PROMOTING SUPPORTIVE PARENTING IN NEW MOTHERS WITH SUBSTANCE-USE PROBLEMS: A PILOT RANDOMIZED TRIAL OF RESIDENTIAL TREATMENT PLUS AN ATTACHMENT-BASED PARENTING PROGRAM

PubMed Central

BERLIN, LISA J.; SHANAHAN, MEGHAN; CARMODY, KAREN APPLEYARD

2015-01-01

This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier’s Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. PMID:25424409

75 FR 34997 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... trial research designs to evaluate the effectiveness of interventions or practices. NIDRR believes that randomized control trial research designs can be appropriate for research that involves evaluating specific interventions. However, in complex service delivery settings, other scientifically rigorous research designs may...

Advancing Evidence in Preterm Neonatal Medicine

ERIC Educational Resources Information Center

Donahue, Pamela K.; Robinson, Karen A.

2010-01-01

Few interventions and treatments for premature infants have undergone the rigors of a randomized controlled trial (RCT), the cornerstone of evidence-based healthcare. Multiple barriers in establishing a quality evidence base for the care of preterm infants are examined including the systematic exclusion of children from drug trials, vulnerability…

Observational Research Rigor Alone Does Not Justify Causal Inference

PubMed Central

Ejima, Keisuke; Li, Peng; Smith, Daniel L.; Nagy, Tim R.; Kadish, Inga; van Groen, Thomas; Dawson, John A.; Yang, Yongbin; Patki, Amit; Allison, David B.

2016-01-01

Background Differing opinions exist on whether associations obtained in observational studies can be reliable indicators of a causal effect if the observational study is sufficiently well controlled and executed. Materials and methods To test this, we conducted two animal observational studies that were rigorously controlled and executed beyond what is achieved in studies of humans. In study 1, we randomized 332 genetically identical C57BL/6J mice into three diet groups with differing food energy allotments and recorded individual self-selected daily energy intake and lifespan. In study 2, 60 male mice (CD1) were paired and divided into two groups for a 2-week feeding regimen. We evaluated the association between weight gain and food consumption. Within each pair, one animal was randomly assigned to an S group in which the animals had free access to food. The second paired animal (R group) was provided exactly the same diet that their S partner ate the day before. Results In study 1, across all three groups, we found a significant negative effect of energy intake on lifespan. However, we found a positive association between food intake and lifespan among the ad libitum feeding group: 29.99 (95% CI: 8.2 to 51.7) days per daily kcal. In study 2, we found a significant (P=0.003) group (randomized vs self-selected)-by-food consumption interaction effect on weight gain. Conclusions At least in nutrition research, associations derived from observational studies may not be reliable indicators of causal effects, even with the most rigorous study designs achievable. PMID:27711975

Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

PubMed Central

Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, Francisco

2017-01-01

Background Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery, particularly in the TMJ field, by proposing a rigorous design in black Merino sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to progress in future treatment options for patients undergoing surgery for TMJ disk replacement. Conclusions The study has commenced, but it is too early to provide results or conclusions. PMID:28254733

An Interaction-Based Approach to Enhancing Secondary School Instruction and Student Achievement

ERIC Educational Resources Information Center

Allen, Joseph; Pianta, Robert; Gregory, Anne; Mikami, Amori; Lun, Janetta

2011-01-01

Improving teaching quality is widely recognized as critical to addressing deficiencies in secondary school education, yet the field has struggled to identify rigorously evaluated teacher-development approaches that can produce reliable gains in student achievement. A randomized controlled trial of My Teaching Partner-Secondary--a Web-mediated…

Poor Implementation of Learner-Centered Practices: A Cautionary Tale

ERIC Educational Resources Information Center

Ikemoto, Gina Schuyler; Steele, Jennifer L.; Pane, John F.

2016-01-01

Many school systems are adopting new curricula in response to more rigorous standards that require higher-order thinking skills. This chapter presents implementation findings from a randomized, controlled trial of the Cognitive Tutor Geometry curriculum. We found a significant negative effect on student achievement despite the curriculum's focus…

Treatment Outcome and Maintenance in Systematic Desensitization: Professional versus Paraprofessional Effectiveness.

ERIC Educational Resources Information Center

Shelton, John L.; Madrazo-Peterson, Rita

1978-01-01

Anxious students were randomly assigned to a wait-list control group; to three groups aided by experienced behavior therapists; or to three groups led by paraprofessionals. Results show paraprofessionals can achieve outcome and maintenance effects equivalent to more rigorously trained professionals. Paraprofessionals can conduct desensitization in…

77 FR 26764 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... two sites, with the random assignment of AFI-eligible cases to program and control groups. The... Families (ACF) is proposing a data collection activity as part of an experimental evaluation of the Assets... outcomes? While some evaluations suggest that IDAs help low-income families save, rigorous experimental...

Assessing Sensitivity of Early Head Start Study Findings to Manipulated Randomization Threats

ERIC Educational Resources Information Center

Green, Sheridan

2013-01-01

Increasing demands for design rigor and an emphasis on evidence-based practice on a national level indicated a need for further guidance related to successful implementation of randomized studies in education. Rigorous and meaningful experimental research and its conclusions help establish a valid theoretical and evidence base for educational…

Enhancing Women's Resistance to Sexual Coercion: A Randomized Controlled Trial of the DATE Program

ERIC Educational Resources Information Center

Simpson Rowe, Lorelei; Jouriles, Ernest N.; McDonald, Renee; Platt, Cora G.; Gomez, Gabriella S.

2012-01-01

Objective: Despite extensive efforts to develop sexual assault prevention programs for college women, few have been rigorously evaluated, and fewer have demonstrable effects on victimization. This study pilots the Dating Assertiveness Training Experience (DATE), designed to train young women in assertiveness skills for responding to sexual…

Designing and Conducting Strong Quasi-Experiments in Education. Version 2

ERIC Educational Resources Information Center

Scher, Lauren; Kisker, Ellen; Dynarski, Mark

2015-01-01

The purpose of this paper is to describe best practices in designing and implementing strong quasi-experimental designs (QED) when assessing the effectiveness of policies, programs or practices. The paper first discusses the issues researchers face when choosing to conduct a QED, as opposed to a more rigorous randomized controlled trial design.…

Mental skills training with basic combat training soldiers: A group-randomized trial.

PubMed

Adler, Amy B; Bliese, Paul D; Pickering, Michael A; Hammermeister, Jon; Williams, Jason; Harada, Coreen; Csoka, Louis; Holliday, Bernie; Ohlson, Carl

2015-11-01

Cognitive skills training has been linked to greater skills, self-efficacy, and performance. Although research in a variety of organizational settings has demonstrated training efficacy, few studies have assessed cognitive skills training using rigorous, longitudinal, randomized trials with active controls. The present study examined cognitive skills training in a high-risk occupation by randomizing 48 platoons (N = 2,432 soldiers) in basic combat training to either (a) mental skills training or (b) an active comparison condition (military history). Surveys were conducted at baseline and 3 times across the 10-week course. Multilevel mixed-effects models revealed that soldiers in the mental skills training condition reported greater use of a range of cognitive skills and increased confidence relative to those in the control condition. Soldiers in the mental skills training condition also performed better on obstacle course events, rappelling, physical fitness, and initial weapons qualification scores, although effects were generally moderated by gender and previous experience. Overall, effects were small; however, given the rigor of the design, the findings clearly contribute to the broader literature by providing supporting evidence that cognitive training skills can enhance performance in occupational and sports settings. Future research should address gender and experience to determine the need for targeting such training appropriately. (c) 2015 APA, all rights reserved).

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

On the evidentiary standards for nutrition advice.

PubMed

Jukola, Saana

2018-06-01

This paper evaluates the application of evidentiary standards originating from evidence-based medicine in nutrition advice. It shows that it is problematic to criticize nutrition recommendations for not being based on randomized controlled trials. Due to practical, ethical and methodological and reasons, it is difficult to conduct rigorous randomized controlled trials for acquiring evidence that is relevant for achieving the goals of population-level nutrition recommendations. Given the non-epistemic goals of the dietary recommendations, criteria of acceptable evidence should be adapted to the goals of the practice and the practical, ethical, and methodological constraints of the situation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.

PubMed

Carson, James W; Carson, Kimberly M; Olsen, Maren K; Sanders, Linda; Porter, Laura S

2017-03-13

Women with metastatic breast cancer (MBC) have average life expectancies of about 2 years, and report high levels of disease-related symptoms including pain, fatigue, sleep disturbance, psychological distress, and functional impairment. There is growing recognition of the limitations of medical approaches to managing such symptoms. Yoga is a mind-body discipline that has demonstrated a positive impact on psychological and functional health in early stage breast cancer patients and survivors, but has not been rigorously studied in advanced cancer samples. This randomized controlled trial examines the feasibility and initial efficacy of a Mindful Yoga program, compared with a social support condition that controls for attention, on measures of disease-related symptoms such as pain and fatigue. The study will be completed by December 2017. Sixty-five women with MBC age ≥ 18 are being identified and randomized with a 2:1 allocation to Mindful Yoga or a support group control intervention. The 120-min intervention sessions take place weekly for 8 weeks. The study is conducted at an urban tertiary care academic medical center located in Durham, North Carolina. The primary feasibility outcome is attendance at intervention sessions. Efficacy outcomes include pain, fatigue, sleep quality, psychological distress, mindfulness and functional capacity at post-intervention, 3-month follow-up, and 6-month follow-up. In this article, we present the challenges of designing a randomized controlled trial with long-term follow-up among women with MBC. These challenges include ensuring adequate recruitment including of minorities, limiting and controlling for selection bias, tailoring of the yoga intervention to address special needs, and maximizing adherence and retention. This project will provide important information regarding yoga as an intervention for women with advanced cancer, including preliminary data on the psychological and functional effects of yoga for MBC patients. This investigation will also establish rigorous methods for future research into yoga as an intervention for this population. ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.

Blended Learning Improves Science Education.

PubMed

Stockwell, Brent R; Stockwell, Melissa S; Cennamo, Michael; Jiang, Elise

2015-08-27

Blended learning is an emerging paradigm for science education but has not been rigorously assessed. We performed a randomized controlled trial of blended learning. We found that in-class problem solving improved exam performance, and video assignments increased attendance and satisfaction. This validates a new model for science communication and education. Copyright © 2015 Elsevier Inc. All rights reserved.

Gathering Evidence on an After-School Supplemental Instruction Program: Design Challenges and Early Findings in Light of NCLB

ERIC Educational Resources Information Center

Chatterji, Madhabi; Kwon, Young Ae; Sng, Clarice

2006-01-01

The No Child Left Behind (NCLB) Act of 2001 requires that public schools adopt research-supported programs and practices, with a strong recommendation for randomized controlled trials (RCTs) as the "gold standard" for scientific rigor in empirical research. Within that policy framework, this paper compares the relative utility of…

Grades of Evidence: Variability in Quality of Findings in Effectiveness Studies of Complex Field Interventions

ERIC Educational Resources Information Center

Chatterji, Madhabi

2007-01-01

This article argues with a literature review that a simplistic distinction between strong and weak evidence hinged on the use of randomized controlled trials (RCTs), the federal "gold standard" for generating rigorous evidence on social programs and policies, is not tenable with evaluative studies of complex, field interventions such as…

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.

PubMed

Tingey, Lauren; Chambers, Rachel; Goklish, Novalene; Larzelere, Francene; Lee, Angelita; Suttle, Rosemarie; Rosenstock, Summer; Lake, Kristin; Barlow, Allison

2017-02-27

American Indian adolescents have one of the highest rates of teen pregnancy and repeat teen births in the US. Substance use is a significant risk factor for unprotected sex, and American Indian adolescents have the highest substance use-related morbidity and mortality of any US racial group. Despite these disparities, there are no existing, evidence-based programs for pregnancy prevention that have been rigorously evaluated among American Indian teens. The proposed study is a randomized controlled trial to test the efficacy of a comprehensive sexual and reproductive health program developed in partnership with an American Indian community. Participants will be American Indians ages 11-19 and their parent or trusted adult, randomized to receive the control condition or intervention called Respecting the Circle of Life: Mind, Body and Spirit. The intervention includes eight lessons delivered to self-selected peer groups during a summer basketball camp and one lesson delivered to the youth and parent/trusted adult together within 3 months after camp. All lessons are administered by trained community health workers from the participating American Indian community. Youth and parent/trusted adult participants will complete assessments at baseline, 3, 9, 12, 24 and 36 months post-intervention completion. The primary outcome variables are sexual/reproductive health knowledge, sexual initiation, condom use self-efficacy and intent to use a condom at next sex as changed from baseline to post-intervention between intervention and control participants. Selected primary outcomes are applicable to all study participants. Currently there are no sexual and reproductive health programs designed specifically for American Indian youth that have been rigorously evaluated and found to have an evidence base. Respecting the Circle of Life is highly innovative by incorporating lesson delivery into a summer basketball camp and involving parents or other trusted adults in curriculum administration. If found successful, it will be the first evidence-based program for teen pregnancy prevention for American Indian youth and adolescents. Clinicaltrials.gov, NCT02904629 . Retrospectively registered on 23 September 2016.

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial.

PubMed

Tucker, Joan S; Edelen, Maria Orlando; Huang, Wenjing

2017-03-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N = 111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention.

Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial

PubMed Central

Tucker, Joan S.; Edelen, Maria Orlando; Huang, Wenjing

2016-01-01

Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N=111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention. PMID:26762375

Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

PubMed Central

Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

2015-01-01

Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

[The efficacy of music and music therapy in the neuromotor rehabilitation].

PubMed

Raglio, Alfredo

2012-01-01

This article review includes the controlled and randomized controlled trials about the use of music and music therapy techniques in the neuromotor rehabilitation. The paper defines the music therapy and delineates the neuroscientific bases and rehabilitative potential of music and music therapy interventions. Significant results are present in the stroke and Parkinson's disease rehabilitation. The Author's conclusions suggest the need of more rigorous studies based on clear procedures and strong methodological research criteria.

Testing the Impact of a Pre-Instructional Digital Game on Middle-Grade Students' Understanding of Photosynthesis

ERIC Educational Resources Information Center

Culp, Katherine McMillan; Martin, Wendy; Clements, Margaret; Lewis Presser, Ashley

2015-01-01

Rigorous studies of the impact of digital games on student learning remain relatively rare, as do studies of games as supports for learning difficult, core curricular concepts in the context of normal classroom practices. This study uses a blocked, cluster randomized controlled trial design to test the impact of a digital game, played as homework…

Collaborative Evaluation of a High School Prevention Curriculum: How Methods of Collaborative Evaluation Enhanced a Randomized Control Trial to Inform Program Improvement

ERIC Educational Resources Information Center

Orsini, Muhsin Michael; Wyrick, David L.; Milroy, Jeffrey J.

2012-01-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome…

Evaluation of the Tennessee Voluntary Prekindergarten Program: Kindergarten and First Grade Follow-Up Results from the Randomized Control Design. Research Report

ERIC Educational Resources Information Center

Lipsey, Mark W.; Hofer, Kerry G.; Dong, Nianbo; Farran, Dale C.; Bilbrey, Carol

2013-01-01

In 2009, Vanderbilt University's Peabody Research Institute, with the assistance of the Tennessee Department of Education's Division of Curriculum and Instruction, initiated a rigorous, independent evaluation of the state's Voluntary Prekindergarten program (TN- VPK). TN-VPK is a full-day prekindergarten program for four-year-old children expected…

Interventions for disorder and severe intoxication in and around licensed premises, 1989-2009.

PubMed

Brennan, Iain; Moore, Simon C; Byrne, Ellie; Murphy, Simon

2011-04-01

To systematically review rigorous evaluation studies into the effectiveness of interventions in and around licensed premises that aimed to reduce severe intoxication and disorder. A systematic search was conducted. Papers that rigorously evaluated interventions based in and around licensed premises to reduce disorder or intoxication were included. Fifteen studies were identified, three randomized controlled trials and 12 non-randomized quasi-experimental evaluations. Outcome measures were intoxication (n = 6), disorder (n = 6) and intoxication and disorder (n = 3). Interventions included responsible beverage service training (n = 5), server violence prevention training (n = 1), enhanced enforcement of licensing regulations (n = 1), multi-level interventions (n = 5), licensee accords (n = 2) and a risk-focused consultation (n = 1). Intervention effects varied, even across studies using similar interventions. Server training courses that are designed to reduce disorder have some potential, although there is a lack of evidence to support their use to reduce intoxication and the evidence base is weak. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Hypnotherapy and Test Anxiety: Two Cognitive-Behavioral Constructs. The Effects of Hypnosis in Reducing Test Anxiety and Improving Academic Achievement in College Students.

ERIC Educational Resources Information Center

Sapp, Marty

A two-group randomized multivariate analysis of covariance (MANCOVA) was used to investigate the effects of cognitive-behavioral hypnosis in reducing test anxiety and improving academic performance in comparison to a Hawthorne control group. Subjects were enrolled in a rigorous introductory psychology course which covered an entire text in one…

The Participant Effects of Private School Vouchers across the Globe: A Meta-Analytic and Systematic Review

ERIC Educational Resources Information Center

Shakeel, M. Danish; Anderson, Kaitlin P.; Wolf, Patrick J.

2016-01-01

The objective of this meta-analysis is to rigorously assess the participant effects of private school vouchers, or in other words, to estimate the average academic impacts that the offer (or use) of a voucher has on a student. This review adds to the literature by being the first to systematically review all Randomized Control Trials (RCTs) in an…

Study Design Rigor in Animal-Experimental Research Published in Anesthesia Journals.

PubMed

Hoerauf, Janine M; Moss, Angela F; Fernandez-Bustamante, Ana; Bartels, Karsten

2018-01-01

Lack of reproducibility of preclinical studies has been identified as an impediment for translation of basic mechanistic research into effective clinical therapies. Indeed, the National Institutes of Health has revised its grant application process to require more rigorous study design, including sample size calculations, blinding procedures, and randomization steps. We hypothesized that the reporting of such metrics of study design rigor has increased over time for animal-experimental research published in anesthesia journals. PubMed was searched for animal-experimental studies published in 2005, 2010, and 2015 in primarily English-language anesthesia journals. A total of 1466 publications were graded on the performance of sample size estimation, randomization, and blinding. Cochran-Armitage test was used to assess linear trends over time for the primary outcome of whether or not a metric was reported. Interrater agreement for each of the 3 metrics (power, randomization, and blinding) was assessed using the weighted κ coefficient in a 10% random sample of articles rerated by a second investigator blinded to the ratings of the first investigator. A total of 1466 manuscripts were analyzed. Reporting for all 3 metrics of experimental design rigor increased over time (2005 to 2010 to 2015): for power analysis, from 5% (27/516), to 12% (59/485), to 17% (77/465); for randomization, from 41% (213/516), to 50% (243/485), to 54% (253/465); and for blinding, from 26% (135/516), to 38% (186/485), to 47% (217/465). The weighted κ coefficients and 98.3% confidence interval indicate almost perfect agreement between the 2 raters beyond that which occurs by chance alone (power, 0.93 [0.85, 1.0], randomization, 0.91 [0.85, 0.98], and blinding, 0.90 [0.84, 0.96]). Our hypothesis that reported metrics of rigor in animal-experimental studies in anesthesia journals have increased during the past decade was confirmed. More consistent reporting, or explicit justification for absence, of sample size calculations, blinding techniques, and randomization procedures could better enable readers to evaluate potential sources of bias in animal-experimental research manuscripts. Future studies should assess whether such steps lead to improved translation of animal-experimental anesthesia research into successful clinical trials.

A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial

PubMed Central

Koufopoulos, Justin T; Conner, Mark T; Gardner, Peter H

2016-01-01

Background Online communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs. Objective Our objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine. Methods This 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an “online community” or “no online community” (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others’ posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site). Results In all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions. Conclusions Joining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT) PMID:27298211

Antimüllerian hormone levels and antral follicle counts are not reduced compared with community controls in patients with rigorously defined unexplained infertility.

PubMed

Greenwood, Eleni A; Cedars, Marcelle I; Santoro, Nanette; Eisenberg, Esther; Kao, Chia-Ning; Haisenleder, Daniel J; Diamond, Michael P; Huddleston, Heather G

2017-12-01

To test the hypothesis that women with unexplained infertility demonstrate evidence of diminished ovarian reserve when compared with a population of community controls. Cross-sectional study. Multicenter university-based clinical practices. Study participants included 277 healthy, normo-ovulatory female partners with rigorously defined unexplained infertility randomly selected from a multicenter trial (Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation). Controls included 226 healthy, normo-ovulatory women not seeking treatment for fertility from a community-based cohort (Ovarian Aging study). Serum antimüllerian hormone (AMH) assay at a central laboratory, FSH, fasting serum metabolic testing, transvaginal ultrasonography for antral follicle counts (AFCs), anthropometric measurements. Average AMH, AFC, and AMH/AFC were compared between infertile and control women by age. Analyses of covariance compared these outcomes while controlling for confounders, including age, race, body mass index, smoking history, and study site. In our models, AMH, AFC, and AMH/AFC ovarian reserve indices did not differ between infertile women and community-based controls, after controlling for age, race, body mass index, smoking history, and study site. Currently utilized predictors of ovarian reserve do not discriminate women with rigorously defined unexplained infertility from healthy community-based women of similar demographic characteristics. Contrary to our hypothesis, among women with FSH in the normal range (≤12 IU/L), women with unexplained infertility did not show evidence of decreased ovarian reserve as measured by AMH and AFC. Ovarian reserve markers in isolation may not serve as predictors of future fertility. Copyright © 2017 American Society for Reproductive Medicine. All rights reserved.

Current Status of Renal Denervation in Hypertension.

PubMed

Briasoulis, Alexander; Bakris, George L

2016-11-01

Over the past 7 years, prospective cohorts and small randomized controlled studies showed that renal denervation therapy (RDN) in patients with resistant hypertension is safe but associated with variable effects on BP which are not substantially better than medical therapy alone. The failure of the most rigorously designed randomized sham-control study, SYMPLICITY HTN-3, to meet the efficacy endpoints has raised several methodological concerns. However, recently reported studies and ongoing trials with improved procedural characteristics, identification of patients with true treatment-resistant hypertension on appropriate antihypertensive regimens further explore potential benefits of RDN. The scope of this review is to summarize evidence from currently completed studies on RDN and discuss future perspectives of RDN therapy in patients with resistant hypertension.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials.

PubMed

Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

2016-01-01

Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [-0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures.

Methodological rigor and citation frequency in patient compliance literature.

PubMed Central

Bruer, J T

1982-01-01

An exhaustive bibliography which assesses the methodological rigor of the patient compliance literature, and citation data from the Science Citation Index (SCI) are combined to determine if methodologically rigorous papers are used with greater frequency than substandard articles by compliance investigators. There are low, but statistically significant, correlations between methodological rigor and citation indicators for 138 patient compliance papers published in SCI source journals during 1975 and 1976. The correlation is not strong enough to warrant use of citation measures as indicators of rigor on a paper-by-paper basis. The data do suggest that citation measures might be developed as crude indicators of methodological rigor. There is no evidence that randomized trials are cited more frequently than studies that employ other experimental designs. PMID:7114334

Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

PubMed

Nelson, Nicole L; Churilla, James R

2017-09-01

Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

Acupuncture-Related Techniques for Psoriasis: A Systematic Review with Pairwise and Network Meta-Analyses of Randomized Controlled Trials.

PubMed

Yeh, Mei-Ling; Ko, Shu-Hua; Wang, Mei-Hua; Chi, Ching-Chi; Chung, Yu-Chu

2017-12-01

There has be a large body of evidence on the pharmacological treatments for psoriasis, but whether nonpharmacological interventions are effective in managing psoriasis remains largely unclear. This systematic review conducted pairwise and network meta-analyses to determine the effects of acupuncture-related techniques on acupoint stimulation for the treatment of psoriasis and to determine the order of effectiveness of these remedies. This study searched the following databases from inception to March 15, 2016: Medline, PubMed, Cochrane Central Register of Controlled Trials, EBSCO (including Academic Search Premier, American Doctoral Dissertations, and CINAHL), Airiti Library, and China National Knowledge Infrastructure. Randomized controlled trials (RCTs) on the effects of acupuncture-related techniques on acupoint stimulation as intervention for psoriasis were independently reviewed by two researchers. A total of 13 RCTs with 1,060 participants were included. The methodological quality of included studies was not rigorous. Acupoint stimulation, compared with nonacupoint stimulation, had a significant treatment for psoriasis. However, the most common adverse events were thirst and dry mouth. Subgroup analysis was further done to confirm that the short-term treatment effect was superior to that of the long-term effect in treating psoriasis. Network meta-analysis identified acupressure or acupoint catgut embedding, compared with medication, and had a significant effect for improving psoriasis. It was noted that acupressure was the most effective treatment. Acupuncture-related techniques could be considered as an alternative or adjuvant therapy for psoriasis in short term, especially of acupressure and acupoint catgut embedding. This study recommends further well-designed, methodologically rigorous, and more head-to-head randomized trials to explore the effects of acupuncture-related techniques for treating psoriasis.

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

PubMed Central

Calhoun, Stacy; Conner, Emma; Miller, Melodi; Messina, Nena

2015-01-01

Substance abuse is a major public health concern that impacts not just the user but also the user’s family. The effect that parental substance abuse has on children has been given substantial attention over the years. Findings from the literature suggest that children of substance-abusing parents have a high risk of developing physical and mental health and behavioral problems. A number of intervention programs have been developed for parents who have a substance abuse problem. There have also been a number of interventions that have been developed for children who have at least one parent with a substance abuse problem. However, it remains unclear how we can best mitigate the negative effects that parental substance abuse has on children due to the scarcity of evaluations that utilize rigorous methodologies such as experimental designs. The purpose of this study is to review randomized controlled trials of intervention programs targeting parents with substance abuse problems and/or children with at least one parent with a substance abuse problem in order to identify programs that show some promise in improving the behavioral and mental health outcomes of children affected by parental substance abuse. Four randomized controlled trials that met our eligibility criteria were identified using major literature search engines. The findings from this review suggest that interventions that focus on improving parenting practices and family functioning may be effective in reducing problems in children affected by parental substance abuse. However, further research utilizing rigorous methodologies are needed in order to identify other successful interventions that can improve the outcomes of these children long after the intervention has ended. PMID:25670915

Coverage Metrics for Requirements-Based Testing: Evaluation of Effectiveness

NASA Technical Reports Server (NTRS)

Staats, Matt; Whalen, Michael W.; Heindahl, Mats P. E.; Rajan, Ajitha

2010-01-01

In black-box testing, the tester creates a set of tests to exercise a system under test without regard to the internal structure of the system. Generally, no objective metric is used to measure the adequacy of black-box tests. In recent work, we have proposed three requirements coverage metrics, allowing testers to objectively measure the adequacy of a black-box test suite with respect to a set of requirements formalized as Linear Temporal Logic (LTL) properties. In this report, we evaluate the effectiveness of these coverage metrics with respect to fault finding. Specifically, we conduct an empirical study to investigate two questions: (1) do test suites satisfying a requirements coverage metric provide better fault finding than randomly generated test suites of approximately the same size?, and (2) do test suites satisfying a more rigorous requirements coverage metric provide better fault finding than test suites satisfying a less rigorous requirements coverage metric? Our results indicate (1) only one coverage metric proposed -- Unique First Cause (UFC) coverage -- is sufficiently rigorous to ensure test suites satisfying the metric outperform randomly generated test suites of similar size and (2) that test suites satisfying more rigorous coverage metrics provide better fault finding than test suites satisfying less rigorous coverage metrics.

The administration to Indonesians of monosodium L-glutamate in Indonesian foods: an assessment of adverse reactions in a randomized double-blind, crossover, placebo-controlled study.

PubMed

Prawirohardjono, W; Dwiprahasto, I; Astuti, I; Hadiwandowo, S; Kristin, E; Muhammad, M; Kelly, M F

2000-04-01

Monosodium L-glutamate (MSG) has been suggested to cause postprandial symptoms after the ingestion of Chinese or oriental meals. Therefore, we examined whether such symptoms could be elicited in Indonesians ingesting levels of MSG typically found in Indonesian cuisine. Healthy volunteers (n = 52) were treated with capsules of placebo or MSG (1.5 and 3.0 g/person) as part of a standardized Indonesian breakfast. The study used a rigorous, randomized, double-blind, crossover design. The occurrence of symptoms after MSG ingestion did not differ from that after consumption of the placebo.

Closed-Loop Control of Complex Networks: A Trade-Off between Time and Energy

NASA Astrophysics Data System (ADS)

Sun, Yong-Zheng; Leng, Si-Yang; Lai, Ying-Cheng; Grebogi, Celso; Lin, Wei

2017-11-01

Controlling complex nonlinear networks is largely an unsolved problem at the present. Existing works focus either on open-loop control strategies and their energy consumptions or on closed-loop control schemes with an infinite-time duration. We articulate a finite-time, closed-loop controller with an eye toward the physical and mathematical underpinnings of the trade-off between the control time and energy as well as their dependence on the network parameters and structure. The closed-loop controller is tested on a large number of real systems including stem cell differentiation, food webs, random ecosystems, and spiking neuronal networks. Our results represent a step forward in developing a rigorous and general framework to control nonlinear dynamical networks with a complex topology.

Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group.

PubMed

Balderson, Benjamin H; McCurry, Susan M; Vitiello, Michael V; Shortreed, Susan M; Rybarczyk, Bruce D; Keefe, Francis J; Korff, Michael Von

2016-01-01

This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Ting-Hao; Tung, Tao-Hsin; Chen, Pei-Shih; Wang, Shu-Hui; Chao, Chuang-Min; Hsiung, Nan-Hsing; Chi, Ching-Chi

2016-01-01

Purpose. Aromatherapy massage is an alternative treatment in reducing the pain of the cancer patients. This study was to investigate whether aromatherapy massage could improve the pain of the cancer patients. Methods. We searched PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 1 January 1990 and 31 July 2015 with a priori defined inclusion and exclusion criteria. The search terms included aromatherapy, essential oil, pain, ache, cancer, tumor, and carcinoma. There were 7 studies which met the selection criteria and 3 studies were eventually included among 63 eligible publications. Results. This meta-analysis included three randomized controlled trials with a total of 278 participants (135 participants in the massage with essential oil group and 143 participants in the control (usual care) group). Compared with the control group, the massage with essential oil group had nonsignificant effect on reducing the pain (standardized mean difference = 0.01; 95% CI [−0.23,0.24]). Conclusion. Aromatherapy massage does not appear to reduce pain of the cancer patients. Further rigorous studies should be conducted with more objective measures. PMID:26884799

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

PubMed

Anheyer, Dennis; Leach, Matthew J; Klose, Petra; Dobos, Gustav; Cramer, Holger

2018-01-01

Background Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. Data sources and study selection MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. Results Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). Conclusions Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

Hombre Seguro (Safe Men): a sexual risk reduction intervention for male clients of female sex workers

PubMed Central

2014-01-01

Background Male clients of female sex workers (FSWs) are at risk of HIV and other sexually transmitted infections (STIs). We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana, Mexico. Methods/Design Male clients of FSWs who were at least 18, were HIV-negative at baseline, and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention, or a time-attention didactic control condition. Each condition lasted approximately one hour. Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline, and at 4, 8, and 12 month follow-ups. Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes. Discussion A total of 400 participants were randomized to one of the two conditions. Analyses indicated that randomization was successful; there were no significant differences between the participants in the two conditions at baseline. Average follow-up was 84% across both conditions. This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial. Trial registration NCT01280838, Date of registration: January 19, 2011. PMID:24885949

Student peer assessment in evidence-based medicine (EBM) searching skills training: an experiment

PubMed Central

Eldredge, Jonathan D.; Bear, David G.; Wayne, Sharon J.; Perea, Paul P.

2013-01-01

Background: Student peer assessment (SPA) has been used intermittently in medical education for more than four decades, particularly in connection with skills training. SPA generally has not been rigorously tested, so medical educators have limited evidence about SPA effectiveness. Methods: Experimental design: Seventy-one first-year medical students were stratified by previous test scores into problem-based learning tutorial groups, and then these assigned groups were randomized further into intervention and control groups. All students received evidence-based medicine (EBM) training. Only the intervention group members received SPA training, practice with assessment rubrics, and then application of anonymous SPA to assignments submitted by other members of the intervention group. Results: Students in the intervention group had higher mean scores on the formative test with a potential maximum score of 49 points than did students in the control group, 45.7 and 43.5, respectively (P = 0.06). Conclusions: SPA training and the application of these skills by the intervention group resulted in higher scores on formative tests compared to those in the control group, a difference approaching statistical significance. The extra effort expended by librarians, other personnel, and medical students must be factored into the decision to use SPA in any specific educational context. Implications: SPA has not been rigorously tested, particularly in medical education. Future, similarly rigorous studies could further validate use of SPA so that librarians can optimally make use of limited contact time for information skills training in medical school curricula. PMID:24163593

Impact of cooking and home food preparation interventions among adults: outcomes and implications for future programs

PubMed Central

Reicks, Marla; Trofholz, Amanda C.; Stang, Jamie S; Laska, Melissa N.

2014-01-01

Objective Cooking programs are growing in popularity; however an extensive review has not examined overall impact. Therefore, this study reviewed previous research on cooking/home food preparation interventions and diet and health-related outcomes among adults and identified implications for practice and research. Design Literature review and descriptive summative method. Main outcome measures Dietary intake, knowledge/skills, cooking attitudes and self-efficacy/confidence, health outcomes. Analysis Articles evaluating effectiveness of interventions that included cooking/home food preparation as the primary aim (January 1980 through December 2011) were identified via OVID MEDLINE, Agricola and Web of Science databases. Studies grouped according to design and outcomes were reviewed for validity using an established coding system. Results were summarized for several outcome categories. Results Of 28 studies identified, 12 included a control group with six as non-randomized and six as randomized controlled trials. Evaluation was done post-intervention for five studies, pre- and post-intervention for 23 and beyond post-intervention for 15. Qualitative and quantitative measures suggested a positive influence on main outcomes. However, non-rigorous study designs, varying study populations, and use of non-validated assessment tools limited stronger conclusions. Conclusions and Implications Well-designed studies are needed that rigorously evaluate long-term impact on cooking behavior, dietary intake, obesity and other health outcomes. PMID:24703245

Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial.

PubMed

Barbee, Anita P; Cunningham, Michael R; van Zyl, Michiel A; Antle, Becky F; Langley, Cheri N

2016-09-01

To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention.

A Randomized Study of How Physicians Interpret Research Funding Disclosures

PubMed Central

Kesselheim, Aaron S.; Robertson, Christopher T.; Myers, Jessica A.; Rose, Susannah L.; Gillet, Victoria; Ross, Kathryn M.; Glynn, Robert J.; Joffe, Steven; Avorn, Jerry

2012-01-01

BACKGROUND The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor. METHODS We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians’ impressions of the trials’ rigor, their confidence in the results, and their willingness to prescribe the drugs. RESULTS The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P = 0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P = 0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P = 0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P = 0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor. CONCLUSIONS Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial’s quality. These effects may influence the translation of clinical research into practice. PMID:22992075

Observational research rigour alone does not justify causal inference.

PubMed

Ejima, Keisuke; Li, Peng; Smith, Daniel L; Nagy, Tim R; Kadish, Inga; van Groen, Thomas; Dawson, John A; Yang, Yongbin; Patki, Amit; Allison, David B

2016-12-01

Differing opinions exist on whether associations obtained in observational studies can be reliable indicators of a causal effect if the observational study is sufficiently well controlled and executed. To test this, we conducted two animal observational studies that were rigorously controlled and executed beyond what is achieved in studies of humans. In study 1, we randomized 332 genetically identical C57BL/6J mice into three diet groups with differing food energy allotments and recorded individual self-selected daily energy intake and lifespan. In study 2, 60 male mice (CD1) were paired and divided into two groups for a 2-week feeding regimen. We evaluated the association between weight gain and food consumption. Within each pair, one animal was randomly assigned to an S group in which the animals had free access to food. The second paired animal (R group) was provided exactly the same diet that their S partner ate the day before. In study 1, across all three groups, we found a significant negative effect of energy intake on lifespan. However, we found a positive association between food intake and lifespan among the ad libitum feeding group: 29·99 (95% CI: 8·2-51·7) days per daily kcal. In study 2, we found a significant (P = 0·003) group (randomized vs. self-selected)-by-food consumption interaction effect on weight gain. At least in nutrition research, associations derived from observational studies may not be reliable indicators of causal effects, even with the most rigorous study designs achievable. © 2016 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

Propensity Score Matching: Retrospective Randomization?

PubMed

Jupiter, Daniel C

Randomized controlled trials are viewed as the optimal study design. In this commentary, we explore the strength of this design and its complexity. We also discuss some situations in which these trials are not possible, or not ethical, or not economical. In such situations, specifically, in retrospective studies, we should make every effort to recapitulate the rigor and strength of the randomized trial. However, we could be faced with an inherent indication bias in such a setting. Thus, we consider the tools available to address that bias. Specifically, we examine matching and introduce and explore a new tool: propensity score matching. This tool allows us to group subjects according to their propensity to be in a particular treatment group and, in so doing, to account for the indication bias. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

What Is the Efficacy of Teaching Psychotherapy to Psychiatry Residents and Medical Students?

PubMed

Truong, Anh; Wu, Peter; Diez-Barroso, Ramon; Coverdale, John

2015-10-01

Because there are no formal reviews, the authors set out to identify and evaluate studies on teaching psychotherapy to psychiatry residents and medical students. PubMed, Embase, and PsycINFO were searched for papers with outcomes on teaching psychotherapy. Search terms included psychotherapy, teaching, residents, medical students, supportive, psychodynamic, cognitive, behavioral, learning, training, skills, competency, and mentalization. Nine studies were found that met inclusion criteria. There were seven studies of psychiatry residents and two of medical students. Only two of the research designs had comparison groups, and these were both randomized controlled trials, while seven of the other designs were pretest and posttest. Teaching methods, course content, and outcome measures varied widely across studies. Common methodological problems included a lack of control, low numbers of subjects as learners, and a lack of validity of the outcome measures. Only one of the studies was judged to be methodologically rigorous. These findings establish a priority for undertaking additional rigorously designed studies in evaluating the teaching of psychotherapy to psychiatry residents and medical students.

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

Why so many "rigorous" evaluations fail to identify unintended consequences of development programs: How mixed methods can contribute.

PubMed

Bamberger, Michael; Tarsilla, Michele; Hesse-Biber, Sharlene

2016-04-01

Many widely-used impact evaluation designs, including randomized control trials (RCTs) and quasi-experimental designs (QEDs), frequently fail to detect what are often quite serious unintended consequences of development programs. This seems surprising as experienced planners and evaluators are well aware that unintended consequences frequently occur. Most evaluation designs are intended to determine whether there is credible evidence (statistical, theory-based or narrative) that programs have achieved their intended objectives and the logic of many evaluation designs, even those that are considered the most "rigorous," does not permit the identification of outcomes that were not specified in the program design. We take the example of RCTs as they are considered by many to be the most rigorous evaluation designs. We present a numbers of cases to illustrate how infusing RCTs with a mixed-methods approach (sometimes called an "RCT+" design) can strengthen the credibility of these designs and can also capture important unintended consequences. We provide a Mixed Methods Evaluation Framework that identifies 9 ways in which UCs can occur, and we apply this framework to two of the case studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Trial registration Current Controlled Trials ISRCTN19506752 PMID:21672213

Rigor in Qualitative Social Work Research: A Review of Strategies Used in Published Articles

ERIC Educational Resources Information Center

Barusch, Amanda; Gringeri, Christina; George, Molly

2011-01-01

This study was conducted to describe strategies used by social work researchers to enhance the rigor of their qualitative work. A template was developed and used to review a random sample of 100 articles drawn from social work journals listed in the "2005 Journal Citation Reports: Science and Social Sciences Edition." Results suggest that the most…

Manual-guided psychosocial treatment. A new virtual requirement for pharmacotherapy trials?

PubMed

Carroll, K M

1997-10-01

The conduct of randomized clinical trials to evaluate the efficacy of pharmacotherapies for mental disorders is guided by research standards (at a high level of rigor) that govern most design elements, including randomization of subjects, use of placebo controls, formulation and dosage of the therapeutic agent, and monitoring of serum levels. In contrast, no such widely accepted guidelines are recognized for standardization of an essential, if unacknowledged, element of all such studies: the concomitant provision of at least a minimal form of psychosocial treatment. Standardized provision of psychosocial treatments in pharmacotherapy trials will foster replicability of findings and address several common problems (e.g., attrition, medication noncompliance, reduction of error variance, and ethical issues associated with placebo controls). Careful selection and standardization of the psychosocial context in which medications are delivered will improve the validity, precision, and power of pharmacotherapy efficacy research, and should be considered a virtual requirement in research design.

Causal inference as an emerging statistical approach in neurology: an example for epilepsy in the elderly.

PubMed

Moura, Lidia Mvr; Westover, M Brandon; Kwasnik, David; Cole, Andrew J; Hsu, John

2017-01-01

The elderly population faces an increasing number of cases of chronic neurological conditions, such as epilepsy and Alzheimer's disease. Because the elderly with epilepsy are commonly excluded from randomized controlled clinical trials, there are few rigorous studies to guide clinical practice. When the elderly are eligible for trials, they either rarely participate or frequently have poor adherence to therapy, thus limiting both generalizability and validity. In contrast, large observational data sets are increasingly available, but are susceptible to bias when using common analytic approaches. Recent developments in causal inference-analytic approaches also introduce the possibility of emulating randomized controlled trials to yield valid estimates. We provide a practical example of the application of the principles of causal inference to a large observational data set of patients with epilepsy. This review also provides a framework for comparative-effectiveness research in chronic neurological conditions.

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis.

PubMed

Hilton, Lara; Hempel, Susanne; Ewing, Brett A; Apaydin, Eric; Xenakis, Lea; Newberry, Sydne; Colaiaco, Ben; Maher, Alicia Ruelaz; Shanman, Roberta M; Sorbero, Melony E; Maglione, Margaret A

2017-04-01

Chronic pain patients increasingly seek treatment through mindfulness meditation. This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults. We conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use. Thirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life. While mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.

A systematic review of randomized trials of mind-body interventions for PTSD.

PubMed

Niles, Barbara L; Mori, DeAnna L; Polizzi, Craig; Pless Kaiser, Anica; Weinstein, Elizabeth S; Gershkovich, Marina; Wang, Chenchen

2018-05-10

To systematically review outcomes from randomized controlled trials (RCTs) of mind-body treatments for PTSD. Inclusion criteria based on guidelines for assessing risk of bias were used to evaluate articles identified through electronic literature searches. Twenty-two RCTs met inclusion standards. In most of the nine mindfulness and six yoga studies, significant between-group effects were found indicating moderate to large effect size advantages for these treatments. In all seven relaxation RCT's, relaxation was used as a control condition and five studies reported significant between-group differences on relevant PTSD outcomes in favor of the target treatments. However, there were large within-group symptom improvements in the relaxation condition for the majority of studies. Although many studies are limited by methodologic weaknesses, recent studies have increased rigor and, in aggregate, the results for mindfulness, yoga, and relaxation are promising. Recommendations for design of future mind-body trials are offered. © 2018 Wiley Periodicals, Inc.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

Jianpi Bushen, a Traditional Chinese Medicine Therapy, Combined with Chemotherapy for Gastric Cancer Treatment: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Yunbo; Zhang, Guijuan; Chen, Xiaoping; Jiang, Xuefeng; Yuan, Naijun; Wang, Yurong; Hao, Xiaoqian

2018-01-01

Objective. To investigate the effects of Jianpi Bushen (JPBS), a traditional Chinese medicine that is used to invigorate the spleen and tonify the kidney, combined with chemotherapy for the treatment of gastric cancer. Methods. Literature retrieval was performed in PubMed, EMBASE, Cochrane Library, MEDLINE, CNKI, Wanfang Data Information Site, and VIP from inception to October 2017. Randomized controlled trials to evaluate the effects of JPBS combined with chemotherapy were identified. The primary reported outcomes were KPS (Karnofsky Performance Status), clinical curative efficiency, immune function, blood system, and nonhematologic system. Review Manager 5.3 (RevMan 5.3) was used for data analysis, and the quality of the studies was also appraised. Results. A total of 26 studies were included with 3098 individuals. The results of the meta-analysis indicated that treatment of gastric cancer with the combination of JPBS and chemotherapy resulted in better outcomes compared to chemotherapy alone. Conclusion. Evidence from the meta-analysis suggested that JPBS combined with chemotherapy has a positive effect on gastric cancer treatment. However, additional rigorously designed and large sample randomized controlled trials are required to confirm the efficacy and safety of this treatment. PMID:29675052

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

PubMed

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

Random Assignment within Schools: Lessons Learned from the Teach for America Experiment

ERIC Educational Resources Information Center

Glazerman, Steven

2012-01-01

Randomized trials are a common way to provide rigorous evidence on the impacts of education programs. This article discusses the trade-offs associated with study designs that involve random assignment of students within schools and describes the experience from one such study of Teach for America (TFA). The TFA experiment faced challenges with…

Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial

PubMed Central

2012-01-01

Background Evidence-Based Medicine (EBM) is an important competency for the healthcare professional. Experimental evidence of EBM educational interventions from rigorous research studies is limited. The main objective of this study was to assess EBM learning (knowledge, attitudes and self-reported skills) in undergraduate medical students with a randomized controlled trial. Methods The educational intervention was a one-semester EBM course in the 5th year of a public medical school in Mexico. The study design was an experimental parallel group randomized controlled trial for the main outcome measures in the 5th year class (M5 EBM vs. M5 non-EBM groups), and quasi-experimental with static-groups comparisons for the 4th year (M4, not yet exposed) and 6th year (M6, exposed 6 months to a year earlier) groups. EBM attitudes, knowledge and self-reported skills were measured using Taylor’s questionnaire and a summative exam which comprised of a 100-item multiple-choice question (MCQ) test. Results 289 Medical students were assessed: M5 EBM=48, M5 non-EBM=47, M4=87, and M6=107. There was a higher reported use of the Cochrane Library and secondary journals in the intervention group (M5 vs. M5 non-EBM). Critical appraisal skills and attitude scores were higher in the intervention group (M5) and in the group of students exposed to EBM instruction during the previous year (M6). The knowledge level was higher after the intervention in the M5 EBM group compared to the M5 non-EBM group (p<0.001, Cohen's d=0.88 with Taylor's instrument and 3.54 with the 100-item MCQ test). M6 Students that received the intervention in the previous year had a knowledge score higher than the M4 and M5 non-EBM groups, but lower than the M5 EBM group. Conclusions Formal medical student training in EBM produced higher scores in attitudes, knowledge and self-reported critical appraisal skills compared with a randomized control group. Data from the concurrent groups add validity evidence to the study, but rigorous follow-up needs to be done to document retention of EBM abilities. PMID:23131115

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

PubMed

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

2016-08-02

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

Towards rigorous analysis of the Levitov-Mirlin-Evers recursion

NASA Astrophysics Data System (ADS)

Fyodorov, Y. V.; Kupiainen, A.; Webb, C.

2016-12-01

This paper aims to develop a rigorous asymptotic analysis of an approximate renormalization group recursion for inverse participation ratios P q of critical powerlaw random band matrices. The recursion goes back to the work by Mirlin and Evers (2000 Phys. Rev. B 62 7920) and earlier works by Levitov (1990 Phys. Rev. Lett. 64 547, 1999 Ann. Phys. 8 697-706) and is aimed to describe the ensuing multifractality of the eigenvectors of such matrices. We point out both similarities and dissimilarities between the LME recursion and those appearing in the theory of multiplicative cascades and branching random walks and show that the methods developed in those fields can be adapted to the present case. In particular the LME recursion is shown to exhibit a phase transition, which we expect is a freezing transition, where the role of temperature is played by the exponent q. However, the LME recursion has features that make its rigorous analysis considerably harder and we point out several open problems for further study.

Development and utilization of complementary communication channels for treatment decision making and survivorship issues among cancer patients: The CIS Research Consortium Experience.

PubMed

Fleisher, Linda; Wen, Kuang Yi; Miller, Suzanne M; Diefenbach, Michael; Stanton, Annette L; Ropka, Mary; Morra, Marion; Raich, Peter C

2015-11-01

Cancer patients and survivors are assuming active roles in decision-making and digital patient support tools are widely used to facilitate patient engagement. As part of Cancer Information Service Research Consortium's randomized controlled trials focused on the efficacy of eHealth interventions to promote informed treatment decision-making for newly diagnosed prostate and breast cancer patients, and post-treatment breast cancer, we conducted a rigorous process evaluation to examine the actual use of and perceived benefits of two complementary communication channels -- print and eHealth interventions. The three Virtual Cancer Information Service (V-CIS) interventions were developed through a rigorous developmental process, guided by self-regulatory theory, informed decision-making frameworks, and health communications best practices. Control arm participants received NCI print materials; experimental arm participants received the additional V-CIS patient support tool. Actual usage data from the web-based V-CIS was also obtained and reported. Print materials were highly used by all groups. About 60% of the experimental group reported using the V-CIS. Those who did use the V-CIS rated it highly on improvements in knowledge, patient-provider communication and decision-making. The findings show that how patients actually use eHealth interventions either singularly or within the context of other communication channels is complex. Integrating rigorous best practices and theoretical foundations is essential and multiple communication approaches should be considered to support patient preferences.

Animal-Assisted Therapy for Post-traumatic Stress Disorder: Lessons from "Case Reports" in Media Stories.

PubMed

Altschuler, Eric L

2018-01-01

Post-traumatic stress disorder (PTSD) can follow war trauma, sexual abuse, other traumas, and even be experienced by commanders for the PTSD of their subordinates. Medications and counseling are sometimes not effective, so new treatments are needed. Some years ago, I suggested that animal-assisted therapy (AAT) (pet therapy) might be beneficial for PTSD. A large randomized controlled trial is underway of canine-assisted therapy for PTSD. Randomized controlled trials are most useful in assessing the efficacy of a medical intervention as these trials control for known and unknown biases. However, due to their very nature and rigorous requirements, knowledge gained from randomized controlled trials may need to be supplemented from other kinds of studies. Here, I note that media reports of AAT for PTSD may effectively function as case reports and suggest further studies: For PTSD, these demonstrate that (1) AAT can be dramatically effective in improving PTSD symptoms; (2) there is the potential for benefit from AAT by multiple different animals besides canines for PTSD; and (3) AAT may have a role in preventing suicide in patients with PTSD. © Association of Military Surgeons of the United States 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Current Evidence on Auricular Therapy for Chemotherapy-Induced Nausea and Vomiting in Cancer Patients: A Systematic Review of Randomized Controlled Trials

PubMed Central

Molassiotis, Alexander; Wang, Tao; Suen, Lorna K. P.

2014-01-01

Auricular therapy (AT) has been historically viewed as a convenient approach adjunct to pharmacological therapy for cancer patients with chemotherapy-induced nausea and vomiting (CINV). The aim of this study was to assess the evidence of the therapeutic effect of AT for CINV management in cancer patients. Relevant randomized controlled trials were retrieved from 12 electronic databases without language restrictions. Meanwhile, manual search was conducted for Chinese journals on complementary medicine published within the last five years, and the reference lists of included studies were also checked to identify any possible eligible studies. Twenty-one studies with 1713 participants were included. The effect rate of AT for managing acute CINV ranged from 44.44% to 93.33% in the intervention groups and 15% to 91.67% in the control groups. For delayed CINV, it was 62.96% to 100% and 25% to 100%, respectively. AT seems to be a promising approach in managing CINV. However, the level of evidence was low and the definite effect cannot be concluded as there were significant methodological flaws identified in the analyzed studies. The implications drawn from the 21 studies put some clues for future practice in this area including the need to conduct more rigorously designed randomized controlled trials. PMID:25525445

Nurse leader mindfulness meditation program for stress management: a randomized controlled trial.

PubMed

Pipe, Teri Britt; Bortz, Jennifer J; Dueck, Amylou; Pendergast, Debra; Buchda, Vicki; Summers, Jay

2009-03-01

The aim of this study was to rigorously evaluate a brief stress management intervention for nurse leaders. Despite the nursing shortage, evidence-based workplace approaches addressing nurse stress have not been well studied. Nurse leaders (n = 33) were randomly assigned to brief mindfulness meditation course (MMC) or leadership course (control). Self-report measures of stress were administered at baseline and within 1 week of course completion. Among MMC participants, change scores (from baseline to postintervention) on several subscales of the Symptom Checklist 90-Revised showed significantly more improvement in self-reported stress symptoms relative to controls. Mindfulness meditation course participants had significantly more improvement in Positive Symptom Distress Index (P = 0.010; confidence interval [CI] = -0.483 to -0.073) and Global Severity Index (P = 0.019; CI = -0.475 to -0.046) and nearly significantly more improvement in Positive Symptom Total (P = 0.066; CI = -16.66 to 0.581) compared with controls. Results support preliminary effectiveness of a 4-week MMC in reducing self-reported stress symptoms among nursing leaders.

Standards and Methodological Rigor in Pulmonary Arterial Hypertension Preclinical and Translational Research.

PubMed

Provencher, Steeve; Archer, Stephen L; Ramirez, F Daniel; Hibbert, Benjamin; Paulin, Roxane; Boucherat, Olivier; Lacasse, Yves; Bonnet, Sébastien

2018-03-30

Despite advances in our understanding of the pathophysiology and the management of pulmonary arterial hypertension (PAH), significant therapeutic gaps remain for this devastating disease. Yet, few innovative therapies beyond the traditional pathways of endothelial dysfunction have reached clinical trial phases in PAH. Although there are inherent limitations of the currently available models of PAH, the leaky pipeline of innovative therapies relates, in part, to flawed preclinical research methodology, including lack of rigour in trial design, incomplete invasive hemodynamic assessment, and lack of careful translational studies that replicate randomized controlled trials in humans with attention to adverse effects and benefits. Rigorous methodology should include the use of prespecified eligibility criteria, sample sizes that permit valid statistical analysis, randomization, blinded assessment of standardized outcomes, and transparent reporting of results. Better design and implementation of preclinical studies can minimize inherent flaws in the models of PAH, reduce the risk of bias, and enhance external validity and our ability to distinguish truly promising therapies form many false-positive or overstated leads. Ideally, preclinical studies should use advanced imaging, study several preclinical pulmonary hypertension models, or correlate rodent and human findings and consider the fate of the right ventricle, which is the major determinant of prognosis in human PAH. Although these principles are widely endorsed, empirical evidence suggests that such rigor is often lacking in pulmonary hypertension preclinical research. The present article discusses the pitfalls in the design of preclinical pulmonary hypertension trials and discusses opportunities to create preclinical trials with improved predictive value in guiding early-phase drug development in patients with PAH, which will need support not only from researchers, peer reviewers, and editors but also from academic institutions, funding agencies, and animal ethics authorities. © 2018 American Heart Association, Inc.

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

PubMed

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

2009-07-02

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

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

PubMed Central

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

2009-01-01

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

Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Bellemans, Johan; Mulier, Michiel

2010-11-16

Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine.The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS), Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment) and intake of pain rescue medication (number per week). In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. NCT01079455.

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

PubMed

McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

Effects of rigor status during high-pressure processing on the physical qualities of farm-raised abalone (Haliotis rufescens).

PubMed

Hughes, Brianna H; Greenberg, Neil J; Yang, Tom C; Skonberg, Denise I

2015-01-01

High-pressure processing (HPP) is used to increase meat safety and shelf-life, with conflicting quality effects depending on rigor status during HPP. In the seafood industry, HPP is used to shuck and pasteurize oysters, but its use on abalones has only been minimally evaluated and the effect of rigor status during HPP on abalone quality has not been reported. Farm-raised abalones (Haliotis rufescens) were divided into 12 HPP treatments and 1 unprocessed control treatment. Treatments were processed pre-rigor or post-rigor at 2 pressures (100 and 300 MPa) and 3 processing times (1, 3, and 5 min). The control was analyzed post-rigor. Uniform plugs were cut from adductor and foot meat for texture profile analysis, shear force, and color analysis. Subsamples were used for scanning electron microscopy of muscle ultrastructure. Texture profile analysis revealed that post-rigor processed abalone was significantly (P < 0.05) less firm and chewy than pre-rigor processed irrespective of muscle type, processing time, or pressure. L values increased with pressure to 68.9 at 300 MPa for pre-rigor processed foot, 73.8 for post-rigor processed foot, 90.9 for pre-rigor processed adductor, and 89.0 for post-rigor processed adductor. Scanning electron microscopy images showed fraying of collagen fibers in processed adductor, but did not show pressure-induced compaction of the foot myofibrils. Post-rigor processed abalone meat was more tender than pre-rigor processed meat, and post-rigor processed foot meat was lighter in color than pre-rigor processed foot meat, suggesting that waiting for rigor to resolve prior to processing abalones may improve consumer perceptions of quality and market value. © 2014 Institute of Food Technologists®

Experimental evaluation of rigor mortis. VII. Effect of ante- and post-mortem electrocution on the evolution of rigor mortis.

PubMed

Krompecher, T; Bergerioux, C

1988-01-01

The influence of electrocution on the evolution of rigor mortis was studied on rats. Our experiments showed that: (1) Electrocution hastens the onset of rigor mortis. After an electrocution of 90 s, a complete rigor develops already 1 h post-mortem (p.m.) compared to 5 h p.m. for the controls. (2) Electrocution hastens the passing of rigor mortis. After an electrocution of 90 s, the first significant decrease occurs at 3 h p.m. (8 h p.m. in the controls). (3) These modifications in rigor mortis evolution are less pronounced in the limbs not directly touched by the electric current. (4) In case of post-mortem electrocution, the changes are slightly less pronounced, the resistance is higher and the absorbed energy is lower as compared with the ante-mortem electrocution cases. The results are completed by two practical observations on human electrocution cases.

The iron cycle in chronic kidney disease (CKD): from genetics and experimental models to CKD patients

PubMed Central

Zumbrennen-Bullough, Kimberly; Babitt, Jodie L.

2014-01-01

Iron is essential for most living organisms but iron excess can be toxic. Cellular and systemic iron balance is therefore tightly controlled. Iron homeostasis is dysregulated in chronic kidney disease (CKD) and contributes to the anemia that is prevalent in this patient population. Iron supplementation is one cornerstone of anemia management in CKD patients, but has not been rigorously studied in large prospective randomized controlled trials. This review highlights important advances from genetic studies and animal models that have provided key insights into the molecular mechanisms governing iron homeostasis and its disturbance in CKD, and summarizes how these findings may yield advances in the care of this patient population. PMID:24235084

LA sprouts randomized controlled nutrition, cooking and gardening programme reduces obesity and metabolic risk in Hispanic/Latino youth.

PubMed

Gatto, N M; Martinez, L C; Spruijt-Metz, D; Davis, J N

2017-02-01

Many programmes for children that involve gardening and nutrition components exist; however, none include experimental designs allowing more rigorous evaluation of their impact on obesity. The objective of this study is to explore the effects of a novel 12-week gardening, nutrition and cooking intervention {'LA Sprouts'} on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles.. This study used a randomized control trial involving four elementary schools [two randomized to intervention {172, 3rd-5th grade students}; two randomized to control {147, 3rd-5th grade students}]. Classes were taught in 90-min sessions once per week for 12 weeks. Data collected at pre-intervention and post-intervention included dietary intake via food frequency questionnaire, anthropometric measures {body mass index, waist circumference}, body fat, and fasting blood samples. LA Sprouts participants compared with controls had significantly greater reductions in body mass index z-scores {-0.1 vs. -0.04, respectively; p = 0.01} and waist circumference {-1.2 vs. 0.1 cm; p < 0.001}. Fewer LA Sprouts participants had the metabolic syndrome after the intervention than before, while controls with metabolic syndrome increased. LA Sprouts participants compared with controls increased dietary fiber intake {+3.4% vs. -16.5%; p = 0.04}. All participants decreased vegetable intake, but decreases were less in LA Sprouts than controls {-3.7% vs. -26.1%; p = 0.04}. Change in fruit intake did not differ between LA Sprouts and controls. LA Sprouts was effective in reducing obesity and metabolic risk; however, additional larger and longer-term studies are warranted. © 2016 World Obesity Federation.

Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

PubMed

Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

2017-09-15

Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

Creating and synthesizing evidence with decision makers in mind: integrating evidence from clinical trials and other study designs.

PubMed

Atkins, David

2007-10-01

Randomized controlled trials (RCTs) remain the accepted "gold standard" for determining the efficacy of new drugs or medical procedures. Randomized trials alone, however, cannot provide all the relevant information decision makers need to determine the relative risks and benefits when choosing the best treatment of individual patients or weighing the implications of particular policies affecting medical therapies. To demonstrate the limitations of RCTs in providing the information needed by medical decision makers, and to show how information from observational studies can supplement evidence from RCTs. Qualitative description of the limitations of RCTs in providing the information needed by medical decision makers, and demonstration of how evidence from additional sources can aid in decision making, using the examples of deciding whether a 60-year-old woman with mildly elevated blood pressure should take daily low-dose aspirin, and whether a hospital network should implement carotid artery surgery for asymptomatic patients. Even the most rigorously designed RCTs leave many questions central to medical decision making unanswered. Research using cohort and case-control designs, disease and intervention registries, and outcomes studies based on administrative data can all shed light on who is most likely to benefit from the treatment, and what the important tradeoffs are. This suggests the need to revise the traditional evidence hierarchy, whereby evidence progresses linearly from basic research to rigorous RCTs. This revised hierarchy recognizes that other research designs can provide important evidence to strengthen our understanding of how to apply research findings in practice.

Implementing the PAIN RelieveIt Randomized Controlled Trial in Hospice Care: Mechanisms for Success and Meeting PCORI Methodology Standards.

PubMed

Ezenwa, Miriam O; Suarez, Marie L; Carrasco, Jesus D; Hipp, Theresa; Gill, Anayza; Miller, Jacob; Shea, Robert; Shuey, David; Zhao, Zhongsheng; Angulo, Veronica; McCurry, Timothy; Martin, Joanna; Yao, Yingwei; Molokie, Robert E; Wang, Zaijie Jim; Wilkie, Diana J

2017-07-01

This purpose of this article is to describe how we adhere to the Patient-Centered Outcomes Research Institute's (PCORI) methodology standards relevant to the design and implementation of our PCORI-funded study, the PAIN RelieveIt Trial. We present details of the PAIN RelieveIt Trial organized by the PCORI methodology standards and components that are relevant to our study. The PAIN RelieveIt Trial adheres to four PCORI standards and 21 subsumed components. The four standards include standards for formulating research questions, standards associated with patient centeredness, standards for data integrity and rigorous analyses, and standards for preventing and handling missing data. In the past 24 months, we screened 2,837 cancer patients and their caregivers; 874 dyads were eligible; 223.5 dyads consented and provided baseline data. Only 55 patients were lost to follow-up-a 25% attrition rate. The design and implementation of the PAIN RelieveIt Trial adhered to PCORI's methodology standards for research rigor.

Distinguishing cause from correlation in tokamak experiments to trigger edge-localised plasma instabilities

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

Webster, Anthony J.; CCFE, Culham Science Centre, Abingdon OX14 3DB

2014-11-15

The generic question is considered: How can we determine the probability of an otherwise quasi-random event, having been triggered by an external influence? A specific problem is the quantification of the success of techniques to trigger, and hence control, edge-localised plasma instabilities (ELMs) in magnetically confined fusion (MCF) experiments. The development of such techniques is essential to ensure tolerable heat loads on components in large MCF fusion devices, and is necessary for their development into economically successful power plants. Bayesian probability theory is used to rigorously formulate the problem and to provide a formal solution. Accurate but pragmatic methods aremore » developed to estimate triggering probabilities, and are illustrated with experimental data. These allow results from experiments to be quantitatively assessed, and rigorously quantified conclusions to be formed. Example applications include assessing whether triggering of ELMs is a statistical or deterministic process, and the establishment of thresholds to ensure that ELMs are reliably triggered.« less

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

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

PubMed

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

2015-03-15

In the past decade, garlic has become one of the most popular complementary therapies for blood pressure (BP) control used by hypertensive patients. Numerous clinical studies have focused on the BP-lowering effect of garlic, but results have been inconsistent. Overall, there is a dearth of information available to guide the clinical community on the efficacy of garlic in hypertensive patients. To systematically review the medical literature to investigate the current evidence of garlic for the treatment of hypertension. PubMed, the Cochrane Library and EMBASE were searched for appropriate articles from their respective inceptions until August 2014. Randomized, placebo-controlled trials comparing garlic vs. a placebo in patients with hypertension were considered. Papers were independently reviewed by two reviewers and were analyzed using Cochrane software Revman 5.2. A total of seven randomized, placebo-controlled trials were identified. Compared with the placebo, this meta-analysis revealed a significant lowering effect of garlic on both systolic BP (WMD: -6.71 mmHg; 95% CI: -12.44 to -0.99; P = 0.02) and diastolic BP (WMD: -4.79 mmHg; 95% CI: -6.60 to -2.99; P < 0.00001). No serious adverse events were reported in any of the trials. The present review suggests that garlic is an effective and safe approach for hypertension. However, more rigorously designed randomized controlled trials focusing on primary endpoints with long-term follow-up are still warranted before garlic can be recommended to treat hypertensive patients. Copyright © 2015 Elsevier GmbH. All rights reserved.

Practice-based evidence study design for comparative effectiveness research.

PubMed

Horn, Susan D; Gassaway, Julie

2007-10-01

To describe a new, rigorous, comprehensive practice-based evidence for clinical practice improvement (PBE-CPI) study methodology, and compare its features, advantages, and disadvantages to those of randomized controlled trials and sophisticated statistical methods for comparative effectiveness research. PBE-CPI incorporates natural variation within data from routine clinical practice to determine what works, for whom, when, and at what cost. It uses the knowledge of front-line caregivers, who develop study questions and define variables as part of a transdisciplinary team. Its comprehensive measurement framework provides a basis for analyses of significant bivariate and multivariate associations between treatments and outcomes, controlling for patient differences, such as severity of illness. PBE-CPI studies can uncover better practices more quickly than randomized controlled trials or sophisticated statistical methods, while achieving many of the same advantages. We present examples of actionable findings from PBE-CPI studies in postacute care settings related to comparative effectiveness of medications, nutritional support approaches, incontinence products, physical therapy activities, and other services. Outcomes improved when practices associated with better outcomes in PBE-CPI analyses were adopted in practice.

Effects of yoga exercises for headaches: a systematic review of randomized controlled trials

PubMed Central

Kim, Sang-Dol

2015-01-01

[Purpose] To assess the evidence for the effectiveness of yoga exercises in the management of headaches. [Subjects and Methods] A search was conducted of six electronic databases to identify randomized controlled trials (RCTs) reporting the effects of yogic intervention on headaches published in any language before January 2015. Quality assessment was conducted using the Cochrane risk of bias tool. [Results] One potential trial was identified and included in this review. The quality critical appraisal indicated a moderate risk of bias. The available data could only be included as a narrative description. Headache intensity and frequency, anxiety and depression scores, and symptomatic medication use were significantly lower in the yoga group compared to the control group. [Conclusion] There is evidence from one RCT that yoga exercises may be beneficial for headaches. However, the findings should be interpreted with caution due to the small number of RCTs. Therefore, further rigorous methodological and high quality RCTs are required to investigate the hypothesis that yoga exercises alleviate headaches, and to confirm and further comprehend the effects of standardized yoga programs on headaches. PMID:26311986

Evaluating the Health Impact of Large-Scale Public Policy Changes: Classical and Novel Approaches

PubMed Central

Basu, Sanjay; Meghani, Ankita; Siddiqi, Arjumand

2018-01-01

Large-scale public policy changes are often recommended to improve public health. Despite varying widely—from tobacco taxes to poverty-relief programs—such policies present a common dilemma to public health researchers: how to evaluate their health effects when randomized controlled trials are not possible. Here, we review the state of knowledge and experience of public health researchers who rigorously evaluate the health consequences of large-scale public policy changes. We organize our discussion by detailing approaches to address three common challenges of conducting policy evaluations: distinguishing a policy effect from time trends in health outcomes or preexisting differences between policy-affected and -unaffected communities (using difference-in-differences approaches); constructing a comparison population when a policy affects a population for whom a well-matched comparator is not immediately available (using propensity score or synthetic control approaches); and addressing unobserved confounders by utilizing quasi-random variations in policy exposure (using regression discontinuity, instrumental variables, or near-far matching approaches). PMID:28384086

Collaborative evaluation of a high school prevention curriculum: How methods of collaborative evaluation enhanced a randomized control trial to inform program improvement.

PubMed

Orsini, Muhsin Michael; Wyrick, David L; Milroy, Jeffrey J

2012-11-01

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome variables that can be used for program improvement. Throughout this project there were many examples of client learning from evaluator and evaluator learning from client. This article presents convincing evidence that collaborative evaluation can improve the design, implementation, and findings of the randomized control trial. Throughout this paper, we discuss many examples of good science, good evaluation, and other practical benefits of practicing collaborative evaluation. Ultimately, the authors created the term pre-formative evaluation to describe the period prior to data collection and before program implementation, when collaborative evaluation can inform program improvement. Copyright © 2012 Elsevier Ltd. All rights reserved.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial.

PubMed

Norman, Wendy V; Kaczorowski, Janusz; Soon, Judith A; Brant, Rollin; Bryan, Stirling; Trouton, Konia J; Dicus, Lyda

2011-06-14

We describe the rationale and protocol for a randomized controlled trial (RCT) to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention) or four weeks (recommended care) post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion) and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one through five years among enrolled women. We highlight considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion.

Zhen Gan Xi Feng Decoction, a Traditional Chinese Herbal Formula, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

PubMed Central

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use. PMID:23573163

Baduanjin Exercise for Stroke Rehabilitation: A Systematic Review with Meta-Analysis of Randomized Controlled Trials

PubMed Central

Wang, Chaoyi; Chen, Xiaoan; Wang, Huiru

2018-01-01

Objective: The purpose of this review was to objectively evaluate the effects of Baduanjin exercise on rehabilitative outcomes in stroke patients. Methods: Both Chinese and English electronic databases were searched for potentially relevant trials. Two review authors independently screened eligible trials against the inclusion criteria, extracted data, and assessed the methodological quality by using the revised PEDro scale. Meta-analysis was only performed for balance function. Results: In total, there were eight randomized controlled trials selected in this systematic review. The aggregated result of four trials has shown a significant benefit in favor of Baduanjin on balance function (Hedges’ g = 2.39, 95% CI 2.14 to 2.65, p < 0.001, I2 = 61.54). Additionally, Baduanjin exercise effectively improved sensorimotor function of lower extremities and ability of daily activities as well as reduced depressive level, leading to improved quality of life. Conclusion: Baduanjin exercise as an adjunctive and safe method may be conducive to help stroke patients achieve the best possible short-term outcome and should be integrated with mainstream rehabilitation programs. More rigorous randomized controlled trials with long-term intervention periods among a large sample size of stroke patients are needed to draw a firm conclusion regarding the rehabilitative effects for this population. PMID:29584623

Random walks on combs

NASA Astrophysics Data System (ADS)

Durhuus, Bergfinnur; Jonsson, Thordur; Wheater, John F.

2006-02-01

We develop techniques to obtain rigorous bounds on the behaviour of random walks on combs. Using these bounds, we calculate exactly the spectral dimension of random combs with infinite teeth at random positions or teeth with random but finite length. We also calculate exactly the spectral dimension of some fixed non-translationally invariant combs. We relate the spectral dimension to the critical exponent of the mass of the two-point function for random walks on random combs, and compute mean displacements as a function of walk duration. We prove that the mean first passage time is generally infinite for combs with anomalous spectral dimension.

Bringing scientific rigor to community-developed programs in Hong Kong.

PubMed

Fabrizio, Cecilia S; Hirschmann, Malia R; Lam, Tai Hing; Cheung, Teresa; Pang, Irene; Chan, Sophia; Stewart, Sunita M

2012-12-31

This paper describes efforts to generate evidence for community-developed programs to enhance family relationships in the Chinese culture of Hong Kong, within the framework of community-based participatory research (CBPR). The CBPR framework was applied to help maximize the development of the intervention and the public health impact of the studies, while enhancing the capabilities of the social service sector partners. Four academic-community research teams explored the process of designing and implementing randomized controlled trials in the community. In addition to the expected cultural barriers between teams of academics and community practitioners, with their different outlooks, concerns and languages, the team navigated issues in utilizing the principles of CBPR unique to this Chinese culture. Eventually the team developed tools for adaptation, such as an emphasis on building the relationship while respecting role delineation and an iterative process of defining the non-negotiable parameters of research design while maintaining scientific rigor. Lessons learned include the risk of underemphasizing the size of the operational and skills shift between usual agency practices and research studies, the importance of minimizing non-negotiable parameters in implementing rigorous research designs in the community, and the need to view community capacity enhancement as a long term process. The four pilot studies under the FAMILY Project demonstrated that nuanced design adaptations, such as wait list controls and shorter assessments, better served the needs of the community and led to the successful development and vigorous evaluation of a series of preventive, family-oriented interventions in the Chinese culture of Hong Kong.

Considerations for Designing Group Randomized Trials of Professional Development with Teacher Knowledge Outcomes

ERIC Educational Resources Information Center

Kelcey, Ben; Phelps, Geoffrey

2013-01-01

Despite recent shifts in research emphasizing the value of carefully designed experiments, the number of studies of teacher professional development with rigorous designs has lagged behind its student outcome counterparts. We outline a framework for the design of group randomized trials (GRTs) with teachers' knowledge as the outcome and…

76 FR 74076 - Notice of Random Assignment Study To Evaluate the YouthBuild Program; Final Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-30

... Evaluate the YouthBuild Program; Final Notice AGENCY: Employment and Training Administration (ETA), Labor... rigorous, nationally-representative estimates of the net impacts of the YouthBuild program. The Department... study. In the sites randomly selected to participate in this evaluation, all applicants for YouthBuild...

Modified Constraint-Induced Therapy for Children with Hemiplegic Cerebral Palsy: A Randomized Trial

ERIC Educational Resources Information Center

Wallen, Margaret; Ziviani, Jenny; Naylor, Olivia; Evans, Ruth; Novak, Iona; Herbert, Robert D.

2011-01-01

Aim: Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study…

Experiment Design for Complex VTOL Aircraft with Distributed Propulsion and Tilt Wing

NASA Technical Reports Server (NTRS)

Murphy, Patrick C.; Landman, Drew

2015-01-01

Selected experimental results from a wind tunnel study of a subscale VTOL concept with distributed propulsion and tilt lifting surfaces are presented. The vehicle complexity and automated test facility were ideal for use with a randomized designed experiment. Design of Experiments and Response Surface Methods were invoked to produce run efficient, statistically rigorous regression models with minimized prediction error. Static tests were conducted at the NASA Langley 12-Foot Low-Speed Tunnel to model all six aerodynamic coefficients over a large flight envelope. This work supports investigations at NASA Langley in developing advanced configurations, simulations, and advanced control systems.

Recommendations for research design of telehealth studies.

PubMed

Chumbler, Neale R; Kobb, Rita; Brennan, David M; Rabinowitz, Terry

2008-11-01

Properly designed randomized controlled trials (RCTs) are the gold standard to use when examining the effectiveness of telehealth interventions on clinical outcomes. Some published telehealth studies have employed well-designed RCTs. However, such methods are not always feasible and practical in particular settings. This white paper addresses not only the need for properly designed RCTs, but also offers alternative research designs, such as quasi-experimental designs, and statistical techniques that can be employed to rigorously assess the effectiveness of telehealth studies. This paper further offers design and measurement recommendations aimed at and relevant to administrative decision-makers, policymakers, and practicing clinicians.

A randomized controlled evaluation of a secondary school mindfulness program for early adolescents: Do we have the recipe right yet?

PubMed

Johnson, Catherine; Burke, Christine; Brinkman, Sally; Wade, Tracey

2017-12-01

Mindfulness is being promoted in schools as a prevention program despite a current small evidence base. The aim of this research was to conduct a rigorous evaluation of the .b ("Dot be") mindfulness curriculum, with or without parental involvement, compared to a control condition. In a randomized controlled design, students (M age 13.44, SD 0.33; 45.4% female) across a broad range of socioeconomic indicators received the nine lesson curriculum delivered by an external facilitator with (N = 191) or without (N = 186) parental involvement, or were allocated to a usual curriculum control group (N = 178). Self-report outcome measures were anxiety, depression, weight/shape concerns, wellbeing and mindfulness. There were no differences in outcomes between any of the three groups at post-intervention, six or twelve month follow-up. Between-group effect sizes (Cohen's d) across the variables ranged from 0.002 to 0.37. A wide range of moderators were examined but none impacted outcome. Further research is required to identify the optimal age, content and length of mindfulness programs for adolescents in universal prevention settings. ACTRN12615001052527. Copyright © 2017 Elsevier Ltd. All rights reserved.

Enhanced Recovery After Surgery (ERAS®) in Individuals with Diabetes: A Systematic Review.

PubMed

Albalawi, Zaina; Laffin, Michael; Gramlich, Leah; Senior, Peter; McAlister, Finlay A

2017-08-01

Prevalence of diabetes in surgical patients is 10-40%. It is well recognized that they have higher rates of complications, and longer stays in hospital compared to patients without diabetes. Enhanced recovery after surgery (ERAS) is an evidence-based multimodal surgical care pathway that improves postoperative complications and length of stay in patients without diabetes. This review evaluates the evidence on whether individuals with diabetes would benefit from ERAS implementation. MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE searched with no language restrictions applied. Conference proceedings and bibliographies were reviewed. Experts in the field were contacted, and www.clinicaltrials.gov searched for ongoing trials. Randomized controlled trials (RCT) looking at individuals with diabetes undergoing surgery randomized to ERAS ® or conventional care. Non-randomized controlled trials, controlled before-after studies, interrupted time series, and cohort studies with concurrent controls were also considered. Two authors independently screened studies. The electronic search yielded 437 references. After removing duplicates, 376 were screened for eligibility. Conference proceedings and bibliographies identified additional references. Searching www.clinicaltrials.gov yielded 59 references. Contacting experts in the field identified no further studies. Fourteen full articles were assessed and subsequently excluded for the following reasons: used an intervention other than ERAS ® , did not include patients with diabetes, or used an uncontrolled observational design. To date, the effects of ERAS ® on patients with diabetes have not been rigorously evaluated. This review highlights the lack of evidence in this area and provides guidance on design for future studies.

A Systematic Review of Interventions to Enhance Healthy Lifestyle Behaviors in Adolescents Delivered via Mobile Phone Text Messaging.

PubMed

Loescher, Lois J; Rains, Stephen A; Kramer, Sandra S; Akers, Chelsie; Moussa, Renee

2018-05-01

To systematically review healthy lifestyle interventions targeted to adolescents and delivered using text messaging (TM). PubMed, Embase, CINAHL, PsycINFO, and Web of Science databases. Study Inclusion Criteria: Research articles published during 2011 to 2014; analyses focused on intervention targeting adolescents (10-19 years), with healthy lifestyle behaviors as main variables, delivered via mobile phone-based TM. The authors extracted data from 27 of 281 articles using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method. Adolescent and setting characteristics, study design and rigor, intervention effectiveness, challenges, and risk of bias. Across studies, 16 (59.3%) of 27 included non-Caucasians. The gender was split for 22 (81.5%) of 27 studies. Thirteen studies were randomized controlled trials. There was heterogeneity among targeted conditions, rigor of methods, and intervention effects. Interventions for monitoring/adherence (n = 8) reported more positive results than those for health behavior change (n = 19). Studies that only included message delivered via TM (n = 14) reported more positive effects than studies integrating multiple intervention components. Interventions delivered using TM presented minimal challenges, but selection and performance bias were observed across studies. Interventions delivered using TM have the potential, under certain conditions, to improve healthy lifestyle behaviors in adolescents. However, the rigor of studies varies, and established theory and validated measures have been inconsistently incorporated.

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

PubMed

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

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Impact of vitamin D supplementation on the outcome of tuberculosis treatment: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Xia, Jingyan; Shi, Liyun; Zhao, Lifang; Xu, Feng

2014-01-01

Vitamin D supplementation is believed to be beneficial in the treatment of patients with tuberculosis (TB), however, results from clinical trials have been inconclusive. We performed a systematic literature search across MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Springer, EBSCO, ProQuest, HighWire Press, and Web of Science, published as of December 2013. We individually inspected citations and extracted data independently. We estimated pooled risk ratios (RR) and 95% confidence intervals (CI) using random-effect models. We also assessed risk of bias using the Jadad scale and the quality of the evidence using GRADE. We included all randomized controlled trials comparing vitamin D with or without standard TB therapy or placebo. A total of five studies were analyzed in our meta analysis covering 841 newly-diagnosed TB cases. Patients receiving vitamin D supplementation had a 39% reduced risk of sputum smear or culture positive after six weeks of anti-TB treatment than those in the control group, although this is not statistically significant (pooled RR 0.61, 95% CI 0.24 to 1.56, P = 0.30). Apart from an increased serum vitamin D level in the supplement group after eight weeks of treatment there was no evidence of any additional adverse effects related to vitamin D. The meta analysis results indicate that vitamin D supplementation does not seem to have any beneficial effect in the treatment of TB. Future rigorous randomized controlled trials are needed to explore whether the supplementation of vitamin D could shorten treatment duration and to confirm whether the polymorphisms of vitamin D receptor have any potentially beneficial effect.

Ginger as an antiemetic modality for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis.

PubMed

Lee, Jiyeon; Oh, Heeyoung

2013-03-01

To evaluate the effect of ginger as an antiemetic modality for the control of chemotherapy-induced nausea and vomiting (CINV). Databases searched included MEDLINE® (PubMed), Embase, CINAHL®, Cochrane Central Register of Controlled Trials, Korean Studies Information Service System, Research Information Sharing Service by the Korean Education and Research Information Service, and Dissertation Central. A systematic review was conducted of five randomized, controlled trials involving 872 patients with cancer. Ginger was compared with placebo or metoclopramide. The participant characteristics, chemotherapy regimen and antiemetic control, ginger preparation and protocol, measurements, results of the studies, adherence to the treatment protocol, and side effects were reviewed systematically. The incidence and severity of acute and delayed CINV were subject to meta-analysis. The incidence of acute nausea (p = 0.67), incidence of acute vomiting (p = 0.37), and severity of acute nausea (p = 0.12) did not differ significantly between the ginger and control groups. Current evidence does not support the use of ginger for the control of CINV. Ginger did not contribute to control of the incidence of acute nausea and vomiting or of the severity of acute nausea. Ginger has long been regarded as a traditional antiemetic modality, but its effectiveness remains to be established. The findings of this study could be incorporated into clinical guidelines, such as the Oncology Nursing Society's Putting Evidence Into Practice resources. Current evidence supports the need for more methodologically rigorous studies in this area. Although ginger is known as a traditional antiemetic, current evidence does not support the effect of ginger in CINV control. The findings of this study inform healthcare providers that its effectiveness remains to be established from methodologically rigorous future trials.

Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

ERIC Educational Resources Information Center

Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

2015-01-01

Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

Realization of a Quantum Random Generator Certified with the Kochen-Specker Theorem

NASA Astrophysics Data System (ADS)

Kulikov, Anatoly; Jerger, Markus; Potočnik, Anton; Wallraff, Andreas; Fedorov, Arkady

2017-12-01

Random numbers are required for a variety of applications from secure communications to Monte Carlo simulation. Yet randomness is an asymptotic property, and no output string generated by a physical device can be strictly proven to be random. We report an experimental realization of a quantum random number generator (QRNG) with randomness certified by quantum contextuality and the Kochen-Specker theorem. The certification is not performed in a device-independent way but through a rigorous theoretical proof of each outcome being value indefinite even in the presence of experimental imperfections. The analysis of the generated data confirms the incomputable nature of our QRNG.

Realization of a Quantum Random Generator Certified with the Kochen-Specker Theorem.

PubMed

Kulikov, Anatoly; Jerger, Markus; Potočnik, Anton; Wallraff, Andreas; Fedorov, Arkady

2017-12-15

Random numbers are required for a variety of applications from secure communications to Monte Carlo simulation. Yet randomness is an asymptotic property, and no output string generated by a physical device can be strictly proven to be random. We report an experimental realization of a quantum random number generator (QRNG) with randomness certified by quantum contextuality and the Kochen-Specker theorem. The certification is not performed in a device-independent way but through a rigorous theoretical proof of each outcome being value indefinite even in the presence of experimental imperfections. The analysis of the generated data confirms the incomputable nature of our QRNG.

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

PubMed

Bradt, Joke

2012-01-01

Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831)

PubMed Central

Kean, James D.; Kaufman, Jordy; Lomas, Justine; Goh, Antionette; White, David; Simpson, David; Scholey, Andrew; Singh, Hemant; Sarris, Jerome; Zangara, Andrea; Stough, Con

2015-01-01

Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6–14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners’ Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831. PMID:26633481

A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831).

PubMed

Kean, James D; Kaufman, Jordy; Lomas, Justine; Goh, Antionette; White, David; Simpson, David; Scholey, Andrew; Singh, Hemant; Sarris, Jerome; Zangara, Andrea; Stough, Con

2015-12-02

Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6-14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners' Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831.

Reflections on experimental research in medical education.

PubMed

Cook, David A; Beckman, Thomas J

2010-08-01

As medical education research advances, it is important that education researchers employ rigorous methods for conducting and reporting their investigations. In this article we discuss several important yet oft neglected issues in designing experimental research in education. First, randomization controls for only a subset of possible confounders. Second, the posttest-only design is inherently stronger than the pretest-posttest design, provided the study is randomized and the sample is sufficiently large. Third, demonstrating the superiority of an educational intervention in comparison to no intervention does little to advance the art and science of education. Fourth, comparisons involving multifactorial interventions are hopelessly confounded, have limited application to new settings, and do little to advance our understanding of education. Fifth, single-group pretest-posttest studies are susceptible to numerous validity threats. Finally, educational interventions (including the comparison group) must be described in detail sufficient to allow replication.

Exercise as Treatment for Anxiety: Systematic Review and Analysis

PubMed Central

Stonerock, Gregory L.; Hoffman, Benson M.; Smith, Patrick J.; Blumenthal, James A.

2015-01-01

Background Exercise has been shown to reduce symptoms of anxiety, but few studies have studied exercise in individuals pre-selected because of their high anxiety. Purpose To review and critically evaluate studies of exercise training in adults with either high levels of anxiety or an anxiety disorder. Methods We conducted a systematic review of randomized clinical trials (RCTs) in which anxious adults were randomized to an exercise or non-exercise control condition. Data were extracted concerning anxiety outcomes and study design. Existing meta-analyses were also reviewed. Results Evidence from 12 RCTs suggested benefits of exercise, for select groups, similar to established treatments and greater than placebo. However, most studies had significant methodological limitations, including small sample sizes, concurrent therapies, and inadequate assessment of adherence and fitness levels. Conclusions Exercise may be a useful treatment for anxiety, but lack of data from rigorous, methodologically sound RCTs precludes any definitive conclusions about its effectiveness. PMID:25697132

Why the evidence for outpatient commitment is good enough.

PubMed

Swanson, Jeffrey W; Swartz, Marvin S

2014-06-01

After nearly three decades of studies evaluating the legal practice of involuntary outpatient commitment, there is yet little consensus about its effectiveness and only limited implementation. Debate continues over how best to assist adults with serious mental illnesses who are unable or unwilling to participate in prescribed community treatment and as a result experience repeated involuntary hospitalizations or involvement with the criminal justice system. The authors comment on the Oxford Community Treatment Order Evaluation Trial (OCTET), a recently conducted randomized trial of outpatient commitment, and discuss the limitations of the study's design for resolving the persistent question of whether compulsory treatment is more effective than purely voluntary treatment for this difficult-to-reach target population. The authors conclude that the search for a definitive and generalizable randomized trial of outpatient commitment may be a quixotic quest; the field should, rather, welcome the results of well-conducted, large-scale, quasi-experimental and naturalistic studies with rigorous multivariable statistical controls.

Exercise as Treatment for Anxiety: Systematic Review and Analysis.

PubMed

Stonerock, Gregory L; Hoffman, Benson M; Smith, Patrick J; Blumenthal, James A

2015-08-01

Exercise has been shown to reduce symptoms of anxiety, but few studies have studied exercise in individuals preselected because of their high anxiety. The objective of this study is to review and critically evaluate studies of exercise training in adults with either high levels of anxiety or an anxiety disorder. We conducted a systematic review of randomized clinical trials (RCTs) in which anxious adults were randomized to an exercise or nonexercise control condition. Data were extracted concerning anxiety outcomes and study design. Existing meta-analyses were also reviewed. Evidence from 12 RCTs suggested benefits of exercise, for select groups, similar to established treatments and greater than placebo. However, most studies had significant methodological limitations, including small sample sizes, concurrent therapies, and inadequate assessment of adherence and fitness levels. Exercise may be a useful treatment for anxiety, but lack of data from rigorous, methodologically sound RCTs precludes any definitive conclusions about its effectiveness.

[Herbal medicine in womens' life cycle].

PubMed

Ben-Arye, Eran; Oren, Amnon; Ben-Arie, Alon

2006-10-01

Women use herbs and other traditional and complementary modalities to treat various ailments throughout their life circle. This article reviewed 19 randomized controlled trials, which studied efficacy and safety of various herbs in the treatment of premenstrual syndrome (PMS), nausea and vomiting in the first trimester of pregnancy and menopausal hot flushes. Preliminary data support the efficacy of Chaste tree fruit (Vitex agnus) in the treatment of PMS, Ginger (Zingiber officinale) in the treatment of hyperemesis gravidarum and (Cimicifuga racemosa) in the treatment of menopausal hot flushes. Additional and more rigorous studies are warranted in order to support the efficacy and safety of these herbal remedies.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

PubMed

Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

2013-10-01

Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

PubMed

Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

2017-08-04

Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

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.

Information interventions for recovery following vehicle-related trauma to persons of working age: a systematic review of the literature.

PubMed

Clay, Fiona J; Collie, Alex; McClure, Roderick J

2012-06-01

Given the burden associated with vehicle-related trauma, there is interest in time and cost effective methods of providing information to assist recovery. This systematic review aims to address the question: "Do targeted early information interventions improve outcomes following vehicle--related injuries for persons of working age?" Ovid Medline, EMBASE, PsychINFO and Cochrane databases were searched for studies published between 1990-April 2011. Included studies were randomized or pseudo--randomized controlled trials of information interventions delivered to working age persons following vehicle-related injuries. Two reviewers independently selected and appraised the studies. Sixteen publications (13 primary studies) met the inclusion criteria and were assessed for bias. Hetero-geneity in terms of the information interventions and measured outcomes was encountered. In 4 of the included studies, the intervention was positively associated with at least one outcome reported. Methodological issues limited the conclusions that could be drawn. Following vehicle-related trauma, people often experience difficulties in ongoing functioning. The current evidence neither supports nor fails to support the effectiveness of information interventions in promoting injury recovery. There is a need for larger more methodologically and conceptually rigorous randomized controlled trials that better consider the type and timing of the intervention.

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

PubMed

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

2008-11-01

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

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial.

PubMed

Lai, Michelle Mei Yee; Roberts, Noel; Martin, Jenepher

2014-09-17

Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students. New approaches are needed to enhance this teaching model. Multisource feedback is a commonly used assessment method for learning among practising clinicians, but this assessment has not been explored rigorously in medical student education. This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance. The Patient Teaching Associate (PTA) Feedback Study is a single site randomized controlled, double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria, Australia, is adapted as a teaching clinic during the day. Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness. Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control. Block randomization will be performed. We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline. We will model data using regression analysis to determine any differences between intervention and control groups. Full ethical approval has been obtained for the study. This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals. This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education, and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613001055796.

Health effects of intermittent fasting: hormesis or harm? A systematic review.

PubMed

Horne, Benjamin D; Muhlestein, Joseph B; Anderson, Jeffrey L

2015-08-01

Intermittent fasting, alternate-day fasting, and other forms of periodic caloric desistance are gaining popularity in the lay press and among animal research scientists. Whether clinical evidence exists for or is strong enough to support the use of such dietary regimens as health interventions is unclear. This review sought to identify rigorous, clinically relevant research studies that provide high-quality evidence that therapeutic fasting regimens are clinically beneficial to humans. A systematic review of the published literature through January 2015 was performed by using sensitive search strategies to identify randomized controlled clinical trials that evaluated the effects of fasting on either clinically relevant surrogate outcomes (e.g., weight, cholesterol) or actual clinical event endpoints [e.g., diabetes, coronary artery disease (CAD)] and any other studies that evaluated the effects of fasting on clinical event outcomes. Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate outcomes. Improvements in weight and other risk-related outcomes were found in the 3 trials. Two observational clinical outcomes studies in humans were found in which fasting was associated with a lower prevalence of CAD or diabetes diagnosis. No randomized controlled trials of fasting for clinical outcomes were identified. Clinical research studies of fasting with robust designs and high levels of clinical evidence are sparse in the literature. Whereas the few randomized controlled trials and observational clinical outcomes studies support the existence of a health benefit from fasting, substantial further research in humans is needed before the use of fasting as a health intervention can be recommended. © 2015 American Society for Nutrition.

Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

PubMed

Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

2017-09-16

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

A new feedback image encryption scheme based on perturbation with dynamical compound chaotic sequence cipher generator

NASA Astrophysics Data System (ADS)

Tong, Xiaojun; Cui, Minggen; Wang, Zhu

2009-07-01

The design of the new compound two-dimensional chaotic function is presented by exploiting two one-dimensional chaotic functions which switch randomly, and the design is used as a chaotic sequence generator which is proved by Devaney's definition proof of chaos. The properties of compound chaotic functions are also proved rigorously. In order to improve the robustness against difference cryptanalysis and produce avalanche effect, a new feedback image encryption scheme is proposed using the new compound chaos by selecting one of the two one-dimensional chaotic functions randomly and a new image pixels method of permutation and substitution is designed in detail by array row and column random controlling based on the compound chaos. The results from entropy analysis, difference analysis, statistical analysis, sequence randomness analysis, cipher sensitivity analysis depending on key and plaintext have proven that the compound chaotic sequence cipher can resist cryptanalytic, statistical and brute-force attacks, and especially it accelerates encryption speed, and achieves higher level of security. By the dynamical compound chaos and perturbation technology, the paper solves the problem of computer low precision of one-dimensional chaotic function.

Experimental evaluation of rigor mortis IX. The influence of the breaking (mechanical solution) on the development of rigor mortis.

PubMed

Krompecher, Thomas; Gilles, André; Brandt-Casadevall, Conception; Mangin, Patrice

2008-04-07

Objective measurements were carried out to study the possible re-establishment of rigor mortis on rats after "breaking" (mechanical solution). Our experiments showed that: *Cadaveric rigidity can re-establish after breaking. *A significant rigidity can reappear if the breaking occurs before the process is complete. *Rigidity will be considerably weaker after the breaking. *The time course of the intensity does not change in comparison to the controls: --the re-establishment begins immediately after the breaking; --maximal values are reached at the same time as in the controls; --the course of the resolution is the same as in the controls.

Strong Shock Propagating Over A Random Bed of Spherical Particles

NASA Astrophysics Data System (ADS)

Mehta, Yash; Salari, Kambiz; Jackson, Thomas L.; Balachandar, S.; Thakur, Siddharth

2017-11-01

The study of shock interaction with particles has been largely motivated because of its wide-ranging applications. The complex interaction between the compressible flow features, such as shock wave and expansion fan, and the dispersed phase makes this multi-phase flow very difficult to predict and control. In this talk we will be presenting results on fully resolved inviscid simulations of shock interaction with random bed of particles. One of the fascinating observations from these simulations are the flow field fluctuations due to the presence of randomly distributed particles. Rigorous averaging (Favre averaging) of the governing equations results in Reynolds stress like term, which can be classified as pseudo turbulence in this case. We have computed this ``Reynolds stress'' term along with individual fluctuations and the turbulent kinetic energy. Average pressure was also computed to characterize the strength of the transmitted and the reflected waves. This work was supported by the U.S. Department of Energy, National Nuclear Security Administration, Advanced Simulation and Computing Program, as a Cooperative Agreement under the Predictive Science Academic Alliance Program.

Unmet Need: Improving mHealth Evaluation Rigor to Build the Evidence Base.

PubMed

Mookherji, Sangeeta; Mehl, Garrett; Kaonga, Nadi; Mechael, Patricia

2015-01-01

mHealth-the use of mobile technologies for health-is a growing element of health system activity globally, but evaluation of those activities remains quite scant, and remains an important knowledge gap for advancing mHealth activities. In 2010, the World Health Organization and Columbia University implemented a small-scale survey to generate preliminary data on evaluation activities used by mHealth initiatives. The authors describe self-reported data from 69 projects in 29 countries. The majority (74%) reported some sort of evaluation activity, primarily nonexperimental in design (62%). The authors developed a 6-point scale of evaluation rigor comprising information on use of comparison groups, sample size calculation, data collection timing, and randomization. The mean score was low (2.4); half (47%) were conducting evaluations with a minimum threshold (4+) of rigor, indicating use of a comparison group, while less than 20% had randomized the mHealth intervention. The authors were unable to assess whether the rigor score was appropriate for the type of mHealth activity being evaluated. What was clear was that although most data came from mHealth projects pilots aimed for scale-up, few had designed evaluations that would support crucial decisions on whether to scale up and how. Whether the mHealth activity is a strategy to improve health or a tool for achieving intermediate outcomes that should lead to better health, mHealth evaluations must be improved to generate robust evidence for cost-effectiveness assessment and to allow for accurate identification of the contribution of mHealth initiatives to health systems strengthening and the impact on actual health outcomes.

Polysaccharide K and Coriolus versicolor extracts for lung cancer: a systematic review.

PubMed

Fritz, Heidi; Kennedy, Deborah A; Ishii, Mami; Fergusson, Dean; Fernandes, Rochelle; Cooley, Kieran; Seely, Dugald

2015-05-01

Polysaccharide K, also known as PSK or Krestin, is derived from the Coriolus versicolor mushroom and is widely used in Japan as an adjuvant immunotherapy for a variety of cancer including lung cancer. Despite reported benefits, there has been no English language synthesis of PSK for lung cancer. To address this knowledge gap, we conducted a systematic review of PSK for the treatment of lung cancer. We searched PubMed, EMBASE, CINAHL, the Cochrane Library, AltHealth Watch, and the Library of Science and Technology from inception to August 2014 for clinical and preclinical evidence pertaining to the safety and efficacy of PSK or other Coriolus versicolor extracts for lung cancer. Thirty-one reports of 28 studies were included for full review and analysis. Six studies were randomized controlled trials, 5 were nonrandomized controlled trials, and 17 were preclinical studies. Nine of the reports were Japanese language publications. Fifteen of 17 preclinical studies supported anticancer effects for PSK through immunomodulation and potentiation of immune surveillance, as well as through direct tumor inhibiting actions in vivo that resulted in reduced tumor growth and antimetastatic effects. Nonrandomized controlled trials showed improvement of various survival measures including median survival and 1-, 2-, and 5-year survival. Randomized controlled trials showed benefits on a range of endpoints, including immune parameters and hematological function, performance status and body weight, tumor-related symptoms such as fatigue and anorexia, as well as survival. Although there were conflicting results for impact on some of the tumor-related symptoms and median survival, overall most randomized controlled trials supported a positive impact for PSK on these endpoints. PSK was safely administered following and in conjunction with standard radiation and chemotherapy. PSK may improve immune function, reduce tumor-associated symptoms, and extend survival in lung cancer patients. Larger, more rigorous randomized controlled trials for PSK in lung cancer patients are warranted. © The Author(s) 2015.

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

PubMed Central

2011-01-01

Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

PubMed

Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

2011-10-03

Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

Evaluating adolescent pregnancy programs: rethinking our priorities.

PubMed

Stahler, G J; DuCette, J P

1991-01-01

Noting that impact evaluations of adolescent pregnancy programs are characterized by poor quality, the authors recommend using a different standard in assessing the value of programs. While the number of adolescent pregnancy programs has multiplied during the last 3 decades, little is known about their impact in ameliorating the negative consequences of too-early childbearing. An ideal evaluation of these programs would randomly select and randomly assign subjects to experimental and control groups. But evaluations conducted by individual program generally face obstacles that limit the randomness of the study. most individual programs lack the financial resources and do not employ the full-time professional evaluators needed to carry out a valid evaluation. These factors result in too short an evaluation period, incomplete and inaccurate data, and lack of randomness in the assignment of control groups. To more accurately assess the impact of the programs, the authors recommend that individual programs focus on process evaluation and collection of complete and reliable data on their clients. From the onset, a program should have a clear description of its content, logic of intervention, and method of implementation. It should maintain thorough records on client characteristics, service utilization, and should conduct long-term follow-ups. For rigorous impact evaluations, programs should rely on 3rd party entities. These independent organizations -- universities or research institutes -- do not have a stake in the outcome of the evaluation, making the study all the more objective. Furthermore, they provide experienced researchers.

Making Sense of Studies That Claim Benefits of Frenotomy in the Absence of Classic Tongue-Tie.

PubMed

Douglas, Pamela

2017-08-01

By performing an in-depth analysis of one high profile example, this article aims to help breastfeeding support professionals understand the methodological flaws that characterize recent studies claiming to show the efficacy of frenotomy for the diagnoses of posterior tongue-tie and upper lip-tie. The example study does not address definitional confusion or control for the effects of the passage of time. It does not consider the effects of caring attention, validation, and lactation consultant support. It also does not consider the extensive research over the past three decades that has established that reflux in the first 6 months of life is benign, even though increased reflux frequency may correlate with unsettled infant behavior. The study authors relied on the hypothesis that reflux is caused by excessive air swallowing in infants with poor latch due to posterior tongue-tie and upper lip-tie, which lacks credible physiological mechanisms or supporting evidence. The authors' claim that conducting a randomized controlled trial to investigate the efficacy of frenotomy would be unethical contradicts the basic principles of good science. This article argues that our breastfeeding women and their babies deserve the most rigorous scientific methods available, and acknowledgment of the biases inherent in less rigorous research, if we are to make appropriate decisions concerning intervention with frenotomy and to prevent unnecessary oral surgery.

Vitex agnus-castus (Chaste-Tree/Berry) in the treatment of menopause-related complaints.

PubMed

van Die, Margaret Diana; Burger, Henry G; Teede, Helena J; Bone, Kerry M

2009-08-01

The origin of the current practice of administering Vitex agnus-castus in menopause-related complaints is uncertain, but appears to be relatively recent. Here we review the evidence for this application of Vitex based on evidence from pharmacological studies and clinical research. The mechanisms of potential relevance in the context of menopause are explored with reference to the current understanding of the endocrinology and neuroendocrinology of menopause and associated symptoms. We conclude that, while evidence from rigorous randomized controlled trials is lacking for the individual herb in this context, emerging pharmacological evidence supports a role for V. agnus-castus in the alleviation of menopausal symptoms and suggests that further investigation may be appropriate.

A review of the ethics of the use of placebo in clinical trials for relapsing-remitting multiple sclerosis therapeutics.

PubMed

Solomon, Andrew J; Bernat, James L

2016-05-01

Randomized placebo-controlled clinical trials have been considered the most rigorous method of evaluating the efficacy of novel treatment interventions. The first effective disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) were approved in the 1990s after a number of pivotal placebo-controlled trials. Since then, the ethics of the continued use of placebo in clinical trials of new DMTs for RRMS has been the subject of repeated policy statements and recommendations by international committees. As further data have accumulated demonstrating a reduction in long-term morbidity and mortality with early initiation of DMT, a growing consensus has emerged that further inclusion of placebo arms in clinical trials of novel RRMS therapies is no longer ethical. Copyright © 2016 Elsevier B.V. All rights reserved.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial.

PubMed

Goodkind, Jessica R; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L; Baca, Brandon; Ndayisenga, Martin; Greene, R Neil; Shantzek, Cece

2017-02-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their feasibility and acceptability. In the current mixed-methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African, and Iraqi refugee adults and to engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013 and 2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, and postintervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs.

CHALLENGES AND INNOVATIONS IN A COMMUNITY-BASED PARTICIPATORY RANDOMIZED CONTROLLED TRIAL

PubMed Central

Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian; Baca, Brandon; Ndaysenga, Martin; Greene, R. Neil; Shantzek, Cece

2016-01-01

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African and Iraqi refugee adults and engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013-2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, post-intervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs. PMID:27179291

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

PubMed

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

2014-06-01

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

Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

PubMed

Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

2016-10-01

To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

On the Concept of Random Orientation in Far-Field Electromagnetic Scattering by Nonspherical Particles

NASA Technical Reports Server (NTRS)

Mishchenko, Michael I.; Yurkin, Maxim A.

2017-01-01

Although the model of randomly oriented nonspherical particles has been used in a great variety of applications of far-field electromagnetic scattering, it has never been defined in strict mathematical terms. In this Letter we use the formalism of Euler rigid-body rotations to clarify the concept of statistically random particle orientations and derive its immediate corollaries in the form of most general mathematical properties of the orientation-averaged extinction and scattering matrices. Our results serve to provide a rigorous mathematical foundation for numerous publications in which the notion of randomly oriented particles and its light-scattering implications have been considered intuitively obvious.

Can performance-based financing help reaching the poor with maternal and child health services? The experience of rural Rwanda.

PubMed

Lannes, Laurence; Meessen, Bruno; Soucat, Agnes; Basinga, Paulin

2016-07-01

More than 20 countries in Africa are scaling up performance-based financing (PBF), but its impact on equity in access to health services remains to be documented. This paper draws on evidence from Rwanda to examine the capacity of PBF to ensure equal access to key health interventions especially in rural areas where most of the poor live. Specifically, it focuses on maternal and child health services, distinguishing two wealth groups, and uses data from a rigorous impact evaluation. Difference-in-difference technique is used, and different model specifications are tested: control for unobserved heterogeneity and common random error using linear probability model, seemingly unrelated regression equations, and clustering and fixed effects. Results suggest that in Rwanda, PBF improved efficiency rather than equity for most health services. We find that PBF achieved efficiency gains by improving access to health services for those easier to reach, generally the relatively more affluent. It turns out to be less effective in reaching the poorest. Our results illustrate the advantages of rigorous randomized impact evaluation data as results published earlier using a nationally representative survey (Demographic and Health Survey) were not able to capture the pro-rich nature of the PBF scheme in Rwanda. Our paper advocates for building mechanisms targeting the vulnerable groups in PBF strategies. It also highlights the need to understand the impact of PBF together with the specific development of health insurance coverage and the organization of the health system. Copyright © 2015 John Wiley & Sons, Ltd.

Do health care institutions value research? A mixed methods study of barriers and facilitators to methodological rigor in pediatric randomized trials.

PubMed

Hamm, Michele P; Scott, Shannon D; Klassen, Terry P; Moher, David; Hartling, Lisa

2012-10-18

Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials. We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct. The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research. A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results.

Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

PubMed

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

Estimation of the time since death--reconsidering the re-establishment of rigor mortis.

PubMed

Anders, Sven; Kunz, Michaela; Gehl, Axel; Sehner, Susanne; Raupach, Tobias; Beck-Bornholdt, Hans-Peter

2013-01-01

In forensic medicine, there is an undefined data background for the phenomenon of re-establishment of rigor mortis after mechanical loosening, a method used in establishing time since death in forensic casework that is thought to occur up to 8 h post-mortem. Nevertheless, the method is widely described in textbooks on forensic medicine. We examined 314 joints (elbow and knee) of 79 deceased at defined time points up to 21 h post-mortem (hpm). Data were analysed using a random intercept model. Here, we show that re-establishment occurred in 38.5% of joints at 7.5 to 19 hpm. Therefore, the maximum time span for the re-establishment of rigor mortis appears to be 2.5-fold longer than thought so far. These findings have major impact on the estimation of time since death in forensic casework.

School-based programmes for preventing smoking.

PubMed

Thomas, R; Perera, R

2006-07-19

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

Efficacy of Auriculotherapy for Constipation in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

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

2014-01-01

Abstract Objectives: To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Methods: Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Results: Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52– 2.79; p<0.00001). The 15 RCTs also showed a moderate, significant effect of auriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13–1.44; p<0.0001). For other symptoms associated with constipation, such as abdominal distension or anorexia, results of the meta-analyses showed no statistical significance. Subgroup analysis revealed that use of S. vaccariae and use of magnetic pellets were both statistically favored over the control in relieving constipation. Conclusions: Current evidence illustrated that auriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation. PMID:25020089

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

PubMed

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

2014-08-01

To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; p<0.00001). The 15 RCTs also showed a moderate, significant effect of auriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13-1.44; p<0.0001). For other symptoms associated with constipation, such as abdominal distension or anorexia, results of the meta-analyses showed no statistical significance. Subgroup analysis revealed that use of S. vaccariae and use of magnetic pellets were both statistically favored over the control in relieving constipation. Current evidence illustrated that auriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

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.

Evidence-based librarianship: an overview.

PubMed

Eldredge, J D

2000-10-01

To demonstrate how the core characteristics of both evidence-based medicine (EBM) and evidence-based health care (EBHC) can be adapted to health sciences librarianship. Narrative review essay involving development of a conceptual framework. The author describes the central features of EBM and EBHC. Following each description of a central feature, the author then suggests ways that this feature applies to health sciences librarianship. First, the decision-making processes of EBM and EBHC are compatible with health sciences librarianship. Second, the EBM and EBHC values of favoring rigorously produced scientific evidence in decision making are congruent with the core values of librarianship. Third, the hierarchical levels of evidence can be applied to librarianship with some modifications. Library researchers currently favor descriptive-survey and case-study methods over systematic reviews, randomized controlled trials, or other higher levels of evidence. The library literature nevertheless contains diverse examples of randomized controlled trials, controlled-comparison studies, and cohort studies conducted by health sciences librarians. Health sciences librarians are confronted with making many practical decisions. Evidence-based librarianship offers a decision-making framework, which integrates the best available research evidence. By employing this framework and the higher levels of research evidence it promotes, health sciences librarians can lay the foundation for more collaborative and scientific endeavors.

Evidence-based librarianship: an overview

PubMed Central

Eldredge, Jonathan D.

2000-01-01

Objective: To demonstrate how the core characteristics of both evidence-based medicine (EBM) and evidence-based health care (EBHC) can be adapted to health sciences librarianship. Method: Narrative review essay involving development of a conceptual framework. The author describes the central features of EBM and EBHC. Following each description of a central feature, the author then suggests ways that this feature applies to health sciences librarianship. Results: First, the decision-making processes of EBM and EBHC are compatible with health sciences librarianship. Second, the EBM and EBHC values of favoring rigorously produced scientific evidence in decision making are congruent with the core values of librarianship. Third, the hierarchical levels of evidence can be applied to librarianship with some modifications. Library researchers currently favor descriptive-survey and case-study methods over systematic reviews, randomized controlled trials, or other higher levels of evidence. The library literature nevertheless contains diverse examples of randomized controlled trials, controlled-comparison studies, and cohort studies conducted by health sciences librarians. Conclusions: Health sciences librarians are confronted with making many practical decisions. Evidence-based librarianship offers a decision-making framework, which integrates the best available research evidence. By employing this framework and the higher levels of research evidence it promotes, health sciences librarians can lay the foundation for more collaborative and scientific endeavors. PMID:11055296

Working memory training in healthy young adults: Support for the null from a randomized comparison to active and passive control groups.

PubMed

Clark, Cameron M; Lawlor-Savage, Linette; Goghari, Vina M

2017-01-01

Training of working memory as a method of increasing working memory capacity and fluid intelligence has received much attention in recent years. This burgeoning field remains highly controversial with empirically-backed disagreements at all levels of evidence, including individual studies, systematic reviews, and even meta-analyses. The current study investigated the effect of a randomized six week online working memory intervention on untrained cognitive abilities in a community-recruited sample of healthy young adults, in relation to both a processing speed training active control condition, as well as a no-contact control condition. Results of traditional null hypothesis significance testing, as well as Bayesian factor analyses, revealed support for the null hypothesis across all cognitive tests administered before and after training. Importantly, all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence, including personality traits, motivation to train, and expectations of cognitive improvement from training. Because these results are consistent with experimental trials of equal or greater methodological rigor, we suggest that future research re-focus on: 1) other promising interventions known to increase memory performance in healthy young adults, and; 2) examining sub-populations or alternative populations in which working memory training may be efficacious.

Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials

PubMed Central

2014-01-01

Background An increasing number of studies have documented the effectiveness of qigong exercise in helping people reduce psychological stress and anxiety, but there is a scarcity of systematic reviews evaluating evidence from randomized controlled trials (RCTs) conducted among healthy subjects. Methods Thirteen databases were searched for RCTs from their inception through June 2013. Effects of qigong exercise were pooled across trials. Standardized mean differences (SMDs) were calculated for the pooled effects. Heterogeneity was assessed using the I 2 test. The risk of bias was assessed using the Cochrane criteria. Results Seven RCTs met the inclusion criteria. Two RCTs suggested that qigong exercise immediately relieved anxiety among healthy adults, compared to lecture attendance and structured movements only. Four RCTs suggested qigong exercise relieved anxiety (pooled SMD = -0.75; 95% CI, -1.11 to -0.40), and three RCTs suggested that qigong exercise reduced stress (pooled SMD = -0.88; 95% CI, -1.22 to -0.55) among healthy subjects following one to three months of qigong practice, compared to wait-list controls. Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults. However, given the limited number of RCTs and their methodological flaws, further rigorously designed RCTs are needed. PMID:24400778

Do psychological interventions reduce depression in hemodialysis patients?: A meta-analysis of randomized controlled trials following PRISMA.

PubMed

Xing, Lu; Chen, Ruiqi; Diao, Yongshu; Qian, Jiahui; You, Chao; Jiang, Xiaolian

2016-08-01

Depression is highly prevalent in hemodialysis patients and results in poor patient outcomes. Although psychological interventions are being developed and used for these patients, there is uncertainty regarding the effectiveness of these interventions. The purpose of this meta-analysis is to evaluate the effects of psychological interventions on depression treatment in hemodialysis patients. All randomized controlled trials (RCTs) relevant to the depression treatment of hemodialysis patients through psychological interventions were retrieved from the following databases: Embase, Pubmed, PsycINFO, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials. The reference lists of identified RCTs were also screened. The Cochrane risk of bias tool was used to evaluate the quality of the studies, RevMan (5.3) was used to analyze the data, and the evidence quality of the combined results was evaluated using GRADE (3.6.1). Eight RCTs were included. The combined results showed that psychological interventions significantly reduced the scores of the Beck Depression Inventory (P<0.001) and interdialysis weight gain (P<0.001). However, due to the high heterogeneity, effect size combinations of sleep quality and quality of life were not performed. Psychological interventions may reduce the degree of depression and improve fluid intake restriction adherence. More rigorously designed research is needed.

Evaluation of direct and indirect effects of seasonal malaria chemoprevention in Mali.

PubMed

Druetz, Thomas

2018-05-25

Randomized controlled trials have established that seasonal malaria chemoprevention (SMC) in children is a promising strategy to reduce malaria transmission in Sahelian West Africa. This strategy was recently introduced in a dozen countries, and about 12 million children received SMC in 2016. However, evidence on SMC effectiveness under routine programme conditions is sparse. We aim to measure the effects of the nationwide SMC programme in Mali on the prevalence of malaria and anemia in children 6-59 months. We used data from the 2015 nationally representative malaria indicator survey. A post-test only with non-randomized control group study was designed. We fitted a generalized structural equation model that controlled for potential bias on observed and non-observed variables (endogenous treatment effect model). Having received SMC reduced by 44% (95% CI [0.39-0.49]) the risk of having a positive rapid diagnostic test for malaria. In addition, the programme indirectly reduced by 18% the risk of moderate-to-severe anemia (95% CI [0.15-0.21]). SMC in Mali has substantial protective effects under routine nationwide programme conditions. Endogenous treatment effects analyses can contribute to rigorously measuring the effectiveness of health programmes and to bridging a widening gap in evaluation methods to measure progress towards achieving malaria elimination.

Wrist-ankle acupuncture (WAA) for primary dysmenorrhea (PD) of young females: study protocol for a randomized controlled trial.

PubMed

Chen, Yingfan; Tian, Sinan; Tian, Jing; Shu, Shi

2017-08-22

Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, specifically among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females. This study will carry out a randomized parallel controlled single-blind trial to observe the immediate analgesia effect of WAA in PD of young females. Sixty participants who meet inclusion criteria will be recruited from September 2016 to September 2017 in Changhai hospital of China. They are randomly assigned to WAA therapy or sham acupuncture groups (30 patients for each group), and then receive real or sham acupuncture treatment, respectively. In this trial, the primary outcome measure is simple form of McGill pain questionnaire (SF-MPQ), while expectation and treatment credibility scale (ETCS), safety assessment, the COX menstrual symptom scale (CMSS), questionnaire about the feeling of being punctured are included in the secondary outcomes. This trial will be the first study protocol designed to evaluate the immediate analgesia effect of WAA in PD of young females. The strengths in methodology, including rigorous randomized, sham-controlled, participants-blinded and assessors-blinded, will guarantee the quality of this study. WAA doesn't require any needling sensation, so non-penetrating sham acupuncture can serve as an effective placebo intervention in this trial. Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-16008546 ; registration date: 27 May 2016).

Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.

PubMed

Das, Sai Krupa; Mason, Shawn T; Vail, Taylor A; Rogers, Gail V; Livingston, Kara A; Whelan, Jillian G; Chin, Meghan K; Blanchard, Caroline M; Turgiss, Jennifer L; Roberts, Susan B

2018-01-01

Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. A worksite-based randomized controlled trial. Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Employees (n = 240) at the randomized worksites. A 2.5-day group-based behavioral intervention. Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors. An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.

A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons

PubMed Central

Whitaker, Rhiannon; Perrett, Stephanie; Zou, Lu; Hickman, Matthew; Lyons, Marion

2015-01-01

Background: The prevalence of hepatitis C (HCV) is elevated within prison populations, yet diagnosis in prisons remains low. Dried blood spot testing (DBST) is a simple procedure for the detection of HCV antibodies; its impact on testing in the prison context is unknown. Methods: We carried out a stepped-wedge cluster-randomized control trial of DBST for HCV among prisoners within five male prisons and one female prison. Each prison was a separate cluster. The order in which the intervention (training in use of DBST for HCV testing and logistic support) was introduced was randomized across clusters. The outcome measure was the HCV testing rate by prison. Imputation analysis was carried out to account for missing data. Planned and actual intervention times differed in some prisons; data were thus analysed by intention to treat (ITT) and by observed step times. Results: There was insufficient evidence of an effect of the intervention on testing rate using either the ITT intervention time (OR: 0.84; 95% CI: 0.68–1.03; P = 0.088) or using the actual intervention time (OR: 0.86; 95% CI: 0.71–1.06; P = 0.153). This was confirmed by the pooled results of five imputed data sets. Conclusions: DBST as a stand-alone intervention was insufficient to increase HCV diagnosis within the UK prison setting. Factors such as staff training and allocation of staff time for regular clinics are key to improving service delivery. We demonstrate that prisons can conduct rigorous studies of new interventions, but data collection can be problematic. Trial registration: International Standard Randomized Controlled Trial Number Register (ISRCTN number ISRCTN05628482). PMID:25061233

Clinical effectiveness of garlic (Allium sativum).

PubMed

Pittler, Max H; Ernst, Edzard

2007-11-01

The objective of this review is to update and assess the clinical evidence based on rigorous trials of the effectiveness of garlic (A. sativum). Systematic searches were carried out in Medline, Embase, Amed, the Cochrane Database of Systematic Reviews, Natural Standard, and the Natural Medicines Comprehensive Database (search date December 2006). Our own files, the bibliographies of relevant papers and the contents pages of all issues of the review journal FACT were searched for further studies. No language restrictions were imposed. To be included, trials were required to state that they were randomized and double blind. Systematic reviews and meta-analyses of garlic were included if based on the results of randomized, double-blind trials. The literature searches identified six relevant systematic reviews and meta-analysis and double-blind randomized trials (RCT) that were published subsequently. These relate to cancer, common cold, hypercholesterolemia, hypertension, peripheral arterial disease and pre-eclampsia. The evidence based on rigorous clinical trials of garlic is not convincing. For hypercholesterolemia, the reported effects are small and may therefore not be of clinical relevance. For reducing blood pressure, few studies are available and the reported effects are too small to be clinically meaningful. For all other conditions not enough data are available for clinical recommendations.

Comparative Effectiveness Research in Oncology

PubMed Central

2013-01-01

Although randomized controlled trials represent the gold standard for comparative effective research (CER), a number of additional methods are available when randomized controlled trials are lacking or inconclusive because of the limitations of such trials. In addition to more relevant, efficient, and generalizable trials, there is a need for additional approaches utilizing rigorous methodology while fully recognizing their inherent limitations. CER is an important construct for defining and summarizing evidence on effectiveness and safety and comparing the value of competing strategies so that patients, providers, and policymakers can be offered appropriate recommendations for optimal patient care. Nevertheless, methodological as well as political and social challenges for CER remain. CER requires constant and sophisticated methodological oversight of study design and analysis similar to that required for randomized trials to reduce the potential for bias. At the same time, if appropriately conducted, CER offers an opportunity to identify the most effective and safe approach to patient care. Despite rising and unsustainable increases in health care costs, an even greater challenge to the implementation of CER arises from the social and political environment questioning the very motives and goals of CER. Oncologists and oncology professional societies are uniquely positioned to provide informed clinical and methodological expertise to steer the appropriate application of CER toward critical discussions related to health care costs, cost-effectiveness, and the comparative value of the available options for appropriate care of patients with cancer. PMID:23697601

Reiki for the Treatment of Fibromyalgia: A Randomized Controlled Trial

PubMed Central

Assefi, Nassim; Bogart, Andy; Goldberg, Jack

2008-01-01

Abstract Objective Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. Design This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. Setting/location The study setting was private medical offices in the Seattle, Washington metropolitan area. Subjects The subjects were comprised 100 adults with fibromyalgia. Intervention Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). Outcome measures The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by selfreport. Improvement between groups was examined in an intention-to-treat analysis. Results Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Conclusion Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms. PMID:18991519

The incidence of secondary vertebral fracture of vertebral augmentation techniques versus conservative treatment for painful osteoporotic vertebral fractures: a systematic review and meta-analysis.

PubMed

Song, Dawei; Meng, Bin; Gan, Minfeng; Niu, Junjie; Li, Shiyan; Chen, Hao; Yuan, Chenxi; Yang, Huilin

2015-08-01

Percutaneous vertebroplasty (PVP) and balloon kyphoplasty (BKP) are minimally invasive and effective vertebral augmentation techniques for managing osteoporotic vertebral compression fractures (OVCFs). Recent meta-analyses have compared the incidence of secondary vertebral fractures between patients treated with vertebral augmentation techniques or conservative treatment; however, the inclusions were not thorough and rigorous enough, and the effects of each technique on the incidence of secondary vertebral fractures remain unclear. To perform an updated systematic review and meta-analysis of the studies with more rigorous inclusion criteria on the effects of vertebral augmentation techniques and conservative treatment for OVCF on the incidence of secondary vertebral fractures. PubMed, MEDLINE, EMBASE, SpringerLink, Web of Science, and the Cochrane Library database were searched for relevant original articles comparing the incidence of secondary vertebral fractures between vertebral augmentation techniques and conservative treatment for patients with OVCFs. Randomized controlled trials (RCTs) and prospective non-randomized controlled trials (NRCTs) were identified. The methodological qualities of the studies were evaluated, relevant data were extracted and recorded, and an appropriate meta-analysis was conducted. A total of 13 articles were included. The pooled results from included studies showed no statistically significant differences in the incidence of secondary vertebral fractures between patients treated with vertebral augmentation techniques and conservative treatment. Subgroup analysis comparing different study designs, durations of symptoms, follow-up times, races of patients, and techniques were conducted, and no significant differences in the incidence of secondary fractures were identified (P > 0.05). No obvious publication bias was detected by either Begg's test (P = 0.360 > 0.05) or Egger's test (P = 0.373 > 0.05). Despite current thinking in the field that vertebral augmentation procedures may increase the incidence of secondary fractures, we found no differences in the incidence of secondary fractures between vertebral augmentation techniques and conservative treatment for patients with OVCFs. © The Foundation Acta Radiologica 2014.

Quasi-experimental study designs series-paper 2: complementary approaches to advancing global health knowledge.

PubMed

Geldsetzer, Pascal; Fawzi, Wafaie

2017-09-01

Quasi-experiments have been infrequently used in the health sciences. Focusing on health systems implementation research, this article details key advantages of quasi-experiments and argues that they can complement (but not replace) randomized evaluations. Specifically, it may be possible to use a quasi-experiment to study the causal effect of an intervention that cannot feasibly be randomized or that would be unethical (e.g., because the intervention has become the standard of care) to test in a randomized controlled trial (RCT). In addition, because they usually take advantage of routinely collected data, quasi-experiments may be feasible when it is too costly (either financially or in terms of the required time) to carry out a RCT - an important advantage in research on health systems, which vary widely between settings. Nonetheless, we argue that RCTs will continue to be indispensable for implementation research because i) the assumptions needed to establish causality with a quasi-experiment are often unverifiable, ii) available data frequently do not allow for a rigorous quasi-experiment, and iii) randomized designs tend to lend themselves more to informing policy makers of causal effects prior to (or during) the full-scale rollout of an intervention than quasi-experiments. Copyright © 2017 Elsevier Inc. All rights reserved.

OCT Amplitude and Speckle Statistics of Discrete Random Media.

PubMed

Almasian, Mitra; van Leeuwen, Ton G; Faber, Dirk J

2017-11-01

Speckle, amplitude fluctuations in optical coherence tomography (OCT) images, contains information on sub-resolution structural properties of the imaged sample. Speckle statistics could therefore be utilized in the characterization of biological tissues. However, a rigorous theoretical framework relating OCT speckle statistics to structural tissue properties has yet to be developed. As a first step, we present a theoretical description of OCT speckle, relating the OCT amplitude variance to size and organization for samples of discrete random media (DRM). Starting the calculations from the size and organization of the scattering particles, we analytically find expressions for the OCT amplitude mean, amplitude variance, the backscattering coefficient and the scattering coefficient. We assume fully developed speckle and verify the validity of this assumption by experiments on controlled samples of silica microspheres suspended in water. We show that the OCT amplitude variance is sensitive to sub-resolution changes in size and organization of the scattering particles. Experimentally determined and theoretically calculated optical properties are compared and in good agreement.

Lessons learned: a pilot study on occupational therapy effectiveness for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Schoen, Sarah A; James, Katherine; Schaaf, Roseann C

2007-01-01

The purpose of this pilot study was to prepare for a randomized controlled study of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) with children who have sensory processing disorders (SPD). A one-group pretest, posttest design with 30 children was completed with a subset of children with SPD, those with sensory modulation disorder. Lessons learned relate to (a) identifying a homogeneous sample with quantifiable inclusion criteria, (b) developing an intervention manual for study replication and a fidelity to treatment measure, (c) determining which outcomes are sensitive to change and relate to parents' priorities, and (d) clarifying rigorous methodologies (e.g., blinded examiners, randomization, power). A comprehensive program of research is needed, including multiple pilot studies to develop enough knowledge that high-quality effectiveness research in occupational therapy can be completed. Previous effectiveness studies in OT-SI have been single projects not based on a unified long-term program of research.

Warm-needle moxibustion for spasticity after stroke: A systematic review of randomized controlled trials.

PubMed

Yang, Liu; Tan, Jing-Yu; Ma, Haili; Zhao, Hongjia; Lai, Jinghui; Chen, Jin-Xiu; Suen, Lorna K P

2018-03-22

Spasticity is a common post-stroke complication, and it results in substantial deterioration in the quality of life of patients. Although potential positive effects of warm-needle moxibustion on spasticity after stroke have been observed, evidence on its definitive effect remains uncertain. This study aimed to summarize clinical evidence pertaining to therapeutic effects and safety of warm-needle moxibustion for treating spasticity after stroke. Randomized controlled trials were reviewed systematically on the basis of the Cochrane Handbook for Systematic Reviews of Interventions. The report follows the PRISMA statement. Ten electronic databases (PubMed, CENTRAL, EMBASE, AMED, CINAHL, Web of Science, CBM, CNKI, WanFang, and VIP) were explored, and articles were retrieved manually from two Chinese journals (The Journal of Traditional Chinese Medicine and Zhong Guo Zhen Jiu) through retrospective search. Randomized controlled trials with warm-needle moxibustion as treatment intervention for patients with limb spasm after stroke were included in this review. The risk of bias assessment tool was utilized in accordance with Cochrane Handbook 5.1.0. All included studies reported spasm effect as primary outcome. Effect size was estimated using relative risk, standardized mean difference, or mean difference with a corresponding 95% confidence interval. Review Manager 5.3 was utilized for meta-analysis. Twelve randomized controlled trials with certain methodological flaws and risk of bias were included, and they involved a total of 878 participants. Warm-needle moxibustion was found to be superior to electroacupuncture or acupuncture in reducing spasm and in promoting motor function and daily living activities. Pooled results for spasm effect and motor function were significant when warm-needle moxibustion was compared with electroacupuncture or acupuncture. A comparison of daily living activities indicated significant differences between warm-needle moxibustion and electroacupuncture. However, no difference was observed between warm-needle moxibustion and acupuncture. Warm-needle moxibustion may be a promising intervention to reduce limb spasm as well as improve motor function and daily living activities for stroke patients with spasticity. However, evidence was not conclusive. Rigorously designed randomized controlled trials with sample sizes larger than that in the included trials should be conducted for verification. Copyright © 2018 Elsevier Ltd. All rights reserved.

Social and behavioral interventions for improving quality of life of HIV infected people receiving antiretroviral therapy: a systematic review and meta-analysis.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan; McNeil, Edward B

2017-04-24

Improvement in quality of life is crucial for HIV infected people. Social and behavioral interventions have been implemented in different contexts to improve the quality of life among HIV infected people. This review appraises the evidence for available interventions that focused on quality of life of HIV infected people receiving antiretroviral therapy (ART). We searched electronic databases for randomized controlled trials of interventions to improve the quality of life of HIV infected people receiving ART. We searched PUBMED and the Cochrane Centre Register of Controlled Trials (CENTRAL) with the terms "social", "behavioral", "educational", "quality of life", "HIV", and "RCT". Searches were conducted for articles published from 1980 to December 16, 2015. Standardized data abstraction methods and searching steps were applied. Twenty-eight studies reported the impact of social or behavioral interventions in quality of life among HIV infected people, of which 15 were conducted in United States of America. A total of 4136 participants were enrolled. Of the 28 studies, four studies included females, two studies included males and remaining studies excluded both males and females. The overall reported methodological quality of the studies was subject to a high risk of bias and the study criteria were unclear in most studies. Twenty-one studies reported a significant intervention effect on at least one quality of life domain. Meta-analyses showed significant improvement in general health, mental health, physical function and environment domains of quality of life among intervention groups. However, the expected impact of the intervention was low to moderate because the rigorousness of the studies was low, information was limited, the sample sizes were small and other the quality of the study designs were poor. Although the available evidence suggests that existing social and behavioral interventions can improve some quality of life domains, the quality of evidence was insufficient to support the notion that these interventions can improve the overall quality of life of HIV infected people receiving ART. Well-designed and rigorous randomized controlled trials with high methodological quality are required.

76 FR 17654 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

... OMB Review; Comment Request Title: Evaluation of Adolescent Pregnancy Prevention Approaches-- First... as part of the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA). PPA is a random assignment evaluation designed to result in rigorous evidence on effective ways to reduce teen pregnancy. The...

New Anomalous Lieb-Robinson Bounds in Quasiperiodic XY Chains

NASA Astrophysics Data System (ADS)

Damanik, David; Lemm, Marius; Lukic, Milivoje; Yessen, William

2014-09-01

We announce and sketch the rigorous proof of a new kind of anomalous (or sub-ballistic) Lieb-Robinson (LR) bound for an isotropic XY chain in a quasiperiodic transversal magnetic field. Instead of the usual effective light cone |x|≤v|t|, we obtain |x|≤v|t|α for some 0<α <1. We can characterize the allowed values of α exactly as those exceeding the upper transport exponent αu+ of a one-body Schrödinger operator. To our knowledge, this is the first rigorous derivation of anomalous quantum many-body transport. We also discuss anomalous LR bounds with power-law tails for a random dimer field.

Random Matrix Theory and the Anderson Model

NASA Astrophysics Data System (ADS)

Bellissard, Jean

2004-08-01

This paper is devoted to a discussion of possible strategies to prove rigorously the existence of a metal-insulator Anderson transition for the Anderson model in dimension d≥3. The possible criterions used to define such a transition are presented. It is argued that at low disorder the lowest order in perturbation theory is described by a random matrix model. Various simplified versions for which rigorous results have been obtained in the past are discussed. It includes a free probability approach, the Wegner n-orbital model and a class of models proposed by Disertori, Pinson, and Spencer, Comm. Math. Phys. 232:83-124 (2002). At last a recent work by Magnen, Rivasseau, and the author, Markov Process and Related Fields 9:261-278 (2003) is summarized: it gives a toy modeldescribing the lowest order approximation of Anderson model and it is proved that, for d=2, its density of states is given by the semicircle distribution. A short discussion of its extension to d≥3 follows.

Using GIS to generate spatially balanced random survey designs for natural resource applications.

PubMed

Theobald, David M; Stevens, Don L; White, Denis; Urquhart, N Scott; Olsen, Anthony R; Norman, John B

2007-07-01

Sampling of a population is frequently required to understand trends and patterns in natural resource management because financial and time constraints preclude a complete census. A rigorous probability-based survey design specifies where to sample so that inferences from the sample apply to the entire population. Probability survey designs should be used in natural resource and environmental management situations because they provide the mathematical foundation for statistical inference. Development of long-term monitoring designs demand survey designs that achieve statistical rigor and are efficient but remain flexible to inevitable logistical or practical constraints during field data collection. Here we describe an approach to probability-based survey design, called the Reversed Randomized Quadrant-Recursive Raster, based on the concept of spatially balanced sampling and implemented in a geographic information system. This provides environmental managers a practical tool to generate flexible and efficient survey designs for natural resource applications. Factors commonly used to modify sampling intensity, such as categories, gradients, or accessibility, can be readily incorporated into the spatially balanced sample design.

The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial.

PubMed

Tian, Jinzhou; Shi, Jing; Wei, Mingqing; Qin, Renan; Ni, Jingnian; Zhang, Xuekai; Li, Ting; Wang, Yongyan

2016-06-08

Vascular dementia (VaD) is the second most common subtype of dementia after Alzheimer's disease (AD). Currently, there are no medications approved for treating patients with VaD. Fufangdanshen (FFDS) tablets (Radix Salviae miltiorrhizae formula tablets) are a traditional Chinese medicine that has been reported to improve memory. However, the existing evidence for FFDS tablets in clinical practice derives from methodologically flawed studies. To further investigate the safety, tolerability, and efficacy of FFDS tables in the treatment of mild to moderate VaD, we designed and reported the methodology for a 24-week randomized, double-blind, parallel, multicenter study. This ongoing study is a double-blind, randomized, parallel placebo-controlled trial. A total of 240 patients with mild to moderate VaD will be enrolled. After a 2-week run-in period, the eligible patients will be randomized to receive either three FFDS or placebo tablets three times per day for 24 weeks, with a follow-up 12 weeks after the last treatment. The primary efficacy measurement will be the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician Interview-Based Impression of Change (CIBIC-plus). The secondary efficacy measurements will include the Mini Mental State Examination (MMSE) and activities of daily living (ADL). Adverse events will also be reported. This randomized trial will be the first rigorous study on the efficacy and safety of FFDS tablets for treating cognitive symptoms in patients with VaD using a rational design. ClinicalTrials.gov: NCT01761227 . Registered on 2 January 2013.

Family-based training program improves brain function, cognition, and behavior in lower socioeconomic status preschoolers

PubMed Central

Neville, Helen J.; Stevens, Courtney; Pakulak, Eric; Bell, Theodore A.; Fanning, Jessica; Klein, Scott; Isbell, Elif

2013-01-01

Using information from research on the neuroplasticity of selective attention and on the central role of successful parenting in child development, we developed and rigorously assessed a family-based training program designed to improve brain systems for selective attention in preschool children. One hundred forty-one lower socioeconomic status preschoolers enrolled in a Head Start program were randomly assigned to the training program, Head Start alone, or an active control group. Electrophysiological measures of children’s brain functions supporting selective attention, standardized measures of cognition, and parent-reported child behaviors all favored children in the treatment program relative to both control groups. Positive changes were also observed in the parents themselves. Effect sizes ranged from one-quarter to half of a standard deviation. These results lend impetus to the further development and broader implementation of evidence-based education programs that target at-risk families. PMID:23818591

Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness.

PubMed

O'Connor, C M; Clemson, L; Brodaty, H; Jeon, Y H; Mioshi, E; Gitlin, L N

2014-05-01

Behavioral and psychological symptoms of dementia (BPSD) are often considered to be the greatest challenge in dementia care, leading to increased healthcare costs, caregiver burden, and placement into care facilities. With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality, the development and rigorous testing of non-pharmacological interventions is vital. A pilot of the Tailored Activities Program (TAP) for reducing problem behaviors in people with dementia was conducted in the United States with promising results. This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population. This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group. This randomized trial aims to recruit 180 participant dyads of a person with dementia and their caregivers. Participants will have a diagnosis of dementia, exhibit behaviors as scored by the Neuropsychiatric Inventory, and the caregiver must have at least 7 h per week contact. Participants will be randomly allocated to intervention (TAP) or control (phone-based education sessions) groups, both provided by a trained occupational therapist. Primary outcome measure will be the revised Neuropsychiatric Inventory - Clinician rating scale (NPI-C) to measure BPSD exhibited by the person with dementia. This trial investigates the effectiveness and cost-effectiveness of TAP within an Australian population. Results will address a significant gap in the current Australian community-support base for people living with dementia and their caregivers.

Mindfulness Interventions.

PubMed

Creswell, J David

2017-01-03

Mindfulness interventions aim to foster greater attention to and awareness of present moment experience. There has been a dramatic increase in randomized controlled trials (RCTs) of mindfulness interventions over the past two decades. This article evaluates the growing evidence of mindfulness intervention RCTs by reviewing and discussing (a) the effects of mindfulness interventions on health, cognitive, affective, and interpersonal outcomes; (b) evidence-based applications of mindfulness interventions to new settings and populations (e.g., the workplace, military, schools); (c) psychological and neurobiological mechanisms of mindfulness interventions; (d) mindfulness intervention dosing considerations; and (e) potential risks of mindfulness interventions. Methodologically rigorous RCTs have demonstrated that mindfulness interventions improve outcomes in multiple domains (e.g., chronic pain, depression relapse, addiction). Discussion focuses on opportunities and challenges for mindfulness intervention research and on community applications.

Complementary therapies for depression: an overview.

PubMed

Ernst, E; Rand, J I; Stevinson, C

1998-11-01

Depression is one of the most common reasons for using complementary and alternative therapies. The aim of this article is to provide an overview of the evidence available on the treatment of depression with complementary therapies. Systematic literature searches were performed using several databases, reference list searching, and inquiry to colleagues. Data extraction followed a predefined protocol. The amount of rigorous scientific data to support the efficacy of complementary therapies in the treatment of depression is extremely limited. The areas with the most evidence for beneficial effects are exercise, herbal therapy (Hypericum perforatum), and, to a lesser extent, acupuncture and relaxation therapies. There is a need for further research involving randomized controlled trials into the efficacy of complementary and alternative therapies in the treatment of depression.

[Dengzhan Xixin injection as an adjuvant treatment for angina pectoris: a systematic review and Meta-analysis of randomized controlled trials].

PubMed

Wang, Feng-jiao; Xie, Yan-ming; Liao, Xing; Jia, Min

2015-08-01

The paper is to systematically evaluate the efficacy and safety of Deng Zhan Xi Xin injection ( DZXXI) as an adjuvant treatment for patients with angina pectoris. The Cochrane Library, Medline, EMbase, CBM, CNKI, VIP, and Wan fang Data base were searched. Randomized controlled trials (RCTs) of DZXXI combined with western medicine routine treatment versus western medicine routine treatment alone for angina pectoris patients were all included. All trials were assessed according to the Cochrane Reviewer' s Handbook 5.1 for Systematic Reviews of Intervention and Meta analyses were performed by RevMan 5. 2 Software. A total of 30RCTs (3 086 patients including 1 572 patients of treatment group and 1 514 patients of control group) were included. Meta-analysis of treatment group compared with control group showed superior effect over reducing cardiovascular events ( OR = 0.33; 95% CI: [0.16, 0.67], P = 0.002, improving effective rate of DZXXI as adjuvant treatment for angina pectoris patients (OR = 3.97; 95% CI: [3.15, 5.02]; P < 0.000 010 and electrocardiogram curative effect (OR = 2.21; 95% CI; [1.83, 2.68]; P < 0.000 010. Funnel figure seemed that there was publication bias. The current limited evidence showed that when compared with the control group, treatment group was superior in improving patients with angina pectoris. But based on the limitations of the study, rigorous design with long follow up clinical trials are necessary for further evidence.

Effective Obesity Treatments

ERIC Educational Resources Information Center

Powell, Lynda H.; Calvin, James E., III; Calvin, James E., Jr.

2007-01-01

To curb the epidemic of obesity in the United States, revised Medicare policy allows support for efficacious obesity treatments. This review summarizes the evidence from rigorous randomized trials (9 lifestyle trials, 5 drug trials, and 2 surgical trials) on the efficacy and risk-benefit profile of lifestyle, drug, and surgical interventions aimed…

USING GIS TO GENERATE SPATIALLY-BALANCED RANDOM SURVEY DESIGNS FOR NATURAL RESOURCE APPLICATIONS

EPA Science Inventory

Sampling of a population is frequently required to understand trends and patterns in natural resource management because financial and time constraints preclude a complete census. A rigorous probability-based survey design specifies where to sample so that inferences from the sam...

Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial.

PubMed

Yang, Mingxiao; Feng, Yue; Pei, Hong; Deng, Shufang; Wang, Minyu; Xiao, Xianjun; Zheng, Hui; Lai, Zhenhong; Chen, Jiao; Li, Xiang; He, Xiaoguo; Liang, Fanrong

2014-10-29

Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due to inadequate sample sizes, low methodological quality, and subclinical dosing regimens of trials to date. Thus, the purpose of this randomized controlled trial (RCT) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP. The present study is a single center, two-arm, open-label RCT. A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio. Patients in the tuina group receive a 20 minutes, 4-step treatment protocol which includes both structural and relaxation massage, administered in 20 sessions over a period of 4 weeks. Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen. The primary outcome measure is the change from baseline back pain and function, measured by Roland-Morris Disability Questionnaire, at two months. Secondary outcome measures include the visual analogue scale, Japanese orthopedic association score (JOAS), and McGill pain questionnaire. The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP. This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP, as well as future research in massage therapy. This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 (http://NCT01973010).

Randomized controlled trial of SecondStory, an intervention targeting posttraumatic growth, with bereaved adults.

PubMed

Roepke, Ann Marie; Tsukayama, Eli; Forgeard, Marie; Blackie, Laura; Jayawickreme, Eranda

2018-06-01

People often report positive psychological changes after adversity, a phenomenon known as posttraumatic growth (PTG). Few PTG-focused interventions have been rigorously tested, and measurement strategies have had significant limitations. This study evaluated the effects of a new group-format psychosocial intervention, SecondStory, aimed at facilitating PTG by helping participants make meaning of the past and plan a purposeful future. In a randomized controlled trial, adults (N = 112, 64% women) bereaved within 5 years were randomly assigned to SecondStory or an active control, expressive writing. The primary outcome, PTG, was measured using two contrasting methods: the Posttraumatic Growth Inventory, which asks participants retrospectively how much they believe they have changed due to struggling with adversity, and the Current-Standing Posttraumatic Growth Inventory, which tracks quantifiable change in participants' standing in PTG domains over time. Secondary outcomes included depression symptoms, posttraumatic stress symptoms, and life satisfaction. Outcomes were measured at 2-week intervals: pretest, posttest, and three follow-up occasions. Hierarchical linear modeling was used to assess whether SecondStory participants experienced greater gains in primary and/or secondary outcomes over the 8-week trial. Results indicated that SecondStory participants did not show significantly greater improvements than control participants on measures of PTG, posttraumatic stress, or life satisfaction, but they did show greater decreases in depression symptoms by the first follow-up. These findings suggest that SecondStory may not facilitate PTG more effectively than existing interventions but may be promising for addressing depression. Positive interventions may productively be refined to support people experiencing trauma and loss. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population

PubMed Central

Redline, Susan; Amin, Raouf; Beebe, Dean; Chervin, Ronald D.; Garetz, Susan L.; Giordani, Bruno; Marcus, Carole L.; Moore, Renee H.; Rosen, Carol L.; Arens, Raanan; Gozal, David; Katz, Eliot S.; Mitchell, Ronald B.; Muzumdar, Hiren; Taylor, H.G.; Thomas, Nina; Ellenberg, Susan

2011-01-01

Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions. Citation: Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517. PMID:22043122

Effects of psychological interventions for patients with osteoarthritis: a systematic review and meta-analysis.

PubMed

Zhang, Lijuan; Fu, Ting; Zhang, Qiuxiang; Yin, Rulan; Zhu, Li; He, Yan; Fu, Wenting; Shen, Biyu

2018-01-01

The aim of this study was to determine the effects of psychological interventions (e.g. cognitive restructuring, relaxation) on physiological and psychological health in osteoarthritis patients. A systematic literature search was done using PubMed, Embase, PsycINFO, Web of Science, China National Knowledge Infrastructure, and Wanfang Database through November 2016. Studies were included if they used a randomized controlled trial designed to explore the effects of psychological interventions in osteoarthritis patients. Two independent authors assessed the methodological quality of the trials using criteria outlined by Jadad et al. Meta-analysis was done with the Revman5.0. Twelve randomized controlled trials, including 1307 osteoarthritis patients, met the study inclusion criteria. Meta-analysis showed that psychological interventions could reduce the levels of pain [standard mean difference (SMD) -0.28, 95% CI -0.48, -0.08, P-value 0.005)] and fatigue (SMD -0.18, 95% CI -0.34, -0.01, P-value 0.04). In addition, psychological interventions significantly improved osteoarthritis patients' self-efficacy (SMD 0.58, 95% CI 0.40, 0.75, P-value 0.00) and pain coping (MD 1.64, 95% CI 0.03, 3.25, P-value 0.05). Although the effects on physical function, anxiety, depression, psychological disability were in the expected direction, they were not statistically significant. In conclusion, the role of psychological interventions in the management of osteoarthritis remains equivocal. Some encouraging results were seen with regard to pain, pain coping, self-efficacy, and fatigue. We believe that more methodologically rigorous large-scale randomized controlled trials are necessary to answer this study question.

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.

Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

PubMed

Rutledge, Thomas; Nidich, Sanford; Schneider, Robert H; Mills, Paul J; Salerno, John; Heppner, Pia; Gomez, Mayra A; Gaylord-King, Carolyn; Rainforth, Maxwell

2014-09-01

Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD. Published by Elsevier Inc.

Ultrametric properties of the attractor spaces for random iterated linear function systems

NASA Astrophysics Data System (ADS)

Buchovets, A. G.; Moskalev, P. V.

2018-03-01

We investigate attractors of random iterated linear function systems as independent spaces embedded in the ordinary Euclidean space. The introduction on the set of attractor points of a metric that satisfies the strengthened triangle inequality makes this space ultrametric. Then inherent in ultrametric spaces the properties of disconnectedness and hierarchical self-similarity make it possible to define an attractor as a fractal. We note that a rigorous proof of these properties in the case of an ordinary Euclidean space is very difficult.

Randomized Trial of Hyperbaric Oxygen Therapy for Children with Autism

ERIC Educational Resources Information Center

Granpeesheh, Doreen; Tarbox, Jonathan; Dixon, Dennis R.; Wilke, Arthur E.; Allen, Michael S.; Bradstreet, James Jeffrey

2010-01-01

Autism Spectrum Disorders (ASDs) are characterized by the presence of impaired development in social interaction and communication and the presence of a restricted repertoire of activity and interests. While numerous treatments for ASDs have been proposed, very few have been subjected to rigorous scientific investigation. Hyperbaric oxygen therapy…

A unified method for evaluating real-time computer controllers: A case study. [aircraft control

NASA Technical Reports Server (NTRS)

Shin, K. G.; Krishna, C. M.; Lee, Y. H.

1982-01-01

A real time control system consists of a synergistic pair, that is, a controlled process and a controller computer. Performance measures for real time controller computers are defined on the basis of the nature of this synergistic pair. A case study of a typical critical controlled process is presented in the context of new performance measures that express the performance of both controlled processes and real time controllers (taken as a unit) on the basis of a single variable: controller response time. Controller response time is a function of current system state, system failure rate, electrical and/or magnetic interference, etc., and is therefore a random variable. Control overhead is expressed as a monotonically nondecreasing function of the response time and the system suffers catastrophic failure, or dynamic failure, if the response time for a control task exceeds the corresponding system hard deadline, if any. A rigorous probabilistic approach is used to estimate the performance measures. The controlled process chosen for study is an aircraft in the final stages of descent, just prior to landing. First, the performance measures for the controller are presented. Secondly, control algorithms for solving the landing problem are discussed and finally the impact of the performance measures on the problem is analyzed.

Linking of uniform random polygons in confined spaces

NASA Astrophysics Data System (ADS)

Arsuaga, J.; Blackstone, T.; Diao, Y.; Karadayi, E.; Saito, M.

2007-03-01

In this paper, we study the topological entanglement of uniform random polygons in a confined space. We derive the formula for the mean squared linking number of such polygons. For a fixed simple closed curve in the confined space, we rigorously show that the linking probability between this curve and a uniform random polygon of n vertices is at least 1-O\\big(\\frac{1}{\\sqrt{n}}\\big) . Our numerical study also indicates that the linking probability between two uniform random polygons (in a confined space), of m and n vertices respectively, is bounded below by 1-O\\big(\\frac{1}{\\sqrt{mn}}\\big) . In particular, the linking probability between two uniform random polygons, both of n vertices, is bounded below by 1-O\\big(\\frac{1}{n}\\big) .

The Modern Design of Experiments for Configuration Aerodynamics: A Case Study

NASA Technical Reports Server (NTRS)

DeLoach, Richard

2006-01-01

The effects of slowly varying and persisting covariate effects on the accuracy and precision of experimental result is reviewed, as is the rationale for run-order randomization as a quality assurance tactic employed in the Modern Design of Experiments (MDOE) to defend against such effects. Considerable analytical complexity is introduced by restrictions on randomization in configuration aerodynamics tests because they involve hard-to-change configuration variables that cannot be randomized conveniently. Tradeoffs are examined between quality and productivity associated with varying degrees of rigor in accounting for such randomization restrictions. Certain characteristics of a configuration aerodynamics test are considered that may justify a relaxed accounting for randomization restrictions to achieve a significant reduction in analytical complexity with a comparably negligible adverse impact on the validity of the experimental results.

Continuous-time random walks with reset events. Historical background and new perspectives

NASA Astrophysics Data System (ADS)

Montero, Miquel; Masó-Puigdellosas, Axel; Villarroel, Javier

2017-09-01

In this paper, we consider a stochastic process that may experience random reset events which relocate the system to its starting position. We focus our attention on a one-dimensional, monotonic continuous-time random walk with a constant drift: the process moves in a fixed direction between the reset events, either by the effect of the random jumps, or by the action of a deterministic bias. However, the orientation of its motion is randomly determined after each restart. As a result of these alternating dynamics, interesting properties do emerge. General formulas for the propagator as well as for two extreme statistics, the survival probability and the mean first-passage time, are also derived. The rigor of these analytical results is verified by numerical estimations, for particular but illuminating examples.

Surface plasmon enhanced cell microscopy with blocked random spatial activation

NASA Astrophysics Data System (ADS)

Son, Taehwang; Oh, Youngjin; Lee, Wonju; Yang, Heejin; Kim, Donghyun

2016-03-01

We present surface plasmon enhanced fluorescence microscopy with random spatial sampling using patterned block of silver nanoislands. Rigorous coupled wave analysis was performed to confirm near-field localization on nanoislands. Random nanoislands were fabricated in silver by temperature annealing. By analyzing random near-field distribution, average size of localized fields was found to be on the order of 135 nm. Randomly localized near-fields were used to spatially sample F-actin of J774 cells (mouse macrophage cell-line). Image deconvolution algorithm based on linear imaging theory was established for stochastic estimation of fluorescent molecular distribution. The alignment between near-field distribution and raw image was performed by the patterned block. The achieved resolution is dependent upon factors including the size of localized fields and estimated to be 100-150 nm.

Random Predictor Models for Rigorous Uncertainty Quantification: Part 2

NASA Technical Reports Server (NTRS)

Crespo, Luis G.; Kenny, Sean P.; Giesy, Daniel P.

2015-01-01

This and a companion paper propose techniques for constructing parametric mathematical models describing key features of the distribution of an output variable given input-output data. By contrast to standard models, which yield a single output value at each value of the input, Random Predictors Models (RPMs) yield a random variable at each value of the input. Optimization-based strategies for calculating RPMs having a polynomial dependency on the input and a linear dependency on the parameters are proposed. These formulations yield RPMs having various levels of fidelity in which the mean, the variance, and the range of the model's parameter, thus of the output, are prescribed. As such they encompass all RPMs conforming to these prescriptions. The RPMs are optimal in the sense that they yield the tightest predictions for which all (or, depending on the formulation, most) of the observations are less than a fixed number of standard deviations from the mean prediction. When the data satisfies mild stochastic assumptions, and the optimization problem(s) used to calculate the RPM is convex (or, when its solution coincides with the solution to an auxiliary convex problem), the model's reliability, which is the probability that a future observation would be within the predicted ranges, is bounded rigorously.

Random Predictor Models for Rigorous Uncertainty Quantification: Part 1

NASA Technical Reports Server (NTRS)

Crespo, Luis G.; Kenny, Sean P.; Giesy, Daniel P.

2015-01-01

This and a companion paper propose techniques for constructing parametric mathematical models describing key features of the distribution of an output variable given input-output data. By contrast to standard models, which yield a single output value at each value of the input, Random Predictors Models (RPMs) yield a random variable at each value of the input. Optimization-based strategies for calculating RPMs having a polynomial dependency on the input and a linear dependency on the parameters are proposed. These formulations yield RPMs having various levels of fidelity in which the mean and the variance of the model's parameters, thus of the predicted output, are prescribed. As such they encompass all RPMs conforming to these prescriptions. The RPMs are optimal in the sense that they yield the tightest predictions for which all (or, depending on the formulation, most) of the observations are less than a fixed number of standard deviations from the mean prediction. When the data satisfies mild stochastic assumptions, and the optimization problem(s) used to calculate the RPM is convex (or, when its solution coincides with the solution to an auxiliary convex problem), the model's reliability, which is the probability that a future observation would be within the predicted ranges, can be bounded tightly and rigorously.

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes

PubMed Central

2013-01-01

Background The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. Methods/design This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. Discussion This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. Trial registration ChiCTR-TRC-12002546 PMID:23442225

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes.

PubMed

Wang, Qiuzhen; Ma, Aiguo; Bygbjerg, Ib Christian; Han, Xiuxia; Liu, Yufeng; Zhao, Shanliang; Cai, Jing

2013-02-26

The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. ChiCTR-TRC-12002546.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy.

PubMed

Fureman, Brandy E; Friedman, Daniel; Baulac, Michel; Glauser, Tracy; Moreno, Jonathan; Dixon-Salazar, Tracy; Bagiella, Emilia; Connor, Jason; Ferry, Jim; Farrell, Kathleen; Fountain, Nathan B; French, Jacqueline A

2017-10-03

The randomized controlled trial is the unequivocal gold standard for demonstrating clinical efficacy and safety of investigational therapies. Recently there have been concerns raised about prolonged exposure to placebo and ineffective therapy during the course of an add-on regulatory trial for new antiepileptic drug approval (typically ∼6 months in duration), due to the potential risks of continued uncontrolled epilepsy for that period. The first meeting of the Research Roundtable in Epilepsy on May 19-20, 2016, focused on "Reducing placebo exposure in epilepsy clinical trials," with a goal of considering new designs for epilepsy regulatory trials that may be added to the overall development plan to make it, as a whole, safer for participants while still providing rigorous evidence of effect. This topic was motivated in part by data from a meta-analysis showing a 3- to 5-fold increased rate of sudden unexpected death in epilepsy in participants randomized to placebo or ineffective doses of new antiepileptic drugs. The meeting agenda included rationale and discussion of different trial designs, including active-control add-on trials, placebo add-on to background therapy with adjustment, time to event designs, adaptive designs, platform trials with pooled placebo control, a pharmacokinetic/pharmacodynamic approach to reducing placebo exposure, and shorter trials when drug tolerance has been ruled out. The merits and limitations of each design were discussed and are reviewed here. © 2017 American Academy of Neurology.

Working memory training in healthy young adults: Support for the null from a randomized comparison to active and passive control groups

PubMed Central

Lawlor-Savage, Linette; Goghari, Vina M.

2017-01-01

Training of working memory as a method of increasing working memory capacity and fluid intelligence has received much attention in recent years. This burgeoning field remains highly controversial with empirically-backed disagreements at all levels of evidence, including individual studies, systematic reviews, and even meta-analyses. The current study investigated the effect of a randomized six week online working memory intervention on untrained cognitive abilities in a community-recruited sample of healthy young adults, in relation to both a processing speed training active control condition, as well as a no-contact control condition. Results of traditional null hypothesis significance testing, as well as Bayesian factor analyses, revealed support for the null hypothesis across all cognitive tests administered before and after training. Importantly, all three groups were similar at pre-training for a variety of individual variables purported to moderate transfer of training to fluid intelligence, including personality traits, motivation to train, and expectations of cognitive improvement from training. Because these results are consistent with experimental trials of equal or greater methodological rigor, we suggest that future research re-focus on: 1) other promising interventions known to increase memory performance in healthy young adults, and; 2) examining sub-populations or alternative populations in which working memory training may be efficacious. PMID:28558000

'Lowering the threshold of effective deterrence'-Testing the effect of private security agents in public spaces on crime: A randomized controlled trial in a mass transit system.

PubMed

Ariel, Barak; Bland, Matthew; Sutherland, Alex

2017-01-01

Supplementing local police forces is a burgeoning multibillion-dollar private security industry. Millions of formal surveillance agents in public settings are tasked to act as preventative guardians, as their high visibility presence is hypothesized to create a deterrent threat to potential offenders. Yet, rigorous evidence is lacking. We randomly assigned all train stations in the South West of England that experienced crime into treatment and controls conditions over a six-month period. Treatment consisted of directed patrol by uniformed, unarmed security agents. Hand-held trackers on every agent yielded precise measurements of all patrol time in the stations. Count-based regression models, estimated marginal means and odds-ratios are used to assess the effect of these patrols on crimes reported to the police by victims, as well as new crimes detected by police officers. Outcomes are measured at both specified target locations to which security guards were instructed to attend, as well as at the entire station complexes. Analyses show that 41% more patrol visits and 29% more minutes spent by security agents at treatment compared to control stations led to a significant 16% reduction in victim-generated crimes at the entirety of the stations' complexes, with a 49% increase in police-generated detections at the target locations. The findings illustrate the efficacy of private policing for crime prevention theory.

Chinese medicine shenfu injection for heart failure: a systematic review and meta-analysis.

PubMed

Wen-Ting, Song; Fa-Feng, Cheng; Li, Xu; Cheng-Ren, Lin; Jian-Xun, Liu

2012-01-01

Objective. Heart failure (HF) is a global public health problem. Early literature studies manifested that Shenfu injection (SFI) is one of the most commonly used traditional Chinese patent medicine for HF in China. This article intended to systematically evaluate the efficacy and safety of SFI for HF. Methods. An extensive search was performed within 6 English and Chinese electronic database up to November 2011. Ninety-nine randomized controlled trails (RCTs) were collected, irrespective of languages. Two authors extracted data and assessed the trial quality independently. RevMan 5.0.2 was used for data analysis. Results. Compared with routine treatment and/or device support, SFI combined with routine treatment and/or device support showed better effect on clinical effect rate, mortality, heart rate, NT-proBNP and 6-minute walk distance. Results in ultrasonic cardiography also showed that SFI combined with routine treatment improved heart function of HF patients. There were no significant difference in blood pressure between SFI and routine treatment groups. Adverse events were reported in thirteen trails with thirteen specific symptoms, while no serious adverse effect was reported. Conclusion. SFI appear to be effective for treating HF. However, further rigorously designed RCTs are warranted because of insufficient methodological rigor in the majority of included trials.

Delivery Of Cascade Screening For Hereditary Conditions: A Scoping Review Of The Literature.

PubMed

Roberts, Megan C; Dotson, W David; DeVore, Christopher S; Bednar, Erica M; Bowen, Deborah J; Ganiats, Theodore G; Green, Ridgely Fisk; Hurst, Georgia M; Philp, Alisdair R; Ricker, Charité N; Sturm, Amy C; Trepanier, Angela M; Williams, Janet L; Zierhut, Heather A; Wilemon, Katherine A; Hampel, Heather

2018-05-01

Cascade screening is the process of contacting relatives of people who have been diagnosed with certain hereditary conditions. Its purpose is to identify, inform, and manage those who are also at risk. We conducted a scoping review to obtain a broad overview of cascade screening interventions, facilitators and barriers to their use, relevant policy considerations, and future research needs. We searched for relevant peer-reviewed literature in the period 1990-2017 and reviewed 122 studies. Finally, we described 45 statutes and regulations related to the use and release of genetic information across the fifty states. We sought standardized best practices for optimizing cascade screening across various geographic and policy contexts, but we found none. Studies in which trained providers contacted relatives directly, rather than through probands (index patients), showed greater cascade screening uptake; however, policies in some states might limit this approach. Major barriers to cascade screening delivery include suboptimal communication between the proband and family and geographic barriers to obtaining genetic services. Few US studies examined interventions for cascade screening or used rigorous study designs such as randomized controlled trials. Moving forward, there remains an urgent need to conduct rigorous intervention studies on cascade screening in diverse US populations, while accounting for state policy considerations.

Benefits of peer support groups in the treatment of addiction

PubMed Central

Tracy, Kathlene; Wallace, Samantha P

2016-01-01

Objective Peer support can be defined as the process of giving and receiving nonprofessional, nonclinical assistance from individuals with similar conditions or circumstances to achieve long-term recovery from psychiatric, alcohol, and/or other drug-related problems. Recently, there has been a dramatic rise in the adoption of alternative forms of peer support services to assist recovery from substance use disorders; however, often peer support has not been separated out as a formalized intervention component and rigorously empirically tested, making it difficult to determine its effects. This article reports the results of a literature review that was undertaken to assess the effects of peer support groups, one aspect of peer support services, in the treatment of addiction. Methods The authors of this article searched electronic databases of relevant peer-reviewed research literature including PubMed and MedLINE. Results Ten studies met our minimum inclusion criteria, including randomized controlled trials or pre-/post-data studies, adult participants, inclusion of group format, substance use-related, and US-conducted studies published in 1999 or later. Studies demonstrated associated benefits in the following areas: 1) substance use, 2) treatment engagement, 3) human immunodeficiency virus/hepatitis C virus risk behaviors, and 4) secondary substance-related behaviors such as craving and self-efficacy. Limitations were noted on the relative lack of rigorously tested empirical studies within the literature and inability to disentangle the effects of the group treatment that is often included as a component of other services. Conclusion Peer support groups included in addiction treatment shows much promise; however, the limited data relevant to this topic diminish the ability to draw definitive conclusions. More rigorous research is needed in this area to further expand on this important line of research. PMID:27729825

Effectiveness of educational nursing home visits on quality of life, functional status and care dependency in older adults with mobility impairments: a randomized controlled trial.

PubMed

Buss, Arne; Wolf-Ostermann, Karin; Dassen, Theo; Lahmann, Nils; Strupeit, Steve

2016-04-01

Facilitating and maintaining functional status (FS) and quality of life (QoL) and avoiding care dependency (CD) are and will increasingly become major tasks of nursing. Educational nursing home visits may have positive effects on FS and QoL in older adults. The aim of this study was to determine the effectiveness of educational home visits on FS, QoL and CD in older adults with mobility impairments. We performed a randomized controlled trial. The study was conducted in the living environments of 123 participants with functional impairments living in Hamburg, Germany. The intervention group received an additional nursing education intervention on mobility and QoL; the control group received care as usual. Data were collected from August 2011 to December 2012 at baseline, 6 months and 12 months of follow-up. The main outcomes were FS (Barthel Index), QoL (WHOQOL-BREF) and CD (Care Dependency Scale). Data were analyzed using descriptive statistics and generalized linear models. In total, 113 participants (57 in the intervention and 56 in the control group) were included in the study. The intervention had no statistical significant effect on FS, QoL and CD. The intervention did not show the benefits that we assumed. Further studies on the effects of educational nursing interventions should be performed using different concepts and rigorous research methods. © 2015 John Wiley & Sons, Ltd.

Chinese Herbal Bath Therapy for the Treatment of Knee Osteoarthritis: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Bo; Zhan, Hongsheng; Chung, Mei; Lin, Xun; Zhang, Min; Pang, Jian; Wang, Chenchen

2015-01-01

Objective. Chinese herbal bath therapy (CHBT) has traditionally been considered to have analgesic and anti-inflammatory effects. We conducted the first meta-analysis evaluating its benefits for patients with knee osteoarthritis (OA). Methods. We searched three English and four Chinese databases through October, 2014. Randomized trials evaluating at least 2 weeks of CHBT for knee OA were selected. The effects of CHBT on clinical symptoms included both pain level (via the visual analog scale) and total effectiveness rate, which assessed pain, physical performance, and wellness. We performed random-effects meta-analyses using mean difference. Results. Fifteen studies totaling 1618 subjects met eligibility criteria. Bath prescription included, on average, 13 Chinese herbs with directions to steam and wash around the knee for 20–40 minutes once or twice daily. Mean treatment duration was 3 weeks. Results from meta-analysis showed superior pain improvement (mean difference = −0.59 points; 95% confidence intervals [CI], −0.83 to −0.36; p < 0.00001) and higher total effectiveness rate (risk ratio = 1.21; 95% CI, 1.15 to 1.28; p < 0.00001) when compared with standard western treatment. No serious adverse events were reported. Conclusion. Chinese herbal bath therapy may be a safe, effective, and simple alternative treatment modality for knee OA. Further rigorously designed, randomized trials are warranted. PMID:26483847

A Randomized Crossover Study of Web-Based Media Literacy to Prevent Smoking

ERIC Educational Resources Information Center

Shensa, Ariel; Phelps-Tschang, Jane; Miller, Elizabeth; Primack, Brian A.

2016-01-01

Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML…

Assessing Student Achievement in Large-Scale Educational Programs Using Hierarchical Propensity Scores

ERIC Educational Resources Information Center

Vaughan, Angela L.; Lalonde, Trent L.; Jenkins-Guarnieri, Michael A.

2014-01-01

Many researchers assessing the efficacy of educational programs face challenges due to issues with non-randomization and the likelihood of dependence between nested subjects. The purpose of the study was to demonstrate a rigorous research methodology using a hierarchical propensity score matching method that can be utilized in contexts where…

Examining Foundations of Qualitative Research: A Review of Social Work Dissertations, 2008-2010

ERIC Educational Resources Information Center

Gringeri, Christina; Barusch, Amanda; Cambron, Christopher

2013-01-01

This study examined the treatment of epistemology and methodological rigor in qualitative social work dissertations. Template-based review was conducted on a random sample of 75 dissertations completed between 2008 and 2010. For each dissertation, we noted the presence or absence of four markers of epistemology: theory, paradigm, reflexivity, and…

Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research12

PubMed Central

Hébert, James R; Frongillo, Edward A; Adams, Swann A; Turner-McGrievy, Gabrielle M; Hurley, Thomas G; Miller, Donald R; Ockene, Ira S

2016-01-01

Research into the role of diet in health faces a number of methodologic challenges in the choice of study design, measurement methods, and analytic options. Heavier reliance on randomized controlled trial (RCT) designs is suggested as a way to solve these challenges. We present and discuss 7 inherent and practical considerations with special relevance to RCTs designed to study diet: 1) the need for narrow focus; 2) the choice of subjects and exposures; 3) blinding of the intervention; 4) perceived asymmetry of treatment in relation to need; 5) temporal relations between dietary exposures and putative outcomes; 6) strict adherence to the intervention protocol, despite potential clinical counter-indications; and 7) the need to maintain methodologic rigor, including measuring diet carefully and frequently. Alternatives, including observational studies and adaptive intervention designs, are presented and discussed. Given high noise-to-signal ratios interjected by using inaccurate assessment methods in studies with weak or inappropriate study designs (including RCTs), it is conceivable and indeed likely that effects of diet are underestimated. No matter which designs are used, studies will require continued improvement in the assessment of dietary intake. As technology continues to improve, there is potential for enhanced accuracy and reduced user burden of dietary assessments that are applicable to a wide variety of study designs, including RCTs. PMID:27184269

Delayed School Start Times and Adolescent Sleep: A Systematic Review of the Experimental Evidence

PubMed Central

Minges, Karl E.; Redeker, Nancy S.

2016-01-01

Summary Many schools have instituted later morning start times to improve sleep, academic, and other outcomes in response to the mismatch between youth circadian rhythms and early morning start times. However, there has been no systematic synthesis of the evidence on the effects of this practice. To examine the impact of delayed school start time on students’ sleep, health, and academic outcomes, electronic databases were systematically searched and data were extracted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Six studies satisfied selection criteria and used pre-post, no control (n=3), randomized controlled trial (n=2), and quasi-experimental (n=1) designs. School start times were delayed 25 to 60 minutes, and correspondingly, total sleep time increased from 25 to 77 minutes per weeknight. Some studies revealed reduced daytime sleepiness, depression, caffeine use, tardiness to class, and trouble staying awake. Overall, the evidence supports recent non-experimental study findings and calls for policy that advocates for delayed school start time to improve sleep. This presents a potential long-term solution to chronic sleep restriction during adolescence. However, there is a need for rigorous randomized study designs and reporting of consistent outcomes, including objective sleep measures and consistent measures of health and academic performance. PMID:26545246

Changing Work and Work-Family Conflict: Evidence from the Work, Family, and Health Network*

PubMed Central

Kelly, Erin L.; Moen, Phyllis; Oakes, J. Michael; Fan, Wen; Okechukwu, Cassandra; Davis, Kelly D.; Hammer, Leslie; Kossek, Ellen; King, Rosalind Berkowitz; Hanson, Ginger; Mierzwa, Frank; Casper, Lynne

2013-01-01

Schedule control and supervisor support for family and personal life are work resources that may help employees manage the work-family interface. However, existing data and designs have made it difficult to conclusively identify the effects of these work resources. This analysis utilizes a group-randomized trial in which some units in an information technology workplace were randomly assigned to participate in an initiative, called STAR, that targeted work practices, interactions, and expectations by (a) training supervisors on the value of demonstrating support for employees’ personal lives and (b) prompting employees to reconsider when and where they work. We find statistically significant, though modest, improvements in employees’ work-family conflict and family time adequacy and larger changes in schedule control and supervisor support for family and personal life. We find no evidence that this intervention increased work hours or perceived job demands, as might have happened with increased permeability of work across time and space. Subgroup analyses suggest the intervention brings greater benefits to employees more vulnerable to work-family conflict. This study advances our understanding of the impact of social structures on individual lives by investigating deliberate organizational changes and their effects on work resources and the work-family interface with a rigorous design. PMID:25349460

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-09-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy's efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = -0.79] and anxiety (SMD = -0.57) compared to active comparators. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. © 2016 American Academy of Pain Medicine.

Changing Work and Work-Family Conflict: Evidence from the Work, Family, and Health Network*

PubMed

Kelly, Erin L; Moen, Phyllis; Oakes, J Michael; Fan, Wen; Okechukwu, Cassandra; Davis, Kelly D; Hammer, Leslie; Kossek, Ellen; King, Rosalind Berkowitz; Hanson, Ginger; Mierzwa, Frank; Casper, Lynne

2014-06-01

Schedule control and supervisor support for family and personal life are work resources that may help employees manage the work-family interface. However, existing data and designs have made it difficult to conclusively identify the effects of these work resources. This analysis utilizes a group-randomized trial in which some units in an information technology workplace were randomly assigned to participate in an initiative, called STAR, that targeted work practices, interactions, and expectations by (a) training supervisors on the value of demonstrating support for employees' personal lives and (b) prompting employees to reconsider when and where they work. We find statistically significant, though modest, improvements in employees' work-family conflict and family time adequacy and larger changes in schedule control and supervisor support for family and personal life. We find no evidence that this intervention increased work hours or perceived job demands, as might have happened with increased permeability of work across time and space. Subgroup analyses suggest the intervention brings greater benefits to employees more vulnerable to work-family conflict. This study advances our understanding of the impact of social structures on individual lives by investigating deliberate organizational changes and their effects on work resources and the work-family interface with a rigorous design.

Study sponsorship and the nutrition research agenda: analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity.

PubMed

Fabbri, Alice; Chartres, Nicholas; Scrinis, Gyorgy; Bero, Lisa A

2017-05-01

To categorize the research topics covered by a sample of randomized controlled trials (RCT) included in systematic reviews of nutrition interventions to address obesity; to describe their funding sources; and to explore the association between funding sources and nutrition research topics. Cross-sectional study. RCT included in Cochrane Reviews of nutrition interventions to address obesity and/or overweight. Two hundred and thirteen RCT from seventeen Cochrane Reviews were included. Funding source and authors' conflicts of interest were disclosed in 82·6 and 29·6 % of the studies, respectively. RCT were more likely to test an intervention to manipulate nutrients in the context of reduced energy intake (44·2 % of studies) than food-level (11·3 %) and dietary pattern-level (0·9 %) interventions. Most of the food industry-sponsored studies focused on interventions involving manipulations of specific nutrients (66·7 %). Only 33·1 % of the industry-funded studies addressed dietary behaviours compared with 66·9 % of the non-industry-funded ones (P=0·002). The level of food processing was poorly considered across all funding sources. The predominance of RCT examining nutrient-specific questions could limit the public health relevance of rigorous evidence available for systematic reviews and dietary guidelines.

Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials.

PubMed

Pittler, M H; Karagülle, M Z; Karagülle, M; Ernst, E

2006-07-01

Low back pain is a major public health concern and complementary treatments are frequently used for this condition. The objective of this systematic review and meta-analysis was to assess the evidence for or against the effectiveness of spa therapy and balneotherapy for treating low back pain. Systematic searches were conducted on Medline, Embase, Amed Cochrane Central, the UK National Research Register and ClincalTrials.gov (all until July 2005). Hand searches were performed and experts contacted. Methodological quality was assessed using a standard scale. Five randomized clinical trials met all inclusion criteria. Quantitative data synthesis was performed. The data for spa therapy, assessed on a 100 mm visual analogue scale (VAS), suggest significant beneficial effects compared with waiting list control groups (weighted mean difference 26.6 mm, 95% confidence interval 20.4-32.8, n=442) for patients with chronic low back pain. For balneotherapy the data, assessed on a 100 mm VAS, also suggest beneficial effects compared with control groups (weighted mean difference 18.8 mm, 95% confidence interval 10.3-27.3, n=138). Even though the data are scarce, there is encouraging evidence suggesting that spa therapy and balneotherapy may be effective for treating patients with low back pain. These data are not compelling but warrant rigorous large-scale trials.

Complementary and alternative medicine for allergic rhinitis.

PubMed

Man, Li-Xing

2009-06-01

Otolaryngologists and other physicians who diagnose and treat allergic rhinitis encounter patients who use complementary medicine and alternative remedies. This article reviews the recent literature regarding complementary and alternative therapies for the treatment of allergic rhinitis. There are a myriad of modalities for treating allergic rhinitis. Few are studied with rigorous randomized, double-blind, placebo-controlled trials for clinical efficacy. Often, the biological mechanisms and adverse effects are even less well understood. A few therapies, including spirulina, butterbur, and phototherapy hold some promise. Thus far, complementary and alternative therapies have not been integrated into the general treatment armamentarium of allergic rhinitis. Several studies report beneficial effects of certain alternative treatments for allergic rhinitis. Additional insight into the mechanisms of action, short-term and long-term effects, and adverse events is needed.

Research Design Options for Intervention Studies.

PubMed

Lobo, Michele A; Kagan, Sarah H; Corrigan, John D

2017-07-01

To review research designs for rehabilitation. Single-case, observational, and qualitative designs are highlighted in terms of recent advances and ability to answer important scientific questions about rehabilitation. Single-case, observational, and qualitative designs can be conducted in a systematic and rigorous manner that provides important information that cannot be acquired using more common designs, such as randomized controlled trials. These less commonly used designs may be more feasible and effective in answering many research questions in the field of rehabilitation. Researchers should consider these designs when selecting the optimal design to answer their research questions. We should improve education about the advantages and disadvantages of existing research designs to enable more critical analysis of the scientific literature we read and review to avoid undervaluing studies not within more commonly used categories.

Launching Effectiveness Research to Guide Practice in Neurosurgery: A National Institute Neurological Disorders and Stroke Workshop Report

PubMed Central

Walicke, Patricia; Abosch, Aviva; Asher, Anthony; Barker, Fred G.; Ghogawala, Zoher; Harbaugh, Robert; Jehi, Lara; Kestle, John; Koroshetz, Walter; Little, Roderick; Rubin, Donald; Valadka, Alex; Wisniewski, Stephen

2017-01-01

Abstract This workshop addressed challenges of clinical research in neurosurgery. Randomized controlled clinical trials (RCTs) have high internal validity, but often insufficiently generalize to real-world practice. Observational studies are inclusive but often lack sufficient rigor. The workshop considered possible solutions, such as (1) statistical methods for demonstrating causality using observational data; (2) characteristics required of a registry supporting effectiveness research; (3) trial designs combining advantages of observational studies and RCTs; and (4) equipoise, an identified challenge for RCTs. In the future, advances in information technology potentially could lead to creation of a massive database where clinical data from all neurosurgeons are integrated and analyzed, ending the separation of clinical research and practice and leading to a new “science of practice.” PMID:28362926

Complementary and alternative medicine use for treatment and prevention of late-life mood and cognitive disorders

PubMed Central

Lavretsky, Helen

2009-01-01

Late-life mood disorders and cognitive aging are the most common reasons for using complementary and alternative therapies. The amount of rigorous scientific data to support the efficacy of complementary therapies in the treatment of depression or cognitive impairment is extremely limited. The areas with the most evidence for beneficial effects are exercise, herbal therapy (Hypericum perforatum), the use of fish oil, and, to a lesser extent, acupuncture and relaxation therapies. There is a need for further research involving randomized, controlled trials to investigate the efficacy of complementary and alternative therapies in the treatment of depression and cognitive impairment in late-life. This research may lead to the development of effective treatment and preventive approaches for these serious conditions. PMID:19956796

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

PubMed Central

Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

2015-01-01

Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo). PMID:25608692

Pre-rigor temperature control of Chinese yellow cattle carcasses to 12-18 °C during chilling improves beef tenderness.

PubMed

Liu, Yuqing; Mao, Yanwei; Zhang, Yimin; Liang, Rongrong; Wang, Renhuan; Zhu, Lixian; Meng, Xianyong; Luo, Xin

2015-02-01

This study evaluates the effects of pre-rigor temperature control on quality traits of Chinese yellow cattle M. longissimus lumborum (LL). One stepwise chilling (SC) treatment was used on one half-carcass, involved a fast chilling (-11 ± 1 °C;0.5 m/s) for 2h, then the refrigeration was stopped to hold a core temperature of 12-18 °C until 10h postmortem, followed by a 1 ± 1 °C chilling (0.5 m/s) to 48h postmortem. The other half-carcass was conventional chilled at 1 ± 1 °C (0.5 m/s) until 48h as control chilling (CC). Quality attributes were evaluated at 1, 7 and 14 days. The SC treatment resulted in decreased WBSF and increased myofibril fragmentation index compared with control. SC-treated LL at 7d postmortem had a lower WBSF than those of CC-treated at 14d. This pre-rigor temperature controlled chilling is a realistic alternative for the beef industry in China to ensure adequate tenderness and shorten aging time.

The Effects of Intra-Aortic Balloon Pumps on Mortality in Patients Undergoing High-Risk Coronary Revascularization: A Meta-Analysis of Randomized Controlled Trials of Coronary Artery Bypass Grafting and Stenting Era

PubMed Central

Wan, You-Dong; Sun, Tong-Wen; Kan, Quan-Cheng; Guan, Fang-Xia; Liu, Zi-Qi; Zhang, Shu-Guang

2016-01-01

Background Intra-aortic balloon pumps (IABP) have generally been used for patients undergoing high-risk mechanical coronary revascularization. However, there is still insufficient evidence to determine whether they can improve outcomes in reperfusion therapy patients, mainly by percutaneous coronary intervention (PCI) with stenting or coronary artery bypass graft (CABG). This study was designed to determine the difference between high-risk mechanical coronary revascularization with and without IABPs on mortality, by performing a meta-analysis on randomized controlled trials of the current era. Methods Pubmed and Embase databases were searched from inception to May 2015. Unpublished data were obtained from the investigators. Randomized clinical trials of IABP and non-IABP in high-risk coronary revascularization procedures (PCI or CABG) were included. In the case of PCI procedures, stents should be used in more than 80% of patients. Numbers of events at the short-term and long-term follow-up were extracted. Results A total of 12 randomized trials enrolling 2155 patients were included. IABPs did not significantly decrease short-term mortality (relative risk (RR) 0.66; 95% CI, 0.42–1.01), or long-term mortality (RR 0.79; 95% CI, 0.47–1.35), with low heterogeneity across the studies. The findings remained stable in patients with acute myocardial infarction with or without cardiogenic shock. But in high-risk CABG patients, IABP was associated with reduced mortality (71 events in 846 patients; RR 0.40; 95%CI 0.25–0.67). Conclusion In patients undergoing high-risk coronary revascularization, IABP did not significantly decrease mortality. But high-risk CABG patients may be benefit from IABP. Rigorous criteria should be applied to the use of IABPs. PMID:26784578

Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

PubMed

Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

2017-08-01

Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from different regions, are needed. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial.

PubMed

Oberai, Praveen; Varanasi, Roja; Padmanabhan, Maya; Upadhyaya, Alok; Singh, Supriya; Singh, Samarendra Pratap; Vikram, Deepika; Khan, Tariq; Prasad, Ramesh; Gupta, A K; Singh, J R; Manchanda, Raj K

2018-06-05

 Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program.  This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy ( n  = 325) or placebo as control ( n  = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat.  A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna ( n  = 116), Stramonium ( n  = 33), Arsenicum album ( n  = 25), Sulfur ( n  = 18), Opium ( n  = 17), and Nux vomica ( n  = 10).  Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated. The Faculty of Homeopathy.

A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial

PubMed Central

2013-01-01

Background Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men. Methods/design MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months. Discussion This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings. Trial registration ClinicalTrials.gov, NCT01092078 PMID:24011142

Challenging mental health related stigma in China: Systematic review and meta-analysis. I. Interventions among the general public.

PubMed

Xu, Ziyan; Rüsch, Nicolas; Huang, Fangfang; Kösters, Markus

2017-09-01

Mental illness stigma is widely endorsed by the general public in China. Evidence-based anti-stigma interventions to reduce public stigma are needed. However, most studies on the efficacy of anti-stigma interventions took place in Western countries and existing Chinese studies were often not included in recent systematic reviews. This review evaluates the efficacy of anti-stigma interventions among the general population in Mainland China, Hong Kong, Taiwan and Macau. Eight databases in English and Chinese were searched for randomized and non-randomized controlled trials. Subgroup analyses compared interventions with and without consumer contact. Standardized mean differences were calculated from eligible studies where possible. We included 9 trials involving 2041 participants. Interventions yielded a small effect on stereotypes reduction and a similar effect on improving mental health literacy. No study assessed discrimination outcomes. Interventions with consumer contact were not superior to those without. There were insufficient data on medium and long term effects. Heterogeneity across studies was moderate. Quality of studies was modest. Further research using rigorous methods is required. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

PubMed

Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

2015-03-26

An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

The GO-ACTIWE randomized controlled trial - An interdisciplinary study designed to investigate the health effects of active commuting and leisure time physical activity.

PubMed

Rosenkilde, Mads; Petersen, Martin Bæk; Gram, Anne Sofie; Quist, Jonas Salling; Winther, Jonas; Kamronn, Simon Due; Milling, Desirée Hornbæk; Larsen, Jakob Eg; Jespersen, Astrid Pernille; Stallknecht, Bente

2017-02-01

Regular physical activity is efficacious for improving metabolic health in overweight and obese individuals, yet, many adults lead sedentary lives. Most exercise interventions have targeted leisure time, but physical activity also takes place in other domains of everyday life. Active commuting represents a promising alternative to increase physical activity, but it has yet to be established whether active commuting conveys health benefits on par with leisure time physical activity (LTPA). A 6-month randomized controlled trial was designed to investigate the effects of increased physical activity in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise). We included 188 overweight and class 1 obese sedentary women and men (20-45years) of which 130 were randomized to either sedentary controls (n=18), active commuting (n=35) or moderate (n=39) or vigorous (n=38) intensity LTPA. At baseline and after 3 and 6months, participants underwent a rigorous 3-day biomedical test regimen followed by free-living measurements. In a sub-sample, physical activity level and energy expenditure were monitored by means of personal assistive technology and the doubly labeled water technique. Additionally, the delivery, reception and routinization of the exercise regimens were investigated by ethnological fieldwork. One year after termination of the intervention, participants will be invited for a follow-up visit to investigate sustained health effects and continuous physical activity adherence. By combining biomedical, technological and humanistic approaches, we aim to understand the health benefits of physical activity in different domains of everyday life, as well as how to improve adherence to physical activity. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial.

PubMed

Chen, Jiao; Feng, Shuwei; Zeng, Jiuzhi; Wu, Xi; Yang, Mingxiao; Tang, Hongzhi; Fan, Huaying; Yang, Jie; Liang, Fanrong

2016-05-21

Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome. This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial. The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome. Chinese Clinical Trial Registry, ChiCTR-IOR-15007358 , registered on 26 October 2015.

A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Kerfoot, B Price; Gagnon, David R; McMahon, Graham T; Orlander, Jay D; Kurgansky, Katherine E; Conlin, Paul R

2017-09-01

Rigorous evidence is lacking whether online games can improve patients' longer-term health outcomes. We investigated whether an online team-based game delivering diabetes self-management education (DSME) to patients via e-mail or mobile application (app) can generate longer-term improvements in hemoglobin A 1c (HbA 1c ). Patients ( n = 456) on oral diabetes medications with HbA 1c ≥58 mmol/mol were randomly assigned between a DSME game (with a civics booklet) and a civics game (with a DSME booklet). The 6-month games sent two questions twice weekly via e-mail or mobile app. Participants accrued points based on performance, with scores posted on leaderboards. Winning teams and individuals received modest financial rewards. Our primary outcome measure was HbA 1c change over 12 months. DSME game patients had significantly greater HbA 1c reductions over 12 months than civics game patients (-8 mmol/mol [95% CI -10 to -7] and -5 mmol/mol [95% CI -7 to -3], respectively; P = 0.048). HbA 1c reductions were greater among patients with baseline HbA 1c >75 mmol/mol: -16 mmol/mol [95% CI -21 to -12] and -9 mmol/mol [95% CI -14 to -5] for DSME and civics game patients, respectively; P = 0.031. Patients with diabetes who were randomized to an online game delivering DSME demonstrated sustained and meaningful HbA 1c improvements. Among patients with poorly controlled diabetes, the DSME game reduced HbA 1c by a magnitude comparable to starting a new diabetes medication. Online games may be a scalable approach to improve outcomes among geographically dispersed patients with diabetes and other chronic diseases. © 2017 by the American Diabetes Association.

The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

PubMed

Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

2016-07-01

Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

Physiological and psychological effects of testosterone during severe energy deficit and recovery: A study protocol for a randomized, placebo-controlled trial for Optimizing Performance for Soldiers (OPS).

PubMed

Pasiakos, Stefan M; Berryman, Claire E; Karl, J Philip; Lieberman, Harris R; Orr, Jeb S; Margolis, Lee M; Caldwell, John A; Young, Andrew J; Montano, Monty A; Evans, William J; Vartanian, Oshin; Carmichael, Owen T; Gadde, Kishore M; Harris, Melissa; Rood, Jennifer C

2017-07-01

The physiological consequences of severe energy deficit include hypogonadism and the loss of fat-free mass. Prolonged energy deficit also impacts physical performance, mood, attentiveness, and decision-making capabilities. This study will determine whether maintaining a eugonadal state during severe, sustained energy deficit attenuates physiological decrements and maintains mental performance. This study will also assess the effects of normalizing testosterone levels during severe energy deficit and recovery on gut health and appetite regulation. Fifty physically active men will participate in a 3-phase, randomized, placebo-controlled study. After completing a 14-d, energy-adequate, diet acclimation phase (protein: 1.6g∙kg -1 ∙d -1 ; fat: 30% total energy intake), participants will be randomized to undergo a 28-d, 55% energy deficit phase with (DEF+TEST: 200mg testosterone enanthate per week) or without (DEF) exogenous testosterone. Diet and physical activity will be rigorously controlled. Recovery from the energy deficit (ad libitum diet, no testosterone) will be assessed until body mass has been recovered within ±2.5% of initial body mass. Body composition, stable isotope methodologies, proteomics, muscle biopsies, whole-room calorimetry, molecular biology, activity/sleep monitoring, personality and cognitive function assessments, functional MRI, and comprehensive biochemistries will be used to assess physiological and psychological responses to energy restriction and recovery feeding while volunteers are in an expected hypogonadal versus eugonadal state. The Optimizing Performance for Soldiers (OPS) study aims to determine whether preventing hypogonadism will mitigate declines in physical and mental function that typically occur during prolonged energy deficit, and the efficacy of testosterone replacement on recovery from severe underfeeding. NCT02734238. Copyright © 2017. Published by Elsevier Inc.

Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials.

PubMed

Yu, Changhe; Ji, Kangshou; Cao, Huijuan; Wang, Ying; Jin, Hwang Hye; Zhang, Zhe; Yang, Guanlin

2015-03-28

The purpose of this systematic review is to assess the effectiveness of acupuncture for angina pectoris. Eleven electronic databases were searched until January 2013. The study included randomized controlled trials that the effectiveness of acupuncture alone was compared to anti-angina medicines (in addition to conventional treatment) and the effectiveness of a combination of acupuncture plus anti-angina medicines was compared to anti-angina medicines alone. The trial selection, data extraction, quality assessment and data analytic procedures outlined in the 2011 Cochrane Handbook were involved. The study included 25 randomized controlled trials (involving 2,058 patients) that met our inclusion criteria. The pooled results showed that the number of patients with ineffectiveness of angina relief was less in the combined acupuncture-anti-angina treatment group than in the anti-angina medicines alone group (RR 0.33, 95% CI 0.23-0.47, p < 0.00001, I2 = 0%). Similarly, compared to the anti-angina medicines alone group, fewer patients in the combined treatment group showed no ECG improvement (RR 0.50, 95% CI 0.40-0.62, p < 0.00001, I2 = 0%). However, no differences were observed between acupuncture treatment alone and anti-angina medicines alone for both outcome measures. Only four trials mentioned adverse effects. One trial found no significant difference between acupuncture and Chinese medicine, and three reported no adverse events. The quality of the trials was found to be low. The findings showed very low evidence to support the use of acupuncture for improving angina symptoms and ECG of angina patients. However, the quality of the trials included in this study was low. Large and rigorously designed trials are needed to confirm the potential benefit and adverse events of acupuncture.

A Meta-Analysis of Red Yeast Rice: An Effective and Relatively Safe Alternative Approach for Dyslipidemia

PubMed Central

Li, Yinhua; Jiang, Long; Jia, Zhangrong; Xin, Wei; Yang, Shiwei; Yang, Qiu; Wang, Luya

2014-01-01

Objective To explore whether red yeast rice is a safe and effective alternative approach for dyslipidemia. Methods Pubmed, the Cochrane Library, EBSCO host, Chinese VIP Information (VIP), China National Knowledge Infrastructure (CNKI), Wanfang Databases were searched for appropriate articles. Randomized trials of RYR (not including Xuezhikang and Zhibituo) and placebo as control in patients with dyslipidemia were considered. Two authors read all papers and independently extracted all relevant information. The primary outcomes were serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C). The secondary outcomes were increased levels of alanine transaminase, aspartate aminotransferase, creatine kinase, creatinine and fasting blood glucose. Results A total of 13 randomized, placebo-controlled trials containing 804 participants were analyzed. Red yeast rice exhibited significant lowering effects on serum TC [WMD = −0.97 (95% CI: −1.13, −0.80) mmol/L, P<0.001], TG [WMD = −0.23 (95% CI: −0.31, −0.14) mmol/L, P<0.001], and LDL-C [WMD = −0.87 (95% CI: −1.03, −0.71) mmol/L, P<0.001] but no significant increasing effect on HDL-C [WMD = 0.08 (95% CI: −0.02, 0.19) mmol/L, P = 0.11] compared with placebo. No serious side effects were reported in all trials. Conclusions The meta-analysis suggests that red yeast rice is an effective and relatively safe approach for dyslipidemia. However, further long-term, rigorously designed randomized controlled trials are still warranted before red yeast rice could be recommended to patients with dyslipidemia, especially as an alternative to statins. PMID:24897342

Educating early childhood care and education providers to improve knowledge and attitudes about reporting child maltreatment: A randomized controlled trial.

PubMed

Mathews, Ben; Yang, Chengwu; Lehman, Erik B; Mincemoyer, Claudia; Verdiglione, Nicole; Levi, Benjamin H

2017-01-01

Early childhood care and education providers (CCPs) work with over 7 million young children. These children are vulnerable to physical, sexual and emotional abuse, and neglect. However, CCPs make less than 1% of all reports of suspected child abuse and neglect that are made to child protective services. CCPs are therefore an untapped resource in the public health response to child maltreatment. However, their knowledge and attitudes about duties to report child maltreatment are poorly understood. Moreover, no rigorous research has tested whether their knowledge and attitudes about reporting child maltreatment can be improved. These gaps in knowledge are important because knowledge of the duty and positive attitudes towards it produce more effective reporting, and little evidence exists about how to enhance cognitive and affective attributes. Using the CONSORT approach, we report a single-blind test-retest randomized controlled trial evaluating iLook Out for Child Abuse, a customized online educational intervention for CCPs to increase knowledge and attitudes towards the reporting duty. 762 participants were randomized with results analyzed for 741 participants (372 in the intervention group; 369 in the control). Knowledge of the reporting duty increased in the intervention group from 13.54 to 16.19 out of 21 (2.65 increase, 95% CI: (2.37, 2.93); large effect size 0.95, p < 0.001); the control group remained stable, moving from 13.54 to 13.59 (0.05 increase, 95% CI: (-0.12, 0.22); negligible effect size 0.03, p = 0.684). Attitudes were enhanced on all 13 items for the intervention group, remaining stable in the control, with significant differences between groups on all items (p < 0.05). Gains were largely sustained at four month follow-up. Findings support education for CCPs and other professions. Future research should also explore effects of education on reporting behavior. US National Institutes of Health NCT02225301.

Study design elements for rigorous quasi-experimental comparative effectiveness research.

PubMed

Maciejewski, Matthew L; Curtis, Lesley H; Dowd, Bryan

2013-03-01

Quasi-experiments are likely to be the workhorse study design used to generate evidence about the comparative effectiveness of alternative treatments, because of their feasibility, timeliness, affordability and external validity compared with randomized trials. In this review, we outline potential sources of discordance in results between quasi-experiments and experiments, review study design choices that can improve the internal validity of quasi-experiments, and outline innovative data linkage strategies that may be particularly useful in quasi-experimental comparative effectiveness research. There is an urgent need to resolve the debate about the evidentiary value of quasi-experiments since equal consideration of rigorous quasi-experiments will broaden the base of evidence that can be brought to bear in clinical decision-making and governmental policy-making.

Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial.

PubMed

Bjorkman, Mikko P; Suominen, Merja H; Pitkälä, Kaisu H; Finne-Soveri, Harriet U; Tilvis, Reijo S

2013-11-14

Age-related muscle loss (that is, sarcopenia) is a common health problem among older people. Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia. Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce. The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people. During 2012 the entire 75 and older population (N = 3,275) living in Porvoo, Finland was contacted via a postal questionnaire. Persons at risk of sarcopenia are screened with hand grip strength and gait speed. Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index. Sarcopenic patients (target N = 250) will be enrolled in a 12-month randomized controlled trial with three arms: 1) no supplementation, 2) protein supplementation (20 grams twice a day), and 3) isocaloric placebo. All the participants will receive instructions on simple home-based exercises, dietary protein, and vitamin D supplementation (20 μg/d). The recruitment of patients will be completed during 2013. The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance. Secondary endpoints will be, among other things, changes in muscle functions, nutritional status, body composition, cognition, quality of life, use of health care services, falls, and mortality. The assessment times will be 0, 6, 12 and 24 months. To our knowledge, this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance. ACTRN12612001253897, date of registration 28 October 2012, first patient was randomized 11 April 2012.

Children's Antisocial Behavior, Mental Health, Drug Use, and Educational Performance After Parental Incarceration

PubMed Central

Murray, Joseph; Farrington, David P.; Sekol, Ivana

2012-01-01

Unprecedented numbers of children experience parental incarceration worldwide. Families and children of prisoners can experience multiple difficulties after parental incarceration, including traumatic separation, loneliness, stigma, confused explanations to children, unstable childcare arrangements, strained parenting, reduced income, and home, school, and neighborhood moves. Children of incarcerated parents often have multiple, stressful life events before parental incarceration. Theoretically, children with incarcerated parents may be at risk for a range of adverse behavioral outcomes. A systematic review was conducted to synthesize empirical evidence on associations between parental incarceration and children's later antisocial behavior, mental health problems, drug use, and educational performance. Results from 40 studies (including 7,374 children with incarcerated parents and 37,325 comparison children in 50 samples) were pooled in a meta-analysis. The most rigorous studies showed that parental incarceration is associated with higher risk for children's antisocial behavior, but not for mental health problems, drug use, or poor educational performance. Studies that controlled for parental criminality or children's antisocial behavior before parental incarceration had a pooled effect size of OR = 1.4 (p < .01), corresponding to about 10% increased risk for antisocial behavior among children with incarcerated parents, compared with peers. Effect sizes did not decrease with number of covariates controlled. However, the methodological quality of many studies was poor. More rigorous tests of the causal effects of parental incarceration are needed, using randomized designs and prospective longitudinal studies. Criminal justice reforms and national support systems might be needed to prevent harmful consequences of parental incarceration for children. PMID:22229730

Children's antisocial behavior, mental health, drug use, and educational performance after parental incarceration: a systematic review and meta-analysis.

PubMed

Murray, Joseph; Farrington, David P; Sekol, Ivana

2012-03-01

Unprecedented numbers of children experience parental incarceration worldwide. Families and children of prisoners can experience multiple difficulties after parental incarceration, including traumatic separation, loneliness, stigma, confused explanations to children, unstable childcare arrangements, strained parenting, reduced income, and home, school, and neighborhood moves. Children of incarcerated parents often have multiple, stressful life events before parental incarceration. Theoretically, children with incarcerated parents may be at risk for a range of adverse behavioral outcomes. A systematic review was conducted to synthesize empirical evidence on associations between parental incarceration and children's later antisocial behavior, mental health problems, drug use, and educational performance. Results from 40 studies (including 7,374 children with incarcerated parents and 37,325 comparison children in 50 samples) were pooled in a meta-analysis. The most rigorous studies showed that parental incarceration is associated with higher risk for children's antisocial behavior, but not for mental health problems, drug use, or poor educational performance. Studies that controlled for parental criminality or children's antisocial behavior before parental incarceration had a pooled effect size of OR = 1.4 (p < .01), corresponding to about 10% increased risk for antisocial behavior among children with incarcerated parents, compared with peers. Effect sizes did not decrease with number of covariates controlled. However, the methodological quality of many studies was poor. More rigorous tests of the causal effects of parental incarceration are needed, using randomized designs and prospective longitudinal studies. Criminal justice reforms and national support systems might be needed to prevent harmful consequences of parental incarceration for children.

Biochemical and hemodynamic changes in normal subjects during acute and rigorous bed rest and ambulation

NASA Astrophysics Data System (ADS)

Zorbas, Yan G.; Kakurin, Vassily J.; Afonin, Victor B.; Yarullin, Vladimir L.

2002-06-01

Rigorous bed rest (RBR) induces significant biochemical and circulatory changes. However, little is known about acute rigorous bed rest (ARBR). Measuring biochemical and circulatory variables during ARBR and RBR the aim of this study was to establish the significance of ARBR effect. Studies were done during 3 days of a pre-bed rest (BR) period and during 7 days of ARBR and RBR period. Thirty normal male individuals aged, 24.1±6.3 years were chosen as subjects. They were divided equally into three groups: 10 subjects placed under active control conditions served as unrestricted ambulatory control subjects (UACS), 10 subjects submitted to an acute rigorous bed rest served as acute rigorous bed rested subjects (ARBRS) and 10 subjects submitted to a rigorous bed rest served as rigorous bed rested subjects (RBRS). The UACS were maintained under an average running distance of 9.7 km day -1. For the ARBR effect simulation, ARBRS were submitted abruptly to BR for 7 days. They did not have any prior knowledge of the exact date and time when they would be asked to confine to RBR. For the RBR effect simulation, RBRS were subjected to BR for 7 days on a predetermined date and time known to them right away from the start of the study. Plasma renin activity (PRA), plasma cortisol (PC), plasma aldosterone (PA), plasma and urinary sodium (Na) and potassium (K) levels, heart rate (HR), cardiac output (CO), and arterial blood pressure (ABP) increased significantly, and urinary aldosterone (UA), stroke volume (SV) and plasma volume (PV) decreased significantly ( p<0.05) in ARBRS and RBRS as compared with their pre-BR values and the values in UACS. Electrolyte, hormonal and hemodynamic responses were significantly ( p<0.05) greater and occurred significantly faster ( p<0.05) during ARBR than RBR. Parameters change insignificantly ( p>0.05) in UACS compared with pre-BR control values. It was concluded that, the more abruptly muscular activity is restricted in experimental subjects while they are very active, the greater hemodynamic and biochemical change there is and probably in individuals whose muscular activity is abruptly terminated after an accident or sudden illness.

Effectiveness and cost effectiveness of cognitive behavioral therapy (CBT) in clinically depressed adolescents: individual CBT versus treatment as usual (TAU).

PubMed

Stikkelbroek, Yvonne; Bodden, Denise Hm; Deković, Maja; van Baar, Anneloes L

2013-11-21

Depressive disorders occur in 2 to 5% of the adolescents and are associated with a high burden of disease, a high risk of recurrence and a heightened risk for development of other problems, like suicide attempts. The effectiveness of cognitive behaviour therapy (CBT), cost-effectiveness of this treatment and the costs of illness of clinical depression in adolescents are still unclear. Although several Randomized Controlled Trials (RCT) have been conducted to establish the efficacy of CBT, the effectiveness has not been established yet. Aim of this study is to conduct a RCT to test the effectiveness of CBT and to establish the cost-effectiveness of CBT under rigorous conditions within routine care provided by professionals already working in mental health institutions. CBT is investigated with a multi-site, RCT using block randomisation. The targeted population is 140 clinically referred depressed adolescents aged 12 to 21 years old. Adolescents are randomly assigned to the experimental (N = 70, CBT) or control condition (N = 70, TAU). Four assessments (pre, post, follow up at 6 and 12 months) and two mediator assessments during treatment are conducted. Primary outcome measure is depression diagnosis based on a semi-structured interview namely the K-SADS-PL. Secondary outcome measures include depressive symptoms, severity and improvement of the depression, global functioning, quality of life, suicide risk, comorbidity, alcohol and drug use, parental depression and psychopathology, parenting and conflicts. Costs and treatment characteristics will also be assessed. Furthermore, moderator and mediator analyses will be conducted. This trial will be the first to compare CBT with TAU under rigorous conditions within routine care and with a complex sample. Furthermore, cost-effectiveness of treatment and cost-of-illness of clinical depression are established which will provide new insights on depression as a disorder and its treatment. Dutch Trial register number NTR2676. The study was financially supported by a grant from ZonMw, the Netherlands organization for health research and development, grant number 157004005.

What Are Naturally Occurring School Lotteries and How Do We Identify Them? Reflections on Methodology

ERIC Educational Resources Information Center

Unterman, Rebecca

2018-01-01

This post is one in a series highlighting MDRC's methodological work. In the past decade, rapid growth in the number of charter schools and school district choice systems has provided education researchers with exciting opportunities to use naturally occurring pockets of randomization to rigorously study the effects of policy-relevant education…

Statistical linearization for multi-input/multi-output nonlinearities

NASA Technical Reports Server (NTRS)

Lin, Ching-An; Cheng, Victor H. L.

1991-01-01

Formulas are derived for the computation of the random input-describing functions for MIMO nonlinearities; these straightforward and rigorous derivations are based on the optimal mean square linear approximation. The computations involve evaluations of multiple integrals. It is shown that, for certain classes of nonlinearities, multiple-integral evaluations are obviated and the computations are significantly simplified.

Program Evaluation: A Variety of Rigorous Methods Can Help Identify Effective Interventions. Report to Congressional Requesters. GAO-10-30

ERIC Educational Resources Information Center

Kingsbury, Nancy

2009-01-01

Recent congressional initiatives seek to focus funds for certain federal social programs on interventions for which randomized experiments show sizable, sustained benefits to participants or society. The private, nonprofit Coalition for Evidence-Based Policy undertook the Top Tier Evidence initiative to help federal programs identify interventions…

Conducting Rigorous Research in Multilingual Context: A Randomized Field Trial of the Good Behavior Game

ERIC Educational Resources Information Center

Kurki, Anja; Wang, Wei; Poduska, Jeanne; Gomez, Mary Jane; Li, Yibing; Brown, C. Hendricks

2012-01-01

This paper describes the design and preliminary results regarding the testing of the Good Behavior Game in schools that vary in their proportion of Latinos and the use of bilingual instruction. The authors discuss how working with multicultural schools/school district has influenced the design, intervention and training, data collection, and…

Assessing significance in a Markov chain without mixing.

PubMed

Chikina, Maria; Frieze, Alan; Pegden, Wesley

2017-03-14

We present a statistical test to detect that a presented state of a reversible Markov chain was not chosen from a stationary distribution. In particular, given a value function for the states of the Markov chain, we would like to show rigorously that the presented state is an outlier with respect to the values, by establishing a [Formula: see text] value under the null hypothesis that it was chosen from a stationary distribution of the chain. A simple heuristic used in practice is to sample ranks of states from long random trajectories on the Markov chain and compare these with the rank of the presented state; if the presented state is a [Formula: see text] outlier compared with the sampled ranks (its rank is in the bottom [Formula: see text] of sampled ranks), then this observation should correspond to a [Formula: see text] value of [Formula: see text] This significance is not rigorous, however, without good bounds on the mixing time of the Markov chain. Our test is the following: Given the presented state in the Markov chain, take a random walk from the presented state for any number of steps. We prove that observing that the presented state is an [Formula: see text]-outlier on the walk is significant at [Formula: see text] under the null hypothesis that the state was chosen from a stationary distribution. We assume nothing about the Markov chain beyond reversibility and show that significance at [Formula: see text] is best possible in general. We illustrate the use of our test with a potential application to the rigorous detection of gerrymandering in Congressional districting.

On the definition of absorbed dose

NASA Astrophysics Data System (ADS)

Grusell, Erik

2015-02-01

Purpose: The quantity absorbed dose is used extensively in all areas concerning the interaction of ionizing radiation with biological organisms, as well as with matter in general. The most recent and authoritative definition of absorbed dose is given by the International Commission on Radiation Units and Measurements (ICRU) in ICRU Report 85. However, that definition is incomplete. The purpose of the present work is to give a rigorous definition of absorbed dose. Methods: Absorbed dose is defined in terms of the random variable specific energy imparted. A random variable is a mathematical function, and it cannot be defined without specifying its domain of definition which is a probability space. This is not done in report 85 by the ICRU, mentioned above. Results: In the present work a definition of a suitable probability space is given, so that a rigorous definition of absorbed dose is possible. This necessarily includes the specification of the experiment which the probability space describes. In this case this is an irradiation, which is specified by the initial particles released and by the material objects which can interact with the radiation. Some consequences are discussed. Specific energy imparted is defined for a volume, and the definition of absorbed dose as a point function involves the specific energy imparted for a small mass contained in a volume surrounding the point. A possible more precise definition of this volume is suggested and discussed. Conclusions: The importance of absorbed dose motivates a proper definition, and one is given in the present work. No rigorous definition has been presented before.

Assessing significance in a Markov chain without mixing

PubMed Central

Chikina, Maria; Frieze, Alan; Pegden, Wesley

2017-01-01

We present a statistical test to detect that a presented state of a reversible Markov chain was not chosen from a stationary distribution. In particular, given a value function for the states of the Markov chain, we would like to show rigorously that the presented state is an outlier with respect to the values, by establishing a p value under the null hypothesis that it was chosen from a stationary distribution of the chain. A simple heuristic used in practice is to sample ranks of states from long random trajectories on the Markov chain and compare these with the rank of the presented state; if the presented state is a 0.1% outlier compared with the sampled ranks (its rank is in the bottom 0.1% of sampled ranks), then this observation should correspond to a p value of 0.001. This significance is not rigorous, however, without good bounds on the mixing time of the Markov chain. Our test is the following: Given the presented state in the Markov chain, take a random walk from the presented state for any number of steps. We prove that observing that the presented state is an ε-outlier on the walk is significant at p=2ε under the null hypothesis that the state was chosen from a stationary distribution. We assume nothing about the Markov chain beyond reversibility and show that significance at p≈ε is best possible in general. We illustrate the use of our test with a potential application to the rigorous detection of gerrymandering in Congressional districting. PMID:28246331

Trends in Study Methods Used in Undergraduate Medical Education Research, 1969–2007

PubMed Central

Baernstein, Amy; Liss, Hillary K.; Carney, Patricia A.; Elmore, Joann G.

2011-01-01

Context Evidence-based medical education requires rigorous studies appraising educational efficacy. Objectives To assess trends over time in methods used to evaluate undergraduate medical education interventions and to identify whether participation of medical education departments or centers is associated with more rigorous methods. Data Sources The PubMed, Cochrane Controlled Trials Registry, Campbell Collaboration, and ERIC databases (January 1966–March 2007) were searched using terms equivalent to students, medical and education, medical crossed with all relevant study designs. Study Selection We selected publications in all languages from every fifth year, plus the most recent 12 months, that evaluated an educational intervention for undergraduate medical students. Four hundred seventy-two publications met criteria for review. Data Extraction Data were abstracted on number of participants; types of comparison groups; whether outcomes assessed were objective, subjective, and/or validated; timing of outcome assessments; funding; and participation of medical education departments and centers. Ten percent of publications were independently abstracted by 2 authors to assess validity of the data abstraction. Results The annual number of publications increased over time from 1 (1969–1970) to 147 (2006–2007). In the most recent year, there was a mean of 145 medical student participants; 9 (6%) recruited participants from multiple institutions; 80 (54%) used comparison groups; 37 (25%) used randomized control groups; 91 (62%) had objective outcomes; 23 (16%) had validated outcomes; 35 (24%) assessed an outcome more than 1 month later; 21 (14%) estimated statistical power; and 66 (45%) reported funding. In 2006–2007, medical education department or center participation, reported in 46 (31%) of the recent publications, was associated only with enrolling more medical student participants (P = .04); for all studies from 1969 to 2007, it was associated only with measuring an objective outcome (P = .048). Between 1969 and 2007, the percentage of publications reporting statistical power and funding increased; percentages did not change for other study features. Conclusions The annual number of published studies of undergraduate medical education interventions demonstrating methodological rigor has been increasing. However, considerable opportunities for improvement remain. PMID:17785648

Conducting Intervention Research among Underserved Populations: Lessons Learned and Recommendations for Researchers

PubMed Central

Pyatak, Elizabeth A.; Blanche, Erna I.; Garber, Susan L.; Diaz, Jesus; Blanchard, Jeanine; Florindez, Lucia; Clark, Florence A.

2013-01-01

Randomized controlled trials (RCTs) are considered the gold standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, as evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodological paper we discuss the challenges and lessons learned in implementing the Lifestyle Redesign® for Pressure Ulcer Prevention in Spinal Cord Injury (LR-PUPS) study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided. PMID:23262157

A simple experimental method to study depigmenting agents.

PubMed

Abella, M L; de Rigal, J; Neveux, S

2007-08-01

The first objective of the study was to verify that a controlled UV exposure of four areas of the forearms together with randomized product application enabled to compare treatment efficacy and then to compare the depigmenting efficacy of different products with a simple experimental method. Sixteen volunteers received 0.7 minimal erythermal dose for four consecutive days. Products tested were ellagic acid (0.5%), vitamin C (5%) and C8-LHA (2%). Product application started 72 h post last exposure, was repeated for 42 days, the control zone being exposed, non-treated. Colour measurements included Chromameter, Chromasphere, Spectro-colorimeter and visual assessment. Comparison of colour values at day 1 and at day 7 showed that all zones were comparably tanned, allowing a rigorous comparison of the treatments. We report a new simple experimental model, which enables the rapid comparison of different depigmenting products. The efficacy and good tolerance of C8-LHA make it an excellent candidate for the treatment of hyperpigmentory disorders.

Effects of monetary reward and punishment on information checking behaviour.

PubMed

Li, Simon Y W; Cox, Anna L; Or, Calvin; Blandford, Ann

2016-03-01

Two experiments were conducted to examine whether checking one's own work can be motivated by monetary reward and punishment. Participants were randomly assigned to one of three conditions: a flat-rate payment for completing the task (Control); payment increased for error-free performance (Reward); payment decreased for error performance (Punishment). Experiment 1 (N = 90) was conducted with liberal arts students, using a general data-entry task. Experiment 2 (N = 90) replicated Experiment 1 with clinical students and a safety-critical 'cover story' for the task. In both studies, Reward and Punishment resulted in significantly fewer errors, more frequent and longer checking, than Control. No such differences were obtained between the Reward and Punishment conditions. It is concluded that error consequences in terms of monetary reward and punishment can result in more accurate task performance and more rigorous checking behaviour than errors without consequences. However, whether punishment is more effective than reward, or vice versa, remains inconclusive. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

A randomized, controlled trial of a school-based intervention to reduce violence and substance use in predominantly Latino high school students.

PubMed

Shetgiri, Rashmi; Kataoka, Sheryl; Lin, Hua; Flores, Glenn

2011-01-01

Few studies have rigorously evaluated school-based interventions to reduce violence and substance use in high school students, especially Latinos. This study assessed the effects of a school-based program on reducing violence and substance use among primarily Latino high school students. Ninth-grade students at risk for violence and substance use were randomized to intervention or control groups. The intervention was based on an existing program developed for white and African American youth. Data on smoking, alcohol and drug use, fighting, and grades were collected at baseline and 4 and 8 months post enrollment. There were 55 students in the control and 53 in the intervention group; 74% of controls and 78% of intervention students were Latino. There were no significant changes in fighting, smoking, or alcohol or drug use, from baseline to 8-month follow-up, between the intervention and control group. Pre and post grade point average (GPA) decreased from 2.3 at baseline to 1.8 at follow-up (p<.01) in the intervention group, with no significant between-group changes in GPA from baseline to follow-up. This school-based program showed no reduction in violence or substance use. The findings suggest that a program targeting non-Latino youth may not be optimal for reducing violence and substance use in Latinos; greater attention to cultural appropriateness and racial/ethnic differences may be needed. There was a decrease in intervention-group GPA but no significant change compared with controls. Further studies of the impact of school-based substance use and violence prevention programs on academics, and the effectiveness of afterschool or community-based programs compared to school-based programs are needed.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

PubMed

Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-04-01

Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Tai Chi Improves Sleep Quality in Healthy Adults and Patients with Chronic Conditions: A Systematic Review and Meta-analysis

PubMed Central

Raman, Gowri; Zhang, Yuan; Minichiello, Vincent J; D'Ambrosio, Carolyn M.; Wang, Chenchen

2017-01-01

Background Physical activity and exercise appear to improve sleep quality. However, the quantitative effects of Tai Chi on sleep quality in the adult population have rarely been examined. We conducted a systematic review and meta-analysis evaluating the effects of Tai Chi on sleep quality in healthy adults and disease populations. Methods Medline, Cochrane Central databases, and review of references were searched through July 31, 2013. English-language studies of all designs evaluating Tai Chi’s effect on sleep outcomes in adults were examined. Data were extracted and verified by 2 reviewers. Extracted information included study setting and design, population characteristics, type and duration of interventions, outcomes, risk of bias and main results. Random effect models meta-analysis was used to assess the magnitude of treatment effect when at least 3 trials reported on the same sleep outcomes. Results Eleven studies (9 randomized and 2 non-randomized trials) totaling 994 subjects published between 2004 and 2012 were identified. All studies except one reported Pittsburg Sleep Quality Index. Nine randomized trials reported that 1.5 to 3 hour each week for a duration of 6 to 24 weeks of Tai Chi significantly improved sleep quality (Effect Size, 0.89; 95% confidence interval [CI], 0.28 to 1.50), in community-dwelling healthy participants and in patients with chronic conditions. Improvement in health outcomes including physical performance, pain reduction, and psychological well-being occurred in the Tai Chi group compared with various controls. Limitations Studies were heterogeneous and some trials were lacking in methodological rigor. Conclusions Tai Chi significantly improved sleep quality in both healthy adults and patients with chronic health conditions, which suggests that Tai Chi may be considered as an alternative behavioral therapy in the treatment of insomnia. High-quality, well-controlled randomized trials are needed to better inform clinical decisions. PMID:28845367

Testing cardiovascular drug safety and efficacy in randomized trials.

PubMed

FitzGerald, Garret A

2014-03-28

Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials that establish efficacy and those that demonstrate effectiveness, drugs that patients actually consume in the real world for clinical benefit. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of effectiveness with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that average results may conceal considerable interindividual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients. Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria-the individual Numbers Needed to Treat to obtain a benefit, such as a life saved. Here, I will consider some reasons why large phase 3 trials-by far the most expensive element of drug development-may fail to address the unmet medical needs, which should justify such effort and investment.

The Utilization of Robotic Pets in Dementia Care.

PubMed

Petersen, Sandra; Houston, Susan; Qin, Huanying; Tague, Corey; Studley, Jill

2017-01-01

Behavioral problems may affect individuals with dementia, increasing the cost and burden of care. Pet therapy has been known to be emotionally beneficial for many years. Robotic pets have been shown to have similar positive effects without the negative aspects of traditional pets. Robotic pet therapy offers an alternative to traditional pet therapy. The study rigorously assesses the effectiveness of the PARO robotic pet, an FDA approved biofeedback device, in treating dementia-related symptoms. A randomized block design with repeated measurements guided the study. Before and after measures included reliable, valid tools such as: RAID, CSDD, GDS, pulse rate, pulse oximetry, and GSR. Participants interacted with the PARO robotic pet, and the control group received standard activity programs. Five urban secure dementia units comprised the setting. 61 patients, with 77% females, average 83.4 years in age, were randomized into control and treatment groups. Compared to the control group, RAID, CSDD, GSR, and pulse oximetry were increased in the treatment group, while pulse rate, pain medication, and psychoactive medication use were decreased. The changes in GSR, pulse oximetry, and pulse rate over time were plotted for both groups. The difference between groups was consistent throughout the 12-week study for pulse oximetry and pulse rate, while GSR had several weeks when changes were similar between groups. Treatment with the PARO robot decreased stress and anxiety in the treatment group and resulted in reductions in the use of psychoactive medications and pain medications in elderly clients with dementia.

The Utilization of Robotic Pets in Dementia Care

PubMed Central

Petersen, Sandra; Houston, Susan; Qin, Huanying; Tague, Corey; Studley, Jill

2016-01-01

Background: Behavioral problems may affect individuals with dementia, increasing the cost and burden of care. Pet therapy has been known to be emotionally beneficial for many years. Robotic pets have been shown to have similar positive effects without the negative aspects of traditional pets. Robotic pet therapy offers an alternative to traditional pet therapy. Objective: The study rigorously assesses the effectiveness of the PARO robotic pet, an FDA approved biofeedback device, in treating dementia-related symptoms. Methods: A randomized block design with repeated measurements guided the study. Before and after measures included reliable, valid tools such as: RAID, CSDD, GDS, pulse rate, pulse oximetry, and GSR. Participants interacted with the PARO robotic pet, and the control group received standard activity programs. Five urban secure dementia units comprised the setting. Results: 61 patients, with 77% females, average 83.4 years in age, were randomized into control and treatment groups. Compared to the control group, RAID, CSDD, GSR, and pulse oximetry were increased in the treatment group, while pulse rate, pain medication, and psychoactive medication use were decreased. The changes in GSR, pulse oximetry, and pulse rate over time were plotted for both groups. The difference between groups was consistent throughout the 12-week study for pulse oximetry and pulse rate, while GSR had several weeks when changes were similar between groups. Conclusions: Treatment with the PARO robot decreased stress and anxiety in the treatment group and resulted in reductions in the use of psychoactive medications and pain medications in elderly clients with dementia. PMID:27716673

A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols.

PubMed

Newton, Robert L; Johnson, William D; Hendrick, Chelsea; Harris, Melissa; Andrews, Emanuel; Johannsen, Neil; Rodarte, Ruben Q; Hsia, Daniel S; Church, Timothy S

2015-07-01

Lack of regular physical activity at prescribed intensity levels is a modifiable risk factor for insulin resistance and the development of diabetes. African American men are at increased risk for developing diabetes and most African American men are not meeting the current recommended levels of physical activity. The primary objective of the Aerobic Plus Resistance Training and Insulin Resistance in African American Men (ARTIIS) study is to determine the effectiveness of an exercise training intervention aimed at reducing diabetes risk factors in African American men at risk for developing diabetes. Insufficiently active 35-70 year old African American men with a family history of diabetes were eligible for the study. The 5-month randomized controlled trial assigns 116 men to an exercise training or healthy living control arm. The exercise training arm combines aerobic and resistance training according to the current national physical activity recommendations and is conducted in community (YMCA) facilities. The healthy living arm receives information promoting healthy lifestyle changes. Insulin response to an oral glucose load is the primary outcome measure, and changes in physiological parameters, cardiorespiratory fitness, strength, body composition, and psychological well-being comprise the secondary outcomes. The ARTIIS study is one of the first adequately powered, rigorously designed studies to investigate the effects of an aerobic plus resistance exercise training program and to assess adherence to exercise training in community facilities, in African American men. Copyright © 2015 Elsevier Inc. All rights reserved.

‘Lowering the threshold of effective deterrence’—Testing the effect of private security agents in public spaces on crime: A randomized controlled trial in a mass transit system

PubMed Central

Bland, Matthew; Sutherland, Alex

2017-01-01

Supplementing local police forces is a burgeoning multibillion-dollar private security industry. Millions of formal surveillance agents in public settings are tasked to act as preventative guardians, as their high visibility presence is hypothesized to create a deterrent threat to potential offenders. Yet, rigorous evidence is lacking. We randomly assigned all train stations in the South West of England that experienced crime into treatment and controls conditions over a six-month period. Treatment consisted of directed patrol by uniformed, unarmed security agents. Hand-held trackers on every agent yielded precise measurements of all patrol time in the stations. Count-based regression models, estimated marginal means and odds-ratios are used to assess the effect of these patrols on crimes reported to the police by victims, as well as new crimes detected by police officers. Outcomes are measured at both specified target locations to which security guards were instructed to attend, as well as at the entire station complexes. Analyses show that 41% more patrol visits and 29% more minutes spent by security agents at treatment compared to control stations led to a significant 16% reduction in victim-generated crimes at the entirety of the stations’ complexes, with a 49% increase in police-generated detections at the target locations. The findings illustrate the efficacy of private policing for crime prevention theory. PMID:29211735

Oral language skills intervention in pre-school-a cautionary tale.

PubMed

Haley, Allyson; Hulme, Charles; Bowyer-Crane, Claudine; Snowling, Margaret J; Fricke, Silke

2017-01-01

While practitioners are increasingly asked to be mindful of the evidence base of intervention programmes, evidence from rigorous trials for the effectiveness of interventions that promote oral language abilities in the early years is sparse. To evaluate the effectiveness of a language intervention programme for children identified as having poor oral language skills in preschool classes. A randomized controlled trial was carried out in 13 UK nursery schools. In each nursery, eight children (N = 104, mean age = 3 years 11 months) with the poorest performance on standardized language measures were selected to take part. All but one child were randomly allocated to either an intervention (N = 52) or a waiting control group (N = 51). The intervention group received a 15-week oral language programme in addition to their standard nursery curriculum. The programme was delivered by trained teaching assistants and aimed to foster vocabulary knowledge, narrative and listening skills. Initial results revealed significant differences between the intervention and control group on measures of taught vocabulary. No group differences were found on any standardized language measure; however, there were gains of moderate effect size in listening comprehension. The study suggests that an intervention, of moderate duration and intensity, for small groups of preschool children successfully builds vocabulary knowledge, but does not generalize to non-taught areas of language. The findings strike a note of caution about implementing language interventions of moderate duration in preschool settings. The findings also highlight the importance of including a control group in intervention studies. © 2016 Royal College of Speech and Language Therapists.

A randomized controlled trial testing a social network intervention to promote physical activity among adolescents.

PubMed

van Woudenberg, Thabo J; Bevelander, Kirsten E; Burk, William J; Smit, Crystal R; Buijs, Laura; Buijzen, Moniek

2018-04-23

The current study examined the effectiveness of a social network intervention to promote physical activity among adolescents. Social network interventions utilize peer influence to change behavior by identifying the most influential individuals within social networks (i.e., influence agents), and training them to promote the target behavior. A total of 190 adolescents (46.32% boys; M age = 12.17, age range: 11-14 years) were randomly allocated to either the intervention or control condition. In the intervention condition, the most influential adolescents (based on peer nominations of classmates) in each classroom were trained to promote physical activity among their classmates. Participants received a research smartphone to complete questionnaires and an accelerometer to measure physical activity (steps per day) at baseline, and during the intervention one month later. A multilevel model tested the effectiveness of the intervention, controlling for clustering of data within participants and days. No intervention effect was observed, b = .04, SE = .10, p = .66. This was one of the first studies to test whether physical activity in adolescents could be promoted via influence agents, and the first social network intervention to use smartphones to do so. Important lessons and implications are discussed concerning the selection criterion of the influence agents, the use of smartphones in social network intervention, and the rigorous analyses used to control for confounding factors. Dutch Trial Registry (NTR): NTR6173 . Registered 5 October 2016 Study procedures were approved by the Ethics Committee of the Radboud University (ECSW2014-100614-222).

Methodological Considerations for Use of Routine Health Information System Data to Evaluate Malaria Program Impact in an Era of Declining Malaria Transmission

PubMed Central

Ashton, Ruth A.; Bennett, Adam; Yukich, Joshua; Bhattarai, Achuyt; Keating, Joseph; Eisele, Thomas P.

2017-01-01

Abstract. Coverage of malaria control interventions is increasing dramatically across endemic countries. Evaluating the impact of malaria control programs and specific interventions on health indicators is essential to enable countries to select the most effective and appropriate combination of tools to accelerate progress or proceed toward malaria elimination. When key malaria interventions have been proven effective under controlled settings, further evaluations of the impact of the intervention using randomized approaches may not be appropriate or ethical. Alternatives to randomized controlled trials are therefore required for rigorous evaluation under conditions of routine program delivery. Routine health management information system (HMIS) data are a potentially rich source of data for impact evaluation, but have been underused in impact evaluation due to concerns over internal validity, completeness, and potential bias in estimates of program or intervention impact. A range of methodologies were identified that have been used for impact evaluations with malaria outcome indicators generated from HMIS data. Methods used to maximize internal validity of HMIS data are presented, together with recommendations on reducing bias in impact estimates. Interrupted time series and dose-response analyses are proposed as the strongest quasi-experimental impact evaluation designs for analysis of malaria outcome indicators from routine HMIS data. Interrupted time series analysis compares the outcome trend and level before and after the introduction of an intervention, set of interventions or program. The dose-response national platform approach explores associations between intervention coverage or program intensity and the outcome at a subnational (district or health facility catchment) level. PMID:28990915

HOME-BASED BLOOD PRESSURE INTERVENTIONS FOR AFRICAN AMERICANS

PubMed Central

Feldman, Penny H.; McDonald, Margaret V.; Mongoven, Jennifer M.; Peng, Timothy R.; Gerber, Linda M.; Pezzin, Liliana E.

2009-01-01

Background Efforts to increase blood pressure (BP) control rates in African Americans, a traditionally underserved, high risk population must address both provider practice and patient adherence issues. The Home-Based BP Intervention for African Americans study is a three-arm randomized controlled trial designed to test two strategies to improve HTN management and outcomes in a decentralized service setting serving a vulnerable and complex home care population. The primary study outcomes are systolic BP, diastolic BP, and BP control; secondary outcomes are nurse adherence to HTN management recommendations, and patient adherence to medication, healthy diet and other self-management strategies. Methods and Results Nurses (N=312) in a nonprofit Medicare-certified home health agency are randomized along with their eligible hypertensive patients (N=845). The two interventions being tested are: (i) a “basic” intervention delivering key evidence-based reminders to home care nurses and patients while the patient is receiving traditional post-acute home health care; and (ii) an “augmented” intervention that includes that same as the basic intervention, plus transition to an ongoing HTN Home Support Program that extends support for 12 months. Outcomes are measured at 3 and 12 months post baseline interview. The interventions will be assessed relative to usual care and to each other. Conclusions Systems change to improve BP management and outcomes in home health will not easily occur without new intervention models and rigorous evaluation of their impact. Results from this trial will provide important information on potential strategies to improve BP control in a low income, chronically ill patient population. PMID:20031844

A 3-arm randomized controlled trial on the effects of dance movement intervention and exercises on elderly with early dementia.

PubMed

Ho, Rainbow Tin Hung; Cheung, Jacob Kai Ki; Chan, Wai Chi; Cheung, Irene Kit Man; Lam, Linda Chiu Wah

2015-10-19

Dementia is characterized by a progressive decline and deterioration of brain regions such as memory, spatial navigation and language, along with disturbances in daily functioning. Non-pharmacological interventions that offer a holistic approach by targeting cognitive functioning, prognosis and the psychological and social effects of dementia require rigorous investigation. The well-established benefits of physical activity for cognitive functioning and psychological support in dementia have been observed with dance-movement intervention. There is substantial evidence that dance-movement interventions provide emotional and social advantages. Thus, a randomized controlled trial (RCT) is planned to investigate the positive effects of a dance movement intervention, compared with mild physical exercise, on the physical and psychological well-being of elderly Chinese individuals with early dementia. A 3-arm RCT with waitlist control design will be used in this study. Two hundred and one elderly participants with very mild to mild dementia will be screened and randomized into the following groups: (i) dance movement based intervention, (ii) stretching and exercise intervention and (iii) no intervention waitlist-control group. The two intervention groups will receive a 1-h intervention, twice a week, for 12 weeks. The participants will be assessed four times over the course of 12 months: baseline before randomization, post-intervention (3 months), 6 months from baseline and 12 months from baseline. The primary outcomes will be compared between assessment points and between groups on neuropsychiatric symptoms, psychosocial well-being and cognitive and daily functioning. Secondary outcomes will assess the changes in salivary cortisol levels and their relationships with the primary outcome measures. This study will provide substantial evidence of the efficacy of a dance-movement-based intervention in slowing down dementia progression, due to its ability to act as a buffer against decline and improve areas affected by dementia. We also anticipate an association between cortisol levels and the outcome measures. The further development of this intervention into a structural program may be warranted for early psychosocial support among elderly populations. The trial has been registered in the Chinese Clinical Trial Registry ( ChiCTR-IOR-15006541 ).

Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial

PubMed Central

2014-01-01

Background Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. Methods/design The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18–60 years, on sick leave 2–12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter “untouched” control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods. Trial registration ClinicalTrials.gov: NCT01926574. PMID:24735616

Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

PubMed

Prathikanti, Sudha; Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

2017-01-01

Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. In adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity. ClinicalTrials.gov NCT01210651.

Treating major depression with yoga: A prospective, randomized, controlled pilot trial

PubMed Central

Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

2017-01-01

Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22–72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. Results In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen’s d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. Conclusion In adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity. Trial registration ClinicalTrials.gov NCT01210651 PMID:28301561

Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial.

PubMed

Volanen, Salla-Maarit; Lassander, Maarit; Hankonen, Nelli; Santalahti, Päivi; Hintsanen, Mirka; Simonsen, Nina; Raevuori, Anu; Mullola, Sari; Vahlberg, Tero; But, Anna; Suominen, Sakari

2016-07-11

Mindfulness has shown positive effects on mental health, mental capacity and well-being among adult population. Among children and adolescents, previous research on the effectiveness of mindfulness interventions on health and well-being has shown promising results, but studies with methodologically sound designs have been called for. Few intervention studies in this population have compared the effectiveness of mindfulness programs to alternative intervention programs with adequate sample sizes. Our primary aim is to explore the effectiveness of a school-based mindfulness intervention program compared to a standard relaxation program among a non-clinical children and adolescent sample, and a non-treatment control group in school context. In this study, we systematically examine the effects of mindfulness intervention on mental well-being (primary outcomes being resilience; existence/absence of depressive symptoms; experienced psychological strengths and difficulties), cognitive functions, psychophysiological responses, academic achievements, and motivational determinants of practicing mindfulness. The design is a cluster randomized controlled trial with three arms (mindfulness intervention group, active control group, non-treatment group) and the sample includes 59 Finnish schools and approx. 3 000 students aged 12-15 years. Intervention consists of nine mindfulness based lessons, 45 mins per week, for 9 weeks, the dose being identical in active control group receiving standard relaxation program called Relax. The programs are delivered by 14 educated facilitators. Students, their teachers and parents will fill-in the research questionnaires before and after the intervention, and they will all be followed up 6 months after baseline. Additionally, students will be followed 12 months after baseline. For longer follow-up, consent to linking the data to the main health registers has been asked from students and their parents. The present study examines systematically the effectiveness of a school-based mindfulness program compared to a standard relaxation program, and a non-treatment control group. A strength of the current study lies in its methodologically rigorous, randomized controlled study design, which allows novel evidence on the effectiveness of mindfulness over and above a standard relaxation program. ISRCTN18642659 . Retrospectively registered 13 October 2015.

The Flipped Classroom: Fertile Ground for Nursing Education Research.

PubMed

Bernard, Jean S

2015-07-16

In the flipped classroom (FC) students view pre-recorded lectures or complete pre-class assignments to learn foundational concepts. Class time involves problem-solving and application activities that cultivate higher-level cognitive skills. A systematic, analytical literature review was conducted to explore the FC's current state of the science within higher education. Examination of this model's definition and measures of student performance, student and faculty perceptions revealed an ill-defined educational approach. Few studies confirmed FC effectiveness; many lacked rigorous design, randomized samples, or control of extraneous variables. Few researchers conducted longitudinal studies to determine sufficiently trends related to FC practice. This study proves relevant to nurse educators transitioning from traditional teaching paradigms to learner-centered models, and provides insight from faculty teaching across disciplines around the world. It reveals pertinent findings and identifies current knowledge gaps that call for further inquiry.

A case series on the potential effect of omega-3-fatty acid supplementation on 24-h heart rate variability and its circadian variation in children with attention deficit (hyperactivity) disorder.

PubMed

Buchhorn, Reiner; Koenig, Julian; Jarczok, Marc N; Eichholz, Hanna; Willaschek, Christian; Thayer, Julian F; Kaess, Michael

2018-06-01

Attention deficit disorder with and without hyperactivity (ADHD) in children is associated with decreased 24-h heart rate variability (HRV). Previous research has shown that supplementation of omega-3-fatty acid increases HRV. Here, we aimed to investigate whether the supplementation of omega-3-fatty acids would increase 24-h HRV in an uncontrolled case series of children with ADHD. HRV was recorded in 18 children and adolescents (age 13.35 ± 2.8 years) before and after omega-3 supplementation. Preliminary results indicate that omega-3 supplementation in children with AD(H)D may reduce mean heart rate and increase its variability. Future studies would do well to implement randomized, placebo-controlled designs with greater methodological rigor.

Effectiveness of urine surveillance as an adjunct to outpatient psychotherapy for drug abusers.

PubMed

Milby, J B; Clarke, C; Toro, C; Thornton, S; Rickert, D

1980-10-01

Twenty-nine polydrug abusers were randomly assigned to three out-patient treatment groups after inpatient detoxification. The groups were outpatient psychotherapy (1) with urine surveillance, (2) without surveillance, and (3) waiting list control. Tests were administered before and 3 months after outpatient treatment began. All groups made positive changes during treatment including significant reduction in drugs abused and numbers of subjects reporting less time spent in illegal activity. Notable significant differences were Group 3's reduction in social introversion vs Groups 1 and 2, and Group 1's retaining fewer drug-using friends and showing greatest reduction in barbiturate use frequency vs Groups 2 and 3. Experimenters concluded urine surveillance was somewhat helpful as an adjunct to outpatient psychotherapy but suggested its effect could be amplified by employing more rigorous surveillance procedures, especially if contingency contracting were utilized.

Interdisciplinary teamwork and leadership: issues for psychiatrists.

PubMed

Rosen, Alan; Callaly, Tom

2005-09-01

To review the constructs and applications of interdisciplinary teams in mental health services, with a particular view to ascertaining the most effective types of teams and their leadership. Some of the most challenging questions from a psychiatrist's viewpoint regarding the functions of interdisciplinary teams in the mental health service are addressed. The effectiveness of the interdisciplinary team in mental health services is supported by an extensive literature that is much more qualitative and descriptive than quantitative and empirically rigorous, except as part of packages of variables subjected to randomized controlled trials. Effective interdisciplinary teamwork in mental health services involves both retaining differentiated disciplinary roles and developing shared core tasks. It requires sound leadership, effective team management, clinical supervision and explicit mechanisms for resolving role conflicts and ensuring safe practices. No one profession should hold a monopoly on leadership.

Summary Time Oriented Record (STOR)—A Progress Report

PubMed Central

Simborg, Donald W.; Whiting-O'Keefe, Quinn E.

1981-01-01

A Summary Time Oriented Medical Record System (STOR) has been designed as a potential replacement for the medical record for use in ambulatory care. As described at the Fourth Annual Symposium, this system has unique characteristics aimed specifically for management of patients with chronic diseases. It is hypothesized that this record design will improve information flow to practitioners at the time of decision-making in ambulatory care, while at the same time reducing manual recording requirements by the practitioner. This system has now been implemented in three specialty clinics at the University of California, San Francisco Medical Center. Rigorous evaluation techniques using prospective randomized control studies are being used in its evaluation. The clinical information includes patient problems, diagnoses, therapies, and ancillary test results. It is implemented on an IBM 4331 computer using the RAMIS data base management system.

Genetic and environmental effects on the muscle structure response post-mortem.

PubMed

Thompson, J M; Perry, D; Daly, B; Gardner, G E; Johnston, D J; Pethick, D W

2006-09-01

This paper reviewed the mechanisms by which glycolytic rate and pre-rigor stretching of muscle impact on meat quality. If muscle is free to shorten during the rigor process extremes in glycolytic rate can impact negatively on meat quality by inducing either cold or rigor shortening. Factors that contribute to variation in glycolytic rate include the glycogen concentration at slaughter and fibre type of the muscle. Glycolysis is highly sensitive to temperature, which is an important factor in heavy grain fed carcasses. An alternative solution to controlling glycolysis is to stretch the muscle pre-rigor so that it cannot shorten, thus providing an insurance against extremes in processing conditions. Results are presented which show a large reduction in variance (both additive and phenotypic) in tenderness caused by pre-rigor stretching. Whilst this did not impact on the heritability of shear force, it did reduce genotype differences. The implications of these results on the magnitude of genotype effects on tenderness is discussed.

Instrument Selection for Randomized Controlled Trials Why This and Not That?

PubMed Central

Records, Kathie; Keller, Colleen; Ainsworth, Barbara; Permana, Paska

2011-01-01

A fundamental linchpin for obtaining rigorous findings in quantitative research involves the selection of survey instruments. Psychometric recommendations are available for the processes for scale development and testing and guidance for selection of established scales. These processes are necessary to address the validity link between the phenomena under investigation, the empirical measures and, ultimately, the theoretical ties between these and the world views of the participants. Detailed information is most often provided about study design and protocols, but far less frequently is a detailed theoretical explanation provided for why specific instruments are chosen. Guidance to inform choices is often difficult to find when scales are needed for specific cultural, ethnic, or racial groups. This paper details the rationale underlying instrument selection for measurement of the major processes (intervention, mediator and moderator variables, outcome variables) in an ongoing study of postpartum Latinas, Madres para la Salud [Mothers for Health]. The rationale underpinning our choices includes a discussion of alternatives, when appropriate. These exemplars may provide direction for other intervention researchers who are working with specific cultural, racial, or ethnic groups or for other investigators who are seeking to select the ‘best’ instrument. Thoughtful consideration of measurement and articulation of the rationale underlying our choices facilitates the maintenance of rigor within the study design and improves our ability to assess study outcomes. PMID:21986392

A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol.

PubMed

Harvey, Sheila; Lees, Shelley; Mshana, Gerry; Pilger, Daniel; Hansen, Christian; Kapiga, Saidi; Watts, Charlotte

2018-04-02

Worldwide, almost one third (30%) of women who have been in a relationship have experienced physical and/or sexual violence from an intimate partner. Given the considerable negative impacts of intimate partner violence (IPV) on women's physical health and well-being, there is an urgent need for rigorous evidence on violence prevention interventions. The study, comprising a cluster randomized controlled trial (RCT) and in-depth qualitative study, will assess the impact on women's past year experience of physical and/or sexual IPV of a participatory gender training curriculum (MAISHA curriculum) delivered to women participating in group-based microfinance in Tanzania. More broadly, the study aims to learn more about the factors that contribute to women's vulnerability to violence and understand how the intervention impacts on the lives of women and their families. Sixty-six eligible microfinance loan groups are enrolled and randomly allocated to: the 10-session MAISHA curriculum, delivered over 20 weeks (n = 33); or, to no intervention (n = 33). Study participants are interviewed at baseline and at 24 months post-intervention about their: household; partner; income; health; attitudes and social norms; relationship (including experiences of different forms of violence); childhood; and community. For the qualitative study and process evaluation, focus group discussions are being conducted with study participants and MAISHA curriculum facilitators. In-depth interviews are being conducted with a purposive sample of 18 participants. The primary outcome, assessed at 24 months post-intervention, is a composite of women's reported experience of physical and/or sexual IPV during the past 12 months. Secondary outcomes include: reported experience of physical, sexual and emotional/psychological IPV during the past 12 months, attitudes towards IPV and reported disclosure of IPV to others. The study forms part of a wider programme of research (MAISHA) that includes: a complementary cluster RCT evaluating the impact of delivering the MAISHA curriculum to women not receiving formal group-based microfinance; an economic evaluation; and a cross-sectional survey of men to explore male risk factors associated with IPV. MAISHA will generate rigorous evidence on violence prevention interventions, as well as further insights into the different forms and consequences of violence and drivers of violence perpetration. ClinicalTrials.gov ID: NCT02592252 , registered retrospectively on 13 August 2015.

Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi.

PubMed

Pitchford, Nicola J

2015-01-01

Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child's developmental stage.

Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

PubMed Central

Pitchford, Nicola J.

2015-01-01

Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1–3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1–3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child’s developmental stage. PMID:25954236

Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First.

PubMed

Leventhal, Katherine Sachs; DeMaria, Lisa M; Gillham, Jane; Andrew, Gracy; Peabody, John W; Leventhal, Steve

2015-10-26

There are 600 million girls in low and middle income countries (LMICs), many of whom are at great risk for poor health and education. There is thus great need for programs that can effectively improve wellbeing for these girls. Although many interventions have been developed to address these issues, most focus on health and education without integrating attention to social and emotional factors. This omission is unfortunate, as nascent evidence indicates that these factors are closely related to health and education. This paper describes the methods of a 4-arm randomized controlled trial among 3,560 adolescent girls in rural Bihar, India that tested whether adding an intervention targeting social-emotional issues (based on a "resilience framework") to an adolescent health intervention would improve emotional, social, physical, and educational wellbeing to a greater extent than its components and a control group. Study arms were: (1) Girls First, a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC); (2) Girls First Resilience Curriculum (RC) alone; (3) Girls First Health Curriculum (HC) alone; and (4) a school-as-usual control group (SC). Seventy-six schools were randomized (19 per condition) and 74 local women with a tenth grade education were trained and monitored to facilitate the program. Quantitative data were collected from 3,560 girls over 4 assessment points with very low rates of participant attrition. Qualitative assessments were conducted with a subset of 99 girls and 27 facilitators. In this article, we discuss guiding principles that facilitated trial implementation, including integrating diverse local and non-local sources of knowledge, focusing on flexibility of planning and implementation, prioritizing systematic measurement selection, and striking a balance between scientific rigor and real-world feasibility. Clinicaltrials.gov NCT02429661 . Registered 24 April 2015.

Interventional procedures and future drug therapy for hypertension

PubMed Central

Lobo, Melvin D.; Sobotka, Paul A.; Pathak, Atul

2017-01-01

Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious. For those patients who either do not tolerate or wish to take medication for hypertension or in whom BP control is not attained despite multiple antihypertensives, a novel class of interventional procedures to manage hypertension has emerged. While most of these target various aspects of the sympathetic nervous system regulation of BP, an additional procedure is now available, which addresses mechanical aspects of the circulation. Most of these new devices are supported by early and encouraging evidence for both safety and efficacy, although it is clear that more rigorous randomized controlled trial data will be essential before any of the technologies can be adopted as a standard of care. PMID:27406184

Encouraging Evidence on a Sector-Focused Advancement Strategy: Two-Year Impacts from the WorkAdvance Demonstration

ERIC Educational Resources Information Center

Hendra, Richard; Greenberg, David H.; Hamilton, Gayle; Oppenheim, Ari; Pennington, Alexandra; Schaberg, Kelsey; Tessler, Betsy L.

2016-01-01

This report summarizes the two-year findings of a rigorous random assignment evaluation of the WorkAdvance model, a sectoral training, and advancement initiative. Launched in 2011, WorkAdvance goes beyond the previous generation of employment programs by introducing demand-driven skills training and a focus on jobs that have career pathways. The…

Are Boys Discriminated in Swedish High Schools?

ERIC Educational Resources Information Center

Hinnerich, Bjorn Tyrefors; Hoglin, Erik; Johannesson, Magnus

2011-01-01

Girls typically have higher grades than boys in school and recent research suggests that part of this gender difference may be due to discrimination of boys in grading. We rigorously test this in a field experiment where a random sample of the same tests in the Swedish language is subject to blind and non-blind grading. The non-blind test score is…

Discrimination against Students with Foreign Backgrounds: Evidence from Grading in Swedish Public High Schools

ERIC Educational Resources Information Center

Hinnerich, Bjorn Tyrefors; Höglin, Erik; Johannesson, Magnus

2015-01-01

We rigorously test for discrimination against students with foreign backgrounds in high school grading in Sweden. We analyse a random sample of national tests in the Swedish language graded both non-blindly by the student's own teacher and blindly without any identifying information. The increase in the test score due to non-blind grading is…

Encouraging Evidence on a Sector-Focused Advancement Strategy: Two-Year Impacts from the WorkAdvance Demonstration. Preview Summary

ERIC Educational Resources Information Center

Hendra, Richard; Greenberg, David H.; Hamilton, Gayle; Oppenheim, Ari; Pennington, Alexandra; Schaberg, Kelsey; Tessler, Betsy L.

2016-01-01

This report summarizes the two-year findings of a rigorous random assignment evaluation of the WorkAdvance model, a sectoral training and advancement initiative. Launched in 2011, WorkAdvance goes beyond the previous generation of employment programs by introducing demand-driven skills training and a focus on jobs that have career pathways. The…

THE EFFECTS ON LEARNING FROM A MOTION PICTURE FILM OF SELECTIVE CHANGES IN SOUND TRACK LOUDNESS LEVEL. FINAL REPORT.

ERIC Educational Resources Information Center

MOAKLEY, FRANCIS X.

EFFECTS OF PERIODIC VARIATIONS IN AN INSTRUCTIONAL FILM'S NORMAL LOUDNESS LEVEL FOR RELEVANT AND IRRELEVANT FILM SEQUENCES WERE MEASURED BY A MULTIPLE CHOICE TEST. RIGOROUS PILOT STUDIES, RANDOM GROUPING OF SEVENTH GRADERS FOR TREATMENTS, AND RATINGS OF RELEVANT AND IRRELEVANT PORTIONS OF THE FILM BY AN UNSPECIFIED NUMBER OF JUDGES PRECEDED THE…

Objective assessment of image quality. IV. Application to adaptive optics

PubMed Central

Barrett, Harrison H.; Myers, Kyle J.; Devaney, Nicholas; Dainty, Christopher

2008-01-01

The methodology of objective assessment, which defines image quality in terms of the performance of specific observers on specific tasks of interest, is extended to temporal sequences of images with random point spread functions and applied to adaptive imaging in astronomy. The tasks considered include both detection and estimation, and the observers are the optimal linear discriminant (Hotelling observer) and the optimal linear estimator (Wiener). A general theory of first- and second-order spatiotemporal statistics in adaptive optics is developed. It is shown that the covariance matrix can be rigorously decomposed into three terms representing the effect of measurement noise, random point spread function, and random nature of the astronomical scene. Figures of merit are developed, and computational methods are discussed. PMID:17106464

Use of software engineering techniques in the design of the ALEPH data acquisition system

NASA Astrophysics Data System (ADS)

Charity, T.; McClatchey, R.; Harvey, J.

1987-08-01

The SASD methodology is being used to provide a rigorous design framework for various components of the ALEPH data acquisition system. The Entity-Relationship data model is used to describe the layout and configuration of the control and acquisition systems and detector components. State Transition Diagrams are used to specify control applications such as run control and resource management and Data Flow Diagrams assist in decomposing software tasks and defining interfaces between processes. These techniques encourage rigorous software design leading to enhanced functionality and reliability. Improved documentation and communication ensures continuity over the system life-cycle and simplifies project management.

Quality properties of pre- and post-rigor beef muscle after interventions with high frequency ultrasound.

PubMed

Sikes, Anita L; Mawson, Raymond; Stark, Janet; Warner, Robyn

2014-11-01

The delivery of a consistent quality product to the consumer is vitally important for the food industry. The aim of this study was to investigate the potential for using high frequency ultrasound applied to pre- and post-rigor beef muscle on the metabolism and subsequent quality. High frequency ultrasound (600kHz at 48kPa and 65kPa acoustic pressure) applied to post-rigor beef striploin steaks resulted in no significant effect on the texture (peak force value) of cooked steaks as measured by a Tenderometer. There was no added benefit of ultrasound treatment above that of the normal ageing process after ageing of the steaks for 7days at 4°C. Ultrasound treatment of post-rigor beef steaks resulted in a darkening of fresh steaks but after ageing for 7days at 4°C, the ultrasound-treated steaks were similar in colour to that of the aged, untreated steaks. High frequency ultrasound (2MHz at 48kPa acoustic pressure) applied to pre-rigor beef neck muscle had no effect on the pH, but the calculated exhaustion factor suggested that there was some effect on metabolism and actin-myosin interaction. However, the resultant texture of cooked, ultrasound-treated muscle was lower in tenderness compared to the control sample. After ageing for 3weeks at 0°C, the ultrasound-treated samples had the same peak force value as the control. High frequency ultrasound had no significant effect on the colour parameters of pre-rigor beef neck muscle. This proof-of-concept study showed no effect of ultrasound on quality but did indicate that the application of high frequency ultrasound to pre-rigor beef muscle shows potential for modifying ATP turnover and further investigation is warranted. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

Rigor mortis development in turkey breast muscle and the effect of electrical stunning.

PubMed

Alvarado, C Z; Sams, A R

2000-11-01

Rigor mortis development in turkey breast muscle and the effect of electrical stunning on this process are not well characterized. Some electrical stunning procedures have been known to inhibit postmortem (PM) biochemical reactions, thereby delaying the onset of rigor mortis in broilers. Therefore, this study was designed to characterize rigor mortis development in stunned and unstunned turkeys. A total of 154 turkey toms in two trials were conventionally processed at 20 to 22 wk of age. Turkeys were either stunned with a pulsed direct current (500 Hz, 50% duty cycle) at 35 mA (40 V) in a saline bath for 12 seconds or left unstunned as controls. At 15 min and 1, 2, 4, 8, 12, and 24 h PM, pectoralis samples were collected to determine pH, R-value, L* value, sarcomere length, and shear value. In Trial 1, the samples obtained for pH, R-value, and sarcomere length were divided into surface and interior samples. There were no significant differences between the surface and interior samples among any parameters measured. Muscle pH significantly decreased over time in stunned and unstunned birds through 2 h PM. The R-values increased to 8 h PM in unstunned birds and 24 h PM in stunned birds. The L* values increased over time, with no significant differences after 1 h PM for the controls and 2 h PM for the stunned birds. Sarcomere length increased through 2 h PM in the controls and 12 h PM in the stunned fillets. Cooked meat shear values decreased through the 1 h PM deboning time in the control fillets and 2 h PM in the stunned fillets. These results suggest that stunning delayed the development of rigor mortis through 2 h PM, but had no significant effect on the measured parameters at later time points, and that deboning turkey breasts at 2 h PM or later will not significantly impair meat tenderness.

The HALT Polycystic Kidney Disease Trials: Design and Implementation

PubMed Central

Torres, Vicente E.; Perrone, Ronald D.; Steinman, Theodore I.; Bae, Kyongtae T.; Miller, J. Philip; Miskulin, Dana C.; Oskoui, Frederic Rahbari; Masoumi, Amirali; Hogan, Marie C.; Winklhofer, Franz T.; Braun, William; Thompson, Paul A.; Meyers, Catherine M.; Kelleher, Cass; Schrier, Robert W.

2010-01-01

Background and objectives: Two HALT PKD trials will investigate interventions that potentially slow kidney disease progression in hypertensive autosomal dominant polycystic kidney disease (ADPKD) patients. Studies were designed in early and later stages of ADPKD to assess the impact of intensive blockade of the renin-angiotensin-aldosterone system and level of BP control on progressive renal disease. Design, settings, participants, and measurements: PKD-HALT trials are multicenter, randomized, double-blind, placebo-controlled trials studying 1018 hypertensive ADPKD patients enrolled over 3 yr with 4 to 8 yr of follow-up. In study A, 548 participants, estimated GFR (eGFR) of >60 ml/min per 1.73 m2 were randomized to one of four arms in a 2-by-2 design: combination angiotensin converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) therapy versus ACEi monotherapy at two levels of BP control. In study B, 470 participants, eGFR of 25 to 60 ml/min per 1.73 m2 compared ACEi/ARB therapy versus ACEi monotherapy, with BP control of 120 to 130/70 to 80 mmHg. Primary outcomes of studies A and B are MR-based percent change kidney volume and a composite endpoint of time to 50% reduction of baseline estimated eGFR, ESRD, or death, respectively. Results: This report describes design issues related to (1) novel endpoints such as kidney volume, (2) home versus office BP measures, and (3) the impact of RAAS inhibition on kidney and patient outcomes, safety, and quality of life. Conclusions: HALT PKD will evaluate potential benefits of rigorous BP control and inhibition of the renin-angiotensin-aldosterone system on kidney disease progression in ADPKD. PMID:20089507

HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial

PubMed Central

2017-01-01

Background The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. Objective The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children’s optimal health and weight. Methods A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Results Enrollment for this study has been completed and statistical data analyses are currently underway. Conclusions This paper describes the HomeStyles intervention with regards to: rationale, the intervention’s logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments, data management, and planned analyses. PMID:28442452

The Effects of Musical Training on Child Development: a Randomized Trial of El Sistema in Venezuela.

PubMed

Alemán, Xiomara; Duryea, Suzanne; Guerra, Nancy G; McEwan, Patrick J; Muñoz, Rodrigo; Stampini, Marco; Williamson, Ariel A

2017-10-01

Many studies have explored the links between music and children's outcomes; however, study designs have not been sufficiently rigorous to support causal findings. This study aims to assess the effects of a large-scale music program on children's developmental functioning in the context of high rates of exposure to violence. The paper describes the results of an experimental evaluation of Venezuela's National System of Youth and Children's Orchestras. The curriculum of the program, better known as "El Sistema," emphasizes social interactions through group instruction and group performances. The randomized control trial was conducted in 16 music centers between May 2012 and November 2013. In total, 2914 children ages 6-14 participated in the experiment, with approximately half receiving an offer of admission to the program in September 2012 and half in September 2013. The treatment group children participated for one semester more than the control group children. After 1 year, full-sample ITT estimates indicate improved self-control (by 0.10 standard deviations) and reduced behavioral difficulties (by 0.08 standard deviations), both significant at 10% after controlling for multiple hypothesis testing. There were no full-sample effects on other domains. Sub-sample effects are larger among (1) children with less-educated mothers and (2) boys, especially those exposed to violence at baseline. In the latter subgroup, we find lower levels of aggressive behavior. We find that the program improved self-control and reduced behavioral difficulties, with the effects concentrated among subgroups of vulnerable children. The results suggest the importance of devising mechanisms to target resources to the most vulnerable children. https://clinicaltrials.gov/ct2/show/NCT02369315.

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations

PubMed Central

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Objective Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy’s efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = −0.79] and anxiety (SMD = −0.57) compared to active comparators. Conclusion Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. PMID:27165970

The Effectiveness of Social Robots for Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.

PubMed

Pu, Lihui; Moyle, Wendy; Jones, Cindy; Todorovic, Michael

2018-06-12

Social robots may promote the health of older adults by increasing their perceived emotional support and social interaction. This review aims to summarize the effectiveness of social robots on outcomes (psychological, physiological, quality of life, or medications) of older adults from randomized controlled trials (RCTs). A mixed-method systematic review of RCTs meeting the study inclusion criteria was undertaken. Eight databases were electronically searched up to September 2017. Participants' characteristics, intervention features, and outcome data were retrieved. The mean difference and standardized mean difference with 95% confidence intervals (CI) were synthesized to pool the effect size. A total of 13 articles from 11 RCTs were identified from 2,204 articles, of which 9 studies were included in the meta-analysis. Risk of bias was relatively high in allocation concealment and blinding. Social robots appeared to have positive impacts on agitation, anxiety, and quality of life for older adults but no statistical significance was found in the meta-analysis. However, results from a narrative review indicated that social robot interactions could improve engagement, interaction, and stress indicators, as well as reduce loneliness and the use of medications for older adults. Social robots appear to have the potential to improve the well-being of older adults, but conclusions are limited due to the lack of high-quality studies. More RCTs are recommended with larger sample sizes and rigorous study designs.

Endoscopic procedure with a modified Reiki intervention: a pilot study.

PubMed

Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

2010-01-01

This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

Robot-assisted hysterectomy for endometrial and cervical cancers: a systematic review.

PubMed

Nevis, Immaculate F; Vali, Bahareh; Higgins, Caroline; Dhalla, Irfan; Urbach, David; Bernardini, Marcus Q

2017-03-01

Total and radical hysterectomies are the most common treatment strategies for early-stage endometrial and cervical cancers, respectively. Surgical modalities include open surgery, laparoscopy, and more recently, minimally invasive robot-assisted surgery. We searched several electronic databases for randomized controlled trials and observational studies with a comparison group, published between 2009 and 2014. Our outcomes of interest included both perioperative and morbidity outcomes. We included 35 observational studies in this review. We did not find any randomized controlled trials. The quality of evidence for all reported outcomes was very low. For women with endometrial cancer, we found that there was a reduction in estimated blood loss between the robot-assisted surgery compared to both laparoscopy and open surgery. There was a reduction in length of hospital stay between robot-assisted surgery and open surgery but not laparoscopy. There was no difference in total lymph node removal between the three modalities. There was no difference in the rate of overall complications between the robot-assisted technique and laparoscopy. For women with cervical cancer, there were no differences in estimated blood loss or removal of lymph nodes between robot-assisted and laparoscopic procedure. Compared to laparotomy, robot-assisted hysterectomy for cervical cancer showed an overall reduction in estimated blood loss. Although robot-assisted hysterectomy is clinically effective for the treatment of both endometrial and cervical cancers, methodologically rigorous studies are lacking to draw definitive conclusions.

Accelerated recovery of Atlantic salmon (Salmo salar) from effects of crowding by swimming.

PubMed

Veiseth, Eva; Fjaera, Svein Olav; Bjerkeng, Bjørn; Skjervold, Per Olav

2006-07-01

The effects of post-crowding swimming velocity (0, 0.35, and 0.70 m/s) and recovery time (1.5, 6, and 12 h) on physiological recovery and processing quality parameters of adult Atlantic salmon (Salmo salar) were determined. Atlantic salmon crowded to a density similar to that of a commercial slaughter process (>200 kg/m(3), 40 min) were transferred to a swimming chamber for recovery treatment. Osmolality and concentrations of cortisol, glucose and lactate in blood plasma were used as physiological stress indicators, whereas image analyses of extent and duration of rigor contraction, and fillet gaping were used as measures of processing quality. Crowded salmon had a 5.8-fold higher plasma cortisol concentration than control salmon (P<0.05). The elevated plasma cortisol concentration was reduced by increasing the swimming velocity, and had returned to control levels after 6 h recovery at high water velocity. Similar effects of swimming velocity were observed for plasma osmolality and lactate concentration. A lower plasma glucose concentration was present in crowded than in control fish (P<0.05), although a typical post-stress elevation in plasma glucose was observed after the recovery treatments. Lower muscle pH was found in crowded compared with control salmon (P<0.05), but muscle pH returned to control levels after 6 h recovery at intermediate and high swimming velocities and after 12 h in the low velocity group. Crowding caused an early onset of rigor mortis contraction. However, subjecting crowded salmon to active swimming for 6 h before slaughter delayed the onset of rigor mortis contraction from 2.5 to 7.5 h post mortem. The extent of rigor mortis contraction was also affected by crowding and post-stress swimming activity (P<0.05), and the largest degree of contraction was found in crowded salmon. In conclusion, active swimming accelerated the return of plasma cortisol, hydromineral balance, and the energy metabolism of adult Atlantic salmon to pre-stress levels. Moreover, an active swimming period delayed the onset of rigor mortis contraction, which has a positive technological implication for the salmon processing industry.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Impact of the National Institutes of Health Focal Segmental Glomerulosclerosis (NIH FSGS) clinical trial on the treatment of steroid-resistant FSGS.

PubMed

Canetta, Pietro A; Radhakrishnan, Jai

2013-03-01

Idiopathic focal segmental glomerulosclerosis (FSGS) is among the most common, morbid and treatment-resistant conditions faced by nephrologists. While glucocorticoids have traditionally been the mainstay of initial treatment, they induce remission in only a minority of patients. A variety of other immunosuppressants have been utilized against steroid-resistant FSGS, but few have been rigorously examined in well-controlled trials. Recently, the results were published from a National Institutes of Health (NIH)-sponsored multicenter randomized trial comparing cyclosporine (CSA) with a combination of mycophenolate mofetil (MMF) and pulse dexamethasone (DEX) for the treatment of steroid-resistant FSGS. No difference in treatment effectiveness was shown between the two groups, and adverse effects were comparable. This was the largest randomized trial ever undertaken in FSGS, but it was unfortunately underpowered to show clinically relevant differences in response rates. This shortcoming, along with particularities of the study population and outcome measures, makes it challenging to draw definitive conclusions from the trial results. Despite these limitations, the trial does provide valuable insights into treatment strategies for FSGS and offers important lessons for planning future research.

Developmental instability: measures of resistance and resilience using pumpkin (Cucurbita pepo L.)

USGS Publications Warehouse

Freeman, D. Carl; Brown, Michelle L.; Dobson, Melissa; Jordan, Yolanda; Kizy, Anne; Micallef, Chris; Hancock, Leandria C.; Graham, John H.; Emlen, John M.

2003-01-01

Fluctuating asymmetry measures random deviations from bilateral symmetry, and thus estimates developmental instability, the loss of ability by an organism to regulate its development. There have been few rigorous tests of this proposition. Regulation of bilateral symmetry must involve either feedback between the sides or independent regulation toward a symmetric set point. Either kind of regulation should decrease asymmetry over time, but only right–left feedback produces compensatory growth across sides, seen as antipersistent growth following perturbation. Here, we describe the developmental trajectories of perturbed and unperturbed leaves of pumpkin, Cucurbita pepoL., grown at three densities. Covering one side of a leaf with aluminium foil for 24 h perturbed leaf growth. Reduced growth on the perturbed side caused leaves to become more asymmetrical than unperturbed controls. After the treatment the size-corrected asymmetry decreased over time. In addition, rescaled range analysis showed that asymmetry was antipersistent rather than random, i.e. fluctuation in one direction was likely to be followed by fluctuations in the opposite direction. Development involves right–left feedback. This feedback reduced size-corrected asymmetry over time most strongly in the lowest density treatment suggesting that developmental instability results from a lack of resilience rather than resistance. 

Use of large healthcare databases for rheumatology clinical research.

PubMed

Desai, Rishi J; Solomon, Daniel H

2017-03-01

Large healthcare databases, which contain data collected during routinely delivered healthcare to patients, can serve as a valuable resource for generating actionable evidence to assist medical and healthcare policy decision-making. In this review, we summarize use of large healthcare databases in rheumatology clinical research. Large healthcare data are critical to evaluate medication safety and effectiveness in patients with rheumatologic conditions. Three major sources of large healthcare data are: first, electronic medical records, second, health insurance claims, and third, patient registries. Each of these sources offers unique advantages, but also has some inherent limitations. To address some of these limitations and maximize the utility of these data sources for evidence generation, recent efforts have focused on linking different data sources. Innovations such as randomized registry trials, which aim to facilitate design of low-cost randomized controlled trials built on existing infrastructure provided by large healthcare databases, are likely to make clinical research more efficient in coming years. Harnessing the power of information contained in large healthcare databases, while paying close attention to their inherent limitations, is critical to generate a rigorous evidence-base for medical decision-making and ultimately enhancing patient care.

Determinism in synthesized chaotic waveforms.

PubMed

Corron, Ned J; Blakely, Jonathan N; Hayes, Scott T; Pethel, Shawn D

2008-03-01

The output of a linear filter driven by a randomly polarized square wave, when viewed backward in time, is shown to exhibit determinism at all times when embedded in a three-dimensional state space. Combined with previous results establishing exponential divergence equivalent to a positive Lyapunov exponent, this result rigorously shows that such reverse-time synthesized waveforms appear equally to have been produced by a deterministic chaotic system.

Reading Partners: The Implementation and Effectiveness of a One-on-One Tutoring Program Delivered by Community Volunteers. Policy Brief

ERIC Educational Resources Information Center

Jacob, Robin Tepper; Smith, Thomas J.; Willard, Jacklyn A.; Rifkin, Rachel E.

2014-01-01

This policy brief summarizes the positive results of a rigorous evaluation of Reading Partners, a widely used program that offers one-on-one tutoring provided by community volunteers to struggling readers in low-income elementary schools. A total of 1,265 students in 19 schools in three states were randomly assigned to receive Reading…

Cluster Randomized Trial of a Large-Scale Education Initiative in the Democratic Republic of Congo: Baseline Findings and Lessons

ERIC Educational Resources Information Center

Aber, John Lawrence; Torrente, Catalina; Annan, Jeannie; Bundervoet, Tom; Shivshanker, Anjuli

2012-01-01

The main purpose of the current paper is to describe and discuss the scientific and practical implications of pursuing rigorous developmental research in a low-income, war-afflicted country such as DRC. In addition, the paper aims to explore the individual, household and school correlates of children's academic performance and mental health and…

Global mean first-passage times of random walks on complex networks.

PubMed

Tejedor, V; Bénichou, O; Voituriez, R

2009-12-01

We present a general framework, applicable to a broad class of random walks on complex networks, which provides a rigorous lower bound for the mean first-passage time of a random walker to a target site averaged over its starting position, the so-called global mean first-passage time (GMFPT). This bound is simply expressed in terms of the equilibrium distribution at the target and implies a minimal scaling of the GMFPT with the network size. We show that this minimal scaling, which can be arbitrarily slow, is realized under the simple condition that the random walk is transient at the target site and independently of the small-world, scale-free, or fractal properties of the network. Last, we put forward that the GMFPT to a specific target is not a representative property of the network since the target averaged GMFPT satisfies much more restrictive bounds.

Universality for 1d Random Band Matrices: Sigma-Model Approximation

NASA Astrophysics Data System (ADS)

Shcherbina, Mariya; Shcherbina, Tatyana

2018-02-01

The paper continues the development of the rigorous supersymmetric transfer matrix approach to the random band matrices started in (J Stat Phys 164:1233-1260, 2016; Commun Math Phys 351:1009-1044, 2017). We consider random Hermitian block band matrices consisting of W× W random Gaussian blocks (parametrized by j,k \\in Λ =[1,n]^d\\cap Z^d ) with a fixed entry's variance J_{jk}=δ _{j,k}W^{-1}+β Δ _{j,k}W^{-2} , β >0 in each block. Taking the limit W→ ∞ with fixed n and β , we derive the sigma-model approximation of the second correlation function similar to Efetov's one. Then, considering the limit β , n→ ∞, we prove that in the dimension d=1 the behaviour of the sigma-model approximation in the bulk of the spectrum, as β ≫ n , is determined by the classical Wigner-Dyson statistics.

Mental Health Interventions for Children in Foster Care: A Systematic Review

PubMed Central

Hambrick, Erin P.; Oppenheim-Weller, Shani; N’zi, Amanda M.; Taussig, Heather N.

2016-01-01

Children in foster care have high rates of adverse childhood experiences and are at risk for mental health problems. These problems can be difficult to ameliorate, creating a need for rigorous intervention research. Previous research suggests that intervening with children in foster care can be challenging for several reasons, including the severity and complexity of their mental health problems, and challenges engaging this often transitory population in mental health services. The goal of this article was to systematically review the intervention research that has been conducted with children in foster care, and to identify future research directions. This review was conducted on mental health interventions for children, ages 0 to 12, in foster care, using ERIC, CINAHL, PsycINFO, PubMed, ProQuest’s Dissertation and Theses Database, Social Services Abstracts, and Social Work Abstracts. It was restricted to interventions that are at least “possibly efficacious” (i.e., supported by evidence from at least one randomized controlled trial). Studies were evaluated for risk of bias. Ten interventions were identified, with diverse outcomes, including mental health and physiological. Six interventions were developed for children in foster care. Interventions not developed for children in foster care were typically adapted to the foster context. Most interventions have yet to be rigorously evaluated in community-based settings with children in foster care. Little research has been conducted on child and family engagement within these interventions, and there is a need for more research on moderators of intervention outcomes and subgroups that benefit most from these interventions. In addition, there is not consensus regarding how to adapt interventions to this population. Future research should focus on developing and testing more interventions with this population, rigorously evaluating their effectiveness in community-based settings, determining necessary adaptations, and identifying which interventions work best for whom. PMID:28496286

A re-examination of the biphasic theory of skeletal muscle growth.

PubMed Central

Levine, A S; Hegarty, P V

1977-01-01

Because of the importance of fibre diameter measurements it was decided to re-evaluate the biphasic theory of skeletal muscle growth and development. This theory proposes an initial memophasic distribution of muscle fibres which changes to a biphasic distribution during development. The theory is based on observations made on certain muscles in mice, where two distinct populations of fibre diameters (20 and 40 micronm) contribute to the biphasic distribution. In the present investigation corss sections of frozen biceps brachii of mice in rigor mortis were examined. The rigor state was used to avoid complications produced by thaw-rigor contraction. The diameters of the outermost and innermost fibres were found to be significantly different. However, if the outer and inner fibres were combined to form one group, no significant difference between this group and other random groups was found. The distributions of all groups were monophasic. The diameters of isolated fibres from mice and rats also displayed a monophasic distribution. This evidence leads to the conclusion that the biphasic theory of muscle growth is untenable. Some of the variables which may occur in fibre size and shape are discussed. Images Fig. 1 PMID:858691

Sampling large random knots in a confined space

NASA Astrophysics Data System (ADS)

Arsuaga, J.; Blackstone, T.; Diao, Y.; Hinson, K.; Karadayi, E.; Saito, M.

2007-09-01

DNA knots formed under extreme conditions of condensation, as in bacteriophage P4, are difficult to analyze experimentally and theoretically. In this paper, we propose to use the uniform random polygon model as a supplementary method to the existing methods for generating random knots in confinement. The uniform random polygon model allows us to sample knots with large crossing numbers and also to generate large diagrammatically prime knot diagrams. We show numerically that uniform random polygons sample knots with large minimum crossing numbers and certain complicated knot invariants (as those observed experimentally). We do this in terms of the knot determinants or colorings. Our numerical results suggest that the average determinant of a uniform random polygon of n vertices grows faster than O(e^{n^2}) . We also investigate the complexity of prime knot diagrams. We show rigorously that the probability that a randomly selected 2D uniform random polygon of n vertices is almost diagrammatically prime goes to 1 as n goes to infinity. Furthermore, the average number of crossings in such a diagram is at the order of O(n2). Therefore, the two-dimensional uniform random polygons offer an effective way in sampling large (prime) knots, which can be useful in various applications.

Testing Cardiovascular Drug Safety and Efficacy in Randomized Trials

PubMed Central

FitzGerald, Garret A.

2014-01-01

Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average, but unbiased estimates of efficacy and risk. Concern has been expressed about how “unrepresentative” populations and conditions that pertain in randomized trials might be of the “real world”, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials which establish “efficacy” and those that demonstrate “effectiveness” - drugs that patients actually consume in the “real world” for clinical benefit1. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of “effectiveness” with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that “average” results may conceal considerable inter-individual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients2,3Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria - the individual Numbers Needed to Treat to obtain a benefit, such as a life saved4. Here, I will consider some reasons why large phase 3 trials - by far the most expensive element of drug development - may fail to address the “unmet medical needs” which should justify such effort and investment. PMID:24677235

The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.

PubMed

Macdougall, Iain C; Bock, Andreas; Carrera, Fernando; Eckardt, Kai-Uwe; Gaillard, Carlo; Van Wyck, David; Roubert, Bernard; Cushway, Timothy; Roger, Simon D

2014-04-01

Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL). The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013. FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

Bayesian exponential random graph modelling of interhospital patient referral networks.

PubMed

Caimo, Alberto; Pallotti, Francesca; Lomi, Alessandro

2017-08-15

Using original data that we have collected on referral relations between 110 hospitals serving a large regional community, we show how recently derived Bayesian exponential random graph models may be adopted to illuminate core empirical issues in research on relational coordination among healthcare organisations. We show how a rigorous Bayesian computation approach supports a fully probabilistic analytical framework that alleviates well-known problems in the estimation of model parameters of exponential random graph models. We also show how the main structural features of interhospital patient referral networks that prior studies have described can be reproduced with accuracy by specifying the system of local dependencies that produce - but at the same time are induced by - decentralised collaborative arrangements between hospitals. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

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

Stress management training for military trainees returned to duty after a mental health evaluation: effect on graduation rates.

PubMed

Cigrang, J A; Todd, S L; Carbone, E G

2000-01-01

A significant proportion of people entering the military are discharged within the first 6 months of enlistment. Mental health related problems are often cited as the cause of discharge. This study evaluated the utility of stress inoculation training in helping reduce the attrition of a sample of Air Force trainees at risk for discharge from basic military training. Participants were 178 trainees referred for a psychological evaluation from basic training. Participants were randomly assigned to a 2-session stress management group or a usual-care control condition. Compared with past studies that used less rigorous methodology, this study did not find that exposure to stress management information increased the probability of graduating basic military training. Results are discussed in terms of possible reasons for the lack of treatment effects and directions for future research.

Nutraceuticals in Acute and Prophylactic Treatment of Migraine.

PubMed

Daniel, Oved; Mauskop, Alexander

2016-04-01

People who suffer from headaches often prefer nutraceutical treatment over traditional pharmacological approaches, due to fear of possible side effects, drug dependence, or addiction. Since treatment with nutraceuticals does not require a doctor's prescription, many patients rely on their own judgment as to when and which one to take, often without consultation or guidance from their physician. Some physicians could provide information about potential efficacy and side effects of various products, but many are not familiar with the nutraceuticals. Widespread skepticism persists among doctors about the effectiveness of these treatments. This is largely due to the lack of rigorous clinical studies. However, even when incontrovertible scientific evidence exists, many physicians remain distrustful of the evidence. The following review summarizes randomized controlled trials of some of the most commonly used non-pharmacological treatments, including magnesium, coenzyme Q10, riboflavin (vitamin B2), petasites, and feverfew (Table 1).

Atomic defects in monolayer WSe2 tunneling FETs studied by systematic ab initio calculations

NASA Astrophysics Data System (ADS)

Wu, Jixuan; Fan, Zhiqiang; Chen, Jiezhi; Jiang, Xiangwei

2018-05-01

Atomic defects in monolayer WSe2 tunneling FETs (TFETs) are studied through systematic ab initio calculations aiming at performance predictions and enhancements. The effects of various defect positions and different passivation atoms are characterized in WSe2 TFETs by rigorous ab initio quantum transport simulations. It is suggested that the Se vacancy (VSe) defect located in the gate-controlled channel region tends to increase the OFF current (I off), whereas it can be well suppressed by oxygen passivation. It is demonstrated that chlorine (Cl) passivation at the source-side tunneling region can largely suppress I off, leading to an impressively improved on–off ratio (I on/I off) compared with that without any defect. However, it is also observed that randomly positioned atomic defects tend to induce significant fluctuation of the TFET output. Further discussions are made with focus on the performance-variability trade-off for robust circuit design.

Substance abuse prevention intervention research with Hispanic populations.

PubMed

Castro, Felipe González; Barrera, Manuel; Pantin, Hilda; Martinez, Charles; Felix-Ortiz, Maria; Rios, Rebeca; Lopez, Vera A; Lopez, Cristy

2006-09-01

Selected studies with specific relevance to substance abuse prevention interventions with Hispanic youth and families were examined to identify prior findings and emerging issues that may guide the design of future substance abuse prevention intervention research and its implementation with Hispanic populations. The origins of prevention research and role of risk and protective factors are examined, including culturally-specific risk and protective factors for Hispanic populations. Correlational studies, non-experimental interventions, and randomized controlled trials were examined for the period of 1974-2003. The literature search yielded 15 articles selected for this review that exhibited adequate methodological rigor. An added search for more recent studies identified three additional articles, for a total of 18 prevention intervention articles that were reviewed. Theoretical and methodological issues and recommendations are presented for future research aimed at improving the efficacy and effectiveness of future prevention intervention studies and their cultural relevance for Hispanic populations.

Nutrient non-equivalence: Does restricting high-potassium plant foods help to prevent hyperkalemia in hemodialysis patients?

PubMed Central

St-Jules, DE; Goldfarb, DS; Sevick, MA

2016-01-01

Hemodialysis patients are often advised to limit their intake of high-potassium foods to help manage hyperkalemia. However, the benefits of this practice are entirely theoretical and not supported by rigorous randomized controlled trials. The hypothesis that potassium restriction is useful is based on the assumption that different sources of dietary potassium are therapeutically equivalent. In fact, animal and plant sources of potassium may differ in their potential to contribute to hyperkalemia. In this commentary, we summarize the historical research basis for limiting high-potassium foods. Ultimately, we conclude that this approach is not evidence-based and may actually present harm to patients. However, given the uncertainty arising from the paucity of conclusive data, we agree that until the appropriate intervention studies are conducted, practitioners should continue to advise restriction of high-potassium foods. PMID:26975777

Nutrient Non-equivalence: Does Restricting High-Potassium Plant Foods Help to Prevent Hyperkalemia in Hemodialysis Patients?

PubMed

St-Jules, David E; Goldfarb, David S; Sevick, Mary Ann

2016-09-01

Hemodialysis patients are often advised to limit their intake of high-potassium foods to help manage hyperkalemia. However, the benefits of this practice are entirely theoretical and not supported by rigorous randomized controlled trials. The hypothesis that potassium restriction is useful is based on the assumption that different sources of dietary potassium are therapeutically equivalent. In fact, animal and plant sources of potassium may differ in their potential to contribute to hyperkalemia. In this commentary, we summarize the historical research basis for limiting high-potassium foods. Ultimately, we conclude that this approach is not evidence-based and may actually present harm to patients. However, given the uncertainty arising from the paucity of conclusive data, we agree that until the appropriate intervention studies are conducted, practitioners should continue to advise restriction of high-potassium foods. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

EEG Derived Neuronal Dynamics during Meditation: Progress and Challenges

PubMed Central

Kaur, Chamandeep; Singh, Preeti

2015-01-01

Meditation advances positivity but how these behavioral and psychological changes are brought can be explained by understanding neurophysiological effects of meditation. In this paper, a broad spectrum of neural mechanics under a variety of meditation styles has been reviewed. The overall aim of this study is to review existing scientific studies and future challenges on meditation effects based on changing EEG brainwave patterns. Albeit the existing researches evidenced the hold for efficacy of meditation in relieving anxiety and depression and producing psychological well-being, more rigorous studies are required with better design, considering client variables like personality characteristics to avoid negative effects, randomized controlled trials, and large sample sizes. A bigger number of clinical trials that concentrate on the use of meditation are required. Also, the controversial subject of epileptiform EEG changes and other adverse effects during meditation has been raised. PMID:26770834

A Systematic Review of Strategies for Implementing Empirically Supported Mental Health Interventions

PubMed Central

Powell, Byron J.; Proctor, Enola K.; Glass, Joseph E.

2013-01-01

Objective This systematic review examines experimental studies that test the effectiveness of strategies intended to integrate empirically supported mental health interventions into routine care settings. Our goal was to characterize the state of the literature and to provide direction for future implementation studies. Methods A literature search was conducted using electronic databases and a manual search. Results Eleven studies were identified that tested implementation strategies with a randomized (n = 10) or controlled clinical trial design (n = 1). The wide range of clinical interventions, implementation strategies, and outcomes evaluated precluded meta-analysis. However, the majority of studies (n = 7; 64%) found a statistically significant effect in the hypothesized direction for at least one implementation or clinical outcome. Conclusions There is a clear need for more rigorous research on the effectiveness of implementation strategies, and we provide several suggestions that could improve this research area. PMID:24791131

Non-equilibrium Phase Transitions: Activated Random Walks at Criticality

NASA Astrophysics Data System (ADS)

Cabezas, M.; Rolla, L. T.; Sidoravicius, V.

2014-06-01

In this paper we present rigorous results on the critical behavior of the Activated Random Walk model. We conjecture that on a general class of graphs, including , and under general initial conditions, the system at the critical point does not reach an absorbing state. We prove this for the case where the sleep rate is infinite. Moreover, for the one-dimensional asymmetric system, we identify the scaling limit of the flow through the origin at criticality. The case remains largely open, with the exception of the one-dimensional totally-asymmetric case, for which it is known that there is no fixation at criticality.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

PubMed Central

Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

A RANDOMIZED CONTROLLED TRIAL OF PROGRESSIVELY REDUCED NICOTINE CONTENT CIGARETTES ON SMOKING BEHAVIORS, BIOMARKERS OF EXPOSURE, AND SUBJECTIVE RATINGS

PubMed Central

Mercincavage, Melissa; Souprountchouk, Valentina; Tang, Kathy Z.; Dumont, Rachel L.; Wileyto, E. Paul; Carmella, Steven G.; Hecht, Stephen S.; Strasser, Andrew A.

2016-01-01

Background The U.S. FDA has the authority to reduce cigarette nicotine content if found to benefit public health. Reduced nicotine content (RNC) cigarette use does not appear to increase harm exposure, but studies have not rigorously assessed smoking behavior or utilized a comprehensive panel of biomarkers. This study examined the effects of progressively decreasing RNC cigarettes on smoking behaviors, biomarkers of exposure, and subjective ratings. Methods 158 daily, non-treatment-seeking smokers participated in a 35-day randomized, unblinded, parallel study. After a 5-day baseline period, participants were randomly assigned to an experimental group (n = 80) that smoked progressively decreasing RNC cigarettes during three 10-day periods, or control group (n =78) that smoked their own brand throughout the study. Results Daily cigarette consumption significantly increased for the intermediate RNCs (P’s < 0.001) but approached baseline rate for the lowest RNC (P = 0.686); in contrast, puffing behavior significantly decreased at intermediate levels and increased for the lowest RNC (P’s < 0.001). Cotinine and NNAL significantly decreased by RNC period (P’s ≤ 0.001–0.02), while CO boost initially increased (P’s = 0.001–0.005). 1-HOP did not change by period (P = 0.109). Conclusions Smoking behaviors changed by RNC period via CPD and puffing behavior. Biomarkers of exposure generally decreased with nicotine content. Impact Findings suggest that RNC use does not ubiquitously reduce smoking behaviors or biomarkers, yet the lowest RNC level tested may reduce harm exposure. This emphasizes the importance of utilizing multiple behavioral and biological measures to address the impact of RNC cigarette smoking. PMID:27197288

Chinese herbal medicine for Henoch-Schönlein purpura in children without renal damage: a systematic review of randomized controlled trials.

PubMed

Yang, Ying; Wang, Congcong; Li, Xinxue; Chai, Qianyun; Fei, Yutong; Xia, Ruyu; Xu, Rongqian; Yang, Li; Liu, Jianping

2015-10-01

Henoch-Schönlein Purpura (HSP) is the most common necrotizing vasculitis affecting children. Traditional Chinese herbal medicine (CHM) was widely used. We aim to explore the evidence of effectiveness and safety of CHM for HSP in children without renal damage. Randomized controlled trials (RCTs) comparing CHM with conventional medications were searched from five databases. Eligible data were pooled using random-effects model using RevMan 5.2 Subgroup analysis for different co-interventions and sensitivity analysis for reducing heterogeneity were implemented. GRADE approach was adopted. We included 15 trials with 1112HSP children (age 1-16 years old), disease duration one day to three months. The overall methodological quality of included trials is relatively low. Adjunctive oral CHM treatments reduced renal damage (6 trials, RR 0.47, 95%CI 0.31-0.72, I(2)=0%), and subsiding time (days) of purpura (5 trials, mean difference (MD) -3.60, 95%CI -4.21 to -2.99, I(2)=23%), joint pain (5 trials, MD -1.04, 95%CI -1.33 to -0.74, I(2)=1%) and abdomen pain (5 trials, MD -1.69, 95%CI -2.51 to -0.86, I(2)=74%). Subgroup and sensitivity analysis did not change the direction of results. No severe adverse events reported. Orally taken adjunctive CHM treatments are effective for children suffering HSP in terms of reducing renal damage and subsiding time of purpura, and could possibly reduce subsiding pain of joint and abdomen. No reliable conclusion regarding safety is possible based on the safety data retrieved. Further rigorous trials are warranted. Copyright © 2015. Published by Elsevier Ltd.

Randomized, Sham-Controlled, Feasibility Trial of Hyperbaric Oxygen for Service Members With Postconcussion Syndrome: Cognitive and Psychomotor Outcomes 1 Week Postintervention.

PubMed

Walker, William C; Franke, Laura Manning; Cifu, David X; Hart, Brett B

2014-06-01

Background Mild traumatic brain injury (mTBI) and residual postconcussion syndrome (PCS) are common among combatants of the recent military conflicts in Iraq and Afghanistan. Hyperbaric oxygen (HBO2) is a proposed treatment but has not been rigorously studied for this condition. Objectives In a secondary analysis, examine for possible effects on psychomotor (balance and fine motor) and cognitive performance 1 week after an HBO2 intervention in service members with PCS after mTBI. Methods A randomized, double-blind, sham control, feasibility trial comparing pretreatment and posttreatment was conducted in 60 male active-duty marines with combat-related mTBI and PCS persisting for 3 to 36 months. Participants were randomized to 1 of 3 preassigned oxygen fractions (10.5%, 75%, or 100%) at 2.0 atmospheres absolute (ATA), resulting in respective groups with an oxygen exposure equivalent to (1) breathing surface air (Sham Air), (2) 100% oxygen at 1.5 ATA (1.5 ATAO2), and (3) 100% oxygen at 2.0 ATA (2.0 ATAO2). Over a 10-week period, participants received 40 hyperbaric chamber sessions of 60 minutes each. Outcome measures, including computerized posturography (balance), grooved pegboard (fine motor speed/dexterity), and multiple neuropsychological tests of cognitive performance, were collected preintervention and 1-week postintervention. Results Despite the multiple sensitive cognitive and psychomotor measures analyzed at an unadjusted 5% significance level, this study demonstrated no immediate postintervention beneficial effect of exposure to either 1.5 ATAO2 or 2.0 ATAO2 compared with the Sham Air intervention. Conclusions These results do not support the use of HBO2 to treat cognitive, balance, or fine motor deficits associated with mTBI and PCS. © The Author(s) 2013.

Central venous access by trainees: a systematic review and meta-analysis of the use of simulation to improve success rate on patients.

PubMed

Madenci, Arin L; Solis, Carolina V; de Moya, Marc A

2014-02-01

Simulation training for invasive procedures may improve patient safety by enabling efficient training. This study is a meta-analysis with rigorous inclusion and exclusion criteria designed to assess the real patient procedural success of simulation training for central venous access. Published randomized controlled trials and prospective 2-group cohort studies that used simulation for the training of procedures involving central venous access were identified. The quality of each study was assessed. The primary outcome was the proportion of trainees who demonstrated the ability to successfully complete the procedure. Secondary outcomes included the mean number of attempts to procedural success and periprocedural adverse events. Proportions were compared between groups using risk ratios (RRs), whereas continuous variables were compared using weighted mean differences. Random-effects analysis was used to determine pooled effect sizes. We identified 550 studies, of which 5 (3 randomized controlled trials, 2 prospective 2-group cohort studies) studies of central venous catheter (CVC) insertion were included in the meta-analysis, composed of 407 medical trainees. The simulation group had a significantly larger proportion of trainees who successfully placed CVCs (RR, 1.09; 95% confidence interval [CI], 1.03-1.16, P<0.01). In addition, the simulation group had significantly fewer mean attempts to CVC insertion (weighted mean difference, -1.42; 95% CI, -2.34 to -0.49, P<0.01). There was no significant difference in the rate of adverse events between the groups (RR, 0.50; 95% CI, 0.19-1.29; P=0.15). Training programs should consider adopting simulation training for CVC insertion to improve the real patient procedural success of trainees.

Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials.

PubMed

Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

2010-01-01

Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication. We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P < .00001), the number of patients with improved symptoms (RR 1.15, 95% CI 1.05 to 1.26, P = .003), and reducing the incidence rate of postherpetic neuralgia (RR 0.06, 95% CI 0.02 to 0.25, P = .0001). Wet cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials. Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed

The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial.

PubMed

Strigo, Tara S; Ephraim, Patti L; Pounds, Iris; Hill-Briggs, Felicia; Darrell, Linda; Ellis, Matthew; Sudan, Debra; Rabb, Hamid; Segev, Dorry; Wang, Nae-Yuh; Kaiser, Mary; Falkovic, Margaret; Lebov, Jill F; Boulware, L Ebony

2015-10-09

Live donor kidney transplantation (LDKT), an optimal therapy for many patients with end-stage kidney disease, is underutilized, particularly by African Americans. Potential recipient difficulties initiating and sustaining conversations about LDKT, identifying willing and medically eligible donors, and potential donors' logistical and financial hurdles have been cited as potential contributors to race disparities in LDKT. Few interventions specifically targeting these factors have been tested. We report the protocol of the Talking about Living Kidney Donation Support (TALKS) study, a study designed to evaluate the effectiveness of behavioral, educational and financial assistance interventions to improve access to LDKT among African Americans on the deceased donor kidney transplant recipient waiting list. We adapted a previously tested educational and social worker intervention shown to improve consideration and pursuit of LDKT among patients and their family members for its use among patients on the kidney transplant waiting list. We also developed a financial assistance intervention to help potential donors overcome logistical and financial challenges they might face during the pursuit of live kidney donation. We will evaluate the effectiveness of these interventions by conducting a randomized controlled trial in which patients on the deceased donor waiting list receive 1) usual care while on the transplant waiting list, 2) the educational and social worker intervention, or 3) the educational and social worker intervention plus the option of participating in the financial assistance program. The primary outcome of the randomized controlled trial will measure potential recipients' live kidney donor activation (a composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) at 1 year. The TALKS study will rigorously assess the effectiveness of promising interventions to reduce race disparities in LDKT. NCT02369354.

Using Community Engagement to Inform and Implement a Community-Randomized Controlled Trial in the Anishinaabek Cervical Cancer Screening Study

PubMed Central

Wood, Brianne; Burchell, Ann N.; Escott, Nicholas; Little, Julian; Maar, Marion; Ogilvie, Gina; Severini, Alberto; Bishop, Lisa; Morrisseau, Kyla; Zehbe, Ingeborg

2013-01-01

Social, political, and economic factors are directly and indirectly associated with the quality and distribution of health resources across Canada. First Nations (FN) women in particular, endure a disproportionate burden of ill health in contrast to the mainstream population. The complex relationship of health, social, and historical determinants are inherent to increased cervical cancer in FN women. This can be traced back to the colonial oppression suffered by Canadian FN and the social inequalities they have since faced. Screening – the Papinacolaou (Pap) test – and early immunization have rendered cervical cancer almost entirely preventable but despite these options, FN women endure notably higher rates of diagnosis and mortality due to cervical cancer. The Anishinaabek Cervical Cancer Screening Study (ACCSS) is a participatory action research project investigating the factors underlying the cervical cancer burden in FN women. ACCSS is a collaboration with 11 FN communities in Northwest Ontario, Canada, and a multidisciplinary research team from across Canada with expertise in cancer biology, epidemiology, medical anthropology, public health, virology, women’s health, and pathology. Interviews with healthcare providers and community members revealed that prior to any formal data collection education must be offered. Consequently, an educational component was integrated into the existing quantitative design of the study: a two-armed, community-randomized trial that compares the uptake of two different cervical screening modalities. In ACCSS, the Research Team integrates community engagement and the flexible nature of participatory research with the scientific rigor of a randomized controlled trial. ACCSS findings will inform culturally appropriate screening strategies, aiming to reduce the disproportionate burden of cervical disease in concert with priorities of the partner FN communities. PMID:24600584

Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis

PubMed Central

Puttarajappa, Chethan; Wijkstrom, Martin; Ganoza, Armando; Lopez, Roberto; Tevar, Amit

2018-01-01

Background Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function. Objective Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus open traditional surgery in obese patients in need of a renal transplant. Methods Electronic searches will be conducted to identify studies comparing open renal transplantation versus robotic-assisted renal transplantation. Costs associated with the two surgical techniques will incorporate the expenses of the resources used for the operations. A decision analysis model will be developed to simulate a randomized controlled trial comparing three interventional arms: (1) continuation of renal replacement therapy for patients who are considered non-suitable candidates for renal transplantation due to obesity, (2) transplant recipients undergoing open transplant surgery, and (3) transplant patients undergoing robotic-assisted renal transplantation. TreeAge Pro 2017 R1 TreeAge Software, Williamstown, MA, USA) will be used to create a Markov model and microsimulation will be used to compare costs and benefits for the two competing surgical interventions. Results The model will simulate a randomized controlled trial of adult obese patients affected by end-stage renal disease undergoing renal transplantation. The absorbing state of the model will be patients' death from any cause. By choosing death as the absorbing state, we will be able simulate the population of renal transplant recipients from the day of their randomization to transplant surgery or continuation on renal replacement therapy to their death and perform sensitivity analysis around patients' age at the time of randomization to determine if age is a critical variable for cost-benefit analysis or cost-effectiveness analysis comparing renal replacement therapy, robotic-assisted surgery or open renal transplant surgery. After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. Conclusions After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. PMID:29519780

Effects of life review on mental health and well-being among cancer patients: A systematic review.

PubMed

Zhang, Xiaoling; Xiao, Huimin; Chen, Ying

2017-09-01

Cancer patients often experience psychological distress. Life review has increasingly been used to enhance their mental health and well-being. However, no systematic review has synthesized the evidence, and its effects remain unclear. To examine and synthesize the best available evidence on the effects of life review on mental health and well-being among cancer patients. Systematic review of randomized controlled trials and clinical controlled trials. Twelve electronic databases were searched for published studies reported in English or Chinese, from inception to September 2016. Other supplementary sources, such as related websites, professional books, reference lists, and author contacts were also used for published or unpublished studies. A comprehensive literature search was conducted to identify eligible randomized controlled trials or clinical controlled trials about the effects of life review on cancer patients. Study selection, quality assessment, and data extraction were independently performed by two reviewers. The results were synthesized without meta-analysis in this review. Fifteen studies (899 participants) were identified; of that total, nine studies were rated as strong in quality, while six studies were of moderate quality. In addition to structured life review interviews, other elements such as memory prompts and a legacy product were integrated into life review programs. A majority of studies indicated that life review programs benefited cancer patients by reducing depression and anxiety, as well as improving their sense of hope, self-esteem and quality of life. Life review can improve mental health and well-being among cancer patients. This suggests that life review can be integrated into typical cancer treatment to enhance patients' mental health and well-being. More research with rigorous design is necessary to further explore the effects of life review. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of social franchising on access to and quality of health services in low- and middle-income countries.

PubMed

Koehlmoos, Tracey Perez; Gazi, Rukhsana; Hossain, S Shahed; Zaman, K

2009-01-21

Social franchising has developed as a possible means of improving provision of health services through engaging the non-state sector in low- and middle-income countries. To examine the evidence that social franchising has on access to and quality of health services in low- and middle-income countries. We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (up to October 2007), Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 3), MEDLINE, Ovid (1950 to September Week 3 2007), EMBASE, Ovid (1980 to 2007 Week 38), CINAHL, Ovid (1982 to September Week 3 2007), EconLit, WebSPIRS (1969 to Sept 2007), LILACS, Science Citation Index Expanded and Social Sciences Citation Index (1975 to March 2008), Sociological Abstracts, CSA Illumnia (1952 September 2007), WHOLIS (1948 November 2007). Randomized controlled trials, non-randomized controlled trials, controlled before and after studies and interrupted time series comparing social franchising models with other models of health service delivery, other social franchising models or absence of health services. Two review authors independently applied the criteria for inclusion and exclusion of studies to scan titles and abstracts. The same two review authors independently screened full reports of selected citations . At each stage, results were compared and discrepancies settled through discussion. No studies were found which were eligible for inclusion in this review. There is a need to develop rigorous studies to evaluate the effects of social franchising on access to and quality of health services in low- and middle-income countries. Such studies should be informed by the wider literature to identify models of social franchising that have a sound theoretical basis and empirical research addressing their reach, acceptability, feasibility, maintenance and measurability.

The effect of interventions targeting screen time reduction: A systematic review and meta-analysis.

PubMed

Wu, Lei; Sun, Samio; He, Yao; Jiang, Bin

2016-07-01

Previous studies have evaluated the effectiveness of interventions aimed at screen time reduction, but the results have been inconsistent. We therefore conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to summarize the accumulating evidence of the impact of interventions targeting screen time reduction on body mass index (BMI) reduction and screen time reduction. The PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for RCTs on the effect of interventions targeting screen time reduction. The primary and secondary outcomes were the mean difference between the treatment and control groups in the changes in BMI and changes in screen viewing time. A random effects model was used to calculate the pooled mean differences. Fourteen trials including 2238 participants were assessed. The pooled analysis suggested that interventions targeting screen time reduction had a significant effect on BMI reduction (-0.15 kg/m, P < 0.001, I = 0) and on screen time reduction (-4.63 h/w, P = 0.003, I = 94.6%). Subgroup analysis showed that a significant effect of screen time reduction was observed in studies in which the duration of intervention was <7 months and that the types of interventions in those studies were health promotion curricula or counseling. Interventions for screen time reduction might be effective in reducing screen time and preventing excess weight. Further rigorous investigations with larger samples and longer follow-up periods are still needed to evaluate the efficacy of screen time reduction both in children and in adults.

Short-term evaluation of a skill-development sexual education program for Spanish adolescents compared with a well-established program.

PubMed

Espada, José P; Morales, Alexandra; Orgilés, Mireia; Jemmott, John B; Jemmott, Loretta S

2015-01-01

The Centers for Disease Control and Prevention highlights the importance of evaluating interventions rigorously and recommends evaluating new interventions against interventions with established efficacy. Competencias para adolescentes con una sexualidad saludable (COMPAS) is a school-based HIV prevention program that has been shown to be effective in reducing sexual risk behaviors among adolescents in Spain. This study evaluates the efficacy of COMPAS program compared with a Spanish-culture adapted version of ¡Cuídate! (Take Care of Yourself), an evidence-based HIV prevention curriculum designed for Latino adolescents in the US. This cluster randomized controlled trial involved 1,563 adolescents attending 18 public high schools located in 5 provinces of Spain. The schools invited to participate were enrolled and randomly assigned to the three experimental conditions: COMPAS, ¡Cuídate!, and control group (CG; no intervention). Generalized estimating equation analyses revealed that both interventions improved attitudes toward people living with human immunodeficiency syndrome (HIV)/AIDS and the HIV test and increased HIV/sexually transmitted infection knowledge and intention to engage in safer sex behaviors compared with the CG. Although only COMPAS increased participants' sexual risk perception and attitude toward condom use compared with the CG, the two interventions did not significantly differ on any outcome. When compared with an established program, COMPAS was at least as effective at increasing the intention to engage in safer sex behaviors as the evidence-based intervention. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Renal Denervation for Treatment of Hypertension: a Second Start and New Challenges.

PubMed

Persu, Alexandre; Kjeldsen, Sverre; Staessen, Jan A; Azizi, Michel

2016-01-01

Following the publication of the randomized controlled but open-label trial Symplicity HTN-2, catheter-based renal sympathetic denervation was proposed as a novel treatment for drug-resistant hypertension. Thousands of procedures were routinely performed in Europe, Australia and Asia, and many observational studies were published. A sudden shift from overoptimistic views to radical scepticism occurred later, when the large US randomized sham-controlled trial Symplicity HTN-3 failed to meet its primary blood pressure lowering efficacy endpoint. Experts are divided on the reasons accounting for the large discrepancy between the results of initial studies and those of Symplicity HTN-3. Indeed, the blood pressure lowering effect associated with renal denervation was overestimated in initial trials due to various patient and physician-related biases, whereas it could have been underestimated in Symplicity HTN-3, which was well designed but not rigorously executed. Still, there is a large consensus on the need to further study catheter-based renal denervation in more controlled conditions, with particular emphasis on identification of predictors of blood pressure response. US and European experts have recently issued very similar recommendations on design of upcoming trials, procedural aspects, drug treatment, patient population and inclusion-exclusion criteria. Application of these new standards may represent a second chance for renal denervation to demonstrate--or not--its efficacy and safety in various patient populations. With its highly standardized treatment regimen, the French trial DENERHTN paved the way for this new approach and may inspire upcoming studies testing novel renal denervation systems in different populations.

Effectiveness of Therapeutic Massage for Generalized Anxiety Disorder: A Randomized Controlled Trial

PubMed Central

Sherman, Karen J.; Ludman, Evette J.; Cook, Andrea J.; Hawkes, Rene J.; Roy-Byrne, Peter P.; Bentley, Susan; Brooks, Marissa Z.; Cherkin, Daniel C.

2010-01-01

Background Although massage is one of the most popular complementary and alternative medical (CAM) treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD). Methods Sixty-eight persons with GAD were randomized to therapeutic massage (n=23), thermotherapy (n=22) or relaxing room therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes included 50% reduction in HARS and symptom resolution of GAD, changes in depressive symptoms (PHQ-8), worry and GAD-related disability. We compared changes in these outcomes in the massage and control groups post- treatment and at 6 months using generalized estimating equation (GEE) regression. Results All groups had improved by the end of treatment (adjusted mean change scores for the HARS ranged from −10.0 to −13.0; p< 0.001) and maintained their gains at the 26 week follow-up. No differences were seen between groups (p=0.39). Symptom reduction and resolution of GAD, depressive symptoms, worry and disability showed similar patterns. Conclusions Massage was not superior to the control treatments, and all showed some clinically important improvements, likely due to some beneficial but generalized relaxation response. Because the relaxing room treatment is substantially less expensive than the other treatments, a similar treatment packaged in a clinically credible manner might be the most cost effective option for persons with GAD who want to try relaxation-oriented CAM therapies. PMID:20186971

Music-based interventions to reduce internalizing symptoms in children and adolescents: A meta-analysis.

PubMed

Geipel, Josephine; Koenig, Julian; Hillecke, Thomas K; Resch, Franz; Kaess, Michael

2018-01-01

Existing systematic reviews provide evidence that music therapy is an effective intervention in the treatment of children and adolescents with psychopathology. The objective of the present review was to systematically review and quantify the effects of music-based interventions in reducing internalizing symptoms (i.e., depression and anxiety) in children and adolescents using a meta-analytical approach. Databases and journals were systematically screened for studies eligible for inclusion in meta-analysis on the effects of music-based interventions in reducing internalizing symptoms. A random-effect meta-analysis using standardized mean differences (SMD) was conducted. Five studies were included. Analysis of data from (randomized) controlled trials, yielded a significant main effect (Hedge's g = -0.73; 95%CI [-1.42;-0.04], Z = 2.08, p = 0.04, k = 5), indicating a greater reduction of internalizing symptoms in youth receiving music-based interventions (n = 100) compared to different control group interventions (n = 95). The existing evidence is limited to studies of low power and methodological quality. Included studies were highly heterogeneous with respect to the nature of the intervention, the measurements applied, the samples studied, and the study design. Findings indicate that music-based interventions may be efficient in reducing the severity of internalizing symptoms in children and adolescents. While these results are encouraging with respect to the application of music-based intervention, rigorous research is necessary to replicate existing findings and provide a broader base of evidence. More research adopting well controlled study designs of high methodological quality is needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Effectiveness and safety of acupuncture in the treatment of Parkinson's disease: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Noh, Hyeonseok; Kwon, Seungwon; Cho, Seung-Yeon; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

2017-10-01

This study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson's disease (PD). English, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using RevMan 5.3. In total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported. We found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of an affordable daycare program on health and economic well-being in Rajasthan, India: protocol for a cluster-randomized impact evaluation study.

PubMed

Nandi, Arijit; Maloney, Shannon; Agarwal, Parul; Chandrashekar, Anoushaka; Harper, Sam

2016-06-09

The provision of affordable and reliable daycare services is a potentially important policy lever for empowering Indian women. Access to daycare might reduce barriers to labor force entry and generate economic opportunities for women, improve education for girls caring for younger siblings, and promote nutrition and learning among children. However, empirical evidence concerning the effects of daycare programs in low-and-middle-income countries is scarce. This cluster-randomized trial will estimate the effect of a community-based daycare program on health and economic well-being over the life-course among women and children living in rural Rajasthan, India. This three-year study takes place in rural communities from five blocks in the Udaipur District of rural Rajasthan. The intervention is the introduction of a full-time, affordable, community-based daycare program. At baseline, 3177 mothers with age eligible children living in 160 village hamlets were surveyed. After the baseline, these hamlets were randomized to the intervention or control groups and respondents will be interviewed on two more occasions. Primary social and economic outcomes include women's economic status and economic opportunity, women's empowerment, and children's educational attainment. Primary health outcomes include women's mental health, as well as children's nutritional status. This interdisciplinary research initiative will provide rigorous evidence concerning the effects of daycare in lower-income settings. In doing so it will address an important research gap and has the potential to inform policies for improving the daycare system in India in ways that promote health and economic well-being. (1) The ISRCTN clinical trial registry (ISRCTN45369145), http://www.isrctn.com/ISRCTN45369145 , registered on May 16, 2016 and (2) The American Economic Association's registry for randomized controlled trials (AEARCTR-0000774), http://www.socialscienceregistry.org/trials/774 , registered on July 15, 2015.

Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial.

PubMed

Hoffman, Risa; Bardon, Ashley; Rosen, Sydney; Fox, Matthew; Kalua, Thoko; Xulu, Thembi; Taylor, Angela; Sanne, Ian

2017-10-13

Requirements for frequent dispensing of antiretroviral therapy (ART) place demands on health systems and can lead to suboptimal adherence and disengagement in care for patients due to the time and cost of frequent clinic visits. Rigorous data are needed to define optimal ART dispensing strategies and to evaluate the impact of a longer medication supply on retention and virologic suppression and determine whether this strategy lowers costs for both the patient and the health system. To date, no randomized studies have tested the benefits of 6-month dispensing of ART compared to 3-month and standard of care approaches. This study will be an unblinded cluster-randomized, matched controlled trial conducted among 8200 stable, HIV-infected individuals age 18 years and older on ART in Malawi and Zambia, to compare three ART dispensing intervals on the outcomes of retention in care (primary outcome), virologic suppression, and cost-effectiveness. Thirty clusters will be matched according to country, facility type, and ART cohort size and randomized to one of three study arms: standard of care, 3-month dispensing, and 6-month dispensing. Study participants will be followed, and outcomes will be measured at 12, 24, and 36 months. A subset of participants (n = 240) and providers (n = 180) will also participate in qualitative interviews to evaluate feasibility and acceptability of different ART dispensing intervals. This study will be the first to compare 6-month and 3-month ART dispensing intervals for stable, HIV-infected individuals in Malawi and Zambia. We focus on outcomes relevant to country programs, including retention, virologic suppression, and cost-effectiveness. Results from the study will help resource-limited health systems better understand the full scope of outcomes resulting from various ART dispensing intervals and help to inform health policy decisions. ClinicalTrials.gov, NCT03101592 . Registered on 18 March 2017. Pan African Clinical Trials, PACTR201706002336105 . Registered on 2 June 2017.

Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS

PubMed Central

Lo, Albert C.; Guarino, Peter; Krebs, Hermano I.; Volpe, Bruce T.; Bever, Christopher T.; Duncan, Pamela W.; Ringer, Robert J.; Wagner, Todd H.; Richards, Lorie G.; Bravata, Dawn M.; Haselkorn, Jodie K.; Wittenberg, George F.; Federman, Daniel G.; Corn, Barbara H.; Maffucci, Alysia D.; Peduzzi, Peter

2017-01-01

Background Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period. Objective To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke. Methods The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment ≥6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale. Results A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9. Conclusions VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010. PMID:19541917

Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

PubMed Central

Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

2014-01-01

Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

Virtual reality and cognitive rehabilitation: a review of current outcome research.

PubMed

Larson, Eric B; Feigon, Maia; Gagliardo, Pablo; Dvorkin, Assaf Y

2014-01-01

Recent advancement in the technology of virtual reality (VR) has allowed improved applications for cognitive rehabilitation. The aim of this review is to facilitate comparisons of therapeutic efficacy of different VR interventions. A systematic approach for the review of VR cognitive rehabilitation outcome research addressed the nature of each sample, treatment apparatus, experimental treatment protocol, control treatment protocol, statistical analysis and results. Using this approach, studies that provide valid evidence of efficacy of VR applications are summarized. Applications that have not yet undergone controlled outcome study but which have promise are introduced. Seventeen studies conducted over the past eight years are reviewed. The few randomized controlled trials that have been completed show that some applications are effective in treating cognitive deficits in people with neurological diagnoses although further study is needed. Innovations requiring further study include the use of enriched virtual environments that provide haptic sensory input in addition to visual and auditory inputs and the use of commercially available gaming systems to provide tele-rehabilitation services. Recommendations are offered to improve efficacy of rehabilitation, to improve scientific rigor of rehabilitation research and to broaden access to the evidence-based treatments that this research has identified.

Symptoms in Response to Controlled Diesel Exhaust More Closely Reflect Exposure Perception Than True Exposure

PubMed Central

Carlsten, Chris; Oron, Assaf P.; Curtiss, Heidi; Jarvis, Sara; Daniell, William; Kaufman, Joel D.

2013-01-01

Background Diesel exhaust (DE) exposures are very common, yet exposure-related symptoms haven’t been rigorously examined. Objective Describe symptomatic responses to freshly generated and diluted DE and filtered air (FA) in a controlled human exposure setting; assess whether such responses are altered by perception of exposure. Methods 43 subjects participated within three double-blind crossover experiments to order-randomized DE exposure levels (FA and DE calibrated at 100 and/or 200 micrograms/m3 particulate matter of diameter less than 2.5 microns), and completed questionnaires regarding symptoms and dose perception. Results For a given symptom cluster, the majority of those exposed to moderate concentrations of diesel exhaust do not report such symptoms. The most commonly reported symptom cluster was of the nose (29%). Blinding to exposure is generally effective. Perceived exposure, rather than true exposure, is the dominant modifier of symptom reporting. Conclusion Controlled human exposure to moderate-dose diesel exhaust is associated with a range of mild symptoms, though the majority of individuals will not experience any given symptom. Blinding to DE exposure is generally effective. Perceived DE exposure, rather than true DE exposure, is the dominant modifier of symptom reporting. PMID:24358296

Effect of Medicinal Herbs on Primary Dysmenorrhoea- a Systematic Review

PubMed Central

Mirabi, Parvaneh; Alamolhoda, Seideh Hanieh; Esmaeilzadeh, Seddigheh; Mojab, Faraz

2014-01-01

Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Herbal medicine may be a suitable alternative. To determine the efficacy and safety of Iranian herbal medicine for primary dysmenorrhea when compared with placebo, no treatment, and other treatment. Electronic searches of the Cochrane Menstrual Disorders and Dysmenorrhoea Group Register of controlled trials, Scopus, Google Scholar, Medline, Pubmed were performed to identify relevant randomized controlled trials (RCTs). The study abstraction and quality assessment of all studies were undertaken following the detailed descriptions of these categories as described in the JADAD Criteria for Systematic Reviews of Interventions. 25 RCTs involving a total of women were included in the review. The review found promising evidence in the form of RCTs for the use of herbal medicine in the treatment of primary dysmenorrhoea compared with pharmacological treatment. However, the results were limited by methodological flaws. Further rigorous no penetrating placebo-controlled RCTs are warranted. The review found promising evidence supporting the use of herbal medicine for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials. PMID:25276177

A Systematic Review of the Efficacy of Bioactive Compounds in Cardiovascular Disease: Phenolic Compounds

PubMed Central

Rangel-Huerta, Oscar D.; Pastor-Villaescusa, Belen; Aguilera, Concepcion M.; Gil, Angel

2015-01-01

The prevalence of cardiovascular diseases (CVD) is rising and is the prime cause of death in all developed countries. Bioactive compounds (BAC) can have a role in CVD prevention and treatment. The aim of this work was to examine the scientific evidence supporting phenolic BAC efficacy in CVD prevention and treatment by a systematic review. Databases utilized were Medline, LILACS and EMBASE, and all randomized controlled trials (RCTs) with prospective, parallel or crossover designs in humans in which the effects of BAC were compared with that of placebo/control were included. Vascular homeostasis, blood pressure, endothelial function, oxidative stress and inflammatory biomarkers were considered as primary outcomes. Cohort, ecological or case-control studies were not included. We selected 72 articles and verified their quality based on the Scottish Intercollegiate Guidelines Network, establishing diverse quality levels of scientific evidence according to two features: the design and bias risk of a study. Moreover, a grade of recommendation was included, depending on evidence strength of antecedents. Evidence shows that certain polyphenols, such as flavonols can be helpful in decreasing CVD risk factors. However, further rigorous evidence is necessary to support the BAC effect on CVD prevention and treatment. PMID:26132993

A mind you can count on: validating breath counting as a behavioral measure of mindfulness.

PubMed

Levinson, Daniel B; Stoll, Eli L; Kindy, Sonam D; Merry, Hillary L; Davidson, Richard J

2014-01-01

Mindfulness practice of present moment awareness promises many benefits, but has eluded rigorous behavioral measurement. To date, research has relied on self-reported mindfulness or heterogeneous mindfulness trainings to infer skillful mindfulness practice and its effects. In four independent studies with over 400 total participants, we present the first construct validation of a behavioral measure of mindfulness, breath counting. We found it was reliable, correlated with self-reported mindfulness, differentiated long-term meditators from age-matched controls, and was distinct from sustained attention and working memory measures. In addition, we employed breath counting to test the nomological network of mindfulness. As theorized, we found skill in breath counting associated with more meta-awareness, less mind wandering, better mood, and greater non-attachment (i.e., less attentional capture by distractors formerly paired with reward). We also found in a randomized online training study that 4 weeks of breath counting training improved mindfulness and decreased mind wandering relative to working memory training and no training controls. Together, these findings provide the first evidence for breath counting as a behavioral measure of mindfulness.

Do behavioral scientists really understand HIV-related sexual risk behavior? A systematic review of longitudinal and experimental studies predicting sexual behavior.

PubMed

Huebner, David M; Perry, Nicholas S

2015-10-01

Behavioral interventions to reduce sexual risk behavior depend on strong health behavior theory. By identifying the psychosocial variables that lead causally to sexual risk, theories provide interventionists with a guide for how to change behavior. However, empirical research is critical to determining whether a particular theory adequately explains sexual risk behavior. A large body of cross-sectional evidence, which has been reviewed elsewhere, supports the notion that certain theory-based constructs (e.g., self-efficacy) are correlates of sexual behavior. However, given the limitations of inferring causality from correlational research, it is essential that we review the evidence from more methodologically rigorous studies (i.e., longitudinal and experimental designs). This systematic review identified 44 longitudinal studies in which investigators attempted to predict sexual risk from psychosocial variables over time. We also found 134 experimental studies (i.e., randomized controlled trials of HIV interventions), but of these only 9 (6.7 %) report the results of mediation analyses that might provide evidence for the validity of health behavior theories in predicting sexual behavior. Results show little convergent support across both types of studies for most traditional, theoretical predictors of sexual behavior. This suggests that the field must expand the body of empirical work that utilizes the most rigorous study designs to test our theoretical assumptions. The inconsistent results of existing research would indicate that current theoretical models of sexual risk behavior are inadequate, and may require expansion or adaptation.

Mental health interventions in Myanmar: a review of the academic and gray literature.

PubMed

Nguyen, A J; Lee, C; Schojan, M; Bolton, P

2018-01-01

Recent political changes in Myanmar provide opportunities to expand mental health (MH) services. Given Myanmar's unique situation, we felt a need to assemble and interpret available local information on MH in Myanmar to inform service design, rather than simply drawing lessons from other countries. We reviewed academic and gray literature on the experience of MH problems in Myanmar and the suitability, availability, and effectiveness of MH and psychosocial programming. We searched: (1) Google Scholar; (2) PubMed; (3) PsychInfo; (4) English-language Myanmar journals and databases; (5) the Mental Health and Psychosocial Support (MHPSS) Network resources website; (6) websites and (7) local contacts of organizations identified during 2010 and 2013 mapping exercise of MHPSS providers; (8) the Myanmar Information Management Unit (MIMU) website; (9) University libraries in Yangon and Mandalay; and (10) identified local MH professionals. Qualitative data suggest that MH conditions resulting from stress are similar to those experienced elsewhere. Fourteen intervention evaluations were identified: three on community-level interventions, three on adult religion-based practice (meditation), four adult psychotherapeutic interventions, and four child-focused interventions. Support for the acceptability and effectiveness of interventions is mostly anecdotal. With the exception of two rigorous, randomized control trials, most evaluations had serious methodologic limitations. Few evaluations of psychotherapeutic or psychosocial programs for people from Myanmar have been published in the black or gray literature. Incorporating rigorous evaluations into existing and future programs is imperative for expanding the evidence base for psychotherapeutic and psychosocial programs in this context.

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq

PubMed Central

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-01-01

ABSTRACT Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein’s government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen’s d, 0.57; P = .02) and dysfunction (Cohen’s d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. PMID:27609624

A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq.

PubMed

Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

2016-09-28

Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein's government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen's d, 0.57; P = .02) and dysfunction (Cohen's d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic relationship can also be effective. © Bass et al.

Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

PubMed Central

Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

2015-01-01

Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID:25972803

Effect of periodontal treatment on preterm birth rate: a systematic review of meta-analyses.

PubMed

López, Néstor J; Uribe, Sergio; Martinez, Benjamín

2015-02-01

Preterm birth is a major cause of neonatal morbidity and mortality in both developed and developing countries. Preterm birth is a highly complex syndrome that includes distinct clinical subtypes in which many different causes may be involved. The results of epidemiological, molecular, microbiological and animal-model studies support a positive association between maternal periodontal disease and preterm birth. However, the results of intervention studies carried out to determine the effect of periodontal treatment on reducing the risk of preterm birth are controversial. This systematic review critically analyzes the methodological issues of meta-analyses of the studies to determine the effect of periodontal treatment to reduce preterm birth. The quality of the individual randomized clinical trials selected is of highest relevance for a systematic review. This article describes the methodological features that should be identified a priori and assessed individually to determine the quality of a randomized controlled trial performed to evaluate the effect of periodontal treatment on pregnancy outcomes. The AMSTAR and the PRISMA checklist tools were used to assess the quality of the six meta-analyses selected, and the bias domain of the Cochrane Collaboration's Tool was applied to evaluate each of the trials included in the meta-analyses. In addition, the methodological characteristics of each clinical trial were assessed. The majority of the trials included in the meta-analyses have significant methodological flaws that threaten their internal validity. The lack of effect of periodontal treatment on preterm birth rate concluded by four meta-analyses, and the positive effect of treatment for reducing preterm birth risk concluded by the remaining two meta-analyses are not based on consistent scientific evidence. Well-conducted randomized controlled trials using rigorous methodology, including appropriate definition of the exposure, adequate control of confounders for preterm birth and application of effective periodontal interventions to eliminate periodontal infection, are needed to confirm the positive association between periodontal disease and preterm birth. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

A Proposed Solution to the Problem with Using Completely Random Data to Assess the Number of Factors with Parallel Analysis

ERIC Educational Resources Information Center

Green, Samuel B.; Levy, Roy; Thompson, Marilyn S.; Lu, Min; Lo, Wen-Juo

2012-01-01

A number of psychometricians have argued for the use of parallel analysis to determine the number of factors. However, parallel analysis must be viewed at best as a heuristic approach rather than a mathematically rigorous one. The authors suggest a revision to parallel analysis that could improve its accuracy. A Monte Carlo study is conducted to…

A Rigorous Temperature-Dependent Stochastic Modelling and Testing for MEMS-Based Inertial Sensor Errors.

PubMed

El-Diasty, Mohammed; Pagiatakis, Spiros

2009-01-01

In this paper, we examine the effect of changing the temperature points on MEMS-based inertial sensor random error. We collect static data under different temperature points using a MEMS-based inertial sensor mounted inside a thermal chamber. Rigorous stochastic models, namely Autoregressive-based Gauss-Markov (AR-based GM) models are developed to describe the random error behaviour. The proposed AR-based GM model is initially applied to short stationary inertial data to develop the stochastic model parameters (correlation times). It is shown that the stochastic model parameters of a MEMS-based inertial unit, namely the ADIS16364, are temperature dependent. In addition, field kinematic test data collected at about 17 °C are used to test the performance of the stochastic models at different temperature points in the filtering stage using Unscented Kalman Filter (UKF). It is shown that the stochastic model developed at 20 °C provides a more accurate inertial navigation solution than the ones obtained from the stochastic models developed at -40 °C, -20 °C, 0 °C, +40 °C, and +60 °C. The temperature dependence of the stochastic model is significant and should be considered at all times to obtain optimal navigation solution for MEMS-based INS/GPS integration.

The impact of rigorous mathematical thinking as learning method toward geometry understanding

NASA Astrophysics Data System (ADS)

Nugraheni, Z.; Budiyono, B.; Slamet, I.

2018-05-01

To reach higher order thinking skill, needed to be mastered the conceptual understanding. RMT is a unique realization of the cognitive conceptual construction approach based on Mediated Learning Experience (MLE) theory by Feurstein and Vygotsky’s sociocultural theory. This was quasi experimental research which was comparing the experimental class that was given Rigorous Mathematical Thinking (RMT) as learning method and control class that was given Direct Learning (DL) as the conventional learning activity. This study examined whether there was different effect of two learning method toward conceptual understanding of Junior High School students. The data was analyzed by using Independent t-test and obtained a significant difference of mean value between experimental and control class on geometry conceptual understanding. Further, by semi-structure interview known that students taught by RMT had deeper conceptual understanding than students who were taught by conventional way. By these result known that Rigorous Mathematical Thinking (RMT) as learning method have positive impact toward Geometry conceptual understanding.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

PubMed Central

Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

2014-01-01

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to: (a) determining pressure ulcer incidence/severity, (b) randomization imbalance, and (c) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence as well as the ability to implement needed mid-course corrections. PMID:24577972

Tank waste remediation system immobilized high-level waste storage project configuration management implementation plan

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

Burgard, K.G.

This Configuration Management Implementation Plan was developed to assist in the management of systems, structures, and components, to facilitate the effective control and statusing of changes to systems, structures, and components; and to ensure technical consistency between design, performance, and operational requirements. Its purpose is to describe the approach Project W-464 will take in implementing a configuration management control, to determine the rigor of control, and to identify the mechanisms for imposing that control.This Configuration Management Implementation Plan was developed to assist in the management of systems, structures, and components, to facilitate the effective control and statusing of changes tomore » systems, structures, and components; and to ensure technical consistency between design, performance, and operational requirements. Its purpose is to describe the approach Project W-464 will take in implementing a configuration management control, to determine the rigor of control, and to identify the mechanisms for imposing that control.« less

Proteomic Biomarkers for Acute Interstitial Lung Disease in Gefitinib-Treated Japanese Lung Cancer Patients

PubMed Central

Kawakami, Takao; Nagasaka, Keiko; Takami, Sachiko; Wada, Kazuya; Tu, Hsiao-Kun; Otsuji, Makiko; Kyono, Yutaka; Dobashi, Tae; Komatsu, Yasuhiko; Kihara, Makoto; Akimoto, Shingo; Peers, Ian S.; South, Marie C.; Higenbottam, Tim; Fukuoka, Masahiro; Nakata, Koichiro; Ohe, Yuichiro; Kudoh, Shoji; Clausen, Ib Groth; Nishimura, Toshihide; Marko-Varga, György; Kato, Harubumi

2011-01-01

Interstitial lung disease (ILD) events have been reported in Japanese non-small-cell lung cancer (NSCLC) patients receiving EGFR tyrosine kinase inhibitors. We investigated proteomic biomarkers for mechanistic insights and improved prediction of ILD. Blood plasma was collected from 43 gefitinib-treated NSCLC patients developing acute ILD (confirmed by blinded diagnostic review) and 123 randomly selected controls in a nested case-control study within a pharmacoepidemiological cohort study in Japan. We generated ∼7 million tandem mass spectrometry (MS/MS) measurements with extensive quality control and validation, producing one of the largest proteomic lung cancer datasets to date, incorporating rigorous study design, phenotype definition, and evaluation of sample processing. After alignment, scaling, and measurement batch adjustment, we identified 41 peptide peaks representing 29 proteins best predicting ILD. Multivariate peptide, protein, and pathway modeling achieved ILD prediction comparable to previously identified clinical variables; combining the two provided some improvement. The acute phase response pathway was strongly represented (17 of 29 proteins, p = 1.0×10−25), suggesting a key role with potential utility as a marker for increased risk of acute ILD events. Validation by Western blotting showed correlation for identified proteins, confirming that robust results can be generated from an MS/MS platform implementing strict quality control. PMID:21799770

Interventional procedures and future drug therapy for hypertension.

PubMed

Lobo, Melvin D; Sobotka, Paul A; Pathak, Atul

2017-04-14

Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious. For those patients who either do not tolerate or wish to take medication for hypertension or in whom BP control is not attained despite multiple antihypertensives, a novel class of interventional procedures to manage hypertension has emerged. While most of these target various aspects of the sympathetic nervous system regulation of BP, an additional procedure is now available, which addresses mechanical aspects of the circulation. Most of these new devices are supported by early and encouraging evidence for both safety and efficacy, although it is clear that more rigorous randomized controlled trial data will be essential before any of the technologies can be adopted as a standard of care. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Demonstration of qubit operations below a rigorous fault tolerance threshold with gate set tomography

DOE PAGES

Blume-Kohout, Robin; Gamble, John King; Nielsen, Erik; ...

2017-02-15

Quantum information processors promise fast algorithms for problems inaccessible to classical computers. But since qubits are noisy and error-prone, they will depend on fault-tolerant quantum error correction (FTQEC) to compute reliably. Quantum error correction can protect against general noise if—and only if—the error in each physical qubit operation is smaller than a certain threshold. The threshold for general errors is quantified by their diamond norm. Until now, qubits have been assessed primarily by randomized benchmarking, which reports a different error rate that is not sensitive to all errors, and cannot be compared directly to diamond norm thresholds. Finally, we usemore » gate set tomography to completely characterize operations on a trapped-Yb +-ion qubit and demonstrate with greater than 95% confidence that they satisfy a rigorous threshold for FTQEC (diamond norm ≤6.7 × 10 -4).« less

Demonstration of qubit operations below a rigorous fault tolerance threshold with gate set tomography

PubMed Central

Blume-Kohout, Robin; Gamble, John King; Nielsen, Erik; Rudinger, Kenneth; Mizrahi, Jonathan; Fortier, Kevin; Maunz, Peter

2017-01-01

Quantum information processors promise fast algorithms for problems inaccessible to classical computers. But since qubits are noisy and error-prone, they will depend on fault-tolerant quantum error correction (FTQEC) to compute reliably. Quantum error correction can protect against general noise if—and only if—the error in each physical qubit operation is smaller than a certain threshold. The threshold for general errors is quantified by their diamond norm. Until now, qubits have been assessed primarily by randomized benchmarking, which reports a different error rate that is not sensitive to all errors, and cannot be compared directly to diamond norm thresholds. Here we use gate set tomography to completely characterize operations on a trapped-Yb+-ion qubit and demonstrate with greater than 95% confidence that they satisfy a rigorous threshold for FTQEC (diamond norm ≤6.7 × 10−4). PMID:28198466

Demonstration of qubit operations below a rigorous fault tolerance threshold with gate set tomography

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

Blume-Kohout, Robin; Gamble, John King; Nielsen, Erik

Quantum information processors promise fast algorithms for problems inaccessible to classical computers. But since qubits are noisy and error-prone, they will depend on fault-tolerant quantum error correction (FTQEC) to compute reliably. Quantum error correction can protect against general noise if—and only if—the error in each physical qubit operation is smaller than a certain threshold. The threshold for general errors is quantified by their diamond norm. Until now, qubits have been assessed primarily by randomized benchmarking, which reports a different error rate that is not sensitive to all errors, and cannot be compared directly to diamond norm thresholds. Finally, we usemore » gate set tomography to completely characterize operations on a trapped-Yb +-ion qubit and demonstrate with greater than 95% confidence that they satisfy a rigorous threshold for FTQEC (diamond norm ≤6.7 × 10 -4).« less

Rigor of cell fate decision by variable p53 pulses and roles of cooperative gene expression by p53

PubMed Central

Murakami, Yohei; Takada, Shoji

2012-01-01

Upon DNA damage, the cell fate decision between survival and apoptosis is largely regulated by p53-related networks. Recent experiments found a series of discrete p53 pulses in individual cells, which led to the hypothesis that the cell fate decision upon DNA damage is controlled by counting the number of p53 pulses. Under this hypothesis, Sun et al. (2009) modeled the Bax activation switch in the apoptosis signal transduction pathway that can rigorously “count” the number of uniform p53 pulses. Based on experimental evidence, here we use variable p53 pulses with Sun et al.’s model to investigate how the variability in p53 pulses affects the rigor of the cell fate decision by the pulse number. Our calculations showed that the experimentally anticipated variability in the pulse sizes reduces the rigor of the cell fate decision. In addition, we tested the roles of the cooperativity in PUMA expression by p53, finding that lower cooperativity is plausible for more rigorous cell fate decision. This is because the variability in the p53 pulse height is more amplified in PUMA expressions with more cooperative cases. PMID:27857606

Atlantic salmon skin and fillet color changes effected by perimortem handling stress, rigor mortis, and ice storage.

PubMed

Erikson, U; Misimi, E

2008-03-01

The changes in skin and fillet color of anesthetized and exhausted Atlantic salmon were determined immediately after killing, during rigor mortis, and after ice storage for 7 d. Skin color (CIE L*, a*, b*, and related values) was determined by a Minolta Chroma Meter. Roche SalmoFan Lineal and Roche Color Card values were determined by a computer vision method and a sensory panel. Before color assessment, the stress levels of the 2 fish groups were characterized in terms of white muscle parameters (pH, rigor mortis, and core temperature). The results showed that perimortem handling stress initially significantly affected several color parameters of skin and fillets. Significant transient fillet color changes also occurred in the prerigor phase and during the development of rigor mortis. Our results suggested that fillet color was affected by postmortem glycolysis (pH drop, particularly in anesthetized fillets), then by onset and development of rigor mortis. The color change patterns during storage were different for the 2 groups of fish. The computer vision method was considered suitable for automated (online) quality control and grading of salmonid fillets according to color.

Effect of pre-rigor stretch and various constant temperatures on the rate of post-mortem pH fall, rigor mortis and some quality traits of excised porcine biceps femoris muscle strips.

PubMed

Vada-Kovács, M

1996-01-01

Porcine biceps femoris strips of 10 cm original length were stretched by 50% and fixed within 1 hr post mortem then subjected to temperatures of 4 °, 15 ° or 36 °C until they attained their ultimate pH. Unrestrained control muscle strips, which were left to shorten freely, were similarly treated. Post-mortem metabolism (pH, R-value) and shortening were recorded; thereafter ultimate meat quality traits (pH, lightness, extraction and swelling of myofibrils) were determined. The rate of pH fall at 36 °C, as well as ATP breakdown at 36 and 4 °C, were significantly reduced by pre-rigor stretch. The relationship between R-value and pH indicated cold shortening at 4 °C. Myofibrils isolated from pre-rigor stretched muscle strips kept at 36 °C showed the most severe reduction of hydration capacity, while paleness remained below extreme values. However, pre-rigor stretched myofibrils - when stored at 4 °C - proved to be superior to shortened ones in their extractability and swelling.

The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer.

PubMed

Zaorsky, Nicholas G; Egleston, Brian L; Horwitz, Eric M; Dicker, Adam P; Nguyen, Paul L; Showalter, Timothy N; Den, Robert B

2016-08-01

Randomized controlled trials (RCTs) are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost-effectiveness of a treatment. For many patients, cancer is a chronic illness; RCTs evaluating treatments for indolent cancers must evolve to facilitate medical decision-making, as "concrete" patient outcomes (eg, survival) will likely be excellent independent of the intervention, and detecting a difference between trial arms may be impossible. In this commentary, we articulate 9 recommendations that we hope future clinical trialists and funding agencies (including those under the National Cancer Institute) will take into consideration when planning RCTs to help guide subsequent interpretation of results and clinical decision making, based on RCTs of external beam radiation therapy dose escalation for the most common indolent cancer in men, that is, prostate cancer. We recommend routinely reporting: (1) race; (2) medical comorbidities; (3) psychiatric comorbidities; (4) insurance status; (5) education; (6) marital status; (7) income; (8) sexual orientation; and (9) facility-related characteristics (eg, number of centers involved, type of facilities, yearly hospital volumes). We discuss how these factors independently affect patient outcomes and toxicities; future clinicians and governing organizations should consider this information to plan RCTs accordingly (to maximize patient accrual and total n), select appropriate endpoints (eg, toxicity, quality of life, sexual function), actively monitor RCTs, and report results so as to identify the optimal treatment among subpopulations.

Is hand sewing comparable with stapling for anastomotic leakage after esophagectomy? A meta-analysis

PubMed Central

Liu, Quan-Xing; Min, Jia-Xin; Deng, Xu-Feng; Dai, Ji-Gang

2014-01-01

AIM: To compare the outcome of hand sewing and stapling for anastomotic leakage after esophagectomy. METHODS: A rigorous study protocol was established according to the recommendations of the Cochrane Collaboration. An electronic database search, hand search, and reference search were used to retrieve all randomized controlled trials that compared hand-sewn and mechanical esophagogastric anastomoses. RESULTS: This study included 15 randomized controlled trials with a total of 2337 patients. The results revealed that there was no significant difference in the incidence of anastomotic leakage between the methods [relative risk (RR) = 0.77, 95% confidence interval (CI): 0.57-1.04; P = 0.09], but a subgroup analysis yielded a significant difference for the sutured layer and year of publication (Ps < 0.05). There was also no significant difference in the incidence of postoperative mortality (RR = 1.52, 95%CI: 0.97-2.40; P = 0.07). However, the anastomotic strictures rate was increased in the stapler group compared with the hand-sewn group (RR = 1.45, 95%CI: 1.11-1.91; P < 0.01) in the end-to-side subgroup, while the incidence of anastomotic strictures was decreased (RR = 0.34, 95%CI: 0.16-0.76; P < 0.01) in the side-to-side subgroup. CONCLUSION: The stapler reduces the anastomotic leakage rate compared with hand sewing. End-to-side stapling increases the risk of anastomotic strictures, but side-to-side stapling decreases the risk. PMID:25493038

Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals

PubMed Central

Sarveravan, Pooneh; Astaneh, Behrooz; Shokrpour, Nasrin

2017-01-01

Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess the quality of RCT reporting vis-à-vis adherence to CONSORT among articles published in Iranian medical journals (English, Persian, CONSORT-endorsing, and non-CONSORT-endorsing). Methods: In this cross-sectional study, all RCTs published in all Iranian medical journals from September 2012 to September 2013 were retrieved to evaluate their adherence to CONSORT. The journals’ instructions for authors were also reviewed to find out whether or not they endorsed CONSORT. The CONSORT 2010 Checklist was used. Microsoft Excel 2007 was applied to analyze the data, and MedCalc was employed to compare the groups. Results: Totally, 492 pharmacological RCTs that met our inclusion criteria were identified. Twenty-five items were reported in fewer than 50% of the articles. The differences between the articles published in Persian and English language journals were statistically significant in 17 items. The differences between the articles published in the CONSORT-endorsing and non-CONSORT-endorsing journals were significant in 8 items. Conclusion: Our findings showed very weak adherence to CONSORT. Authors, reviewers, and editors should be trained to use standards expressed by the CONSORT Group in reporting RCTs. PMID:29184261

TREATMENT SWITCHING: STATISTICAL AND DECISION-MAKING CHALLENGES AND APPROACHES.

PubMed

Latimer, Nicholas R; Henshall, Chris; Siebert, Uwe; Bell, Helen

2016-01-01

Treatment switching refers to the situation in a randomized controlled trial where patients switch from their randomly assigned treatment onto an alternative. Often, switching is from the control group onto the experimental treatment. In this instance, a standard intention-to-treat analysis does not identify the true comparative effectiveness of the treatments under investigation. We aim to describe statistical methods for adjusting for treatment switching in a comprehensible way for nonstatisticians, and to summarize views on these methods expressed by stakeholders at the 2014 Adelaide International Workshop on Treatment Switching in Clinical Trials. We describe three statistical methods used to adjust for treatment switching: marginal structural models, two-stage adjustment, and rank preserving structural failure time models. We draw upon discussion heard at the Adelaide International Workshop to explore the views of stakeholders on the acceptability of these methods. Stakeholders noted that adjustment methods are based on assumptions, the validity of which may often be questionable. There was disagreement on the acceptability of adjustment methods, but consensus that when these are used, they should be justified rigorously. The utility of adjustment methods depends upon the decision being made and the processes used by the decision-maker. Treatment switching makes estimating the true comparative effect of a new treatment challenging. However, many decision-makers have reservations with adjustment methods. These, and how they affect the utility of adjustment methods, require further exploration. Further technical work is required to develop adjustment methods to meet real world needs, to enhance their acceptability to decision-makers.

Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management

PubMed Central

Zhang, Xiu-lai; Chen, Meng; Zhu, Ling-ling

2017-01-01

Despite increased awareness of the potential of herb-drug interactions (HDIs), the lack of rigorous clinical evidence regarding the significance provides a challenge for clinicians and consumers to make rational decisions about the safe combination of herbal and conventional medicines. This review addressed HDIs based on evidence from randomized controlled trials (RCTs). Literature was identified by performing a PubMed search till January 2017. Risk description and clinical risk management were described. Among 74 finally included RCTs, 17 RCTs (22.97%) simply addressed pharmacodynamic HDIs. Fifty-seven RCTs (77.03%) investigated pharmacokinetic HDIs and twenty-eight of them showed potential or actual clinical relevance. The extent of an HDI may be associated with the factors such as pharmacogenomics, dose of active ingredients in herbs, time course of interaction, characteristics of the object drugs (e.g., administration routes and pharmacokinetic profiles), modification of herbal prescription compositions, and coexistence of inducers and inhibitors. Clinical professionals should enhance risk management on HDIs such as increasing awareness of potential changes in therapeutic risk and benefits, inquiring patients about all currently used conventional medicines and herbal medicines and supplements, automatically detecting highly substantial significant HDI by computerized reminder system, selecting the alternatives, adjusting dose, reviewing the appropriateness of physician orders, educating patients to monitor for drug-interaction symptoms, and paying attention to follow-up visit and consultation. PMID:28491115

Numerical simulation of a shear-thinning fluid through packed spheres

NASA Astrophysics Data System (ADS)

Liu, Hai Long; Moon, Jong Sin; Hwang, Wook Ryol

2012-12-01

Flow behaviors of a non-Newtonian fluid in spherical microstructures have been studied by a direct numerical simulation. A shear-thinning (power-law) fluid through both regular and randomly packed spheres has been numerically investigated in a representative unit cell with the tri-periodic boundary condition, employing a rigorous three-dimensional finite-element scheme combined with fictitious-domain mortar-element methods. The present scheme has been validated for the classical spherical packing problems with literatures. The flow mobility of regular packing structures, including simple cubic (SC), body-centered cubic (BCC), face-centered cubic (FCC), as well as randomly packed spheres, has been investigated quantitatively by considering the amount of shear-thinning, the pressure gradient and the porosity as parameters. Furthermore, the mechanism leading to the main flow path in a highly shear-thinning fluid through randomly packed spheres has been discussed.

A nurse-delivered, clinic-based intervention to address intimate partner violence among low-income women in Mexico City: findings from a cluster randomized controlled trial.

PubMed

Gupta, Jhumka; Falb, Kathryn L; Ponta, Oriana; Xuan, Ziming; Campos, Paola Abril; Gomez, Annabel Arellano; Valades, Jimena; Cariño, Gisele; Olavarrieta, Claudia Diaz

2017-07-12

Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time. Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P < 0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P < 0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P = 0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (β, 1.45; 95% CI, 0.14-2.75; P = 0.03) and safety planning behaviors (β, 0.41; 95% CI, 0.02-0.79; P = 0.04). While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental quality of life. Nurses can play a supportive role in assisting women with IPV experiences. Clinicaltrials.gov ( NCT01661504 ). Registration Date: August 2, 2012.

Injection-salting of pre rigor fillets of Atlantic salmon (Salmo salar).

PubMed

Birkeland, Sveinung; Akse, Leif; Joensen, Sjurdur; Tobiassen, Torbjørn; Skåra, Torstein

2007-01-01

The effects of temperature (-1, 4, and 10 degrees C), brine concentration (12% and 25% NaCl), injection volumes, and needle densities were investigated on fillet weight gain (%), salt content (%), fillet contraction (%), and muscle gaping in pre rigor brine-injected fillets of Atlantic salmon (Salmo salar). Increased brine concentration (12% to 25%) significantly increased the initial (< 5 min after injection) and final contraction (24 h after injection) of pre rigor fillets. Increased brine concentration significantly reduced weight gain and increased salt content but had no significant effect on muscle gaping. The temperatures tested did not significantly affect weight gain, fillet contraction, or gaping score. Significant regressions (P < 0.01) between the injection volume and weight gain (range: 2.5% to 15.5%) and salt content (range: 1.7% to 6.5%) were observed for injections of pre rigor fillets. Double injections significantly increased the weight gain and salt content compared to single injections. Initial fillet contraction measured 30 min after brine injection increased significantly (P < 0.01) with increasing brine injection volume but no significant difference in the fillet contraction was observed 12 h after brine injection (range: 7.9% to 8.9%). Brine-injected post rigor control fillets obtained higher weight gain, higher salt content, more muscle gaping, and significantly lower fillet contraction compared to the pre rigor injected fillets. Injection-salting is an applicable technology as a means to obtain satisfactory salt contents and homogenously distribute the salt into the muscle of pre rigor fillets of Atlantic salmon before further processing steps such as drying and smoking.

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Quasi experimental designs in pharmacist intervention research.

PubMed

Krass, Ines

2016-06-01

Background In the field of pharmacist intervention research it is often difficult to conform to the rigorous requirements of the "true experimental" models, especially the requirement of randomization. When randomization is not feasible, a practice based researcher can choose from a range of "quasi-experimental designs" i.e., non-randomised and at time non controlled. Objective The aim of this article was to provide an overview of quasi-experimental designs, discuss their strengths and weaknesses and to investigate their application in pharmacist intervention research over the previous decade. Results In the literature quasi experimental studies may be classified into five broad categories: quasi-experimental design without control groups; quasi-experimental design that use control groups with no pre-test; quasi-experimental design that use control groups and pre-tests; interrupted time series and stepped wedge designs. Quasi-experimental study design has consistently featured in the evolution of pharmacist intervention research. The most commonly applied of all quasi experimental designs in the practice based research literature are the one group pre-post-test design and the non-equivalent control group design i.e., (untreated control group with dependent pre-tests and post-tests) and have been used to test the impact of pharmacist interventions in general medications management as well as in specific disease states. Conclusion Quasi experimental studies have a role to play as proof of concept, in the pilot phases of interventions when testing different intervention components, especially in complex interventions. They serve to develop an understanding of possible intervention effects: while in isolation they yield weak evidence of clinical efficacy, taken collectively, they help build a body of evidence in support of the value of pharmacist interventions across different practice settings and countries. However, when a traditional RCT is not feasible for logistical and/or ethical reasons researchers should endeavour to use the more robust of the quasi experimental designs.

Acupuncture for the Treatment of Peripheral Neuropathy: A Systematic Review and Meta-Analysis.

PubMed

Dimitrova, Alexandra; Murchison, Charles; Oken, Barry

2017-03-01

Neuropathy and its associated pain pose great therapeutic challenges. While there has been a recent surge in acupuncture use and research, little remains known about its effects on nerve function. This review aims to assess the efficacy of acupuncture in the treatment of neuropathy of various etiologies. The Medline, AMED, Cochrane, Scopus, CINAHL, and clintrials.gov databases were systematically searched from inception to July 2015. Randomized controlled trials (RCTs) assessing acupuncture's efficacy for poly- and mononeuropathy were reviewed. Parallel and crossover RCTs focused on acupuncture's efficacy were reviewed and screened for eligibility. The Scale for Assessing Scientific Quality of Investigations in Complementary and Alternative Medicine was used to assess RCT quality. RCTs with score of >9 and active control treatments such as sham acupuncture or medical therapy were included. Fifteen studies were included: 13 original RCTs, a long-term follow-up, and a re-analysis of a prior RCT. The selected RCTs studied acupuncture for neuropathy caused by diabetes, Bell's palsy, carpal tunnel syndrome, human immunodeficiency virus (HIV), and idiopathic conditions. Acupuncture regimens, control conditions, and outcome measures differed among studies, and various methodological issues were identified. Still, the majority of RCTs showed benefit for acupuncture over control in the treatment of diabetic neuropathy, Bell's palsy, and carpal tunnel syndrome. Acupuncture is probably effective in the treatment of HIV-related neuropathy, and there is insufficient evidence for its benefits in idiopathic neuropathy. Acupuncture appears to improve nerve conduction study parameters in both sensory and motor nerves. Meta-analyses were conducted on all diabetic neuropathy and Bell's palsy individual subject data (six RCTs; a total of 680 subjects) using a summary estimate random effects model, which showed combined odds ratio of 4.23 (95% confidence interval 2.3-7.8; p < 0.001) favoring acupuncture over control for neuropathic symptoms. Acupuncture is beneficial in some peripheral neuropathies, but more rigorously designed studies using sham-acupuncture control are needed to characterize its effect and optimal use better.

The effects of pilates on mental health outcomes: A meta-analysis of controlled trials.

PubMed

Fleming, Karl M; Herring, Matthew P

2018-04-01

This meta-analysis estimated the population effect size for Pilates effects on mental health outcomes. Articles published prior to August 2017 were located with searches of Pubmed, Medline, Cinahl, SportDiscus, Science Direct, PsychINFO, Web of Science, and Cochrane Controlled Trial Register using combinations of: Pilates, Pilates method, mental health, anxiety, and depression. Eight English-language publications that included allocation to a Pilates intervention or non-active control and a measure of anxiety and/or depressive symptoms at baseline and after the Pilates intervention were selected. Participant and intervention characteristics, anxiety and depressive symptoms and other mental health outcomes, including feelings of energy and fatigue and quality of life, were extracted. Hedges' d effect sizes were computed, study quality was assessed, and random effects models estimated sampling error and population variance. Pilates resulted in significant, large, heterogeneous reductions in depressive (Δ = 1.27, 95%CI: 0.44, 2.09; z = 3.02, p ≤ 0.003; N = 6, n = 261) and anxiety symptoms (Δ = 1.29, 95%CI: 0.24, 2.33; z = 2.40, p ≤ 0.02; N = 5, n = 231) and feelings of fatigue (Δ = 0.93, 95%CI: 0.21, 1.66; z = 2.52, p ≤ 0.012; N = 3, n = 161), and increases in feelings of energy (Δ = 1.49, 95%CI: 0.67, 2.30; z = 3.57, p < 0.001; N = 2, n = 116). Though this review included a small number of controlled trials with small sample sizes and non-active control conditions of variable quality, the available evidence reviewed here supports that Pilates improves mental health outcomes. Rigorously designed randomized controlled trials, including those that compare Pilates to other empirically-supported therapies, are needed to better understand Pilates' clinical effectiveness and plausible mechanisms of effects. Copyright © 2018 Elsevier Ltd. All rights reserved.

Rigorous evaluation of chemical measurement uncertainty: liquid chromatographic analysis methods using detector response factor calibration

NASA Astrophysics Data System (ADS)

Toman, Blaza; Nelson, Michael A.; Bedner, Mary

2017-06-01

Chemical measurement methods are designed to promote accurate knowledge of a measurand or system. As such, these methods often allow elicitation of latent sources of variability and correlation in experimental data. They typically implement measurement equations that support quantification of effects associated with calibration standards and other known or observed parametric variables. Additionally, multiple samples and calibrants are usually analyzed to assess accuracy of the measurement procedure and repeatability by the analyst. Thus, a realistic assessment of uncertainty for most chemical measurement methods is not purely bottom-up (based on the measurement equation) or top-down (based on the experimental design), but inherently contains elements of both. Confidence in results must be rigorously evaluated for the sources of variability in all of the bottom-up and top-down elements. This type of analysis presents unique challenges due to various statistical correlations among the outputs of measurement equations. One approach is to use a Bayesian hierarchical (BH) model which is intrinsically rigorous, thus making it a straightforward method for use with complex experimental designs, particularly when correlations among data are numerous and difficult to elucidate or explicitly quantify. In simpler cases, careful analysis using GUM Supplement 1 (MC) methods augmented with random effects meta analysis yields similar results to a full BH model analysis. In this article we describe both approaches to rigorous uncertainty evaluation using as examples measurements of 25-hydroxyvitamin D3 in solution reference materials via liquid chromatography with UV absorbance detection (LC-UV) and liquid chromatography mass spectrometric detection using isotope dilution (LC-IDMS).

Estimation of gloss from rough surface parameters

NASA Astrophysics Data System (ADS)

Simonsen, Ingve; Larsen, Åge G.; Andreassen, Erik; Ommundsen, Espen; Nord-Varhaug, Katrin

2005-12-01

Gloss is a quantity used in the optical industry to quantify and categorize materials according to how well they scatter light specularly. With the aid of phase perturbation theory, we derive an approximate expression for this quantity for a one-dimensional randomly rough surface. It is demonstrated that gloss depends in an exponential way on two dimensionless quantities that are associated with the surface randomness: the root-mean-square roughness times the perpendicular momentum transfer for the specular direction, and a correlation function dependent factor times a lateral momentum variable associated with the collection angle. Rigorous Monte Carlo simulations are used to access the quality of this approximation, and good agreement is observed over large regions of parameter space.

Preventing Sexual Violence in Adolescence: Comparison of a Scientist-Practitioner Program and a Practitioner Program Using a Cluster-Randomized Design.

PubMed

Muck, Christoph; Schiller, Eva-Maria; Zimmermann, Maria; Kärtner, Joscha

2018-02-01

Numerous school-based prevention programs have been developed by scientists and practitioners to address sexual violence in adolescence. However, such programs struggle with two major challenges. First, the effectiveness of many well-established practitioner programs has not been rigorously evaluated. Second, effective scientific programs may be hard to implement into everyday school practice. Combining the knowledge of scientists and practitioners in a scientist-practitioner program could be a helpful compromise. The aim of the present study is to evaluate the effects of a scientist-practitioner program and a practitioner program using a cluster-randomized experimental design. Twenty-seven school classes were randomly assigned to either one of two programs or a control group. Outcome variables (knowledge, attitudes, behavior, and iatrogenic effects) were assessed at pretest, posttest, and a 6-month follow-up for 453 adolescents (55% female, Mage = 14.18). Short-term effects were found in both programs regarding general knowledge, knowledge of professional help, and victim-blaming attitudes. Long-term effects were found in both programs regarding general knowledge and knowledge of professional help and, in the practitioner program, in a reduction of victimization. No other effects were found on attitudes and behavior. No iatrogenic effects in the form of increased anxiety were found. Both the scientist-practitioner and the practitioner program show promise for the prevention of sexual violence in adolescence; in particular, the practitioner program may be a more cost-effective method.

Can Using Rigorous Evidence to Guide Federal Education Funds Improve Student Achievement? Randomized Trials Show Encouraging Initial Results for DoED's Investing in Innovation Fund

ERIC Educational Resources Information Center

Coalition for Evidence-Based Policy, 2014

2014-01-01

An important recent development in evidence-based policy is the federal government's use of a "tiered evidence" approach to allocating funding in grant programs such as the U.S. Department of Education's Investing in Innovation Fund (i3). A central feature of this approach is that the largest grants are awarded to fund large-scale…

Rigor of non-dairy galactose restriction in early childhood, measured by retrospective survey, does not associate with severity of five long-term outcomes quantified in 231 children and adults with classic galactosemia

PubMed Central

Frederick, Allison B.; Cutler, David J.; Fridovich-Keil, Judith L.

2017-01-01

One of many vexing decisions faced by parents of an infant with classic galactosemia (CG) is how carefully to restrict non-dairy galactose from their growing child’s diet. Until recently, many experts recommended vigorous lifelong dietary restriction of milk and all high-galactose dairy products as well as some non-dairy sources of galactose such as legumes and specific fruits and vegetables. Recently, experts have begun to relax their recommendations. The new recommendations, that restrict only high galactose dairy products, were made in the face of uncertainty, however, because no sufficiently powered study had been reported testing for possible association between rigor of non-dairy galactose restriction and severity of long-term outcomes in CG. Here we describe the largest study of diet and outcomes in CG reported to date, conducted using information gathered from 231 patients with CG and 71 unaffected sibling controls. We compared rigor of dietary galactose restriction, measured using a 4-point scale by a retrospective parent-response survey, with outcomes including growth, adaptive behaviors, receipt of speech therapy, receipt of special educational services, and for girls and women, a plasma marker of ovarian function (AMH). Our results confirmed the expected differences between patients and controls, but among patients showed no significant association between rigor of non-dairy galactose restriction in early childhood and any of the outcomes quantified. Indeed, some weak associations were seen suggesting that rigorous restriction of non-dairy galactose may be deleterious rather than beneficial. Despite limitations, these findings support the ongoing trend toward diet liberalization with regard to non-dairy sources of galactose for children and adults with classic galactosemia. PMID:28695375

Hypnotherapy for smoking cessation.

PubMed

Barnes, Jo; Dong, Christine Y; McRobbie, Hayden; Walker, Natalie; Mehta, Monaz; Stead, Lindsay F

2010-10-06

Hypnotherapy is widely promoted as a method for aiding smoking cessation. It is proposed to act on underlying impulses to weaken the desire to smoke or strengthen the will to stop. To evaluate the efficacy of hypnotherapy for smoking cessation. We searched the Cochrane Tobacco Addiction Group Specialized Register and the databases MEDLINE, EMBASE, AMED, SCI, SSCI using the terms smoking cessation and hypnotherapy or hypnosis. Date of most recent searches July 2010. There were no language restrictions. We considered randomized controlled trials of hypnotherapy which reported smoking cessation rates at least six months after the beginning of treatment. Three authors independently extracted data on participant characteristics, the type and duration of the hypnotherapy, the nature of the control group, smoking status, method of randomization, and completeness of follow up. They also independently assessed the quality of the included studies.The main outcome measure was abstinence from smoking after at least six months follow up. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates where available. Those lost to follow up were considered to be smoking. We summarised effects as risk ratios (RR). Where possible, we performed meta-analysis using a fixed-effect model. We also noted any adverse events reported. Eleven studies compared hypnotherapy with 18 different control interventions. There was significant heterogeneity between the results of the individual studies, with conflicting results for the effectiveness of hypnotherapy compared to no treatment, or to advice, or psychological treatment. We did not attempt to calculate pooled risk ratios for the overall effect of hypnotherapy. There was no evidence of a greater effect of hypnotherapy when compared to rapid smoking or psychological treatment. Direct comparisons of hypnotherapy with cessation treatments considered to be effective had confidence intervals that were too wide to infer equivalence. We have not shown that hypnotherapy has a greater effect on six-month quit rates than other interventions or no treatment. There is not enough evidence to show whether hypnotherapy could be as effective as counselling treatment. The effects of hypnotherapy on smoking cessation claimed by uncontrolled studies were not confirmed by analysis of randomized controlled trials.

Control group design: enhancing rigor in research of mind-body therapies for depression.

PubMed

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research.

Control Group Design: Enhancing Rigor in Research of Mind-Body Therapies for Depression

PubMed Central

Kinser, Patricia Anne; Robins, Jo Lynne

2013-01-01

Although a growing body of research suggests that mind-body therapies may be appropriate to integrate into the treatment of depression, studies consistently lack methodological sophistication particularly in the area of control groups. In order to better understand the relationship between control group selection and methodological rigor, we provide a brief review of the literature on control group design in yoga and tai chi studies for depression, and we discuss challenges we have faced in the design of control groups for our recent clinical trials of these mind-body complementary therapies for women with depression. To address the multiple challenges of research about mind-body therapies, we suggest that researchers should consider 4 key questions: whether the study design matches the research question; whether the control group addresses performance, expectation, and detection bias; whether the control group is ethical, feasible, and attractive; and whether the control group is designed to adequately control for nonspecific intervention effects. Based on these questions, we provide specific recommendations about control group design with the goal of minimizing bias and maximizing validity in future research. PMID:23662111

Evaluation of physical dimension changes as nondestructive measurements for monitoring rigor mortis development in broiler muscles.

PubMed

Cavitt, L C; Sams, A R

2003-07-01

Studies were conducted to develop a non-destructive method for monitoring the rate of rigor mortis development in poultry and to evaluate the effectiveness of electrical stimulation (ES). In the first study, 36 male broilers in each of two trials were processed at 7 wk of age. After being bled, half of the birds received electrical stimulation (400 to 450 V, 400 to 450 mA, for seven pulses of 2 s on and 1 s off), and the other half were designated as controls. At 0.25 and 1.5 h postmortem (PM), carcasses were evaluated for the angles of the shoulder, elbow, and wing tip and the distance between the elbows. Breast fillets were harvested at 1.5 h PM (after chilling) from all carcasses. Fillet samples were excised and frozen for later measurement of pH and R-value, and the remainder of each fillet was held on ice until 24 h postmortem. Shear value and pH means were significantly lower, but R-value means were higher (P < 0.05) for the ES fillets compared to the controls, suggesting acceleration of rigor mortis by ES. The physical dimensions of the shoulder and elbow changed (P < 0.05) during rigor mortis development and with ES. These results indicate that physical measurements of the wings maybe useful as a nondestructive indicator of rigor development and for monitoring the effectiveness of ES. In the second study, 60 male broilers in each of two trials were processed at 7 wk of age. At 0.25, 1.5, 3.0, and 6.0 h PM, carcasses were evaluated for the distance between the elbows. At each time point, breast fillets were harvested from each carcass. Fillet samples were excised and frozen for later measurement of pH and sacromere length, whereas the remainder of each fillet was held on ice until 24 h PM. Shear value and pH means (P < 0.05) decreased, whereas sarcomere length means (P < 0.05) increased over time, indicating rigor mortis development. Elbow distance decreased (P < 0.05) with rigor development and was correlated (P < 0.01) with shear value (r = 0.2581), sarcomere length (r = -0.3079), and pH (r = 0.6303). These results suggest that elbow distance could be used in conjunction with other detection methods for optically automating measurement of rigor mortis development in broiler carcasses.

Pólya number and first return of bursty random walk: Rigorous solutions

NASA Astrophysics Data System (ADS)

Wan, J.; Xu, X. P.

2012-03-01

The recurrence properties of random walks can be characterized by Pólya number, i.e., the probability that the walker has returned to the origin at least once. In this paper, we investigate Pólya number and first return for bursty random walk on a line, in which the walk has different step size and moving probabilities. Using the concept of the Catalan number, we obtain exact results for first return probability, the average first return time and Pólya number for the first time. We show that Pólya number displays two different functional behavior when the walk deviates from the recurrent point. By utilizing the Lagrange inversion formula, we interpret our findings by transferring Pólya number to the closed-form solutions of an inverse function. We also calculate Pólya number using another approach, which corroborates our results and conclusions. Finally, we consider the recurrence properties and Pólya number of two variations of the bursty random walk model.

Effects of the Visual Exercise Environments on Cognitive Directed Attention, Energy Expenditure and Perceived Exertion

PubMed Central

Rogerson, Mike; Barton, Jo

2015-01-01

Green exercise research often reports psychological health outcomes without rigorously controlling exercise. This study examines effects of visual exercise environments on directed attention, perceived exertion and time to exhaustion, whilst measuring and controlling the exercise component. Participants completed three experimental conditions in a randomized counterbalanced order. Conditions varied by video content viewed (nature; built; control) during two consistently-ordered exercise bouts (Exercise 1: 60% VO2peakInt for 15-mins; Exercise 2: 85% VO2peakInt to voluntary exhaustion). In each condition, participants completed modified Backwards Digit Span tests (a measure of directed attention) pre- and post-Exercise 1. Energy expenditure, respiratory exchange ratio and perceived exertion were measured during both exercise bouts. Time to exhaustion in Exercise 2 was also recorded. There was a significant time by condition interaction for Backwards Digit Span scores (F2,22 = 6.267, p = 0.007). Scores significantly improved in the nature condition (p < 0.001) but did not in the built or control conditions. There were no significant differences between conditions for either perceived exertion or physiological measures during either Exercise 1 or Exercise 2, or for time to exhaustion in Exercise 2. This was the first study to demonstrate effects of controlled exercise conducted in different visual environments on post-exercise directed attention. Via psychological mechanisms alone, visual nature facilitates attention restoration during moderate-intensity exercise. PMID:26133125

Effects of the Visual Exercise Environments on Cognitive Directed Attention, Energy Expenditure and Perceived Exertion.

PubMed

Rogerson, Mike; Barton, Jo

2015-06-30

Green exercise research often reports psychological health outcomes without rigorously controlling exercise. This study examines effects of visual exercise environments on directed attention, perceived exertion and time to exhaustion, whilst measuring and controlling the exercise component. Participants completed three experimental conditions in a randomized counterbalanced order. Conditions varied by video content viewed (nature; built; control) during two consistently-ordered exercise bouts (Exercise 1: 60% VO2peakInt for 15-mins; Exercise 2: 85% VO2peakInt to voluntary exhaustion). In each condition, participants completed modified Backwards Digit Span tests (a measure of directed attention) pre- and post-Exercise 1. Energy expenditure, respiratory exchange ratio and perceived exertion were measured during both exercise bouts. Time to exhaustion in Exercise 2 was also recorded. There was a significant time by condition interaction for Backwards Digit Span scores (F2,22 = 6.267, p = 0.007). Scores significantly improved in the nature condition (p < 0.001) but did not in the built or control conditions. There were no significant differences between conditions for either perceived exertion or physiological measures during either Exercise 1 or Exercise 2, or for time to exhaustion in Exercise 2. This was the first study to demonstrate effects of controlled exercise conducted in different visual environments on post-exercise directed attention. Via psychological mechanisms alone, visual nature facilitates attention restoration during moderate-intensity exercise.

A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

PubMed

Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

2012-04-25

The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

American Occupation Control Over Broadcasting in Japan, 1945-1952.

ERIC Educational Resources Information Center

Luther, Catherine A.; Boyd, Douglas A.

1997-01-01

Examines military occupation force's role in shaping Japan's contemporary broadcasting system. Notes that controls placed on Japanese broadcasters were often rigorous and uncompromising, despite Washington's initial instructions to give guidance to the Japanese without overt control. Suggests that this domination created an environment conducive…

Solution-Processed Carbon Nanotube True Random Number Generator.

PubMed

Gaviria Rojas, William A; McMorrow, Julian J; Geier, Michael L; Tang, Qianying; Kim, Chris H; Marks, Tobin J; Hersam, Mark C

2017-08-09

With the growing adoption of interconnected electronic devices in consumer and industrial applications, there is an increasing demand for robust security protocols when transmitting and receiving sensitive data. Toward this end, hardware true random number generators (TRNGs), commonly used to create encryption keys, offer significant advantages over software pseudorandom number generators. However, the vast network of devices and sensors envisioned for the "Internet of Things" will require small, low-cost, and mechanically flexible TRNGs with low computational complexity. These rigorous constraints position solution-processed semiconducting single-walled carbon nanotubes (SWCNTs) as leading candidates for next-generation security devices. Here, we demonstrate the first TRNG using static random access memory (SRAM) cells based on solution-processed SWCNTs that digitize thermal noise to generate random bits. This bit generation strategy can be readily implemented in hardware with minimal transistor and computational overhead, resulting in an output stream that passes standardized statistical tests for randomness. By using solution-processed semiconducting SWCNTs in a low-power, complementary architecture to achieve TRNG, we demonstrate a promising approach for improving the security of printable and flexible electronics.

A Gender Bias Habit-Breaking Intervention Led to Increased Hiring of Female Faculty in STEMM Departments.

PubMed

Devine, Patricia G; Forscher, Patrick S; Cox, William T L; Kaatz, Anna; Sheridan, Jennifer; Carnes, Molly

2017-11-01

Addressing the underrepresentation of women in science is a top priority for many institutions, but the majority of efforts to increase representation of women are neither evidence-based nor rigorously assessed. One exception is the gender bias habit-breaking intervention (Carnes et al., 2015), which, in a cluster-randomized trial involving all but two departmental clusters ( N = 92) in the 6 STEMM focused schools/colleges at the University of Wisconsin - Madison, led to increases in gender bias awareness and self-efficacy to promote gender equity in academic science departments. Following this initial success, the present study compares, in a preregistered analysis, hiring rates of new female faculty pre- and post-manipulation. Whereas the proportion of women hired by control departments remained stable over time, the proportion of women hired by intervention departments increased by an estimated 18 percentage points ( OR = 2.23, d OR = 0.34). Though the preregistered analysis did not achieve conventional levels of statistical significance ( p < 0.07), our study has a hard upper limit on statistical power, as the cluster-randomized trial has a maximum sample size of 92 departmental clusters. These patterns have undeniable practical significance for the advancement of women in science, and provide promising evidence that psychological interventions can facilitate gender equity and diversity.

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

Acupuncture for polycystic ovarian syndrome

PubMed Central

Jo, Junyoung; Lee, Yoon Jae; Lee, Hyangsook

2017-01-01

Abstract Background: This systematic review aimed at summarizing and evaluating the evidence from randomized controlled trials (RCTs) using acupuncture to treat polycystic ovarian syndrome (PCOS), specifically focusing on ovulation rate, menstrual rate, and related hormones. Methods: Fifteen databases were searched electronically through February 2016. Our review included RCTs of women with PCOS; these RCTs compared acupuncture with sham acupuncture, medication, or no treatment. Two reviewers independently extracted data. Data were pooled and expressed as mean differences (MDs) for continuous outcomes and risk ratios for dichotomous outcomes, with 95% confidence intervals (CIs) using a random-effects model. Results: We found a low level of evidence that acupuncture is more likely to improve ovulation rate (MD 0.35, 95% CI: 0.14–0.56) and menstruation rate (MD 0.50, 95% CI: 0.32–0.68) compared with no acupuncture. We found statistically significant pooled benefits of acupuncture treatment as an adjunct to medication in luteinizing hormone (LH), LH/follicular stimulating hormone (FSH) ratio, testosterone, fasting insulin, and pregnancy rates, but the level of evidence was low/very low. Conclusion: There is limited evidence to judge the efficacy and safety of acupuncture on key reproductive outcomes in women with PCOS. Large-scale, long-term RCTs with rigorous methodological input are needed. PMID:28591042

An operations-partnered evaluation of care redesign for high-risk patients in the Veterans Health Administration (VHA): Study protocol for the PACT Intensive Management (PIM) randomized quality improvement evaluation.

PubMed

Chang, Evelyn T; Zulman, Donna M; Asch, Steven M; Stockdale, Susan E; Yoon, Jean; Ong, Michael K; Lee, Martin; Simon, Alissa; Atkins, David; Schectman, Gordon; Kirsh, Susan R; Rubenstein, Lisa V

2018-06-01

Patient-centered medical homes have made great strides providing comprehensive care for patients with chronic conditions, but may not provide sufficient support for patients at highest risk for acute care use. To address this, the Veterans Health Administration (VHA) initiated a five-site demonstration project to evaluate the effectiveness of augmenting the VA's Patient Aligned Care Team (PACT) medical home with PACT Intensive Management (PIM) teams for Veterans at highest risk for hospitalization. Researchers partnered with VHA leadership to design a mixed-methods prospective multi-site evaluation that met leadership's desire for a rigorous evaluation conducted as quality improvement rather than research. We conducted a randomized QI evaluation and assigned high-risk patients to participate in PIM and compared them with high-risk Veterans receiving usual care through PACT. The summative evaluation examines whether PIM: 1) decreases VHA emergency department and hospital use; 2) increases satisfaction with VHA care; 3) decreases provider burnout; and 4) generates positive returns on investment. The formative evaluation aims to support improved care for high-risk patients at demonstration sites and to inform future initiatives for high-risk patients. The evaluation was reviewed by representatives from the VHA Office of Research and Development and the Office of Research Oversight and met criteria for quality improvement. VHA aims to function as a learning organization by rapidly implementing and rigorously testing QI innovations prior to final program or policy development. We observed challenges and opportunities in designing an evaluation consistent with QI standards and operations priorities, while also maintaining scientific rigor. This trial was retrospectively registered at ClinicalTrials.gov on April 3, 2017: NCT03100526. Protocol v1, FY14-17. Copyright © 2018 Elsevier Inc. All rights reserved.

Systematic review of the application of quality improvement methodologies from the manufacturing industry to surgical healthcare.

PubMed

Nicolay, C R; Purkayastha, S; Greenhalgh, A; Benn, J; Chaturvedi, S; Phillips, N; Darzi, A

2012-03-01

The demand for the highest-quality patient care coupled with pressure on funding has led to the increasing use of quality improvement (QI) methodologies from the manufacturing industry. The aim of this systematic review was to identify and evaluate the application and effectiveness of these QI methodologies to the field of surgery. MEDLINE, the Cochrane Database, Allied and Complementary Medicine Database, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, Embase, Health Business(™) Elite, the Health Management Information Consortium and PsycINFO(®) were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Empirical studies were included that implemented a described QI methodology to surgical care and analysed a named outcome statistically. Some 34 of 1595 articles identified met the inclusion criteria after consensus from two independent investigators. Nine studies described continuous quality improvement (CQI), five Six Sigma, five total quality management (TQM), five plan-do-study-act (PDSA) or plan-do-check-act (PDCA) cycles, five statistical process control (SPC) or statistical quality control (SQC), four Lean and one Lean Six Sigma; 20 of the studies were undertaken in the USA. The most common aims were to reduce complications or improve outcomes (11), to reduce infection (7), and to reduce theatre delays (7). There was one randomized controlled trial. QI methodologies from industry can have significant effects on improving surgical care, from reducing infection rates to increasing operating room efficiency. The evidence is generally of suboptimal quality, and rigorous randomized multicentre studies are needed to bring evidence-based management into the same league as evidence-based medicine. Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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

Testing the efficacy of Yoga as a Complementary Therapy for Smoking Cessation: Design and Methods of the BreathEasy trial

PubMed Central

Bock, Beth C; Rosen, Rochelle K.; Fava, Joseph L.; Gaskins, Ronnesia B.; Jennings, Ernestine; Thind, Herpreet; Carmody, James; Dunsiger, Shira I; Gidron, Naama; Becker, Bruce M.; Marcus, Bess H.

2014-01-01

Smokers trying to quit encounter many challenges including nicotine withdrawal symptoms, cigarette craving, increased stress and negative mood and concern regarding weight gain. These phenomena make it difficult to successfully quit smoking. Studies in non-smoking populations show that yoga reduces stress and negative mood and improves weight control. By increasing mindfulness we anticipate that yoga may also improve smokers’ ability to cope with the negative symptoms associated with quitting. Yoga may also improve cognitive deliberation which is needed to make effective choices and avoid smoking in tempting situations. The BreathEasy study is a rigorous, randomized controlled clinical trial examining the efficacy of Iyengar yoga as a complementary therapy to cognitive-behavioral therapy for smoking cessation. All participants are given an 8-week program of smoking cessation classes, and are randomized to either twice weekly yoga (Yoga) or twice-weekly health and wellness classes which serve as a control for contact and participant burden (CTL). Assessments are conducted at baseline, 8 weeks, 3, 6, and 12 months follow up. The primary outcome is prolonged abstinence using an intention-to-treat approach. Multiple internal and external audits using blind data collection are employed to ensure treatment fidelity and reliability of study results. To understand why yoga may be more effective than CTL, we will examine mechanisms of action (i.e., mediators) underlying intervention efficacy. We will examine maintenance of yoga practice and smoking status at each follow up. Focus groups and interviews will be used to enrich our understanding of the relationship of yoga practice and smoking abstinence. PMID:24937018

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations

PubMed Central

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Purpose Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = −.20] and active (SMD = −0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = −1.06) and anxiety (SMD = −1.24). Conclusion Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. PMID:27165967

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-08-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = -.20] and active (SMD = -0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = -1.06) and anxiety (SMD = -1.24). Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. © 2016 American Academy of Pain Medicine.

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.

The effects of Tai Chi on physical and psychosocial function among persons with multiple sclerosis: A systematic review.

PubMed

Taylor, Emily; Taylor-Piliae, Ruth E

2017-04-01

Conduct a systematic review to evaluate the effects of Tai Chi on physical and psychosocial function among individuals with Multiple Sclerosis. An electronic literature search of 12 databases using controlled vocabulary function and keywords from inception through August 2016. All Tai Chi intervention studies assessing physical and psychosocial function among persons with Multiple Sclerosis were included. Study quality was scored using an established tool examining 16 study elements (range=0-32). A total of 91 articles were retrieved, with 3 additional articles identified through reviewing bibliographies of relevant articles. A total of 8 studies (randomized controlled trials, n=3; quasi-experimental, n=5) enrolled 193 participants with Multiple Sclerosis. Studies were conducted in the USA (n=3), Europe (n=3), Iran, (n=1), and India (n=1). A total of 3 studies reported using the Yang style of Tai Chi (not specified, n=5 studies). The Tai Chi intervention averaged 27 sessions over 11 weeks. Study quality scores for the randomized controlled trials had a mean score of 23 (range 19-26), while quality scores for quasi-experimental studies had a mean score of 20 (range 13-26). Overall, participants enrolled in Tai Chi had better balance, gait and flexibility, less fatigue and depression, and better quality of life after the intervention; though mixed results were reported. The results indicate that Tai Chi is likely safe and may provide physical and psychosocial benefits in individuals with Multiple Sclerosis. Further research is needed using more rigorous study designs to assess the benefits of Tai Chi for individuals with Multiple Sclerosis. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

PubMed

Udsen, Flemming Witt; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars Holger

2014-05-21

Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone. The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight). There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial. Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

Recent Developments: PKI Square Dish for the Soleras Project

NASA Technical Reports Server (NTRS)

Rogers, W. E.

1984-01-01

The Square Dish solar collectors are subjected to rigorous design attention regarding corrosion at the site, and certification of the collector structure. The microprocessor controls and tracking mechanisms are improved in the areas of fail safe operations, durability, and low parasitic power requirements. Prototype testing demonstrates performance efficiency of approximately 72% at 730 F outlet temperature. Studies are conducted that include developing formal engineering design studies, developing formal engineering design drawing and fabrication details, establishing subcontracts for fabrication of major components, and developing a rigorous quality control system. The improved design is more cost effective to product and the extensive manuals developed for assembly and operation/maintenance result in faster field assembly and ease of operation.

Recent developments: PKI square dish for the Soleras Project

NASA Astrophysics Data System (ADS)

Rogers, W. E.

1984-03-01

The Square Dish solar collectors are subjected to rigorous design attention regarding corrosion at the site, and certification of the collector structure. The microprocessor controls and tracking mechanisms are improved in the areas of fail safe operations, durability, and low parasitic power requirements. Prototype testing demonstrates performance efficiency of approximately 72% at 730 F outlet temperature. Studies are conducted that include developing formal engineering design studies, developing formal engineering design drawing and fabrication details, establishing subcontracts for fabrication of major components, and developing a rigorous quality control system. The improved design is more cost effective to product and the extensive manuals developed for assembly and operation/maintenance result in faster field assembly and ease of operation.

HomeStyles, A Web-Based Childhood Obesity Prevention Program for Families With Preschool Children: Protocol for a Randomized Controlled Trial.

PubMed

Byrd-Bredbenner, Carol; Martin-Biggers, Jennifer; Koenings, Mallory; Quick, Virginia; Hongu, Nobuko; Worobey, John

2017-04-25

The home environment is where young children spend most of their time, and is critically important to supporting behaviors that promote health and prevent obesity. However, the home environment and lifestyle patterns remain understudied, and few interventions have investigated parent-led makeovers designed to create home environments that are supportive of optimal child health and healthy child weights. The aim of the HomeStyles randomized controlled trial (RCT) is to determine whether the Web-based HomeStyles intervention enables and motivates parents to shape the weight-related aspects of their home environments and lifestyle behavioral practices (diet, exercise, and sleep) to be more supportive of their preschool children's optimal health and weight. A rigorous RCT utilizing an experimental group and an attention control group, receiving a bona fide contemporaneous treatment equal in nonspecific treatment effects and differing only in subject matter content, will test the effect of HomeStyles on a diverse sample of families with preschool children. This intervention is based on social cognitive theory and uses a social ecological framework, and will assess: intrapersonal characteristics (dietary intake, physical activity level, and sleep) of parents and children; family interpersonal or social characteristics related to diet, physical activity, media use, and parental values and self-efficacy for obesity-preventive practices; and home environment food availability, physical activity space and supports in and near the home, and media availability and controls in the home. Enrollment for this study has been completed and statistical data analyses are currently underway. This paper describes the HomeStyles intervention with regards to: rationale, the intervention's logic model, sample eligibility criteria and recruitment, experimental group and attention control intervention content, study design, instruments, data management, and planned analyses. ©Carol Byrd-Bredbenner, Jennifer Martin-Biggers, Mallory Koenings, Virginia Quick, Nobuko Hongu, John Worobey. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.04.2017.

Impact of post-rigor high pressure processing on the physicochemical and microbial shelf-life of cultured red abalone (Haliotis rufescens).

PubMed

Hughes, Brianna H; Perkins, L Brian; Yang, Tom C; Skonberg, Denise I

2016-03-01

High pressure processing (HPP) of post-rigor abalone at 300MPa for 10min extended the refrigerated shelf-life to four times that of unprocessed controls. Shucked abalone meats were processed at 100 or 300MPa for 5 or 10min, and stored at 2°C for 35days. Treatments were analyzed for aerobic plate count (APC), total volatile base nitrogen (TVBN), K-value, biogenic amines, color, and texture. APC did not exceed 10(6) and TVBN levels remained below 35mg/100g for 35days for the 300MPa treatments. No biogenic amines were detected in the 300MPa treatments, but putrescine and cadaverine were detected in the control and 100MPa treatments. Color and texture were not affected by HPP or storage time. These results indicate that post-rigor processing at 300MPa for 10min can significantly increase refrigerated shelf-life of abalone without affecting chemical or physical quality characteristics important to consumers. Copyright © 2015 Elsevier Ltd. All rights reserved.

Measuring CAMD technique performance. 2. How "druglike" are drugs? Implications of Random test set selection exemplified using druglikeness classification models.

PubMed

Good, Andrew C; Hermsmeier, Mark A

2007-01-01

Research into the advancement of computer-aided molecular design (CAMD) has a tendency to focus on the discipline of algorithm development. Such efforts are often wrought to the detriment of the data set selection and analysis used in said algorithm validation. Here we highlight the potential problems this can cause in the context of druglikeness classification. More rigorous efforts are applied to the selection of decoy (nondruglike) molecules from the ACD. Comparisons are made between model performance using the standard technique of random test set creation with test sets derived from explicit ontological separation by drug class. The dangers of viewing druglike space as sufficiently coherent to permit simple classification are highlighted. In addition the issues inherent in applying unfiltered data and random test set selection to (Q)SAR models utilizing large and supposedly heterogeneous databases are discussed.

Using Temporal Correlations and Full Distributions to Separate Intrinsic and Extrinsic Fluctuations in Biological Systems

NASA Astrophysics Data System (ADS)

Hilfinger, Andreas; Chen, Mark; Paulsson, Johan

2012-12-01

Studies of stochastic biological dynamics typically compare observed fluctuations to theoretically predicted variances, sometimes after separating the intrinsic randomness of the system from the enslaving influence of changing environments. But variances have been shown to discriminate surprisingly poorly between alternative mechanisms, while for other system properties no approaches exist that rigorously disentangle environmental influences from intrinsic effects. Here, we apply the theory of generalized random walks in random environments to derive exact rules for decomposing time series and higher statistics, rather than just variances. We show for which properties and for which classes of systems intrinsic fluctuations can be analyzed without accounting for extrinsic stochasticity and vice versa. We derive two independent experimental methods to measure the separate noise contributions and show how to use the additional information in temporal correlations to detect multiplicative effects in dynamical systems.

Demonstration of Qubit Operations Below a Rigorous Fault Tolerance Threshold With Gate Set Tomography (Open Access, Publisher’s Version)

DTIC Science & Technology

2017-02-15

Maunz2 Quantum information processors promise fast algorithms for problems inaccessible to classical computers. But since qubits are noisy and error-prone...information processors have been demonstrated experimentally using superconducting circuits1–3, electrons in semiconductors4–6, trapped atoms and...qubit quantum information processor has been realized14, and single- qubit gates have demonstrated randomized benchmarking (RB) infidelities as low as 10

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

Best Practices for Gauging Evidence of Causality in Air Pollution Epidemiology.

PubMed

Dominici, Francesca; Zigler, Corwin

2017-12-15

The contentious political climate surrounding air pollution regulations has brought some researchers and policy-makers to argue that evidence of causality is necessary before implementing more stringent regulations. Recently, investigators in an increasing number of air pollution studies have purported to have used "causal analysis," generating the impression that studies not explicitly labeled as such are merely "associational" and therefore less rigorous. Using 3 prominent air pollution studies as examples, we review good practices for how to critically evaluate the extent to which an air pollution study provides evidence of causality. We argue that evidence of causality should be gauged by a critical evaluation of design decisions such as 1) what actions or exposure levels are being compared, 2) whether an adequate comparison group was constructed, and 3) how closely these design decisions approximate an idealized randomized study. We argue that air pollution studies that are more scientifically rigorous in terms of the decisions made to approximate a randomized experiment are more likely to provide evidence of causality and should be prioritized among the body of evidence for regulatory review accordingly. Our considerations, although presented in the context of air pollution epidemiology, can be broadly applied to other fields of epidemiology. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services.

PubMed

Garrido, Melissa M; Allman, Richard M; Pizer, Steven D; Rudolph, James L; Thomas, Kali S; Sperber, Nina R; Van Houtven, Courtney H; Frakt, Austin B

2017-11-01

A path-breaking example of the interplay between geriatrics and learning healthcare systems is the Veterans Health Administration's (VHA's) planned roll-out of a program for providing participant-directed home- and community-based services to veterans with cognitive and functional limitations. We describe the design of a large-scale, stepped-wedge, cluster-randomized trial of the Veteran-Directed Home- and Community-Based Services (VD-HCBS) program. From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers will be randomized to times to begin offering VD-HCBS to veterans at risk of nursing home placement. Services will be provided to community-dwelling participants with support from Aging and Disability Network Agencies. The VHA Partnered Evidence-based Policy Resource Center (PEPReC) is coordinating the evaluation, which includes collaboration from operational stakeholders from the VHA and Administration for Community Living and interdisciplinary researchers from the Center of Innovation in Long-Term Services and Supports and the Center for Health Services Research in Primary Care. For older veterans with functional limitations who are eligible for VD-HCBS, we will evaluate health outcomes (hospitalizations, emergency department visits, nursing home admissions, days at home) and healthcare costs associated with VD-HCBS availability. Learning healthcare systems facilitate diffusion of innovation while enabling rigorous evaluation of effects on patient outcomes. The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously. PEPReC's experience designing an evaluation with researchers and operations stakeholders may serve as a framework for others seeking to develop rapid, rigorous, large-scale evaluations of delivery system innovations targeted to older adults. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Spillover, nonlinearity, and flexible structures

NASA Technical Reports Server (NTRS)

Bass, Robert W.; Zes, Dean

1991-01-01

Many systems whose evolution in time is governed by Partial Differential Equations (PDEs) are linearized around a known equilibrium before Computer Aided Control Engineering (CACE) is considered. In this case, there are infinitely many independent vibrational modes, and it is intuitively evident on physical grounds that infinitely many actuators would be needed in order to control all modes. A more precise, general formulation of this grave difficulty (spillover problem) is due to A.V. Balakrishnan. A possible route to circumvention of this difficulty lies in leaving the PDE in its original nonlinear form, and adding the essentially finite dimensional control action prior to linearization. One possibly applicable technique is the Liapunov Schmidt rigorous reduction of singular infinite dimensional implicit function problems to finite dimensional implicit function problems. Omitting details of Banach space rigor, the formalities of this approach are given.

Influences of Aerobic Dance on Cognitive Performance in Adults with Schizophrenia.

PubMed

Chen, Ming-De; Kuo, Yu-Hsin; Chang, Yen-Ching; Hsu, Su-Ting; Kuo, Chang-Chih; Chang, Jyh-Jong

2016-12-01

Cognitive impairment is one of the core features of schizophrenia. This study examined the influences of an aerobic dance programme on the cognitive functions of people with schizophrenia. A quasi-experimental matched-control design was applied. The experimental group (n = 17) participated in a 60-minute aerobic dance group class three times a week for 3 months. The control group (n = 19) participated in colouring and handwriting activities. Cognitive functions were measured before and after the interventions for both groups. The intervention group experienced significant improvements in processing speed, memory and executive function, whereas no significant changes were noted in any measures in the control group. While there were no significant between-group differences, the data showed approximately medium effect sizes that favoured the intervention group in regard to processing speed (Cohen's d = 0.51), memory (d = 0.35-0.41) and the spontaneity and fluency aspects of executive function (d = 0.51). While the small sample size and lack of randomization were the primary methodological shortcomings, this study provides preliminary results supporting aerobic dance as an adjunct activity-based intervention to improve cognitive functions in people with schizophrenia. More rigorous studies are needed to validate the findings. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Early rigorous control interventions can largely reduce dengue outbreak magnitude: experience from Chaozhou, China.

PubMed

Liu, Tao; Zhu, Guanghu; He, Jianfeng; Song, Tie; Zhang, Meng; Lin, Hualiang; Xiao, Jianpeng; Zeng, Weilin; Li, Xing; Li, Zhihao; Xie, Runsheng; Zhong, Haojie; Wu, Xiaocheng; Hu, Wenbiao; Zhang, Yonghui; Ma, Wenjun

2017-08-02

Dengue fever is a severe public heath challenge in south China. A dengue outbreak was reported in Chaozhou city, China in 2015. Intensified interventions were implemented by the government to control the epidemic. However, it is still unknown the degree to which intensified control measures reduced the size of the epidemics, and when should such measures be initiated to reduce the risk of large dengue outbreaks developing? We selected Xiangqiao district as study setting because the majority of the indigenous cases (90.6%) in Chaozhou city were from this district. The numbers of daily indigenous dengue cases in 2015 were collected through the national infectious diseases and vectors surveillance system, and daily Breteau Index (BI) data were reported by local public health department. We used a compartmental dynamic SEIR (Susceptible, Exposed, Infected and Removed) model to assess the effectiveness of control interventions, and evaluate the control effect of intervention timing on dengue epidemic. A total of 1250 indigenous dengue cases was reported from Xiangqiao district. The results of SEIR modeling using BI as an indicator of actual control interventions showed a total of 1255 dengue cases, which is close to the reported number (n = 1250). The size and duration of the outbreak were highly sensitive to the intensity and timing of interventions. The more rigorous and earlier the control interventions implemented, the more effective it yielded. Even if the interventions were initiated several weeks after the onset of the dengue outbreak, the interventions were shown to greatly impact the prevalence and duration of dengue outbreak. This study suggests that early implementation of rigorous dengue interventions can effectively reduce the epidemic size and shorten the epidemic duration.

Reducing School Mobility: A Randomized Trial of a Relationship-Building Intervention

PubMed Central

Fiel, Jeremy E.; Haskins, Anna R.; López Turley, Ruth N.

2013-01-01

Student turnover has many negative consequences for students and schools, and the high mobility rates of disadvantaged students may exacerbate inequality. Scholars have advised schools to reduce mobility by building and improving relationships with and among families, but such efforts are rarely tested rigorously. A cluster-randomized field experiment in 52 predominantly Hispanic elementary schools in San Antonio, TX, and Phoenix, AZ, tested whether student mobility in early elementary school was reduced through Families and Schools Together (FAST), an intervention that builds social capital among families, children, and schools. FAST failed to reduce mobility overall but substantially reduced the mobility of Black students, who were especially likely to change schools. Improved relationships among families help explain this finding. PMID:25346541

Interventions to address parenting and parental substance abuse: conceptual and methodological considerations.

PubMed

Neger, Emily N; Prinz, Ronald J

2015-07-01

Parental substance abuse is a serious problem affecting the well-being of children and families. The co-occurrence of parental substance abuse and problematic parenting is recognized as a major public health concern. This review focuses on 21 outcome studies that tested dual treatment of substance abuse and parenting. A summary of theoretical conceptualizations of the connections between substance abuse and parenting provides a backdrop for the review. Outcomes of the dual treatment studies were generally positive with respect to reduction of parental substance use and improvement of parenting. Research in this area varied in methodological rigor and needs to overcome challenges regarding design issues, sampling frame, and complexities inherent in such a high-risk population. This area of work can be strengthened by randomized controlled trials, use of mixed-methods outcome measures, consideration of parent involvement with child protective services, involvement of significant others in treatment, provision of concrete supports for treatment attendance and facilitative public policies. Copyright © 2015 Elsevier Ltd. All rights reserved.

What can comparative effectiveness research, propensity score and registry study bring to Chinese medicine?

PubMed

Liao, Xing; Xie, Yan-ming

2014-10-01

The impact of evidence-based medicine and clinical epidemiology on clinical research has contributed to the development of Chinese medicine in modern times over the past two decades. Many concepts and methods of modern science and technology are emerging in Chinese medicine research, resulting in constant progress. Systematic reviews, randomized controlled trials and other advanced mathematic approaches and statistical analysis methods have brought reform to Chinese medicine. In this new era, Chinese medicine researchers have many opportunities and challenges. On the one hand, Chinese medicine researchers need to dedicate themselves to providing enough evidence to the world through rigorous studies, whilst on the other hand, they also need to keep up with the speed of modern medicine research. For example, recently, real world study, comparative effectiveness research, propensity score techniques and registry study have emerged. This article aims to inspire Chinese medicine researchers to explore new areas by introducing these new ideas and new techniques.

Interventions to Address Parenting and Parental Substance Abuse: Conceptual and Methodological Considerations

PubMed Central

Neger, Emily N.; Prinz, Ronald J.

2015-01-01

Parental substance abuse is a serious problem affecting the well-being of children and families. The co-occurrence of parental substance abuse and problematic parenting is recognized as a major public health concern. This review focuses on 21 outcome studies that tested dual treatment of substance abuse and parenting. A summary of theoretical conceptualizations of the connections between substance abuse and parenting provides a backdrop for the review. Outcomes of the dual treatment studies were generally positive with respect to reduction of parental substance use and improvement of parenting. Research in this area varied in methodological rigor and needs to overcome challenges regarding design issues, sampling frame, and complexities inherent in such a high-risk population. This area of work can be strengthened by randomized controlled trials, use of mixed-methods outcome measures, consideration of parent involvement with child protective services, involvement of significant others in treatment, provision of concrete supports for treatment attendance and facilitative public policies. PMID:25939033

Measuring Hope Among Children Affected by Armed Conflict: Cross-Cultural Construct Validity of the Children's Hope Scale.

PubMed

Haroz, Emily E; Jordans, Mark; de Jong, Joop; Gross, Alden; Bass, Judith; Tol, Wietse

2017-06-01

We investigated the cross-cultural construct validity of hope, a factor associated with mental health protection and promotion, using the Children's Hope Scale (CHS). The sample ( n = 1,057; 48% girls) included baseline data from three cluster-randomized controlled trials with children affected by armed conflict ( n = 329 Burundi; n = 403 Indonesia; n = 325 Nepal). The confirmatory factor analysis in each country indicated good fit for the hypothesized two-factor model. Analysis by gender indicated that configural invariance was supported and that scalar invariance was demonstrated in Indonesia. However, metric and scalar invariance were not supported in Burundi and Nepal. In country comparisons, configural and metric invariance were met, but scalar invariance was not supported. Evidence from this study supports the use of the CHS within various sociocultural settings and across genders, but direct comparisons of CHS scores across groups should be done with caution. Rigorous evaluations of the measurement properties of mental health protective and promotive factors are necessary to inform both research and practice.

Polyphenols from cocoa and vascular health-a critical review.

PubMed

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E

2009-11-20

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted.

Polyphenols from Cocoa and Vascular Health—A Critical Review

PubMed Central

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E.

2009-01-01

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted. PMID:20057946

Dramatic pretend play games uniquely improve emotional control in young children.

PubMed

Goldstein, Thalia R; Lerner, Matthew D

2017-09-15

Pretense is a naturally occurring, apparently universal activity for typically developing children. Yet its function and effects remain unclear. One theorized possibility is that pretense activities, such as dramatic pretend play games, are a possible causal path to improve children's emotional development. Social and emotional skills, particularly emotional control, are critically important for social development, as well as academic performance and later life success. However, the study of such approaches has been criticized for potential bias and lack of rigor, precluding the ability to make strong causal claims. We conducted a randomized, component control (dismantling) trial of dramatic pretend play games with a low-SES group of 4-year-old children (N = 97) to test whether such practice yields generalized improvements in multiple social and emotional outcomes. We found specific effects of dramatic play games only on emotional self-control. Results suggest that dramatic pretend play games involving physicalizing emotional states and traits, pretending to be animals and human characters, and engaging in pretend scenarios in a small group may improve children's emotional control. These findings have implications for the function of pretense and design of interventions to improve emotional control in typical and atypical populations. Further, they provide support for the unique role of dramatic pretend play games for young children, particularly those from low-income backgrounds. A video abstract of this article can be viewed at: https://youtu.be/2GVNcWKRHPk. © 2017 John Wiley & Sons Ltd.

Effectiveness of family group conferencing in preventing repeat referrals to child protective services and out-of-home placements.

PubMed

Hollinshead, Dana M; Corwin, Tyler W; Maher, Erin J; Merkel-Holguin, Lisa; Allan, Heather; Fluke, John D

2017-07-01

Rigorous research on the efficacy of family group conferencing is rare. This randomized control trial study used an intent-to-treat approach to examine whether a referral to a family group conference (FGC) was associated with re-referrals, substantiated re-referrals, or out-of-home placements among child welfare-involved families receiving in-home services. We found no significant associations between treatment and control group assignment and the three outcomes for the sample as a whole. However, families with more children had higher odds of a re-referral and a substantiated re-referral, families with more than one parent had higher odds of re-referral, and families where a substance abuse services referral was noted had higher odds of out-of-home placement. In interaction models with race, we found that families with African American mothers who were referred for an FGC were more likely to be re-referred compared to other families, but no differences were identified with respect to their rates of substantiated re-referrals or out-of-home placements. Implications are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Workplace physical activity interventions: a systematic review.

PubMed

To, Quyen G; Chen, Ted T L; Magnussen, Costan G; To, Kien G

2013-01-01

To assess the effectiveness of workplace interventions in improving physical activity. EBSCO research database (and all subdatabases). Articles were published from 2000 to 2010 in English, had appropriate designs, and measured employees' physical activity, energy consumption, and/or body mass index (BMI) as primary outcomes. Articles that did not meet the inclusion criteria were excluded. Data extracted included study design, study population, duration, intervention activities, outcomes, and results. Data were synthesized into one table. Results of each relevant outcome including p values were combined. Twelve (60%) of 20 selected interventions reported an improvement in physical activity level, steps, or BMI, and there was one slowed step reduction in the intervention group. Among these, 10 were less than 6 months in duration; 9 used pedometers; 6 applied Internet-based approaches; and 5 included activities targeting social and environmental levels. Seven of 8 interventions with pre-posttest and quasi-experimental controlled design showed improvement on at least one outcome. However, 7 of 12 randomized controlled trials (RCTs) did not prove effective in any outcome. Interventions that had less rigorous research designs, used pedometers, applied Internet-based approaches, and included activities at social and environmental levels were more likely to report being effective than those without these characteristics.

Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases

PubMed Central

Gasser, Peter; Holstein, Dominique; Michel, Yvonne; Doblin, Rick; Yazar-Klosinski, Berra; Passie, Torsten; Brenneisen, Rudolf

2014-01-01

Abstract A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted. PMID:24594678

Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases.

PubMed

Gasser, Peter; Holstein, Dominique; Michel, Yvonne; Doblin, Rick; Yazar-Klosinski, Berra; Passie, Torsten; Brenneisen, Rudolf

2014-07-01

A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted.

Efficacy of Acupuncture in Reducing Preoperative Anxiety: A Meta-Analysis

PubMed Central

Bae, Hyojeong; Bae, Hyunsu; Min, Byung-Il; Cho, Seunghun

2014-01-01

Background. Acupuncture has been shown to reduce preoperative anxiety in several previous randomized controlled trials (RCTs). In order to assess the preoperative anxiolytic efficacy of acupuncture therapy, this study conducted a meta-analysis of an array of appropriate studies. Methods. Four electronic databases (MEDLINE, EMBASE, CENTRAL, and CINAHL) were searched up to February 2014. In the meta-analysis data were included from RCT studies in which groups receiving preoperative acupuncture treatment were compared with control groups receiving a placebo for anxiety. Results. Fourteen publications (N = 1,034) were included. Six publications, using the State-Trait Anxiety Inventory-State (STAI-S), reported that acupuncture interventions led to greater reductions in preoperative anxiety relative to sham acupuncture (mean difference = 5.63, P < .00001, 95% CI [4.14, 7.11]). Further eight publications, employing visual analogue scales (VAS), also indicated significant differences in preoperative anxiety amelioration between acupuncture and sham acupuncture (mean difference = 19.23, P < .00001, 95% CI [16.34, 22.12]). Conclusions. Acupuncture therapy aiming at reducing preoperative anxiety has a statistically significant effect relative to placebo or nontreatment conditions. Well-designed and rigorous studies that employ large sample sizes are necessary to corroborate this finding. PMID:25254059

Health coaching to improve healthy lifestyle behaviors: an integrative review.

PubMed

Olsen, Jeanette M; Nesbitt, Bonnie J

2010-01-01

Chronic diseases account for 70% of U.S. deaths. Health coaching may help patients adopt healthy lifestyle behaviors that prevent and control diseases. This integrative review analyzed health coaching studies for evidence of effectiveness and to identify key program features. Multiple electronic databases were utilized, yielding a final sample of 15 documents. The search was limited to peer-reviewed research articles published between 1999 and 2008. Studies were further analyzed if they (1) specifically cited coaching as a program intervention, and (2) applied the intervention to research. Articles describing various quantitative and qualitative methodologies were critically analyzed using a systematic method. Data were synthesized using a matrix format according to purpose, method, intervention, findings, critique, and quality rating. All 15 studies utilized nonprobability sampling, 7 (47%) with randomized intervention and control groups. Significant improvements in one or more of the behaviors of nutrition, physical activity, weight management, or medication adherence were identified in six (40%) of the studies. Common features of effective programs were goal setting (73%), motivational interviewing (27%), and collaboration with health care providers (20%). Health coaching studies with well-specified methodologies and more rigorous designs are needed to strengthen findings; however, this behavioral change intervention suggests promise.

Application methods of infrared thermal images in the health care field of traditional Chinese medicine

NASA Astrophysics Data System (ADS)

Li, Ziru; Zhang, Xusheng

2008-12-01

Infrared thermal imaging (ITI) is the potential imaging technique for the health care field of traditional Chinese medicine (TCM). Successful application demands obeying the characteristics and regularity of the ITI of human body and designing rigorous trials. First, the influence of time must be taken into account as the ITI of human body varies with time markedly. Second, relative magnitude is preferred to be the index of the image features. Third, scatter diagrams and the method of least square could present important information for evaluating the health care effect. A double-blind placebo-controlled randomized trial was undertaken to study the influences of Shengsheng capsule, one of the TCM health food with immunity adjustment function, on the ITI of human body. The results showed that the effect of Shengsheng capsule to people with weak constitution or in the period of being weak could be reflected objectively by ITI. The relative efficacy rate was 81.3% for the trial group and 30.0% for the control group, there was significant difference between the two groups (P=0.003). So the sensitivity and objectivity of ITI are of great importance to the health care field of TCM.

Mindfulness training effects for parents and educators of children with special needs.

PubMed

Benn, Rita; Akiva, Tom; Arel, Sari; Roeser, Robert W

2012-09-01

Parents and teachers of children with special needs face unique social-emotional challenges in carrying out their caregiving roles. Stress associated with these roles impacts parents' and special educators' health and well-being, as well as the quality of their parenting and teaching. No rigorous studies have assessed whether mindfulness training (MT) might be an effective strategy to reduce stress and cultivate well-being and positive caregiving in these adults. This randomized controlled study assessed the efficacy of a 5-week MT program for parents and educators of children with special needs. Participants receiving MT showed significant reductions in stress and anxiety and increased mindfulness, self-compassion, and personal growth at program completion and at 2 months follow-up in contrast to waiting-list controls. Relational competence also showed significant positive changes, with medium-to-large effect sizes noted on measures of empathic concern and forgiveness. MT significantly influenced caregiving competence specific to teaching. Mindfulness changes at program completion mediated outcomes at follow-up, suggesting its importance in maintaining emotional balance and facilitating well-being in parents and teachers of children with developmental challenges. PsycINFO Database Record (c) 2012 APA, all rights reserved.

Cluster Randomized Controlled Trial Evaluation of a Gender Equity and Family Planning Intervention for Married Men and Couples in Rural India

PubMed Central

Raj, Anita; Ghule, Mohan; Ritter, Julie; Battala, Madhusudana; Gajanan, Velhal; Nair, Saritha; Dasgupta, Anindita; Silverman, Jay G.; Balaiah, Donta; Saggurti, Niranjan

2016-01-01

Background Despite ongoing recommendations to increase male engagement and gender-equity (GE) counseling in family planning (FP) services, few such programs have been implemented and rigorously evaluated. This study evaluates the impact of CHARM, a three-session GE+FP counseling intervention delivered by male health care providers to married men, alone (sessions 1&2) and with their wives (session 3) in India. Methods and Findings A two-armed cluster randomized controlled trial was conducted with young married couples (N = 1081 couples) recruited from 50 geographic clusters (25 clusters randomized to CHARM and a control condition, respectively) in rural Maharashtra, India. Couples were surveyed on demographics, contraceptive behaviors, and intimate partner violence (IPV) attitudes and behaviors at baseline and 9 &18-month follow-ups, with pregnancy testing at baseline and 18-month follow-up. Outcome effects on contraceptive use and incident pregnancy, and secondarily, on contraceptive communication and men’s IPV attitudes and behaviors, were assessed using logistic generalized linear mixed models. Most men recruited from CHARM communities (91.3%) received at least one CHARM intervention session; 52.5% received the couple’s session with their wife. Findings document that women from the CHARM condition, relative to controls, were more likely to report contraceptive communication at 9-month follow-up (AOR = 1.77, p = 0.04) and modern contraceptive use at 9 and 18-month follow-ups (AORs = 1.57–1.58, p = 0.05), and they were less likely to report sexual IPV at 18-month follow-up (AOR = 0.48, p = 0.01). Men in the CHARM condition were less likely than those in the control clusters to report attitudes accepting of sexual IPV at 9-month (AOR = 0.64, p = 0.03) and 18-month (AOR = 0.51, p = 0.004) follow-up, and attitudes accepting of physical IPV at 18-month follow-up (AOR = 0.64, p = 0.02). No significant effect on pregnancy was seen. Conclusions Findings demonstrate that men can be engaged in FP programming in rural India, and that such an approach inclusive of GE counseling can improve contraceptive practices and reduce sexual IPV in married couples. Trial Registration ClinicalTrials.gov NCT01593943 PMID:27167981

Telemedicine in the management of chronic pain: a cost analysis study.

PubMed

Pronovost, Antoine; Peng, Philip; Kern, Ralph

2009-08-01

Telemedicine provides patients with easy and remote access to consultant expertise irrespective of geographic location. In a randomized controlled trial, this study has applied a rigorous costing methodology to the use of telemedicine in chronic pain management. We performed a randomized two-period crossover trial comparing in-person (IP) consultation with telemedicine (TM) consultation in the management of chronic pain. Over an 18-month period, 26 patients each completed two diaries capturing their direct and indirect travel costs, daily pain scores, and satisfaction with physician consultation. Costing models were developed to account for direct, indirect, fixed, and variable costs in order to perform break-even analyses. Sensitivity analysis was performed over a broad range of assumptions. Direct patient costs were significantly lower in the TM group than in the IP group, with median cost and interquartile range 133 dollars (28-377) vs 443 dollars (292-1075), respectively (P = 0.001). More patients were highly satisfied with the TM consultation than with the IP consultation (56 and 24%, respectively; P < 0.05). Break-even annual patient volume was estimated at 57 patients. A two-way sensitivity analysis controlling for annual patient volume and round-trip distance indicated that TM remains cost-effective at volumes >50 patients/year or at round-trip distances >200 km. Telemedicine is cost-effective over a broad range of assumptions, including annual patient volumes, travel distance, fuel costs, amortization, and discount rates. This study provides data from a real-world setting to determine relevant thresholds and targets for establishing a TM program for patients who are undergoing chronic pain therapy.

NEDE: an open-source scripting suite for developing experiments in 3D virtual environments.

PubMed

Jangraw, David C; Johri, Ansh; Gribetz, Meron; Sajda, Paul

2014-09-30

As neuroscientists endeavor to understand the brain's response to ecologically valid scenarios, many are leaving behind hyper-controlled paradigms in favor of more realistic ones. This movement has made the use of 3D rendering software an increasingly compelling option. However, mastering such software and scripting rigorous experiments requires a daunting amount of time and effort. To reduce these startup costs and make virtual environment studies more accessible to researchers, we demonstrate a naturalistic experimental design environment (NEDE) that allows experimenters to present realistic virtual stimuli while still providing tight control over the subject's experience. NEDE is a suite of open-source scripts built on the widely used Unity3D game development software, giving experimenters access to powerful rendering tools while interfacing with eye tracking and EEG, randomizing stimuli, and providing custom task prompts. Researchers using NEDE can present a dynamic 3D virtual environment in which randomized stimulus objects can be placed, allowing subjects to explore in search of these objects. NEDE interfaces with a research-grade eye tracker in real-time to maintain precise timing records and sync with EEG or other recording modalities. Python offers an alternative for experienced programmers who feel comfortable mastering and integrating the various toolboxes available. NEDE combines many of these capabilities with an easy-to-use interface and, through Unity's extensive user base, a much more substantial body of assets and tutorials. Our flexible, open-source experimental design system lowers the barrier to entry for neuroscientists interested in developing experiments in realistic virtual environments. Copyright © 2014 Elsevier B.V. All rights reserved.

Randomized clinical trials in pediatric critical care: Rarely done but desperately needed.

PubMed

Randolph, Adrienne G.; Lacroix, Jacques

2002-04-01

OBJECTIVE: To review the benefits and challenges of using the randomized, controlled trial (RCT) study design to evaluate preventive and therapeutic interventions in pediatric critical care medicine. CONCLUSIONS: The RCT design is able to control for many sources of potential bias that other types of study designs cannot. The findings of RCTs often contradict the findings of less rigorous study designs. Before performing an RCT, there must exist a state of clinical equipoise, a sufficient number of eligible patients must be available, and the epidemiology of the disorder in question must be well studied. There are many challenges to performing high-quality RCTs. Studying multiple element support strategies in the critically ill patient population is more complex than studying a single drug therapy. High patient and practice variability and hazy diagnostic definitions can dilute the signal-to-noise ratio. Most interventions in critical care are expected to have a modest or small effect. This markedly increases the requisite sample size. There is a paucity of accepted clinically important measurements of the outcome of critical care, making mortality a common outcome to evaluate with a not-so-common incidence. Developmental issues, the inability to give informed consent, and the failure to perform the appropriate pharmacokinetic and safety studies are additional challenges facing pediatric investigators. Despite these limitations, a good RCT remains the best way to prove that an intervention is working or not. Indeed, RCTs are and will remain the "gold standard" method to estimate the efficacy of a therapeutic or prophylactic intervention.

Controlled protein adsorption on PMOXA/PAA based coatings by thermally induced immobilization

NASA Astrophysics Data System (ADS)

Mumtaz, Fatima; Chen, Chaoshi; Zhu, Haikun; Pan, Chao; Wang, Yanmei

2018-05-01

In this work, poly(2-methyl-2-oxazoline-random-glycidyl methacrylate) (PMOXA-r-GMA) and poly(acrylic acid)-block-poly(glycidyl methacrylate) (PAA-b-PGMA) copolymers were synthesized via cationic ring-opening polymerization (CROP) of 2-methyl-2-oxazoline (MOXA) and reversible addition-fragmentation chain transfer (RAFT) polymerization of acrylic acid (AA) followed by their random and block copolymerization with glycidyl methacrylate (GMA), respectively, and then characterized carefully. PMOXA/PAA based coatings were then prepared by simply spin coating the mixture of PMOXA-r-GMA and PAA-b-PGMA copolymer solutions onto silicon/glass substrates followed by annealing at 110 °C. The coatings were rigorously characterized by using X-ray photoelectron spectroscopy (XPS), the static water contact angle (WCA) test, ellipsometry and atomic force microscopy (AFM). The results demonstrated that the coating based mixed PMOXA/PAA brushes with desired surface composition could be attained by simply maintaining their percentage in the mixture of PMOXA-r-GMA and PAA-b-PGMA copolymer solutions. Finally, the switchable behavior of PMOXA/PAA based coatings toward bovine serum albumin (BSA) adsorption was investigated by fluorescein isothiocyanate-labelled BSA (FITC-BSA) assay and quartz crystal microbalance with dissipation monitoring (QCM-D), which indicated that the coating based mixed PMOXA/PAA brushes could control BSA adsorption/desorption from very low to high amount (>90% desorption) through adjusting the composition of PMOXA-r-GMA and PAA-b-PGMA solution used in preparing PMOXA/PAA based coatings upon pH and ionic strength change. Furthermore, PMOXA/PAA based coatings displayed efficient repeatability of reversible BSA adsorption/desorption cycles.

The role of omega-3 fatty acids in acute pancreatitis: a meta-analysis of randomized controlled trials.

PubMed

Lei, Qiu Cheng; Wang, Xin Ying; Xia, Xian Feng; Zheng, Hua Zhen; Bi, Jing Cheng; Tian, Feng; Li, Ning

2015-03-31

To determine whether treatment with omega-3 fatty acids (ω-3 FA) provides benefits to patients with acute pancreatitis (AP). The Cochrane Library, PubMed, Embase, Web of Science, and Chinese Biomedical Literature Database were searched. Data analysis was performed using Revman 5.2 software. A total of eight randomized controlled trials (RCTs) were included. Overall, ω-3 FA treatment resulted in a significantly reduced risk of mortality (RR 0.35; 95% CI 0.16 to 0.75, p < 0.05), infectious complications (RR 0.54; 95% CI 0.34 to 0.85, p < 0.05) and length of hospital stay (MD -6.50; 95% CI -9.54 to -3.46, p < 0.05), but not length of ICU stay (MD -1.98; 95% CI -6.92 to 2.96, p > 0.05). In subgroup analysis, only patients who received ω-3 FA parenterally had some statistically significant benefits in terms of mortality (risk ratio (RR) 0.37; 95% confidence interval (CI) 0.16 to 0.86, p < 0.05), infectious complications (RR 0.5; 95% CI 0.28 to 0.9, p < 0.05) and length of hospital stay (mean difference (MD) -8.13; 95% CI -10.39 to -5.87, p < 0.001). The administration of ω-3 FA may be beneficial for decreasing mortality, infectious complications, and length of hospital stay in AP, especially when used parenterally. Large and rigorously designed RCTs are required to elucidate the efficacy of parenteral or enteral ω-3 FA treatment in AP.

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

PubMed

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

2017-01-01

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

The effect of changing the built environment on physical activity: a quantitative review of the risk of bias in natural experiments.

PubMed

Benton, Jack S; Anderson, Jamie; Hunter, Ruth F; French, David P

2016-10-07

Evidence regarding the association of the built environment with physical activity is influencing policy recommendations that advocate changing the built environment to increase population-level physical activity. However, to date there has been no rigorous appraisal of the quality of the evidence on the effects of changing the built environment. The aim of this review was to conduct a thorough quantitative appraisal of the risk of bias present in those natural experiments with the strongest experimental designs for assessing the causal effects of the built environment on physical activity. Eligible studies had to evaluate the effects of changing the built environment on physical activity, include at least one measurement before and one measurement of physical activity after changes in the environment, and have at least one intervention site and non-intervention comparison site. Given the large number of systematic reviews in this area, studies were identified from three exemplar systematic reviews; these were published in the past five years and were selected to provide a range of different built environment interventions. The risk of bias in these studies was analysed using the Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions (ACROBAT-NRSI). Twelve eligible natural experiments were identified. Risk of bias assessments were conducted for each physical activity outcome from all studies, resulting in a total of fifteen outcomes being analysed. Intervention sites included parks, urban greenways/trails, bicycle lanes, paths, vacant lots, and a senior citizen's centre. All outcomes had an overall critical (n = 12) or serious (n = 3) risk of bias. Domains with the highest risk of bias were confounding (due to inadequate control sites and poor control of confounding variables), measurement of outcomes, and selection of the reported result. The present review focused on the strongest natural experiments conducted to date. Given this, the failure of existing studies to adequately control for potential sources of bias highlights the need for more rigorous research to underpin policy recommendations for changing the built environment to increase physical activity. Suggestions are proposed for how future natural experiments in this area can be improved.

Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches.

PubMed

Vanderploeg, Rodney D; Schwab, Karen; Walker, William C; Fraser, Jamie A; Sigford, Barbara J; Date, Elaine S; Scott, Steven G; Curtiss, Glenn; Salazar, Andres M; Warden, Deborah L

2008-12-01

To determine the relative efficacy of 2 different acute traumatic brain injury (TBI) rehabilitation approaches: cognitive didactic versus functional-experiential, and secondarily to determine relative efficacy for different patient subpopulations. Randomized, controlled, intent-to-treat trial comparing 2 alternative TBI treatment approaches. Four Veterans Administration acute inpatient TBI rehabilitation programs. Adult veterans or active duty military service members (N=360) with moderate to severe TBI. One and a half to 2.5 hours of protocol-specific cognitive-didactic versus functional-experiential rehabilitation therapy integrated into interdisciplinary acute Commission for Accreditation of Rehabilitation Facilities-accredited inpatient TBI rehabilitation programs with another 2 to 2.5 hours daily of occupational and physical therapy. Duration of protocol treatment varied from 20 to 60 days depending on the clinical needs and progress of each participant. The 2 primary outcome measures were functional independence in living and return to work and/or school assessed by independent evaluators at 1-year follow-up. Secondary outcome measures consisted of the FIM, Disability Rating Scale score, and items from the Present State Exam, Apathy Evaluation Scale, and Neurobehavioral Rating Scale. The cognitive-didactic and functional-experiential treatments did not result in overall group differences in the broad 1-year primary outcomes. However, analysis of secondary outcomes found differentially better immediate posttreatment cognitive function (mean+/-SD cognitive FIM) in participants randomized to cognitive-didactic treatment (27.3+/-6.2) than to functional treatment (25.6+/-6.0, t332=2.56, P=.01). Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm, whereas participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm. Results from this large multicenter randomized controlled trial comparing cognitive-didactic and functional-experiential approaches to brain injury rehabilitation indicated improved but similar long-term global functional outcome. Participants in the cognitive treatment arm achieved better short-term functional cognitive performance than patients in the functional treatment arm. The current increase in war-related brain injuries provides added urgency for rigorous study of rehabilitation treatments. (http://ClinicalTrials.gov ID# NCT00540020.).

A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

PubMed Central

2011-01-01

Background We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. Methods This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. Results The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age. Conclusion Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822. PMID:21510905

Nutritional supplements for patients being treated for active visceral leishmaniasis.

PubMed

Custodio, Estefanía; López-Alcalde, Jesús; Herrero, Mercè; Bouza, Carmen; Jimenez, Carolina; Storcksdieck Genannt Bonsmann, Stefan; Mouratidou, Theodora; López-Cuadrado, Teresa; Benito, Agustin; Alvar, Jorge

2018-03-26

Visceral leishmaniasis (VL) is a disease caused by a parasite, which can lead to death if untreated. Poor nutritional status hastens the progression of VL infection, and VL worsens malnutrition status. Malnutrition is one of the poor prognostic factors identified for leishmaniasis. However, the effects of nutritional supplementation in people treated for VL are not known. To assess the effects of oral nutritional supplements in people being treated with anti-leishmanial drug therapy for VL. We searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and two trial registers up to 12 September 2017. We checked conference proceedings and WHO consultative meeting reports, the reference lists of key documents and existing reviews, and contacted experts and nutritional supplement companies. Randomized controlled trials (RCTs), quasi-randomized controlled trials (quasi-RCTs), and non-randomized controlled trials (NRCTs) of any oral nutritional supplement, compared to no nutritional intervention, placebo, or dietary advice alone, in people being treated for VL. Two review authors independently screened the literature search results for studies that met the inclusion criteria. We had planned for two review authors to independently extract data and assess the risk of bias of the included studies. We planned to follow the Cochrane standard methodological procedures for assessing risk of bias and analysing the data. We identified no eligible studies for this review, either completed or ongoing. We found no studies, either completed or ongoing, that assessed the effects of oral nutritional supplements in people with VL who were being treated with anti-leishmanial drug therapy. Thus, we could not draw any conclusions on the impact of these interventions on primary cure of VL, definitive cure of VL, treatment completion, self-reported recovery from illness or resolution of symptoms, weight gain, increased skinfold thickness, other measures of lean or total mass, or growth in children.This absence of evidence should not be interpreted as evidence of no effect for nutritional supplements in people under VL treatment. It means that we did not identify research that fulfilled our review inclusion criteria.The effects of oral nutritional supplements in people with VL who are being treated with anti-leishmanial drug therapy have yet to be determined by rigorous experimental studies, such as cluster-randomized trials, that focus on outcomes relevant for patients.

A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.

PubMed

Labrique, Alain B; Christian, Parul; Klemm, Rolf D W; Rashid, Mahbubur; Shamim, Abu Ahmed; Massie, Allan; Schulze, Kerry; Hackman, Andre; West, Keith P

2011-04-21

We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity, maternal and infant micronutrient status, fetal and infant growth and prematurity, external birth defects and postnatal infant growth to 3 months of age. Aspects of study site selection and its "resonance" with national and rural qualities of Bangladesh, the trial's design, methods and allocation group comparability achieved by randomization, field procedures and innovative approaches to solving challenges in trial conduct are described and discussed. This trial is registered with http://Clinicaltrials.gov as protocol NCT00198822.

Separating intrinsic from extrinsic fluctuations in dynamic biological systems

PubMed Central

Paulsson, Johan

2011-01-01

From molecules in cells to organisms in ecosystems, biological populations fluctuate due to the intrinsic randomness of individual events and the extrinsic influence of changing environments. The combined effect is often too complex for effective analysis, and many studies therefore make simplifying assumptions, for example ignoring either intrinsic or extrinsic effects to reduce the number of model assumptions. Here we mathematically demonstrate how two identical and independent reporters embedded in a shared fluctuating environment can be used to identify intrinsic and extrinsic noise terms, but also how these contributions are qualitatively and quantitatively different from what has been previously reported. Furthermore, we show for which classes of biological systems the noise contributions identified by dual-reporter methods correspond to the noise contributions predicted by correct stochastic models of either intrinsic or extrinsic mechanisms. We find that for broad classes of systems, the extrinsic noise from the dual-reporter method can be rigorously analyzed using models that ignore intrinsic stochasticity. In contrast, the intrinsic noise can be rigorously analyzed using models that ignore extrinsic stochasticity only under very special conditions that rarely hold in biology. Testing whether the conditions are met is rarely possible and the dual-reporter method may thus produce flawed conclusions about the properties of the system, particularly about the intrinsic noise. Our results contribute toward establishing a rigorous framework to analyze dynamically fluctuating biological systems. PMID:21730172

Separating intrinsic from extrinsic fluctuations in dynamic biological systems.

PubMed

Hilfinger, Andreas; Paulsson, Johan

2011-07-19

From molecules in cells to organisms in ecosystems, biological populations fluctuate due to the intrinsic randomness of individual events and the extrinsic influence of changing environments. The combined effect is often too complex for effective analysis, and many studies therefore make simplifying assumptions, for example ignoring either intrinsic or extrinsic effects to reduce the number of model assumptions. Here we mathematically demonstrate how two identical and independent reporters embedded in a shared fluctuating environment can be used to identify intrinsic and extrinsic noise terms, but also how these contributions are qualitatively and quantitatively different from what has been previously reported. Furthermore, we show for which classes of biological systems the noise contributions identified by dual-reporter methods correspond to the noise contributions predicted by correct stochastic models of either intrinsic or extrinsic mechanisms. We find that for broad classes of systems, the extrinsic noise from the dual-reporter method can be rigorously analyzed using models that ignore intrinsic stochasticity. In contrast, the intrinsic noise can be rigorously analyzed using models that ignore extrinsic stochasticity only under very special conditions that rarely hold in biology. Testing whether the conditions are met is rarely possible and the dual-reporter method may thus produce flawed conclusions about the properties of the system, particularly about the intrinsic noise. Our results contribute toward establishing a rigorous framework to analyze dynamically fluctuating biological systems.

The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

PubMed

Kirkpatrick, Beth D; Colgate, E Ross; Mychaleckyj, Josyf C; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Nayak, Uma; Taniuchi, Mami; Naylor, Caitlin; Qadri, Firdausi; Ma, Jennie Z; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Petri, William A

2015-04-01

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings. © The American Society of Tropical Medicine and Hygiene.

Jammed systems of oriented needles always percolate on square lattices

NASA Astrophysics Data System (ADS)

Kondrat, Grzegorz; Koza, Zbigniew; Brzeski, Piotr

2017-08-01

Random sequential adsorption (RSA) is a standard method of modeling adsorption of large molecules at the liquid-solid interface. Several studies have recently conjectured that in the RSA of rectangular needles, or k -mers, on a square lattice, percolation is impossible if the needles are sufficiently long (k of order of several thousand). We refute these claims and present rigorous proof that in any jammed configuration of nonoverlapping, fixed-length, horizontal, or vertical needles on a square lattice, all clusters are percolating clusters.

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests.

PubMed

Ferrante di Ruffano, Lavinia; Dinnes, Jacqueline; Sitch, Alice J; Hyde, Chris; Deeks, Jonathan J

2017-02-24

There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due to their methodological complexity, they have not been subjected to a systematic appraisal of their methodological quality. The extent to which these trials may be producing biased results therefore remains unknown. We set out to address this issue by conducting a methodological review of published test-treatment trials to determine how often they implement adequate methods to limit bias and safeguard the validity of results. We ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL, including RCTs which randomized patients to diagnostic tests and measured patient outcomes after treatment. Tests used for screening, monitoring or prognosis were excluded. We assessed adequacy of sequence generation, allocation concealment and intention-to-treat, appropriateness of primary analyses, blinding and reporting of power calculations, and extracted study characteristics including the primary outcome. One hundred three trials compared 105 control with 119 experimental interventions, and reported 150 primary outcomes. Randomization and allocation concealment were adequate in 57 and 37% of trials. Blinding was uncommon (patients 5%, clinicians 4%, outcome assessors 21%), as was an adequate intention-to-treat analysis (29%). Overall 101 of 103 trials (98%) were at risk of bias, as judged using standard Cochrane criteria. Test-treatment trials are particularly susceptible to attrition and inadequate primary analyses, lack of blinding and under-powering. These weaknesses pose much greater methodological and practical challenges to conducting reliable RCT evaluations of test-treatment strategies than standard treatment interventions. We suggest a cautious approach that first examines whether a test-treatment intervention can accommodate the methodological safeguards necessary to minimize bias, and highlight that test-treatment RCTs require different methods to ensure reliability than standard treatment trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0286-0 .

Mechanical properties of frog skeletal muscles in iodoacetic acid rigor.

PubMed Central

Mulvany, M J

1975-01-01

1. Methods have been developed for describing the length: tension characteristics of frog skeletal muscles which go into rigor at 4 degrees C following iodoacetic acid poisoning either in the presence of Ca2+ (Ca-rigor) or its absence (Ca-free-rigor). 2. Such rigor muscles showed less resistance to slow stretch (slow rigor resistance) that to fast stretch (fast rigor resistance). The slow and fast rigor resistances of Ca-free-rigor muscles were much lower than those of Ca-rigor muscles. 3. The slow rigor resistance of Ca-rigor muscles was proportional to the amount of overlap between the contractile filaments present when the muscles were put into rigor. 4. Withdrawing Ca2+ from Ca-rigor muscles (induced-Ca-free rigor) reduced their slow and fast rigor resistances. Readdition of Ca2+ (but not Mg2+, Mn2+ or Sr2+) reversed the effect. 5. The slow and fast rigor resistances of Ca-rigor muscles (but not of Ca-free-rigor muscles) decreased with time. 6.The sarcomere structure of Ca-rigor and induced-Ca-free rigor muscles stretched by 0.2lo was destroyed in proportion to the amount of stretch, but the lengths of the remaining intact sarcomeres were essentially unchanged. This suggests that there had been a successive yielding of the weakeast sarcomeres. 7. The difference between the slow and fast rigor resistance and the effect of calcium on these resistances are discussed in relation to possible variations in the strength of crossbridges between the thick and thin filaments. Images Plate 1 Plate 2 PMID:1082023

A Methodological Analysis of Randomized Clinical Trials of Computer-Assisted Therapies for Psychiatric Disorders: Toward Improved Standards for an Emerging Field

PubMed Central

Kiluk, Brian D.; Sugarman, Dawn E.; Nich, Charla; Gibbons, Carly J.; Martino, Steve; Rounsaville, Bruce J.; Carroll, Kathleen M.

2013-01-01

Objective Computer-assisted therapies offer a novel, cost-effective strategy for providing evidence-based therapies to a broad range of individuals with psychiatric disorders. However, the extent to which the growing body of randomized trials evaluating computer-assisted therapies meets current standards of methodological rigor for evidence-based interventions is not clear. Method A methodological analysis of randomized clinical trials of computer-assisted therapies for adult psychiatric disorders, published between January 1990 and January 2010, was conducted. Seventy-five studies that examined computer-assisted therapies for a range of axis I disorders were evaluated using a 14-item methodological quality index. Results Results indicated marked heterogeneity in study quality. No study met all 14 basic quality standards, and three met 13 criteria. Consistent weaknesses were noted in evaluation of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles. Studies utilizing weaker comparison conditions (e.g., wait-list controls) had poorer methodological quality scores and were more likely to report effects favoring the computer-assisted condition. Conclusions While several well-conducted studies have indicated promising results for computer-assisted therapies, this emerging field has not yet achieved a level of methodological quality equivalent to those required for other evidence-based behavioral therapies or pharmacotherapies. Adoption of more consistent standards for methodological quality in this field, with greater attention to potential adverse events, is needed before computer-assisted therapies are widely disseminated or marketed as evidence based. PMID:21536689

The association between the combined oral contraceptive pill and insulin resistance, dysglycemia and dyslipidemia in women with polycystic ovary syndrome: a systematic review and meta-analysis of observational studies.

PubMed

Halperin, Ilana J; Kumar, Shoba Sujana; Stroup, Donna F; Laredo, Sheila E

2011-01-01

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of young women. First-line treatment is often the oral contraceptive pill (OC), but evidence suggests that OC may worsen metabolic outcomes in this population. We undertook this meta-analysis of observational studies and cohorts from within randomized controlled studies to investigate the association between OC use and dysglycemia, dyslipidemia and insulin resistance (IR) in women with PCOS. We searched MEDLINE (1966-April 2010), EMBASE (1980-April 2010) and All EBM Reviews. We included prospective cohorts and RCTs that treated women, aged 13-44, with PCOS with OC for at least 3 months. Blinded quality assessment and data extraction were conducted on 35 included studies by two independent reviewers. We used random effects methods to calculate weighted mean differences as the effect size. We investigated heterogeneity using sequential removal of studies, subgroup analysis and meta-regression. OC use was significantly associated with an increase in high-density lipoprotein cholesterol (HDL-C) (P = 0.004) and triglycerides (P = 0.004). Significant heterogeneity was found in glucose, cholesterol, HDL-C, low-density lipoprotein cholesterol triglycerides, fasting glucose to insulin ratios and homeostatic model assessments-IR. Study characteristics such as mean BMI, mean age and duration of study could explain some of the heterogeneity. Use of OC was not associated with clinically significant adverse metabolic consequences. Because of limitations of the underlying studies, further research including rigorously designed randomized trials would more definitively confirm our findings.

What Do We Really Know About the Safety of Tai Chi?: A Systematic Review of Adverse Event Reports in Randomized Trials

PubMed Central

Wayne, Peter M.; Berkowitz, Danielle L.; Litrownik, Daniel E.; Buring, Julie E.; Yeh, Gloria Y.

2014-01-01

Objective Systematically review frequency and quality of adverse event (AE) reports in randomized clinical trials (RCTs) of Tai Chi (TC). Data Sources Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms were tai chi, taiji, tai chi chuan. Data were independently extracted by two investigators. Study Selection We included all available randomized controlled trials (RCTs) that were published in English and used Tai Chi as an intervention. Inclusion and exclusion of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data Extraction Eligible RCTs were categorized with respect to AE reporting: 1) No mention of protocols for monitoring AEs or reports of AEs; 2) Reports of AEs either with or without explicit protocols for monitoring AEs. Data Synthesis 153 eligible RCTs were identified, most targeting older adults. Only 50 eligible trials (33%) included reporting of AEs, and of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to rigor of systematic monitoring in both Tai Chi and comparison groups. Reported AEs were typically minor and expected, and primarily musculoskeletal related (e.g., knee and back pain); no intervention-related serious AEs were reported. Conclusions Tai Chi is unlikely to result in serious adverse events, but may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of Tai Chi. PMID:24878398

Safety of early discharge for low-risk patients with febrile neutropenia: a multicenter randomized controlled trial.

PubMed

Talcott, James A; Yeap, Beow Y; Clark, Jack A; Siegel, Robert D; Loggers, Elizabeth Trice; Lu, Charles; Godley, Paul A

2011-10-20

Febrile neutropenia commonly complicates cancer chemotherapy. Outpatient treatment may reduce costs and improve patient comfort but risk progression of undetected medical problems. By using our validated algorithm, we identified medically stable inpatients admitted for febrile neutropenia (neutrophils < 500/μL) after chemotherapy and randomly assigned them to continued inpatient antibiotic therapy or early discharge to receive identical antibiotic treatment at home. Our primary outcome was the occurrence of any serious medical complication, defined as evidence of medical instability requiring urgent medical attention. We enrolled 117 patients with 121 febrile neutropenia episodes before study termination for poor accrual. We excluded five episodes as ineligible and three because of inadequate documentation of the study outcome. Treatment groups were clinically similar, but sociodemographic imbalances occurred because of block randomization. The median presenting absolute neutrophil count was 100/μL. Hematopoietic growth factors were used in 38% of episodes. The median neutropenia duration was 4 days (range, 1 to 15 days). Five outpatients were readmitted to the hospital. Major medical complications occurred in five episodes (8%) in the hospital arm and four (9%) in the home arm (95% CI for the difference, -10% to 13%; P = .56). No study patient died. Patient-reported quality of life was similar on both arms. We found no evidence of adverse medical consequences from home care, despite a protocol designed to detect evidence of clinical deterioration. These results should reassure clinicians who elect to treat rigorously characterized low-risk patients with febrile neutropenia in suitable outpatient settings with appropriate surveillance for unexpected clinical deterioration.

Standardized Test Results: KEEP and Control Students. 1975-1976, Technical Report #69.

ERIC Educational Resources Information Center

Antill, Ellen; Speidel, Gisela E.

This report presents the results of various standardized measures administered to Kamehameha Early Education Program (KEEP) students and control students in the school year 1975-1976. In contrast to previous comparisons, KEEP employed more rigorous procedures for the selection of the control students and for the conditions of test administration.…

Extensibility of the myofilaments in vertebrate skeletal muscle as revealed by stretching rigor muscle fibers

PubMed Central

1983-01-01

The extensibility of the myofilaments in vertebrate skeletal muscle was studied by stretching glycerinated rabbit psoas muscle fibers in rigor state and examining the resulting extension of sarcomere structures under an electron microscope. Although stretches applied to rigor fibers produced a successive yielding of the weakest sarcomeres, the length of the remaining intact sarcomeres in many myofibrils was fairly uniform, being definitely longer than the sarcomeres in the control, nonstretched part of rigor fibers. The stretch-induced increase in sarcomere length was found to be taken up by the extension of the H zone and the I band, whereas the amount of overlap between the thick and thin filaments did not change appreciably with stretches of 10-20%. The thick filament extension in the H zone was localized in the bare regions, whereas the thin filament extension in the I band appeared to take place uniformly along the filament length. No marked increase in the Z-line width was observed even with stretches of 20-30%. These results clearly demonstrate the extensibility of the thick and thin filaments. The possible contribution of the myofilament compliance to the series elastic component (SEC) in vertebrate skeletal muscle fibers is discussed on the basis of the electron microscopic data and the force-extension curve of the SEC in rigor fibers. PMID:6682885

Protocol for a Randomized Controlled Trial of Proactive Web-Based Versus Telephone-Based Information and Support: Can Electronic Platforms Deliver Effective Care for Lung Cancer Patients?

PubMed

Paul, Christine L; Boyes, Allison W; O'Brien, Lorna; Baker, Amanda L; Henskens, Frans A; Roos, Ian; Clinton-McHarg, Tara; Bellamy, Douglas; Colburn, Glenda; Rose, Shiho; Cox, Martine E; Fradgley, Elizabeth A; Baird, Hannah; Barker, Daniel

2016-10-26

Community-based services such as telephone support lines can provide valuable informational, emotional, and practical support for cancer patients via telephone- or Web-based (live chat or email) platforms. However, very little rigorous research has examined the efficacy of such services in improving patient outcomes. This study will determine whether: proactive telephone or Web-delivered support produces outcomes superior to printed information; and Web-delivered support produces outcomes comparable to telephone support. A consecutive sample of 501 lung cancer outpatients will be recruited from 50 Australian health services to participate in a patient-randomized controlled trial (RCT). Eligible individuals must: be 18 years or older; have received a lung cancer diagnosis (including mesothelioma) within the previous 4 months; have an approximate life expectancy of at least 6 months; and have Internet access. Participants will be randomly allocated to receive: (1) an information booklet, (2) proactive telephone support, or (3) proactive Web support, chat, and/or email. The primary patient outcomes will be measured by the General Health Questionnaire (GHQ-12) and Health Education and Impact Questionnaire (heiQ) at 3 and 6 months post recruitment. The acceptability of proactive recruitment strategies will also be assessed. It is hypothesized that participants receiving telephone or Web support will report reduced distress (GHQ-12 scores that are 0.3 standard deviations (SD) lower) and greater self-efficacy (heiQ scores that are 0.3 SDs higher) than participants receiving booklets. Individuals receiving Web support will report heiQ scores within 0.29 SDs of individuals receiving telephone support. If proven effective, electronic approaches such as live-chat and email have the potential to increase the accessibility and continuity of supportive care delivered by community-based services. This evidence may also inform the redesigning of helpline-style services to be effective and responsive to patient needs.

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial.

PubMed

Gelli, Aulo; Becquey, Elodie; Ganaba, Rasmane; Headey, Derek; Hidrobo, Melissa; Huybregts, Lieven; Verhoef, Hans; Kenfack, Romain; Zongouri, Sita; Guedenet, Hannah

2017-09-06

The SELEVER study is designed to evaluate the impact of an integrated agriculture-nutrition package of interventions (including poultry value chain development, women's empowerment activities, and a behavior change communications strategy to promote improved diets and feeding, care, and hygiene practices) on the diets, health, and nutritional status of women and children in Burkina Faso. This paper presents the rationale and study design. The impact evaluation involves a cluster randomized controlled trial design that will be implemented in 120 rural communities/villages within 60 communes supported by SELEVER in the Boucle de Mouhoun, Centre-Ouest, and Haut-Bassins regions of Burkina Faso. Communities will be randomly assigned to one of three treatment arms, including: (1) SELEVER intervention group; (2) SELEVER with an intensive WASH component; and (3) control group without intervention. Primary outcomes include the mean probability of adequacy of diets for women and children (aged 2-4 years at baseline), infant and young child feeding practices of caregivers of children aged 0-2 years, and household poultry production and sales. Intermediate outcomes along the agriculture and nutrition pathways will also be measured, including child nutrition status and development. The evaluation will follow a mixed-methods approach, including a panel of child-, household-, community-, and market-level surveys, and data collection points during post-harvest and lean seasons, as well as one year after implementation completion to examine sustainability. To our knowledge, this study is the first to rigorously examine from a food systems perspective, the simultaneous impact of scaling-up nutrition-specific and nutrition-sensitive interventions through a livestock value-chain and community-intervention platform, across nutrition, health, and agriculture domains. The findings of this evaluation will provide evidence to support the design of market-based nutrition-sensitive interventions. ISRCTN registry, ISRCTN16686478 . Registered on 2 December 2016.

Effect of Oral Valproic Acid vs Placebo for Vision Loss in Patients With Autosomal Dominant Retinitis Pigmentosa: A Randomized Phase 2 Multicenter Placebo-Controlled Clinical Trial.

PubMed

Birch, David G; Bernstein, Paul S; Iannacone, Alessandro; Pennesi, Mark E; Lam, Byron L; Heckenlively, John; Csaky, Karl; Hartnett, Mary Elizabeth; Winthrop, Kevin L; Jayasundera, Thiran; Hughbanks-Wheaton, Dianna K; Warner, Judith; Yang, Paul; Fish, Gary Edd; Teske, Michael P; Sklaver, Neal L; Erker, Laura; Chegarnov, Elvira; Smith, Travis; Wahle, Aimee; VanVeldhuisen, Paul C; McCormack, Jennifer; Lindblad, Robert; Bramer, Steven; Rose, Stephen; Zilliox, Patricia; Francis, Peter J; Weleber, Richard G

2018-06-07

There are no approved drug treatments for autosomal dominant retinitis pigmentosa, a relentlessly progressive cause of adult and childhood blindness. To evaluate the potential efficacy and assess the safety of orally administered valproic acid (VPA) in the treatment of autosomal dominant retinitis pigmentosa. Multicenter, phase 2, prospective, interventional, placebo-controlled, double-masked randomized clinical trial. The study took place in 6 US academic retinal degeneration centers. Individuals with genetically characterized autosomal dominant retinitis pigmentosa were randomly assigned to receive treatment or placebo for 12 months. Analyses were intention-to-treat. Oral VPA 500 mg to 1000 mg daily for 12 months or placebo. The primary outcome measure was determined prior to study initiation as the change in visual field area (assessed by the III4e isopter, semiautomated kinetic perimetry) between baseline and month 12. The mean (SD) age of the 90 participants was 50.4 (11.6) years. Forty-four (48.9%) were women, 87 (96.7%) were white, and 79 (87.8%) were non-Hispanic. Seventy-nine participants (87.8%) completed the study (42 [95.5%] received placebo and 37 [80.4%] received VPA). Forty-two (46.7%) had a rhodopsin mutation. Most adverse events were mild, although 7 serious adverse events unrelated to VPA were reported. The difference between the VPA and placebo arms for mean change in the primary outcome was -150.43 degree2 (95% CI, -290.5 to -10.03; P = .035). This negative value indicates that the VPA arm had worse outcomes than the placebo group. This study brings to light the key methodological considerations that should be applied to the rigorous evaluation of treatments for these conditions. This study does not provide support for the use of VPA in the treatment of autosomal dominant retinitis pigmentosa. ClinicalTrials.gov Identifier: NCT01233609.

Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials

PubMed Central

Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

2011-01-01

Background Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with western medication. Methods We included randomized controlled trials on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials quality independently. RevMan 5.0.18 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Results 8 RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medications regarding the number of cured patients (RR 2.49, 95%CI 1.91 to 3.24, p<0.00001), the number of patients with improved symptoms (RR 1.15, 95%CI 1.05 to 1.26, p=0.003), and reducing the incidence rate of postherpetic neuralgia (RR 0.06, 95%CI 0.02 to 0.25, p=0.0001). Wet cupping plus medications was significantly better than medications alone on number of cured patients (RR 1.93, 95%CI 1.23 to 3.04, p=0.005), but no difference in symptom improvement (RR 1.00, 95%CI 0.92 to 1.08, p=0.98). There were no serious adverse effects with related to wet cupping therapy in the included trials. Conclusions Wet cupping appears to be effective in treatment of herpes zoster. However, further large, rigorous designed trials are warranted. PMID:21280462

Effect of vitamin D supplementation on knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Diao, Naicheng; Yang, Bo; Yu, Fei

2017-12-01

To provide evidence regarding the effect of vitamin D supplementation on symptomatic knee osteoarthritis (OA). A systematic review and meta-analysis was performed to quantitatively pool the results from randomized clinical trials. Studies were identified from a search of the Embase, MEDLINE and Web of Science databases up to January 22, 2017, and also from conference abstracts, ClinicalTrials.gov and the reference lists of identified studies. A standardized mean difference (SMD) was used to assess effect sizes, as outcomes were reported on different scales. Depending on the degree of heterogeneity, random-effects or fixed-effects models were used to pool outcomes. Up to January 22, 2017, four clinical trials containing 570 subjects in the vitamin D supplementation group and 560 subjects in the placebo group were identified. All of the included studies were of high quality and had a low risk of bias for each domain. The results indicated that vitamin D supplementation had a statistically significant but small-to-moderate effect on pain control in patients with knee OA (SMD=-0.32, 95% CI: -0.63 to -0.02). However, no effects were observed for the change in tibial cartilage volume (SMD=0.12, 95% CI: -0.05 to 0.29) or joint space width (SMD=0.07, 95% CI: -0.08 to 0.23). The subgroup analysis indicated that vitamin D supplementation had no significant effect regardless of whether patients had sufficient or insufficient serum 25(OH)D levels at baseline. The results of this study indicate that vitamin D supplementation may not have a clinically significant effect on pain control or structure progression among patients with knee OA. Longer-term clinical trials with rigorous measurement of symptom and radiologic changes are required to further clarify the effect of vitamin D supplementation in patients with symptomatic knee OA and low serum 25(OH)D levels. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Human-rated Safety Certification of a High Voltage Robonaut Lithium-ion Battery

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith; Yayathi, S.; Johnson, M.; Waligora, T.; Verdeyen, W.

2013-01-01

NASA's rigorous certification process is being followed for the R2 high voltage battery program for use of R2 on International Space Station (ISS). Rigorous development testing at appropriate levels to credible off-nominal conditions and review of test data led to design improvements for safety at the virtual cell, cartridge and battery levels. Tests were carried out at all levels to confirm that both hardware and software controls work. Stringent flight acceptance testing of the flight battery will be completed before launch for mission use on ISS.

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial.

PubMed

Kriss, Jennifer L; Frew, Paula M; Cortes, Marielysse; Malik, Fauzia A; Chamberlain, Allison T; Seib, Katherine; Flowers, Lisa; Ault, Kevin A; Howards, Penelope P; Orenstein, Walter A; Omer, Saad B

2017-03-13

Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups. We conducted a prospective randomized controlled trial to pilot test two interventions - an affective messaging video and a cognitive messaging iBook - among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy. Among the enrolled women (n=106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26-6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66-4.09). From baseline to follow-up, women's reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman's physician. Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings. clinicaltrials.gov Identifier: NCT01740310. Copyright © 2017 Elsevier Ltd. All rights reserved.

Systematic review on randomized controlled trials of coronary heart disease complicated with depression treated with Chinese herbal medicines.

PubMed

Wang, An-Lu; Chen, Zhuo; Luo, Jing; Shang, Qing-Hua; Xu, Hao

2016-01-01

This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=-1.06; 95% confidence interval (CI)-2.38 to 0.26; n=501; I(2)=73%], but it was associated with a statistically significant difference in the 8th week (MD=-1.00; 95% CI-1.64 to-0.36; n=436; I(2)=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=-1.99; 95% CI-3.80 to-0.18; n=90) and in the 8th week (MD=-5.61; 95% CI-6.26 to-4.97; n=242; I(2)=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.

Limited Evidence on the Management of Respiratory Tract Infections in Down’s Syndrome

PubMed Central

Reed, Kate; Venekamp, Roderick P.; Hayward, Andrew; Littlejohns, Peter; Schilder, Anne; Lakhanpaul, Monica

2016-01-01

Aims: To systematically review the effectiveness of preventative and therapeutic interventions for respiratory tract infections (RTIs) in people with Down’s syndrome. Methods: Databases were searched for any published and ongoing studies of respiratory tract diseases in children and adults with Down’s syndrome. These databases were searched for controlled trials, cohort studies and controlled before–after studies. Trial registries were searched for ongoing studies. Initially, all study types were included to provide a broad overview of the existing evidence base. However, those with a critical risk of bias were excluded using the Cochrane Risk of Bias tool. Results: A total of 13,575 records were identified from which 5 studies fulfilled the eligibility criteria and 3 fulfilled our criteria for data extraction. One randomized controlled trial of moderate risk of bias compared zinc therapy with placebo. Outcome data were only reported for 50 (78%) children who presented with extreme symptoms; no benefit of zinc therapy was found. One non-randomized controlled trial with serious risk of bias included 26 children and compared pidotimod (an immunostimulant) with no treatment; pidotimod was associated with fewer upper RTI recurrences compared with no treatment (1.43 vs. 3.82). A prospective cohort study with moderate risk of bias compared 532 palivizumab treated children with 233 untreated children and found that children treated with palivizumab had fewer respiratory syncytial virus-related hospitalization (23 untreated and 8 treated), but the same number of overall RTI-related hospitalizations (73 untreated and 74 treated) in the first 2 years of life. Conclusions: The evidence base for the management of RTIs in people with Down’s syndrome is incomplete; current studies included children only and carry a moderate to serious risk of bias. Methodologic rigorous studies are warranted to guide clinicians in how best to prevent and treat RTIs in children with Down’s syndrome. PMID:27273687

The Methodological Quality and Effectiveness of Technology-Based Smoking Cessation Interventions for Disadvantaged Groups: A Systematic Review and Meta-analysis.

PubMed

Boland, Veronica C; Stockings, Emily A; Mattick, Richard P; McRobbie, Hayden; Brown, Jamie; Courtney, Ryan J

2018-02-07

To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups. Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer. Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01). Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups. This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups. © The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effectiveness of a smart phone app on improving immunization of children in rural Sichuan Province, China: study protocol for a paired cluster randomized controlled trial.

PubMed

Chen, Li; Wang, Wei; Du, Xiaozhen; Rao, Xiuqin; van Velthoven, Michelle Helena; Yang, Ruikan; Zhang, Lin; Koepsell, Jeanne Catherine; Li, Ye; Wu, Qiong; Zhang, Yanfeng

2014-03-20

Although good progress has been achieved in expanding immunization of children in China, disparities exist across different provinces. Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas. The rapid development of mobile health technology (mHealth) provides unprecedented opportunities for improving health services and reaching underserved populations. However, there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications (apps). This study aims to assess the effectiveness of a smart phone-based app (Expanded Program on Immunization app, or EPI app) on improving the coverage of children's immunization. This cluster randomized trial will take place in Xuanhan County, Sichuan Province, China. Functionalities of the app include the following: to make appointments automatically, record and update children's immunization information, generate a list of children who missed their vaccination appointments, and send health education information to village doctors. After pairing, 36 villages will be randomly allocated to the intervention arm (n=18) and control arm (n=18). The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas. A household survey will be used at baseline and at endline (8 months of implementation). The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine, Rotavirus vaccine and Pneumococcal conjugate vaccine. Multidimensional evaluation of the app will also be conducted to assess usability and feasibility. This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China. This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings. Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960.

Acupuncture for ankle sprain: systematic review and meta-analysis

PubMed Central

2013-01-01

Background Ankle sprain is one of the most frequently encountered musculoskeletal injuries; however, the efficacy of acupuncture in treating ankle sprains remains uncertain. We therefore performed a systematic review to evaluate the evidence regarding acupuncture for ankle sprains. Methods We searched 15 data sources and two trial registries up to February 2012. Randomized controlled trials of acupuncture were included if they involved patients with ankle sprains and reported outcomes of symptom improvement, including pain. A Cochrane risk of bias assessment tool was used. Risk ratio (RR) or mean difference (MD) was calculated with 95% confidence intervals (CIs) in a random effects model. Subgroup analyses were performed based on acupuncture type, grade of sprain, and control type. Sensitivity analyses were also performed with respect to risk of bias, sample size, and outcomes reported. Results Seventeen trials involving 1820 participants were included. Trial quality was generally poor, with just three reporting adequate methods of randomization and only one a method of allocation concealment. Significantly more participants in acupuncture groups reported global symptom improvement compared with no acupuncture groups (RR of symptoms persisting with acupuncture = 0.56, 95% CI 0.42–0.77). However, this is probably an overestimate due to the heterogeneity (I2 = 51%) and high risk of bias of the included studies. Acupuncture as an add-on treatment also improved global symptoms compared with other treatments only, without significant variability (RR 0.61, 95% CI 0.51–0.73, I2 = 1%). The benefit of acupuncture remained significant when the analysis was limited to two studies with a low risk of bias. Acupuncture was more effective than various controls in relieving pain, facilitating return to normal activity, and promoting quality of life, but these analyses were based on only a small number of studies. Acupuncture did not appear to be associated with adverse events. Conclusions Given methodological shortcomings and the small number of high-quality primary studies, the available evidence is insufficient to recommend acupuncture as an evidence-based treatment option. This calls for further rigorous investigations. PMID:23496981

Alternating current cranial electrotherapy stimulation (CES) for depression.

PubMed

Kavirajan, Harish C; Lueck, Kristin; Chuang, Kenneth

2014-07-08

Depression is a mood disorder with a prevalence of approximately 1% to 3% worldwide, representing the fourth leading cause of disease burden globally. The current standard treatments of psychological therapy and antidepressant medications are not effective for everyone, and psychotropic drugs may be associated with significant adverse effects. Cranial electrical stimulation (CES) treatment, in which a low intensity electrical current is administered through the use of a small, portable electrical device, has been reported to have efficacy in the treatment of depression with minimal adverse effects. This systematic review investigated the scientific evidence regarding the efficacy and safety of CES in treatment of acute depression compared to sham, or simulated, CES treatment. To assess the effectiveness and safety of alternating current cranial electrotherapy stimulation (CES) compared with sham CES for acute depression. We searched The Cochrane Collaboration Depression, Anxiety and Neurosis review group's specialized register (CCDANCTR-Studies and CCDANCTR-References) to February 24, 2014 This register contains relevant randomized controlled trials from: The Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We examined reference lists of review papers and books on CES. We contacted authors, other experts in the field and CES manufacturing companies for knowledge of suitable published or unpublished trials. Randomized controlled trials of CES versus sham CES for the acute treatment of depressive disorder in adults aged 18 to 75 years. We planned to extract data from the original reports of included studies independently by two authors. The main outcomes to be assessed were:(1) the efficacy of CES in reducing symptoms of depression as reflected in change scores on standardized depression rating scales.(2) the tolerability of CES treatment to participants, as reflected in rates of discontinuation due to adverse effects.We planned to analyze data using Review Manager 5. No studies met the inclusion criteria for this review. There are insufficient methodologically rigorous studies of CES in treatment of acute depression. There is a need for double-blind randomized controlled trials of CES in the treatment of acute depression.