Methods Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. Results The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants’ therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Conclusion Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. Trial registration ClinicalTrials.Gov.UK Identifier - NCT01132976 PMID:23414174

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

PubMed

McMurran, Mary; Cox, W Miles; Whitham, Diane; Hedges, Lucy

2013-02-17

There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. ClinicalTrials.Gov.UK Identifier - NCT01132976.

Expansion of the gateway multisite recombination cloning toolkit.

PubMed

Shearin, Harold K; Dvarishkis, Alisa R; Kozeluh, Craig D; Stowers, R Steven

2013-01-01

Precise manipulation of transgene expression in genetic model organisms has led to advances in understanding fundamental mechanisms of development, physiology, and genetic disease. Transgene construction is, however, a precondition of transgene expression, and often limits the rate of experimental progress. Here we report an expansion of the modular Gateway MultiSite recombination-cloning platform for high efficiency transgene assembly. The expansion includes two additional destination vectors and entry clones for the LexA binary transcription system, among others. These new tools enhance the expression levels possible with Gateway MultiSite generated transgenes and make possible the generation of LexA drivers and reporters with Gateway MultiSite cloning. In vivo data from transgenic Drosophila functionally validating each novel component are presented and include neuronal LexA drivers, LexAop2 red and green fluorescent synaptic vesicle reporters, TDC2 and TRH LexA, GAL4, and QF drivers, and LexAop2, UAS, and QUAS channelrhodopsin2 T159C reporters.

Expansion of the Gateway MultiSite Recombination Cloning Toolkit

PubMed Central

Shearin, Harold K.; Dvarishkis, Alisa R.; Kozeluh, Craig D.; Stowers, R. Steven

2013-01-01

Precise manipulation of transgene expression in genetic model organisms has led to advances in understanding fundamental mechanisms of development, physiology, and genetic disease. Transgene construction is, however, a precondition of transgene expression, and often limits the rate of experimental progress. Here we report an expansion of the modular Gateway MultiSite recombination-cloning platform for high efficiency transgene assembly. The expansion includes two additional destination vectors and entry clones for the LexA binary transcription system, among others. These new tools enhance the expression levels possible with Gateway MultiSite generated transgenes and make possible the generation of LexA drivers and reporters with Gateway MultiSite cloning. In vivo data from transgenic Drosophila functionally validating each novel component are presented and include neuronal LexA drivers, LexAop2 red and green fluorescent synaptic vesicle reporters, TDC2 and TRH LexA, GAL4, and QF drivers, and LexAop2, UAS, and QUAS channelrhodopsin2 T159C reporters. PMID:24204935

Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

PubMed Central

Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

2010-01-01

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

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

Comparison of Antipsychotics for Metabolic Problems (CAMP): A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk

PubMed Central

Stroup, T. Scott; McEvoy, Joseph P.; Ring, Kimberly D.; Hamer, Robert H.; LaVange, Lisa M.; Swartz, Marvin S.; Rosenheck, Robert A.; Perkins, Diana O.; Nussbaum, Abraham M.; Lieberman, Jeffrey A.

2013-01-01

Objective We conducted a multi-site, randomized controlled trial examining the strategy of switching from olanzapine, quetiapine, or risperidone to aripiprazole to ameliorate metabolic risk factors for cardiovascular disease. Method Patients with schizophrenia or schizoaffective disorder with BMI ≥ 27 and non-HDL cholesterol (non-HDL-C) ≥ 130 mg/dl on a stable dosage of olanzapine, quetiapine, or risperidone were randomly assigned to stay on the current medication (n=106) or switch to aripiprazole (n=109) for 24 weeks. All participants were enrolled in a behaviorally oriented diet and exercise program. Raters were blinded to treatment assignment. The primary and key secondary outcomes were non-HDL-C change and efficacy failure, respectively. Results The pre-specified primary analysis included 89 switchers and 98 stayers who had at least one post-baseline non-HDL-C measurement. The least squares mean estimates of non-HDL-C decreased more for the switch than the stay groups (−20.2 vs. −10.8 mg/dl). Switching was associated with larger reductions in weight (2.9 kg) and a net reduction of serum triglycerides of 32.7 mg/dl. Twenty-two (20.6%) switchers and 18 (17.0%) stayers experienced protocol-defined efficacy failure. Forty-seven (43.9%) switchers and 26 (24.5%) stayers discontinued the assigned antipsychotic before 24 weeks. Conclusion Switching to aripiprazole led to improvement of non-HDL-C and other metabolic parameters. Rates of efficacy failure were similar between groups, but switching to aripiprazole was associated with a higher rate of treatment discontinuation. In the context of close clinical monitoring, switching from an antipsychotic with high metabolic risk to one with lower risk to improve metabolic parameters is an effective strategy. PMID:21768610

Developmental progression to early adult binge drinking and marijuana use from worsening versus stable trajectories of adolescent ADHD and delinquency

PubMed Central

Howard, Andrea L.; Molina, Brooke S. G.; Swanson, James M.; Hinshaw, Stephen P.; Belendiuk, Katherine A.; Harty, Seth C.; Arnold, L. Eugene; Abikoff, Howard B.; Hechtman, Lily; Stehli, Annamarie; Greenhill, Laurence L.; Newcorn, Jeffrey H.; Wigal, Timothy

2015-01-01

Aims To examine the association between developmental trajectories of inattention, hyperactivity-impulsivity, and delinquency through childhood and adolescence (ages 8-16) and subsequent binge drinking and marijuana use in early adulthood (age 21). Design Prospective naturalistic follow-up of children with attention-deficit/hyperactivity disorder (ADHD) previously enrolled in a randomized controlled trial (RCT). Treatment-phase assessments occurred at 3, 9, and 14 months after randomization; follow-up assessments occurred at 24 months, 36 months, and 6, 8, and 12 years after randomization. Setting Secondary analysis of data from the Multimodal Treatment Study of ADHD (MTA), a multi-site RCT comparing the effects of careful medication management, intensive behavior therapy, their combination, and referral to usual community care. Participants 579 children with DSM-IV ADHD combined type, aged 7.0 and 9.9 years old at baseline (M=8.5, SD=.80). Measurements Ratings of inattention, hyperactivity-impulsivity, and delinquency were collected from multiple informants at baseline and through the 8-year follow-up. Self-reports of binge drinking and marijuana use were collected at the 12-year follow-up (M age 21). Findings Trajectories of worsening inattention symptoms and delinquency (and less apparent improvement in hyperactivity-impulsivity) were associated with higher rates of early adult binge drinking and marijuana use, compared with trajectories of stable or improving symptoms and delinquency (of 24 comparisons, 22 p-values <.05), even when symptom levels in stable trajectories were high. Conclusions Worsening inattention symptoms and delinquency during adolescence are associated with increased-levels of early adult substance use; this pattern may reflect a developmental course of vulnerability to elevated substance use in early adulthood. PMID:25664657

Developmental progression to early adult binge drinking and marijuana use from worsening versus stable trajectories of adolescent attention deficit/hyperactivity disorder and delinquency.

PubMed

Howard, Andrea L; Molina, Brooke S G; Swanson, James M; Hinshaw, Stephen P; Belendiuk, Katherine A; Harty, Seth C; Arnold, L Eugene; Abikoff, Howard B; Hechtman, Lily; Stehli, Annamarie; Greenhill, Laurence L; Newcorn, Jeffrey H; Wigal, Timothy

2015-05-01

To examine the association between developmental trajectories of inattention, hyperactivity-impulsivity and delinquency through childhood and adolescence (ages 8-16 years) and subsequent binge drinking and marijuana use in early adulthood (age 21 years). Prospective naturalistic follow-up of children with attention deficit/hyperactivity disorder (ADHD) previously enrolled in a randomized controlled trial (RCT). Treatment-phase assessments occurred at 3, 9 and 14 months after randomization; follow-up assessments occurred at 24 months, 36 months, and 6, 8 and 12 years after randomization. Secondary analysis of data from the Multimodal Treatment Study of ADHD (MTA), a multi-site RCT comparing the effects of careful medication management, intensive behavior therapy, their combination, and referral to usual community care. A total of 579 children with DSM-IV ADHD combined type, aged 7.0 and 9.9 years at baseline (mean = 8.5, SD = 0.80). Ratings of inattention, hyperactivity-impulsivity and delinquency were collected from multiple informants at baseline and through the 8-year follow-up. Self-reports of binge drinking and marijuana use were collected at the 12-year follow-up (mean age 21 years). Trajectories of worsening inattention symptoms and delinquency (and less apparent improvement in hyperactivity-impulsivity) were associated with higher rates of early adult binge drinking and marijuana use, compared with trajectories of stable or improving symptoms and delinquency (of 24 comparisons, all P-values <0.05), even when symptom levels in stable trajectories were high. Worsening inattention symptoms and delinquency during adolescence are were associated with higher levels of early adult substance use; this pattern may reflect a developmental course of vulnerability to elevated substance use in early adulthood. © 2015 Society for the Study of Addiction.

A randomized trial comparing live and telemedicine deliveries of an imagery-based behavioral intervention for breast cancer survivors: reducing symptoms and barriers to care.

PubMed

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

2015-08-01

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). Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-h 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 (WL) group (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-month and 3-month post-treatments including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. Linear multilevel modeling analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared with 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. Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared with WL. Further, there were no significant differences between LD and TD, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas. Copyright © 2014 John Wiley & Sons, Ltd.

Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial.

PubMed

Watson, Dennis P; Ray, Bradley; Robison, Lisa; Xu, Huiping; Edwards, Rhiannon; Salyers, Michelle P; Hill, James; Shue, Sarah

2017-01-01

There is a lack of evidence-based substance use disorder treatment and services targeting returning inmates. Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT) is a community-driven, recovery-oriented approach to substance abuse care which has the potential to address this service gap. SUPPORT is modeled after Indiana's Access to Recovery program, which was closed due to lack of federal support despite positive improvements in clients' recovery outcomes. SUPPORT builds on noted limitations of Indiana's Access to Recovery program. The ultimate goal of this project is to establish SUPPORT as an effective and scalable recovery-oriented system of care. A necessary step we must take before launching a large clinical trial is pilot testing the SUPPORT intervention. The pilot will take place at Public Advocates in Community Re-Entry (PACE), nonprofit serving individuals with felony convictions who are located in Marion County, Indiana (Indianapolis). The pilot will follow a basic parallel randomized design to compare clients receiving SUPPORT with clients receiving standard services. A total of 80 clients within 3 months of prison release will be recruited to participate and randomly assigned to one of the two intervention arms. Quantitative measures will be collected at multiple time points to understand SUPPORT's impact on recovery capital and outcomes. We will also collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences. Successful completion of this pilot will prepare us to conduct a multi-site clinical trial. The ultimate goal of this future work is to develop an evidence-based and scalable approach to treating substance use disorder among persons returning to society after incarceration. ClinicalTrials.gov (Clinical Trials ID: NCT03132753 and Protocol Number: 1511731907). Registered 28 April 2017.

Randomized control trial of computer-based training targeting alertness in older adults: the ALERT trial protocol.

PubMed

VanVleet, Thomas; Voss, Michelle; Dabit, Sawsan; Mitko, Alex; DeGutis, Joseph

2018-05-03

Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes. We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects. The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design. ClinicalTrials.gov identifier: NCT02416401.

Meditation programs for veterans with posttraumatic stress disorder: Aggregate findings from a multi-site evaluation.

PubMed

Heffner, Kathi L; Crean, Hugh F; Kemp, Jan E

2016-05-01

Interest in meditation to manage posttraumatic stress disorder (PTSD) symptoms is increasing. Few studies have examined the effectiveness of meditation programs offered to Veterans within Department of Veterans Affairs (VA) mental health services. The current study addresses this gap using data from a multisite VA demonstration project. Evaluation data collected at 6 VA sites (N = 391 Veterans) before and after a meditation program, and a treatment-as-usual (TAU) program, were examined here using random effects meta-analyses. Site-specific and aggregate between group effect sizes comparing meditation programs to TAU were determined for PTSD severity measured by clinical interview and self-report. Additional outcomes included experiential avoidance and mindfulness. In aggregate, analyses showed medium effect sizes for meditation programs compared to TAU for PTSD severity (clinical interview: effect size (ES) = -0.32; self-report: ES = -0.39). Similarly sized effects of meditation programs were found for overall mindfulness (ES = 0.41) and 1 specific aspect of mindfulness, nonreactivity to inner experience (ES = .37). Additional findings suggested meditation type and program completion differences each moderated program effects. VA-sponsored meditation programs show promise for reducing PTSD severity in Veterans receiving mental health services. Where meditation training fits within mental health services, and for whom programs will be of interest and effective, require further clarification. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Cost of Behavioral Interventions Utilizing Electronic Drug Monitoring for Antiretroviral Therapy Adherence

PubMed Central

Rasu, Rafia S.; Malewski, David F.; Banderas, Julie W.; Thomson, Domonique Malomo; Goggin, Kathy

2013-01-01

Objective To provide data on the actual costs associated with behavioral ART adherence interventions and electronic drug monitoring used in a clinical trial to inform their implementation in future studies and real-world practice. Methods Direct and time costs were calculated from a multi-site three-arm randomized controlled ART adherence trial. HIV positive participants (n = 204) were randomized to standard care (SC), enhanced counseling (EC), or EC and modified directly observed therapy (mDOT) interventions. Electronic drug monitoring (EDM) was used. Costs were calculated for various components of the 24-week adherence intervention. This economic evaluation was conducted from the perspective of an agency that may wish to implement these strategies. Sensitivity analyses were conducted to examine costs and savings associated with different scenarios. Results Total direct costs were $126,068 ($618/patient). Initial time costs were $53,590 ($262/patient). Base cost of labor was $0.36/minute. EC costs for 134 patients were $18,427 ($137/patient) and mDOT for 64 patients cost $18,638 ($291/patient). Total per patient costs were: SC=$880, EC=$1,018, EC/mDOT=$1,309. Removing driving costs evidenced the most variable impact on savings between the three study arms. The tornado diagram (sensitivity analysis) showed a graphical representation of how each sensitivity assumption reduced costs compared to each other and the resulting comparative costs for each group. Conclusion This novel economic analysis provides valuable cost information to guide treatment implementation and research design decisions. PMID:23337364

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

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 Multisite Evaluation of Reading Is Fundamental: Summary Report.

ERIC Educational Resources Information Center

Parker, Ronald K.; And Others

Reading Is Fundamental (RIF) is a national program that seeks to motivate children to read. Implemented by local sponsors and aimed at disadvantaged groups, it offers participating children a wide selection of attractive paperback books about interesting people, places, and events. The multisite evaluation summarized in this report studied…

A Multisite Evaluation of Reading Is Fundamental: Technical Report.

ERIC Educational Resources Information Center

Parker, Ronald K.; And Others

Reading Is Fundamental (RIF) is a national program that seeks to motivate children to read. Implemented by local sponsors and aimed at disadvantaged groups, it offers participating children a wide selection of attractive paperbound books about interesting people, places, and events. The multisite evaluation discussed in this technical report…

Network cyberinfrastructure as a shared platform to support multi-site research

USDA-ARS?s Scientific Manuscript database

Multi-site research across the Long-term Agroecosystem Research (LTAR) network requires access to data and information. We present some existing examples where you can get data from across the network and summarize the rich inventory of measurements taken across LTAR sites. But data management suppo...

EMERGEncy ID NET: Review of a 20-Year Multisite Emergency Department Emerging Infections Research Network

PubMed Central

Santibanez, Scott; Fischer, Leah S; Krishnadasan, Anusha; Sederdahl, Bethany; Merlin, Toby; Moran, Gregory J; Talan, David A; Mower, William; Sullivan, Matthew; Abrahamian, Fredrick M; Ong, Sam; Gross, Eric; Salhi, Bisan; Heilpern, Katherine; Hess, Jeremy; Karras, David; Biros, Michelle; Dunbar, Lala; Takhar, Sukhjit; Pollack, Charles; Runge, Jeffrey; Cheney, Paul; Rothrock, Stephen; O’Brian, John; Citron, Diane; Goldstein, Ellie; Finegold, Sydney; Nakase, Janet; Newdow, Michael; Merchant, Guy; Pathmarajah, Kavitha; Gonzalez, Eva; Mulrow, Mary; Bussman, Silas; Kalugdnan, Vernon; Peterson, Stephen; Pitts, Seth; Narayan, Kamil; Rubin, Ada; Kemble, Laurie; Beckham, Danielle; Neal, Niccole; Yagapen, Annick; Von Hofen, Carol; Hatala, Kathleen; Fuentes, Shelley; Sibley, Debbi; Colucci, Ashley; Hernandez, Jackeline; Cruse, Hope; Usher, Sarah; Hendrickson, Audrey; Dehnkamp, Kimberly; Zeglin, Britney; Jambaulikar, Guruprasad; Gorwitz, Rachel; Limbago, Brandi; Kuehnert, Matthew; Jarvis, William; Slutsker, Larry; Arvay, Melissa; Conn, Laura

2017-01-01

Abstract As providers of frontline clinical care for patients with acute and potentially life-threatening infections, emergency departments (EDs) have the priorities of saving lives and providing care quickly and efficiently. Although these facilities see a diversity of patients 24 hours per day and can collect prospective data in real time, their ability to conduct timely research on infectious syndromes is not well recognized. EMERGEncy ID NET is a national network that demonstrates that EDs can also collect data and conduct research in real time. This network collaborates with the Centers for Disease Control and Prevention (CDC) and other partners to study and address a wide range of infectious diseases and clinical syndromes. In this paper, we review selected highlights of EMERGEncy ID NET’s history from 1995 to 2017. We focus on the establishment of this multisite research network and the network’s collaborative research on a wide range of ED clinical topics. PMID:29670931

Conceptualizing the multidimensional nature of self-efficacy: assessment of situational context and level of behavioral challenge to maintain safer sex. National Institute of Mental Health Multisite HIV Prevention Trial Group.

PubMed

Murphy, D A; Stein, J A; Schlenger, W; Maibach, E

2001-07-01

A. Bandura (1991) argued that self-efficacy measurement should be specific both to the situation in which the behavior occurs and level of challenge in that situation. Measures consistent with the 2 dimensions were developed with graded challenge levels and differing gender-appropriate situations. Participants were 1,496 controls in the National Institute of Mental Health Multisite HIV Prevention Trial recruited from STD clinics and health service centers (925 women and 571 men). The authors tested 4 separate-sex confirmatory factor analysis models as follows: (a) Condom negotiation efficacy as a unitary construct across situations and gradation of difficulty; (b) situation as preeminent, which transfers across skills whatever the gradation of difficulty; (c) skill as predominant, irrespective of situation; and (d) a multidimensional design that simultaneously accounts for both situation and graded difficulty. Consistent with Bandura's theory, the multidimensional model provided the best fit for both samples.

A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes.

PubMed

Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

2015-07-01

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. 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/behavioral outcomes. 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. Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. The methodological quality of all included studies was independently evaluated by two reviewers using the Jadad score. Mean scores and P-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: 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 as compared to placebo in improving the following conditions: depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition, saffron use was also effective in reducing excessive snacking behavior. Findings from initial clinical trials suggest that saffron may improve the symptoms and the 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.

Randomized Trial of a Peer-Led, Telephone-Based Empowerment Intervention for Persons With Chronic Spinal Cord Injury Improves Health Self-Management.

PubMed

Houlihan, Bethlyn Vergo; Brody, Miriam; Everhart-Skeels, Sarah; Pernigotti, Diana; Burnett, Sam; Zazula, Judi; Green, Christa; Hasiotis, Stathis; Belliveau, Timothy; Seetharama, Subramani; Rosenblum, David; Jette, Alan

2017-06-01

To evaluate the impact of "My Care My Call" (MCMC), a peer-led, telephone-based health self-management intervention in adults with chronic spinal cord injury (SCI). Single-blinded randomized controlled trial. General community. Convenience sample of adults with SCI (N=84; mean time post-SCI, 9.9y; mean age, 46y; 73.8% men; 44% with paraplegia; 58% white). Trained peer health coaches applied the person-centered health self-management intervention with 42 experimental subjects over 6 months on a tapered call schedule. The 42 control subjects received usual care. Both groups received the MCMC Resource Guide. Primary outcome-health self-management as measured by the Patient Activation Measure (PAM). Secondary outcomes-global ratings of service/resource use, health-related quality of life, and quality of primary care. Intervention participants averaged 12 calls over 6 months (averaging 21.8min each), with distinct variation. At 6 months, intervention participants reported a significantly greater change in PAM scores (6mo: estimate, 7.029; 95% confidence interval, .1018-13.956; P=.0468) compared with controls, with a trend toward significance at 4 months. At 6 months, intervention participants reported a significantly greater decrease in social/role activity limitations (estimate, -.443; P=.0389), greater life satisfaction (estimate, 1.0091; P=.0522), greater services/resources awareness (estimate, 1.678; P=.0253), greater overall service use (estimate, 1.069; P=.0240), and a greater number of services used (estimate, 1.542; P=.0077). Subgroups most impacted by MCMC on PAM change scores included the following: high social support, white persons, men, 1 to 6 years postinjury, and tetraplegic. This trial demonstrates that the MCMC peer-led, health self-management intervention achieved a positive impact on self-management to prevent secondary conditions in adults with SCI. These results warrant a larger, multisite trial of its efficacy and cost-effectiveness. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

PubMed

de Bont, Paul A J M; van den Berg, David P G; van der Vleugel, Berber M; de Roos, Carlijn; Mulder, Cornelis L; Becker, Eni S; de Jongh, Ad; van der Gaag, Mark; van Minnen, Agnes

2013-05-23

Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. Trial registration: ISRCTN79584912.

A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

PubMed Central

2013-01-01

Background Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. Methods/Design A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. Discussion The results from the post treatment measurement can be considered strong empirical indicators of the safety and effectiveness of prolonged exposure and EMDR. The six-month and twelve-month follow-up data have the potential of reliably providing documentation of the long-term effects of both treatments on the various outcome variables. Data from pre-treatment and midtreatment can be used to reveal possible pathways of change. Trial registration Trial registration: ISRCTN79584912 PMID:23702050

Trans-oceanic Remote Power Hardware-in-the-Loop: Multi-site Hardware, Integrated Controller, and Electric Network Co-simulation

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

Lundstrom, Blake R.; Palmintier, Bryan S.; Rowe, Daniel

Electric system operators are increasingly concerned with the potential system-wide impacts of the large-scale integration of distributed energy resources (DERs) including voltage control, protection coordination, and equipment wear. This prompts a need for new simulation techniques that can simultaneously capture all the components of these large integrated smart grid systems. This paper describes a novel platform that combines three emerging research areas: power systems co-simulation, power hardware in the loop (PHIL) simulation, and lab-lab links. The platform is distributed, real-time capable, allows for easy internet-based connection from geographically-dispersed participants, and is software platform agnostic. We demonstrate its utility by studyingmore » real-time PHIL co-simulation of coordinated solar PV firming control of two inverters connected in multiple electric distribution network models, prototypical of U.S. and Australian systems. Here, the novel trans-pacific closed-loop system simulation was conducted in real-time using a power network simulator and physical PV/battery inverter at power at the National Renewable Energy Laboratory in Golden, CO, USA and a physical PV inverter at power at the Commonwealth Scientific and Industrial Research Organisation's Energy Centre in Newcastle, NSW, Australia. This capability enables smart grid researchers throughout the world to leverage their unique simulation capabilities for multi-site collaborations that can effectively simulate and validate emerging smart grid technology solutions.« less

Trans-oceanic Remote Power Hardware-in-the-Loop: Multi-site Hardware, Integrated Controller, and Electric Network Co-simulation

DOE PAGES

Lundstrom, Blake R.; Palmintier, Bryan S.; Rowe, Daniel; ...

2017-07-24

Electric system operators are increasingly concerned with the potential system-wide impacts of the large-scale integration of distributed energy resources (DERs) including voltage control, protection coordination, and equipment wear. This prompts a need for new simulation techniques that can simultaneously capture all the components of these large integrated smart grid systems. This paper describes a novel platform that combines three emerging research areas: power systems co-simulation, power hardware in the loop (PHIL) simulation, and lab-lab links. The platform is distributed, real-time capable, allows for easy internet-based connection from geographically-dispersed participants, and is software platform agnostic. We demonstrate its utility by studyingmore » real-time PHIL co-simulation of coordinated solar PV firming control of two inverters connected in multiple electric distribution network models, prototypical of U.S. and Australian systems. Here, the novel trans-pacific closed-loop system simulation was conducted in real-time using a power network simulator and physical PV/battery inverter at power at the National Renewable Energy Laboratory in Golden, CO, USA and a physical PV inverter at power at the Commonwealth Scientific and Industrial Research Organisation's Energy Centre in Newcastle, NSW, Australia. This capability enables smart grid researchers throughout the world to leverage their unique simulation capabilities for multi-site collaborations that can effectively simulate and validate emerging smart grid technology solutions.« less

Oral cannabidiol does not produce a signal for abuse liability in frequent marijuana smokers

PubMed Central

Babalonis, Shanna; Haney, Margaret; Malcolm, Robert J.; Lofwall, Michelle R.; Votaw, Victoria R.; Sparenborg, Steven; Walsh, Sharon L.

2017-01-01

Background Cannabidiol (CBD) is a naturally occurring constituent of the marijuana plant. In the past few years, there has been great interest in the therapeutic effects of isolated CBD and it is currently being explored for numerous disease conditions (e.g., pain, epilepsy, cancer, various drug dependencies). However, CBD remains a Schedule I drug on the U.S. Controlled Substances Act (CSA). Despite its status, there are no well-controlled data available regarding its abuse liability. Methods Healthy, frequent marijuana users (n=31) were enrolled in this within subject, randomized, placebo-controlled, double-blind, multisite study that administered oral cannabidiol (0, 200, 400, 800 mg) alone and in combination with smoked marijuana (0.01%, 5.3-5.8% THC). Participants received one dose combination across 8 once-weekly outpatient sessions (7.5 hrs). The primary findings on the drug interaction effects were previously reported (Haney et al., 2016). The present study is a secondary analysis of the data to examine the abuse liability profile of oral cannabidiol (200, 400, 800 mg) in comparison to oral placebo and active smoked marijuana (5.3-5.8% THC). Results Active marijuana reliably produced abuse-related subjective effects (e.g., high) (p<.05). However, CBD was placebo-like on all measures collected (p>.05). Conclusions Overall, CBD did not display any signals of abuse liability at the doses tested and these data may help inform U.S. regulatory decisions regarding CBD schedule on the CSA. PMID:28088032

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.

Testing the Feasibility of Fidelity Evaluation in a Multisite, Multiprogram Initiative

ERIC Educational Resources Information Center

Cornish, Disa Lubker; Losch, Mary E.; Avery, Mitchell

2016-01-01

Monitoring fidelity of implementation is a critical task when initiating evidence-based programs. This pilot study sought to identify best practices in a fidelity monitoring process and determine the feasibility of continuing a fidelity monitoring process with a multisite, multiprogram initiative. A fidelity log was created for each of 11…

A Multi-Site Study on Medical School Selection, Performance, Motivation and Engagement

ERIC Educational Resources Information Center

Wouters, A.; Croiset, G.; Schripsema, N. R.; Cohen-Schotanus, J.; Spaai, G. W.; Hulsman, R. L.; Kusurkar, R. A.

2017-01-01

Medical schools seek ways to improve their admissions strategies, since the available methods prove to be suboptimal for selecting the best and most motivated students. In this multi-site cross-sectional questionnaire study, we examined the value of (different) selection procedures compared to a weighted lottery procedure, which includes direct…

Development and Implementation of a Multisite Evaluation for the Women, Co-Occurring Disorders and Violence Study

ERIC Educational Resources Information Center

Giard, Julienne; Hennigan, Karen; Huntington, Nicholas; Vogel, Wendy; Rinehart, Debbie; Mazelis, Ruta; Nadlicki, Terri; Veysey, Bonita M.

2005-01-01

In this article we describe the development and implementation of the Substance Abuse and Mental Health Services Administration's (SAMHSA's) multisite Women, Co-Occurring Disorders and Violence Study (WCDVS), highlighting some of the challenges encountered, decisions made, and lessons learned. Four themes are discussed. First, the unique…

How Does a Multi-Site Institution Plan Effectively?

ERIC Educational Resources Information Center

Jefferson, Curtis F.

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

Toward Better Research on--and Thinking about--Evaluation Influence, Especially in Multisite Evaluations

ERIC Educational Resources Information Center

Mark, Melvin M.

2011-01-01

Evaluation is typically carried out with the intention of making a difference in the understandings and actions of stakeholders and decision makers. The author provides a general review of the concepts of evaluation "use," evaluation "influence," and "influence pathways," with connections to multisite evaluations. The study of evaluation influence…

A Multisite Psychotherapy and Medication Trial for Depressed Adolescents: Background and Benefits

ERIC Educational Resources Information Center

Kratochvil, Christopher J.; Simons, Anne; Vitiello, Benedetto; Walkup, John; Emslie, Graham; Rosenberg, David; March, John S.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) is an NIMH-supported multisite clinical trial that compares the effectiveness of a depression-specific cognitive behavioral therapy (CBT), medication management with fluoxetine (FLX), the combination of CBT and FLX (COMB), and medical management with pill placebo (PBO). TADS was…

Nonlinear instabilities of multi-site breathers in Klein-Gordon lattices

DOE PAGES

Cuevas-Maraver, Jesus; Kevrekidis, Panayotis G.; Pelinovsky, Dmitry E.

2016-08-01

Here, we explore the possibility of multi-site breather states in a nonlinear Klein–Gordon lattice to become nonlinearly unstable, even if they are found to be spectrally stable. The mechanism for this nonlinear instability is through the resonance with the wave continuum of a multiple of an internal mode eigenfrequency in the linearization of excited breather states. For the nonlinear instability, the internal mode must have its Krein signature opposite to that of the wave continuum. This mechanism is not only theoretically proposed, but also numerically corroborated through two concrete examples of the Klein–Gordon lattice with a soft (Morse) and amore » hard (Φ 4) potential. Compared to the case of the nonlinear Schrödinger lattice, the Krein signature of the internal mode relative to that of the wave continuum may change depending on the period of the multi-site breather state. For the periods for which the Krein signatures of the internal mode and the wave continuum coincide, multi-site breather states are observed to be nonlinearly stable.« less

Distribution of Bell-inequality violation versus multiparty-quantum-correlation measures

NASA Astrophysics Data System (ADS)

Sharma, Kunal; Das, Tamoghna; Sen (de), Aditi; Sen, Ujjwal

Violation of a Bell inequality guarantees the existence of quantum correlations in a shared quantum state. A pure bipartite quantum state, having nonvanishing quantum correlation, always violates a Bell inequality. Such correspondence is absent for multipartite pure quantum states in the case of multipartite correlation function Bell inequalities with two settings at each site. We establish a connection between the monogamy of Bell-inequality violation and multiparty quantum correlations for shared multisite quantum states. We believe that the relation is generic, as it is true for a number of different multisite measures that are defined from radically different perspectives. Precisely, we quantify the multisite-quantum-correlation content in the states by generalized geometric measure, a genuine multisite entanglement measure, as well as three monogamybased multiparty-quantum-correlation measures, viz., 3-tangle, quantum-discord score, and quantum-work-deficit score. We find that generalized Greenberger-Horne-Zeilinger states and another single-parameter family of states, which we refer to as the special Greenberger-Horne-Zeilinger states, have the status of extremal states in such relations.

Non-Gaussian spatiotemporal simulation of multisite daily precipitation: downscaling framework

NASA Astrophysics Data System (ADS)

Ben Alaya, M. A.; Ouarda, T. B. M. J.; Chebana, F.

2018-01-01

Probabilistic regression approaches for downscaling daily precipitation are very useful. They provide the whole conditional distribution at each forecast step to better represent the temporal variability. The question addressed in this paper is: how to simulate spatiotemporal characteristics of multisite daily precipitation from probabilistic regression models? Recent publications point out the complexity of multisite properties of daily precipitation and highlight the need for using a non-Gaussian flexible tool. This work proposes a reasonable compromise between simplicity and flexibility avoiding model misspecification. A suitable nonparametric bootstrapping (NB) technique is adopted. A downscaling model which merges a vector generalized linear model (VGLM as a probabilistic regression tool) and the proposed bootstrapping technique is introduced to simulate realistic multisite precipitation series. The model is applied to data sets from the southern part of the province of Quebec, Canada. It is shown that the model is capable of reproducing both at-site properties and the spatial structure of daily precipitations. Results indicate the superiority of the proposed NB technique, over a multivariate autoregressive Gaussian framework (i.e. Gaussian copula).

Distribution of Bell-inequality violation versus multiparty-quantum-correlation measures

NASA Astrophysics Data System (ADS)

Sharma, Kunal; Das, Tamoghna; SenDe, Aditi; Sen, Ujjwal

2016-06-01

Violation of a Bell inequality guarantees the existence of quantum correlations in a shared quantum state. A pure bipartite quantum state, having nonvanishing quantum correlation, always violates a Bell inequality. Such correspondence is absent for multipartite pure quantum states in the case of multipartite correlation function Bell inequalities with two settings at each site. We establish a connection between the monogamy of Bell-inequality violation and multiparty quantum correlations for shared multisite quantum states. We believe that the relation is generic, as it is true for a number of different multisite measures that are defined from radically different perspectives. Precisely, we quantify the multisite-quantum-correlation content in the states by generalized geometric measure, a genuine multisite entanglement measure, as well as three monogamy-based multiparty-quantum-correlation measures, viz., 3-tangle, quantum-discord score, and quantum-work-deficit score. We find that generalized Greenberger-Horne-Zeilinger states and another single-parameter family of states, which we refer to as the special Greenberger-Horne-Zeilinger states, have the status of extremal states in such relations.

Safer Sex Media Messages and Adolescent Sexual Behavior: 3-Year Follow-Up Results From Project iMPPACS

PubMed Central

Romer, Daniel; Valois, Robert F.; Vanable, Peter; Carey, Michael P.; Stanton, Bonita; Brown, Larry; DiClemente, Ralph; Salazar, Laura F.

2013-01-01

Objectives. We estimated the long-term (36-month) effects of Project iMPPACS, a multisite randomized controlled trial of mass media and small-group intervention for African American adolescents. Methods. We collected 6 waves of longitudinal data on program participants aged 14 to 17 years (n = 1139) in Providence, Rhode Island; Syracuse, New York; Columbia, South Carolina; and Macon, Georgia, 36 months (December 2009–December 2010) after the intervention began (August 2006–January 2008). Seemingly unrelated regressions at each wave estimated the effects of 3 types of mass media messages (the thematic mediators: selection, pleasure, and negotiation) on condom use intention and self-reported unprotected vaginal sex events. Results. All 3 mediators of behavior change that were introduced during the media intervention were sustained at the follow-up assessments at least 18 months after the intervention ended, with intention having the largest correlation. Unprotected vaginal sex increased with each wave of the study, although cities receiving media exposure had smaller increases. Conclusions. Project iMPPACS demonstrates that mass media influence delivered over an extended period, when adolescents were beginning to learn patterns of behavior associated with sex, persisted after the media program ended. PMID:23153149

Rehabilitation robotics

PubMed Central

KREBS, H.I.; VOLPE, B.T.

2015-01-01

This chapter focuses on rehabilitation robotics which can be used to augment the clinician’s toolbox in order to deliver meaningful restorative therapy for an aging population, as well as on advances in orthotics to augment an individual’s functional abilities beyond neurorestoration potential. The interest in rehabilitation robotics and orthotics is increasing steadily with marked growth in the last 10 years. This growth is understandable in view of the increased demand for caregivers and rehabilitation services escalating apace with the graying of the population. We will provide an overview on improving function in people with a weak limb due to a neurological disorder who cannot properly control it to interact with the environment (orthotics); we will then focus on tools to assist the clinician in promoting rehabilitation of an individual so that s/he can interact with the environment unassisted (rehabilitation robotics). We will present a few clinical results occurring immediately poststroke as well as during the chronic phase that demonstrate superior gains for the upper extremity when employing rehabilitation robotics instead of usual care. These include the landmark VA-ROBOTICS multisite, randomized clinical study which demonstrates clinical gains for chronic stroke that go beyond usual care at no additional cost. PMID:23312648

Rehabilitation robotics.

PubMed

Krebs, H I; Volpe, B T

2013-01-01

This chapter focuses on rehabilitation robotics which can be used to augment the clinician's toolbox in order to deliver meaningful restorative therapy for an aging population, as well as on advances in orthotics to augment an individual's functional abilities beyond neurorestoration potential. The interest in rehabilitation robotics and orthotics is increasing steadily with marked growth in the last 10 years. This growth is understandable in view of the increased demand for caregivers and rehabilitation services escalating apace with the graying of the population. We provide an overview on improving function in people with a weak limb due to a neurological disorder who cannot properly control it to interact with the environment (orthotics); we then focus on tools to assist the clinician in promoting rehabilitation of an individual so that s/he can interact with the environment unassisted (rehabilitation robotics). We present a few clinical results occurring immediately poststroke as well as during the chronic phase that demonstrate superior gains for the upper extremity when employing rehabilitation robotics instead of usual care. These include the landmark VA-ROBOTICS multisite, randomized clinical study which demonstrates clinical gains for chronic stroke that go beyond usual care at no additional cost. Copyright © 2013 Elsevier B.V. All rights reserved.

Clinical Research That Matters: Designing Outcome-Based Research for Older Adults to Qualify for Systematic Reviews and Meta-Analyses.

PubMed

Lee, Jeannie K; Fosnight, Susan M; Estus, Erica L; Evans, Paula J; Pho, Victoria B; Reidt, Shannon; Reist, Jeffrey C; Ruby, Christine M; Sibicky, Stephanie L; Wheeler, Janel B

2018-01-01

Though older adults are more sensitive to the effects of medications than their younger counterparts, they are often excluded from manufacturer-based clinical studies. Practice-based research is a practical method to identify medication-related effects in older patients. This research also highlights the role of a pharmacist in improving care in this population. A single study rarely has strong enough evidence to change geriatric practice, unless it is a large-scale, multisite, randomized controlled trial that specifically targets older adults. It is important to design studies that may be used in systematic reviews or meta-analyses that build a stronger evidence base. Recent literature has documented a gap in advanced pharmacist training pertaining to research skills. In this paper, we hope to fill some of the educational gaps related to research in older adults. We define best practices when deciding on the type of study, inclusion and exclusion criteria, design of the intervention, how outcomes are measured, and how results are reported. Well-designed studies increase the pool of available data to further document the important role that pharmacists have in optimizing care of older patients.

Safer sex media messages and adolescent sexual behavior: 3-year follow-up results from project iMPPACS.

PubMed

Hennessy, Michael; Romer, Daniel; Valois, Robert F; Vanable, Peter; Carey, Michael P; Stanton, Bonita; Brown, Larry; DiClemente, Ralph; Salazar, Laura F

2013-01-01

We estimated the long-term (36-month) effects of Project iMPPACS, a multisite randomized controlled trial of mass media and small-group intervention for African American adolescents. We collected 6 waves of longitudinal data on program participants aged 14 to 17 years (n = 1139) in Providence, Rhode Island; Syracuse, New York; Columbia, South Carolina; and Macon, Georgia, 36 months (December 2009-December 2010) after the intervention began (August 2006-January 2008). Seemingly unrelated regressions at each wave estimated the effects of 3 types of mass media messages (the thematic mediators: selection, pleasure, and negotiation) on condom use intention and self-reported unprotected vaginal sex events. All 3 mediators of behavior change that were introduced during the media intervention were sustained at the follow-up assessments at least 18 months after the intervention ended, with intention having the largest correlation. Unprotected vaginal sex increased with each wave of the study, although cities receiving media exposure had smaller increases. Project iMPPACS demonstrates that mass media influence delivered over an extended period, when adolescents were beginning to learn patterns of behavior associated with sex, persisted after the media program ended.

Managing personal health information in distributed research network environments.

PubMed

Bredfeldt, Christine E; Butani, Amy L; Pardee, Roy; Hitz, Paul; Padmanabhan, Sandy; Saylor, Gwyn

2013-10-08

Studying rare outcomes, new interventions and diverse populations often requires collaborations across multiple health research partners. However, transferring healthcare research data from one institution to another can increase the risk of data privacy and security breaches. A working group of multi-site research programmers evaluated the need for tools to support data security and data privacy. The group determined that data privacy support tools should: 1) allow for a range of allowable Protected Health Information (PHI); 2) clearly identify what type of data should be protected under the Health Insurance Portability and Accountability Act (HIPAA); and 3) help analysts identify which protected health information data elements are allowable in a given project and how they should be protected during data transfer. Based on these requirements we developed two performance support tools to support data programmers and site analysts in exchanging research data. The first tool, a workplan template, guides the lead programmer through effectively communicating the details of multi-site programming, including how to run the program, what output the program will create, and whether the output is expected to contain protected health information. The second performance support tool is a checklist that site analysts can use to ensure that multi-site program output conforms to expectations and does not contain protected health information beyond what is allowed under the multi-site research agreements. Together the two tools create a formal multi-site programming workflow designed to reduce the chance of accidental PHI disclosure.

A P&T Committee’s Transition to a Complete Electronic Meeting System—A Multisite Institution Experience

PubMed Central

Al-Jedai, Ahmed H.; Algain, Roaa A.; Alghamidi, Said A.; Al-Jazairi, Abdulrazaq S.; Amin, Rashid; Bin Hussain, Ibrahim Z.

2017-01-01

Purpose In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. Summary We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. Conclusion The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites. PMID:29018301

A P&T Committee's Transition to a Complete Electronic Meeting System-A Multisite Institution Experience.

PubMed

Al-Jedai, Ahmed H; Algain, Roaa A; Alghamidi, Said A; Al-Jazairi, Abdulrazaq S; Amin, Rashid; Bin Hussain, Ibrahim Z

2017-10-01

In the last few decades, changes to formulary management processes have taken place in institutions with closed formulary systems. However, many P&T committees continued to operate using traditional paper-based systems. Paper-based systems have many limitations, including confidentiality, efficiency, open voting, and paper wastage. This becomes more challenging when dealing with a multisite P&T committee that handles formulary matters across the whole health care system. In this paper, we discuss the implementation of the first paperless, completely electronic, Web-based formulary management system across a large health care system in the Middle East. We describe the transitioning of a multisite P&T committee in a large tertiary care institution from a paper-based to an all-electronic system. The challenges and limitations of running a multisite P&T committee utilizing a paper system are discussed. The design and development of a Web-based committee floor management application that can be used from notebooks, tablets, and hand-held devices is described. Implementation of a flexible, interactive, easy-to-use, and efficient electronic formulary management system is explained in detail. The development of an electronic P&T committee meeting system that encompasses electronic document sharing, voting, and communication could help multisite health care systems unify their formularies across multiple sites. Our experience might not be generalizable to all institutions because this depends heavily on system features, existing processes and workflow, and implementation across different sites.

"I know what you told me, but this is what I think:" perceived risk of Alzheimer disease among individuals who accurately recall their genetics-based risk estimate.

PubMed

Linnenbringer, Erin; Roberts, J Scott; Hiraki, Susan; Cupples, L Adrienne; Green, Robert C

2010-04-01

This study evaluates the Alzheimer disease risk perceptions of individuals who accurately recall their genetics-based Alzheimer disease risk assessment. Two hundred forty-six unaffected first-degree relatives of patients with Alzheimer disease were enrolled in a multisite randomized controlled trial examining the effects of communicating APOE genotype and lifetime Alzheimer disease risk information. Among the 158 participants who accurately recalled their Alzheimer disease risk assessment 6 weeks after risk disclosure, 75 (47.5%) believed their Alzheimer disease risk was more than 5% points different from the Alzheimer disease risk estimate they were given. Within this subgroup, 69.3% believed that their Alzheimer disease risk was higher than what they were told (discordant high), whereas 30.7% believed that their Alzheimer disease risk was lower (discordant low). Participants with a higher baseline risk perception were more likely to have a discordant-high risk perception (P < 0.05). Participants in the discordant-low group were more likely to be APOE epsilon4 positive (P < 0.05) and to score higher on an Alzheimer disease controllability scale (P < 0.05). Our results indicate that even among individuals who accurately recall their Alzheimer disease risk assessment, many people do not take communicated risk estimates at face value. Further exploration of this clinically relevant response to risk information is warranted.

An Effectiveness Trial of a New Enhanced Dissonance Eating Disorder Prevention Program among Female College Students

PubMed Central

Stice, Eric; Butryn, Meghan L.; Rohde, Paul; Shaw, Heather; Marti, C. Nathan

2014-01-01

Objective Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Method Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Results Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced healthcare utilization or unhealthy weight gain. Conclusions This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. PMID:24189570

Mediators of effects of a selective family-focused violence prevention approach for middle school students.

PubMed

2012-02-01

This study examined how parenting and family characteristics targeted in a selective prevention program mediated effects on key youth proximal outcomes related to violence perpetration. The selective intervention was evaluated within the context of a multi-site trial involving random assignment of 37 schools to four conditions: a universal intervention composed of a student social-cognitive curriculum and teacher training, a selective family-focused intervention with a subset of high-risk students, a condition combining these two interventions, and a no-intervention control condition. Two cohorts of sixth-grade students (total N = 1,062) exhibiting high levels of aggression and social influence were the sample for this study. Analyses of pre-post change compared to controls using intent-to-treat analyses found no significant effects. However, estimates incorporating participation of those assigned to the intervention and predicted participation among those not assigned revealed significant positive effects on student aggression, use of aggressive strategies for conflict management, and parental estimation of student's valuing of achievement. Findings also indicated intervention effects on two targeted family processes: discipline practices and family cohesion. Mediation analyses found evidence that change in these processes mediated effects on some outcomes, notably aggressive behavior and valuing of school achievement. Results support the notion that changing parenting practices and the quality of family relationships can prevent the escalation in aggression and maintain positive school engagement for high-risk youth.

Role of Social Support in Predicting Caregiver Burden

PubMed Central

Rodakowski, Juleen; Skidmore, Elizabeth R.; Rogers, Joan C.; Schulz, Richard

2012-01-01

Objective To examine the unique contribution of social support to burden in caregivers of adults aging with spinal cord injuries (SCI). Design Secondary analyses of cross-sectional data from a large cohort of adults aging with SCI and their primary caregivers. Setting Multiple community locations in Pittsburgh, PA, and Miami, FL. Participants Caregivers of community-dwelling adults aging with SCI (n=173) were interviewed as part of a multisite randomized clinical trial. The mean age of caregivers was 53 years (SD=15) and of care-recipients 55 years (SD=13). Interventions Not applicable. Main Outcome Measures The primary outcome was caregiver burden measured with the Abridged Version of the Zarit Burden Interview. A hierarchical multiple regression analysis examined social supports (social integration, received social support, and negative social interactions) effect on burden in caregivers of adults aging while controlling for demographic characteristics and caregiving characteristics. Results After controlling for demographic characteristics and caregiving characteristics, social integration (β̂ =−.16, P<.05), received social support (β̂ =−.15, P<.05), and negative social interactions (β̂ =.21, P<.01) were significant independent predictors of caregiver burden. Conclusions Findings demonstrate that social support is an important factor associated with burden in caregivers of adults aging with SCI. Social support should be considered for assessments and interventions designed to identify and reduce caregiver burden. PMID:22824248

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Carey, Evan P; Sullivan, Mark D; Nelson, Karin M; Hattler, Brack; McBryde, Connor F; Lehmann, Kenneth G; Gianola, Katherine; Heidenreich, Paul A; Rumsfeld, John S

2015-05-01

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

Childhood Traumatic Grief: A Multi-Site Empirical Examination of the Construct and Its Correlates

ERIC Educational Resources Information Center

Brown, Elissa J.; Amaya-Jackson, Lisa; Cohen, Judith; Handel, Stephanie; De Bocanegra, Heike Thiel; Zatta, Eileen; Goodman, Robin F.; Mannarino, Anthony

2008-01-01

This study evaluated the construct of childhood traumatic grief (CTG) and its correlates through a multi-site assessment of 132 bereaved children and adolescents. Youth completed a new measure of the characteristics, attributions, and reactions to exposure to death (CARED), as well as measures of CTG, posttraumatic stress disorder (PTSD),…

What Works Clearinghouse Quick Review: "Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Experiment"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2014

2014-01-01

"Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Experiment," examined the impact of the Talent Transfer Initiative (TTI) on both student achievement and teacher retention in 10 school districts across seven states. The initiative gave bonuses to high-performing teachers for them to transfer to and stay…

Latent Variable Regression 4-Level Hierarchical Model Using Multisite Multiple-Cohorts Longitudinal Data. CRESST Report 801

ERIC Educational Resources Information Center

Choi, Kilchan

2011-01-01

This report explores a new latent variable regression 4-level hierarchical model for monitoring school performance over time using multisite multiple-cohorts longitudinal data. This kind of data set has a 4-level hierarchical structure: time-series observation nested within students who are nested within different cohorts of students. These…

Multi-Sited Ethnography and the Field of Educational Research

ERIC Educational Resources Information Center

Pierides, Dean

2010-01-01

This paper responds to the challenge of how educational research might be practised in a contemporary world that is no longer necessarily organised by nearness and unity. Focusing on ethnography, it argues for what a multi-sited imaginary contributes to research in the field of education. By giving prominence to the notion of multi-sited…

Collaborative Imaginaries and Multi-Sited Ethnography: Space-Time Dimensions of Engagement in an Afterschool Science Programme for Girls

ERIC Educational Resources Information Center

Rahm, Jrene

2012-01-01

Temporal and spatial configurations that constitute learning and identity work across practices have been little explored in studies of science literacy development. Grounded in multi-sited ethnography, this paper explores diverse girls' engagement with and identity work in science locally, inside a newsletter activity in an afterschool programme…

Documenting the Impact of Multisite Evaluations on the Science, Technology, Engineering, and Mathematics Field

ERIC Educational Resources Information Center

Roseland, Denise; Greenseid, Lija O.; Volkov, Boris B.; Lawrenz, Frances

2011-01-01

This chapter discusses the impact that four multisite National Science Foundation (NSF) evaluations had on the broader field of science, technology, engineering, and mathematics education and evaluation. Three approaches were used to investigate the broader impact of these evaluations on the field: (a) a citation analysis, (b) an on-line survey,…

Multi-Site Ethnography, Hypermedia and the Productive Hazards of Digital Methods: A Struggle for Liveness

ERIC Educational Resources Information Center

Gallagher, Kathleen; Freeman, Barry

2011-01-01

This article explores the possibilities and frustrations of using digital methods in a multi-sited ethnographic research project. The project, "Urban School Performances: The interplay, through live and digital drama, of local-global knowledge about student engagement", is a study of youth and teachers in drama classrooms in contexts of…

The Peculiar Institution?: A Multisite Case Study of Athletic Department Cultures at Small Christian Institutions

ERIC Educational Resources Information Center

Ramseyer, Paul Robert

2017-01-01

This multisite case study explored the perceptions of athletic department members of the important factors of organizational cultures in athletic departments at small Christian institutions in the Midwestern United States. The study comprised of site visits to three small Christian institutions in the Midwestern United States. At each site, six…

A Qualitative Multi-Site Case Study: Examining Principals' Leadership Styles and School Performance

ERIC Educational Resources Information Center

Preyear, Loukisha

2015-01-01

The purpose of this qualitative multi-site case study was to explore the impact of principals' leadership styles on student academic achievement in a high-poverty low-performing school district in Louisiana. A total of 17 participants, principals and teachers, from this school district were used in this study. Data source triangulation of…

Reliability of instruments in a cooperative, multisite study: employment intervention demonstration program.

PubMed

Salyers, M P; McHugo, G J; Cook, J A; Razzano, L A; Drake, R E; Mueser, K T

2001-09-01

Reliability of well-known instruments was examined in 202 people with severe mental illness participating in a multisite vocational study. We examined interrater reliability of the Positive and Negative Syndrome Scale (PANSS) and the internal consistency and test-retest reliability of the PANSS, the Rosenberg Self-Esteem Scale, the Medical Outcomes Study Short Form-36 (SF-36), and the Quality of Life Interview. Most scales had good levels of reliability, with intraclass correlation coefficients (ICCs) and coefficient alphas above .70. However, the SF-36 scales were generally less stable over time, particularly Social Functioning (ICC = .55). Test-retest reliability was lower among less educated respondents and among ethnic minorities. We recommend close monitoring of psychometric issues in future multisite studies.

Childhood Sexual Abuse Patterns, Psychosocial Correlates, and Treatment Outcomes among Adults in Drug Abuse Treatment

ERIC Educational Resources Information Center

Boles, Sharon M.; Joshi, Vandana; Grella, Christine; Wellisch, Jean

2005-01-01

This study reports on the effects of having a history of childhood sexual abuse (CSA) on treatment outcomes among substance abusing men and women (N = 2,434) in a national, multisite study of drug treatment outcomes. A history of CSA was reported by 27.2% of the women and 9.2% of the men. Controlling for gender, compared to patients without CSA,…

Automatic Traffic Advisory and Resolution Service (ATARS) Multi-Site Algorithms. Revision 1,

DTIC Science & Technology

1980-10-01

Summary Concept Description The Automatic Traffic Advisory and Resolution Service is a ground based collision avoidance system to be implemented in the...capability. A ground based computer processes the data and continuously provides proximity warning information and, when necessary, resolution advisories to...of ground- based air traffic control which provides proximity warning and separation services to uncontrolled aircraft in a given region of airspace. it

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.

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.

Multisite Ion Model in Concentrated Solutions of Divalent Cations (MgCl2 and CaCl2): Osmotic Pressure Calculations

PubMed Central

2015-01-01

Accurate force field parameters for ions are essential for meaningful simulation studies of proteins and nucleic acids. Currently accepted models of ions, especially for divalent ions, do not necessarily reproduce the right physiological behavior of Ca2+ and Mg2+ ions. Saxena and Sept (J. Chem. Theor. Comput.2013, 9, 3538–3542) described a model, called the multisite-ion model, where instead of treating the ions as an isolated sphere, the charge was split into multiple sites with partial charge. This model provided accurate inner shell coordination of the ion with biomolecules and predicted better free energies for proteins and nucleic acids. Here, we expand and refine the multisite model to describe the behavior of divalent ions in concentrated MgCl2 and CaCl2 electrolyte solutions, eliminating the unusual ion–ion pairing and clustering of ions which occurred in the original model. We calibrate and improve the parameters of the multisite model by matching the osmotic pressure of concentrated solutions of MgCl2 to the experimental values and then use these parameters to test the behavior of CaCl2 solutions. We find that the concentrated solutions of both divalent ions exhibit the experimentally observed behavior with correct osmotic pressure, the presence of solvent separated ion pairs instead of direct ion pairs, and no aggregation of ions. The improved multisite model for (Mg2+ and Ca2+) can be used in classical simulations of biomolecules at physiologically relevant salt concentrations. PMID:25482831

Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.

PubMed

Davis, Lori L; Kyriakides, Tassos C; Suris, Alina M; Ottomanelli, Lisa A; Mueller, Lisa; Parker, Pamela E; Resnick, Sandra G; Toscano, Richard; Scrymgeour, Alexandra A; Drake, Robert E

2018-04-01

Posttraumatic stress disorder (PTSD) often interferes with a person's ability to obtain or sustain employment, which leads to premature exit from the labor force and reduced income. To determine whether individual placement and support (IPS)-supported employment is more effective than stepwise vocational rehabilitation involving transitional work assignments at helping veterans with PTSD attain steady, competitive employment. The Veterans Individual Placement and Support Toward Advancing Recovery (VIP-STAR) study was a prospective, multisite, randomized clinical trial that included 541 unemployed veterans with PTSD at 12 Veterans Affairs medical centers. Data were collected from December 23, 2013, to May 3, 2017. Intent-to-treat analysis was performed. Individual placement and support is a supported employment intervention that rapidly engages people with disabilities in community job development to obtain work based on their individual job preferences. Transitional work is a stepwise vocational rehabilitation intervention that assigns people temporarily to noncompetitive jobs as preparation for competitive employment in the community. A priori hypotheses were that, compared with those in transitional work, more participants in the IPS group would become steady workers (primary) and earn more income from competitive jobs (secondary) over 18 months. Steady worker was defined as holding a competitive job for at least 50% of the 18-month follow-up period. A total of 541 participants (n = 271 IPS; n = 270 transitional work) were randomized. Mean (SD) age was 42.2 (11) years; 99 (18.3%) were women, 274 (50.6%) were white, 225 (41.6%) were African American, and 90 (16.6%) were of Hispanic, Spanish, or Latino ethnicity. More participants in the IPS group achieved steady employment than in the transitional work group (105 [38.7%] vs 63 [23.3%]; odds ratio, 2.14; 95% CI, 1.46-3.14). A higher proportion of IPS participants attained any competitive job (186 [68.6%] vs 154 [57.0%]; P = .005) and had higher cumulative earnings from competitive jobs (median [interquartile range] $7290 [$23 174] in IPS vs $1886 [$17 167] in transitional work; P = .004). This multisite trial demonstrated significantly greater effectiveness of IPS-supported employment over stepwise transitional work vocational rehabilitation for veterans living with chronic PTSD. The results provide supporting evidence for increasing access to IPS for veterans living with PTSD. clinicaltrials.gov Identifier: NCT01817712.

Awareness of Diagnosis and Knowledge of HPV in Women Patients: Data from a Multi-Site Study

ERIC Educational Resources Information Center

McCree, Donna Hubbard; Daley, Ellen M.; Gorbach, Pamina; Hamm, Robert M.; Sharpe, Patricia A.; Brandt, Heather M.; McFarlane, Mary; Kerndt, Peter; McDermott, Robert J.; Perrin, Karen M.; St. Lawrence, Janet S.

2010-01-01

Background: Persistent infection with high-risk types of human papillomavirus (HPV) is associated with cervical and other anogenital cancers. Purpose: This paper reports results of awareness of an HPV diagnosis and HPV knowledge from a multi-site study of HPV knowledge, attitudes and behavior, and the impact of an HPV diagnosis on women and their…

An Examination of Diversity within Three Southeastern Academic Libraries: A Mixed-Methods, Multi-Site Study

ERIC Educational Resources Information Center

Shaffer, Christopher A.

2014-01-01

The purpose of this study was to determine the extent to which three academic libraries in the Southeastern United States could be considered diverse. This was a multi-site, mixed methods study. It examined the climate and culture of the libraries, which was assessed through two methods; the first, through survey responses from full-time faculty…

The Setting-up of Multi-Site School Collaboratives: The Benefits of This Organizational Reform in Terms of Networking Opportunities and Their Effects

ERIC Educational Resources Information Center

Mifsud, Denise

2015-01-01

This article, which is set within the Maltese education scenario of unfolding decentralization through the setting-up of multi-site school collaboratives (legally termed "colleges") via a policy mandate, explores a particular aspect of this reform--that of "networking". This is examined in terms of the potential for…

A Hierarchical Modeling Approach to Data Analysis and Study Design in a Multi-Site Experimental fMRI Study

ERIC Educational Resources Information Center

Zhou, Bo; Konstorum, Anna; Duong, Thao; Tieu, Kinh H.; Wells, William M.; Brown, Gregory G.; Stern, Hal S.; Shahbaba, Babak

2013-01-01

We propose a hierarchical Bayesian model for analyzing multi-site experimental fMRI studies. Our method takes the hierarchical structure of the data (subjects are nested within sites, and there are multiple observations per subject) into account and allows for modeling between-site variation. Using posterior predictive model checking and model…

Replication and Comparison of the Newly Proposed ADOS-2, Module 4 Algorithm in ASD without ID: A Multi-Site Study

ERIC Educational Resources Information Center

Pugliese, Cara E.; Kenworthy, Lauren; Bal, Vanessa Hus; Wallace, Gregory L.; Yerys, Benjamin E.; Maddox, Brenna B.; White, Susan W.; Popal, Haroon; Armour, Anna Chelsea; Miller, Judith; Herrington, John D.; Schultz, Robert T.; Martin, Alex; Anthony, Laura Gutermuth

2015-01-01

Recent updates have been proposed to the Autism Diagnostic Observation Schedule-2 Module 4 diagnostic algorithm. This new algorithm, however, has not yet been validated in an independent sample without intellectual disability (ID). This multi-site study compared the original and revised algorithms in individuals with ASD without ID. The revised…

Progress in centralised ethics review processes: Implications for multi-site health evaluations.

PubMed

Prosser, Brenton; Davey, Rachel; Gibson, Diane

2015-04-01

Increasingly, public sector programmes respond to complex social problems that intersect specific fields and individual disciplines. Such responses result in multi-site initiatives that can span nations, jurisdictions, sectors and organisations. The rigorous evaluation of public sector programmes is now a baseline expectation. For evaluations of large and complex multi-site programme initiatives, the processes of ethics review can present a significant challenge. However in recent years, there have been new developments in centralised ethics review processes in many nations. This paper provides the case study of an evaluation of a national, inter-jurisdictional, cross-sector, aged care health initiative and its encounters with Australian centralised ethics review processes. Specifically, the paper considers progress against the key themes of a previous five-year, five nation study (Fitzgerald and Phillips, 2006), which found that centralised ethics review processes would save time, money and effort, as well as contribute to more equitable workloads for researchers and evaluators. The paper concludes with insights for those charged with refining centralised ethics review processes, as well as recommendations for future evaluators of complex multi-site programme initiatives. Copyright © 2015 Elsevier Ltd. All rights reserved.

Conducting Rapid, Relevant Research

PubMed Central

Glasgow, Russell E.; Kessler, Rodger S.; Ory, Marcia G.; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2015-01-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current “gold standard” clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation–focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include: use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. PMID:24953520

Conducting rapid, relevant research: lessons learned from the My Own Health Report project.

PubMed

Glasgow, Russell E; Kessler, Rodger S; Ory, Marcia G; Roby, Dylan; Gorin, Sherri Sheinfeld; Krist, Alex

2014-08-01

The lengthy and uncertain translation of research into clinical practice is well documented. Much of the current "gold standard" clinical research is slow, expensive, and lacks perceived relevance for practitioners and decision makers. In contrast, we summarize experiences conducting the My Own Health Report (MOHR) project to collect and address patient reported measures using principles of rapid, relevant pragmatic research. The methods used for rapid design and fielding of the MOHR project to improve attention to health behaviors and mental health are detailed. Within the multisite, pragmatic, implementation-focused MOHR study, we describe the four phases of the research and the key decisions made and actions taken within each. We provide concrete examples of how relevant research can be conducted transparently to rapidly provide information to practitioners. Data were collected and analyzed in 2013. The multisite (seven research centers partnered with 18 clinics) cluster randomized pragmatic delayed intervention trial was conducted in less than 18 months from receipt of funding applications to completion of data collection. Phases that were especially accelerated included funding and review, and recruitment and implementation. Conducting complex studies rapidly and efficiently is a realistic goal. Key lessons learned for prevention research include use of existing research networks; use of web-based assessment/feedback tools that are tailored to fit local needs; engaging relevant stakeholders early on and throughout the process to minimize need for redesign; and making pragmatic decisions that balance internal and external validity concerns rather than waiting for perfect solutions. Published by Elsevier Inc.

Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics.

PubMed

Persell, Stephen D; Friedberg, Mark W; Meeker, Daniella; Linder, Jeffrey A; Fox, Craig R; Goldstein, Noah J; Shah, Parth D; Knight, Tara K; Doctor, Jason N

2013-06-27

Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider's rate of inappropriate antibiotic prescribing relative to top-performing peers is reported back to the provider periodically by email. We enrolled 269 clinicians (practicing attending physicians or advanced practice nurses) in 49 participating clinic sites and collected baseline data. The primary outcome is the antibiotic prescribing rate for office visits with non-antibiotic-appropriate ARI diagnoses. Secondary outcomes will examine antibiotic prescribing more broadly. The 18-month intervention period will be followed by a one year follow-up period to measure persistence of effects after interventions cease. The ongoing BEARI Trial will evaluate the effectiveness of behavioral economic strategies in reducing inappropriate prescribing of antibiotics. ClinicalTrials.gov: NCT01454947.

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 .

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.

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD.

PubMed

Schnurr, Paula P; Chard, Kathleen M; Ruzek, Josef I; Chow, Bruce K; Shih, Mei-Chiung; Resick, Patricia A; Foa, Edna B; Marx, Brian P; Huang, Grant D; Lu, Ying

2015-03-01

CERV-PTSD is a randomized controlled trial of two of the most effective treatments for PTSD, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT). Despite solid evidence that both treatments are effective, there is limited evidence about their effectiveness relative to one another. The primary objective is to compare the effectiveness of PE and CPT for reducing PTSD symptom severity in a healthcare system that offers both treatments. The secondary objective is to compare the effectiveness of PE and CPT for reducing the severity of comorbid mental health problems and service utilization as well as improving functioning and quality of life. The tertiary objective is to examine whether discrepancy between patient preferences and treatment assignment reduces the effectiveness of each treatment. Exploratory analyses will examine whether demographic and clinical characteristics predict differential response to PE and CPT. The study is designed to randomize 900 male and female veterans with PTSD due to any traumatic military event to receive PE or CPT. The standard dose of treatment is 12 weekly sessions but veterans who improve more rapidly may finish in fewer sessions and veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms, measured during and after treatment and then 3 and 6 months later. As a large multi-site trial with men and women, CERV-PTSD is designed to advance the delivery of care for PTSD by providing conclusive information about whether one treatment is better than the other, overall, and for different types of patients. Published by Elsevier Inc.

A Multiple-City RCT of Housing First With Assertive Community Treatment for Homeless Canadians With Serious Mental Illness.

PubMed

Aubry, Tim; Goering, Paula; Veldhuizen, Scott; Adair, Carol E; Bourque, Jimmy; Distasio, Jino; Latimer, Eric; Stergiopoulos, Vicky; Somers, Julian; Streiner, David L; Tsemberis, Sam

2016-03-01

Housing First with assertive community treatment (ACT) is a promising approach to assist people with serious mental illness to exit homelessness. The article presents two-year findings from a multisite trial on the effectiveness of Housing First with ACT. The study design was a randomized controlled trial conducted in five Canadian cities. A sample of 950 participants with serious mental illness who were absolutely homeless or precariously housed were randomly assigned to receive either Housing First with ACT (N=469) or treatment as usual (N=481). Housing First participants spent more time in stable housing than participants in treatment as usual (71% versus 29%, adjusted absolute difference [AAD]=42%, p<.01). Compared with treatment-as-usual participants, Housing First participants who entered housing did so more quickly (73 versus 220 days, AAD=146.4, p<.001), had longer housing tenures at the study end-point (281 versus 115 days, AAD=161.8, p<.01), and rated the quality of their housing more positively (adjusted standardized mean difference [ASMD]=.17, p<.01). Housing First participants reported higher quality of life (ASMD=.15, p<.01) and were assessed as having better community functioning (ASMD=.18, p<.01) over the two-year period. Housing First participants showed significantly greater gains in community functioning and quality of life in the first year; however, differences between the two groups were attenuated by the end of the second year. Housing First with ACT is an effective approach in various contexts for assisting individuals with serious mental illness to rapidly exit homelessness.

Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial.

PubMed

Sharps, Phyllis W; Bullock, Linda F; Campbell, Jacquelyn C; Alhusen, Jeanne L; Ghazarian, Sharon R; Bhandari, Shreya S; Schminkey, Donna L

2016-11-01

Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling.

A Test of Kangaroo Care on Preterm Infant Breastfeeding

PubMed Central

Tully, Kristin P.; Holditch-Davis, Diane; White-Traut, Rosemary C.; David, Richard; O’Shea, T. Michael; Geraldo, Victoria

2015-01-01

Objective To test the effects of kangaroo care (KC) on breastfeeding outcomes in preterm infants compared to two control groups and to explore whether maternal-infant characteristics and the mother’s choice to use KC were related to breastfeeding measures. Design Secondary analysis of a multisite, stratified, and randomized 3-arm trial. The treatment groups used KC, auditory-tactile-visual-vestibular (ATVV) intervention, or preterm infant care information. Setting Neonatal intensive care units from 4 hospitals in the United States from 2006–2011. Participants Racially diverse mothers (N=231) and their preterm infants born weighing < 1750 grams. Methods Mothers and their infants were enrolled once the infants were no longer critically ill, weighed at least 1000 grams, and could be safely held outside of the incubator by parents. Participants were instructed by study nurses; those allocated to either KC or ATVV were asked to engage in these interactions for a minimum of 3 times a week in the hospital and at home until 2 months adjusted age. Results Feeding at the breast during hospitalization, the duration of post-discharge breastfeeding, and breastfeeding exclusivity after hospital discharge did not differ statistically among the treatment groups. Regardless of group assignment, married, older, and more educated women were more likely to feed at the breast during hospitalization. Mothers who practiced KC, regardless of randomly allocated group, were more likely to provide their milk than those who did not practice KC. Breastfeeding duration was greatest among more educated women. Conclusion As implemented in this study, assignment to KC did not appear to influence the measured breastfeeding outcomes. PMID:26815798

Domestic Violence Enhanced Perinatal Home Visits: The DOVE Randomized Clinical Trial

PubMed Central

Bullock, Linda F.; Campbell, Jacquelyn C.; Alhusen, Jeanne L.; Ghazarian, Sharon R.; Bhandari, Shreya S.; Schminkey, Donna L.

2016-01-01

Abstract Background: Perinatal intimate partner violence (IPV) is common and has significant negative health outcomes for mothers and infants. This study evaluated the effectiveness of an IPV intervention in reducing violence among abused women in perinatal home visiting programs. Materials and Methods: This assessor-blinded multisite randomized control trial of 239 women experiencing perinatal IPV was conducted from 2006 to 2012 in U.S. urban and rural settings. The Domestic Violence Enhanced Home Visitation Program (DOVE) intervention group (n = 124) received a structured abuse assessment and six home visitor-delivered empowerment sessions integrated into home visits. All participants were screened for IPV and referred appropriately. IPV was measured by the Conflicts Tactics Scale2 at baseline through 24 months postpartum. Results: There was a significant decrease in IPV over time (F = 114.23; p < 0.001) from baseline to 1, 3, 6, 12, 18, and 24 months postpartum (all p < 0.001). Additional models examining change in IPV from baseline indicated a significant treatment effect (F = 6.45; p < 0.01). Women in the DOVE treatment group reported a larger mean decrease in IPV scores from baseline compared to women in the usual care group (mean decline 40.82 vs. 35.87). All models accounted for age and maternal depression as covariates. Conclusions: The DOVE intervention was effective in decreasing IPV and is brief, thereby facilitating its incorporation within well-woman and well-child care visits, as well as home visiting programs, while satisfying recommendations set forth in the Affordable Care Act for IPV screening and brief counseling. PMID:27206047

Clinical benefits of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens users.

PubMed

Campbell, Robert; Kame, Gregory; Leach, Norman; Paul, Matthew; White, Eric; Zigler, Lamar

2012-03-01

To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) containing a diblock copolymer, poly(oxyethylene)-poly(oxybutylene), designed to improve the wetting properties of silicone-hydrogel lenses. This 90-day, randomized, concurrently controlled, double-masked, multisite study involved 573 subjects at 30 investigational sites in the United states. Existing lens wearers were randomly assigned to either regimen 1 (OPTI-FREE PureMoist, a newly developed formulation, Alcon Laboratories Inc., Fort Worth, TX) or regimen 2 (renu fresh, Bausch and Lomb Inc., Rochester, NY). At baseline, days 7, 30, 60, and 90, the subjects recorded subjective evaluations relating to lens acceptability and comfort, wearing time, and rewetting drop frequency, whereas investigators assessed slitlamp findings (including corneal fluorescein staining), lens deposits (modified Rudko), visual acuity, and adverse events. Group IV lenses were collected for ex vivo measurement of lysozyme deposits. Differences favoring regimen 1 were noted on day 90 for subjective evaluations of lens comfort (insertion, removal, overall); lens moisture and freshness; gentle on eye; clear vision; and lens handling (all P<0.004). Corneal fluorescein staining severity and area and lysozyme deposits (group IV lenses) were lower with regimen 1 (P<0.0001). This 90-day study shows that the new MPDS designed for silicone-hydrogel lenses is safe and effective when used by both silicone-hydrogel and traditional soft lens wearers. By improving comfort and decreasing lysozyme deposits and corneal fluorescein staining, the new MPDS enhances patients' wearing experience and helps maintain optimal lens performance.

Predictors of adherence to pharmacological and behavioral treatment in a cessation trial among smokers in Aleppo, Syria

PubMed Central

Ben Taleb, Ziyad; Ward, Kenneth D; Asfar, Taghrid; Bahelah, Raed; Maziak, Wasim

2015-01-01

Introduction The development of evidence-based smoking cessation programs is in its infancy in developing countries, which continue to bear the main brunt of the tobacco epidemic. Adherence to treatment recommendations is an important determinant of the success of smoking cessation programs, but little is known about factors influencing adherence to either pharmacological or behavioral treatment in developing countries settings. Our study represents the first attempt to examine the predictors of adherence to cessation treatment in a low-income developing country. Methods Predictors of adherence to pharmacological and behavioral treatment were identified by analyzing data from a multi-site, two-group, parallel-arm, double-blind, randomized, placebo-controlled smoking cessation trial in primary care clinics in Aleppo, Syria. Participants received 3 in-person behavioral counseling sessions plus 5 brief follow-up phone counseling sessions, and were randomized to either 6 weeks of nicotine or placebo patch. Results Of the 269 participants, 68% adhered to pharmacological treatment, while 70% adhered to behavioral counseling. In logistic regression modeling, lower adherence to pharmacological and behavioral treatment was associated with higher daily smoking at baseline, greater withdrawal symptoms, and perception of receiving placebo instead of active nicotine patch. Women showed lower adherence than men to behavioral treatment, while being assigned to placebo condition and baseline waterpipe use were associated with lower adherence to pharmacological treatment. Conclusion Adherence to cessation treatment for cigarette smokers in low-income countries such as Syria may benefit from integrated cessation components that provide intensive treatment for subjects with higher nicotine dependence, and address concurrent waterpipe use at all stages. PMID:26077603

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.

Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial.

PubMed

Guest, Rebecca; Tran, Yvonne; Gopinath, Bamini; Cameron, Ian D; Craig, Ashley

2016-07-16

It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss of employment, delayed return to work, financial and familial stress, and increased medical and compensation costs. The major aim of this research is to investigate the efficacy of interventions for preventing the development of psychological distress following a motor vehicle crash. The efficacy of two brief interventions will be examined: a cognitive behaviour therapy (CBT) programme, targeting mood and anxiety, and a lifestyle programme, targeting sleep, diet and physical activity. This is a randomized, controlled multisite study. Participants include at least 180 adults injured in a motor vehicle crash who have entered a compensation process. Research will compare outcomes in three groups randomly assigned to: one group of 60 adults, who receive a brief email-delivered CBT programme, with one session every 2 weeks for 10 weeks and telephone contact every 2 weeks; a second group of 60 adults, who receive a brief email-delivered lifestyle intervention involving one session every 2 weeks for 10 weeks with telephone contact; and an active waiting-list control group of 60 adults who are provided claims processing-related reading material along with telephone contact every 2 weeks for 10 weeks. Participants will be recruited within 12 weeks of the motor vehicle crash, and will be comprehensively assessed before and after treatment, and 6 and 12 months post-injury. Assuming an α probability level of 0.05 and a power of 80 %, at least 180 participants will be recruited. The primary outcome measure is the presence and severity of psychological distress or disorder. Secondary outcome measures include assessment of self-efficacy, resilience employment status, social activity and support, lifestyle and physical health factors, along with process outcome measures of treatment acceptability, feasibility and generalizability. This study will determine whether brief email-delivered interventions distributed soon after the injury and entry into the claims process can be effective in preventing the development of psychological distress. ANZCTR, ACTRN12615000326594 . Registered on 9 April 2015.

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

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

National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: a cluster randomized trial.

PubMed

El-Bassel, Nabila; Jemmott, John B; Landis, J Richard; Pequegnat, Willo; Wingood, Gina M; Wyatt, Gail E; Bellamy, Scarlett L

2010-09-27

Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy. To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups. Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P = .006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P < .001). The adjusted mean number of (log)unprotected intercourse acts was lower in the intervention group than in the comparison group (mean difference, -1.52; 95% CI, -2.07 to -0.98; P < .001). The cumulative STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison groups. The overall HIV seroconversion at the 12-month follow-up was 5 (2 in the intervention group, 3 in the comparison group) of 535 individuals, which translates to 935 per 100,000 population. To our knowledge, this is the first randomized controlled intervention trial to report significant reductions in HIV/STD risk behaviors among African American HIV serodiscordant couples. clinicaltrials.gov Identifier: NCT00644163.

Identifying Autism from Resting-State fMRI Using Long Short-Term Memory Networks.

PubMed

Dvornek, Nicha C; Ventola, Pamela; Pelphrey, Kevin A; Duncan, James S

2017-09-01

Functional magnetic resonance imaging (fMRI) has helped characterize the pathophysiology of autism spectrum disorders (ASD) and carries promise for producing objective biomarkers for ASD. Recent work has focused on deriving ASD biomarkers from resting-state functional connectivity measures. However, current efforts that have identified ASD with high accuracy were limited to homogeneous, small datasets, while classification results for heterogeneous, multi-site data have shown much lower accuracy. In this paper, we propose the use of recurrent neural networks with long short-term memory (LSTMs) for classification of individuals with ASD and typical controls directly from the resting-state fMRI time-series. We used the entire large, multi-site Autism Brain Imaging Data Exchange (ABIDE) I dataset for training and testing the LSTM models. Under a cross-validation framework, we achieved classification accuracy of 68.5%, which is 9% higher than previously reported methods that used fMRI data from the whole ABIDE cohort. Finally, we presented interpretation of the trained LSTM weights, which highlight potential functional networks and regions that are known to be implicated in ASD.

Identifying Autism from Resting-State fMRI Using Long Short-Term Memory Networks

PubMed Central

Dvornek, Nicha C.; Ventola, Pamela; Pelphrey, Kevin A.; Duncan, James S.

2017-01-01

Functional magnetic resonance imaging (fMRI) has helped characterize the pathophysiology of autism spectrum disorders (ASD) and carries promise for producing objective biomarkers for ASD. Recent work has focused on deriving ASD biomarkers from resting-state functional connectivity measures. However, current efforts that have identified ASD with high accuracy were limited to homogeneous, small datasets, while classification results for heterogeneous, multi-site data have shown much lower accuracy. In this paper, we propose the use of recurrent neural networks with long short-term memory (LSTMs) for classification of individuals with ASD and typical controls directly from the resting-state fMRI time-series. We used the entire large, multi-site Autism Brain Imaging Data Exchange (ABIDE) I dataset for training and testing the LSTM models. Under a cross-validation framework, we achieved classification accuracy of 68.5%, which is 9% higher than previously reported methods that used fMRI data from the whole ABIDE cohort. Finally, we presented interpretation of the trained LSTM weights, which highlight potential functional networks and regions that are known to be implicated in ASD. PMID:29104967

Interracial Contact and Racial Constancy: A Multi-Site Study of Racial Intergroup Bias in 3-5 Year Old Anglo-British Children

ERIC Educational Resources Information Center

Rutland, Adam; Cameron, Lindsey; Bennett, Laura; Ferrell, Jennifer

2005-01-01

This paper examined the influence of interracial contact and racial constancy on the racial intergroup bias of young Anglo-British children. This multi-site study was conducted in areas of Great Britain that varied in terms of racial diversity. The study also investigated whether preschool children express bias on positive, but not negative,…

The Study to Explore Early Development (SEED): A Multisite Epidemiologic Study of Autism by the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network

ERIC Educational Resources Information Center

Schendel, Diana E.; DiGuiseppi, Carolyn; Croen, Lisa A.; Fallin, M. Daniele; Reed, Philip L.; Schieve, Laura A.; Wiggins, Lisa D.; Daniels, Julie; Grether, Judith; Levy, Susan E.; Miller, Lisa; Newschaffer, Craig; Pinto-Martin, Jennifer; Robinson, Cordelia; Windham, Gayle C.; Alexander, Aimee; Aylsworth, Arthur S.; Bernal, Pilar; Bonner, Joseph D.; Blaskey, Lisa; Bradley, Chyrise; Collins, Jack; Ferretti, Casara J.; Farzadegan, Homayoon; Giarelli, Ellen; Harvey, Marques; Hepburn, Susan; Herr, Matthew; Kaparich, Kristina; Landa, Rebecca; Lee, Li-Ching; Levenseller, Brooke; Meyerer, Stacey; Rahbar, Mohammad H.; Ratchford, Andria; Reynolds, Ann; Rosenberg, Steven; Rusyniak, Julie; Shapira, Stuart K.; Smith, Karen; Souders, Margaret; Thompson, Patrick Aaron; Young, Lisa; Yeargin-Allsopp, Marshalyn

2012-01-01

The Study to Explore Early Development (SEED), a multisite investigation addressing knowledge gaps in autism phenotype and etiology, aims to: (1) characterize the autism behavioral phenotype and associated developmental, medical, and behavioral conditions and (2) investigate genetic and environmental risks with emphasis on immunologic, hormonal,…

The Challenges and Benefits of Employing a Mobile Research Fellow to Facilitate Team Work on a Large, Interdisciplinary, Multi-Sited Project

ERIC Educational Resources Information Center

Sugden, Fraser; Punch, Samantha

2014-01-01

Over the last few years research funding has increasingly moved in favour of large, multi-partner, interdisciplinary and multi-site research projects. This article explores the benefits and challenges of employing a full-time research fellow to work across multiple field sites, with all the local research teams, on an international,…

MULTI-SITE EVALUATIONS OF CANDIDATE METHODOLOGIES FOR DETERMINING COARSE PARTICULATE (PM 10-2.5) CONCENTRATIONS: AUGUST 2005 UPDATED REPORT REGARDING SECOND-GENERATION AND NEW PM 10-2.5 SAMPLERS

EPA Science Inventory

Multi-site field studies were conducted to evaluate the performance of sampling methods for measuring the coarse fraction of PM10 (PM10 2.5) in ambient air. The field studies involved the use of both time-integrated filter-based and direct continuous methods. Despite operationa...

Buspirone versus methylphenidate in the treatment of children with attention- deficit/ hyperactivity disorder: randomized double-blind study.

PubMed

Mohammadi, Mohammad-Reza; Hafezi, Poopak; Galeiha, Ali; Hajiaghaee, Reza; Akhondzadeh, Shahin

2012-01-01

A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for < 30kg and 30 mg/day for > 30kg) (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for < 30kg and 30 mg/day for > 30kg (group 2) for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD) and -15.60±7.81 (mean±SD) for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD) and -22.40±9.90 (mean±SD) for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of buspirone was less effective than methylphenidate in the treatment of ADHD.

Multisite rainfall downscaling and disaggregation in a tropical urban area

NASA Astrophysics Data System (ADS)

Lu, Y.; Qin, X. S.

2014-02-01

A systematic downscaling-disaggregation study was conducted over Singapore Island, with an aim to generate high spatial and temporal resolution rainfall data under future climate-change conditions. The study consisted of two major components. The first part was to perform an inter-comparison of various alternatives of downscaling and disaggregation methods based on observed data. This included (i) single-site generalized linear model (GLM) plus K-nearest neighbor (KNN) (S-G-K) vs. multisite GLM (M-G) for spatial downscaling, (ii) HYETOS vs. KNN for single-site disaggregation, and (iii) KNN vs. MuDRain (Multivariate Rainfall Disaggregation tool) for multisite disaggregation. The results revealed that, for multisite downscaling, M-G performs better than S-G-K in covering the observed data with a lower RMSE value; for single-site disaggregation, KNN could better keep the basic statistics (i.e. standard deviation, lag-1 autocorrelation and probability of wet hour) than HYETOS; for multisite disaggregation, MuDRain outperformed KNN in fitting interstation correlations. In the second part of the study, an integrated downscaling-disaggregation framework based on M-G, KNN, and MuDRain was used to generate hourly rainfall at multiple sites. The results indicated that the downscaled and disaggregated rainfall data based on multiple ensembles from HadCM3 for the period from 1980 to 2010 could well cover the observed mean rainfall amount and extreme data, and also reasonably keep the spatial correlations both at daily and hourly timescales. The framework was also used to project future rainfall conditions under HadCM3 SRES A2 and B2 scenarios. It was indicated that the annual rainfall amount could reduce up to 5% at the end of this century, but the rainfall of wet season and extreme hourly rainfall could notably increase.

Quantification of source impact to PM using three-dimensional weighted factor model analysis on multi-site data

NASA Astrophysics Data System (ADS)

Shi, Guoliang; Peng, Xing; Huangfu, Yanqi; Wang, Wei; Xu, Jiao; Tian, Yingze; Feng, Yinchang; Ivey, Cesunica E.; Russell, Armistead G.

2017-07-01

Source apportionment technologies are used to understand the impacts of important sources of particulate matter (PM) air quality, and are widely used for both scientific studies and air quality management. Generally, receptor models apportion speciated PM data from a single sampling site. With the development of large scale monitoring networks, PM speciation are observed at multiple sites in an urban area. For these situations, the models should account for three factors, or dimensions, of the PM, including the chemical species concentrations, sampling periods and sampling site information, suggesting the potential power of a three-dimensional source apportionment approach. However, the principle of three-dimensional Parallel Factor Analysis (Ordinary PARAFAC) model does not always work well in real environmental situations for multi-site receptor datasets. In this work, a new three-way receptor model, called "multi-site three way factor analysis" model is proposed to deal with the multi-site receptor datasets. Synthetic datasets were developed and introduced into the new model to test its performance. Average absolute error (AAE, between estimated and true contributions) for extracted sources were all less than 50%. Additionally, three-dimensional ambient datasets from a Chinese mega-city, Chengdu, were analyzed using this new model to assess the application. Four factors are extracted by the multi-site WFA3 model: secondary source have the highest contributions (64.73 and 56.24 μg/m3), followed by vehicular exhaust (30.13 and 33.60 μg/m3), crustal dust (26.12 and 29.99 μg/m3) and coal combustion (10.73 and 14.83 μg/m3). The model was also compared to PMF, with general agreement, though PMF suggested a lower crustal contribution.

Multisite accelerometry for sleep and wake classification in children.

PubMed

Lamprecht, Marnie L; Bradley, Andrew P; Tran, Tommy; Boynton, Alison; Terrill, Philip I

2015-01-01

Actigraphy is a useful alternative to the gold standard polysomnogram for non-invasively measuring sleep and wakefulness. However, it is unable to accurately assess sleep fragmentation due to its inability to differentiate restless sleep from wakefulness and quiet wake from sleep. This presents significant limitations in the assessment of sleep-related breathing disorders where sleep fragmentation is a common symptom. We propose that this limitation may be caused by hardware constraints and movement representation techniques. Our objective was to determine if multisite tri-axial accelerometry improves sleep and wake classification. Twenty-four patients aged 6-15 years (median: 8 years, 16 male) underwent a diagnostic polysomnogram while simultaneously recording motion from the left wrist and index fingertip, upper thorax and left ankle and great toe using a custom accelerometry system. Movement was quantified using several features and two feature selection techniques were employed to select optimal features for restricted feature set sizes. A heuristic was also applied to identify movements during restless sleep. The sleep and wake classification performance was then assessed and validated against the manually scored polysomnogram using discriminant analysis. Tri-axial accelerometry measured at the wrist significantly improved the wake detection when compared to uni-axial accelerometry (specificity at 85% sensitivity: 71.3(14.2)% versus 55.2(24.7)%, p < 0.01). Multisite accelerometry significantly improved the performance when compared to the single wrist placement (specificity at 85% sensitivity: 82.1(12.5)% versus 71.3(14.2)%, p < 0.05). Our results indicate that multisite accelerometry offers a significant performance benefit which could be further improved by analysing movement in raw multisite accelerometry data.

Planning and conducting a multi-institutional project on fatigue.

PubMed

Nail, L M; Barsevick, A M; Meek, P M; Beck, S L; Jones, L S; Walker, B L; Whitmer, K R; Schwartz, A L; Stephen, S; King, M E

1998-09-01

To describe the process used in proposal development and study implementation for a complex multisite project on cancer treatment-related fatigue (CRF), identify strategies used to manage the project, and provide recommendations for teams planning multisite research. Information derived from project team meeting records, correspondence, proposals, and personal recollection. The project was built on preexisting relationships among the three site investigators who then built a team including faculty, research coordinators, staff nurses, and students. Study sites had a range of organizational models, and the proposal was designed to capitalize on the organizational and resource strengths of each setting. Three team members drawn from outside oncology nursing provided expertise in measurement and experience with fatigue in other populations. Planning meetings were critical to the success of the project. Conference calls, fax technology, and electronic mail were used for communication. Flexibility was important in managing crises and shifting responsibility for specific components of the work. The team documented and evaluated the process used for multisite research, completed a major instrumentation study, and developed a cognitive-behavioral intervention for CRF. Accomplishments during the one-year planning grant exceeded initial expectations. The process of conducting multisite research is complex, especially when the starting point is a planning grant with specific research protocols to be developed and implemented over one year. Explicit planning for decision-making processes to be used throughout the project, acknowledging the differences among the study settings and planning the protocols to capitalize upon those differences, and recruiting a strong research team that included a member with planning grant and team-building expertise were essential elements for success. Specific recommendations for others planning multisite research are related to team-building, team membership, communication, behavioral norms, role flexibility, resources, feedback, problem management, and shared recognition.

Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial.

PubMed

Slade, Mike; Bird, Victoria; Clarke, Eleanor; Le Boutillier, Clair; McCrone, Paul; Macpherson, Rob; Pesola, Francesca; Wallace, Genevieve; Williams, Julie; Leamy, Mary

2015-06-01

Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking. We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. This trial is registered, number ISRCTN02507940. 14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group. Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs. Implementation of REFOCUS could increase staff recovery-promotion behaviours and improve patient-rated recovery. National Institute for Health Research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Multisite experimental cost study of intensive psychiatric community care.

PubMed

Rosenheck, R; Neale, M; Leaf, P; Milstein, R; Frisman, L

1995-01-01

A 2-year experimental cost study of 10 Intensive Psychiatric Community Care (IPCC) programs was conducted at Department of Veterans Affairs (VA) medical centers in the Northeast. High hospital users were randomly assigned to either IPCC (n = 454) or standard VA care (n = 419) at four neuropsychiatric (NP) and six general medical and surgical (GMS) hospitals. National computerized data were used to track all VA health care service usage and costs for 2 years following program entry. At 9 of the 10 sites, IPCC treatment resulted in reduced inpatient service usage. Overall, for IPCC patients compared with control patients, average inpatient usage was 89 days (33%) less while average cost per patient (for IPCC inpatient, and outpatient services) was $15,556 (20%) less. Additionally, costs for IPCC patients compared with control patients were $33,295 (29%) less at NP sites but were $6,273 (15%) greater at GMS sites. At both NP and GMS sites, costs were lower for IPCC patients in two subgroups: veterans over age 45 and veterans with high levels of inpatient service use before program entry. No interaction was noted between the impact of IPCC on costs and other clinical or sociodemographic characteristics. Similarly, no linear relationship was observed between the intensity of IPCC services and the impact of IPCC on VA costs, although the two sites that did not fully implement the IPCC program had the poorest results. With these sites excluded, the total cost of care for IPCC patients at GMS sites was $579 (3%) more per year than that for the control patients.

Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia.

PubMed

Goode, Rachel H; Rettiganti, Mallikarjuna; Li, Jingyun; Lyle, Robert E; Whiteside-Mansell, Leanne; Barrett, Kathleen W; Casey, Patrick H

2016-12-01

Neonatal hypoglycemia has been associated with abnormalities on brain imaging and a spectrum of developmental delays, although historical and recent studies show conflicting results. We compared the cognitive, academic, and behavioral outcomes of preterm infants with neonatal hypoglycemia with those of normoglycemic controls at 3 to 18 years of age. A secondary analysis of data from the Infant Health and Development Program, a national, multisite, randomized controlled longitudinal intervention study of long-term health and developmental outcomes in preterm infants. Of the 985 infants enrolled in the Infant Health and Development Program, 745 infants had glucose levels recorded. Infants were stratified into 4 groups by glucose level. By using standardized cognitive, academic, and behavioral assessments performed at 3, 8, and 18 years of age, we compared groups after adjusting for intervention status, birth weight, gestational age, sex, severity of neonatal course, race, maternal education, and maternal preconception weight. No significant differences were observed in cognitive or academic skills between the control and effected groups at any age. Participants with more severe neonatal hypoglycemia reported fewer problem behaviors at age 18 than those without hypoglycemia. No significant differences in intellectual or academic achievement were found between preterm infants with and without hypoglycemia. A statistical difference was found in behavior at age 18, with hypoglycemic children showing fewer problematic behaviors than normoglycemic children. This difference was not clinically meaningful. Using extended outcomes, our results are consistent with previous studies that found no significant neurodevelopmental outcomes associated with neonatal hypoglycemia in preterm-born children. Copyright © 2016 by the American Academy of Pediatrics.

Developmental Outcomes of Preterm Infants With Neonatal Hypoglycemia

PubMed Central

Rettiganti, Mallikarjuna; Li, Jingyun; Lyle, Robert E.; Whiteside-Mansell, Leanne; Barrett, Kathleen W.; Casey, Patrick H.

2016-01-01

BACKGROUND AND OBJECTIVES: Neonatal hypoglycemia has been associated with abnormalities on brain imaging and a spectrum of developmental delays, although historical and recent studies show conflicting results. We compared the cognitive, academic, and behavioral outcomes of preterm infants with neonatal hypoglycemia with those of normoglycemic controls at 3 to 18 years of age. METHODS: A secondary analysis of data from the Infant Health and Development Program, a national, multisite, randomized controlled longitudinal intervention study of long-term health and developmental outcomes in preterm infants. Of the 985 infants enrolled in the Infant Health and Development Program, 745 infants had glucose levels recorded. Infants were stratified into 4 groups by glucose level. By using standardized cognitive, academic, and behavioral assessments performed at 3, 8, and 18 years of age, we compared groups after adjusting for intervention status, birth weight, gestational age, sex, severity of neonatal course, race, maternal education, and maternal preconception weight. RESULTS: No significant differences were observed in cognitive or academic skills between the control and effected groups at any age. Participants with more severe neonatal hypoglycemia reported fewer problem behaviors at age 18 than those without hypoglycemia. CONCLUSIONS: No significant differences in intellectual or academic achievement were found between preterm infants with and without hypoglycemia. A statistical difference was found in behavior at age 18, with hypoglycemic children showing fewer problematic behaviors than normoglycemic children. This difference was not clinically meaningful. Using extended outcomes, our results are consistent with previous studies that found no significant neurodevelopmental outcomes associated with neonatal hypoglycemia in preterm-born children. PMID:27940690

Proton adsorption onto alumina: extension of multisite complexation (MUSIC) theory

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

Nagashima, K.; Blum, F.D.

1999-09-01

The adsorption isotherm of protons onto a commercial {gamma}-alumina sample was determined in aqueous nitric acid with sodium nitrate as a background electrolyte. Three discrete regions could be discerned in the log-log plots of the proton isotherm determined at the solution pH 5 to 2. The multisite complexation (MUSIC) model was modified to analyze the simultaneous adsorption of protons onto various kinds of surface species.

Creative Entextualizations of Discourses about Race in Multi-Sited Discursive Practices in the Brazilian "Periphery"

ERIC Educational Resources Information Center

Guimarães, Thayse Figueira; Moita-Lopes, Luiz Paulo

2017-01-01

This paper focuses on Luan's race performances both on the web and in classroom interaction. Luan is a black young man, who identifies himself as gay. The study is part of a multi-sited ethnographic piece of research on a group of high-school students in the state sector, in the "periphery" of a town on the Rio de Janeiro State north…

The value and potential of multisited ethnography for science education research: a review of Jrène Rahm's Science in the Making at the Margin

NASA Astrophysics Data System (ADS)

Beeman-Cadwallader, Nicole

2012-03-01

Rahm sought to illuminate how children and youth make meaning of science in three out-of-school time programs, and the identity work that is done through the trajectory of their youth toward their young adulthood. Through using multisited ethnography, she asserts that we can learn more about what the youth say about their science learning and science literacy development in these programs. She has revealed through her rich data the potential value of multisited ethnography for science education research. A similar theme of insider/outsider status to science emerged in each of the three sites. The nature of the data collected in Rahm's multisited ethnography allowed for the unveiling of the similarities in this theme, but also made evident the nuanced ways that this theme presented itself differently across the three sites. The additional potential came through in the varied data Rahm could have delved into and did not. A unique characteristic of ethnographic research, that is not necessarily present in other research methods, is that a wide array of varied data is collected. An analysis of documents, images, and observational field notes, which go beyond interview data, may provide deeper understandings previously untouched in science education.

Use of personal digital assistants for data collection in a multi-site AIDS stigma study in rural south Nyanza, Kenya.

PubMed

Onono, M A; Carraher, N; Cohen, R C; Bukusi, E A; Turan, J M

2011-09-01

To describe the development, cost effectiveness and implementation of a PDA based electronic system to collect, verify and manage data from a multi-site study on HIV/AIDS stigma and pregnancy in a rural, resource-poor area. We worked within a large prevention of mother-to-child-transmission (PMTCT) program in nine rural health facilities to implement a PDA-based data collection system and to study the feasibility of its use in a multisite HIV research study in rural Kenya. The PDAs were programmed for collecting screening and eligibility data, and responses to structured interviews on HIV/AIDS stigma and violence in three local languages. Between November 2007 and December 2008, nine PDAs were used by Clinic and Community Health Assistants to enrol 1,270 participants on to the PMTCT program. Successes included: capacity-building of interviewers, low cost of implementation, quick turnaround time of data entry with good data quality, and convenience. Our study demonstrated the feasibility of utilizing PDAs for data collection in a multi-site observational study on HIV/AIDS stigma conducted in remote rural health facilities in Kenya. However, appropriate and frequent data backup protocols need to be established and paper forms are still needed as backup tools in resource-poor settings.

The impact of parent-delivered intervention on parents of very young children with autism.

PubMed

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2014-02-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n = 49) with community intervention (n = 49) for children aged 12 and 24 months. The P-ESDM group reported no increase in parenting stress, whereas the Community group experienced an increase over the same 3-month period. Parental sense of competence did not differ. Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups. This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD.

The impact of parent-delivered intervention on parents of very young children with autism

PubMed Central

Estes, Annette; Vismara, Laurie; Mercado, Carla; Fitzpatrick, Annette; Elder, Lauren; Greenson, Jessica; Lord, Catherine; Munson, Jeffrey; Winter, Jamie; Young, Gregory; Dawson, Geraldine; Rogers, Sally

2013-01-01

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n=49) with community intervention (n=49) for children aged 12 and 24 months. The P-ESDM group reported no increase in parenting stress, whereas the Community group experienced an increase over the same 3-month period. Parental sense of competence did not differ. Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups. This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD. PMID:23838727