Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

ERIC Educational Resources Information Center

Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

2010-01-01

In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

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

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

In Defense of the Randomized Controlled Trial for Health Promotion Research

PubMed Central

Rosen, Laura; Manor, Orly; Engelhard, Dan; Zucker, David

2006-01-01

The overwhelming evidence about the role lifestyle plays in mortality, morbidity, and quality of life has pushed the young field of modern health promotion to center stage. The field is beset with intense debate about appropriate evaluation methodologies. Increasingly, randomized designs are considered inappropriate for health promotion research. We have reviewed criticisms against randomized trials that raise philosophical and practical issues, and we will show how most of these criticisms can be overcome with minor design modifications. By providing rebuttal to arguments against randomized trials, our work contributes to building a sound methodological base for health promotion research. PMID:16735622

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

PubMed

Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

2017-01-01

Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

Clinical Trials in Vision Research

MedlinePlus

... the treatment group . If you are in the control group , you could receive the standard treatment for a ... Researchers randomly assign participants to the treatment and control groups. In most studies, you have an equal chance ...

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

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

PubMed

Flory, James; Karlawish, Jason

2012-12-01

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

ASSISTments Dataset from Multiple Randomized Controlled Experiments

ERIC Educational Resources Information Center

Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

2016-01-01

In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

Computer-Assisted Learning in Elementary Reading: A Randomized Control Trial

ERIC Educational Resources Information Center

Shannon, Lisa Cassidy; Styers, Mary Koenig; Wilkerson, Stephanie Baird; Peery, Elizabeth

2015-01-01

This study evaluated the efficacy of Accelerated Reader, a computer-based learning program, at improving student reading. Accelerated Reader is a progress-monitoring, assessment, and practice tool that supports classroom instruction and guides independent reading. Researchers used a randomized controlled trial to evaluate the program with 344…

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

PubMed Central

Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

2015-01-01

Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

High Angular Resolution Microwave Sensing with Large, Sparse, Random Arrays

DTIC Science & Technology

1983-11-01

RESEARCH AFOSR 82-0012 DTIC s" A6 19M UNIVERSITY of PENNSYLVANIA VALLEY FORGE RESEARCH CENTER THE MOORE SCHOOL OF ELECTRICAL ENGINEERING PHILADELPHIA...MICROWAVE SENSING WITH LARGE, SPARSE, RANDOM ARRAYS Final Scientific Report AIR FORCE OFFICE OF SCIENTIFIC RESEARCH AFOSR 82-0012 Valley Forge Research ...CONTROLLING OFFICE NAME AND ADDRESS 12. REPORT DATE Air Force Office of Scientific Research /NE Nov 1983 - . Bildin 41073. NUMBER Or PAG ES BOllinZ AFB, DIC

Lessons learned in research: an attempt to study the effects of magnetic therapy.

PubMed

Szor, Judy K; Holewinski, Paul

2002-02-01

Difficulties related to chronic wound healing research are frequently discussed, but results of less-than-perfect studies commonly are not published. A 16-week, randomized controlled double-blind study attempted to investigate the effect of static magnetic therapy on the healing of diabetic foot ulcers. Of 56 subjects, 37 completed the study. Because of the small sample size, randomization did not control for differences between the two groups, and the data could not be analyzed in any meaningful way. The challenges of performing magnetic therapy research are discussed and considerations for future studies are noted.

Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

ERIC Educational Resources Information Center

Logue, Alexandra W.; Watanabe-Rose, Mari

2014-01-01

This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

Study design and "evidence" in patient-oriented research.

PubMed

Concato, John

2013-06-01

Individual studies in patient-oriented research, whether described as "comparative effectiveness" or using other terms, are based on underlying methodological designs. A simple taxonomy of study designs includes randomized controlled trials on the one hand, and observational studies (such as case series, cohort studies, and case-control studies) on the other. A rigid hierarchy of these design types is a fairly recent phenomenon, promoted as a tenet of "evidence-based medicine," with randomized controlled trials receiving gold-standard status in terms of producing valid results. Although randomized trials have many strengths, and contribute substantially to the evidence base in clinical care, making presumptions about the quality of a study based solely on category of research design is unscientific. Both the limitations of randomized trials as well as the strengths of observational studies tend to be overlooked when a priori assumptions are made. This essay presents an argument in support of a more balanced approach to evaluating evidence, and discusses representative examples from the general medical as well as pulmonary and critical care literature. The simultaneous consideration of validity (whether results are correct "internally") and generalizability (how well results apply to "external" populations) is warranted in assessing whether a study's results are accurate for patients likely to receive the intervention-examining the intersection of clinical and methodological issues in what can be called a medicine-based evidence approach. Examination of cause-effect associations in patient-oriented research should recognize both the strengths and limitations of randomized trials as well as observational studies.

Permission Form Synopses to Improve Parents' Understanding of Research: A Randomized Trial

PubMed Central

D'Angio, Carl T.; Wang, Hongyue; Hunn, Julianne E.; Pryhuber, Gloria S.; Chess, Patricia R.; Lakshminrusimha, Satyan

2017-01-01

Objective We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control). Study Design This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured. Result Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8 ± 5.7 v. 16.3 ± 3.5), subjective understanding (median 6.0 v. 6.5), or overall satisfaction with consent (median 7.0 v. 6.5) between control and intervention groups (all p>0.50). Conclusion A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited. PMID:28358380

A brief randomized controlled intervention targeting parents improves grades during middle school.

PubMed

Destin, Mesmin; Svoboda, Ryan C

2017-04-01

Despite a growing number of brief, psychosocial interventions that improve academic achievement, little research investigates how to leverage parents during such efforts. We designed and tested a randomized controlled intervention targeting parents to influence important discussions about the future and responses to academic difficulty experienced by their adolescent during eighth grade in the United States. We recruited experienced parents to convey the main messages of the intervention in a parent panel format. As expected, current parents who were randomly assigned to observe the parent panel subsequently planned to talk with their adolescents sooner about future opportunities and to respond more positively to experiences of academic difficulty than parents who were randomly assigned to a control group. The intervention also led to a significant increase in student grades, which was mediated by parents' responses to academic difficulty. We suggest an increase in experimental research that utilizes parents to influence student achievement. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

PubMed

Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

PubMed

Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

2016-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

Mathematic Model of Digital Control System with PID Regulator and Regular Step of Quantization with Information Transfer via the Channel of Plural Access

NASA Astrophysics Data System (ADS)

Abramov, G. V.; Emeljanov, A. E.; Ivashin, A. L.

Theoretical bases for modeling a digital control system with information transfer via the channel of plural access and a regular quantization cycle are submitted. The theory of dynamic systems with random changes of the structure including elements of the Markov random processes theory is used for a mathematical description of a network control system. The characteristics of similar control systems are received. Experimental research of the given control systems is carried out.

Randomized Controlled Trials Evaluating Effect of Television Advertising on Food Intake in Children: Why Such a Sensitive Topic is Lacking Top-Level Evidence?

PubMed

Gregori, Dario; Ballali, Simonetta; Vecchio, Maria Gabriella; Sciré, Antonella Silvia; Foltran, Francesca; Berchialla, Paola

2014-01-01

The aim of this study was to perform a systematic review of evidence coming from randomized controlled trials (RCT) aimed at assessing the effect of television advertising on food intake in children from 4 to 12 years old. Randomized controlled trials were searched in PubMed database and included if they assessed the effect of direct exposure to television food advertising over the actual energy intake of children. Seven studies out of 2166 fulfilled the inclusion criteria. The association between television advertising and energy intake is based on a very limited set of randomized researches lacking a solid ground of first-level evidence.

Why Randomized Trials Are Challenging within Adventure Therapy Research: Lessons Learned in Norway

ERIC Educational Resources Information Center

Gabrielsen, Leiv Einar; Fernee, Carina Ribe; Aasen, Gunnar Oland; Eskedal, Leif Torvald

2016-01-01

There are few high-quality studies using randomized controlled trials (RCTs) in the adventure and wilderness therapy literature. Thus, a unison call is heard for more such studies to be carried out. This article presents a Norwegian wilderness therapy research project that planned to incorporate this "gold standard" that is regarded as…

Lesson Study to Scale up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

ERIC Educational Resources Information Center

Lewis, Catherine; Perry, Rebecca

2017-01-01

An understanding of fractions eludes many U.S. students, and research-based knowledge about fraction, such as the utility of linear representations, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study…

Interventions to prevent misconduct and promote integrity in research and publication.

PubMed

Marusic, Ana; Wager, Elizabeth; Utrobicic, Ana; Rothstein, Hannah R; Sambunjak, Dario

2016-04-04

Improper practices and unprofessional conduct in clinical research have been shown to waste a significant portion of healthcare funds and harm public health. Our objective was to evaluate the effectiveness of educational or policy interventions in research integrity or responsible conduct of research on the behaviour and attitudes of researchers in health and other research areas. We searched the CENTRAL, MEDLINE, LILACS and CINAHL health research bibliographical databases, as well as the Academic Search Complete, AGRICOLA, GeoRef, PsycINFO, ERIC, SCOPUS and Web of Science databases. We performed the last search on 15 April 2015 and the search was limited to articles published between 1990 and 2014, inclusive. We also searched conference proceedings and abstracts from research integrity conferences and specialized websites. We handsearched 14 journals that regularly publish research integrity research. We included studies that measured the effects of one or more interventions, i.e. any direct or indirect procedure that may have an impact on research integrity and responsible conduct of research in its broadest sense, where participants were any stakeholders in research and publication processes, from students to policy makers. We included randomized and non-randomized controlled trials, such as controlled before-and-after studies, with comparisons of outcomes in the intervention versus non-intervention group or before versus after the intervention. Studies without a control group were not included in the review. We used the standard methodological procedures expected by Cochrane. To assess the risk of bias in non-randomized studies, we used a modified Cochrane tool, in which we used four out of six original domains (blinding, incomplete outcome data, selective outcome reporting, other sources of bias) and two additional domains (comparability of groups and confounding factors). We categorized our primary outcome into the following levels: 1) organizational change attributable to intervention, 2) behavioural change, 3) acquisition of knowledge/skills and 4) modification of attitudes/perceptions. The secondary outcome was participants' reaction to the intervention. Thirty-one studies involving 9571 participants, described in 33 articles, met the inclusion criteria. All were published in English. Fifteen studies were randomized controlled trials, nine were controlled before-and-after studies, four were non-equivalent controlled studies with a historical control, one was a non-equivalent controlled study with a post-test only and two were non-equivalent controlled studies with pre- and post-test findings for the intervention group and post-test for the control group. Twenty-one studies assessed the effects of interventions related to plagiarism and 10 studies assessed interventions in research integrity/ethics. Participants included undergraduates, postgraduates and academics from a range of research disciplines and countries, and the studies assessed different types of outcomes.We judged most of the included randomized controlled trials to have a high risk of bias in at least one of the assessed domains, and in the case of non-randomized trials there were no attempts to alleviate the potential biases inherent in the non-randomized designs.We identified a range of interventions aimed at reducing research misconduct. Most interventions involved some kind of training, but methods and content varied greatly and included face-to-face and online lectures, interactive online modules, discussion groups, homework and practical exercises. Most studies did not use standardized or validated outcome measures and it was impossible to synthesize findings from studies with such diverse interventions, outcomes and participants. Overall, there is very low quality evidence that various methods of training in research integrity had some effects on participants' attitudes to ethical issues but minimal (or short-lived) effects on their knowledge. Training about plagiarism and paraphrasing had varying effects on participants' attitudes towards plagiarism and their confidence in avoiding it, but training that included practical exercises appeared to be more effective. Training on plagiarism had inconsistent effects on participants' knowledge about and ability to recognize plagiarism. Active training, particularly if it involved practical exercises or use of text-matching software, generally decreased the occurrence of plagiarism although results were not consistent. The design of a journal's author contribution form affected the truthfulness of information supplied about individuals' contributions and the proportion of listed contributors who met authorship criteria. We identified no studies testing interventions for outcomes at the organizational level. The numbers of events and the magnitude of intervention effects were generally small, so the evidence is likely to be imprecise. No adverse effects were reported. The evidence base relating to interventions to improve research integrity is incomplete and the studies that have been done are heterogeneous, inappropriate for meta-analyses and their applicability to other settings and population is uncertain. Many studies had a high risk of bias because of the choice of study design and interventions were often inadequately reported. Even when randomized designs were used, findings were difficult to generalize. Due to the very low quality of evidence, the effects of training in responsible conduct of research on reducing research misconduct are uncertain. Low quality evidence indicates that training about plagiarism, especially if it involves practical exercises and use of text-matching software, may reduce the occurrence of plagiarism.

Understanding Medical Research

MedlinePlus

... hear about the results of a new medical research study. Sometimes the results of one study seem ... a randomized controlled clinical trial? Where was the research done? If a new treatment was being tested, ...

Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

PubMed Central

Harrison, R; Dey, P; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R; Logue, J P; Leidecker, V; Hopwood, P

2001-01-01

In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11139305

Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

2014-01-01

The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

Reducing Developmental Risk for Emotional/Behavioral Problems: A Randomized Controlled Trial Examining the Tools for Getting Along Curriculum

ERIC Educational Resources Information Center

Daunic, Ann P.; Smith, Stephen W.; Garvan, Cynthia W.; Barber, Brian R.; Becker, Mallory K.; Peters, Christine D.; Taylor, Gregory G.; Van Loan, Christopher L.; Li, Wei; Naranjo, Arlene H.

2012-01-01

Researchers have demonstrated that cognitive-behavioral intervention strategies--such as social problem solving--provided in school settings can help ameliorate the developmental risk for emotional and behavioral difficulties. In this study, we report the results of a randomized controlled trial of Tools for Getting Along (TFGA), a social…

Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

ERIC Educational Resources Information Center

Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

2014-01-01

This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

ERIC Educational Resources Information Center

Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

2011-01-01

The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…

Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

ERIC Educational Resources Information Center

Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

2008-01-01

Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

Randomized Controlled Trial Examining the Effectiveness of a Tailored Self-Help Smoking-Cessation Intervention for Postsecondary Smokers

ERIC Educational Resources Information Center

Travis, Heather E.; Lawrance, Kelli-an G.

2009-01-01

Objective: Between September 2002 and February 2003, the authors assessed the effectiveness of a new, age-tailored, self-help smoking-cessation program for college students. Participants: College student smokers (N = 216) from 6 Ontario universities participated. Methods: The researchers used a randomized controlled trial with a 3-month telephone…

Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

ERIC Educational Resources Information Center

Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

2014-01-01

How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

DTIC Science & Technology

2014-10-01

alternative therapy for PTSD. Our collaborative group (Maharishi University of Management Research Institute, VA San Diego Healthcare System, University of...Prolonged Exposure, and PTSD Health Education, and are supervised by the research team for quality control . No study-related adverse events have...by the research team for quality control . For home practice, over 70% of subjects have indicated compliance with their home practice program (at

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

PubMed

Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

2012-02-01

Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (P<0.05), but not in the control groups (ns). In study 1, a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group (P<0.05), and a trend in the same direction was seen in study 2 (P=0.17). The results seen at 3 months were sustained up to 1 year. Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

PubMed

Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

2015-08-28

Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

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.

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

PubMed Central

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2017-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014–2015 school year. The study’s rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area. PMID:28936104

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

PubMed

Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

2016-07-06

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

PubMed Central

2016-01-01

Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

Training mentors of clinical and translational research scholars: a randomized controlled trial.

PubMed

Pfund, Christine; House, Stephanie C; Asquith, Pamela; Fleming, Michael F; Buhr, Kevin A; Burnham, Ellen L; Eichenberger Gilmore, Julie M; Huskins, W Charles; McGee, Richard; Schurr, Kathryn; Shapiro, Eugene D; Spencer, Kimberly C; Sorkness, Christine A

2014-05-01

To determine whether a structured mentoring curriculum improves research mentoring skills. The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors' self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors' awareness as measured by their self-reported retrospective change in MCA scores, mentees' ratings of their mentors' competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. A total of 283 mentor-mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors' behavior (P = .002) than those paired with control mentors. This RCT demonstrates that a competency-based research mentor training program can improve mentors' skills.

Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

NASA Astrophysics Data System (ADS)

Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

2018-02-01

The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

Rigorous Program Evaluations on a Budget: How Low-Cost Randomized Controlled Trials Are Possible in Many Areas of Social Policy

ERIC Educational Resources Information Center

Coalition for Evidence-Based Policy, 2012

2012-01-01

The increasing ability of social policy researchers to conduct randomized controlled trials (RCTs) at low cost could revolutionize the field of performance-based government. RCTs are widely judged to be the most credible method of evaluating whether a social program is effective, overcoming the demonstrated inability of other, more common methods…

Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

ERIC Educational Resources Information Center

Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

2009-01-01

The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

The Effects of Math Video Games on Learning: A Randomized Evaluation Study with Innovative Impact Estimation Techniques. CRESST Report 841

ERIC Educational Resources Information Center

Chung, Gregory K. W. K.; Choi, Kilchan; Baker, Eva L.; Cai, Li

2014-01-01

A large-scale randomized controlled trial tested the effects of researcher-developed learning games on a transfer measure of fractions knowledge. The measure contained items similar to standardized assessments. Thirty treatment and 29 control classrooms (~1500 students, 9 districts, 26 schools) participated in the study. Students in treatment…

A Literature Review of Randomized Controlled Trials of the Organization of Care at the End of Life

ERIC Educational Resources Information Center

Thomas, Roger E.; Wilson, Donna; Sheps, Sam

2006-01-01

We searched nine electronic databases for randomized controlled trials (RCTs) about care at the end of life and found 23 RCTs. We assessed their quality using the criteria of the Cochrane Collaboration. The RCTs researched three themes: (a) the effect of providing palliative care through dedicated community teams on quality of life, on the…

[Rethinking clinical research in surgical oncology. From comic opera to quality control].

PubMed

Evrard, Serge

2016-01-01

The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Impact of referral source and study applicants' preference for randomly assigned service on research enrollment, service engagement, and evaluative outcomes.

PubMed

Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

2005-04-01

The inability to blind research participants to their experimental conditions is the Achilles' heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants' preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Three Cox regression analyses measured the impact of applicants' service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice.

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

Engagement practices that join scientific methods with community wisdom: Designing a patient-centered, randomized control trial with a Pacific Islander Community

PubMed Central

Goulden, Peter A.; Bursac, Zoran; Hudson, Jonell; Purvis, Rachel S.; Yeary, Karen H. Kim; Aitaoto, Nia; Kohler, Peter O.

2016-01-01

This article illustrates how a collaborative research process can successfully engage an underserved minority community to address health disparities. Pacific Islanders, including the Marshallese, are one of the fastest growing US populations. They face significant health disparities, including extremely high rates of type 2 diabetes. This article describes the engagement process of designing patient-centered outcomes research with Marshallese stakeholders, highlighting the specific influences of their input on a randomized control trial to address diabetes. Over 18 months, an interdisciplinary research team used community-based participatory principles to conduct patient-engaged outcomes research that involved 31 stakeholders in all aspects of research design, from defining the research question to making decisions about budgets and staffing. This required academic researcher flexibility, but yielded a design linking scientific methodology with community wisdom. PMID:27325179

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Why we need more than just randomized controlled trials to establish the effectiveness of online social networks for health behavior change.

PubMed

Vandelanotte, Corneel; Maher, Carol A

2015-01-01

Despite their popularity and potential to promote health in large populations, the effectiveness of online social networks (e.g., Facebook) to improve health behaviors has been somewhat disappointing. Most of the research examining the effectiveness of such interventions has used randomized controlled trials (RCTs). It is asserted that the modest outcomes may be due to characteristics specific to both online social networks and RCTs. The highly controlled nature of RCTs stifles the dynamic nature of online social networks. Alternative and ecologically valid research designs that evaluate online social networks in real-life conditions are needed to advance the science in this area.

Quality Control for Interviews to Obtain Dietary Recalls from Children for Research Studies

PubMed Central

SHAFFER, NICOLE M.; THOMPSON, WILLIAM O.; BAGLIO, MICHELLE L.; GUINN, CAROLINE H.; FRYE, FRANCESCA H. A.

2005-01-01

Quality control is an important aspect of a study because the quality of data collected provides a foundation for the conclusions drawn from the study. For studies that include interviews, establishing quality control for interviews is critical in ascertaining whether interviews are conducted according to protocol. Despite the importance of quality control for interviews, few studies adequately document the quality control procedures used during data collection. This article reviews quality control for interviews and describes methods and results of quality control for interviews from two of our studies regarding the accuracy of children's dietary recalls; the focus is on quality control regarding interviewer performance during the interview, and examples are provided from studies with children. For our two studies, every interview was audio recorded and transcribed. The audio recording and typed transcript from one interview conducted by each research dietitian either weekly or daily were randomly selected and reviewed by another research dietitian, who completed a standardized quality control for interviews checklist. Major strengths of the methods of quality control for interviews in our two studies include: (a) interviews obtained for data collection were randomly selected for quality control for interviews, and (b) quality control for interviews was assessed on a regular basis throughout data collection. The methods of quality control for interviews described may help researchers design appropriate methods of quality control for interviews for future studies. PMID:15389417

WWC Review of the Report "Accommodations for English Language Learner Students: The Effect of Linguistic Modification of Math Test Item Sets"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

The research described in this report is a randomized controlled trial in which seventh- and eighth-grade students were randomly assigned to complete a set of 25 math questions delivered with either standard language or language that had undergone "linguistic modification" by the research team. The purpose of the study was to assess the…

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.

Implementing Mother Tongue Instruction in the Real World: Results from a Medium-Scale Randomized Controlled Trial in Kenya

ERIC Educational Resources Information Center

Piper, Benjamin; Zuilkowski, Stephanie S.; Ong'ele, Salome

2016-01-01

Research in sub-Saharan Africa investigating the effect of mother tongue (MT) literacy instruction at medium scale is limited. A randomized controlled trial of MT literacy instruction was implemented in 2013 and 2014 as part of the Primary Math and Reading (PRIMR) Initiative in Kenya. We compare the effect of two treatment groups--the base PRIMR…

The Heterogeneous Effect of Information on Student Performance: Evidence from a Randomized Control Trial in Mexico. Policy Research Working Paper 7422

ERIC Educational Resources Information Center

Avitabile, Ciro; de Hoyos, Rafael

2015-01-01

A randomized control trial was conducted to study whether providing 10th grade students with information about the returns to upper secondary and tertiary education, and a source of financial aid for tertiary education, can contribute to improve student performance. The study finds that the intervention had no effects on the probability of taking…

Prospective Randomized Trial of the Military Anti-Shock Garment

DTIC Science & Technology

1987-12-20

No prospective, controlled, randomized studies of !.’AST use were available in the scientific literature. Numerous --ports of MAST use were available...in the scientific literature. ,umerous reports of MAST causing compartment syndromes and amputations did appear in the literature. Beginning in 1983...research funding, computerization of these work sheets became possible, making analysis possible. In that no definitive or scientific clinically controlled

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Paradigm War Revived? On the Diagnosis of Resistance to Randomized Controlled Trials and Systematic Review in Education

ERIC Educational Resources Information Center

Hammersley, Martyn

2008-01-01

There has been considerable discussion in recent years about the role in educational research of randomized controlled trials (RCTs) and systematic reviews (SR). Advocacy of these methods arose partly as a result of the spread of the notion of evidence-based practice from medicine into other fields, and of the rise of the "new public…

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.

Examining clinical supervision as a mechanism for changes in practice: a research protocol.

PubMed

Dilworth, Sophie; Higgins, Isabel; Parker, Vicki; Kelly, Brian; Turner, Jane

2014-02-01

This paper describes the research protocol for a study exploring if and how clinical supervision facilitates change in practice relating to psychosocial aspects of care for Health Professionals, who have been trained to deliver a psychosocial intervention to adults with cancer. There is a recognized need to implement care that is in line with clinical practice guidelines for the psychosocial care of adults with cancer. Clinical supervision is recommended as a means to support Health Professionals in providing the recommended psychosocial care. A qualitative design embedded within an experimental, stepped wedge randomized control trial. The study will use discourse analysis to analyse audio-recorded data collected in clinical supervision sessions that are being delivered as one element of a large randomized control trial. The sessions will be attended primarily by nurses, but including physiotherapists, radiation therapists, occupational therapists. The Health Professionals are participants in a randomized control trial designed to reduce anxiety and depression of distressed adults with cancer. The sessions will be facilitated by psychiatrists experienced in psycho-oncology and the provision of clinical supervision. The proposed research is designed specifically to facilitate exploration of the mechanisms by which clinical supervision enables Health Professionals to deliver a brief, tailored psychosocial intervention in the context of their everyday practice. This is the first study to use discourse analysis embedded within an experimental randomized control trial to explore the mechanisms of change generated within clinical supervision by analysing the discourse within the clinical supervision sessions. © 2013 John Wiley & Sons Ltd.

Sexual Harassment Prevention Initiatives: Quantitative and Qualitative Approaches

DTIC Science & Technology

2010-10-28

design , and the time series with nonequivalent control group design . The experimental research approach will randomly assign participants...Leedy & Ormrod, 2005). According to Fife- Schaw (2006) there are three quasi-experimental designs : the nonequivalent control group design , the time...that have controlled and isolated variables. A specific quantitative approach available to the researcher is the use of surveys. Surveys, in

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...

Training Mentors of Clinical and Translational Research Scholars: A Randomized Controlled Trial

PubMed Central

Pfund, Christine; House, Stephanie C.; Asquith, Pamela; Fleming, Michael F.; Buhr, Kevin A.; Burnham, Ellen L.; Gilmore, Julie M. Eichenberger; Huskins, W. Charles; McGee, Richard; Schurr, Kathryn; Shapiro, Eugene D.; Spencer, Kimberly C.; Sorkness, Christine A.

2014-01-01

Purpose To determine whether a structured mentoring curriculum improves research mentoring skills. Method The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors’ self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors’ awareness as measured by their self-reported retrospective change in MCA scores, mentees’ ratings of their mentors’ competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. Results A total of 283 mentor–mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors’ behavior (P = .002) than those paired with control mentors. Conclusions This RCT demonstrates that a competency-based research mentor training program can improve mentors’ skills. PMID:24667509

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

DTIC Science & Technology

2010-01-01

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

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.

Omega 3/6 Fatty Acids for Reading in Children: A Randomized, Double-Blind, Placebo-Controlled Trial in 9-Year-Old Mainstream Schoolchildren in Sweden

ERIC Educational Resources Information Center

Johnson, Mats; Fransson, Gunnar; Östlund, Sven; Areskoug, Björn; Gillberg, Christopher

2017-01-01

Background: Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties. We aimed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren. Methods: We performed a 3-month parallel, randomized, double-blind, placebo-controlled trial followed by 3-month active…

Medical Students' and Tutors' Experiences of Directed and Self-Directed Learning Programs in Evidence-Based Medicine: A Qualitative Evaluation Accompanying a Randomized Controlled Trial

ERIC Educational Resources Information Center

Bradley, Peter; Oterholt, Christina; Nordheim, Lena; Bjorndal, Arild

2005-01-01

This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In…

How Important Is ‘Accuracy’ of Surrogate Decision-Making for Research Participation?

PubMed Central

Kim, Scott Y. H.; Kim, H. Myra; Ryan, Kerry A.; Appelbaum, Paul S.; Knopman, David S.; Damschroder, Laura; De Vries, Raymond

2013-01-01

Background There is a longstanding concern about the accuracy of surrogate consent in representing the health care and research preferences of those who lose their ability to decide for themselves. We sought informed, deliberative views of the older general public (≥50 years old) regarding their willingness to participate in dementia research and to grant leeway to future surrogates to choose an option contrary to their stated wishes. Methodology/Principal Findings 503 persons aged 50+ recruited by random digit dialing were randomly assigned to one of three groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after the deliberation session (or equivalent time), and one month after the session, regarding their willingness to participate in dementia research and to give leeway to surrogates, regarding studies of varying risk-benefit profiles (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial). At baseline, 48% (gene transfer scenario) to 92% (drug RCT) were willing to participate in future dementia research. A majority of respondents (57–71% depending on scenario) were willing to give leeway to future surrogate decision-makers. Democratic deliberation increased willingness to participate in all scenarios, to grant leeway in 3 of 4 scenarios (lumbar puncture, vaccine, and gene transfer), and to enroll loved ones in research in all scenarios. On average, respondents were more willing to volunteer themselves for research than to enroll their loved ones. Conclusions/Significance Most people were willing to grant leeway to their surrogates, and this willingness was either sustained or increased after democratic deliberation, suggesting that the attitude toward leeway is a reliable opinion. Eliciting a person’s current preferences about future research participation should also involve eliciting his or her leeway preferences. PMID:23382969

Impact of Referral Source and Study Applicants’ Preference for Randomly Assigned Service on Research Enrollment, Service Engagement, and Evaluative Outcomes

PubMed Central

Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

2009-01-01

Objective The inability to blind research participants to their experimental conditions is the Achilles’ heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants’ preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Method Three Cox regression analyses measured the impact of applicants’ service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. Results A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Conclusions Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice. PMID:15800153

Statistical process control in nursing research.

PubMed

Polit, Denise F; Chaboyer, Wendy

2012-02-01

In intervention studies in which randomization to groups is not possible, researchers typically use quasi-experimental designs. Time series designs are strong quasi-experimental designs but are seldom used, perhaps because of technical and analytic hurdles. Statistical process control (SPC) is an alternative analytic approach to testing hypotheses about intervention effects using data collected over time. SPC, like traditional statistical methods, is a tool for understanding variation and involves the construction of control charts that distinguish between normal, random fluctuations (common cause variation), and statistically significant special cause variation that can result from an innovation. The purpose of this article is to provide an overview of SPC and to illustrate its use in a study of a nursing practice improvement intervention. Copyright © 2011 Wiley Periodicals, Inc.

The crime prevention value of hot spots policing.

PubMed

Braga, Anthony A

2006-08-01

This paper reviews the available research evidence on the effectiveness of hot spots policing programs in reducing crime and disorder. The research identified five randomized controlled experiments and four non-equivalent control group quasi-experiments evaluating the effects of hot spots policing interventions on crime. Seven of nine selected evaluations reported noteworthy crime and disorder reductions. Meta-analyses of the randomized experiments revealed statistically significant mean effect sizes favoring hot spots policing interventions in reducing citizen calls for service in treatment places relative to control places. When immediate spatial displacement was measured, it was very limited and unintended crime prevention benefits were associated with the hot spots policing programs. The results of this review suggest that hot spots policing is an effective crime prevention strategy.

Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma

PubMed Central

Unguru, Yoram; Joffe, Steven; Fernandez, Conrad V.; Yu, Alice L.

2013-01-01

In 2009, the Children's Oncology Group (COG) phase III randomized controlled trial, ANBL0032, found that adding immunotherapy (Ch14.18) to standard therapy significantly improved outcomes in patients with high-risk neuroblastoma when administered within 110 days after autologous stem-cell transplantation (SCT). After careful deliberation and consultation, the COG Neuroblastoma Committee decided to offer Ch14.18 to prior trial participants who had been randomly assigned to the control arm (no immunotherapy), regardless of the time that had elapsed since SCT. This decision occurred in the context of a limited supply of Ch14.18 and no data regarding its role when administered beyond 110 days. In this article, we analyze the numerous ethical challenges highlighted by the ANBL0032 trial, including the limits of researchers' reciprocity-based obligations to study participants, post-trial access to beneficial therapies, and the balance between scientific knowledge and parental hope. These deliberations may be useful to other researchers when considering their ethical obligations to control-arm participants in the wake of a positive randomized trial. PMID:23295797

Causal inference from observational data.

PubMed

Listl, Stefan; Jürges, Hendrik; Watt, Richard G

2016-10-01

Randomized controlled trials have long been considered the 'gold standard' for causal inference in clinical research. In the absence of randomized experiments, identification of reliable intervention points to improve oral health is often perceived as a challenge. But other fields of science, such as social science, have always been challenged by ethical constraints to conducting randomized controlled trials. Methods have been established to make causal inference using observational data, and these methods are becoming increasingly relevant in clinical medicine, health policy and public health research. This study provides an overview of state-of-the-art methods specifically designed for causal inference in observational data, including difference-in-differences (DiD) analyses, instrumental variables (IV), regression discontinuity designs (RDD) and fixed-effects panel data analysis. The described methods may be particularly useful in dental research, not least because of the increasing availability of routinely collected administrative data and electronic health records ('big data'). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Engagement and Retention of Suicide Attempters in Clinical Research

PubMed Central

Gibbons, Carly J.; Stirman, Shannon Wiltsey; Brown, Gregory K.; Beck, Aaron T.

2010-01-01

Background High attrition rates in longitudinal research can limit study generalizability, threaten internal validity, and decrease statistical power. Research has demonstrated that there can be significant differences between participants who complete a research study and those who drop out prematurely, and that treatment outcomes may be dependent on retention in a treatment protocol. Aims The current paper describes the challenges encountered when implementing a randomized controlled trial of cognitive therapy for the prevention of suicide attempts and the solutions developed to overcome these problems. Methods Problems unique to suicide attempters are discussed, and strategies successfully implemented to boost retention rates are provided. Results The methods implemented appeared to increase retention rates in the randomized controlled trial. Conclusions Many steps can be taken to work with this difficult population, and researchers are encouraged to be as involved and flexible with participants as possible. PMID:20418211

Clinical outcomes research in gynecologic oncology.

PubMed

Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

Put Me in Coach: A Commentary on the RPSD Exchange.

ERIC Educational Resources Information Center

Hardman, Michael L.

2003-01-01

This commentary discusses principles concerning requirements for scientifically based research under No Child Left Behind: scientific inquiry begins with important research questions, not specific methodologies; the logic that scientifically based research equates with randomized controlled trials will result in research and practice disconnects;…

Reporting guidelines for primary research: Saying what you did.

PubMed

O'Connor, Annette

2010-12-01

Reporting guidelines aim to facilitate publication of a full and accurate description of research conducted. The motivations for a full and accurate description of research is to enable reproduction of the study, assessment of bias, extraction of data from the study, and to fulfill an ethical obligation to maximize the utility of research findings. Many reporting guidelines exist and most are based on a specific study design such as randomized controlled trials (CONSORT statement) and observational studies (STROBE statement). The REFLECT statement focuses on randomized control trials in livestock and food safety studies. The REFLECT statement has increased emphasis on conveying information about animal housing, group level allocation and challenge studies. Guidelines can be used by authors, reviewers and editors to provide readers with a full and accurate description of the work conducted. Copyright © 2010 Elsevier B.V. All rights reserved.

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial.

PubMed

Wong, Y Joel; Owen, Jesse; Gabana, Nicole T; Brown, Joshua W; McInnis, Sydney; Toth, Paul; Gilman, Lynn

2018-03-01

Although the past decade has witnessed growing research interest in positive psychological interventions (PPIs), their potential as adjunctive interventions for psychotherapy remains relatively unexplored. Therefore, this article expands the frontiers of PPI research by reporting the first randomized controlled trial to test a gratitude writing adjunctive intervention for psychotherapy clients. Participants were 293 adults seeking university-based psychotherapy services. Participants were randomly assigned to one of three conditions: (a) control (psychotherapy only), (b) a psychotherapy plus expressive writing, and (c) a psychotherapy plus gratitude writing. Participants in the gratitude condition wrote letters expressing gratitude to others, whereas those in the expressive writing condition wrote about their deepest thoughts and feelings about stressful experiences. About 4 weeks as well as 12 weeks after the conclusion of the writing intervention, participants in the gratitude condition reported significantly better mental health than those in the expressive and control conditions, whereas those in the expressive and control conditions did not differ significantly. Moreover, lower proportions of negative emotion words in participants' writing mediated the positive effect of condition (gratitude versus expressive writing) on mental health. These findings are discussed in light of the use of gratitude interventions as adjunctive interventions for psychotherapy clients.

Comparing three knowledge communication strategies - Diffusion, Dissemination and Translation - through randomized controlled studies.

PubMed

Lane, Joseph P; Stone, Vathsala I

2015-01-01

This paper describes a series of three randomized controlled case studies comparing the effectiveness of three strategies for communicating new research-based knowledge (Diffusion, Dissemination, Translation), to different Assistive Technology (AT) stakeholder groups. Pre and post intervention measures for level of knowledge use (unaware, aware, interested, using) via the LOKUS instrument, assessed the relative effectiveness of the three strategies. The latter two approaches were both more effective than diffusion but also equally effective. The results question the value added by tailoring research findings to specific audiences, and instead supports the critical yet neglected role for relevance in determining knowledge use by stakeholders.

Nonlinear analyses of composite aerospace structures in sonic fatigue

NASA Technical Reports Server (NTRS)

Mei, Chuh

1993-01-01

This report summarizes the semiannual research progress, accomplishments, and future plans performed under the NASA Langley Research Center Grant No. NAG-1-1358. The primary research effort of this project is the development of analytical methods for the prediction of nonlinear random response of composite aerospace structures subjected to combined acoustic and thermal loads. The progress, accomplishments, and future plates on four sonic fatigue research topics are described. The sonic fatigue design and passive control of random response of shape memory alloy hybrid composites presented in section 4, which is suited especially for HSCT, is a new initiative.

Nonlinear analyses of composite aerospace structures in sonic fatigue

NASA Astrophysics Data System (ADS)

Mei, Chuh

1993-06-01

This report summarizes the semiannual research progress, accomplishments, and future plans performed under the NASA Langley Research Center Grant No. NAG-1-1358. The primary research effort of this project is the development of analytical methods for the prediction of nonlinear random response of composite aerospace structures subjected to combined acoustic and thermal loads. The progress, accomplishments, and future plates on four sonic fatigue research topics are described. The sonic fatigue design and passive control of random response of shape memory alloy hybrid composites presented in section 4, which is suited especially for HSCT, is a new initiative.

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

PubMed

Martínez-Alonso, E; Ramos, J M

2016-06-01

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

75 FR 39220 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... free to choose experimental, quasi-experimental, case-control, or other applicable research designs...: Nothing in the priority either precludes or requires the use of randomized experimental trials of VR...

Implementation of Possession Laws and the Social Ecology of Tobacco Control

ERIC Educational Resources Information Center

Livingood, William C.; Woodhouse, Lynn D.; Wludyka, Peter

2009-01-01

The objective of this evaluation research was to assess the impact of programs intended to support the enforcement component of a comprehensive youth tobacco control. The research method was a survey of a randomly stratified cluster sample of law enforcement officers. Results of the evaluation showed that the enforcement behaviors of officers were…

Improving Preschoolers' Mathematics Achievement with Tablets: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Schacter, John; Jo, Booil

2017-01-01

With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered…

Randomized Trial of Suicide Gatekeeper Training for Social Work Students

ERIC Educational Resources Information Center

Jacobson, Jodi M.; Osteen, Phillip J.; Sharpe, Tanya L.; Pastoor, Jennifer B.

2012-01-01

Problem: Education and research on social work's role in preventing client suicide is limited. Method: Seventy advanced master of social work students were randomly assigned to either the training group (Question, Persuade, and Referral suicide gatekeeper training) or the control group. Outcomes measured over time included suicide knowledge,…

Randomized Controlled Studies and Alternative Designs in Outcome Studies: Challenges and Opportunities

ERIC Educational Resources Information Center

Shadish, William R.

2011-01-01

This article reviews several decades of the author's meta-analytic and experimental research on the conditions under which nonrandomized experiments can approximate the results from randomized experiments (REs). Several studies make clear that we can expect accurate effect estimates from the regression discontinuity design, though its statistical…

Effects of combination oral care on oral health, dry mouth and salivary pH of intubated patients: A randomized controlled trial.

PubMed

Jang, Chun Sun; Shin, Yong Soon

2016-10-01

Intubated patients are at risk of oral health problems. Although a variety of oral care regimens for intubated patients have been studied, there is a lack of research on the effects of combination oral care that includes tooth brushing, chlorhexidine and cold water. This open-labelled, randomized, controlled trial aimed to evaluate the effects of combination oral care on oral health status. Participants aged 20 years and older were recruited on the first day after intubation through convenience sampling in a medical intensive care unit. Random assignment was performed using an internet randomization service. The primary outcome was oral health status. Data were collected during May and June 2013. Participants were randomized to one of two groups (23 intervention and 21 control). The final analysis included 18 patients with combination oral care and 17 in the control group. The intervention group had better oral health (effect size = 1.56), less dry mouth and higher salivary pH than the control group. Any additional burden of providing combination oral care to patients who are mechanically ventilated is worthwhile in terms of clinical outcomes. © 2016 John Wiley & Sons Australia, Ltd.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial.

PubMed

Rowe, Sarah L; Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-30

Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG). ©Sarah L Rowe, Krisna Patel, Rebecca S French, Claire Henderson, Dennis Ougrin, Mike Slade, Paul Moran. Originally published in JMIR Mental Health (http://mental.jmir.org), 30.01.2018.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial

PubMed Central

Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-01

Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. Trial Registration International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG) PMID:29382626

Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

PubMed Central

Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

2011-01-01

Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

PubMed

Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

2011-05-01

To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs.

PubMed

Schelvis, Roosmarijn M C; Oude Hengel, Karen M; Burdorf, Alex; Blatter, Birgitte M; Strijk, Jorien E; van der Beek, Allard J

2015-09-01

Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of alternative designs for the evaluation of occupational health interventions, which permit causal inferences, formulated along two study design approaches: experimental (stepped-wedge) and observational (propensity scores, instrumental variables, multiple baseline design, interrupted time series, difference-in-difference, and regression discontinuity). For each design, the unique characteristics are presented including the advantages and disadvantages compared to the RCT, illustrated by empirical examples in occupational health. This overview shows that several appropriate alternatives for the RCT design are feasible and available, which may provide sufficiently strong evidence to guide decisions on implementation of interventions in workplaces. Researchers are encouraged to continue exploring these designs and thus contribute to evidence-based occupational health.

A randomized controlled trial of skin care protocols for facial resurfacing: lessons learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research study.

PubMed

Pannucci, Christopher J; Reavey, Patrick L; Kaweski, Susan; Hamill, Jennifer B; Hume, Keith M; Wilkins, Edwin G; Pusic, Andrea L

2011-03-01

The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.

WWC Review of the Report "Closing the Achievement Gap through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten." What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2015

2015-01-01

In the 2014 report, "Closing the Achievement Gap Through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten," researchers examined the impacts of "Tools of the Mind" on cognitive and academic…

Are results of randomized controlled trials useful to psychotherapists?

PubMed

Persons, J B; Silberschatz, G

1998-02-01

Two clinicians provided opposite answers to the title question: Persons argued that information from randomized controlled trials (RCTs) is vital to clinicians, and Silberschatz argued that information from RCTs is irrelevant to clinicians. Persons argued that clinicians cannot provide top quality care to their patients without attending to findings of RCTs and that clinicians have an ethical responsibility to inform patients about, recommend, and provide treatments supported by RCTs before informing patients about, recommending, and providing treatments shown to be inferior in RCTs or not evaluated in RCTs. Silberschatz argued that RCTs do not and cannot answer questions that concern practicing clinicians. He advocates alternative research approaches (effectiveness studies, quasi-experimental methods, case-specific research) for studying psychotherapy.

Expert Opinion Is Necessary: Delphi Panel Methodology Facilitates a Scientific Approach to Consensus.

PubMed

Hohmann, Erik; Brand, Jefferson C; Rossi, Michael J; Lubowitz, James H

2018-02-01

Our current trend and focus on evidence-based medicine is biased in favor of randomized controlled trials, which are ranked highest in the hierarchy of evidence while devaluing expert opinion, which is ranked lowest in the hierarchy. However, randomized controlled trials have weaknesses as well as strengths, and no research method is flawless. Moreover, stringent application of scientific research techniques, such as the Delphi Panel methodology, allows survey of experts in a high quality and scientific manner. Level V evidence (expert opinion) remains a necessary component in the armamentarium used to determine the answer to a clinical question. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Clinical Knowledge from Observational Studies: Everything You Wanted to Know but Were Afraid to Ask.

PubMed

Gershon, Andrea S; Jafarzadeh, S Reza; Wilson, Kevin C; Walkey, Allan J

2018-05-07

Well-done randomized trials provide accurate estimates of treatment effect by producing groups that are similar on all measures except for the intervention of interest. However, inferences of efficacy in tightly-controlled experimental settings may not translate into similar effectiveness in real-world settings. Observational studies generally enable inferences over a wider range of patient characteristics and evaluation of a broader range of outcomes over a longer period than randomized trials. However, clinicians are often reluctant to incorporate the findings of observational studies into clinical practice. Reason for uncertainty regarding observational studies include a lack of familiarity with observational research methods, occasional disagreements between results of observational studies and randomized trials, the perceived risk of spurious results from systematic bias, and prior teaching that randomized trials are the most reliable source of medical evidence. We propose that a better understanding of observational research will enhance clinicians' ability to distinguish reliable observational studies from those that are subjected to biases and, therefore, provide more confidence to apply observational research results into clinical practice when appropriate. Herein, we explain why observational studies may be perceived as less conclusive than randomized trials, address situations in which observational research and randomized trials produced different findings, and provide information on observational study design so that quality can be evaluated. We conclude that observational research is a valuable source of medical evidence and that clinical action is strongest when supported by both high quality observational studies and randomized trials.

[Scientific research in public health institutions of the City of Buenos Aires].

PubMed

Ferrero, Fernando; Ossorio, María Fabiana; Eiguch, Kumiko

2013-01-01

Hospitals with academic activities offer better services to their patients. The Government of Buenos Aires City (GBAC) has an important network of health facilities, but there is little information regarding their academic activities. Our aim was to estimate the proportion of articles included in MEDLINE originated in GBAC hospitals, to evaluate their contribution regarding the whole country (Argentina), and to describe some characteristics of these papers. It is a cross-sectional study based on a MEDLINE search, using the name of each of the 33 GBAC hospitals in the "affiliation" field. Among 22 million references, 1781 belonged to GBAC hospitals (4.4% of all references from Argentina); 66.5% were in English, 83.7% were related to humans, 30.1% were from the last 5 years, 8.3% included high level scientific evidence research (meta-analysis or randomized controlled trials), and 31.1% included research in children. Regarding the rest of the references from Argentina, those from GBAC hospitals included less papers in English (66.5% vs. 90.0%; OR: 0.22; p < 0.0001), less recent papers (30.1% vs. 34.6%; OR: 0.81; p < 0.0001), more research in humans (83.7% vs. 37.3%; OR: 8.65; p < 0.0001), more randomized controlled trials (8.0% vs. 2.8%; OR: 2,9; p < 0.0001), and more research in children (31.1% vs. 9.2%; OR: 4.44; p < 0.0001). GBAC hospitals contributed with 4.4% of references attributed to Argentina in MEDLINE. References from GBAC hospitals were less recent, and included more randomized controlled trials and research in children.

Rehabilitation R and D Progress Reports, 1991

DTIC Science & Technology

1991-01-01

FES) is a challeng- work of our group , we are addressing the problem ing problem. A crucial difficulty is controlling the of designing a functional FES... control data. Background infor- research to design and evaluate interventions which mation will be obtained on the visual, sensory, help to reduce the...the senior was randomly Larger scale research is planned to investigate assigned to either a control or service group . the incidence of minor accidents

Hybrid Implementation Model of Community-Partnered Early Intervention for Toddlers with Autism: A Randomized Trial

ERIC Educational Resources Information Center

Shire, Stephanie Y.; Chang, Ya-Chih; Shih, Wendy; Bracaglia, Suzanne; Kodjoe, Maria; Kasari, Connie

2017-01-01

Background: Interventions found to be effective in research settings are often not as effective when implemented in community settings. Considering children with autism, studies have rarely examined the efficacy of laboratory-tested interventions on child outcomes in community settings using randomized controlled designs. Methods: One hundred and…

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

PubMed

Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward; Johnson, Dayna; Considine, Shannon; Bourgeois, Renee; Melkonian, Christina; Miree, Cheryl; Johnson, Christine Cole; Lu, Mei

2016-01-01

Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings. We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention. 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

Enhancing students’ mathematical problem posing skill through writing in performance tasks strategy

NASA Astrophysics Data System (ADS)

Kadir; Adelina, R.; Fatma, M.

2018-01-01

Many researchers have studied the Writing in Performance Task (WiPT) strategy in learning, but only a few paid attention on its relation to the problem-posing skill in mathematics. The problem-posing skill in mathematics covers problem reformulation, reconstruction, and imitation. The purpose of the present study was to examine the effect of WiPT strategy on students’ mathematical problem-posing skill. The research was conducted at a Public Junior Secondary School in Tangerang Selatan. It used a quasi-experimental method with randomized control group post-test. The samples were 64 students consists of 32 students of the experiment group and 32 students of the control. A cluster random sampling technique was used for sampling. The research data were obtained by testing. The research shows that the problem-posing skill of students taught by WiPT strategy is higher than students taught by a conventional strategy. The research concludes that the WiPT strategy is more effective in enhancing the students’ mathematical problem-posing skill compared to the conventional strategy.

Peer-counseling for women newly diagnosed with breast cancer: A randomized community/research collaboration trial.

PubMed

Giese-Davis, Janine; Bliss-Isberg, Caroline; Wittenberg, Lynne; White, Jennifer; Star, Path; Zhong, Lihong; Cordova, Matthew J; Houston, Debra; Spiegel, David

2016-08-01

We conducted a randomized controlled trial of peer-counseling for newly diagnosed breast cancer (BC) patients as a community/research collaboration testing an intervention developed jointly by a community-based-organization serving women with cancer and university researchers. We recruited 104 women newly diagnosed with BC at any disease stage. Prior to randomization, all received a one-time visit with an oncology nurse who offered information and resources. Afterwards, we randomized half to receive a match with a Navigator with whom they could have contact for up to 6 months. We recruited, trained, and supervised 30 peer counselors who became "Navigators." They were at least one-year post-diagnosis with BC. Controls received no further intervention. We tested the effect of intervention on breast-cancer-specific well-being and trauma symptoms as primary outcomes, and several secondary outcomes. In exploratory analyses, we tested whether responding to their diagnosis as a traumatic stressor moderated outcomes. We found that, compared with the control group, receiving a peer-counseling intervention significantly improved breast-cancer-specific well-being (p=0.01, Cohen's d=0.41) and maintained marital adjustment (p=0.01, Cohen's d=0.45) more effectively. Experiencing the diagnosis as a traumatic stressor moderated outcomes: those with a peer counselor in the traumatic stressor group improved significantly more than controls on well-being, trauma and depression symptoms, and cancer self-efficacy. Having a peer counselor trained and supervised to recognize and work with trauma symptoms can improve well-being and psychosocial morbidity during the first year following diagnosis of BC. Cancer 2016;122:2408-2417. © 2016 American Cancer Society. © 2016 American Cancer Society.

Implementation research design: integrating participatory action research into randomized controlled trials

PubMed Central

Leykum, Luci K; Pugh, Jacqueline A; Lanham, Holly J; Harmon, Joel; McDaniel, Reuben R

2009-01-01

Background A gap continues to exist between what is known to be effective and what is actually delivered in the usual course of medical care. The goal of implementation research is to reduce this gap. However, a tension exists between the need to obtain generalizeable knowledge through implementation trials, and the inherent differences between healthcare organizations that make standard interventional approaches less likely to succeed. The purpose of this paper is to explore the integration of participatory action research and randomized controlled trial (RCT) study designs to suggest a new approach for studying interventions in healthcare settings. Discussion We summarize key elements of participatory action research, with particular attention to its collaborative, reflective approach. Elements of participatory action research and RCT study designs are discussed and contrasted, with a complex adaptive systems approach used to frame their integration. Summary The integration of participatory action research and RCT design results in a new approach that reflects not only the complex nature of healthcare organizations, but also the need to obtain generalizeable knowledge regarding the implementation process. PMID:19852784

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

PubMed

Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

2015-11-01

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

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework

PubMed Central

Young, Diana L.; Goodie, Adam S.; Hall, Daniel B.

2010-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one’s knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed. PMID:21278906

Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework.

PubMed

Young, Diana L; Goodie, Adam S; Hall, Daniel B

2011-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one's knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed.

Animal research as a basis for clinical trials.

PubMed

Faggion, Clovis M

2015-04-01

Animal experiments are critical for the development of new human therapeutics because they provide mechanistic information, as well as important information on efficacy and safety. Some evidence suggests that authors of animal research in dentistry do not observe important methodological issues when planning animal experiments, for example sample-size calculation. Low-quality animal research directly interferes with development of the research process in which multiple levels of research are interconnected. For example, high-quality animal experiments generate sound information for the further planning and development of randomized controlled trials in humans. These randomized controlled trials are the main source for the development of systematic reviews and meta-analyses, which will generate the best evidence for the development of clinical guidelines. Therefore, adequate planning of animal research is a sine qua non condition for increasing efficacy and efficiency in research. Ethical concerns arise when animal research is not performed with high standards. This Focus article presents the latest information on the standards of animal research in dentistry, more precisely in the field of implant dentistry. Issues on precision and risk of bias are discussed, and strategies to reduce risk of bias in animal research are reported. © 2015 Eur J Oral Sci.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

PubMed

Jermendy, György

2018-04-01

The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

Review of Yoga Therapy During Cancer Treatment

PubMed Central

Danhauer, Suzanne C.; Addington, Elizabeth L.; Sohl, Stephanie J.; Chaoul, Alejandro; Cohen, Lorenzo

2017-01-01

Purpose Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Methods Studies were identified via research databases and reference lists. Inclusion criteria: (1) children or adults undergoing cancer treatment; (2) intervention stated as yoga or component of yoga; and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria: (1) samples receiving hormone therapy only; (2) interventions involving only meditation; and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results Results of non-randomized (adult: n=8, pediatric: n=4) and randomized controlled trials (adult: n=13, pediatric: n=0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Conclusions Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines. PMID:28064385

Improving the evidence base in palliative care to inform practice and policy: thinking outside the box.

PubMed

Aoun, Samar M; Nekolaichuk, Cheryl

2014-12-01

The adoption of evidence-based hierarchies and research methods from other disciplines may not completely translate to complex palliative care settings. The heterogeneity of the palliative care population, complexity of clinical presentations, and fluctuating health states present significant research challenges. The aim of this narrative review was to explore the debate about the use of current evidence-based approaches for conducting research, such as randomized controlled trials and other study designs, in palliative care, and more specifically to (1) describe key myths about palliative care research; (2) highlight substantive challenges of conducting palliative care research, using case illustrations; and (3) propose specific strategies to address some of these challenges. Myths about research in palliative care revolve around evidence hierarchies, sample heterogeneity, random assignment, participant burden, and measurement issues. Challenges arise because of the complex physical, psychological, existential, and spiritual problems faced by patients, families, and service providers. These challenges can be organized according to six general domains: patient, system/organization, context/setting, study design, research team, and ethics. A number of approaches for dealing with challenges in conducting research fall into five separate domains: study design, sampling, conceptual, statistical, and measures and outcomes. Although randomized controlled trials have their place whenever possible, alternative designs may offer more feasible research protocols that can be successfully implemented in palliative care. Therefore, this article highlights "outside the box" approaches that would benefit both clinicians and researchers in the palliative care field. Ultimately, the selection of research designs is dependent on a clearly articulated research question, which drives the research process. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Randomized Trial of Healthy Families Arizona: Quantitative and Qualitative Outcomes

ERIC Educational Resources Information Center

LeCroy, Craig Winston; Davis, Melinda F.

2017-01-01

Home visitation has the potential to improve parent, child, and maternal outcomes and has become a widely implemented prevention program across the United States. The purpose of this research was to use a randomized controlled trial to assess the short-term effectiveness of the Arizona Healthy Families program across a range of outcomes. Two…

A Randomized Trial of Brief Interventions for Problem and Pathological Gamblers

ERIC Educational Resources Information Center

Petry, Nancy M.; Weinstock, Jeremiah; Ledgerwood, David M.; Morasco, Benjamin

2008-01-01

Limited research exists regarding methods for reducing problem gambling. Problem gamblers (N = 180) were randomly assigned to assessment only control, 10 min of brief advice, 1 session of motivational enhancement therapy (MET), or 1 session of MET plus 3 sessions of cognitive-behavioral therapy. Gambling was assessed at baseline, at 6 weeks, and…

Big Math for Little Kids: The Effectiveness of a Preschool and Kindergarten Mathematics Curriculum

ERIC Educational Resources Information Center

Lewis Presser, Ashley; Clements, Margaret; Ginsburg, Herbert; Ertle, Barbrina

2015-01-01

Research Findings: Big Math for Little Kids (BMLK) is a mathematics curriculum developed for use with 4- and 5-year-old children. To investigate the BMLK curriculum's effect on children's mathematics knowledge, this cluster-randomized controlled trial randomly assigned child care centers to provide mathematics instruction to children, using either…

77 FR 5850 - Notice of Random Assignment Study To Evaluate Workforce Investment Act Adult and Dislocated...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

...: One commenter was concerned about 50 percent of the participants being placed in a control group. The... impact methodology for the evaluation. The design of the study was described as follows: The evaluation... eligible for intensive services would be randomly assigned to one of three groups. The three research...

WWC Review of the Report "Same-Language-Subtitling (SLS): Using Subtitled Music Video for Reading Growth". What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

This randomized controlled trial examined the impacts of "Same-Language-Subtitling" ("SLS"), a karaoke-style subtitling intervention, on the reading comprehension skills of secondary school students in Kaneohe, Hawaii. Researchers randomly assigned 198 secondary school students with learning disabilities (ages 14 to 19) to…

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2013-10-01

and Therapy, 47, 902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing ( EMDR ): Basic principles...Hopper, E. K., Korn, D. L., & Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine...Josef Ruzek, Ph.D. CONTRACTING ORGANIZATION: Palo Alto Institute for Research and Education Palo Alto, CA 94304 REPORT

Motivational Interviewing delivered by existing prison staff: a randomized controlled study of effectiveness on substance use after release.

PubMed

Forsberg, Lars Georg; Ernst, Denise; Sundqvist, Kristina; Farbring, Carl Åke

2011-01-01

A sample of 296 drug-using inmates in 14 Swedish prisons was randomized during 2004-2006 into three intervention groups; Motivational Interviewing delivered by counselors with workshop-only training, or by counselors with workshop training followed by peer group supervision, and controls. Drug and alcohol use was measured by the Addiction Severity Index (ASI) at intake and at 10 months after release. Complete data from 114 clients were analyzed by a stepwise regression analysis. All three groups reduced alcohol and drug use. Limitations in the study are discussed and future research is suggested. The study is financed by grants from the Research Committee of the National Prison and Probation Administration.

The advocacy in action study a cluster randomized controlled trial to reduce pedestrian injuries in deprived communities.

PubMed

Lyons, R A; Towner, E; Christie, N; Kendrick, D; Jones, S J; Hayes, M; Kimberlee, R; Sarvotham, T; Macey, S; Brussoni, M; Sleney, J; Coupland, C; Phillips, C

2008-04-01

Road traffic-related injury is a major global public health problem. In most countries, pedestrian injuries occur predominantly to the poorest in society. A number of evaluated interventions are effective in reducing these injuries. Very little research has been carried out into the distribution and determinants of the uptake of these interventions. Previous research has shown an association between local political influence and the distribution of traffic calming after adjustment for historical crash patterns. This led to the hypothesis that advocacy could be used to increase local politicians knowledge of pedestrian injury risk and effective interventions, ultimately resulting in improved pedestrian safety. To design an intervention to improve the uptake of pedestrian safety measures in deprived communities. Electoral wards in deprived areas of England and Wales with a poor record of pedestrian safety for children and older adults. Design mixedmethods study, incorporating a cluster randomized controlled trial. Data mixture of Geographical Information Systems data collision locations, road safety interventions, telephone interviews, and questionnaires. Randomization 239 electoral wards clustered within 57 local authorities. Participants 615 politicians representing intervention and control wards. Intervention a package of tailored information including maps of pedestrian injuries was designed for intervention politicians, and a general information pack for controls. Primary outcome number of road safety interventions 25 months after randomization. Secondary outcomes politicians interest and involvement in injury prevention cost of interventions. Process evaluation use of advocacy pack, facilitators and barriers to involvement, and success.

Approaches to answering critical CER questions.

PubMed

Kinnier, Christine V; Chung, Jeanette W; Bilimoria, Karl Y

2015-01-01

While randomized controlled trials (RCTs) are the gold standard for research, many research questions cannot be ethically and practically answered using an RCT. Comparative effectiveness research (CER) techniques are often better suited than RCTs to address the effects of an intervention under routine care conditions, an outcome otherwise known as effectiveness. CER research techniques covered in this section include: effectiveness-oriented experimental studies such as pragmatic trials and cluster randomized trials, treatment response heterogeneity, observational and database studies including adjustment techniques such as sensitivity analysis and propensity score analysis, systematic reviews and meta-analysis, decision analysis, and cost effectiveness analysis. Each section describes the technique and covers the strengths and weaknesses of the approach.

78 FR 32394 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

... to account for the randomized, controlled, experimental design of the proposed research and..., the Agency undertook consumer research to evaluate alternatives (Refs. 1 to 3). More recently, FDA conducted qualitative consumer research on the format of the Nutrition Facts label on behalf of the Agency's...

What Works May Hurt: Side Effects in Education

ERIC Educational Resources Information Center

Zhao, Yong

2017-01-01

Medical research is held as a field for education to emulate. Education researchers have been urged to adopt randomized controlled trials, a more "scientific" research method believed to have resulted in the advances in medicine. But a much more important lesson education needs to borrow from medicine has been ignored. That is the study…

Intervention Research and Program Evaluation in the School Setting: Issues and Alternative Research Designs

ERIC Educational Resources Information Center

de Anda, Diane

2007-01-01

This article discusses the difficulties in conducting intervention research or evaluating intervention programs in a school setting. In particular, the problems associated with randomization and obtaining control groups are examined. The use of quasi-experimental designs, specifically a paired comparison design using the individual as his or her…

ENHANCEMENT OF LEARNING ON SAMPLE SIZE CALCULATION WITH A SMARTPHONE APPLICATION: A CLUSTER-RANDOMIZED CONTROLLED TRIAL.

PubMed

Ngamjarus, Chetta; Chongsuvivatwong, Virasakdi; McNeil, Edward; Holling, Heinz

2017-01-01

Sample size determination usually is taught based on theory and is difficult to understand. Using a smartphone application to teach sample size calculation ought to be more attractive to students than using lectures only. This study compared levels of understanding of sample size calculations for research studies between participants attending a lecture only versus lecture combined with using a smartphone application to calculate sample sizes, to explore factors affecting level of post-test score after training sample size calculation, and to investigate participants’ attitude toward a sample size application. A cluster-randomized controlled trial involving a number of health institutes in Thailand was carried out from October 2014 to March 2015. A total of 673 professional participants were enrolled and randomly allocated to one of two groups, namely, 341 participants in 10 workshops to control group and 332 participants in 9 workshops to intervention group. Lectures on sample size calculation were given in the control group, while lectures using a smartphone application were supplied to the test group. Participants in the intervention group had better learning of sample size calculation (2.7 points out of maximnum 10 points, 95% CI: 24 - 2.9) than the participants in the control group (1.6 points, 95% CI: 1.4 - 1.8). Participants doing research projects had a higher post-test score than those who did not have a plan to conduct research projects (0.9 point, 95% CI: 0.5 - 1.4). The majority of the participants had a positive attitude towards the use of smartphone application for learning sample size calculation.

The prevalence of patient engagement in published trials: a systematic review.

PubMed

Fergusson, Dean; Monfaredi, Zarah; Pussegoda, Kusala; Garritty, Chantelle; Lyddiatt, Anne; Shea, Beverley; Duffett, Lisa; Ghannad, Mona; Montroy, Joshua; Hassan Murad, M; Pratt, Misty; Rader, Tamara; Shorr, Risa; Yazdi, Fatemeh

2018-01-01

With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials. The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included. Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results. The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined.

Control of the peachtree borer using beneficial nematodes

USDA-ARS?s Scientific Manuscript database

The peachtree borer, Synanthedon exitiosa, is a major pest of peaches and other stone fruits. Our research indicates that entomopathogenic nematodes, also known as beneficial nematodes, can be used effectively to control the insect. We conducted replicated experiments in randomized block designs ov...

Evaluation of Electromyographic Biofeedback for the Quadriceps Femoris: A Systematic Review

PubMed Central

Wasielewski, Noah J.; Parker, Tonya M.; Kotsko, Kevin M.

2011-01-01

Objective: To critically review evidence for the effectiveness of electromyographic biofeedback (EMGB) of the quadriceps femoris muscle in treating various knee conditions. Data Sources: Databases used to locate randomized controlled trials included PubMed (1980–2010), Cumulative Index of Nursing and Allied Health Literature (CINAHL, 1995–2007), Web of Science (1986–2010), SPORTDiscus (1990–2007), and Physiotherapy Evidence Database (PEDro). Key words were knee and biofeedback. Study Selection: The criteria for selection were clinical randomized controlled trials in which EMGB of the quadriceps femoris was used for various knee conditions of musculoskeletal origin. Trials were excluded because of research designs other than randomized controlled trials, articles published in a non-English language, inclusion of healthy research participants, inability to identify EMGB as the source of clinical improvement, and lack of pain, functional outcome, or quadriceps torque as outcome measures. Data Extraction: Twenty specific data points were abstracted from each clinical trial under the broad categories of attributes of the patient and injury, treatment variables for the EMGB group, treatment variables for the control group, and attributes of the research design. Data Synthesis: Eight trials yielded a total of 319 participants with patellofemoral pain syndrome (n = 86), anterior cruciate ligament reconstruction (n = 52), arthroscopic surgery (n = 91), or osteoarthritis (n = 90). The average methodologic score of the included studies was 4.6/10 based on PEDro criteria. Pooled analyses demonstrated heterogeneity of the included studies, rendering the interpretation of the pooled data inappropriate. The EMGB appeared to benefit short-term postsurgical pain or quadriceps strength in 3 of 4 postsurgical investigations but was ineffective for chronic knee conditions such as patellofemoral pain and osteoarthritis in all 4 studies. Because the findings are based on limited data, caution is warranted until more randomized controlled trials are conducted to support or refute the general trends observed in this report. PMID:22488142

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

PubMed

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

2009-10-01

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

Research of MPPT for photovoltaic generation based on two-dimensional cloud model

NASA Astrophysics Data System (ADS)

Liu, Shuping; Fan, Wei

2013-03-01

The cloud model is a mathematical representation to fuzziness and randomness in linguistic concepts. It represents a qualitative concept with expected value Ex, entropy En and hyper entropy He, and integrates the fuzziness and randomness of a linguistic concept in a unified way. This model is a new method for transformation between qualitative and quantitative in the knowledge. This paper is introduced MPPT (maximum power point tracking, MPPT) controller based two- dimensional cloud model through analysis of auto-optimization MPPT control of photovoltaic power system and combining theory of cloud model. Simulation result shows that the cloud controller is simple and easy, directly perceived through the senses, and has strong robustness, better control performance.

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.

Network Randomization and Dynamic Defense for Critical Infrastructure Systems

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

Chavez, Adrian R.; Martin, Mitchell Tyler; Hamlet, Jason

2015-04-01

Critical Infrastructure control systems continue to foster predictable communication paths, static configurations, and unpatched systems that allow easy access to our nation's most critical assets. This makes them attractive targets for cyber intrusion. We seek to address these attack vectors by automatically randomizing network settings, randomizing applications on the end devices themselves, and dynamically defending these systems against active attacks. Applying these protective measures will convert control systems into moving targets that proactively defend themselves against attack. Sandia National Laboratories has led this effort by gathering operational and technical requirements from Tennessee Valley Authority (TVA) and performing research and developmentmore » to create a proof-of-concept solution. Our proof-of-concept has been tested in a laboratory environment with over 300 nodes. The vision of this project is to enhance control system security by converting existing control systems into moving targets and building these security measures into future systems while meeting the unique constraints that control systems face.« less

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

PubMed

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

2015-05-30

Online gambling has been legalized in France in 2010. Licenses are issued to gambling operators who demonstrate their ability to respect the legal framework (security, taxation, consumer protection, etc.). The preventive measures to protect vulnerable gamblers include an obligation to provide online gambling moderators. These moderators should allow gamblers to limit their bets, exclude themselves from the website for 7 days, and consult the balance of the gambler's account at any time. However, there are only a few published reports of empirical research investigating the effectiveness of Internet-based protective measures implemented by French law. Moreover, no empirical research has yet studied the impact of bonuses on gambling behaviors. This research is an experimental randomized controlled trial, risk prevention targeted. The research is divided into four sub-studies depending on the studied moderator: limiting bonuses, self-exclusion, self-limitation and information. The study sample consists of 485 volunteers. For each experimental condition and the control groups, the sample is composed of gamblers equally recruited from gamblers having preferences in each of the three major forms of games (lottery and scratch tickets, sports and horserace betting, and poker). For each form of gambling, the gamblers are recruited in order to obtain as many problem gamblers as non-problem gamblers. According to the randomization, the experimental session begins. The experimental session is a gambling situation on a computer in our research center. The gambler is invited to play on his favorite gambling site as usual, with his own gambler account and his own money. Data collected comprise sociodemographic characteristics, gambling habits, an interview about enjoyment and feeling out of control during the gambling session, moderator impact on gambling practice, statement of gambling parameters and questionnaires (BMIS, GRCS, CPGI, GACS). Moderator efficiency is assessed based on the two major characteristics of gambling behavior: money wagered and time spent in gambling. The results of this research will be important to prevent online problem gambling and influence policy-makers. NCT01789580. Registered 8 February 2013.

Effect of foot massage to decrease physiological lower leg oedema in late pregnancy: a randomized controlled trial in Turkey.

PubMed

Coban, Ayden; Sirin, Ahsen

2010-10-01

This study aims to evaluate the effect of foot massage for decreasing physiological lower leg oedema in late pregnancy. Eighty pregnant women were randomly divided into two groups; study group had a 20 min foot massage daily for 5 days whereas the control group did not receive any intervention beyond standard prenatal care. The research was conducted between March and August 2007 in Manisa Province Health Ministry Central Primary Health Care Clinic 1, in Manisa, Western Turkey. Compared with the control group, women in the experimental group had a significantly smaller lower leg circumference (right and left, ankle, instep and metatarsal-phalanges joint) after 5 days of massage. The results obtained from our research show that foot massage was found to have a positive effect on decreasing normal physiological lower leg oedema in late pregnancy. © 2010 Blackwell Publishing Asia Pty Ltd.

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

PubMed

2016-09-01

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

Impact of Probiotics on Necrotizing Enterocolitis

PubMed Central

Underwood, Mark A.

2016-01-01

A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention. PMID:27836423

A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder: The UCLA PEERS(®) Program.

PubMed

Laugeson, Elizabeth A; Gantman, Alexander; Kapp, Steven K; Orenski, Kaely; Ellingsen, Ruth

2015-12-01

Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young adults with ASD. Using a randomized controlled design, 22 young adults 18-24 years of age were randomly assigned to a treatment (n = 12) or delayed treatment control (n = 10) group. Results revealed that the treatment group improved significantly in overall social skills, frequency of social engagement, and social skills knowledge, and significantly reduced ASD symptoms related to social responsiveness following PEERS. Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed.

Diminishing the self-stigma of mental illness by coming out proud.

PubMed

Corrigan, Patrick W; Larson, Jonathon E; Michaels, Patrick J; Buchholz, Blythe A; Rossi, Rachel Del; Fontecchio, Malia Javier; Castro, David; Gause, Michael; Krzyżanowski, Richard; Rüsch, Nicolas

2015-09-30

This randomized controlled trial examined the impact of the Coming Out Proud (COP) program on self-stigma, stigma stress, and depression. Research participants who experienced mental health challenges were randomly assigned to a three session COP program (n=51) or a waitlist control (n=75). Outcome measures that assessed the progressively harmful stages of self-stigma, stigma stress appraisals, and depression were administered at pre-test, post-test, and one-month follow-up. People completing COP showed significant improvement at post-test and follow-up in the more harmful aspects of self-stigma compared to the control group. COP participants also showed improvements in stigma stress appraisals. Women participating in COP showed significant post-test and follow-up reductions in depression after COP compared to the control group. Men did not show this effect. Future research should determine whether these benefits also enhance attitudes related to recovery, empowerment, and self-determination. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Sexual Arousal and Self-Control: Results from a Preliminary Experimental Test of the Stability of Self-Control

ERIC Educational Resources Information Center

Bouffard, Jeffrey; Kunzi, Tasha

2012-01-01

A central proposition of Gottfredson and Hirschi's (1990) General Theory of Crime is the relative stability of low self-control, however research on "self-control strength" suggests that it may vary across contexts. The current study examines these differing conceptions by randomly assigning participants to one of two sexual arousal conditions or…

The Transfer of Cognitive Speed of Processing Training to Older Adults’ Driving Mobility Across 5 Years

PubMed Central

Edwards, Jerri D.; O’Connor, Melissa L.; Ball, Karlene K.; Wadley, Virginia G.; Vance, David E.

2016-01-01

Objectives. Multilevel models assessed the effects of cognitive speed of processing training (SPT) on older adults’ self-reported driving using intention-to-treat (ITT, randomization to training or control conditions) and dosage (treatment-received via number of training sessions) analyses across 5 years. Method. Participants randomized to SPT (n = 598) were compared with those randomized to either the no-contact control (n = 598) or memory training, which served as an active control (n = 610). Driving mobility (frequency, exposure, and space) was assessed over time. Results. No significant effects were found within the ITT analyses. However, number of SPT sessions did affect driving mobility outcomes. In the full sample (N = 1,806), higher SPT doses were associated with maintained driving frequency as compared with both control groups, but no effects were found for driving exposure or space. Subsample analyses (n = 315) revealed that persons at-risk for mobility declines (i.e., poor initial processing speed) who received additional booster SPT sessions reported greater maintenance of both driving frequency and exposure over time as compared with the no-contact and active control groups. Discussion. These results and prior research indicate that cognitive SPT transfers to prolonged driving mobility among older adults. Future research should investigate the mechanisms behind transfer effects to real-world activities, such as driving. PMID:25878053

Effects of Family-Center Empowerment Model on the Lifestyle of Heart Failure Patients: A Randomized Controlled Clinical Trial

PubMed Central

Rakhshan, Mahnaz; Kordshooli, Khadijeh Rahimi; Ghadakpoor, Soraya

2015-01-01

Background: Cardiovascular diseases are the most prevalent disorders in developed countries and heart failure is the major one among them. This disease is caused by numerous factors and one of the most considerable risk factors is unhealthy lifestyle. So the aim of this research was to study the effect of family-center empowerment model on the lifestyle of heart failure patients. Methods: This is a randomized controlled clinical trial on 70 heart failure patients referring to Hazrate Fatemeh heart clinic in Shiraz. After convenience sampling the patients were divided into two control and intervention groups using block randomization Method. The intervention based on family-center empowerment model was performed during 5 sessions. Research tools are lifestyle and demographic information questionnaires. Results: Both intervention and control groups were similar regarding their demographic information (P>0.001). Before the intervention on lifestyle, all measures of the two groups were equal (P>0.001) but after the intervention; statistically significant differences were reported in all dimensions of lifestyle, the total lifestyle score in the intervention group was 70.09±16.38 and in the control group -6.03±16.36 (P<0.001). Conclusion: Performing the family-center empowerment model for heart failure patients is practically possible, leading to improvement or refinement of their and their families’ lifestyle. Trial Registration Number: IRCT 2014072018468N3 PMID:26448952

A randomized trial of social media from Circulation.

PubMed

Fox, Caroline S; Bonaca, Marc A; Ryan, John J; Massaro, Joseph M; Barry, Karen; Loscalzo, Joseph

2015-01-06

Medical journals use social media to distribute the findings of published articles. Whether social media exposure to original articles improves article impact metrics is uncertain. Articles were randomized to receive targeted social media exposure from Circulation, including postings on the journal's Facebook and Twitter feeds. The primary end point was 30-day article page views. We conducted an intention-to-treat analysis comparing article page views by the Wilcoxon Rank sum test between articles randomized to social media as compared with those in the control group, which received no social media from Circulation. Prespecified subgroups included article type (population/clinical/basic), US versus non-US corresponding author, and whether the article received an editorial. Overall, 243 articles were randomized: 121 in the social media arm and 122 in the control arm. There was no difference in median 30-day page views (409 [social media] versus 392 [control], P=0.80). No differences were observed by article type (clinical, population, or basic science; P=0.19), whether an article had an editorial (P=0.87), or whether the corresponding author was from the United States (P=0.73). A social media strategy for a cardiovascular journal did not increase the number of times an article was viewed. Further research is necessary to understand and quantify the ways in which social media can increase the impact of published cardiovascular research. © 2014 American Heart Association, Inc.

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. PMID:21988774

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial.

PubMed

Doyle, Conor; Panda, Pradeep; Van de Poel, Ellen; Radermacher, Ralf; Dror, David M

2011-10-11

Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. © 2011 Doyle et al; licensee BioMed Central Ltd.

Randomized Evaluation of Peer Support Arrangements to Support the Inclusion of High School Students with Severe Disabilities

ERIC Educational Resources Information Center

Carter, Erik W.; Asmus, Jennifer; Moss, Colleen K.; Biggs, Elizabeth E.; Bolt, Dan M.; Born, Tiffany L.; Brock, Matthew E.; Cattey, Gillian N.; Chen, Rui; Cooney, Molly; Fesperman, Ethan; Hochman, Julia M.; Huber, Heartley B.; Lequia, Jenna L.; Lyons, Gregory; Moyseenko, Kerrie A.; Riesch, Lindsay M.; Shalev, Rebecca A.; Vincent, Lori B.; Weir, Katie

2016-01-01

Enhancing the social and learning experiences of students with severe disabilities in inclusive classrooms has been a long-standing focus of research, legislative, and advocacy efforts. The authors used a randomized controlled experimental design to examine the efficacy of peer support arrangements to improve academic and social outcomes for 51…

Yoga Improves Academic Performance in Urban High School Students Compared to Physical Education: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Hagins, Marshall; Rundle, Andrew

2016-01-01

Yoga programs within schools have become more widespread but research regarding the potential effect on academic achievement remains limited. This study cluster-randomized 112 students within a single New York City public high school to participate in either school-based yoga or physical education (PE) for an entire academic year. The primary…

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

ERIC Educational Resources Information Center

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Non-Randomized Studies as a Source of Complementary, Sequential or Replacement Evidence for Randomized Controlled Trials in Systematic Reviews on the Effects of Interventions

ERIC Educational Resources Information Center

Schünemann, Holger J.; Tugwell, Peter; Reeves, Barnaby C.; Akl, Elie A.; Santesso, Nancy; Spencer, Frederick A.; Shea, Beverley; Wells, George; Helfand, Mark

2013-01-01

The terms applicability, generalizability, external validity and transferability are related, sometimes used interchangeably and have in common that they lack a clear and consistent definition in the classic epidemiological literature. However, all of these terms generally describe one overarching theme: whether or not available research evidence…

Can Mentoring Help Female Assistant Professors? Interim Results from a Randomized Trial. NBER Working Paper No. 15707

ERIC Educational Resources Information Center

Blau, Francine D.; Currie, Janet M.; Croson, Rachel T. A.; Ginther, Donna K.

2010-01-01

While much has been written about the potential benefits of mentoring in academia, very little research documents its effectiveness. We present data from a randomized controlled trial of a mentoring program for female economists organized by the Committee for the Status of Women in the Economics Profession and sponsored by the National Science…

Challenges and Recommendations for Placebo Controls in Randomized Trials in Physical and Rehabilitation Medicine

PubMed Central

Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L.; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

2010-01-01

Compared to other specialties, the field of Physical and Rehabilitation Medicine (PRM) has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional PRM treatments. The best way to change this disadvantage is through well-conducted clinical research, such as the standard placebo or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in PRM that ultimately translates in a better clinical care. To address the challenges for the use of placebo in PRM randomized clinical trials, and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in PRM, (2) challenges for the use of placebo in PRM, (3) bioethical issues, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group. PMID:20090428

Diabetes in pregnancy outcomes: a systematic review and proposed codification of definitions.

PubMed

Feig, Denice S; Corcoy, Rosa; Jensen, Dorte Moller; Kautzky-Willer, Alexandra; Nolan, Christopher J; Oats, Jeremy J N; Sacks, David A; Caimari, Francisca; McIntyre, H David

2015-10-01

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed

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

2014-02-01

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

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

Communicating to Policymakers: What to Do with Ambiguous Results from Three Impact Studies of the Same Education Program

ERIC Educational Resources Information Center

Hartry, Ardice

2013-01-01

This paper considers one challenge from recent emphasis on rigorous research for decision-making in education: the interpretation of non-replicated findings. Under Clinton and Bush, the federal government called for and funded highly rigorous research. The "gold-standard" for research was randomized-control trials (RCTs), which…

Trial Registration: Understanding and Preventing Reporting Bias in Social Work Research

ERIC Educational Resources Information Center

Harrison, Bronwyn A.; Mayo-Wilson, Evan

2014-01-01

Randomized controlled trials are considered the gold standard for evaluating social work interventions. However, published reports can systematically overestimate intervention effects when researchers selectively report large and significant findings. Publication bias and other types of reporting biases can be minimized through prospective trial…

Major Depression Can Be Prevented

ERIC Educational Resources Information Center

Munoz, Ricardo F.; Beardslee, William R.; Leykin, Yan

2012-01-01

The 2009 Institute of Medicine report on prevention of mental, emotional, and behavioral disorders (National Research Council & Institute of Medicine, 2009b) presented evidence that major depression can be prevented. In this article, we highlight the implications of the report for public policy and research. Randomized controlled trials have shown…

Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

PubMed

Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

2014-10-01

This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

Review of yoga therapy during cancer treatment.

PubMed

Danhauer, Suzanne C; Addington, Elizabeth L; Sohl, Stephanie J; Chaoul, Alejandro; Cohen, Lorenzo

2017-04-01

Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

76 FR 51056 - Notice of Random Assignment Study To Evaluate the YouthBuild Program; Request for Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... assigned to the control group can re-apply to the YouthBuild program. The Department is soliciting comments... ``utilize appropriate methodology and research designs, including the use of control groups chosen by.... Accordingly, ETA is conducting a multisite control group evaluation to provide rigorous estimates [[Page 51058...

CENTRAL, PEDro, PubMed, and EMBASE are the most comprehensive databases indexing randomized controlled trials of physical therapy interventions.

PubMed

Michaleff, Zoe A; Costa, Leonardo O P; Moseley, Anne M; Maher, Christopher G; Elkins, Mark R; Herbert, Robert D; Sherrington, Catherine

2011-02-01

Many bibliographic databases index research studies evaluating the effects of health care interventions. One study has concluded that the Physiotherapy Evidence Database (PEDro) has the most complete indexing of reports of randomized controlled trials of physical therapy interventions, but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro. The purpose of this study was to compare the completeness of indexing of reports of randomized controlled trials of physical therapy interventions by 8 bibliographic databases. This study was an audit of bibliographic databases. Prespecified criteria were used to identify 400 reports of randomized controlled trials from the reference lists of systematic reviews published in 2008 that evaluated physical therapy interventions. Eight databases (AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO, and PubMed) were searched for each trial report. The proportion of the 400 trial reports indexed by each database was calculated. The proportions of the 400 trial reports indexed by the databases were as follows: CENTRAL, 95%; PEDro, 92%; PubMed, 89%; EMBASE, 88%; CINAHL, 53%; AMED, 50%; Hooked on Evidence, 45%; and PsycINFO, 6%. Almost all of the trial reports (99%) were found in at least 1 database, and 88% were indexed by 4 or more databases. Four trial reports were uniquely indexed by a single database only (2 in CENTRAL and 1 each in PEDro and PubMed). The results are only applicable to searching for English-language published reports of randomized controlled trials evaluating physical therapy interventions. The 4 most comprehensive databases of trial reports evaluating physical therapy interventions were CENTRAL, PEDro, PubMed, and EMBASE. Clinicians seeking quick answers to clinical questions could search any of these databases knowing that all are reasonably comprehensive. PEDro, unlike the other 3 most complete databases, is specific to physical therapy, so studies not relevant to physical therapy are less likely to be retrieved. Researchers could use CENTRAL, PEDro, PubMed, and EMBASE in combination to conduct exhaustive searches for randomized trials in physical therapy.

The life in sight application study (LISA): design of a randomized controlled trial to assess the role of an assisted structured reflection on life events and ultimate life goals to improve quality of life of cancer patients

PubMed Central

2013-01-01

Background It is widely recognized that spiritual care plays an important role in physical and psychosocial well-being of cancer patients, but there is little evidence based research on the effects of spiritual care. We will conduct a randomized controlled trial on spiritual care using a brief structured interview scheme supported by an e-application. The aim is to examine whether an assisted reflection on life events and ultimate life goals can improve quality of life of cancer patients. Methods/Design Based on the findings of our previous research, we have developed a brief interview model that allows spiritual counsellors to explore, explicate and discuss life events and ultimate life goals with cancer patients. To support the interview, we created an e-application for a PC or tablet. To examine whether this assisted reflection improves quality of life we will conduct a randomized trial. Patients with advanced cancer not amenable to curative treatment options will be randomized to either the intervention or the control group. The intervention group will have two consultations with a spiritual counsellor using the interview scheme supported by the e-application. The control group will receive care as usual. At baseline and one and three months after randomization all patients fill out questionnaires regarding quality of life, spiritual wellbeing, empowerment, satisfaction with life, anxiety and depression and health care consumption. Discussion Having insight into one’s ultimate life goals may help integrating a life event such as cancer into one’s life story. This is the first randomized controlled trial to evaluate the role of an assisted structured reflection on ultimate life goals to improve patients’ quality of life and spiritual well being. The intervention is brief and based on concepts and skills that spiritual counsellors are familiar with, it can be easily implemented in routine patient care and incorporated in guidelines on spiritual care. Trial registration The study is registered at ClinicalTrials.gov: NCT01830075 PMID:23889978

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

PubMed

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

2017-01-01

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

Experimental Evaluation of the Effects of a Research-Based Preschool Mathematics Curriculum

ERIC Educational Resources Information Center

Clements, Douglas H.; Sarama, Julie

2008-01-01

A randomized-trials design was used to evaluate the effectiveness of a preschool mathematics program based on a comprehensive model of research-based curricula development. Thirty-six preschool classrooms were assigned to experimental (Building Blocks), comparison (a different preschool mathematics curriculum), or control conditions. Children were…

Interrupted Time Series Analysis: A Research Technique for Evaluating Social Programs for the Elderly

ERIC Educational Resources Information Center

Calsyn, Robert J.; And Others

1977-01-01

After arguing that treatment programs for the elderly need to be evaluated with better research designs, the authors illustrate how interrupted time series analysis can be used to evaluate programs for the elderly when random assignment to experimental and control groups is not possible. (Author)

Perceptions of the Performance of Community College Faculty: Dissertation Research Findings.

ERIC Educational Resources Information Center

Vickers, Mozelle Carver

A sample of 30 instructors nominated as effective teachers to the Piper Foundation and 31 randomly selected control instructors from the same 14 Texas colleges were evaluated by students, former students, administrators, peers, and the instructors themselves. The research instrument incorporated ten sets of characteristics expressed as polar…

Brief Instrumental School-Based Mentoring for Middle School Students: Theory and Impact

ERIC Educational Resources Information Center

McQuillin, Samuel D.; Lyons, Michael D.

2016-01-01

This study evaluated the efficacy of an intentionally brief school-based mentoring program. This academic goal-focused mentoring program was developed through a series of iterative randomized controlled trials, and is informed by research in social cognitive theory, cognitive dissonance theory, motivational interviewing, and research in academic…

Patients’ Perspectives of Enrollment in Research Without Consent- The Patients’ Experiences in Emergency Research- ProTECT Study (PEER-ProTECT)

PubMed Central

Dickert, Neal W; Scicluna, Victoria M; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Wright, David W; Pentz, Rebecca D

2016-01-01

Objective Research in acute illness often requires an exception from informed consent (EFIC). Few studies have assessed the views of patients enrolled in EFIC trials. This study was designed to assess the views of patients and their surrogates of EFIC enrollment in a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. Design Interactive interview study. Setting Nested within the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) trial, a Phase III randomized controlled trial in acute traumatic brain injury (TBI). Participants Patients and surrogates (for patients incapable of being interviewed) enrolled in ProTECT III under EFIC at 12 sites. Measurements Interviews focused on respondents’ acceptance of EFIC enrollment in ProTECT, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Main Results 85 individuals were interviewed. 84% had positive attitudes toward ProTECT III inclusion. 78% found their inclusion under EFIC acceptable, and 72% found use of EFIC in ProTECT III acceptable in general. Only 2 respondents clearly disagreed with both personal and general EFIC enrollment. The most common concerns (26%) related to absence of consent. 80% and 92% were accepting of placebo use and randomization, respectively. Though there were few black respondents (n=11), they were less accepting of personal EFIC enrollment than white respondents (55% vs 83%, p= 0.0494). Conclusions Acceptance of EFIC in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. EFIC enrollment appears generally consistent with patients’ preferences. PMID:25574795

Women's experiences as members of attention control and experimental intervention groups in a randomized controlled trial.

PubMed

Beal, Claudia C; Stuifbergen, Alexa; Volker, Deborah; Becker, Heather

2009-12-01

Attention control groups are often used in research testing the efficacy of psychosocial and behavioural interventions in order to control for placebo effects. The authors conducted a descriptive qualitative study to investigate how participants viewed their experiences in attention control and experimental intervention groups following a randomized controlled trial for women with fibromyalgia syndrome. Moderately structured interviews were conducted with 18 women (12 from the experimental intervention group and 6 from the attention control group). Members of the control group reported some benefits but few behavioural changes as a result of participating in the RCT, and some participants expressed disappointment at not receiving the intervention. Perceptions of changes in attitudes towards fibromyalgia syndrome and behaviours reported by the intervention group appear to be consistent with the theory underlying the intervention. Possible placebo effects identified in both groups include negative and positive social interactions with other participants.

Recruiting participants for randomized controlled trials of music therapy: a practical illustration.

PubMed

Porter, Sam; McConnell, Tracey; Lynn, Fiona; McLaughlin, Katrina; Cardwell, Christopher; Holmes, Valerie

2014-01-01

Failure to recruit sufficient numbers of participants to randomized controlled trials is a common and serious problem. This problem may be additionally acute in music therapy research. To use the experience of conducting a large randomized controlled trial of music therapy for young people with emotional and behavioral difficulties to illustrate the strategies that can be used to optimize recruitment; to report on the success or otherwise of those strategies; and to draw general conclusions about the most effective approaches. Review of the methodological literature, and a narrative account and realist analysis of the recruitment process. The strategies adopted led to the achievement of the recruitment target of 250 subjects, but only with an extension to the recruitment period. In the pre-protocol stage of the research, these strategies included the engagement of non-music therapy clinical investigators, and extensive consultation with clinical stakeholders. In the protocol development and initial recruitment stages, they involved a search of systematic reviews of factors leading to under-recruitment and of interventions to promote recruitment, and the incorporation of their insights into the research protocol and practices. In the latter stages of recruitment, various stakeholders including clinicians, senior managers and participant representatives were consulted in an attempt to uncover the reasons for the low recruitment levels that the research was experiencing. The primary mechanisms to promote recruitment are education, facilitation, audit and feedback, and time allowed. The primary contextual factors affecting the effectiveness of these mechanisms are professional culture and organizational support. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Efficacy of PCI's "Reading Program--Level One": A Report of a Randomized Experiment in Brevard Public Schools and Miami-Dade County Public Schools. Research Report

ERIC Educational Resources Information Center

Toby, Megan; Ma, Boya; Jaciw, Andrew; Cabalo, Jessica

2008-01-01

PCI Education sought scientifically based evidence on the effectiveness of the "PCI Reading Program--Level One" for students with severe disabilities. During the 2007-2008 academic year. Empirical Education conducted a randomized control trial (RCT) in two Florida districts, Brevard and Miami-Dade County Public Schools. For this…

A Randomized Controlled Trial to Evaluate Outcomes of a Workplace Self-Management Intervention and an Intensive Monitoring Intervention

ERIC Educational Resources Information Center

Schopp, Laura H.; Clark, Mary J.; Lamberson, William R.; Uhr, David J.; Minor, Marian A.

2017-01-01

The purpose of this study was to determine and compare outcomes of two voluntary workplace health management methods: an adapted worksite self-management (WSM) approach and an intensive health monitoring (IM) approach. Research participants were randomly assigned to either the WSM group or the IM group by a computer-generated list (n = 180; 92 WSM…

The Efficacy of PCI's Reading Program--Level One: A Report of a Randomized Experiment in Brevard Public Schools and Miami-Dade County Public Schools. Research Summary

ERIC Educational Resources Information Center

Empirical Education Inc., 2008

2008-01-01

PCI Education sought scientifically based evidence on the effectiveness of the "PCI Reading Program--Level One" for students with severe disabilities. During the 2007-2008 academic year. Empirical Education conducted a randomized control trial (RCT) in two Florida districts, Brevard and Miami-Dade County Public Schools. For this…

Effect of play therapy on behavioral problems of maladjusted preschool children.

PubMed

Jafari, Niloufar; Mohammadi, Mohammad Reza; Khanbani, Mehdi; Farid, Saeedeh; Chiti, Parisa

2011-01-01

The present research was conducted to study the effect of play therapy on reducing behavioral problems of children with oppositional defiant disorder. Using multistage cluster sampling, regions 6, 7, and 8 in Tehran were selected. Among kindergartens of these areas, 3 kindergartens which were supported by the welfare organization were randomly selected. Of all the pre-school children of these 3 kindergartens, 40 children who could have behavioral disorder, according to their teachers and parents, were carefully tested. Of them, 16 children who showed severe symptoms of oppositional defiant disorder, were selected via the results obtained from the child symptom inventory questionnaire (CSI-4), teacher's form, and a researcher-made self-control checklist, Then, the subjects were randomly divided into one control and one experimental group. This research is quasi-experimental, and is conducted using pre-test, post-test, and control group. Values of the calculated F for oppositional defiant disorder in control group and experimental group was meaningful after fixing the effect of pre-test (P<0/001). Therefore, a meaningful difference existed between the means of post-test scores of disobedience disorder in the experimental and control groups through the fixed effect of the pre-test effect. Comparison of adjusted means of the 2 groups showed that the mean of attention-deficit hyperactivity disorder (ADHD) in experimental group was lower than control group. Therefore, applying play therapy reduced severity of ADHD in those children in experimental group compared to those in control group who did not receive such instructions. Results of this research demonstrates that children's disobedience can be reduced by play therapy.

Strategies to retain participants in a long-term HIV prevention randomized controlled trial: Lessons from the MINTS-II study

PubMed Central

Horvath, Keith J.; Nygaard, Kate; Danilenko, Gene P.; Goknur, Sinan; Oakes, J. Michael; Rosser, B.R. Simon

2012-01-01

Achieving satisfactory retention in online HIV prevention trials typically have proved difficult, particularly over extended timeframes. The overall aim of this study was to assess factors associated with retention in the Men’s INTernet Study II (MINTS-II), a randomized controlled trial of a sexual risk reduction intervention for men who have sex with men. Participants were recruited via e-mails and banner advertisements in December, 2007 to participate in the MINTS-II Sexpulse intervention and followed over a 12-month period. Retention across the treatment and control arms was 85.2% at 12 months. Factors associated with higher retention included: randomization to the control arm, previous participation in a study by the research team, e-mail and telephone reminders to complete a survey once it was available to take, and fewer e-mail contacts between surveys. The results provide evidence that achieving satisfactory retention is possible in online HIV prevention trials, and suggest best practices for maximizing retention. PMID:21538084

Is a 6-week supervised pelvic floor muscle exercise program effective in preventing stress urinary incontinence in late pregnancy in primigravid women?: a randomized controlled trial.

PubMed

Sangsawang, Bussara; Sangsawang, Nucharee

2016-02-01

The study investigated the effect of a 6-week supervised pelvic floor muscle exercise (PFME) program to prevent stress urinary incontinence (SUI) at 38 weeks' gestation. We conducted a randomized controlled trial into two arms design: one intervention group and one control group, using the randomly computer-generated numbers. A research assistant, who was not involved with care of the participants, randomly drawn up and opened the envelope for each participant to allocate into the intervention group and the control group. The investigators could not be blinded to allocation. Seventy primigravid women who had continent with gestational ages of 20-30 weeks were randomly assigned to participate in the intervention (n=35) and control groups (n=35). The intervention was a supervised 6-week PFME program with verbal instruction and a handbook, three training sessions of 45 min with the main researcher (at 1st, 3rd and 5th week of the program) and self-daily training at home for an overall period of 6 weeks. The control condition was the PFME and the stop test had been trained by the main researcher to all of the participants in the intervention group. The primary outcome was self-reported of SUI, and the secondary outcome was the severity of SUI in pregnant women which comprises of frequency, volume of urine leakage and score of perceived severity of SUI in late pregnancy at 38th weeks of pregnancy. Statistical analysis was performed using Chi-square test, Independent-sample t-test, and Mann-Whitney U-test. Significance P-value was <0.05. At the end of the intervention, 2 of 35 women in the intervention group and 5 of 35 women in the control group dropped out of the study. Therefore, the total of the study participants consisted of 63 pregnant women (33 in the intervention group and 30 in the control group). Fewer women in the intervention group reported SUI than the control group: 9 of 33 (27.3%) versus 16 of 30 (53.3%) at 38 weeks' gestational age (OR 3.05, 95% CI 1.07-8.70, P=0.018). The 6-week supervised PFME program was effective in preventing SUI and decreasing the SUI severity in pregnant women who reported SUI at late pregnancy. The women who performed PFME program under the training sessions once every two weeks found that the program demands less time, incurs lower costs and possibly offers more motivation to exercise. This 6-week supervised PFME program may be suitable in real clinical situation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Aacap 2002 Research Forum: Placebo and Alternatives to Placebo in Randomized Controlled Trials in Pediatric Psychopharmacology

ERIC Educational Resources Information Center

March, John; Kratochvil, Christopher; Clarke, Gregory; Beardslee, William; Derivan, Albert; Emslie, Graham; Green, Evelyn P.; Heiligenstein, John; Hinshaw, Stephen; Hoagwood, Kimberly; Jensen, Peter; Lavori, Philip; Leonard, Henrietta; McNulty, James; Michaels, M. Alex; Mossholder, Andrew; Osher, Trina; Petti, Theodore; Prentice, Ernest; Vitiello, Benedetto; Wells, Karen

2004-01-01

Objective: The use of placebo in the pediatric age group has come under increasing scrutiny. At the 2002 Annual Meeting of the American Academy of Child and Adolescent Psychiatry, the Academy's Workgroup on Research conducted a research forum. The purpose was to identify challenges and their solutions regarding the use of placebo in randomized…

The Moral, Social and Political Responsibility of Educational Researchers: Resisting the Current Quest for Certainty

ERIC Educational Resources Information Center

Delandshere, Ginette

2004-01-01

In the last decade a number of national and international activities and public policies in the US have converged to prescribe a particular conception of educational research. Randomized control trials have been set as the ''gold standard'' and educational researchers are now pressed to come up with ''solid'' evidenced-based findings of ''what…

Theory-Based Interventions Combining Mental Simulation and Planning Techniques to Improve Physical Activity: Null Results from Two Randomized Controlled Trials.

PubMed

Meslot, Carine; Gauchet, Aurélie; Allenet, Benoît; François, Olivier; Hagger, Martin S

2016-01-01

Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioral theories advocate the importance of both motivation and volition in interventions to change health behavior. Interventions adopting self-regulation strategies that foster motivational and volitional components may, therefore, have utility in promoting regular physical activity participation. We tested the efficacy of an intervention adopting motivational (mental simulation) and volitional (implementation intentions) components to promote a regular physical activity in two studies. Study 1 adopted a cluster randomized design in which participants ( n = 92) were allocated to one of three conditions: mental simulation plus implementation intention, implementation intention only, or control. Study 2 adopted a 2 (mental simulation vs. no mental simulation) × 2 (implementation intention vs. no implementation intention) randomized controlled design in which fitness center attendees ( n = 184) were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behavior was measured by self-report (Study 1) or fitness center attendance (Study 2) at 4- (Studies 1 and 2) and 19- (Study 2 only) week follow-up periods. Findings revealed no statistically significant main or interactive effects of the mental simulation and implementation intention conditions on physical activity outcomes in either study. Findings are in contrast to previous research which has found pervasive effects for both intervention strategies. Findings are discussed in light of study limitations including the relatively small sample sizes, particularly for Study 1, deviations in the operationalization of the intervention components from previous research and the lack of a prompt for a goal intention. Future research should focus on ensuring uniformity in the format of the intervention components, test the effects of each component alone and in combination using standardized measures across multiple samples, and systematically explore effects of candidate moderators.

Theory-Based Interventions Combining Mental Simulation and Planning Techniques to Improve Physical Activity: Null Results from Two Randomized Controlled Trials

PubMed Central

Meslot, Carine; Gauchet, Aurélie; Allenet, Benoît; François, Olivier; Hagger, Martin S.

2016-01-01

Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioral theories advocate the importance of both motivation and volition in interventions to change health behavior. Interventions adopting self-regulation strategies that foster motivational and volitional components may, therefore, have utility in promoting regular physical activity participation. We tested the efficacy of an intervention adopting motivational (mental simulation) and volitional (implementation intentions) components to promote a regular physical activity in two studies. Study 1 adopted a cluster randomized design in which participants (n = 92) were allocated to one of three conditions: mental simulation plus implementation intention, implementation intention only, or control. Study 2 adopted a 2 (mental simulation vs. no mental simulation) × 2 (implementation intention vs. no implementation intention) randomized controlled design in which fitness center attendees (n = 184) were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behavior was measured by self-report (Study 1) or fitness center attendance (Study 2) at 4- (Studies 1 and 2) and 19- (Study 2 only) week follow-up periods. Findings revealed no statistically significant main or interactive effects of the mental simulation and implementation intention conditions on physical activity outcomes in either study. Findings are in contrast to previous research which has found pervasive effects for both intervention strategies. Findings are discussed in light of study limitations including the relatively small sample sizes, particularly for Study 1, deviations in the operationalization of the intervention components from previous research and the lack of a prompt for a goal intention. Future research should focus on ensuring uniformity in the format of the intervention components, test the effects of each component alone and in combination using standardized measures across multiple samples, and systematically explore effects of candidate moderators. PMID:27899904

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

PubMed

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

2009-07-01

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

The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions. Methods/Design An explanatory randomized controlled trial - called the Worry Intervention Trial (WIT) - with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline), 8 weeks (post treatment) and 24 weeks (follow-up). The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data). Both traditional regression and newer instrumental variables analyses will examine mediation. The trial is funded by the UK Medical Research Council (MRC)/NHS National Institute of Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme. Discussion This will be the first large randomized controlled trial specifically focused upon persecutory delusions. The project will produce a brief, easily administered intervention that can be readily used in mental health services. Trial registration Current Controlled Trials ISRCTN23197625 PMID:23171601

An Evaluation of the Effectiveness of Recruitment Methods: The Staying Well after Depression Randomized Controlled Trial

PubMed Central

Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J. Mark G.

2014-01-01

Background Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited and trials often fail to report sufficient details about the recruitment sources and resources utilised. Purpose We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. Methods We describe eight recruitment methods utilised and two further sources not initiated by the research team and examine their efficacy in terms of (i) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial, (ii) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants, and (iii) comparison of sociodemographic characteristics of individuals recruited from different sources. Results Poster advertising, web-based advertising and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. Limitations It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in other geographical locations. Recruitment source was unavailable for participants who could not be reached after the initial contact. Thus, it is possible that the efficiency of certain methods of recruitment was poorer than estimated. Efficacy and costs of other recruitment initiatives, such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly, were not analysed. Conclusions Website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting. Future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future RCTs. PMID:24686105

An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial.

PubMed

Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G

2014-04-01

Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in other geographical locations. Recruitment source was unavailable for participants who could not be reached after the initial contact. Thus, it is possible that the efficiency of certain methods of recruitment was poorer than estimated. Efficacy and costs of other recruitment initiatives, such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly, were not analysed. Website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting. Future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future RCTs.

Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial.

PubMed

Uysal, Neşe; Kutlutürkan, Sevinç; Uğur, Işıl

2017-06-01

This randomized controlled clinical study aimed to determine the effect of 2 foot massage methods on symptom control in people with colorectal cancer who received chemoradiotherapy. Data were collected between June 16, 2015, and February 10, 2016, in the Department of Radiation Oncology of an oncology training and research hospital. The sample comprised 60 participants. Data were collected using an introductory information form, common terminology criteria for adverse events and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and CR29. Participants were randomly allocated to 3 groups: classical foot massage, reflexology, and standard care control. The classical massage group received foot massage using classical massage techniques, and the reflexology group received foot reflexology focusing on symptom-oriented reflexes twice a week during a 5-week chemoradiotherapy treatment schedule. The control group received neither classical massage nor reflexology. All patients were provided with the same clinic routine care. The classical massage was effective in reducing pain level and distension incidence while foot reflexology was effective in reducing pain and fatigue level, lowering incidence of distension and urinary frequency and improving life quality. © 2017 John Wiley & Sons Australia, Ltd.

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

A binary motor imagery tasks based brain-computer interface for two-dimensional movement control

NASA Astrophysics Data System (ADS)

Xia, Bin; Cao, Lei; Maysam, Oladazimi; Li, Jie; Xie, Hong; Su, Caixia; Birbaumer, Niels

2017-12-01

Objective. Two-dimensional movement control is a popular issue in brain-computer interface (BCI) research and has many applications in the real world. In this paper, we introduce a combined control strategy to a binary class-based BCI system that allows the user to move a cursor in a two-dimensional (2D) plane. Users focus on a single moving vector to control 2D movement instead of controlling vertical and horizontal movement separately. Approach. Five participants took part in a fixed-target experiment and random-target experiment to verify the effectiveness of the combination control strategy under the fixed and random routine conditions. Both experiments were performed in a virtual 2D dimensional environment and visual feedback was provided on the screen. Main results. The five participants achieved an average hit rate of 98.9% and 99.4% for the fixed-target experiment and the random-target experiment, respectively. Significance. The results demonstrate that participants could move the cursor in the 2D plane effectively. The proposed control strategy is based only on a basic two-motor imagery BCI, which enables more people to use it in real-life applications.

A review of mind-body therapies in the treatment of cardiovascular disease. Part 1: Implications for the elderly.

PubMed

Luskin, F M; Newell, K A; Griffith, M; Holmes, M; Telles, S; Marvasti, F F; Pelletier, K R; Haskell, W L

1998-05-01

A review of research on complementary and alternative treatments, specifically mind-body techniques, was conducted at Stanford University. The goals of the review were to establish a comprehensive literature review and to provide a rationale for future research concerning successful aging. Computerized searches were conducted using MEDLINE, PsychInfo, Stanford Library, Dissertation Abstracts, Lexus-Nexus, the Internet, and interviews conducted with practitioners. All studies since 1990 that examined mind-body treatments of cardiovascular disorders in the elderly were included. Mind-body practices evaluated were social support, cognitive-behavioral treatment, meditation, the placebo effect, hope, faith, imagery, spiritual healing, music therapy, hypnosis, yoga, t'ai chi, qigong and aikido. Studies conducted after 1990 were a priority, but when more recent literature was scarce, other studies using randomized, controlled trials were included. Mind-body techniques were found to be efficacious primarily as complementary and sometimes as stand-alone alternative treatments for cardiovascular disease-related conditions. Studies provided evidence for treatment efficacy, but the need for further controlled research was evident. Reviewers found only a handful of randomized, controlled research studies conducted in the United States. As a result, there is a lack of replicated studies with which to determine appropriate treatment dosage and the mechanisms by which many of the practices work. Compelling anecdotal evidence, the presence of some controlled research, overall cost effectiveness, and the lack of side effects resulting from mind-body treatments make further investigation a high priority.

The Transfer of Cognitive Speed of Processing Training to Older Adults' Driving Mobility Across 5 Years.

PubMed

Ross, Lesley A; Edwards, Jerri D; O'Connor, Melissa L; Ball, Karlene K; Wadley, Virginia G; Vance, David E

2016-01-01

Multilevel models assessed the effects of cognitive speed of processing training (SPT) on older adults' self-reported driving using intention-to-treat (ITT, randomization to training or control conditions) and dosage (treatment-received via number of training sessions) analyses across 5 years. Participants randomized to SPT (n = 598) were compared with those randomized to either the no-contact control (n = 598) or memory training, which served as an active control (n = 610). Driving mobility (frequency, exposure, and space) was assessed over time. No significant effects were found within the ITT analyses. However, number of SPT sessions did affect driving mobility outcomes. In the full sample (N = 1,806), higher SPT doses were associated with maintained driving frequency as compared with both control groups, but no effects were found for driving exposure or space. Subsample analyses (n = 315) revealed that persons at-risk for mobility declines (i.e., poor initial processing speed) who received additional booster SPT sessions reported greater maintenance of both driving frequency and exposure over time as compared with the no-contact and active control groups. These results and prior research indicate that cognitive SPT transfers to prolonged driving mobility among older adults. Future research should investigate the mechanisms behind transfer effects to real-world activities, such as driving. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial.

PubMed

Gür, Gözde; Ayhan, Cigdem; Yakut, Yavuz

2017-06-01

Core stabilization training is used to improve postural balance in musculoskeletal problems. The purpose of this study was to investigate the effectiveness of stabilization training in adolescent idiopathic scoliosis. A randomized controlled trial, pretest-posttest design. In total, 25 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: stabilization group ( n = 12) and control group ( n = 13). The stabilization group received core stabilization in addition to traditional rehabilitation, and the control group received traditional rehabilitation for 10 weeks. Assessment included Cobb's angle on radiograph, apical vertebral rotation in Adam's test, trunk asymmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Trunk Appearance Perception Scale), and quality of life (Scoliosis Research Society-22 questionnaire). Inter-group comparisons showed significantly greater improvements in the mean change in lumbar apical vertebral rotation degree and the pain domain of Scoliosis Research Society-22 in the stabilization group than those in the control group ( p < 0.05). No significant differences were observed for other measurements between the groups; however, trends toward greater improvement were observed in the stabilization group. Core stabilization training in addition to traditional exercises was more effective than traditional exercises alone in the correction of vertebral rotation and reduction of pain in adolescent idiopathic scoliosis. Clinical relevance Stabilization exercises are more effective in reducing rotation deformity and pain than traditional exercises in the conservative rehabilitation of adolescent idiopathic scoliosis. These improvements suggest that stabilization training should be added to rehabilitation programs in adolescent idiopathic scoliosis.

A framework for understanding cancer comparative effectiveness research data needs.

PubMed

Carpenter, William R; Meyer, Anne-Marie; Abernethy, Amy P; Stürmer, Til; Kosorok, Michael R

2012-11-01

Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely and often don't adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs. We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality's cancer comparative effectiveness research programs. A new model was iteratively developed and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective. Immediately relevant for federally funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research's ability to yield findings clinicians, policy makers, and stakeholders can confidently act on. Copyright © 2012 Elsevier Inc. All rights reserved.

Active control of the forced and transient response of a finite beam. M.S. Thesis

NASA Technical Reports Server (NTRS)

Post, John T.

1990-01-01

Structural vibrations from a point force are modelled on a finite beam. This research explores the theoretical limit on controlling beam vibrations utilizing another point source as an active controller. Three different types of excitation are considered, harmonic, random, and transient. For harmonic excitation, control over the entire beam length is possible only when the excitation frequency is near a resonant frequency of the beam. Control over a subregion may be obtained even between resonant frequencies at the cost of increasing the vibration outside of the control region. For random excitation, integrating the expected value of the displacement squared over the required interval, is shown to yield the identical cost function as obtained by integrating the cost function for harmonic excitation over all excitation frequencies. As a result, it is always possible to reduce the cost function for random excitation whether controlling the entire beam or just a subregion, without ever increasing the vibration outside the region in which control is desired. The last type of excitation considered is a single, transient pulse. The form of the controller is specified as either one or two delayed pulses, thus constraining the controller to be casual. The best possible control is examined while varying the region of control and the controller location. It is found that control is always possible using either one or two control pulses.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

Randomized controlled trials in evidence-based mental health care: getting the right answer to the right question.

PubMed

Essock, Susan M; Drake, Robert E; Frank, Richard G; McGuire, Thomas G

2003-01-01

The purpose of clinical research is to answer this question: Would a new treatment, when added to the existing range of treatment options available in practice, help patients? Randomized controlled trials (RCTs)--in particular, double-blind RCTs--have important methodological advantages over observational studies for addressing this question. These advantages, however, come at a price. RCTs compare treatments using a particular allocation rule for assigning patients to treatments (random assignment) that does not mimic real-world practice. "Favorable" results from an RCT indicating that a new treatment is superior to existing treatments are neither necessary nor sufficient for establishing a "yes" answer to the question posed above. Modeled on an experimental design, RCTs are expensive in time and money and must compare simple differences in treatments. Findings have a high internal validity but may not address the needs of the field, particularly where treatment is complex and rapidly evolving. Design of clinical research needs to take account of the way treatments are allocated in actual practice and include flexible designs to answer important questions most effectively.

Clinical trial design for orthodontists.

PubMed

Pandis, Nikolaos; Cobourne, Martyn T

2013-06-01

High-quality research should form the basis of all clinical practice. Randomized controlled trials currently provide the gold standard for investigating the effectiveness of treatment interventions and these are increasingly being used in orthodontics. Here we discuss the reasons why this form of investigation provides the most useful evidence for assessing treatment outcome. The methods available to achieve true randomization, a fundamental component in the design of these trials, are also discussed. In addition, we focus on how to minimize bias in clinical research, not only during the design and management of a trial, but also when disseminating results. We focus on the importance of using control groups correctly and describe methods that are available to adequately power a trial. Finally, we emphasise the importance of accurate and transparent reporting, which facilitates correct communication and assessment of the evidence.

Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1.

PubMed

Jansen, Jeroen P; Fleurence, Rachael; Devine, Beth; Itzler, Robbin; Barrett, Annabel; Hawkins, Neil; Lee, Karen; Boersma, Cornelis; Annemans, Lieven; Cappelleri, Joseph C

2011-06-01

Evidence-based health-care decision making requires comparisons of all relevant competing interventions. In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment. Mixed treatment comparisons, a special case of network meta-analysis, combine direct and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than a traditional meta-analysis. This report from the ISPOR Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on the interpretation of indirect treatment comparisons and network meta-analysis to assist policymakers and health-care professionals in using its findings for decision making. We start with an overview of how networks of randomized, controlled trials allow multiple treatment comparisons of competing interventions. Next, an introduction to the synthesis of the available evidence with a focus on terminology, assumptions, validity, and statistical methods is provided, followed by advice on critically reviewing and interpreting an indirect treatment comparison or network meta-analysis to inform decision making. We finish with a discussion of what to do if there are no direct or indirect treatment comparisons of randomized, controlled trials possible and a health-care decision still needs to be made. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

PubMed

Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

2015-01-01

To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

PubMed

Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

2001-10-01

A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

Reducing Child Problem Behaviors and Improving Teacher-Child Interactions and Relationships: A Randomized Controlled Trial of Best in Class

ERIC Educational Resources Information Center

Sutherland, Kevin S.; Conroy, Maureen A.; Algina, James; Ladwig, Crystal; Jesse, Gabriel; Gyure, Maria

2018-01-01

Research has consistently linked early problem behavior with later adjustment problems, including antisocial behavior, learning problems and risk for the development of emotional/behavioral disorders (EBDs). Researchers have focused upon developing effective intervention programs for young children who arrive in preschool exhibiting chronic…

Adolescent Sexual Health Education: Does It Work? Can It Work Better? An Analysis of Recent Research and Media Reports.

ERIC Educational Resources Information Center

McKay Alexander; Fisher, William; Maticka-Tyndale, Eleanor; Barrett, Michael

2001-01-01

Examines and critiques a recent research report, "Interventions to Reduce Unintended Pregnancies among Adolescents: Systematic Review of Randomized Controlled Trials" (DeCenso, Guyatt, Willan, & Griffith, 2002) and subsequent media coverage suggesting that adolescent sex education programs do not work. The paper describes evidence…

The Effects of Scenario Planning on Participant Reports of Resilience

ERIC Educational Resources Information Center

Chermack, Thomas J.; Coons, Laura M.; O'barr, Gregory; Khatami, Shiva

2017-01-01

Purpose: The purpose of this research is to examine the effects of scenario planning on participant ratings of resilience. Design/methodology/approach: The research design is a quasi experimental pretest/posttest with treatment and control groups. Random selection or assignment was not achieved. Findings: Results show a significant difference in…

Regression Discontinuity Design in Gifted and Talented Education Research

ERIC Educational Resources Information Center

Matthews, Michael S.; Peters, Scott J.; Housand, Angela M.

2012-01-01

This Methodological Brief introduces the reader to the regression discontinuity design (RDD), which is a method that when used correctly can yield estimates of research treatment effects that are equivalent to those obtained through randomized control trials and can therefore be used to infer causality. However, RDD does not require the random…

Effects of Early Writing Intervention Delivered within a Data-Based Instruction Framework

ERIC Educational Resources Information Center

Jung, Pyung-Gang; McMaster, Kristen L.; delMas, Robert C.

2017-01-01

We examined effects of research-based early writing intervention delivered within a data-based instruction (DBI) framework for children with intensive needs. We randomly assigned 46 students with and without disabilities in Grades 1 to 3 within classrooms to either treatment or control. Treatment students received research-based early writing…

The Effects of Maple Integrated Strategy on Engineering Technology Students' Understanding of Integral Calculus

ERIC Educational Resources Information Center

Salleh, Tuan Salwani; Zakaria, Effandi

2016-01-01

The objective of this research is to investigate the effectiveness of a learning strategy using Maple in integral calculus. This research was conducted using a quasi-experimental nonequivalent control group design. One hundred engineering technology students at a technical university were chosen at random. The effectiveness of the learning…

The Effects of ABRACADABRA on Reading Outcomes: A Meta-Analysis of Applied Field Research

ERIC Educational Resources Information Center

Abrami, Philip; Borohkovski, Eugene; Lysenko, Larysa

2015-01-01

This meta-analysis summarizes research on the effects of a comprehensive, interactive web-based software (AXXX) on the development of reading competencies among kindergarteners and elementary students. Findings from seven randomized control trials and quasi-experimental studies undertaken in a variety of contexts across Canada, Australia and Kenya…

The Effects of POWERSOURCE[C] Intervention on Student Understanding of Basic Mathematical Principles. CRESST Report 763

ERIC Educational Resources Information Center

Phelan, Julia; Choi, Kilchan; Vendlinski, Terry; Baker, Eva L.; Herman, Joan L.

2009-01-01

This report describes results from field-testing of POWERSOURCE[C] formative assessment alongside professional development and instructional resources. The researchers at the National Center for Research, on Evaluation, Standards, & Student Testing (CRESST) employed a randomized, controlled design to address the following question: Does the…

Applying Randomized Controlled Trials and Systematic Reviews in Social Work Research

ERIC Educational Resources Information Center

Soydan, Haluk

2008-01-01

This article elaborates on the centrality of interventions for social work practice and the importance of understanding the effects of interventions for a more efficient, harmless, transparent, and ethical social work practice. Low-bias research designs and meta-analyses are important means of generating the best possible evidence on what works in…

Outcome Benchmarks for Adaptations of Research-Supported Treatments for Adult Traumatic Stress

ERIC Educational Resources Information Center

Rubin, Allen; Parrish, Danielle E.; Washburn, Micki

2016-01-01

This article provides benchmark data on within-group effect sizes from published randomized controlled trials (RCTs) that evaluated the efficacy of research-supported treatments (RSTs) for adult traumatic stress. Agencies can compare these benchmarks to their treatment group effect size to inform their decisions as to whether the way they are…

[On the present situation in psychotherapy and its implications - A critical analysis of the facts].

PubMed

Tschuschke, Volker; Freyberger, Harald J

2015-01-01

The currently dominating research paradigm in evidence-based medicine is expounded and discussed regarding the problems deduced from so-called empirically supported treatments (EST) in psychology and psychotherapy. Prevalent political and economic as well as ideological backgrounds influence the present dominance of the medical model in psychotherapy by implementing the randomized-controlled research design as the standard in the field. It has been demonstrated that randomized controlled trials (RCTs) are inadequate in psychotherapy research, not the least because of the high complexity of the psychotherapy and the relatively weak role of the treatment concept in the change process itself. All major meta-analyses show that the Dodo bird verdict is still alive, thereby demonstrating that the medical model in psychotherapy with its RCT paradigm cannot explain the equivalence paradox. The medical model is inappropriate, so that the contextual model is proposed as an alternative. Extensive process-outcome research is suggested as the only viable and reasonable way to identify highly complex interactions between the many factors regularly involved in change processes in psychotherapy.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

Evidentiary Pluralism as a Strategy for Research and Evidence-Based Practice in Rehabilitation Psychology

PubMed Central

Tucker, Jalie A.; Reed, Geoffrey M.

2008-01-01

This paper examines the utility of evidentiary pluralism, a research strategy that selects methods in service of content questions, in the context of rehabilitation psychology. Hierarchical views that favor randomized controlled clinical trials (RCTs) over other evidence are discussed, and RCTs are considered as they intersect with issues in the field. RCTs are vital for establishing treatment efficacy, but whether they are uniformly the best evidence to inform practice is critically evaluated. We argue that because treatment is only one of several variables that influence functioning, disability, and participation over time, an expanded set of conceptual and data analytic approaches should be selected in an informed way to support an expanded research agenda that investigates therapeutic and extra-therapeutic influences on rehabilitation processes and outcomes. The benefits of evidentiary pluralism are considered, including helping close the gap between the narrower clinical rehabilitation model and a public health disability model. KEY WORDS: evidence-based practice, evidentiary pluralism, rehabilitation psychology, randomized controlled trials PMID:19649150

Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial.

PubMed

Christidis, Nikolaos; Omrani, Shahin; Fredriksson, Lars; Gjelset, Mattias; Louca, Sofia; Hedenberg-Magnusson, Britt; Ernberg, Malin

2015-01-01

Serotonin (5-HT) mediates pain by peripheral 5-HT3-receptors. Results from a few studies indicate that intramuscular injections of 5-HT3-antagonists may reduce musculoskeletal pain. The aim of this study was to investigate if repeated intramuscular tender-point injections of the 5-HT3-antagonist granisetron alleviate pain in patients with myofascial temporomandibular disorders (M-TMD). This prospective, randomized, controlled, double blind, parallel-arm trial (RCT) was carried out during at two centers in Stockholm, Sweden. The randomization was performed by a researcher who did not participate in data collection with an internet-based application ( www.randomization.com ). 40 patients with a diagnose of M-TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were randomized to receive repeated injections, one week apart, with either granisetron (GRA; 3 mg) or isotonic saline as control (CTR). The median weekly pain intensities decreased significantly at all follow-ups (1-, 2-, 6-months) in the GRA-group (Friedman test; P < 0.05), but not in the CTR-group (Friedman-test; P > 0.075). The numbers needed to treat (NNT) were 4 at the 1- and 6-month follow-ups, and 3.3 at the 2-month follow-up in favor of granisetron. Repeated intramuscular tender-point injections with granisetron provide a new pharmacological treatment possibility for myofascial pain patients with repeated intramuscular tender-point injections with the serotonin type 3 antagonist granisetron. It showed a clinically relevant pain reducing effect in the temporomandibular region, both in a short- and long-term aspect. European Clinical Trials Database 2005-006042-41 as well as at Clinical Trials NCT02230371 .

Contexts for Teacher Practice: (Re)Considering the Role of Context in Interventions in Early Childhood Teacher Engagement with New Approaches to Shared Book Reading

ERIC Educational Resources Information Center

Delaney, Katherine K.; Neuman, Susan B.

2016-01-01

Although the randomized controlled trial has been regarded as the "sine qua non" in recent years, we argue that understanding contexts for teacher practice is a critical factor in the implementation of intervention, but has often been overlooked in educational research design. In this paper, we argue that randomized trials may not be…

A framework for understanding cancer comparative effectiveness research data needs

PubMed Central

Carpenter, William R; Meyer, Anne-Marie; Abernethy, Amy P.; Stürmer, Til; Kosorok, Michael R.

2012-01-01

Objective Randomized controlled trials remain the gold standard for evaluating cancer intervention efficacy. Randomized trials are not always feasible, practical, or timely, and often don’t adequately reflect patient heterogeneity and real-world clinical practice. Comparative effectiveness research can leverage secondary data to help fill knowledge gaps randomized trials leave unaddressed; however, comparative effectiveness research also faces shortcomings. The goal of this project was to develop a new model and inform an evolving framework articulating cancer comparative effectiveness research data needs. Study Design and Setting We examined prevalent models and conducted semi-structured discussions with 76 clinicians and comparative effectiveness research researchers affiliated with the Agency for Healthcare Research and Quality’s cancer comparative effectiveness research programs. Results A new model was iteratively developed, and presents cancer comparative effectiveness research and important measures in a patient-centered, longitudinal chronic care model better-reflecting contemporary cancer care in the context of the cancer care continuum, rather than a single-episode, acute-care perspective. Conclusion Immediately relevant for federally-funded comparative effectiveness research programs, the model informs an evolving framework articulating cancer comparative effectiveness research data needs, including evolutionary enhancements to registries and epidemiologic research data systems. We discuss elements of contemporary clinical practice, methodology improvements, and related needs affecting comparative effectiveness research’s ability to yield findings clinicians, policymakers, and stakeholders can confidently act on. PMID:23017633

The effects of reflexology on pain and sleep deprivation in patients with rheumatoid arthritis: A randomized controlled trial.

PubMed

Bakir, Ercan; Baglama, Sevgin Samancioglu; Gursoy, Savas

2018-05-01

This study was intended to examine the effect of foot reflexology on RA patients' pain and sleep quality. This is a randomized controlled trial and was held at the "Rheumatology Follow-up Polyclinic" in Turkey between January-July 2015. A total of 60 patients were included in the research. A sociodemographic data form, the Pittsburgh Sleep Quality Index (PSQI) and the Visual Analogue Scale (VAS) were used. Foot Reflexology was administered to the experimental group. The research found that the pain scores of the experimental group were statistically more significant than those of the control group (p < .01). The experimental group's average pain was reduced by the six weeks of foot reflexology. The total PSQI score of the experimental group was lowered. Foot reflexology is a non-pharmacological nursing intervention that may reduce the pain and sleep deprivation symptoms of RA patients. Copyright © 2018 Elsevier Ltd. All rights reserved.

Relationships between digital signal processing and control and estimation theory

NASA Technical Reports Server (NTRS)

Willsky, A. S.

1978-01-01

Research areas associated with digital signal processing and control and estimation theory are identified. Particular attention is given to image processing, system identification problems (parameter identification, linear prediction, least squares, Kalman filtering), stability analyses (the use of the Liapunov theory, frequency domain criteria, passivity), and multiparameter systems, distributed processes, and random fields.

The Girlfriends Project: Evaluating a Promising Community-Based Intervention from a Bottom-Up Perspective

ERIC Educational Resources Information Center

Hawk, Mary

2015-01-01

Randomized controlled trials are the gold standard in research but may not fully explain or predict outcome variations in community-based interventions. Demonstrating efficacy of externally driven programs in well-controlled environments may not translate to community-based implementation where resources and priorities vary. A bottom-up evaluation…

Does Playworks Work? Findings from a Randomized Controlled Trial

ERIC Educational Resources Information Center

James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

2013-01-01

Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

Just-in-Time Teaching Techniques through Web Technologies for Vocational Students' Reading and Writing Abilities

ERIC Educational Resources Information Center

Chantoem, Rewadee; Rattanavich, Saowalak

2016-01-01

This research compares the English language achievements of vocational students, their reading and writing abilities, and their attitudes towards learning English taught with just-in-time teaching techniques through web technologies and conventional methods. The experimental and control groups were formed, a randomized true control group…

Massage Therapy in Children with Asthma: A Systematic Review and Meta-Analysis.

PubMed

Wu, Ji; Yang, Xi-Wen; Zhang, Ming

2017-01-01

To systematically evaluate the efficacy of massage, a traditional treatment method of traditional Chinese medicine on children with asthma. Literatures from 5 databases using the date ranging from 1 January, 1990, to 13 December, 2016, were reviewed, which were all randomized controlled trials evaluating the efficacy on children with asthma and effect on lung function mainly by massage therapy. 14 researches with 1299 patients were included in the meta-analysis. Compared with control group, a better efficacy was found in treatment group, which focused on massage therapy. Compared with control group, there was remarkable increase on FEV1 as well as PEF in treatment group. All studies have shown that massage therapy has a significantly positive effect on children with asthma, improves the pulmonary function parameters of large airway, reduces the plasma concentrations of PAF and prostaglandin, and increases the levels of PAF-AH and DP1; therefore, it greatly improves pulmonary function. However, the limited research designs of included studies lead to high risk of bias. More randomized controlled trials with better methodological quality are needed to further confirm the effectiveness of massage.

PACS in an intensive care unit: results from a randomized controlled trial

NASA Astrophysics Data System (ADS)

Bryan, Stirling; Weatherburn, Gwyneth C.; Watkins, Jessamy; Walker, Samantha; Wright, Carl; Waters, Brian; Evans, Jeff; Buxton, Martin J.

1998-07-01

The objective of this research was to assess the costs and benefits associated with the introduction of a small PACS system into an intensive care unit (ICU) at a district general hospital in north Wales. The research design adopted for this study was a single center randomized controlled trial (RCT). Patients were randomly allocated either to a trial arm where their x-ray imaging was solely film-based or to a trial arm where their x-ray imaging was solely PACS based. Benefit measures included examination-based process measures, such as image turn-round time, radiation dose and image unavailability; and patient-related process measures, which included adverse events and length of stay. The measurement of costs focused on additional 'radiological' costs and the costs of patient management. The study recruited 600 patients. The key findings from this study were that the installation of PACS was associated with important benefits in terms of image availability, and important costs in both monetary and radiation dose terms. PACS-related improvements in terms of more timely 'clinical actions' were not found. However, the qualitative aspect of the research found that clinicians were advocates of the technology and believed that an important benefit of PACS related to improved image availability.

Rebuilding from Resilience: Research Framework for a Randomized Controlled Trial of Community-led Interventions to Prevent Domestic Violence in Aboriginal Communities1

PubMed Central

Andersson, Neil; Shea, Beverley; Amaratunga, Carol; McGuire, Patricia; Sioui, Georges

2010-01-01

This research framework, which competed successfully in the 2008 CIHR open operating grants competition, focuses on protocols to measure the impact of community-led interventions to reduce domestic violence in Aboriginal communities. The project develops and tests tools and procedures for a randomized controlled trial of prevention of family violence. Women’s shelters mainly deal with victims of domestic violence, and the framework also addresses other types of domestic violence (male and female children, elderly, and disabled). The partner shelters are in Aboriginal communities across Canada, on and off reserve, in most provinces and territories. The baseline study applies a questionnaire developed by the shelters. Testing the stepped wedge design in an Aboriginal context, shelters randomized themselves to two waves of intervention, half the shelters receiving the resources for the first wave. A repeat survey after two years will measure the difference between first wave and second wave, after which the resources will shift to the second wave. At least two Aboriginal researchers will complete their doctoral studies in the project. The steering committee of 12 shelter directors guides the project and ensures ethical standards related to their populations. Each participating community and the University of Ottawa reviewed and passed the proposal. PMID:20975853

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.

Personal health and consumer informatics. The impact of health oriented social media applications on health outcomes.

PubMed

Gibbons, M C

2013-01-01

The rapid evolution in the world-wide use of Social Media tools suggests the emergence of a global phenomenon that may have implications in the Personal Health and Consumer Health Informatics domains. However the impact of these tools on health outcomes is not known. The goal of this research was to review the randomized controlled trial (RCT) evidence of the impact of health oriented Social Media informatics tools on health outcomes. Evaluations of Social Media consumer health tools were systematically reviewed. Research was limited to studies published in the English language, published in Medline, published in the calendar year 2012 and limited to studies that utilized a RCT methodological design. Two high quality Randomized Controlled Trials among over 600 articles published in Medline were identified. These studies indicate that Social Media interventions may be able to significantly improve pain control among patients with chronic pain and enhance weight loss maintenance among individuals attempting to lose weight. Significantly more research needs to be done to confirm these early findings, evaluate additional health outcomes and further evaluate emerging health oriented Social Media interventions. Chronic pain and weight control have both socially oriented determinants. These studies suggest that understanding the social component of a disease may ultimately provide novel therapeutic targets and socio-clinical interventional strategies.

Citation classics in periodontology: a controlled study.

PubMed

Nieri, Michele; Saletta, Daniele; Guidi, Luisa; Buti, Jacopo; Franceschi, Debora; Mauro, Saverio; Pini-Prato, Giovanpaolo

2007-04-01

The aims of this study were to identify the most cited articles in Periodontology published from January 1990 to March 2005; and to analyse the differences between citation Classics and less cited articles. The search was carried out in four international periodontal journals: Journal of Periodontology, Journal of Clinical Periodontology, International Journal of Periodontics and Restorative Dentistry and Journal of Periodontal Research. The Classics, that are articles cited at least 100 times, were identified using the Science Citation Index database. From every issue of the journals that contained a Classic, another article was randomly selected and used as a Control. Fifty-five Classics and 55 Controls were identified. Classic articles were longer, used more images, had more authors, and contained more self-references than Controls. Moreover Classics had on the average a bigger sample size, often dealt with etiopathogenesis and prognosis, but were rarely controlled or randomized studies. Classic articles play an instructive role, but are often non-Controlled studies.

Online Alcohol Assessment and Feedback for Hazardous and Harmful Drinkers: Findings From the AMADEUS-2 Randomized Controlled Trial of Routine Practice in Swedish Universities.

PubMed

Bendtsen, Preben; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim

2015-07-09

Previous research on the effectiveness of online alcohol interventions for college students has shown mixed results. Small benefits have been found in some studies and because online interventions are inexpensive and possible to implement on a large scale, there is a need for further study. This study evaluated the effectiveness of national provision of a brief online alcohol intervention for students in Sweden. Risky drinkers at 9 colleges and universities in Sweden were invited by mail and identified using a single screening question. These students (N=1605) gave consent and were randomized into a 2-arm parallel group randomized controlled trial consisting of immediate or delayed access to a fully automated online assessment and intervention with personalized feedback. After 2 months, there was no strong evidence of effectiveness with no statistically significant differences in the planned analyses, although there were some indication of possible benefit in sensitivity analyses suggesting an intervention effect of a 10% reduction (95% CI -30% to 10%) in total weekly alcohol consumption. Also, differences in effect sizes between universities were seen with participants from a major university (n=365) reducing their weekly alcohol consumption by 14% (95% CI -23% to -4%). However, lower recruitment than planned and differential attrition in the intervention and control group (49% vs 68%) complicated interpretation of the outcome data. Any effects of current national provision are likely to be small and further research and development work is needed to enhance effectiveness. International Standard Randomized Controlled Trial Number (ISRCTN): 02335307; http://www.isrctn.com/ISRCTN02335307 (Archived by WebCite at http://www.webcitation.org/6ZdPUh0R4).

Performance analysis of Integrated Communication and Control System networks

NASA Technical Reports Server (NTRS)

Halevi, Y.; Ray, A.

1990-01-01

This paper presents statistical analysis of delays in Integrated Communication and Control System (ICCS) networks that are based on asynchronous time-division multiplexing. The models are obtained in closed form for analyzing control systems with randomly varying delays. The results of this research are applicable to ICCS design for complex dynamical processes like advanced aircraft and spacecraft, autonomous manufacturing plants, and chemical and processing plants.

Effect of Play Therapy on Behavioral Problems of Maladjusted Preschool Children

PubMed Central

Mohammadi, Mohammad Reza; Khanbani, Mehdi; Farid, Saeedeh; Chiti, Parisa

2011-01-01

Objective The present research was conducted to study the effect of play therapy on reducing behavioral problems of children with oppositional defiant disorder. Method Using multistage cluster sampling, regions 6, 7, and 8 in Tehran were selected. Among kindergartens of these areas, 3 kindergartens which were supported by the welfare organization were randomly selected. Of all the pre-school children of these 3 kindergartens, 40 children who could have behavioral disorder, according to their teachers and parents, were carefully tested. Of them, 16 children who showed severe symptoms of oppositional defiant disorder, were selected via the results obtained from the child symptom inventory questionnaire (CSI-4), teacher's form, and a researcher-made self-control checklist, Then, the subjects were randomly divided into one control and one experimental group. This research is quasi-experimental, and is conducted using pre-test, post-test, and control group. Results Values of the calculated F for oppositional defiant disorder in control group and experimental group was meaningful after fixing the effect of pre-test (P<0/001). Therefore, a meaningful difference existed between the means of post-test scores of disobedience disorder in the experimental and control groups through the fixed effect of the pre-test effect. Comparison of adjusted means of the 2 groups showed that the mean of attention-deficit hyperactivity disorder (ADHD) in experimental group was lower than control group. Therefore, applying play therapy reduced severity of ADHD in those children in experimental group compared to those in control group who did not receive such instructions. Conclusion Results of this research demonstrates that children's disobedience can be reduced by play therapy. PMID:22952519

Feasibility, acceptability, and effects of gentle Hatha yoga for women with major depression: Findings from a randomized controlled mixed-methods study

PubMed Central

Kinser, Patricia Anne; Bourguignon, Cheryl; Whaley, Diane; Hauenstein, Emily; Taylor, Ann Gill

2013-01-01

Major depressive disorder (MDD) is a common, debilitating chronic condition in the United States and worldwide. Particularly in women, depressive symptoms are often accompanied by high levels of stress and ruminations, or repetitive self-critical negative thinking. There is a research and clinical imperative to evaluate complementary therapies that are acceptable and feasible for women with depression and that target specific aspects of depression in women, such as ruminations. To begin to address this need, we conducted a randomized, controlled, mixed-methods community-based study comparing an 8-week yoga intervention with an attention-control activity in 27 women with MDD. After controlling for baseline stress, there was a decrease in depression over time in both the yoga group and the attention-control group, with the yoga group having a unique trend in decreased ruminations. Participants in the yoga group reported experiencing increased connectedness and gaining a coping strategy through yoga. The findings provide support for future large scale research to explore the effects of yoga for depressed women and the unique role of yoga in decreasing rumination. PMID:23706890

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

PubMed

Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

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

PubMed Central

Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

2011-01-01

A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

Physical activity measurements affected participants' behavior in a randomized controlled trial.

PubMed

van Sluijs, Esther M F; van Poppel, Mireille N M; Twisk, Jos W R; van Mechelen, Willem

2006-04-01

Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

Analysis of causality from observational studies and its application in clinical research in Intensive Care Medicine.

PubMed

Coscia Requena, C; Muriel, A; Peñuelas, O

2018-02-28

Random allocation of treatment or intervention is the key feature of clinical trials and divides patients into treatment groups that are approximately balanced for baseline, and therefore comparable covariates except for the variable treatment of the study. However, in observational studies, where treatment allocation is not random, patients in the treatment and control groups often differ in covariates that are related to intervention variables. These imbalances in covariates can lead to biased estimates of the treatment effect. However, randomized clinical trials are sometimes not feasible for ethical, logistical, economic or other reasons. To resolve these situations, interest in the field of clinical research has grown in designing studies that are most similar to randomized experiments using observational (i.e. non-random) data. Observational studies using propensity score analysis methods have been increasing in the scientific papers of Intensive Care. Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. However, studies with propensity indexes may be confusing, and intensivists are not familiar with this methodology and may not fully understand the importance of this technique. The objectives of this review are: to describe the fundamentals of propensity index methods; to present the techniques to adequately evaluate propensity index models; to discuss the advantages and disadvantages of these techniques. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Essential considerations in developing attention control groups in behavioral research.

PubMed

Aycock, Dawn M; Hayat, Matthew J; Helvig, Ashley; Dunbar, Sandra B; Clark, Patricia C

2018-06-01

Attention control groups strengthen randomized controlled trials of behavioral interventions, but researchers need to give careful consideration to the attention control activities. A comparative effectiveness research framework provides an ideal opportunity for an attention control group as a supplement to standard care, so participants potentially receive benefit regardless of group assignment. The anticipated benefit of the control condition must be independent of the study outcome. Resources needed for attention control activities need to be carefully considered and ethical considerations carefully weighed. In this paper we address nine considerations for the design and implementation of attention control groups: (1) ensure attention control activities are not associated with the outcome; (2) avoid contamination of the intervention or control group; (3) design comparable control and intervention activities; (4) ensure researcher training to adequately administer both treatment arms; (5) design control activities to be interesting and acceptable to participants; (6) evaluate attention control activities; (7) consider additional resources needed to implement attention control activities; (8) quantifying the effects of attention control and intervention groups; and (9) ethical considerations with attention control groups. Examples from the literature and ongoing research are presented. Careful planning for the attention control group is as important as for the intervention group. Researchers can use the considerations presented here to assist in planning for the best attention control group for their study. © 2018 Wiley Periodicals, Inc.

A Comparison of Seventh Grade Thai Students' Reading Comprehension and Motivation to Read English through Applied Instruction Based on the Genre-Based Approach and the Teacher's Manual

ERIC Educational Resources Information Center

Sawangsamutchai, Yutthasak; Rattanavich, Saowalak

2016-01-01

The objective of this research is to compare the English reading comprehension and motivation to read of seventh grade Thai students taught with applied instruction through the genre-based approach and teachers' manual. A randomized pre-test post-test control group design was used through the cluster random sampling technique. The data were…

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

The Oregon health insurance experiment: when limited policy resources provide research opportunities.

PubMed

Allen, Heidi; Baicker, Katherine; Taubman, Sarah; Wright, Bill; Finkelstein, Amy

2013-12-01

In 2008 Oregon allocated access to its Medicaid expansion program, Oregon Health Plan Standard, by drawing names from a waiting list by lottery. The lottery was chosen by policy makers and stakeholders as the preferred way to allocate limited resources. At the same time, it also gave rise to the Oregon Health Insurance Experiment: an unprecedented opportunity to do a randomized evaluation - the gold standard in medical and scientific research - of the impact of expanding Medicaid. In this article we provide historical context for Oregon's decision to conduct a lottery, discuss the importance of randomized controlled designs for policy evaluation, and describe some of the practical challenges in successfully capitalizing on the research opportunity presented by the Oregon lottery through public-academic partnerships. Since policy makers will always face tough choices about how to distribute scarce resources, we urge thoughtful consideration of the opportunities to incorporate randomization that can substantially improve the evidence available to inform policy decisions without compromising policy goals.

Causal Inference and the Comparative Interrupted Time Series Design: Findings from Within-Study Comparisons

ERIC Educational Resources Information Center

St. Clair, Travis; Hallberg, Kelly; Cook, Thomas D.

2014-01-01

Researchers are increasingly using comparative interrupted time series (CITS) designs to estimate the effects of programs and policies when randomized controlled trials are not feasible. In a simple interrupted time series design, researchers compare the pre-treatment values of a treatment group time series to post-treatment values in order to…

Effect of Polya Problem-Solving Model on Senior Secondary School Students' Performance in Current Electricity

ERIC Educational Resources Information Center

Olaniyan, Ademola Olatide; Omosewo, Esther O.; Nwankwo, Levi I.

2015-01-01

This study was designed to investigate the Effect of Polya Problem-Solving Model on Senior School Students' Performance in Current Electricity. It was a quasi experimental study of non- randomized, non equivalent pre-test post-test control group design. Three research questions were answered and corresponding three research hypotheses were tested…

Change, Self-Organization and the Search for Causality in Educational Research and Practice

ERIC Educational Resources Information Center

Koopmans, Matthijs

2014-01-01

Causality is an inextricable part of the educational process, as our understanding of what works in education depends on our ability to make causal attributions. Yet, the research and policy literature in education tends to define causality narrowly as the attribution of educational outcomes to intervention effects in a randomized control trial…

The Impact of an Unconditional Cash Transfer on Early Child Development: The Zambia Child Grant Program

ERIC Educational Resources Information Center

Seidenfeld, David; Prencipe, Leah; Handa, Sudhanshu; Hawkinson, Laura

2015-01-01

Little research has been conducted on unconditional cash transfers (UCTs) despite their growing prevalence in Africa, including South Africa, Zambia, Zimbabwe, Kenya, Malawi, Lesotho, and Uganda. In this study, researchers implemented a randomized control trial with over 2,500 households to investigate the impact of Africa's child grant program on…

Validity of electronic diet recording nutrient estimates compared to dietitian analysis of diet records: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Background: Dietary intake assessment with diet records (DR) is a standard research and practice tool in nutrition. Manual entry and analysis of DR is time-consuming and expensive. New electronic tools for diet entry by clients and research participants may reduce the cost and effort of nutrient int...

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…

Does clinical equipoise apply to cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research. PMID:21569349

Simulation of foulant bioparticle topography based on Gaussian process and its implications for interface behavior research

NASA Astrophysics Data System (ADS)

Zhao, Leihong; Qu, Xiaolu; Lin, Hongjun; Yu, Genying; Liao, Bao-Qiang

2018-03-01

Simulation of randomly rough bioparticle surface is crucial to better understand and control interface behaviors and membrane fouling. Pursuing literature indicated a lack of effective method for simulating random rough bioparticle surface. In this study, a new method which combines Gaussian distribution, Fourier transform, spectrum method and coordinate transformation was proposed to simulate surface topography of foulant bioparticles in a membrane bioreactor (MBR). The natural surface of a foulant bioparticle was found to be irregular and randomly rough. The topography simulated by the new method was quite similar to that of real foulant bioparticles. Moreover, the simulated topography of foulant bioparticles was critically affected by parameters correlation length (l) and root mean square (σ). The new method proposed in this study shows notable superiority over the conventional methods for simulation of randomly rough foulant bioparticles. The ease, facility and fitness of the new method point towards potential applications in interface behaviors and membrane fouling research.

Using Non-experimental Data to Estimate Treatment Effects

PubMed Central

Stuart, Elizabeth A.; Marcus, Sue M.; Horvitz-Lennon, Marcela V.; Gibbons, Robert D.; Normand, Sharon-Lise T.

2009-01-01

While much psychiatric research is based on randomized controlled trials (RCTs), where patients are randomly assigned to treatments, sometimes RCTs are not feasible. This paper describes propensity score approaches, which are increasingly used for estimating treatment effects in non-experimental settings. The primary goal of propensity score methods is to create sets of treated and comparison subjects who look as similar as possible, in essence replicating a randomized experiment, at least with respect to observed patient characteristics. A study to estimate the metabolic effects of antipsychotic medication in a sample of Florida Medicaid beneficiaries with schizophrenia illustrates methods. PMID:20563313

Randomized controlled trials in dentistry: common pitfalls and how to avoid them.

PubMed

Fleming, Padhraig S; Lynch, Christopher D; Pandis, Nikolaos

2014-08-01

Clinical trials are used to appraise the effectiveness of clinical interventions throughout medicine and dentistry. Randomized controlled trials (RCTs) are established as the optimal primary design and are published with increasing frequency within the biomedical sciences, including dentistry. This review outlines common pitfalls associated with the conduct of randomized controlled trials in dentistry. Common failings in RCT design leading to various types of bias including selection, performance, detection and attrition bias are discussed in this review. Moreover, methods of minimizing and eliminating bias are presented to ensure that maximal benefit is derived from RCTs within dentistry. Well-designed RCTs have both upstream and downstream uses acting as a template for development and populating systematic reviews to permit more precise estimates of treatment efficacy and effectiveness. However, there is increasing awareness of waste in clinical research, whereby resource-intensive studies fail to provide a commensurate level of scientific evidence. Waste may stem either from inappropriate design or from inadequate reporting of RCTs; the importance of robust conduct of RCTs within dentistry is clear. Optimal reporting of randomized controlled trials within dentistry is necessary to ensure that trials are reliable and valid. Common shortcomings leading to important forms or bias are discussed and approaches to minimizing these issues are outlined. Copyright © 2014 Elsevier Ltd. All rights reserved.

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

PubMed

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

Sericea lespdeza as an aid in the control of Emeria spp. in lambs

USDA-ARS?s Scientific Manuscript database

The objective of this research was to examine the effects of feeding sericea lespedeza leaf meal [SL, Lespedeza cuneata (Dum.-Cours. G. Don)] on control of coccidiosis in lambs. In Exp. 1, naturally infected lambs (n = 76) were weaned (102.7 ± 1.4 d of age) in May (spring) and randomly assigned to ...

Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review.

PubMed

Hoagwood, Kimberly Eaton; Acri, Mary; Morrissey, Meghan; Peth-Pierce, Robin

2017-01-01

To systematically review experimental evidence about animal-assisted therapies (AAT) for children or adolescents with or at risk for mental health conditions, we reviewed all experimental AAT studies published between 2000-2015, and compared studies by animal type, intervention, and outcomes. Studies were included if used therapeutically for children and adolescents (≤21 years) with or at risk for a mental health problem; used random assignment or a waitlist comparison/control group; and included child-specific outcome data. Of 1,535 studies, 24 met inclusion criteria. Of 24 studies identified, almost half were randomized controlled trials, with 9 of 11 published in the past two years. The largest group addresses equine therapies for autism. Findings are generally promising for positive effects associated with equine therapies for autism and canine therapies for childhood trauma. The AAT research base is slim; a more focused research agenda is outlined.

Treatment of eating disorders in child and adolescent psychiatry.

PubMed

Herpertz-Dahlmann, Beate

2017-11-01

Recent research on the multimodal treatment of eating disorders in child and adolescent psychiatry has yielded a significant increase in randomized controlled trials and systematic reviews. This review aims to present relevant findings published during the last 2 years related to medical and psychological treatment of anorexia nervosa, bulimia nervosa and avoidant/restrictive food intake disorder (ARFID). For anorexia nervosa, recent reports described the efficacy of different treatment settings, lengths of hospital stay and high vs. low-calorie refeeding programmes. For both anorexia and bulimia nervosa, a number of randomized controlled trials comparing individual and family-oriented treatment approaches were published. For the newly defined ARFID, only very preliminary results on possible treatment approaches implying a multidisciplinary treatment programme were obtained. Although there is some evidence of the effectiveness of new child and adolescent psychiatric treatment approaches to eating disorders, the relapse rate remains very high, and there is an urgent need for ongoing intensive research.

Influence of Problem Based Learning on Critical Thinking Skills and Competence Class VIII SMPN 1 Gunuang Omeh, 2016/2017

NASA Astrophysics Data System (ADS)

Aswan, D. M.; Lufri, L.; Sumarmin, R.

2018-04-01

This research intends to determine the effect of Problem Based Learning models on students' critical thinking skills and competences. This study was a quasi-experimental research. The population of the study was the students of class VIII SMPN 1 Subdistrict Gunuang Omeh. Random sample selection is done by randomizing the class. Sample class that was chosen VIII3 as an experimental class given that treatment study based on problems and class VIII1 as control class that treatment usually given study. Instrument that used to consist of critical thinking test, cognitive tests, observation sheet of affective and psychomotor. Independent t-test and Mann Whitney U test was used for the analysis. Results showed that there was significant difference (sig <0.05) between control and experimental group. The conclusion of this study was Problem Based Learning models affected the students’ critical thinking skills and competences.

Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

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

PubMed Central

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

2014-01-01

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

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

PubMed Central

John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

2016-01-01

Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship – Quasi-Experimental Designs

PubMed Central

Schweizer, Marin L.; Braun, Barbara I.; Milstone, Aaron M.

2016-01-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt non-randomized interventions. Quasi-experimental studies can be categorized into three major types: interrupted time series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. PMID:27267457

How to Measure Motivational Interviewing Fidelity in Randomized Controlled Trials: Practical Recommendations.

PubMed

Jelsma, Judith G M; Mertens, Vera-Christina; Forsberg, Lisa; Forsberg, Lars

2015-07-01

Many randomized controlled trials in which motivational interviewing (MI) is a key intervention make no provision for the assessment of treatment fidelity. This methodological shortcoming makes it impossible to distinguish between high- and low-quality MI interventions, and, consequently, to know whether MI provision has contributed to any intervention effects. This article makes some practical recommendations for the collection, selection, coding and reporting of MI fidelity data, as measured using the Motivational Interviewing Treatment Integrity Code. We hope that researchers will consider these recommendations and include MI fidelity measures in future studies. Copyright © 2015 Elsevier Inc. All rights reserved.

Bias from historical control groups used in orthodontic research: a meta-epidemiological study.

PubMed

Papageorgiou, Spyridon N; Koretsi, Vasiliki; Jäger, Andreas

2017-02-01

The validity of meta-analysis is dependent upon the quality of included studies. Here, we investigated whether the design of untreated control groups (i.e. source and timing of data collection) influences the results of clinical trials in orthodontic research. This meta-epidemiological study used unrestricted literature searching for meta-analyses in orthodontics including clinical trials with untreated control groups. Differences in standardized mean differences (ΔSMD) and their 95% confidence intervals (CIs) were calculated according to the untreated control group through multivariable random-effects meta-regression controlling for nature of the interventional group and study sample size. Effects were pooled with random-effects synthesis, followed by mixed-effect subgroup and sensitivity analyses. Studies with historical control groups reported deflated treatment effects compared to studies with concurrent control groups (13 meta-analyses; ΔSMD = -0.31; 95% CI = -0.53, -0.10; P = 0.004). Significant differences were found according to the type of historical control group (based either on growth study or clinical archive; 11 meta-analyses; ΔSMD = 0.40; 95% CI = 0.21, 0.59; P < 0.001). The use of historical control groups in orthodontic clinical research was associated with deflation of treatment effects, which was independent from whether the interventional group was prospective or retrospective and from the study's sample size. Caution is warranted when interpreting clinical studies with historical untreated control groups or when interpreting systematic reviews that include such studies. PROSPERO (CRD42015024179). None. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Methodological and Ethical Challenges in a Web-Based Randomized Controlled Trial of a Domestic Violence Intervention

PubMed Central

Valpied, Jodie; Koziol-McLain, Jane; Glass, Nancy; Hegarty, Kelsey

2017-01-01

The use of Web-based methods to deliver and evaluate interventions is growing in popularity, particularly in a health care context. They have shown particular promise in responding to sensitive or stigmatized issues such as mental health and sexually transmitted infections. In the field of domestic violence (DV), however, the idea of delivering and evaluating interventions via the Web is still relatively new. Little is known about how to successfully navigate several challenges encountered by the researchers while working in this area. This paper uses the case study of I-DECIDE, a Web-based healthy relationship tool and safety decision aid for women experiencing DV, developed in Australia. The I-DECIDE website has recently been evaluated through a randomized controlled trial, and we outline some of the methodological and ethical challenges encountered during recruitment, retention, and evaluation. We suggest that with careful consideration of these issues, randomized controlled trials can be safely conducted via the Web in this sensitive area. PMID:28351830

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

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

A randomized controlled trial on the efficacy of thoracic CT screening for lung cancer in non-smokers and smokers of <30 pack-years aged 50-64 years (JECS study): research design.

PubMed

Sagawa, Motoyasu; Nakayama, Tomio; Tanaka, Makoto; Sakuma, Tsutomu; Sobue, Tomotaka

2012-12-01

In order to assess the efficacy of lung cancer screening using low-dose thoracic computed tomography, compared with chest roentgenography, in people aged 50-64 years with a smoking history of <30 pack-years, a randomized controlled trial is being conducted in Japan. The screening methods are randomly assigned individually. The duration of this trial is 10 years. In the intervention arm, low-dose thoracic computed tomography is performed for each participant in the first and the sixth years. In the control arm, chest roentgenography is performed for each participant in the first year. The participants in both arms are also encouraged to receive routine lung cancer screening using chest roentgenography annually. The interpretation of radiological findings and the follow-up of undiagnosed nodules are to be carried out according to the guidelines published in Japan. The required sample size is calculated to be 17 500 subjects for each arm.

A Randomized, Controlled Pilot Study of a Single-Session Psychoeducation Treatment for Urban, Culturally Diverse, Trauma-Exposed Adults.

PubMed

Ghafoori, Bita; Fisher, Dennis; Korosteleva, Olga; Hong, Madelyn

2016-06-01

This randomized pilot study aimed to determine whether a single session of psychoeducation improved mental health outcomes, attitudes toward treatment, and service engagement among urban, impoverished, culturally diverse, trauma-exposed adults. Sixty-seven individuals were randomly assigned to a single-session psychoeducation treatment or a delayed treatment comparison control group. The control group was found to be superior to the treatment group at posttest with respect to symptoms of posttraumatic stress disorder, anxiety, and occupational and family disability. At follow-up, all participants had completed the psychoeducation treatment, and a mixed-effects model indicated significant improvements over time in symptoms of posttraumatic stress disorder, anxiety, depression, somatization, and attitudes toward treatment. Ninety-eight percent of the participants reported the psychoeducation was helpful at follow-up. Participants also reported a 19.1% increase in mental health service utilization at follow-up compared with baseline. Implications for treatment and future research are discussed.

School-Based Service-Learning for Promoting Citizenship in Young People: A Systematic Review

DTIC Science & Technology

2005-09-06

nonequivalent pre- and post-test design with control group was utilized but participants were not randomized to groups . The sample...other methodology. She notes the limitations of the research chosen for the review (i.e., most studies lack a control group , do not track effects over...experimental and control groups Pre- and post- test design Surveys “Service-learning”12 Intervention groups : Service-learning

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

TakeCARE, a Video Bystander Program to Help Prevent Sexual Violence on College Campuses: Results of Two Randomized, Controlled Trials

PubMed Central

Jouriles, Ernest N.; McDonald, Renee; Rosenfield, David; Levy, Nicole; Sargent, Kelli; Caiozzo, Christina; Grych, John H.

2015-01-01

Objective The present research reports on two randomized controlled trials evaluating TakeCARE, a video bystander program designed to help prevent sexual violence on college campuses. Method In Study 1, students were recruited from psychology courses at two universities. In Study 2, first-year students were recruited from a required course at one university. In both studies, students were randomly assigned to view one of two videos: TakeCARE or a control video on study skills. Just before viewing the videos, students completed measures of bystander behavior toward friends and ratings of self-efficacy for performing such behaviors. The efficacy measure was administered again after the video, and both the bystander behavior measure and the efficacy measure were administered at either one (Study 1) or two (Study 2) months later. Results In both studies, students who viewed TakeCARE, compared to students who viewed the control video, reported engaging in more bystander behavior toward friends and greater feelings of efficacy for performing such behavior. In Study 1, feelings of efficacy mediated effects of TakeCARE on bystander behavior; this result did not emerge in Study 2. Conclusions This research demonstrates that TakeCARE, a video bystander program, can positively influence bystander behavior toward friends. Given its potential to be easily distributed to an entire campus community, TakeCARE might be an effective addition to campus efforts to prevent sexual violence. PMID:27867694

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol

PubMed Central

Kangovi, Shreya; Mitra, Nandita; Turr, Lindsey; Huo, Hairong; Grande, David; Long, Judith A.

2017-01-01

Upstream interventions – e.g. housing programs and community health worker interventions-address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence. At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients’ selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases. PMID:27965180

Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study.

PubMed

2008-12-01

To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an omega-3 fatty acid, improves the motor features of Huntington disease. Six-month multicenter, randomized, double-blind, placebo-controlled trial followed by a 6-month open-label phase without disclosing initial treatment assignments. Forty-one research sites in the United States and Canada. Three hundred sixteen adults with Huntington disease, enriched for a population with shorter trinucleotide (cytosine-adenine-guanine) repeat length expansions. Random assignment to placebo or ethyl-EPA, 1 g twice a day, followed by open-label treatment with ethyl-EPA. Six-month change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale analyzed for all research participants and those with shorter cytosine-adenine-guanine repeat length expansions (<45). At 6 months, the Total Motor Score 4 point change for patients receiving ethyl-EPA did not differ from that for those receiving placebo. No differences were found in measures of function, cognition, or global impression. Before public disclosure of the 6-month placebo-controlled results, 192 individuals completed the open-label phase. The Total Motor Score 4 change did not worsen for those who received active treatment for 12 continuous months compared with those who received active treatment for only 6 months (2.0-point worsening; P=.02). Ethyl-EPA was not beneficial in patients with Huntington disease during 6 months of placebo-controlled evaluation. Clinical Trial Registry clinicaltrials.gov Identifier: NCT00146211.

Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study.

PubMed

Maynard, Olivia M; Leonards, Ute; Attwood, Angela S; Bauld, Linda; Hogarth, Lee; Munafò, Marcus R

2014-06-25

Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Current Controlled Trials ISRCTN52982308 (registered 27 June 2013).

Effectiveness of Treatment Approaches for Children and Adolescents with Reading Disabilities: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

2014-01-01

Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities, research should intensify the application of blinded randomized controlled trials. PMID:24587110

Design challenges in transdiagnostic psychotherapy research: Comparing Transdiagnostic Behavior Therapy (TBT) to existing evidence-based psychotherapy in veterans with affective disorders.

PubMed

Gros, Daniel F

2015-07-01

To address the limitations of disorder-specific approaches, newer transdiagnostic approaches to psychotherapy have been developed to provide a single treatment that is capable of addressing several, related disorders. However, the recruitment of multiple diagnoses presents many challenges to the traditional design of psychotherapy randomized controlled trials (RCTs). The goal of the manuscript is to present the challenges and rationale for designing a RCT for transdiagnostic treatment to inform and aid in the development of future investigations. A recently funded and ongoing RCT for Transdiagnostic Behavior Therapy (TBT) is used as an example to discuss the related design challenges. The TBT study involves the recruitment of 96 veteran participants with any of the following eight principal diagnoses: posttraumatic stress disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, generalized anxiety disorder, specific phobia, major depressive disorder, or persistent depressive disorder. Within the TBT study, participants will complete a semi-structured diagnostic interview and a series of transdiagnostic self-report measures to determine eligibility and assess baseline symptomatology. Qualifying participants will be randomized to TBT or control psychotherapy. Additional assessments will be completed at post-treatment and 6-month follow-up. Due to the transdiagnostic nature of the sample, adjustments to the recruitment and randomization procedures, selection of measures, selection of control psychotherapy, and analysis plan were required. These adjustments have implications to future trials on transdiagnostic psychotherapy protocols as well as future research in line with the transdiagnostic focus of the National Institute of Mental Health's Research Domain Criteria (RDoC) funding strategy. Published by Elsevier Inc.

Comparison of Address-based Sampling and Random-digit Dialing Methods for Recruiting Young Men as Controls in a Case-Control Study of Testicular Cancer Susceptibility

PubMed Central

Clagett, Bartholt; Nathanson, Katherine L.; Ciosek, Stephanie L.; McDermoth, Monique; Vaughn, David J.; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A.

2013-01-01

Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-phone numbers and address-based sampling (ABS), to recruit primarily white men aged 18–55 years into a study of testicular cancer susceptibility conducted in the Philadelphia, Pennsylvania, metropolitan area between 2009 and 2012. With few exceptions, eligible and enrolled controls recruited by means of RDD and ABS were similar with regard to characteristics for which data were collected on the screening survey. While we find ABS to be a comparably effective method of recruiting young males compared with landline RDD, we acknowledge the potential impact that selection bias may have had on our results because of poor overall response rates, which ranged from 11.4% for landline RDD to 1.7% for ABS. PMID:24008901

Ultrasound enhanced thrombolysis: Clinical evidence

NASA Astrophysics Data System (ADS)

Alexandrov, Andrei V.

2005-04-01

Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.

A randomized controlled trial of students for nutrition and eXercise: a community-based participatory research study.

PubMed

Bogart, Laura M; Cowgill, Burton O; Elliott, Marc N; Klein, David J; Hawes-Dawson, Jennifer; Uyeda, Kimberly; Elijah, Jacinta; Binkle, David G; Schuster, Mark A

2014-09-01

To conduct a randomized controlled trial of Students for Nutrition and eXercise, a 5-week middle school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. We randomly selected schools (five intervention, five waitlist control) from the Los Angeles Unified School District. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student, representing an average of 1,515 students (SD = 323) per intervention school and 1,524 students (SD = 266) per control school. A total of 2,997 seventh-graders (75% of seventh-graders across schools) completed pre- and postintervention surveys assessing psychosocial variables. Consistent with community-based participatory research principles, the school district was an equal partner, and a community advisory board provided critical input. Relative to control schools, intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in the proportion of students buying snacks at school. Specifically, the intervention was associated with relative increases of 15.3% more fruits served (p = .006), 10.4% more lunches served (p < .001), and 11.9% fewer snacks sold (p < .001) than would have been expected in its absence. Pre-to-post intervention, intervention school students reported more positive attitudes about cafeteria food (p = .02) and tap water (p = .03), greater obesity-prevention knowledge (p = .006), increased intentions to drink water from the tap (p = .04) or a refillable bottle (p = .02), and greater tap water consumption (p = .04) compared with control school students. Multilevel school-based interventions may promote healthy adolescent dietary behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Enhancement of the efficiency of the automatic control system to control the thermal load of steam boilers fired with fuels of several types

NASA Astrophysics Data System (ADS)

Ismatkhodzhaev, S. K.; Kuzishchin, V. F.

2017-05-01

An automatic control system to control the thermal load (ACS) in a drum-type boiler under random fluctuations in the blast-furnace and coke-oven gas consumption rates and to control action on the natural gas consumption is considered. The system provides for use of a compensator by the basic disturbance, the blast-furnace gas consumption rate. To enhance the performance of the system, it is proposed to use more accurate mathematical second-order delay models of the channels of the object under control in combination with calculation by frequency methods of the controller parameters as well as determination of the structure and parameters of the compensator considering the statistical characteristics of the disturbances and using simulation. The statistical characteristics of the random blast-furnace gas consumption signal based on experimental data are provided. The random signal is presented in the form of the low-frequency (LF) and high-frequency (HF) components. The models of the correlation functions and spectral densities are developed. The article presents the results of calculating the optimal settings of the control loop with the controlled variable in the form of the "heat" signal with the restricted frequency variation index using three variants of the control performance criteria, viz., the linear and quadratic integral indices under step disturbance and the control error variance under random disturbance by the blastfurnace gas consumption rate. It is recommended to select a compensator designed in the form of series connection of two parts, one of which corresponds to the operator inverse to the transfer function of the PI controller, i.e., in the form of a really differentiating element. This facilitates the realization of the second part of the compensator by the invariance condition similar to transmitting the compensating signal to the object input. The results of simulation under random disturbance by the blast-furnace gas consumption are reported. Recommendations are made on the structure and parameters of the shaping filters for modeling the LF and HF components of the random signal. The results of the research may find applications in the systems to control the thermal processes with compensation of basic disturbances, in particular, in boilers for combustion of accompanying gases.

Self-reported use of complementary and alternative medicine therapies in a reflexology randomized clinical trial.

PubMed

Wyatt, Gwen; Sikorskii, Alla; You, Mei

2013-01-01

According to the National Center for Complementary and Alternative Medicine (NCCAM), about one-third of American cancer patients have used complementary and alternative medicine (CAM). The objective of this secondary analysis was an assessment of the use of other CAM by women with advanced breast cancer who were undergoing chemotherapy and who participated in a randomized clinical trial (RCT) studying the safety and efficacy of reflexology. For this secondary analysis, the research team hypothesized an increased CAM use due to exposure to the reflexology trial. For this secondary analysis, the team conducted telephone interviews at baseline, wk 5, and wk 11 to assess the use of 23 common CAM therapies. The study took place at 14 medical oncology clinics across the Midwestern United States. Participants included women with advanced breast cancer who were undergoing chemotherapy and/or hormonal therapy. In the study related to this secondary analysis, the research team randomly assigned the women to one of three primary groups: (1) reflexology; (2) lay foot manipulation (LFM); and (3) control. In addition, the research team used two test groups to establish the study's protocol: (1) test reflexology and (2) test LFM. For this secondary analysis, the research team considered the two reflexology groups (test and intervention) and the two LFM groups (test and intervention) to be the active groups, comparing their use of CAM to the control group's use at the selected time points. The research team used a linear, mixed-effects model to analyze the number of therapies used at the three time points. The team performed t tests to compare therapy use at baseline for those women who completed the study vs those who dropped out. The team used the CAM-use instrument. In total, 385 women participated. The research team found no differences in CAM use for the active groups vs the control group over time or in those women who stayed in the study vs those who dropped out. The team found an increase in CAM use at wk 5 compared to baseline, followed by a decrease at wk 11; however, the time trends were the same in the active groups and the control group In women with advanced breast cancer, researchers can rely upon one assessment of CAM use during an RCT of a CAM therapy.

Walnut consumption increases activation of the insula to highly desirable food cues: A randomized, double-blind, placebo-controlled, cross-over fMRI study.

PubMed

Farr, Olivia M; Tuccinardi, Dario; Upadhyay, Jagriti; Oussaada, Sabrina M; Mantzoros, Christos S

2018-01-01

The use of walnuts is recommended for obesity and type 2 diabetes, although the mechanisms through which walnuts may improve appetite control and/or glycaemic control remain largely unknown. To determine whether short-term walnut consumption could alter the neural control of appetite using functional magnetic resonance imaging, we performed a randomized, placebo-controlled, double-blind, cross-over trial of 10 patients who received, while living in the controlled environment of a clinical research center, either walnuts or placebo (using a validated smoothie delivery system) for 5 days each, separated by a wash-out period of 1 month. Walnut consumption decreased feelings of hunger and appetite, assessed using visual analog scales, and increased activation of the right insula to highly desirable food cues. These findings suggest that walnut consumption may increase salience and cognitive control processing of highly desirable food cues, leading to the beneficial metabolic effects observed. © 2017 John Wiley & Sons Ltd.

Interventions aimed at increasing research use in nursing: a systematic review

PubMed Central

Thompson, David S; Estabrooks, Carole A; Scott-Findlay, Shannon; Moore, Katherine; Wallin, Lars

2007-01-01

Background There has been considerable interest recently in developing and evaluating interventions to increase research use by clinicians. However, most work has focused on medical practices; and nursing is not well represented in existing systematic reviews. The purpose of this article is to report findings from a systematic review of interventions aimed at increasing research use in nursing. Objective To assess the evidence on interventions aimed at increasing research use in nursing. Methods A systematic review of research use in nursing was conducted using databases (Medline, CINAHL, Healthstar, ERIC, Cochrane Central Register of Controlled Trials, and Psychinfo), grey literature, ancestry searching (Cochrane Database of Systematic Reviews), key informants, and manual searching of journals. Randomized controlled trials and controlled before- and after-studies were included if they included nurses, if the intervention was explicitly aimed at increasing research use or evidence-based practice, and if there was an explicit outcome to research use. Methodological quality was assessed using pre-existing tools. Data on interventions and outcomes were extracted and categorized using a pre-established taxonomy. Results Over 8,000 titles were screened. Three randomized controlled trials and one controlled before- and after-study met the inclusion criteria. The methodological quality of included studies was generally low. Three investigators evaluated single interventions. The most common intervention was education. Investigators measured research use using a combination of surveys (three studies) and compliance with guidelines (one study). Researcher-led educational meetings were ineffective in two studies. Educational meetings led by a local opinion leader (one study) and the formation of multidisciplinary committees (one study) were both effective at increasing research use. Conclusion Little is known about how to increase research use in nursing, and the evidence to support or refute specific interventions is inconclusive. To advance the field, we recommend that investigators: (1) use theoretically informed interventions to increase research use, (2) measure research use longitudinally using theoretically informed and psychometrically sound measures of research use, as well as, measuring patient outcomes relevant to the intervention, and (3) use more robust and methodologically sound study designs to evaluate interventions. If investigators aim to establish a link between using research and improved patient outcomes they must first identify those interventions that are effective at increasing research use. PMID:17498301

Vitamin E in aging persons with Down syndrome: A randomized, placebo-controlled clinical trial.

PubMed

Sano, Mary; Aisen, Paul S; Andrews, Howard F; Tsai, Wei-Yann; Lai, Florence; Dalton, Arthur J

2016-05-31

To determine whether vitamin E would slow the progression of cognitive deterioration and dementia in aging persons with Down syndrome (DS). A randomized, double-blind controlled clinical trial was conducted at 21 clinical sites, and researchers trained in research procedures recruited adults with DS older than 50 years to participate. Participants were randomly assigned to receive 1,000 IU of vitamin E orally twice daily for 3 years or identical placebo. The primary outcome was change on the Brief Praxis Test (BPT). Secondary outcomes included incident dementia and measures of clinical global change, cognition, function, and behavior. A total of 337 individuals were randomized, 168 to vitamin E and 169 to placebo. Both groups demonstrated deterioration on the BPT with no difference between drug and placebo. At baseline, 26% were diagnosed with dementia and there was an overall rate of incident dementia of 11%/year with no difference between groups. There was no effect on the secondary outcome measures. Though numerically higher in the treatment group, there was no difference in the number of adverse events (p = 0.079) and deaths (p = 0.086) between groups. Vitamin E did not slow the progression of cognitive deterioration in older individuals with DS. This study provides Class II evidence that vitamin E does not significantly slow the progression of cognitive deterioration in aging persons with DS. © 2016 American Academy of Neurology.

Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention.

PubMed

Fox, Caroline S; Gurary, Ellen B; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

2016-04-27

A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30-day page views. Whether insufficient social media intensity contributed to these results is uncertain. Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journal's accounts. To increase social media intensity, a larger base of followers was built using advertising and organic growth, and posts were presented in triplicate and boosted on Facebook and retweeted on Twitter. The primary outcome was 30-day page views. Stopping rules were established at the point that 50% of the manuscripts were randomized and had 30-day follow-up to compare groups on 30-day page views. The trial was stopped for futility on September 26, 2015. Overall, 74 manuscripts were randomized to receive social media exposure, and 78 manuscripts were randomized to the control arm. The intervention and control arms were similar based on article type (P=0.85), geographic location of the corresponding author (P=0.33), and whether the manuscript had an editorial (P=0.80). Median number of 30-day page views was 499.5 in the social media arm and 450.5 in the control arm; there was no evidence of a treatment effect (P=0.38). There were no statistically significant interactions of treatment by manuscript type (P=0.86), by corresponding author (P=0.35), by trimester of publication date (P=0.34), or by editorial status (P=0.79). A more intensive social media strategy did not result in increased 30-day page views of original research. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial.

PubMed

Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun; McTiernan, Anne

2016-07-15

Obese and sedentary persons have an increased risk for cancer, but underlying mechanisms are poorly understood. Angiogenesis is common to adipose tissue formation and remodeling, and to tumor vascularization. A total of 439 overweight/obese, healthy, postmenopausal women [body mass index (BMI) > 25 kg/m(2)] ages 50-75 years, recruited between 2005 and 2008 were randomized to a 4-arm 12-month randomized controlled trial, comparing a caloric restriction diet arm (goal: 10% weight loss, N = 118), aerobic exercise arm (225 minutes/week of moderate-to-vigorous activity, N = 117), a combined diet + exercise arm (N = 117), or control (N = 87) on circulating levels of angiogenic biomarkers. VEGF, plasminogen activator inhibitor-1 (PAI-1), and pigment epithelium-derived factor (PEDF) were measured by immunoassay at baseline and 12 months. Changes were compared using generalized estimating equations, adjusting for baseline BMI, age, and race/ethnicity. Participants randomized to the diet + exercise arms had statistically significantly greater reductions in PAI-1 at 12 months compared with controls (-19.3% vs. +3.48%, respectively, P < 0.0001). Participants randomized to the diet and diet + exercise arms had statistically significantly greater reductions in PEDF (-9.20%, -9.90%, respectively, both P < 0.0001) and VEGF (-8.25%, P = 0.0005; -9.98%, P < 0.0001, respectively) compared with controls. There were no differences in any of the analytes in participants randomized to the exercise arm compared with controls. Increasing weight loss was statistically significantly associated with linear trends of greater reductions in PAI-1, PEDF, and VEGF. Weight loss is significantly associated with reduced circulating VEGF, PEDF, and PAI-1, and could provide incentive for reducing weight as a cancer prevention method in overweight and obese individuals. Cancer Res; 76(14); 4226-35. ©2016 AACR. ©2016 American Association for Cancer Research.

Knowledge translation strategies for enhancing nurses' evidence-informed decision making: a scoping review.

PubMed

Yost, Jennifer; Thompson, David; Ganann, Rebecca; Aloweni, Fazila; Newman, Kristine; McKibbon, Ann; Dobbins, Maureen; Ciliska, Donna

2014-06-01

Nurses are increasingly expected to engage in evidence-informed decision making (EIDM); the use of research evidence with information about patient preferences, clinical context and resources, and their clinical expertise in decision making. Strategies for enhancing EIDM have been synthesized in high-quality systematic reviews, yet most relate to physicians or mixed disciplines. Existing reviews, specific to nursing, have not captured a broad range of strategies for promoting the knowledge and skills for EIDM, patient outcomes as a result of EIDM, or contextual information for why these strategies "work." To conduct a scoping review to identify and map the literature related to strategies implemented among nurses in tertiary care for promoting EIDM knowledge, skills, and behaviours, as well as patient outcomes and contextual implementation details. A search strategy was developed and executed to identify relevant research evidence. Participants included registered nurses, clinical nurse specialists, nurse practitioners, and advanced practice nurses. Strategies were those enhancing nurses' EIDM knowledge, skills, or behaviours, as well as patient outcomes. Relevant studies included systematic reviews, randomized controlled trials, cluster randomized controlled trials, non-randomized trials (including controlled before and after studies), cluster non-randomized trials, interrupted time series designs, prospective cohort studies, mixed-method studies, and qualitative studies. Two reviewers performed study selection and data extraction using standardized forms. Disagreements were resolved through discussion or third party adjudication. Using a narrative synthesis, the body of research was mapped by design, clinical areas, strategies, and provider and patient outcomes to determine areas appropriate for a systematic review. There are a sufficiently high number of studies to conduct a more focused systematic review by care settings, study design, implementation strategies, or outcomes. A focused review could assist in determining which strategies can be recommended for enhancing EIDM knowledge, skills, and behaviours among nurses in tertiary care. © 2014 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Sigma Theta Tau International.

Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial

PubMed Central

2013-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. Methods/design This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient’s global impression of change and adverse events. Safety will be assessed at each visit. Discussion The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA. Trial registration Clinical Research Information Service: KCT0000506 PMID:23945074

Interesting Practitioners in Training in Empirically Supported Treatments: Research Reviews versus Case Studies

PubMed Central

Stewart, Rebecca E.; Chambless, Dianne L.

2010-01-01

It has been repeatedly demonstrated that clinicians rely more on clinical judgment than on research findings. We hypothesized that psychologists in practice might be more open to adopting empirically supported treatments (ESTs) if outcome results were presented with a case study. Psychologists in private practice (N = 742) were randomly assigned to receive a research review of data from randomized controlled trials of cognitive-behavioral treatment (CBT) and medication for bulimia, a case study of CBT for a fictional patient with bulimia, or both. Results indicated that the inclusion of case examples renders ESTs more compelling and interests clinicians in gaining training. Despite these participants’ training in statistics, the inclusion of the statistical information had no influence on attitudes or training willingness beyond that of the anecdotal case information. PMID:19899142

A Randomized Controlled Trial of a Mindfulness and Acceptance Group Therapy for Residential Substance Use Patients.

PubMed

Shorey, Ryan C; Elmquist, Joanna; Gawrysiak, Michael J; Strauss, Catherine; Haynes, Ellen; Anderson, Scott; Stuart, Gregory L

2017-09-19

Substance use disorders are understood as a chronically relapsing condition that is difficult to treat. However, in recent years there have been promising developments in the treatment of substance use disorders, specifically with interventions based on mindfulness and acceptance and commitment therapy. Little research has examined whether these types of interventions may positively impact residential substance use treatment outcomes. Thus, in the current study we developed and examined, in a randomized controlled trial, a 4-week, eight-session, adjunctive mindfulness and acceptance group therapy for patients in residential substance use treatment. Our primary outcomes were substance use cravings, psychological flexibility, and dispositional mindfulness at treatment discharge. Patients (N = 117) from a private residential substance use facility were randomized to receive the adjunctive mindfulness and acceptance group or treatment-as-usual. Patients were assessed at treatment intake and at discharge from a 28-30-day residential program. Although treatment groups did not statistically differ at discharge on any primary outcome, small effect sizes favored the mindfulness and acceptance group on cravings and psychological flexibility. Conclusions/Importance: Continued research is needed to determine whether the addition of mindfulness and acceptance-based interventions improve outcomes long term following residential substance use treatment.

Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

PubMed Central

Bass, Kristin M.; Stark, Louisa A.

2014-01-01

How can researchers in K–12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The researchers asked whether the curricular materials improved students’ understanding of the content more than an alternative set of activities. The field test was conducted in a diverse public high school setting with 145 students who were randomly assigned to a treatment or comparison condition. Findings indicate that students in the treatment condition scored significantly higher on the posttest than did students in the comparison group (effect size: Cohen's d = 0.40). The paper discusses the strengths and limitations of the RCT, the contextual factors that influenced its enactment, and recommendations for others wishing to conduct small-scale rigorous evaluations in educational settings. Our intention is for this paper to serve as a case study for university science faculty members who wish to employ scientifically rigorous evaluations in K–12 settings while limiting the scope and budget of their work. PMID:25452482

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

PubMed

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

2017-08-01

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

Efficacy of a DVD-Based Smoking Cessation Intervention for African Americans

PubMed Central

Baker, Elizabeth A.; Robinson, Robert G.

2014-01-01

Introduction: Previous research suggests that African American smokers may have improved outcomes if interventions are culturally specific. However, few interventions sufficiently address the unique needs of this population in a format with large reach potential. The purpose of this study was to test the efficacy of a newly developed digital video disc (DVD)-based cessation intervention targeting African Americans. Methods: In a 2-arm randomized trial, smokers (N = 140) were randomly assigned to view either the new Pathways to Freedom (PTF) DVD or a standard control DVD. Participants were assessed at baseline, immediately postviewing the DVD, and at a 1-month follow-up. The primary outcomes were feasibility and process variables, including intervention evaluations, readiness to quit, and risk perceptions, and smoking-related behavior changes were examined as secondary outcomes. Results: Findings demonstrated the hypothesized positive effects of the PTF DVD compared with the control DVD on content evaluations, risk perceptions, and readiness to quit at follow-up. Conclusions: We found initial evidence for the efficacy of the PTF DVD as a stand-alone intervention. Future research will test the efficacy of the DVD for smoking cessation in a larger randomized trial. The ultimate goal of this research is to validate a new intervention for an underserved community of smokers that can be used in multiple settings, such as community health clinics, primary care, quitlines, cessation clinics, and seminars/workshops. PMID:24838844

Informed consent in research to improve the number and quality of deceased donor organs.

PubMed

Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

2011-02-01

Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.

A systematic review of studies of web portals for patients with diabetes mellitus.

PubMed

Coughlin, Steven S; Williams, Lovoria B; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control.

A systematic review of studies of web portals for patients with diabetes mellitus

PubMed Central

Williams, Lovoria B.; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control. PMID:28736732

Effect of Solution Focused Group Counseling for High School Students in Order to Struggle with School Burnout

ERIC Educational Resources Information Center

Ates, Bünyamin

2016-01-01

In this research, the effect of solution focused group counseling upon high school students struggling with school burnout was analyzed. The research was an experimental study in which a pre-test post-test control group random design was used, depending upon the real experimental model. The study group included 30 students that volunteered from…

Empirical Benchmarks of Hidden Bias in Educational Research: Implication for Assessing How well Propensity Score Methods Approximate Experiments and Conducting Sensitivity Analysis

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark

2014-01-01

When randomized control trials (RCT) are not feasible, researchers seek other methods to make causal inference, e.g., propensity score methods. One of the underlined assumptions for the propensity score methods to obtain unbiased treatment effect estimates is the ignorability assumption, that is, conditional on the propensity score, treatment…

Trauma to the Psyche and Soma: A Case Study of Posttraumatic Stress Disorder and Comorbid Problems Arising from a Road Traffic Collision

ERIC Educational Resources Information Center

Wald, Jaye; Taylor, Steven

2006-01-01

Randomized controlled studies have shown that cognitive-behavioral therapies are effective for treating various forms of posttraumatic stress disorder (PTSD), with most research focusing on combat or sexual-assault-related PTSD. A challenge currently facing researchers and practitioners is to develop specialized protocols for treating other forms…

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…

Analysis of Parent, Teacher, and Consultant Speech Exchanges and Educational Outcomes of Students with Autism during COMPASS Consultation

ERIC Educational Resources Information Center

Ruble, Lisa; Birdwhistell, Jessie; Toland, Michael D.; McGrew, John H.

2011-01-01

The significant increase in the numbers of students with autism combined with the need for better trained teachers (National Research Council, 2001) call for research on the effectiveness of alternative methods, such as consultation, that have the potential to improve service delivery. Data from 2 randomized controlled single-blind trials indicate…

Parent Reflections of Experiences of Participating in a Randomized Controlled Trial of a Behavioral Intervention for Infants at Risk of Autism Spectrum Disorders

ERIC Educational Resources Information Center

Freuler, Ashley C.; Baranek, Grace T.; Tashjian, Christene; Watson, Linda R.; Crais, Elizabeth R.; Turner-Brown, Lauren M.

2014-01-01

Background: Despite the mounting evidence of efficacy of early intervention for children with autism spectrum disorders, there is little research that considers the various perceptions and resources with which parents respond to the pressures and opportunities associated with participation in early intervention. Research is particularly lacking…

The National Partnership for Quality Afterschool Learning Randomized Controlled Trial Studies of Promising Afterschool Programs: Summary of Findings. Afterschool Research Brief. Issue No. 3

ERIC Educational Resources Information Center

Vaden-Kiernan, Michael; Jones, Debra Hughes; Rudo, Zena; Fitzgerald, Robert; Hartry, Ardice; Chambers, Bette; Smith, Dewi; Muller, Patricia; Moss, Marcey A.

2008-01-01

Recent evaluations and research syntheses of afterschool programs rated as high quality show they are associated with increases in student achievement and other positive socio-behavioral outcomes (Lauer et al., 2006; Vandell, Reisner, & Pierce, 2007). Those examinations provide a springboard for the next much-needed area of…

Application to graduate psychology programs by undergraduate students of color: the impact of a research training program.

PubMed

Hall, Gordon C Nagayama; Allard, Carolyn B

2009-07-01

The top 86 students were selected from a pool of approximately 400 applicants to a summer clinical psychology research training program for undergraduate students of color. Forty-three of the students were randomly assigned to 1 of 2 clinical psychology research training programs, and 43 were randomly assigned to a control condition without training. The multicultural version of the training program emphasized the cultural context of psychology in all areas of training, whereas cultural context was de-emphasized in the monocultural version of the program. Although the cultural content of the 2 training programs was effectively manipulated as indicated by a fidelity check by an outside expert, there were no significant differences between the effects of the 2 programs on the outcomes measured in this study. The primary differences in this study were between students who did versus those who did not participate in a training program. Sixty-five percent of the students who completed the multicultural training program applied to graduate schools in psychology, compared with 47% of those who completed the monocultural training program, and 31% of those in the control group. Participation in summer research training programs also increased self-perceptions of multicultural competence.

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.

To share or not to share: a randomized trial of consent for data sharing in genome research.

PubMed

McGuire, Amy L; Oliver, Jill M; Slashinski, Melody J; Graves, Jennifer L; Wang, Tao; Kelly, P Adam; Fisher, William; Lau, Ching C; Goss, John; Okcu, Mehmet; Treadwell-Deering, Diane; Goldman, Alica M; Noebels, Jeffrey L; Hilsenbeck, Susan G

2011-11-01

Despite growing concerns toward maintaining participants' privacy, individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing. Our purpose was to assess the effect on research enrollment and data sharing decisions of three different consent types (traditional, binary, or tiered) with varying levels of control and choices regarding data sharing. A single-blinded, randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston, Texas, between January 2008 and August 2009. Participants were randomly assigned to one of three experimental consent documents (traditional, n = 110; binary, n = 103; and tiered, n = 110). Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation. Before debriefing, 83.9% of participants chose public data release. After debriefing, 53.1% chose public data release, 33.1% chose restricted (controlled access database) release, and 13.7% opted out of data sharing. Only one participant declined genome study participation due to data sharing concerns. Our findings indicate that most participants are willing to publicly release their genomic data; however, a significant portion prefers restricted release. These results suggest discordance between existing data sharing policies and participants' judgments and desires.

Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned.

PubMed

Sygna, Karin; Johansen, Safora; Ruland, Cornelia M

2015-09-25

To test seven different strategies for recruitment in a randomized controlled trial, to report documented response data from each strategy, and to discuss recruitment challenges. We used 5 opt-in (potential participants have to do something active to contact or be contacted by the researcher) and 2 opt-out (potential participants have the option to decline being contacted about a study) recruitment strategies from February 2013 until July 2014 to contact 1562 cancer patient candidates for participation in a randomized controlled trial. For each of these cancer patients a caregiver was also invited to take part in the study. Of the 1562 candidates, 22.6 % were ineligible on initial contact, 56.7 % declined to participate on initial contact, and 8.9 % agreed orally to participate but did not complete the enrollment. The 2 opt-out strategies, on-site recruitment and routine care letters recruitment, yielded the highest number of recruited participants with 79 dyads and 58 dyads respectively, constituting 42.7 % and 31.4 % of the total number of enrolled candidates. The 5 opt-in recruitment approaches yielded 49 dyads for the study. Almost half of these dyads were recruited using the approach termed "relying on providers at the hospital." In this study, opt-out recruitment strategies appeared to be the most effective. Registration number NCT01867723 , registered February 2012.

The Science of Cancer Prevention

Cancer.gov

The science of cancer prevention is described by Dr. Barnett S. Kramer, M.D., M.P.H., director of the Division of Cancer Prevention, National Cancer Institute (NCI). The Division of Cancer Prevention administers a broad spectrum of research that spans basic pre-clinical, laboratory research, supportive and palliative care research, early detection, and randomized controlled clinical trials. The Division also supports the Cancer Prevention Fellowship Program and is devoted to the balanced communication of scientific results.

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial

PubMed Central

Young, Kim-wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Purpose Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. Research methods In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. Results The paired-samples t-test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. Conclusion This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in improving the cognitive and short-term memory abilities of PwMCI. PMID:29026292

From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

PubMed Central

Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

2011-01-01

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

Aquacel(®) Ag dressing versus Acticoat™ dressing in partial thickness burns: a prospective, randomized, controlled study in 100 patients. Part 1: burn wound healing.

PubMed

Verbelen, Jozef; Hoeksema, Henk; Heyneman, Alexander; Pirayesh, Ali; Monstrey, Stan

2014-05-01

Studies comparing contemporary silver dressings in burns are scarce. In a prospective, randomized, controlled study, counting 50 patients/research group, we compared two frequently used silver dressings, Acticoat™ and Aquacel(®) Ag, in the management of partial thickness burns with a predicted healing time between 7 and 21 days as assessed by laser Doppler imaging between 48 and 72h after burn. Variables investigated were related to baseline research group characteristics, wound healing, bacteriology, economics, nurse, and patient experience. Both research groups were comparably composed taking into account gender, age and burn characteristics. Similar results were obtained as to healing time and bacterial control with both silver dressings. A statistically significant difference in favor of the Aquacel(®) Ag dressing was found for average ease of use (p<0.001), average ease of application (p=0.001), patient pain (p<0.001), patient comfort with the dressing (p=0.017), silver staining (p<0.001), and cost effectiveness (p<0.001). Both silver dressings resulted in comparable healing times and bacterial control but the Aquacel(®) Ag dressing significantly increased comfort for patients as well as nurses and was significantly more cost-effective than the Acticoat™ dressing for the given indication. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Measuring New Environmental Paradigm Based on Students' Knowledge about Ecosystem and Locus of Control

ERIC Educational Resources Information Center

Putrawan, I. Made

2015-01-01

This research is aimed at obtaining information related to instrument development of Students' New Environmental Paradigm (NEP) based on their knowledge about ecosystem and Locus of Control (LOC). A survey method has been carried out by selecting senior high school students randomly with n = 362 (first stage 2013) and n = 722 (2014). Data analysed…

Randomized, Controlled Trial of CBT Training for PTSD Providers

DTIC Science & Technology

2013-10-01

Statistician and Co- Investigator), Michelle Pucillo, MPH (Project Manager ), Gayatri Ranganathan , MS (Statistician), Julia Coleman (Research Associate...Journal of Consulting and Clinical Psychology, 74, 898-907. Ruzek, J. I., Friedman, M. J., & Murray, S. (2005). Toward a knowledge management system...result in superior CBT skills than wait-list control. Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based

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.

Brief mindfulness-based therapy for chronic tension-type headache: a randomized controlled pilot study.

PubMed

Cathcart, Stuart; Galatis, Nicola; Immink, Maarten; Proeve, Michael; Petkov, John

2014-01-01

Mindfulness-based therapy (MBT) has been demonstrated to be effective for reducing chronic pain symptoms; however, the use of MBT for Chronic Tension-Type Headache (CTH) exclusively has to date not been examined. Typically, MBT for chronic pain has involved an 8-week program based on Mindfulness Based Stress Reduction. Recent research suggests briefer mindfulness-based treatments may be effective for chronic pain. To conduct a pilot study into the efficacy of brief MBT for CTH. We conducted a randomized controlled trial of a brief (6-session, 3-week) MBT for CTH. Results indicated a significant decrease in headache frequency and an increase in the mindfulness facet of Observe in the treatment but not wait-list control group. Brief MBT may be an effective intervention for CTH.

Work, Recovery, and Comorbidity in Schizophrenia: A Randomized Controlled Trial of Cognitive Remediation

PubMed Central

McGurk, Susan R.; Mueser, Kim T.; DeRosa, Thomas J.; Wolfe, Rosemarie

2009-01-01

Employment is central to the concept of recovery in severe mental illness. However, common comorbid conditions present significant obstacles to consumers seeking employment and benefiting from vocational rehabilitation. We review research on the effects of three common comorbid conditions on work and response to vocational rehabilitation, including cognitive impairment, substance abuse, and medical conditions, followed by research on vocational rehabilitation. We then present the results of a randomized controlled trial evaluating the effects of adding cognitive remediation to a vocational rehabilitation program compared with vocational rehabilitation alone in 34 consumers with severe mental illness. Consumers who received both cognitive remediation and vocational rehabilitation demonstrated significantly greater improvements on a cognitive battery over 3 months than those who received vocational rehabilitation alone and had better work outcomes over the 2-year follow-up period. Substance abuse was associated with worse employment outcomes, but did not interact with treatment group, whereas medical comorbidity was not related to work outcomes. More research is warranted to evaluate the interactions between substance abuse and medical comorbidity with vocational rehabilitation and cognitive remediation. PMID:19269925

The effect of integrating constructivist and evidence-based practice on baccalaureate nursing student's cognitive load and learning performance in a research course.

PubMed

Hsieh, Suh-Ing; Hsu, Li-Ling; Huang, Tzu-Hsin

2016-07-01

Baccalaureate nursing students perceive research as unattractive, doubt the value of nursing research, and do not appreciate the link of research with practice. No studies have examined students' cognitive load during an evidence-based practice research course versus a traditional research course. To assess the effect of integrating constructivist theories and evidence-based practice on student cognitive load and learning performance in a research course. A true experimental study. A Registered Nurse-to-Bachelor of Science in Nursing program. Six classes of second-year students. Students were randomly allocated to the control group (two classes) or the experimental group (two classes) using cluster randomization. The control group underwent "traditional research"; the experimental group experienced "integrating evidence-based practice into research." Instruments for outcome assessment include the Cognitive Load Scale, cognitive test, team critique paper, and qualitative feedback on course satisfaction. The between-subjects effects were compared by Analysis of Covariance. The experimental group had significantly higher mental load (8.74 vs. 7.27, p<.001), mental effort (11.07 vs. 10.07, p=.009), mental efficiency (0.33 vs. -0.31, p<.001), and research knowledge (70.61 vs. 44.92, p<.001) than the control group. The experimental group had better critique paper scores in introduction (92.80%), literature review (91.70%), and assignment requirement and writing (89.40%). Some experimental learners expressed satisfaction with learning evidence-based practice (17.78%) and critiquing a research article (7.78%). Integrating evidence-based practice into a research course not only improved the research knowledge of baccalaureate nursing students, but also increased their mental load, mental effort, and mental efficiency. Additional studies may track learners' responses to different learning systems using the developed instrument to measure the three types of cognitive load. These findings may help educators design more effective and interesting curricula for integrating research and evidence-based practice into the studies of student nurses. Copyright © 2016. Published by Elsevier Ltd.

The First National Student Conference: NASA University Research Centers at Minority Institutions

NASA Technical Reports Server (NTRS)

Daso, Endwell O. (Editor); Mebane, Stacie (Editor)

1997-01-01

The conference includes contributions from 13 minority universities with NASA University Research Centers. Topics discussed include: leadership, survival strategies, life support systems, food systems, simulated hypergravity, chromium diffusion doping, radiation effects on dc-dc converters, metal oxide glasses, crystal growth of Bil3, science and communication on wheels, semiconductor thin films, numerical solution of random algebraic equations, fuzzy logic control, spatial resolution of satellite images, programming language development, nitric oxide in the thermosphere and mesosphere, high performance polyimides, crossover control in genetic algorithms, hyperthermal ion scattering, etc.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick S; Ravani, Pietro

2015-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick; Ravani, Pietro

2009-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires the definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, ensure adequate samples, measure input and output variables appropriately, consider external and internal validities, limit bias, and address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

Computer Decision Support Software Safely Improves Glycemic Control in the Burn Intensive Care Unit: A Randomized Controlled Clinical Study

DTIC Science & Technology

2011-01-01

Program Jointly Managed by the USA MRMC, NIH, NASA, and the Juvenile Diabetes Research Foundation and Combat Casualty Care Division, United States Army...were performed in the CP group (p = 0.0003), and nursing staff compliance with CP recommendations was greater (p < 0.0001). Conclusions—Glycemic...enhanced consistency in practice, providing standardization among nursing staff. Keywords Glycemic control; hypoglycemia; computer decision support

Evaluating information prescriptions in two clinical environments*

PubMed Central

Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

2011-01-01

Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

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.

Comparing Two Web-Based Smoking Cessation Programs: Randomized Controlled Trial

PubMed Central

McKay, H Garth; Seeley, John R; Lichtenstein, Edward; Gau, Jeff M

2008-01-01

Background Smoking cessation remains a significant public health problem. Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change. To date, the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals. Objective We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program (Quit Smoking Network; QSN) or a Web-based exercise enhancement program (Active Lives) adapted somewhat to encourage smoking cessation. Methods The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs: (1) the QSN intervention condition presented cognitive-behavioral strategies, and (2) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting. The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting. The QSN condition was designed to be more engaging (eg, it included multimedia components) and to present much greater content than is typically found in smoking cessation programs. Results Contrary to our hypotheses, no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments. While participants in the QSN intervention condition spent more time than controls visiting the online program, the median number of 1.0 visit in each condition and the substantial attrition (60.8% at the 6-month follow-up) indicate that participants were not as engaged as we had expected. Conclusions Contrary to our hypothesis, our test of two Web-based smoking cessation conditions, an intervention and an attention placebo control, failed to show differences at 3- and 6-month assessments. We explored possible reasons for this finding, including limited engagement of participants and simplifying program content and architecture. Future research needs to address methods to improve participant engagement in online smoking cessation programs. Possible approaches in this regard can include new informed consent procedures that better explain the roles and responsibilities of being a research participant, new program designs that add more vitality (changing content from visit to visit), and new types of reminders pushed out to participants to encourage return visits. Simplifying program content through a combination of enhanced tailoring and information architecture also merits further research attention. PMID:19017582

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.

Training for Rapid Interpretation of Voluminous Multimodal Data

DTIC Science & Technology

2008-04-01

determined after the reserach that the corresponding FAC for the randomness and oversensitivity biases could be reasonably construed as true incidents...and the low overall susceptibility to errors in Experiment 4 made control comparisons irrelevant. Further research might employ similar methodology

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

PubMed

Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

2018-07-01

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

A Randomized Longitudinal Factorial Design to Assess Malaria Vector Control and Disease Management Interventions in Rural Tanzania

PubMed Central

Kramer, Randall A.; Mboera, Leonard E. G.; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H.; Paul, Christopher J.; Miranda, Marie Lynn

2014-01-01

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials. PMID:24840349

Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

PubMed

Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

2017-02-01

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

A randomized longitudinal factorial design to assess malaria vector control and disease management interventions in rural Tanzania.

PubMed

Kramer, Randall A; Mboera, Leonard E G; Senkoro, Kesheni; Lesser, Adriane; Shayo, Elizabeth H; Paul, Christopher J; Miranda, Marie Lynn

2014-05-16

The optimization of malaria control strategies is complicated by constraints posed by local health systems, infrastructure, limited resources, and the complex interactions between infection, disease, and treatment. The purpose of this paper is to describe the protocol of a randomized factorial study designed to address this research gap. This project will evaluate two malaria control interventions in Mvomero District, Tanzania: (1) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology; and (2) vector control through community-supported larviciding. Six study villages were assigned to each of four groups (control, early detection and treatment, larviciding, and early detection and treatment plus larviciding). The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys. Recurring entomological surveying, household surveying, and focus group discussions will provide additional valuable insights. At baseline, 962 households across all 24 villages participated in a household survey; 2,884 members from 720 of these households participated in subsequent malariometric surveying. The study design will allow us to estimate the effect sizes of different intervention mixtures. Careful documentation of our study protocol may also serve other researchers designing field-based intervention trials.

A contextual perspective on talented female participants and their development in extracurricular STEM programs.

PubMed

Stoeger, Heidrun; Schirner, Sigrun; Laemmle, Lena; Obergriesser, Stefanie; Heilemann, Michael; Ziegler, Albert

2016-08-01

We advocate a more contextual perspective in giftedness research. In our view, doing so opens up three particularly interesting research areas, which we refer to as the participation issue, the effectiveness issue, and the interaction issue. To illustrate their utility, we examined characteristics of females participating in German high achiever-track secondary education who had applied for participation in a 1-year extracurricular e-mentoring program in science, technology, engineering, and mathematics (STEM) (n = 1237). Their characteristics were compared with male and female random-sample control groups. We assessed the effectiveness of the mentoring program by comparing the developmental trajectories of program participants with those of three control groups: applicants who were randomly chosen for later participation (waiting-list control group) and a female and a male control group. Finally, we examined whether differences in program effectiveness could be partially explained by characteristics of the interaction with the domain. Program applicants possessed more advantageous individual characteristics but, unexpectedly, less advantageous home and school environments than female and male members of the control groups. Program participation affected positive changes in certainty about career goals (independent of STEM) and in the number of STEM activities. The amount of STEM communication partially explained differences in program effectiveness. © 2016 New York Academy of Sciences.

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

PubMed Central

2012-01-01

Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate ‘activity’ stages (focus: failure-free survival), and a final ‘efficacy’ stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design. (2) Adding New Therapy: An application to add a new research arm was approved by the funder, (who also organized peer review), industrial partner and regulatory and ethical bodies. This was all done in advance of any decision to stop current therapies. Conclusions The STAMPEDE experience shows that recruitment to a MAMS trial and mid-flow changes its design are achievable with good planning. This benefits patients and the scientific community as research treatments are evaluated in a more efficient and cost-effective manner. Trial registration ISRCTN78818544, NCT00268476 First patient into trial: 17 October 2005 First patient into abiraterone comparison: 15 November 2011 PMID:22978443

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.

PubMed

Sydes, Matthew R; Parmar, Mahesh K B; Mason, Malcolm D; Clarke, Noel W; Amos, Claire; Anderson, John; de Bono, Johann; Dearnaley, David P; Dwyer, John; Green, Charlene; Jovic, Gordana; Ritchie, Alastair W S; Russell, J Martin; Sanders, Karen; Thalmann, George; James, Nicholas D

2012-09-15

Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate 'activity' stages (focus: failure-free survival), and a final 'efficacy' stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design.(2) Adding New Therapy: An application to add a new research arm was approved by the funder, (who also organized peer review), industrial partner and regulatory and ethical bodies. This was all done in advance of any decision to stop current therapies. The STAMPEDE experience shows that recruitment to a MAMS trial and mid-flow changes its design are achievable with good planning. This benefits patients and the scientific community as research treatments are evaluated in a more efficient and cost-effective manner. ISRCTN78818544, NCT00268476. First patient into trial: 17 October 2005. First patient into abiraterone comparison: 15 November 2011.

H-index in medicine is driven by original research.

PubMed

Nowak, Jan K; Lubarski, Karol; Kowalik, Lukasz M; Walkowiak, Jaroslaw

2018-02-28

To investigate the contribution of selected types of articles to h-indices of medical researchers. We used the Web of Science to export the publication records of various members from 26 scientific medical societies (13 European, 13 North American) associated with 13 medical specialties. Those included were presidents (n=26), heads of randomly chosen committees (n=52), and randomly selected members of those committees (n=52). Publications contributing to h-index were categorized as research articles, reviews, guidelines, meta-analyses, or other published work. Overall, 3259 items authored by 129 scholars were analyzed. The median h-index was 19.5. The median contribution of research articles to h-index was 84.4%. Researchers in the upper h-index tercile (≥28.5) had a larger share of research articles that contributed to h-index in comparison with those in the lower h-index tercile (≤12.5) (median 87.3% [1st-3rd quartile: 80.0%-93.1%] vs 80.0% [50.0%-88.9%], P=0.015). We observed an analogous difference with regard to guidelines (1.1% [0%-3.7%] vs 0% [0%-0%], P=0.007). Original research drives h-indices in medicine. Although guidelines contribute to h-indices in medicine, their influence is low. The specific role of randomized controlled trials in building h-index in medicine remains to be assessed.

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

Fraction Intervention for Students With Mathematics Difficulties: Lessons Learned From Five Randomized Controlled Trials.

PubMed

Fuchs, Lynn S; Malone, Amelia S; Schumacher, Robin F; Namkung, Jessica; Wang, Amber

In this article, the authors summarize results from 5 randomized controlled trials assessing the effects of intervention to improve the fraction performance of fourth-grade students at risk for difficulty in learning about fractions. The authors begin by explaining the importance of competence with fractions and why an instructional focus on fractions magnitude understanding may improve learning. They then describe an intervention that relies strongly on this type of understanding about fractions instruction, and they provide an overview of the intervention's overall effects. This is followed by an overview of 5 intervention components for which the authors isolated effects. They conclude by discussing some of the lessons learned from this research program.

Inspection of care: Findings from an innovative demonstration

PubMed Central

Morris, John N.; Sherwood, Clarence C.; Dreyer, Paul

1989-01-01

In this article, information is presented concerning the efficacy of a sample-based approach to completing inspection of care reviews of Medicaid-supported nursing home residents. Massachusetts nursing homes were randomly assigned to full (the control group) or sample (the experimental group) review conditions. The primary research focus was to determine whether the proportion of facilities found to be deficient (based on quality of care and level of care criteria) in the experimental sample was comparable to the proportion in the control sample. The findings supported such a hypothesis: Deficient facilities appear to be equally identifiable using the random or full-sampling protocols, and the process can be completed with a considerable savings of surveyor time. PMID:10313458

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Cognitive-behavioral therapy for sleep disturbances in treating posttraumatic stress disorder symptoms: A meta-analysis of randomized controlled trials.

PubMed

Ho, Fiona Yan-Yee; Chan, Christian S; Tang, Kristen Nga-Sze

2016-02-01

Sleep disturbances are frequently reported in patients with posttraumatic stress disorder (PTSD). There is evidence that sleep disturbance is not only a secondary symptom but also a risk factor for PTSD. Sleep-specific psychological treatments provide an alternative to conventional trauma-focused psychological treatments. The current meta-analysis evaluated the efficacy of sleep-specific cognitive-behavioral therapy (CBT) in mitigating PTSD, sleep, and depressive symptoms. A total of 11 randomized controlled trials were included in the meta-analytic comparisons between sleep-specific CBT and waiting-list control groups at posttreatment. Random effects models showed significant reduction in self-report PTSD and depressive symptoms and insomnia severity in the sleep-specific CBT group. The corresponding effect sizes, measured in Hedges' g, were 0.58, 0.44, and 1.15, respectively. The effect sizes for sleep diary-derived sleep onset latency, wake after sleep onset, and sleep efficiency were 0.83, 1.02 and 1.15, respectively. The average study attrition rate of sleep-specific CBT was relatively low (12.8%), with no significant difference from the control group (9.4%). In conclusion, sleep-specific CBT appears to be efficacious and feasible in treating PTSD symptoms. Due to the relatively small number of randomized controlled trials available, further research is warranted to confirm its efficacy and acceptability, especially in comparison to trauma-specific psychological treatments. Copyright © 2015 Elsevier Ltd. All rights reserved.

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

PubMed

Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-09-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

PubMed Central

Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-01-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

Health effects of cow's milk consumption in infants up to 3 years of age: a systematic review and meta-analysis.

PubMed

Griebler, Ursula; Bruckmüller, Melanie U; Kien, Christina; Dieminger, Birgit; Meidlinger, Bettina; Seper, Katrin; Hitthaller, Ariane; Emprechtinger, Robert; Wolf, Alexandra; Gartlehner, Gerald

2016-02-01

To summarize the best available evidence regarding the short- and long-term health effects of cow's milk intake in healthy, full-term infants up to 3 years of age. We conducted a systematic review and meta-analysis. We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data. We included (randomized/non-randomized) controlled trials and observational studies. We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case-control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow's milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case-control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow's milk. We did not find negative associations for other health effects. Cow's milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow's milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants' Fe requirements can be met.

Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

PubMed

Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

2016-02-01

Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster effect was taken into account, the difference in Insomnia Severity Index reduction between the intervention versus control groups was non-significant, the results highlight that reductions in insomnia severity can be gained using trained pharmacists providing brief behavioural interventions. Future research in this area is warranted, with appropriately sized studies using the conventional, robust randomized trial design. © 2015 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

PubMed

Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 < .05) with a moderate effect size, but not self-rated HRQoL, Qualitative analysis suggested several group elements relating to its effectiveness. This present RCT shows that the psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

Translating basic behavioral and social science research to clinical application: the EVOLVE mixed methods approach.

PubMed

Peterson, Janey C; Czajkowski, Susan; Charlson, Mary E; Link, Alissa R; Wells, Martin T; Isen, Alice M; Mancuso, Carol A; Allegrante, John P; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B

2013-04-01

To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease populations. We employed a sequential mixed methods model (EVOLVE) to design and test the PA/SA intervention in order to increase physical activity in people with coronary artery disease (post-percutaneous coronary intervention [PCI]) or asthma (ASM) and to improve medication adherence in African Americans with hypertension (HTN). In an initial qualitative phase, we explored participant values and beliefs. We next pilot tested and refined the intervention and then conducted 3 randomized controlled trials with parallel study design. Participants were randomized to combined PA/SA versus an informational control and were followed bimonthly for 12 months, assessing for health behaviors and interval medical events. Over 4.5 years, we enrolled 1,056 participants. Changes were sequentially made to the intervention during the qualitative and pilot phases. The 3 randomized controlled trials enrolled 242 participants who had undergone PCI, 258 with ASM, and 256 with HTN (n = 756). Overall, 45.1% of PA/SA participants versus 33.6% of informational control participants achieved successful behavior change (p = .001). In multivariate analysis, PA/SA intervention remained a significant predictor of achieving behavior change (p < .002, odds ratio = 1.66), 95% CI [1.22, 2.27], controlling for baseline negative affect, comorbidity, gender, race/ethnicity, medical events, smoking, and age. The EVOLVE method is a means by which basic behavioral science research can be translated into efficacious interventions for chronic disease populations.

A Randomized Controlled Trial (RCT) to Assess and Improve the Effectiveness of Post-Deployment Screening for Mental Illness

DTIC Science & Technology

2014-09-01

Committee (Ref 187/GEN/10, the King’s College London Psychiatry, Nursing & Midwifery Research Ethics Subcommittee (Ref PNM/10/10/11-112) and the US Army...Ministry of Defence Research Ethics Committee (Ref 187/GEN/1) and the King’s College London Psychiatry, Nursing and Midwifery Research Ethics...increase acceptability of mental health screening programmes in paediatric care [22,23]. Concerns about the practicalities of implementing screening

A Randomized Controlled Trial (RCT) to Assess and Improve the Effectiveness of Post-deployment Screening for Mental Illness

DTIC Science & Technology

2014-03-01

Defence Ethics Committee (Ref 187/GEN/10, the King’s College London Psychiatry, Nursing & Midwifery Research Ethics Subcommittee (Ref PNM/10/10/11-112...March 2011 by The Ministry of Defence Research Ethics Committee (Ref 187/GEN/1) and the King’s College London Psychiatry, Nursing and Midwifery Research...been found to increase acceptability of mental health screening programmes in paediatric care [22,23]. Concerns about the practicalities of

Experimental evaluation of the effects of drug information on antibiotic prescribing: a study in outpatient care in an area of Sri lanka.

PubMed

Angunawela, I I; Diwan, V K; Tomson, G

1991-06-01

The intervention level of epidemiology is useful for studying effects in health systems research. Due to practical and ethical reasons, it is often difficult to apply experimental methods such as classical randomized clinical trials in the field. However with alternative approaches such as 'randomization by group' some of these problems can be overcome. Drug information has since long been considered as an instrument to influence physicians, however evaluation of its effects is a new field of research. In the present study the impact of drug information on prescribing behaviour was evaluated in an outpatient setting in Sri Lanka. The study included 15 state health institutions (45 prescribers) with a common drug formulary. Groups of prescribers were randomized into two interventions; newsletters and newsletters reinforced by a group seminar, and one control group. The target topic was 'rational prescribing of antibiotics'. Some 18,766 randomly selected outpatient drug prescriptions were studied. Antibiotics (and sulphonamides) were prescribed to 33.2% of the patients. An overall trend towards a decrease in proportion of patients prescribed antibiotics in the two intervention groups was seen, although the difference was not significant (p greater than 0.05) compared to the control group. This is similar to the effect of written information on prescribing in other studies. A mean difference of -7.4% in written, -7.3% in written + seminar and -0.4% in the control group was shown. The general antibiotic prescribing pattern did not change in any of the three groups. Penicillin was the most commonly prescribed antibiotic and tetracycline was only rarely prescribed to children. This experiment indicates the feasibility of drug information intervention studies in developing countries.(ABSTRACT TRUNCATED AT 250 WORDS)

Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention.

PubMed

Mills, Nicola; Gaunt, Daisy; Blazeby, Jane M; Elliott, Daisy; Husbands, Samantha; Holding, Peter; Rooshenas, Leila; Jepson, Marcus; Young, Bridget; Bower, Peter; Tudur Smith, Catrin; Gamble, Carrol; Donovan, Jenny L

2018-03-01

The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments. Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1-6.9 and after 6.9-8.2 (scale 0-10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high-surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0-10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made "a lot" of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences. Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Randomized controlled trials and meta-analysis in medical education: what role do they play?

PubMed

Cook, David A

2012-01-01

Education researchers seek to understand what works, for whom, in what circumstances. Unfortunately, educational environments are complex and research itself is highly context dependent. Faced with these challenges, some have argued that qualitative methods should supplant quantitative methods such as randomized controlled trials (RCTs) and meta-analysis. I disagree. Good qualitative and mixed-methods research are complementary to, rather than exclusive of, quantitative methods. The complexity and challenges we face should not beguile us into ignoring methods that provide strong evidence. What, then, is the proper role for RCTs and meta-analysis in medical education? First, the choice of study design depends on the research question. RCTs and meta-analysis are appropriate for many, but not all, study goals. They have compelling strengths but also numerous limitations. Second, strong methods will not compensate for a pointless question. RCTs do not advance the science when they make confounded comparisons, or make comparison with no intervention. Third, clinical medicine now faces many of the same challenges we encounter in education. We can learn much from other fields about how to handle complexity in RCTs. Finally, no single study will definitively answer any research question. We need carefully planned, theory-building, programmatic research, reflecting a variety of paradigms and approaches, as we accumulate evidence to change the art and science of education.

Use of Formative Research to Develop a Yoga Curriculum for High-Risk Youth: Implementation Considerations

ERIC Educational Resources Information Center

Miller, Shari; Herman-Stahl, Mindy; Fishbein, Diana; Lavery, Bud; Johnson, Michelle; Markovits, Lara

2014-01-01

The purpose of this study is to elucidate the use of formative research to adapt, develop, and pretest a mindful yoga curriculum for high-risk youth attending a nontraditional high school. The formative work was conducted in the first year of a larger project to test the efficacy of a mindful yoga program through a randomized controlled trial. The…

Operational Evaluation of Self-Paced Instruction in U.S. Army Training.

DTIC Science & Technology

1979-01-01

one iteration of each course, and the on -going refinement and adjustment of managerial techniques. Research Approach A quasi - experimental approach was...research design employed experimental and control groups , posttest only with non-random groups . The design dealt with the six major areas identified as...course on Interpersonal Communications were conducted in the conventional, group -paced manner. Experimental course materials. Wherever possible, existing

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

A randomized controlled trial of the effectiveness of a pre-recruitment primer letter to increase participation in a study of colorectal screening and surveillance.

PubMed

Paul, Christine; Courtney, Ryan; Sanson-Fisher, Rob; Carey, Mariko; Hill, David; Simmons, Jody; Rose, Shiho

2014-04-01

Recruiting cancer patients is a barrier often encountered in research trials. However, very few randomized trials explore strategies to improve participation rates. The purpose of this study was to evaluate the effectiveness of a pre-recruitment primer letter to recruit persons diagnosed with colorectal cancer for a research trial. Potentially eligible participants were identified by the Victorian Cancer Registry. A total of 1,062 participants were randomized to receive either a mailed explanatory primer letter designed to encourage research participation, or no primer letter. Two weeks after the intervention, the Victorian Cancer Registry sought permission from patients to release their contact details to researchers. Those who agreed were contacted and invited to the study. Pre-recruitment encouragement was not effective at increasing recruitment, with no significant differences demonstrated between experimental groups. Overall, 40% (n = 425) consented to participate, 25% (n = 243) refused and 35% (n = 394) did not respond. While this study demonstrated disappointing outcomes, pre-recruitment letters should not be ruled out as an approach altogether. Rather, future research should explore whether other factors to increase motivation, such as intensity and timing, are feasible and acceptable for contacting cancer patients. Australian and New Zealand Clinical Trials Registry, ACTRN12609000628246.

Coaching to Augment Mentoring to Achieve Faculty Diversity: A Randomized Controlled Trial.

PubMed

Williams, Simon N; Thakore, Bhoomi K; McGee, Richard

2016-08-01

The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students' perceptions of the achievability and desirability of an academic career. The authors tested (July 2012-July 2013), with Northwestern University ethical approval, the Academy via a longitudinal randomized controlled trial. Participants were 121 latter-stage biomedical PhD students. The authors collected data via questionnaires, interviews, and meeting recordings. The case study shows how group career coaching can effectively supplement traditional one-to-one research mentoring; provide new role models for underrepresented minority students; and provide theory-based lenses through which to engage in open conversations about race, gender, and science careers. Repeated-measures analysis of variance showed that perceived achievability increased in the Academy group from baseline to one-year follow-up (mean, 5.75 versus 6.39) but decreased in the control group (6.58 versus 5.81). Perceived desirability decreased significantly less (P < .05) in the Academy group (7.00 versus 6.36) than in the control group (7.83 versus 5.97). Early results suggest that an academic career coaching model can effectively supplement traditional research mentoring and promote persistence toward academic careers.

The design of instructional tools affects secondary school students' learning of cardiopulmonary resuscitation (CPR) in reciprocal peer learning: a randomized controlled trial.

PubMed

Iserbyt, Peter; Byra, Mark

2013-11-01

Research investigating design effects of instructional tools for learning Basic Life Support (BLS) is almost non-existent. To demonstrate the design of instructional tools matter. The effect of spatial contiguity, a design principle stating that people learn more deeply when words and corresponding pictures are placed close (i.e., integrated) rather than far from each other on a page was investigated on task cards for learning Cardiopulmonary Resuscitation (CPR) during reciprocal peer learning. A randomized controlled trial. A total of 111 students (mean age: 13 years) constituting six intact classes learned BLS through reciprocal learning with task cards. Task cards combine a picture of the skill with written instructions about how to perform it. In each class, students were randomly assigned to the experimental group or the control. In the control, written instructions were placed under the picture on the task cards. In the experimental group, written instructions were placed close to the corresponding part of the picture on the task cards reflecting application of the spatial contiguity principle. One-way analysis of variance found significantly better performances in the experimental group for ventilation volumes (P=.03, ηp2=.10) and flow rates (P=.02, ηp2=.10). For chest compression depth, compression frequency, compressions with correct hand placement, and duty cycles no significant differences were found. This study shows that the design of instructional tools (i.e., task cards) affects student learning. Research-based design of learning tools can enhance BLS and CPR education. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Rodríguez-Torres, Janet; Fajardo-Contreras, Waldo; Díaz-Pelegrina, Ana; Valenza, Marie Carmen

2016-12-01

To evaluate the effects of a home-based upper limb training program on arm function in patients with multiple sclerosis (MS). Additionally, the effects of this program on manual dexterity, handgrip strength, and finger prehension force were analyzed. Randomized, single-blind controlled trial. Home based. Patients with a clinical diagnosis of MS acknowledging impaired manual ability (N=37) were randomized into 2 groups. Patients in the experimental group were included in a supervised home-based upper limb training program for 8 weeks twice a week. Patients in the control group received information in the form of a leaflet with a schedule of upper limb exercise training. The primary outcome measure was arm function (motor functioning assessed using the finger tapping test and a functional measure, the Action Research Arm Test). The secondary outcome measures were manual dexterity assessed with the Purdue Pegboard Test and handgrip strength and finger prehension force evaluated with a handgrip and a pinch dynamometer, respectively. After 8 weeks, a significant between-group improvement (P<.05) was found on the Action Research Arm Test bilaterally and the finger tapping test in the most affected upper limb. The secondary outcomes also improved in the most affected limb in the experimental group. An 8-week home-based intervention program focused on upper limbs twice a week improved arm function and physiologic variables with a primary focus on the more affected extremity in patients with MS compared with the control group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

PubMed Central

2013-01-01

Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Trial registration Current Controlled Trials ISRCTN70202532 PMID:23890316

The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

PubMed

Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

2013-07-29

In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts. Current Controlled Trials ISRCTN70202532.

META-ANALYSIS OF ACUTE EXERCISE EFFECTS ON STATE ANXIETY: AN UPDATE OF RANDOMIZED CONTROLLED TRIALS OVER THE PAST 25 YEARS.

PubMed

Ensari, Ipek; Greenlee, Tina A; Motl, Robert W; Petruzzello, Steven J

2015-08-01

One prominent and well-cited meta-analysis published nearly 25 years ago reported that an acute or single bout of exercise reduced state anxiety by approximately ¼ standard deviation. We conducted a meta-analysis of randomized controlled trials (RCTs) published after that meta-analysis for updating our understanding of the acute effects of exercise on state anxiety. We searched PubMed, EBSCOHost, Medline, PsycINFO, ERIC, and ScienceDirect for RCTs of acute exercise and state anxiety as an outcome. There were 36 RCTs that met inclusion criteria and yielded data for effect size (ES) generation (Cohen's d). An overall ES was calculated using a random effects model and expressed as Hedge's g. The weighted mean ES was small (Hedge's g = 0.16, standard error (SE) = 0.06), but statistically significant (P < 0.05), and indicated that a single bout of exercise resulted in an improvement in state anxiety compared with control. The overall ES was heterogeneous and post hoc, exploratory analyses using both random- and fixed-effects models identified several variables as moderators including sample age, sex and health status, baseline activity levels, exercise intensity, modality and control condition, randomization, overall study quality, and the anxiety measure (P < 0.05). The cumulative evidence from high quality studies indicates that acute bouts of exercise can yield a small reduction in state anxiety. The research is still plagued by floor effects associated with recruiting persons with normal or lower levels of state anxiety, and this should be overcome in subsequent trials. © 2015 Wiley Periodicals, Inc.

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

PubMed

Montalvo, Wanda; Larson, Elaine

2014-11-01

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

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.

A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial.

PubMed

Pothier, Kristell; Soriano, G; Lussier, M; Naudin, A; Costa, N; Guyonnet, S; Piau, A; Ousset, P J; Nourhashemi, F; Vellas, B; de Souto Barreto, P

2018-01-24

Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people. This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults. One hundred and twenty older adults (≥ 65 years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness. We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency. The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

PubMed

Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

2016-03-01

Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

PubMed

Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

2014-07-01

The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

[SOPHO-NET - a research network on psychotherapy for social phobia].

PubMed

Leichsenring, Falk; Salzer, Simone; Beutel, Manfred E; von Consbruch, Katrin; Herpertz, Stephan; Hiller, Wolfgang; Hoyer, Jürgen; Hüsing, Johannes; Irle, Eva; Joraschky, Peter; Konnopka, Alexander; König, Hans-Helmut; de Liz, Therese; Nolting, Björn; Pöhlmann, Karin; Ruhleder, Mirjana; Schauenburg, Henning; Stangier, Ulrich; Strauss, Bernhard; Subic-Wrana, Claudia; Vormfelde, Stefan V; Weniger, Godehard; Willutzki, Ulrike; Wiltink, Jörg; Leibing, Eric

2009-01-01

This paper presents the Social Phobia Psychotherapy Research Network (SOPHO-NET). SOPHO-NET is among the five research networks on psychotherapy funded by "Bundesministerium für Bildung und Forschung". The research program encompasses a coordinated group of studies of social phobia. In the central project (Study A), a multi-center randomized controlled trial, refined models of manualized cognitive-behavioral therapy (CBT) and manualized short-term psychodynamic psychotherapy (STPP) are compared in the treatment of social phobia. A sample of n=512 outpatients will be randomized to either CBT, STPP or wait list. For quality assurance and treatment integrity, a specific project has been established (Project Q). Study A is complemented by four interrelated projects focusing on attachment style (Study B1), cost-effectiveness (Study B2), polymorphisms in the serotonin transporter gene (Study C1) and on structural and functional deviations of hippocampus and amygdala (Study C2). Thus, the SOPHO-NET program allows for a highly interdisciplinary research of psychotherapy in social phobia.

Future directions in physical activity intervention research: expanding our focus to sedentary behaviors, technology, and dissemination.

PubMed

Lewis, Beth A; Napolitano, Melissa A; Buman, Matthew P; Williams, David M; Nigg, Claudio R

2017-02-01

Despite the increased health risks of a sedentary lifestyle, only 49 % of American adults participate in physical activity (PA) at the recommended levels. In an effort to move the PA field forward, we briefly review three emerging areas of PA intervention research. First, new intervention research has focused on not only increasing PA but also on decreasing sedentary behavior. Researchers should utilize randomized controlled trials, common terminology, investigate which behaviors should replace sedentary behaviors, evaluate long-term outcomes, and focus across the lifespan. Second, technology has contributed to an increase in sedentary behavior but has also led to innovative PA interventions. PA technology research should focus on large randomized trials with evidence-based components, explore social networking and innovative apps, improve PA monitoring, consider the lifespan, and be grounded in theory. Finally, in an effort to maximize public health impact, dissemination efforts should address the RE-AIM model, health disparities, and intervention costs.

Future directions in physical activity intervention research: expanding our focus to sedentary behaviors, technology, and dissemination

PubMed Central

Napolitano, Melissa A.; Buman, Matthew P.; Williams, David M.; Nigg, Claudio R.

2016-01-01

Despite the increased health risks of a sedentary lifestyle, only 49 % of American adults participate in physical activity (PA) at the recommended levels. In an effort to move the PA field forward, we briefly review three emerging areas of PA intervention research. First, new intervention research has focused on not only increasing PA but also on decreasing sedentary behavior. Researchers should utilize randomized controlled trials, common terminology, investigate which behaviors should replace sedentary behaviors, evaluate long-term outcomes, and focus across the lifespan. Second, technology has contributed to an increase in sedentary behavior but has also led to innovative PA interventions. PA technology research should focus on large randomized trials with evidence-based components, explore social networking and innovative apps, improve PA monitoring, consider the lifespan, and be grounded in theory. Finally, in an effort to maximize public health impact, dissemination efforts should address the RE-AIM model, health disparities, and intervention costs. PMID:27722907

Randomized controlled trial of care bundles with chlorhexidine dressing and advanced dressings to prevent catheter-related bloodstream infections in pediatric hematology-oncology patients.

PubMed

Gerçeker, Gülçin Özalp; Yardımcı, Figen; Aydınok, Yeşim

2017-06-01

To compare the effects of the care bundles including chlorhexidine dressing and advanced dressings on the catheter-related bloodstream infection (CRBSI) rates in pediatric hematology-oncology patients with central venous catheters (CVCs). Twenty-seven PHO patients were recruited to participate in a prospective, randomized study in Turkey. The researcher used care bundles with chlorhexidine dressing in the experimental group (n = 14), and care bundles with advanced dressings in the control group (n = 13). According to the study results, 28.6% of the patients in the experimental group had CRBSI, while this rate was 38.5% in the control group patients. The CRBSI rate in the experimental group was 3.9, and the control group had 4.4 per 1000 inpatient catheter days. There was no exit-site infection in the experimental group. However, the control group had 1.7 per 1000 inpatient catheter days. Even though there was no difference between the two groups in which the researcher implemented care bundles with chlorhexidine dressing and advanced dressings in terms of CRBSI development, there was reduction in the CRBSI rates thanks to the care bundle approach. It is possible to control the CRBSI rates using care bundles in pediatric hematology-oncology patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Neurorehabilitation in Parkinson's Disease: A Critical Review of Cognitive Rehabilitation Effects on Cognition and Brain.

PubMed

Díez-Cirarda, María; Ibarretxe-Bilbao, Naroa; Peña, Javier; Ojeda, Natalia

2018-01-01

Parkinson's disease (PD) patients experience cognitive impairment which has been related to reduced quality of life and functional disability. These symptoms usually progress until dementia occurs. Some studies have been published assessing the efficacy of cognitive treatments on improving cognition, functional outcome, and producing changes in brain activity. A critical review was performed to present up-to-date neurorehabilitation effects of cognitive rehabilitation in PD, with special emphasis on the efficacy on cognition, quality of life aspects, brain changes, and the longitudinal maintenance of these changes. After exclusions, 13 studies were reviewed, including 6 randomized controlled trials for the efficacy on cognition, 2 randomized controlled trials regarding the brain changes after cognitive training, and 5 studies which evaluated the long-term effects of cognitive treatments. Cognitive rehabilitation programs have demonstrated to be effective on improving cognitive functions, but more research is needed focusing on the efficacy on improving behavioral aspects and producing brain changes in patients with PD. Moreover, there is a need of randomized controlled trials with long-term follow-up periods.

High-intensity training enhances executive function in children in a randomized, placebo-controlled trial

PubMed Central

Moreau, David; Kirk, Ian J; Waldie, Karen E

2017-01-01

Background: Exercise-induced cognitive improvements have traditionally been observed following aerobic exercise interventions; that is, sustained sessions of moderate intensity. Here, we tested the effect of a 6 week high-intensity training (HIT) regimen on measures of cognitive control and working memory in a multicenter, randomized (1:1 allocation), placebo-controlled trial. Methods: 318 children aged 7-13 years were randomly assigned to a HIT or an active control group matched for enjoyment and motivation. In the primary analysis, we compared improvements on six cognitive tasks representing two cognitive constructs (N = 305). Secondary outcomes included genetic data and physiological measurements. Results: The 6-week HIT regimen resulted in improvements on measures of cognitive control [BFM = 3.38, g = 0.31 (0.09, 0.54)] and working memory [BFM = 5233.68, g = 0.54 (0.31, 0.77)], moderated by BDNF genotype, with met66 carriers showing larger gains post-exercise than val66 homozygotes. Conclusion: This study suggests a promising alternative to enhance cognition, via short and potent exercise regimens. Clinical Trial Registration: Protocol #015078, University of Auckland. Funding: Centre for Brain Research: David Moreau and Karen E Waldie (9133-3706255). DOI: http://dx.doi.org/10.7554/eLife.25062.001 PMID:28825973

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

PubMed Central

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

2013-01-01

Objective To determine whether cognitive behavior therapy (CBT), which we previously showed restored ovarian function in women with functional hypothalamic amenorrhea (FHA), also ameliorated hypercortisolemia and improved other neuroendocrine and metabolic concomitants of in FHA. Design Randomized controlled trial. Intervention CBT vs. observation. Setting Clinical research center at an academic medical university. Patient(s) Seventeen women with FHA were randomized either to CBT or observation. Main Outcome Measure(s) Circulatory concentrations of cortisol, leptin, TSH, total and free thyronine (T3), and total and free thyroxine (T4) before and immediately after completion of CBT or observation. Each woman served as her own control. Results CBT but not observation reduced cortisol levels in women with FHA. There were no changes in cortisol, leptin, TSH, T3, or T4 levels in women randomized to observation. Women treated with CBT showed increased levels of leptin and TSH, while levels of T3 and T4 remained unchanged. Conclusions CBT ameliorated hypercortisolism and improved neuroendocrine and metabolic concomitants of FHA while observation did not. We conclude that a cognitive, nonpharmacological approach aimed at alleviating problematic attitudes not only restored ovarian activity but also improved neuroendocrine and metabolic function in women with FHA. PMID:23507474

The Effect of Omega-3 on Circulating Adiponectin in Adults with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Bahreini, Mehdi; Ramezani, Amir-Hossein; Shishehbor, Farideh; Mansoori, Anahita

2018-01-04

Whether consumption of omega-3 affects circulating adiponectin has not been established. The objective of this study was to evaluate the effect of omega-3 (food or supplement) on circulating adiponectin in patients with type 2 diabetes through a systematic review of meta-analyses of randomized controlled trials. PubMed, Scopus and Web of Science were searched for relevant studies through May 2016. Two researchers screened and abstracted the literature independently. Pooled estimates were obtained using the random-effects models. Overall, omega-3 increased adiponectin by 0.57 µg/mL (95% confidence interval [CI] 0.15 to 1.31; p=0.01, I-square=74.2% p for heterogeneity <0.001). The source of observed heterogeneity was explored by subgroup analyses. In subgroup analyses, adiponectin levels increased only in those who had consumed omega-3 for more than 8 weeks. This systematic review and meta-analysis of randomized, placebo-controlled clinical trials suggests that omega-3 in patients with type 2 diabetes increases circulating adiponectin. These findings support the potentially beneficial effects of dietary omega-3 in patients with type 2 diabetes on pathways related to adiponectin metabolism. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

Identification and selection of cases and controls in the Pneumonia Etiology Research for Child Health project.

PubMed

Deloria-Knoll, Maria; Feikin, Daniel R; Scott, J Anthony G; O'Brien, Katherine L; DeLuca, Andrea N; Driscoll, Amanda J; Levine, Orin S

2012-04-01

Methods for the identification and selection of patients (cases) with severe or very severe pneumonia and controls for the Pneumonia Etiology Research for Child Health (PERCH) project were needed. Issues considered include eligibility criteria and sampling strategies, whether to enroll hospital or community controls, whether to exclude controls with upper respiratory tract infection (URTI) or nonsevere pneumonia, and matching criteria, among others. PERCH ultimately decided to enroll community controls and an additional human immunodeficiency virus (HIV)-infected control group at high HIV-prevalence sites matched on age and enrollment date of cases; controls with symptoms of URTI or nonsevere pneumonia will not be excluded. Systematic sampling of cases (when necessary) and random sampling of controls will be implemented. For each issue, we present the options that were considered, the advantages and disadvantages of each, the rationale for the methods selected for PERCH, and remaining implications and limitations.

Statistical modeling of software reliability

NASA Technical Reports Server (NTRS)

Miller, Douglas R.

1992-01-01

This working paper discusses the statistical simulation part of a controlled software development experiment being conducted under the direction of the System Validation Methods Branch, Information Systems Division, NASA Langley Research Center. The experiment uses guidance and control software (GCS) aboard a fictitious planetary landing spacecraft: real-time control software operating on a transient mission. Software execution is simulated to study the statistical aspects of reliability and other failure characteristics of the software during development, testing, and random usage. Quantification of software reliability is a major goal. Various reliability concepts are discussed. Experiments are described for performing simulations and collecting appropriate simulated software performance and failure data. This data is then used to make statistical inferences about the quality of the software development and verification processes as well as inferences about the reliability of software versions and reliability growth under random testing and debugging.

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial.

PubMed

García-Escalera, Julia; Valiente, Rosa M; Chorot, Paloma; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-08-21

Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR). ©Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.08.2017.

A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents

PubMed Central

Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C. M. E.; Granic, Isabela

2016-01-01

Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11–15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the “at-risk” cut-off on the Spence Children Anxiety Survey were eligible. Adolescents’ anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents’ anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants’ expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

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

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial.

PubMed

Young, Kim-Wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. The paired-samples t -test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in improving the cognitive and short-term memory abilities of PwMCI.

The Effect of Learning Based on Technology Model and Assessment Technique toward Thermodynamic Learning Achievement

NASA Astrophysics Data System (ADS)

Makahinda, T.

2018-02-01

The purpose of this research is to find out the effect of learning model based on technology and assessment technique toward thermodynamic achievement by controlling students intelligence. This research is an experimental research. The sample is taken through cluster random sampling with the total respondent of 80 students. The result of the research shows that the result of learning of thermodynamics of students who taught the learning model of environmental utilization is higher than the learning result of student thermodynamics taught by simulation animation, after controlling student intelligence. There is influence of student interaction, and the subject between models of technology-based learning with assessment technique to student learning result of Thermodynamics, after controlling student intelligence. Based on the finding in the lecture then should be used a thermodynamic model of the learning environment with the use of project assessment technique.

Results of a Randomized Controlled Trial of Student Success Skills

ERIC Educational Resources Information Center

Webb, Linda; Carey, John; Villares, Elizabeth; Wells, Craig; Sayer, Aline

2014-01-01

Numerous authors have reviewed research to determine which skills are considered fundamental to successful academic and social outcomes for students (Hattie, Briggs, & Purdie, 1996; Masten & Coatworth, 1998; Wang, Haertel, & Walberg, 1994; Zins, Weissberg, Wang, & Walberg, 2004). These skills include: (1) cognitive and…

76 FR 28788 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... studies have been quasi-experimental designs focused on short term workload assessments as outcomes. The... experimental research to define further the effectiveness and cost-benefit of MSD control interventions. A... prospective experimental design (multiple baselines across groups with randomization). These interventions...

Clinical efficacy of a herbal dentifrice on dentinal hypersensitivity: a randomized controlled clinical trial.

PubMed

Kumari, M; Naik, S B; Rao, N S; Martande, S S; Pradeep, A R

2013-12-01

Dentinal hypersensitivity is a common problem and there is a growing interest in herbal based formulations for the treatment of oral diseases. This study was conducted to assess the efficacy of a commercially available novel herbal dentifrice in reduction of dentinal hypersensitivity. A total of 73 subjects (38 males and 35 females; aged 25-60 years) were randomly divided into two groups: Group 1 - a placebo dentifrice (The Himalaya Drug Company Research and Development, Makali, Bangalore) and Group 2 - (test group), a commercially available herbal dentifrice (Hi Ora K, The Himalaya Drug Company Research and Development, Makali, Bangalore). Sensitivity scores for controlled air stimulus and cold water were recorded at baseline, 6 weeks and 12 weeks. The test group was found to be significantly better compared to the placebo group at the end of 6 and 12 weeks in reduction of dentinal hypersensitivity. The novel herbal dentifrice can be recommended for treatment of dentinal hypersensitivity. © 2013 Australian Dental Association.

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

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.

The cognitive-enhancing effects of Bacopa monnieri: a systematic review of randomized, controlled human clinical trials.

PubMed

Pase, Matthew P; Kean, James; Sarris, Jerome; Neale, Chris; Scholey, Andrew B; Stough, Con

2012-07-01

Traditional knowledge suggests that Bacopa monnieri enhances cognitive performance. Such traditional beliefs have now been scientifically tested through a handful of randomized, controlled human clinical trials. The current systematic review aimed to examine the scientific evidence as to whether Bacopa can enhance cognitive performance in humans. A systematic review of randomized controlled trials is presented. Multiple databases were systematically searched by multiple authors. Relevant trials were objectively assessed for methodological quality. The subjects studied were adult humans without dementia or significant cognitive impairment. B. monnieri, including Bacopa extracts, were administered over long-term supplementation periods. Any validated cognitive test, whether a primary or secondary outcome. Six (6) studies met the final inclusion criteria and were included in review. Trials were all conducted over 12 weeks. Across trials, three different Bacopa extracts were used at dosages of 300-450 mg extract per day. All reviewed trials examined the effects of Bacopa on memory, while other cognitive domains were less well studied. There were no cognitive tests in the areas of auditory perceptual abilities or idea production and only a paucity of research in the domains of reasoning, number facility, and language behavior. Across studies, Bacopa improved performance on 9 of 17 tests in the domain of memory free recall. There was little evidence of enhancement in any other cognitive domains. There is some evidence to suggest that Bacopa improves memory free recall with evidence for enhancement in other cognitive abilities currently lacking perhaps due to inconsistent measures employed by studies across these cognitive domains. Research into the nootropic effects of Bacopa is in its infancy, with research still yet to investigate the effects of Bacopa across all human cognitive abilities. Similarly, future research should examine the nootropic effects of Bacopa at varied dosages and across different extracts.

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

PubMed

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

2016-12-01

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a non-invasive therapeutic technique used to theoretically aid in scar tissue breakdown and absorption, fascial mobilization, and improved tissue healing. Researchers have hypothesized that utilizing IASTM will improve muscular efficiency and performance; yet previous Investigations has been focused on treating injury. The purpose of this investigation was to explore the effects of IASTM on muscle performance to assess if typical treatment application affected measures of muscular performance. A pretest-posttest randomized control design. A convenience sample of 48 physically active adults (mean age 24 ± 4 years), randomly assigned to one of three groups: quadriceps treatment group, triceps surae treatment group, or control group. Participants performed a five-minute warm-up on a Monark bicycle ergometer before performing three countermovement vertical jumps (CMJ). Immediately after, the IASTM treatment was applied by one researcher for three minutes on each leg at the specified site (e.g., quadriceps) for those assigned to the treatment groups, while the control group rested for six minutes. Immediately following treatment, participants performed three additional CMJs. Pre- and post-testing included measures of vertical jump height (JH), peak power (PP) and peak velocity (PV). There were no statistically significant differences found between treatment groups in JH, PP, or PV or across pre- and post-test trials. These preliminary findings suggest that standard treatment times of IASTM do not produce an immediate effect in muscular performance in healthy participants. This may help clinicians determine the optimal sequencing of IASTM when it is part of a pre-performance warm-up program. Future research should be conducted to determine the muscle performance effects of IASTM in individuals with known myofascial restriction and to determine optimal treatment parameters, such as instrument type, amount of pressure, and treatment time necessary to affect muscular performance. 1b.

Effects of martial arts on health status: a systematic review.

PubMed

Bu, Bin; Haijun, Han; Yong, Liu; Chaohui, Zhang; Xiaoyuan, Yang; Singh, Maria Fiatarone

2010-11-01

To systematically summarize the evidence for the effects of martial arts on health and fitness, to show the strengths of different types of martial arts, and to get a more complete picture of the impacts of martial arts on health, and also to provide a basis for future research on martial arts as an exercise prescription in exercise therapy. We searched for "martial arts"health" and "random" in eight databases (n= 5432). Randomized controlled trials and controlled clinical trials on the health effects of martial arts were included in the study. The final analysis included 28 papers (one general martial arts, one kung fu, sixteen tai chi, six judo, three karate, and one taekwondo). Among the disciplines of martial arts, tai chi was the most well-studied, followed by judo, karate, and taekwondo. Research topics varied widely, and included health, injuries, competition, morals and psychology, and herbal medicine. Most found positive effects on health. Tai chi is no-contact, low-impact, soft body and mindfulness exercise, which has been widely adopted by elderly people and proven to be a beneficial health promotion exercise. Research on judo, karate, and taekwondo mainly focused on improvements to athletes' competitive abilities, rather than on health effects. We did not find any published randomized controlled trials or controlled clinical trials on aikido, kendo, sumo, kyudo, qi gong, or other disciplines. Since martial arts are widely practiced, their effects on physiology, morphology, immunology, and neurology should be further studied in order to help people to select the best discipline or style to accomplish their purposes. This necessitates categorizing and classifying the disciplines and styles according to their effects on different body systems and levels of contact, as well as standardizing evaluation criteria for martial arts. Martial arts as an exercise prescription can then move from an experience-based to an evidence-based treatment. © 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

The influence of formative assessments on student motivation, achievement, and conceptual change

NASA Astrophysics Data System (ADS)

Yin, Yue

2005-07-01

This study connected research on formative assessment, motivation, and conceptual change. In particular, it examined three research questions: (1) Can formative assessment improve students' motivational beliefs? (2) Can formative assessment improve students' achievement in science and bring about conceptual change? and (3) Are students' science achievement and conceptual change correlated with their motivational beliefs? Formative assessment in this study refers to assessments embedded in an inquiry-based curriculum. To answer those questions, a randomized experiment was conducted. One thousand and two 6th or 7th graders of 12 teachers in 12 different schools in six states participated in the study. The 12 teachers were matched in pairs and randomly assigned to the experimental and control group. The experimental group employed embedded formative assessments while teaching a science curriculum unit and the control group taught the same unit without formative assessments. All the students were given a motivation survey and one or more achievement tests at pre- and posttest. By comparing the experimental and control students' motivation and achievement scores at pretest and posttest, I examined whether the formative assessment treatment affected students' motivation, learning, and conceptual change. By correlating students' posttest motivation, achievement as well as conceptual change scores, I examined whether students' motivation was related to their achievement and conceptual change. Analyses indicated that, the embedded assessments used by the experimental group did not significantly influence students' motivation, achievement, or conceptual change compared to students in the control group. Most motivation beliefs were correlated with students' achievement in a way similar to what has been reported in the literature. They were not correlated with students' conceptual change scores as hypothesized. Teachers, as well as some contextual factors associated with teachers, were extremely influential on students' motivation, achievement, and conceptual change; teacher effects overshadowed the treatment effect. This study revealed many of the challenges and problems teachers, researchers and randomized experiments are likely to encounter. It also highlighted the difficulty and importance of high-fidelity formative assessment implementation. Finally, it suggested that a cognitive approach in studying conceptual change still has great value to further research.

Factors of quality of financial report of local government in Indonesia

NASA Astrophysics Data System (ADS)

Muda, Iskandar; Haris Harahap, Abdul; Erlina; Ginting, Syafruddin; Maksum, Azhar; Abubakar, Erwin

2018-03-01

The purpose of this research is to find out whether the Accounting Information System and Internal Control in Local Revenue Office to the affect the Quality of Financial Report of Local Government. The sampling was conducted by using simple random sampling method in which the sample was determined without considering strata. The data research was conducted by distributing the questionnaires. The results showed that the degree of Accounting Information System and Internal Control simultaneously affect the Quality of Financial Report of Local Government. However, partially, Partially, accounting information system influence to the quality of financial report of local government and the internal control does not affect the quality of financial report.

Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

PubMed

Silverman, Michael J

2014-01-01

Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

Study of The Vector Product using Three Dimensions Vector Card of Engineering in Pathumwan Institute of Technology

NASA Astrophysics Data System (ADS)

Mueanploy, Wannapa

2015-06-01

The objective of this research was to offer the way to improve engineering students in Physics topic of vector product. The sampling of this research was the engineering students at Pathumwan Institute of Technology during the first semester of academic year 2013. 1) Select 120 students by random sampling are asked to fill in a satisfaction questionnaire scale, to select size of three dimensions vector card in order to apply in the classroom. 2) Select 60 students by random sampling to do achievement test and take the test to be used in the classroom. The methods used in analysis of achievement test by the Kuder-Richardson Method (KR- 20). The results show that 12 items of achievement test are appropriate to be applied in the classroom. The achievement test gets Difficulty (P) = 0.40-0.67, Discrimination = 0.33-0.73 and Reliability (r) = 0.70.The experimental in the classroom. 3) Select 60 students by random sampling divide into two groups; group one (the controlled group) with 30 students was chosen to study in the vector product lesson by the regular teaching method. Group two (the experimental group) with 30 students was chosen to learn the vector product lesson with three dimensions vector card. 4) Analyzed data between the controlled group and the experimental group, the result showed that experimental group got higher achievement test than the controlled group significant at .01 level.

Effect of vasoconstriction on pain after mandibular third molar surgery: A single-blind, randomized controlled trial.

PubMed

Martin, Wilhelmus J J M; Skorpil, Nynke E; Ashton-James, Claire E; Tuinzing, D Bram; Forouzanfar, Tymour

2016-01-01

Previous research has demonstrated the efficacy of using local compression to reduce postoperative pain after third molar surgery. It has been theorized that compression reduces pain intensity through vasoconstriction. The current research tests the veracity of this vasoconstriction hypothesis by testing the impact of local epinephrine (a local vasoconstrictor) versus a control on patients' pain ratings over 7 days following surgery. Fifty patients scheduled for mandibular third molar surgery were randomly assigned to receive one cartridge of Ultracaine DS Forte (the treatment group) or one cartridge of Ultracaine DS (the control group) after surgical removal of the third molar. Participants used the visual analog scale (VAS) to provide daily ratings of pain intensity for 7 days following surgery. In addition, on day 7, the perceived effectiveness of the pain treatment was measured with the global perceived effect (GPE) scale. A quality- of-life questionnaire was also completed. A repeated-measures ANOVA indicated that the treatment group perceived significantly less pain than the control group on days 2 to 7 following surgery. In addition, 77.8% of the treatment group perceived their pain treatment to be successful, while only 69.6% of the control group reported that their pain was reduced successfully by day 7. The results of this study provide an initial proof of concept that epinephrine may have an analgesic effect on the period following third molar surgery. Further research with larger sample sizes is needed to strengthen evidence for the clinical utility of offering localized epinephrine to patients following third molar surgery.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

PubMed

Wong, Connie S

2013-05-01

The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

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).

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2015-01-01

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

Thrombophilia and pregnancy complications: cause or association?

PubMed

Middeldorp, S

2007-07-01

Both acquired and inherited thrombophilia is associated with an increased risk of pregnancy failure (i.e. sporadic and recurrent miscarriage, late fetal loss), as well as hypertensive pregnancy complications such as pre-eclampsia and HELLP syndrome. The question of whether this relationship can be considered causal is rather philosophical. For practical purposes, the consistency and strengths of associations, potential mechanisms and, most importantly, the possibility to intervene with anticoagulants are reviewed. Relevant methodological issues in the case of thrombophilia and pregnancy complications consist of differences between observational and experimental research and quality issues in randomized controlled trials. The mechanisms associating thrombophilia and pregnancy complications are likely to involve effects on trophoblast differentiation rather than mere hypercoagulability. Therapeutic options comprise aspirin as well as (low molecular weight) heparin. For women with antiphospholipid antibody syndrome, this treatment is often suggested although the evidence is limited. For women with inherited thrombophilia and unexplained recurrent pregnancy loss, at present there is no evidence supporting treatment. Observational research is hampered by severe methodological flaws or inconsistent results. Two published randomized trials have not used an adequate comparator (i.e. no treatment or placebo). Currently, randomized controlled trials with no treatment or placebo are being carried out and results should be awaited before implementing a potentially harmful intervention in pregnant women with inherited thrombophilia and a history of pregnancy complications.

Effect of Table Tennis Trainings on Certain Physical and Physiological Parameters in Children Aged 10-12

ERIC Educational Resources Information Center

Tas, Murat; Sinanoglu, Ahmet

2017-01-01

In the research it was aimed to examine the effects of basic table tennis trainings, which were implemented on girls aged 10-12 for 16 weeks, on certain physical and physiological parameters. A total of 40 students, as randomly selected 20 test groups and 20 control groups at an age range of 10-12 participated in the research. These students were…

Hypothermia for neonatal hypoxic-ischemic encephalopathy: NICHD Neonatal Research Network contribution to the field.

PubMed

Shankaran, Seetha; Natarajan, Girija; Chalak, Lina; Pappas, Athina; McDonald, Scott A; Laptook, Abbot R

2016-10-01

In this article, we summarize the NICHD Neonatal Research Network (NRN) trial of whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy in relation to other randomized controlled trials (RCTs) of hypothermia neuroprotection. We describe the NRN secondary studies that have been published in the past 10 years evaluating clinical, genetic, biochemical, and imaging biomarkers of outcome. Copyright © 2016 Elsevier Inc. All rights reserved.

Peer characteristics associated with improved glycemic control in a randomized controlled trial of a reciprocal peer support program for diabetes.

PubMed

Kaselitz, Elizabeth; Shah, Megha; Choi, Hwajung; Heisler, Michele

2018-01-01

Objective In a secondary analysis of a randomized controlled trial of diabetes reciprocal peer support, we examined characteristics of peers associated with improvements in their partner's glycemic control. Methods A total of 102 adults with diabetes were randomized to the reciprocal peer support arm (vs. a nurse care management arm). The primary outcome was change in A1c over six months. Intermediate outcomes were insulin initiation and peer engagement. A number of baseline characteristics of peers were hypothesized to influence outcomes for their peer, and concordant characteristics of peer dyads were hypothesized that would influence outcomes for both peer partners. Results Improvement in A1c was associated with having a peer older than oneself ( P < .05) or with higher diabetes-related distress ( P < .01). Participants with peers who reported poorer health at baseline had worse glycemic control at follow-up ( P < .01). Hypothesized concordant characteristics were not associated with A1c improvements. Participants whose peers had a more controlled self-regulation style were more likely to initiate insulin ( P < .05). Discussion The improved outcomes of peers whose partners were older and reported more diabetes distress at baseline supports the need for further research into the peer characteristics that lead to improved outcomes. This could allow for better matching and more effective partnerships.

The Effect of Teaching Model ‘Learning Cycles 5E’ toward Students’ Achievement in Learning Mathematic at X Years Class SMA Negeri 1 Banuhampu 2013/2014 Academic Year

NASA Astrophysics Data System (ADS)

Yeni, N.; Suryabayu, E. P.; Handayani, T.

2017-02-01

Based on the survey showed that mathematics teacher still dominated in teaching and learning process. The process of learning is centered on the teacher while the students only work based on instructions provided by the teacher without any creativity and activities that stimulate students to explore their potential. Realized the problem above the writer interested in finding the solution by applying teaching model ‘Learning Cycles 5E’. The purpose of his research is to know whether teaching model ‘Learning Cycles 5E’ is better than conventional teaching in teaching mathematic. The type of the research is quasi experiment by Randomized Control test Group Only Design. The population in this research were all X years class students. The sample is chosen randomly after doing normality, homogeneity test and average level of students’ achievement. As the sample of this research was X.7’s class as experiment class used teaching model learning cycles 5E and X.8’s class as control class used conventional teaching. The result showed us that the students achievement in the class that used teaching model ‘Learning Cycles 5E’ is better than the class which did not use the model.

Family nurse practitioner student perception of journal abstract usefulness in clinical decision making: a randomized controlled trial.

PubMed

Johnson, Heather L; Fontelo, Paul; Olsen, Cara H; Jones, Kenneth D; Gimbel, Ronald W

2013-11-01

To assess family nurse practitioner (FNP) student perception of research abstract usefulness in clinical decision making. A randomized controlled trial conducted in a simulated environment with graduate FNP students of the Graduate School of Nursing, Uniformed Services University of the Health Sciences. Given a clinical case study and modified MEDLINE search tool accessible via an iPad device, participants were asked to develop a treatment plan and complete a data collection form. The primary measure was perceived usefulness of the research abstracts in clinical decision making regarding a simulated obese patient seeking to prevent type 2 diabetes. Secondary measures related to participant demographics and accessibility and usefulness of full-text manuscripts. The majority of NP students identified readily available research abstracts as useful in shaping their clinical decision making. The presence or absence of full-text manuscripts associated with the abstracts did not appear to influence the perceived abstract usefulness. The majority of students with full-text manuscript access in the timed simulated clinical encounter read at least one paper, but cited insufficient time to read full-text as a constraint. Research abstracts at point of care may be valuable to FNPs if easily accessible and integrated into clinical workflow. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

Selection of population controls for a Salmonella case-control study in the UK using a market research panel and web-survey provides time and resource savings.

PubMed

Mook, P; Kanagarajah, S; Maguire, H; Adak, G K; Dabrera, G; Waldram, A; Freeman, R; Charlett, A; Oliver, I

2016-04-01

Timely recruitment of population controls in infectious disease outbreak investigations is challenging. We evaluated the timeliness and cost of using a market research panel as a sampling frame for recruiting controls in a case-control study during an outbreak of Salmonella Mikawasima in the UK in 2013. We deployed a web-survey by email to targeted members of a market research panel (panel controls) in parallel to the outbreak control team interviewing randomly selected public health staff by telephone and completing paper-based questionnaires (staff controls). Recruitment and completion of exposure history web-surveys for panel controls (n = 123) took 14 h compared to 15 days for staff controls (n = 82). The average staff-time cost per questionnaire for staff controls was £13·13 compared to an invoiced cost of £3·60 per panel control. Differences in the distribution of some exposures existed between these control groups but case-control studies using each group found that illness was associated with consumption of chicken outside of the home and chicken from local butchers. Recruiting market research panel controls offers time and resource savings. More rapid investigations would enable more prompt implementation of control measures. We recommend that this method of recruiting controls is considered in future investigations and assessed further to better understand strengths and limitations.

Economic evaluations and their use in infection prevention and control: a narrative review.

PubMed

Rennert-May, Elissa; Conly, John; Leal, Jenine; Smith, Stephanie; Manns, Braden

2018-01-01

The objective of this review is to provide a comprehensive overview of the different types of economic evaluations that can be utilized by Infection Prevention and Control practitioners with a particular focus on the use of the quality adjusted life year, and its associated challenges. We also highlight existing economic evaluations published within Infection Prevention and Control, research gaps and future directions. Narrative Review. To date the majority of economic evaluations within Infection Prevention and Control are considered partial economic evaluations. Acknowledging the challenges, which include variable utilities within infection prevention and control, a lack of randomized controlled trials, and difficulty in modelling infectious diseases in general, future economic evaluation studies should strive to be consistent with published guidelines for economic evaluations. This includes the use of quality adjusted life years. Further research is required to estimate utility scores of relevance within Infection Prevention and Control.

Methodological Characteristics and Future Directions for Plyometric Jump Training Research: A Scoping Review.

PubMed

Ramirez-Campillo, Rodrigo; Álvarez, Cristian; García-Hermoso, Antonio; Ramírez-Vélez, Robinson; Gentil, Paulo; Asadi, Abbas; Chaabene, Helmi; Moran, Jason; Meylan, Cesar; García-de-Alcaraz, Antonio; Sanchez-Sanchez, Javier; Nakamura, Fabio Y; Granacher, Urs; Kraemer, William; Izquierdo, Mikel

2018-05-01

Recently, there has been a proliferation of published articles on the effect of plyometric jump training, including several review articles and meta-analyses. However, these types of research articles are generally of narrow scope. Furthermore, methodological limitations among studies (e.g., a lack of active/passive control groups) prevent the generalization of results, and these factors need to be addressed by researchers. On that basis, the aims of this scoping review were to (1) characterize the main elements of plyometric jump training studies (e.g., training protocols) and (2) provide future directions for research. From 648 potentially relevant articles, 242 were eligible for inclusion in this review. The main issues identified related to an insufficient number of studies conducted in females, youths, and individual sports (~ 24.0, ~ 37.0, and ~ 12.0% of overall studies, respectively); insufficient reporting of effect size values and training prescription (~ 34.0 and ~ 55.0% of overall studies, respectively); and studies missing an active/passive control group and randomization (~ 40.0 and ~ 20.0% of overall studies, respectively). Furthermore, plyometric jump training was often combined with other training methods and added to participants' daily training routines (~ 47.0 and ~ 39.0% of overall studies, respectively), thus distorting conclusions on its independent effects. Additionally, most studies lasted no longer than 7 weeks. In future, researchers are advised to conduct plyometric training studies of high methodological quality (e.g., randomized controlled trials). More research is needed in females, youth, and individual sports. Finally, the identification of specific dose-response relationships following plyometric training is needed to specifically tailor intervention programs, particularly in the long term.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

System impact research – increasing public health and health care system performance

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background Interventions directed to system features of public health and health care should increase health and welfare of patients and population. Aims To build a new framework for studies aiming to assess the impact of public health or health care system, and to consider the role of Randomized Controlled Trials (RCTs) and of Benchmarking Controlled Trials (BCTs). Methods The new concept is partly based on the author's previous paper on the Benchmarking Controlled Trial. The validity and generalizability considerations were based on previous methodological studies on RCTs and BCTs. Results The new concept System Impact Research (SIR) covers all the studies which aim to assess the impact of the public health system or of the health care system on patients or on population. There are two kinds of studies in System Impact Research: Benchmarking Controlled Trials (observational) and Randomized Controlled Trials (experimental). The term impact covers in particular accessibility, quality, effectiveness, safety, efficiency, and equality. Conclusions System Impact Research – creating the scientific basis for policy decision making - should be given a high priority in medical, public health and health economic research, and should also be used for improving performance. Leaders at all levels of health and social care can use the evidence from System Impact Research for the benefit of patients and population.Key messagesThe new concept of SIR is defined as a research field aiming at assessing the impacts on patients and on populations of features of public health and health and social care systems or of interventions trying to change these features.SIR covers all features of public health and health and social care system, and actions upon these features. The term impact refers to all effects caused by the public health and health and social care system or parts of it, with particular emphasis on accessibility, quality, effectiveness, adverse effects, efficiency, and equality of services.SIR creates the scientific basis for policy decisions. Leaders at all levels of health and social care can use the evidence from SIR for the benefit of the patients and the population. PMID:26977939

System impact research - increasing public health and health care system performance.

PubMed

Malmivaara, Antti

2016-01-01

Interventions directed to system features of public health and health care should increase health and welfare of patients and population. To build a new framework for studies aiming to assess the impact of public health or health care system, and to consider the role of Randomized Controlled Trials (RCTs) and of Benchmarking Controlled Trials (BCTs). The new concept is partly based on the author's previous paper on the Benchmarking Controlled Trial. The validity and generalizability considerations were based on previous methodological studies on RCTs and BCTs. The new concept System Impact Research (SIR) covers all the studies which aim to assess the impact of the public health system or of the health care system on patients or on population. There are two kinds of studies in System Impact Research: Benchmarking Controlled Trials (observational) and Randomized Controlled Trials (experimental). The term impact covers in particular accessibility, quality, effectiveness, safety, efficiency, and equality. System Impact Research - creating the scientific basis for policy decision making - should be given a high priority in medical, public health and health economic research, and should also be used for improving performance. Leaders at all levels of health and social care can use the evidence from System Impact Research for the benefit of patients and population. Key messages The new concept of SIR is defined as a research field aiming at assessing the impacts on patients and on populations of features of public health and health and social care systems or of interventions trying to change these features. SIR covers all features of public health and health and social care system, and actions upon these features. The term impact refers to all effects caused by the public health and health and social care system or parts of it, with particular emphasis on accessibility, quality, effectiveness, adverse effects, efficiency, and equality of services. SIR creates the scientific basis for policy decisions. Leaders at all levels of health and social care can use the evidence from SIR for the benefit of the patients and the population.

Size of Coarse Woody Debris 5 Years After Girdling and Removal Treatments in 50-Year-Old Loblolly Pine Plantations

Treesearch

M. Boyd Edwards

2004-01-01

In 1996, a study began at Savannah River Site to investigate large-scale replicated forest areas to control coarse woody debris for integrated biodiversity objectives. Research design was a randomized complete block with four treatments replicated in four blocks, resulting in 16 plots. The treatments applied to 50-year-old loblolly pine stands were (1) control, (2)...

Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

PubMed

Schmidt, Jennifer; Martin, Alexandra

2015-12-01

Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p < .01; r > .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

78 FR 24423 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-25

... an experimental research design. Program applicants who are eligible for CSPED services will be randomly assigned to either a program group that is offered program services or a control group that is not...) conducting focus groups with program participants to elicit participation experiences; (3) administering a...

Methodological Issues in Research on Web-Based Behavioral Interventions

PubMed Central

Danaher, Brian G; Seeley, John R

2013-01-01

Background Web-based behavioral intervention research is rapidly growing. Purpose We review methodological issues shared across Web-based intervention research to help inform future research in this area. Methods We examine measures and their interpretation using exemplar studies and our research. Results We report on research designs used to evaluate Web-based interventions and recommend newer, blended designs. We review and critique methodological issues associated with recruitment, engagement, and social validity. Conclusions We suggest that there is value to viewing this burgeoning realm of research from the broader context of behavior change research. We conclude that many studies use blended research designs, that innovative mantling designs such as the Multiphase Optimization Strategy and Sequential Multiple Assignment Randomized Trial methods hold considerable promise and should be used more widely, and that Web-based controls should be used instead of usual care or no-treatment controls in public health research. We recommend topics for future research that address participant recruitment, engagement, and social validity. PMID:19806416

Xuebijing in the treatment of patients with sepsis.

PubMed

Shi, Heng; Hong, Yun; Qian, Jianfang; Cai, Xiaofang; Chen, Shanwen

2017-02-01

There are more than 18 million patients diagnosed with sepsis every year. In China, Xuebijing (XBJ) injection is a traditional medicine that is widely used in the treatment of sepsis. However, the efficacy of XBJ in treatment of randomized controlled trials (RCTs) remains unclear. This meta-analysis was to evaluate the clinical efficacy of XBJ based on randomized case-control studies. PubMed, Cochrane, Embase, Wanfang, CNKI, and WeiPu (VIP) databases were searched to identify all the relative randomized case-control. The latest research was done in June, 2016. Relative risks (RR), weighted mean difference (WMD) along with 95% confidence interval (95%CI) were used to analyze the main outcomes. Statistical analysis was performed using STATA 10.0 (TX, USA). The qualities of the involved articles were accessed by the Jadad scale. Forty-nine randomized case-control studies met the inclusion and exclusion criteria, with 1861 patients in the control group and 2023 patients in the XBJ group. Compared with the conventional therapy, XBJ injection could significantly reduce the APACHE-IIscore (WMD: -3.70, 95%CI: -4.31-[-3.09]), PCT (WMD: -1.26μg/L, 95%CI: -1.63μg/L-[-0.88μg/L]), WBC (WMD: -1.48×10 9 /L, 95%CI: -2.03×10 9 /L-[-0.94×10 9 /L]), CRP (WMD: -24.38mg/L, 95%CI:-30.49mg/L-[-18.26mg/L]), NEU (WMD: -4.68, 95%CI: -8.32-[-1.04]), T 0 (WMD: -0.50, 95%CI: -0.92-[-0.07]). The 28-day mortality of the XBJ group was significantly lower than the control group (RR: 0.51; 95%CI: 0.44-0.59). XBJ injection has a significant clinical efficacy in the therapy of patients with sepsis. However, there is a need for more randomized, lager-sample size, high-quality, and multicenter studies to confirm the extract efficacy of XBJ injection. Copyright © 2016 Elsevier Inc. All rights reserved.

Two Randomized Controlled Pilot Trials of Social Forces to Improve Statin Adherence among Patients with Diabetes.

PubMed

Reese, Peter P; Kessler, Judd B; Doshi, Jalpa A; Friedman, Joelle; Mussell, Adam S; Carney, Caroline; Zhu, Jingsan; Wang, Wenli; Troxel, Andrea; Young, Peinie; Lawnicki, Victor; Rajpathak, Swapnil; Volpp, Kevin

2016-04-01

Medication nonadherence is an important obstacle to cardiovascular disease management. To improve adherence through real-time feedback based on theories of how social forces influence behavior. Two randomized controlled pilot trials called PROMOTE and SUPPORT. Participants stored statin medication in wireless-enabled pill bottles that transmitted adherence data to researchers. Adults with diabetes and a history of low statin adherence based on pharmacy refills (i.e., Medication Possession Ratio [MPR] <80% in the pre-randomization screening period). In PROMOTE, each participant was randomized to 1) weekly messages in which that participant's statin adherence was compared to that of other participants (comparison), 2) weekly summaries of that participant's statin adherence (summary), or 3) control. In SUPPORT, each participant identified another person (the Medication Adherence Partner [MAP]) to receive reports about that participant's adherence, and was randomized to 1) daily reports to MAP, 2) weekly reports to MAP, 3) reports to MAP only if dose was missed, or 4) control. Adherence measured by pill bottle. Among 45,000 health plan members contacted by mail, <1% joined the trial. Participants had low baseline MPRs (median = 60%, IQR 41-72%) but high pill-bottle adherence (90% in PROMOTE, 92% in SUPPORT) during the trial. In PROMOTE (n = 201) and SUPPORT (n = 200), no intervention demonstrated significantly better adherence vs. In a subgroup of PROMOTE participants with the lowest pre-study MPR, pill-bottle-measured adherence in the comparison arm (89%) was higher than the control (86%) and summary (76%) arms, but differences were non-significant (p = 0.10). Interventions based on social forces did not improve medication adherence vs. control over a 3-month period. Given the low percentage of invited individuals who enrolled, the studies may have attracted participants who required little encouragement to improve adherence other than study participation.

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

PubMed

Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

2014-11-20

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities. http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Construction of databases: advances and significance in clinical research.

PubMed

Long, Erping; Huang, Bingjie; Wang, Liming; Lin, Xiaoyu; Lin, Haotian

2015-12-01

Widely used in clinical research, the database is a new type of data management automation technology and the most efficient tool for data management. In this article, we first explain some basic concepts, such as the definition, classification, and establishment of databases. Afterward, the workflow for establishing databases, inputting data, verifying data, and managing databases is presented. Meanwhile, by discussing the application of databases in clinical research, we illuminate the important role of databases in clinical research practice. Lastly, we introduce the reanalysis of randomized controlled trials (RCTs) and cloud computing techniques, showing the most recent advancements of databases in clinical research.

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

PubMed

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

2015-08-01

Research has shown that orthodontic patients are more likely to retain information presented in an audiovisual format. However, there has been little research on the effectiveness of audiovisual information provided through different routes such as the Internet. This parallel-group randomized controlled trial assessed whether provision of audiovisual information on the YouTube (Google, San Bruno, Calif) Web site to orthodontic patients undergoing fixed appliance treatment results in improved patient knowledge when compared with conventional methods of information provision. The effects of sex and ethnicity were also investigated. Participants were recruited from the Department of Orthodontics of the Eastman Dental Hospital, University College London Hospitals NHS Foundation Trust, United Kingdom. The patients were 13 years of age and over, with no history of orthodontic treatment, and patient and parental (where appropriate) consent were obtained. The participants were randomized into control (n = 34) and intervention (n = 33) groups using a random number table; there was stratification based on age group, with permuted blocks of 10 patients. Both groups were given routine verbal and written patient information related to fixed appliances, and the participants in the intervention group were sent 3 e-mails over 6 weeks requesting that they view a 6-minute YouTube video containing similar information but in audiovisual format. Patient knowledge was measured using identical questionnaires answered on the day of recruitment (baseline) and again 6 to 8 weeks later. The researchers were unaware of group allocations when enrolling patients and scoring questionnaires. Sixty participants (89.55%) completed the study. Those who completed the trial in the intervention group (n = 30) demonstrated significantly greater improvements in knowledge than did those in the control group (n = 30), scoring, on average, almost 1 point more (95% CI for the difference, 0.305-1.602; P = 0.005) on the final questionnaire. Ethnicity had a statistically significant effect on improvement in knowledge, but sex did not. No harm to any patient was noted during the trial. Presenting audiovisual information through the YouTube Web site to orthodontic patients resulted in a significant improvement in patient knowledge. Supplementation of verbal and written patient information with audiovisual information via the Internet is therefore worthy of consideration. National Research and Ethics Service (REC number 12/LO/0863), United Kingdom. The protocol was not published before trial commencement. No funding or conflict of interest to be declared. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Cognitive Behavioral Therapy for Insomnia in Posttraumatic Stress Disorder: A Randomized Controlled Trial

PubMed Central

Talbot, Lisa S.; Maguen, Shira; Metzler, Thomas J.; Schmitz, Martha; McCaslin, Shannon E.; Richards, Anne; Perlis, Michael L.; Posner, Donn A.; Weiss, Brandon; Ruoff, Leslie; Varbel, Jonathan; Neylan, Thomas C.

2014-01-01

Study Objectives: Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning. Design: Randomized controlled trial with two arms: CBT-I and monitor-only waitlist control. Setting: Department of Veterans Affairs (VA) Medical Center. Participants: Forty-five adults (31 females: [mean age 37 y (22-59 y)] with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females). Interventions: Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist. Measurements and Results: Measures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares. Conclusions: Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine. Clinical Trial Information: Trial Name: Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder. URL: http://clinicaltrials.gov/ct2/show/NCT00881647. Registration Number: NCT00881647. Citation: Talbot LS; Maguen S; Metzler TJ; Schmitz M; McCaslin SE; Richards A; Perlis ML; Posner DA; Weiss B; Ruoff L; Varbel J; Neylan TC. Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. SLEEP 2014;37(2):327-341. PMID:24497661

Racial Variation in Treatment Preferences and Willingness to Randomize in the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Arega, Addisalem; Birkmeyer, Nancy J. O.; Lurie, Jon D. N.; Tosteson, Tor; Gibson, Jennifer; Taylor, Brett; Weinstein, James N.

2009-01-01

Study Design Analysis of baseline data for patients enrolled in SPORT, a project conducting three randomized and three observational cohort studies of surgical and non-operative treatments for intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). Objective To explore racial variation in treatment preferences and willingness to be randomized. Summary of Background Data Increasing minority participation in research has been a priority at the NIH. Prior studies have documented lower rates of participation in research and preferences for invasive treatment among African Americans. Methods Patients enrolled in SPORT (March 2000-February 2005) that reported data on their race (n=2323) were classified as White (87%), Black (8%) or Other (5%). Treatment preferences (non-operative, unsure, surgical), and willingness to be randomized were compared among these groups while controlling for baseline differences using multivariate logistic regression. Results There were numerous significant differences in baseline characteristics among the racial groups. Following adjustment for these differences, Blacks remained less likely to prefer surgical treatment among both IDH (White: 55%, Black: 37%, Other: 55%, p=0.023) and SpS/DS (White: 46%, Black: 30%, Other: 43%, p=0.017) patients. Higher randomization rates among Black IDH patients (46% vs. 30%) were no longer significant following adjustment (OR=1.45, p=0.235). Treatment preference remained a strong independent predictor of randomization in multivariate analyses for both IDH (unsure OR = 3.88, p<0.001 and surgical OR=0.23, p<0.001) and SpS/DS (unsure OR = 6.93, p<0.001 and surgical OR= 0.45, p<0.001) patients. Conclusions Similar to prior studies, Black participants were less likely than Whites or Others to prefer surgical treatment; however, they were no less likely to agree to be randomized. Treatment preferences were strongly related to both race and willingness to be randomized. PMID:16946665

Exploring the Benefits of Respite Services to Family Caregivers: Methodological Issues and Current Findings

PubMed Central

Zarit, Steven H.; Liu, Yin; Bangerter, Lauren R.; Rovine, Michael J.

2017-01-01

Objectives There is growing emphasis on empirical validation of the efficacy of community-based services for older people and their families, but research on services such as respite care faces methodological challenges that have limited the growth of outcome studies. We identify problems associated with the usual research approaches for studying respite care, with the goal of stimulating use of novel and more appropriate research designs that can lead to improved studies of community-based services. Method Using the concept of research validity, we evaluate the methodological approaches in the current literature on respite services, including adult day services, in-home respite and overnight respite. Results Although randomized control trials (RCTs) are possible in community settings, validity is compromised by practical limitations of randomization and other problems. Quasi-experimental and interrupted time series designs offer comparable validity to RCTs and can be implemented effectively in community settings. Conclusion An emphasis on RCTs by funders and researchers is not supported by scientific evidence. Alternative designs can lead to development of a valid body of research on community services such as respite. PMID:26729467

Exploring the benefits of respite services to family caregivers: methodological issues and current findings.

PubMed

Zarit, Steven H; Bangerter, Lauren R; Liu, Yin; Rovine, Michael J

2017-03-01

There is growing emphasis on empirical validation of the efficacy of community-based services for older people and their families, but research on services such as respite care faces methodological challenges that have limited the growth of outcome studies. We identify problems associated with the usual research approaches for studying respite care, with the goal of stimulating use of novel and more appropriate research designs that can lead to improved studies of community-based services. Using the concept of research validity, we evaluate the methodological approaches in the current literature on respite services, including adult day services, in-home respite and overnight respite. Although randomized control trials (RCTs) are possible in community settings, validity is compromised by practical limitations of randomization and other problems. Quasi-experimental and interrupted time series designs offer comparable validity to RCTs and can be implemented effectively in community settings. An emphasis on RCTs by funders and researchers is not supported by scientific evidence. Alternative designs can lead to development of a valid body of research on community services such as respite.

Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

PubMed Central

Côté, José

2016-01-01

Background Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes. Objective This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes. Methods A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period. Results The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites. Conclusions By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical activity promotion in adult populations with type 2 diabetes. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r) PMID:26869015

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

The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial.

PubMed

Freeman, Daniel; Startup, Helen; Myers, Elissa; Harvey, Allison; Geddes, John; Yu, Ly-Mee; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Lister, Rachel

2013-07-11

Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation. We will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014. This will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations. Current Controlled Trials ISRCTN 33695128.

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

PubMed

Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

2018-02-27

Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

Performance of time-varying predictors in multilevel models under an assumption of fixed or random effects.

PubMed

Baird, Rachel; Maxwell, Scott E

2016-06-01

Time-varying predictors in multilevel models are a useful tool for longitudinal research, whether they are the research variable of interest or they are controlling for variance to allow greater power for other variables. However, standard recommendations to fix the effect of time-varying predictors may make an assumption that is unlikely to hold in reality and may influence results. A simulation study illustrates that treating the time-varying predictor as fixed may allow analyses to converge, but the analyses have poor coverage of the true fixed effect when the time-varying predictor has a random effect in reality. A second simulation study shows that treating the time-varying predictor as random may have poor convergence, except when allowing negative variance estimates. Although negative variance estimates are uninterpretable, results of the simulation show that estimates of the fixed effect of the time-varying predictor are as accurate for these cases as for cases with positive variance estimates, and that treating the time-varying predictor as random and allowing negative variance estimates performs well whether the time-varying predictor is fixed or random in reality. Because of the difficulty of interpreting negative variance estimates, 2 procedures are suggested for selection between fixed-effect and random-effect models: comparing between fixed-effect and constrained random-effect models with a likelihood ratio test or fitting a fixed-effect model when an unconstrained random-effect model produces negative variance estimates. The performance of these 2 procedures is compared. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

PubMed Central

Synnot, Anneliese; Maas, Andrew I.; Menon, David K.; Cooper, D. James; Rosenfeld, Jeffrey V.; Gruen, Russell L.

2016-01-01

Abstract Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative effectiveness research and precision medicine, are needed to fully realize the potential of acute TBI research to benefit patients. PMID:26711675

Efficacy and safety of Vernonia cinerea (L.) Less. for smoking cessation: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Puttarak, Panupong; Pornpanyanukul, Patarachai; Meetam, Thunyaluk; Bunditanukul, Katha; Chaiyakunapruk, Nathorn

2018-04-01

Several randomized controlled trials have investigated Vernonia cinerea (L.) Less. for smoking cessation but there remains no critical summary of overall findings. This study uses systematic review and meta-analysis to summarize the efficacy and safety of V. cinerea. Nine databases were searched through November 2017. Randomized controlled trials that reported the smoking cessation effect of V. cinerea were included. Data were extracted by two independent researchers. Study quality was assessed using the Cochrane risk of bias and JADAD score. The estimates of pooled effects were calculated as relative risk (RR) with 95% CI using a random-effects model. Five trials with 347 smokers were included. V. cinerea treatment group was significantly associated with cessation rate higher than that in the control group with no evidence of heterogeneity for both continuous abstinence rate (CAR) at week 8 with risk ratio (RR): 1.69, 95% CI [1.00, 2.86]; week 12 RR: 2.18, 95% CI [1.17, 4.04]) and 7-day point prevalence abstinence rate (PAR) (week 8 RR: 1.51, 95% CI [1.01, 2.27]; week 12 RR: 1.93, 95% CI [1.24, 2.99]) at week 8 and 12, respectively. There was no significant difference of all adverse events between the treatment and the control groups. Our study demonstrates that V. cinerea has potential efficacy for smoking cessation. Further well-design RCTs of standardized V. cinerea compared with standard treatment should be conducted to strengthen this evidence. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effects of Massage on Blood Pressure in Patients With Hypertension and Prehypertension: A Meta-analysis of Randomized Controlled Trials.

PubMed

Liao, I-Chen; Chen, Shiah-Lian; Wang, Mei-Yeh; Tsai, Pei-Shan

2016-01-01

Massage may help reduce blood pressure; previous studies on the effect of massage on blood pressure have presented conflicting findings. In addition, no systematic review is available. The aim of this study was to evaluate the evidence concerning the effect of massage on blood pressure in patients with hypertension or prehypertension. A search was performed on electronic database records up to October 31, 2013, based on the following medical subject headings or keywords: hypertension, massage, chiropractic, manipulation, and blood pressure. The methodological quality of randomized controlled trials was assessed based on the Cochrane collaboration tool. A meta-analysis was performed to evaluate the effect of massage on hypertension. The study selection, data extraction, and validation were performed independently by 2 reviewers. Nine randomized controlled trials met our inclusion criteria. The results of this study show that massage contributes to significantly enhanced reduction in both systolic blood pressure (SBP) (mean difference, -7.39 mm Hg) and diastolic blood pressure (DBP) (mean difference, -5.04 mm Hg) as compared with control treatments in patients with hypertension and prehypertension. The effect size (Hedges g) for SBP and DBP was -0.728 (95% confidence interval, -1.182 to -0.274; P = .002) and -0.334 (95% confidence interval, -0.560 to -0.107; P = .004), respectively. This systematic review found a medium effect of massage on SBP and a small effect on DBP in patients with hypertension or prehypertension. High-quality randomized controlled trials are urgently required to confirm these results, although the findings of this study can be used to guide future research.

The effect of ginseng (genus Panax) on blood pressure: a systematic review and meta-analysis of randomized controlled clinical trials.

PubMed

Komishon, A M; Shishtar, E; Ha, V; Sievenpiper, J L; de Souza, R J; Jovanovski, E; Ho, H V T; Duvnjak, L S; Vuksan, V

2016-10-01

Pre-clinical evidence indicates the potential for ginseng to reduce cardiovascular disease risk and acutely aid in blood pressure (BP) control. Clinical evidence evaluating repeated ginseng exposure, however, is controversial, triggering consumer and clinician concern. A systematic review and meta-analysis were conducted to assess whether ginseng has an effect on BP. MEDLINE, EMBASE, Cochrane and CINAHL were searched for relevant randomized controlled trials ⩾4 weeks that compared the effect of ginseng on systolic (SBP), diastolic (DBP) and/or mean arterial (MAP) BPs to control. Two independent reviewers extracted data and assessed methodological quality and risk of bias. Data were pooled using random-effects models and expressed as mean differences (MD) with 95% confidence intervals (CIs). Heterogeneity was assessed and quantified. Seventeen studies satisfied eligibility criteria (n=1381). No significant effect of ginseng on SBP, DBP and MAP was found. Stratified analysis, although not significant, appears to favour systolic BP improvement in diabetes, metabolic syndrome and obesity (MD=-2.76 mm Hg (95% CI=-6.40, 0.87); P=0.14). A priori subgroup analyses revealed significant association between body mass index and treatment differences (β=-0.95 mm Hg (95% CI=-1.56, -0.34); P=0.007). Ginseng appears to have neutral vascular affects; therefore, should not be discouraged for concern of increased BP. More high-quality, randomized, controlled trials assessing BP as a primary end point, and use of standardized ginseng root or extracts are warranted to limit evidence of heterogeneity in ginseng research and to better understand its cardiovascular health potential.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up. Trial registration Current Controlled Trials ISRCTN99944116 PMID:23714362

Being bad in a video game can make us more morally sensitive.

PubMed

Grizzard, Matthew; Tamborini, Ron; Lewis, Robert J; Wang, Lu; Prabhu, Sujay

2014-08-01

Several researchers have demonstrated that the virtual behaviors committed in a video game can elicit feelings of guilt. Researchers have proposed that such guilt could have prosocial consequences. However, this proposition has not been supported with empirical evidence. The current study examined this issue in a 2×2 (video game play vs. real world recollection×guilt vs. control) experiment. Participants were first randomly assigned to either play a video game or complete a memory recall task. Next, participants were randomly assigned to either a guilt-inducing condition (game play as a terrorist/recall of acts that induce guilt) or a control condition (game play as a UN soldier/recall of acts that do not induce guilt). Results of the study indicate several important findings. First, the current results replicate previous research indicating that immoral virtual behaviors are capable of eliciting guilt. Second, and more importantly, the guilt elicited by game play led to intuition-specific increases in the salience of violated moral foundations. These findings indicate that committing "immoral" virtual behaviors in a video game can lead to increased moral sensitivity of the player. The potential prosocial benefits of these findings are discussed.

Improving data sharing in research with context-free encoded missing data.

PubMed

Hoevenaar-Blom, Marieke P; Guillemont, Juliette; Ngandu, Tiia; Beishuizen, Cathrien R L; Coley, Nicola; Moll van Charante, Eric P; Andrieu, Sandrine; Kivipelto, Miia; Soininen, Hilkka; Brayne, Carol; Meiller, Yannick; Richard, Edo

2017-01-01

Lack of attention to missing data in research may result in biased results, loss of power and reduced generalizability. Registering reasons for missing values at the time of data collection, or-in the case of sharing existing data-before making data available to other teams, can save time and efforts, improve scientific value and help to prevent erroneous assumptions and biased results. To ensure that encoding of missing data is sufficient to understand the reason why data are missing, it should ideally be context-free. Therefore, 11 context-free codes of missing data were carefully designed based on three completed randomized controlled clinical trials and tested in a new randomized controlled clinical trial by an international team consisting of clinical researchers and epidemiologists with extended experience in designing and conducting trials and an Information System expert. These codes can be divided into missing due to participant and/or participation characteristics (n = 6), missing by design (n = 4), and due to a procedural error (n = 1). Broad implementation of context-free missing data encoding may enhance the possibilities of data sharing and pooling, thus allowing more powerful analyses using existing data.

Assessing Health Promotion Interventions: Limitations of Traditional Research Methods in Community-Based Studies.

PubMed

Dressel, Anne; Schneider, Robert; DeNomie, Melissa; Kusch, Jennifer; Welch, Whitney; Sosa, Mirtha; Yeldell, Sally; Maida, Tatiana; Wineberg, Jessica; Holt, Keith; Bernstein, Rebecca

2017-09-01

Most low-income Americans fail to meet physical activity recommendations. Inactivity and poor diet contribute to obesity, a risk factor for multiple chronic diseases. Health promotion activities have the potential to improve health outcomes for low-income populations. Measuring the effectiveness of these activities, however, can be challenging in community settings. A "Biking for Health" study tested the impact of a bicycling intervention on overweight or obese low-income Latino and African American adults to reduce barriers to cycling and increase physical activity and fitness. A randomized controlled trial was conducted in Milwaukee, Wisconsin, in summer 2015. A 12-week bicycling intervention was implemented at two sites with low-income, overweight, or obese Latino and African American adults. We found that randomized controlled trial methodology was suboptimal for use in this small pilot study and that it negatively affected participation. More discussion is needed about the effectiveness of using traditional research methods in community settings to assess the effectiveness of health promotion interventions. Modifications or alternative methods may yield better results. The aim of this article is to discuss the effectiveness and feasibility of using traditional research methods to assess health promotion interventions in community-based settings.

The effect of problem solving and decision making skills on tendency to depression and anxiety in patients with type 2 diabetes.

PubMed

Abazarian, Elaheh; Baboli, M Teimourzadeh; Abazarian, Elham; Ghashghaei, F Esteki

2015-01-01

Diabetes is the most prevalent disease that has involved 177 million people all over the world and, due to this, these patients suffer from depression and anxiety and they should use special methods for controlling the same. The aim of this research is the study of the effect of problem solving and decision making skill on the rate of the tendency to depression and anxiety. This research is a quasi-experimental (case-control) study. Statistically, the population of the present study was all diabetic patients of Qaemshahr who were controlled by physicians in 2011-2012. Thirty files were selected randomly from them and divided into two 15 patients' groups (control and subject group) randomly. The measurement tools were Back depression inventory (21 items) and Zank anxiety questionnaire that were distributed among two groups. Then, the subject group participated in eight sessions of teaching problem solving and decision making courses separately, and the second group (control group) did not receive any instruction. Finally, both groups had passed post-test and the data obtained from the questionnaires were studied by variance analysis statistical methods. The results showed that teaching problem solving and decision making skills was very effective in reducing diabetic patients' depression and anxiety and resulted in reducing their depression and anxiety.

The effect of problem solving and decision making skills on tendency to depression and anxiety in patients with type 2 diabetes

PubMed Central

Abazarian, Elaheh; Baboli, M Teimourzadeh; Abazarian, Elham; Ghashghaei, F Esteki

2015-01-01

Background: Diabetes is the most prevalent disease that has involved 177 million people all over the world and, due to this, these patients suffer from depression and anxiety and they should use special methods for controlling the same. The aim of this research is the study of the effect of problem solving and decision making skill on the rate of the tendency to depression and anxiety. Materials and Methods: This research is a quasi-experimental (case-control) study. Statistically, the population of the present study was all diabetic patients of Qaemshahr who were controlled by physicians in 2011-2012. Thirty files were selected randomly from them and divided into two 15 patients’ groups (control and subject group) randomly. The measurement tools were Back depression inventory (21 items) and Zank anxiety questionnaire that were distributed among two groups. Then, the subject group participated in eight sessions of teaching problem solving and decision making courses separately, and the second group (control group) did not receive any instruction. Results: Finally, both groups had passed post-test and the data obtained from the questionnaires were studied by variance analysis statistical methods. Conclusion: The results showed that teaching problem solving and decision making skills was very effective in reducing diabetic patients’ depression and anxiety and resulted in reducing their depression and anxiety. PMID:26261814

A single blind randomized control trial on support groups for Chinese persons with mild dementia.

PubMed

Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

2014-01-01

Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

Translational models of infection prevention and control: lessons from studying high risk aging populations.

PubMed

Mody, Lona

2018-06-13

The present review describes our research experiences and efforts in advancing the field of infection prevention and control in nursing facilities including postacute and long-term care settings. There are over two million infections in postacute and long-term care settings each year in the United States and $4 billion in associated costs. To define a target group most amenable to infection prevention and control interventions, we sought to quantify the relation between indwelling device use and microbial colonization in nursing facility patients. Using various methodologies including survey methods, observational epidemiology, randomized controlled studies, and collaboratives, we showed that indwelling device type is related to the site of multidrug-resistant organism (MDRO) colonization; multianatomic site colonization with MDROs is common; community-associated methicillin-resistant Staphylococcus aureus (MRSA) appeared in the nursing facility setting almost immediately following its emergence in acute care; (4) MDRO prevalence and catheter-associated infection rates can be reduced through a multimodal targeted infection prevention intervention; and (5) using a collaborative approach, such an intervention can be successfully scaled up. Our work advances the infection prevention field through translational research utilizing various methodologies, including quantitative and qualitative surveys, patient-oriented randomized controlled trials, and clinical microbiologic and molecular methods. The resulting interventions employ patient-oriented methods to reduce infections and antimicrobial resistance, and with partnerships from major national entities, can be implemented nationally.

The effects of trunk stabilization exercise on bone density after menopause.

PubMed

Kang, Jeong-Il; Jeong, Dae-Keun; Choi, Hyun

2015-12-01

[Purpose] This study examined the effect of low intensity exercise on bone density by conducting trunk stabilization exercise on females after menopause for 24 weeks. [Subjects and Methods] Thirty three female subjects over 47 years old and under the age of 53 were selected and 16 for experimental group and 17 for control group were randomly selected. Experimental group had performed spinal and pelvic stabilization exercise 30 minutes a day, 5times a week, for 24 weeks. Except for the daily life, control group did not participate in any characteristic movement. Bone density of every member in experimental group was measured using average value of bone density of 1st-4th lumbar through quantitative computer tomography. [Results] There was a meaningful difference in only control group about measured value of bone density within each group, experimental and control group, but there was no meaningful difference in measured value of bone density between two groups, experimental group and control group. [Conclusion] Through this research, we could see the fact that although trunk stability exercise could not change bone density meaningfully, it could maintain bone density. In the future, it is randomly necessary to study things related this because results of researches can show different results according to exercise intensity, exercise period, age, weight, hormone status and mediation period. It is considered that it will help to prevent and treat patients with osteoporosis a lot.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

PubMed

Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

2013-02-01

Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

PubMed Central

2013-01-01

Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate. PMID:23368699

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

PubMed Central

Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

2009-01-01

Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

The clinical application of teaching people about pain.

PubMed

Louw, Adriaan; Zimney, Kory; O'Hotto, Christine; Hilton, Sandra

2016-07-01

Teaching people about the neurobiology and neurophysiology of their pain experience has a therapeutic effect and has been referred to as pain neuroscience education (PNE). Various high-quality randomized controlled trials and systematic reviews have shown increasing efficacy of PNE decreasing pain, disability, pain catastrophization, movement restrictions, and healthcare utilization. Research studies, however, by virtue of their design, are very controlled environments and, therefore, in contrast to the ever-increasing evidence for PNE, little is known about the clinical application of this emerging therapy. In contrast, case studies, case series, and expert opinion and perspectives by authorities in the world of pain science provide clinicians with a glimpse into potential "real" clinical application of PNE in the face of the ever-increasing chronic pain epidemic. By taking the material from the randomized controlled trials, systematic reviews, case series, case studies, and expert opinion, this article aims to provide a proposed layout of the clinical application of PNE. The article systematically discusses key elements of PNE including examination, educational content, and delivery methods, merging of PNE with movement, goal setting, and progression. This perspectives article concludes with a call for research into the clinical application of PNE.

Effect of pravastatin on survival in patients with advanced hepatocellular carcinoma. A randomized controlled trial

PubMed Central

Kawata, S; Yamasaki, E; Nagase, T; Inui, Y; Ito, N; Matsuda, Y; Inada, M; Tamura, S; Noda, S; Imai, Y; Matsuzawa, Y

2001-01-01

Chemotherapy is not effective for hepatocellular carcinoma (HCC). HMG-CoA redutase inhibitors have cytostatic activity for cancer cells, but their clinical usefulness is unknown. To investigate whether pravastatin, a potent HMG-CoA reductase inhibitor, prolongs survival in patients with advanced HCC, this randomized controlled trial was conducted between February 1990 and February 1998 at Osaka University Hospital. 91 consecutive patients <71 years old (mean age 62) with unresectable HCC were enroled in this study. 8 patients were withdrawn because of progressive liver dysfunction; 83 patients were randomized to standard treatment with or without pravastatin. All patients underwent transcatheter arterial embolization (TAE) followed by oral 5-FU 200 mg−1d for 2 months. Patients were then randomly assigned to control (n = 42) and pravastatin (n = 41) groups. Pravastatin was administered at a daily dose of 40 mg. The effect of pravastatin on tumour growth was assessed by ultrasonography. Primary endpoint was death due to progression of HCC. The duration of pravastatin administration was 16.5 ± 9.8 months (mean ± SD). No patients in either group were lost to follow-up. Median survival was 18 months in the pravastatin group versus 9 months in controls (P = 0.006). The Cox proportional hazards model showed that pravastatin was a significant factor contributing to survival. Pravastatin prolonged the survival of patients with advanced HCC, suggesting its value for adjuvant treatment. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11286466

Gel of chamomile vs. urea cream to prevent acute radiation dermatitis in patients with head and neck cancer: a randomized controlled trial.

PubMed

Ferreira, Elaine Barros; Ciol, Marcia A; Vasques, Christiane Inocêncio; Bontempo, Priscila de Souza Maggi; Vieira, Nayara Narley Pires; Silva, Luis Felipe Oliveira E; Avelino, Samuel Ramalho; Dos Santos, Marcos Antônio; Dos Reis, Paula Elaine Diniz

2016-08-01

To compare a gel made with chamomile (Chamomilla recutita) with a cream of urea as an intervention to delay the time to occurrence of radiation dermatitis. Radiation dermatitis is one of the most common adverse effects of radiotherapy in patients with head and neck cancer. It is characterized by erythema, itching, pain, skin breakage and burning sensation, and there is no consensus on how to prevent it. The study is a randomized controlled clinical trial. We will recruit 48 individuals with head and neck cancer who will be starting their radiotherapy and randomize them to receive either gel of chamomile or cream of urea, as an intervention for prevention of radiation dermatitis. Social-demographic data will be collected at baseline, and clinical data will be collected before the initiation of radiotherapy. Participants will be followed weekly to assess development of radiation dermatitis. The protocol is funded by Conselho Nacional de Pesquisa e Desenvolvimento Científico (Brazil). The study was approved by a research ethics committee. Given the clinical relevance of preventing radiation dermatitis and the lack of evidence supporting specific preventive interventions, it is important to study new products that might be efficacious to prevent this complication. This article presents the protocol of a randomized controlled trial comparing a gel made with chamomile (intervention) with a cream of urea (control) to prevent radiation dermatitis in patients with head and neck cancer undergoing radiotherapy. © 2016 John Wiley & Sons Ltd.

Complementary physical therapies for movement disorders in Parkinson's disease: a systematic review.

PubMed

Alves Da Rocha, P; McClelland, J; Morris, M E

2015-12-01

The growth and popularity of complementary physical therapies for Parkinson's disease (PD) attempt to fill the gap left by conventional exercises, which does not always directly target wellbeing, enjoyment and social participation. To evaluate the effects of complementary physical therapies on motor performance, quality of life and falls in people living with PD. Systematic review with meta-analysis. Outpatients--adults diagnosed with idiopathic PD, male or female, modified Hoehn and Yahr scale I-IV, any duration of PD, any duration of physical treatment or exercise. Randomized controlled trials, non-randomized controlled trials and case series studies were identified by systematic searching of health and rehabilitation electronic databases. A standardized form was used to extract key data from studies by two independent researchers. 1210 participants from 20 randomized controlled trials, two non-randomized controlled trials and 13 case series studies were included. Most studies had moderately strong methodological quality. Dancing, water exercises and robotic gait training were an effective adjunct to medical management for some people living with PD. Virtual reality training, mental practice, aerobic training, boxing and Nordic walking training had a small amount of evidence supporting their use in PD. On balance, alternative physical therapies are worthy of consideration when selecting treatment options for people with this common chronic disease. Complementary physical therapies such as dancing, hydrotherapy and robotic gait training appear to afford therapeutic benefits, increasing mobility and quality of life, in some people living with PD.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients.

PubMed

Krieger, Janice L; Neil, Jordan M; Strekalova, Yulia A; Sarge, Melanie A

2017-03-01

Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. © The Author 2016. Published by Oxford University Press.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients

PubMed Central

Neil, Jordan M.; Strekalova, Yulia A.; Sarge, Melanie A.

2017-01-01

Abstract Background: Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Methods: Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Results: Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). Conclusions: The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. PMID:27794035

HYPERTENSION IMPROVEMENT PROJECT (HIP): RANDOMIZED TRIAL OF QUALITY IMPROVEMENT FOR PHYSICIANS AND LIFESTYLE MODIFICATION FOR PATIENTS

PubMed Central

Svetkey, Laura P.; Pollak, Kathryn I.; Yancy, William S.; Dolor, Rowena J.; Batch, Bryan C.; Samsa, Greg; Matchar, David B.; Lin, Pao-Hwa

2009-01-01

Despite widely publicized hypertension treatment guidelines for physicians and lifestyle recommendations for patients, blood pressure control rates remain low. In community-based primary care clinics, we performed a nested, 2×2 randomized, controlled trial of physician intervention vs. control and/or patient intervention vs. control. Physician Intervention included internet-based training, self-monitoring, and quarterly feedback reports. Patient Intervention included 20 weekly group sessions followed by 12 monthly phone counseling contacts, and focused on weight loss, DASH dietary pattern, exercise, and reduced sodium intake. The primary outcome was change in systolic blood pressure at 6 months. Eight primary care practices (32 physicians) were randomized to Physician Intervention or Control. Within those practices, 574 patients were randomized to Patient Intervention or Control. Patients’ mean age was 60 years, 61% female, 37% African American. BP data were available for 91% of patients at 6 months. The main effect of Physician Intervention on systolic blood pressure at 6 months, adjusted for baseline pressure, was 0.3 mmHg (95% CI −1.5 to 2.2; p = 0.72). The main effect of the Patient Intervention was −2.6 mmHg (95% CI −4.4, −0.7; p = 0.01). The interaction of the 2 interventions was significant (p = 0.03); the largest impact was observed with the combination of Physician and Patient Intervention (−9.7 ± 12.7 mmHg). Differences between treatment groups did not persist at 18 months. Combined physician and patient intervention lowers blood pressure; future research should focus on enhancing effectiveness and sustainability of these interventions. PMID:19920081

Prevalence of binge and loss of control eating among children and adolescents with overweight and obesity: An exploratory meta-analysis.

PubMed

He, Jinbo; Cai, Zhihui; Fan, Xitao

2017-02-01

Due to the inconsistency of the research findings in the current literature, the prevalence of binge and loss of control (LOC) eating among children and adolescents with overweight and obesity remains unclear. By using the meta-analytic approach, this article aimed at exploring the prevalence of binge/LOC eating among children and adolescents with overweight and obesity, and at identifying potential moderators, which may have contributed to the heterogeneity of the existing research findings. Four electronic databases (PubMed, Web of Science, EBSCOhost, and ProQuest Dissertations & Theses Global) were searched. The search period covered the research literature up to April 2016. A random-effects meta-analysis model was used to estimate the overall prevalence. Weighted random-effects model ANOVAs and univariate random-effects meta-regression were applied for the analysis of categorical moderators and continuous moderators, respectively. Thirty-six studies were identified. The overall prevalence of binge/LOC eating was estimated to be 26.3% (95% CI: 23.1-29.7%), with 22.2% (95% CI: 18.6-26.3%) and 31.2% (95% CI: 26.1-36.9%) for binge eating and LOC eating, respectively. Treatment status, binge eating vs. LOC eating and assessment methods appeared to be associated with the inconsistencies of the prevalence rates across the studies. The findings of this meta-analysis indicated that binge/LOC eating was prevalent among more than one quarter of children and adolescents with overweight and obesity. Considering the close relationship between disordered eating behaviors and obesity, future research concerning overweight and obesity among children and adolescents needs to take binge/LOC eating into consideration. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:91-103). © 2016 Wiley Periodicals, Inc.

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

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).

Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial.

PubMed

Talbot, Lisa S; Maguen, Shira; Metzler, Thomas J; Schmitz, Martha; McCaslin, Shannon E; Richards, Anne; Perlis, Michael L; Posner, Donn A; Weiss, Brandon; Ruoff, Leslie; Varbel, Jonathan; Neylan, Thomas C

2014-02-01

Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning. RANDOMIZED CONTROLLED TRIAL WITH TWO ARMS: CBT-I and monitor-only waitlist control. Department of Veterans Affairs (VA) Medical Center. Forty-five adults (31 females: [mean age 37 y (22-59 y)] with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females). Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist. Measures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares. Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress disorder should include behavioral sleep medicine. TRIAL NAME: Cognitive Behavioral Treatment Of Insomnia In Posttraumatic Stress Disorder. URL: http://clinicaltrials.gov/ct2/show/NCT00881647. NCT00881647.

A Randomized Controlled Trial of Students for Nutrition and eXercise (SNaX): A Community-Based Participatory Research Study

PubMed Central

Bogart, Laura M.; Cowgill, Burton O.; Elliott, Marc N.; Klein, David J.; Hawes-Dawson, Jennifer; Uyeda, Kimberly; Elijah, Jacinta; Binkle, David G.; Schuster, Mark A.

2014-01-01

Purpose To conduct a randomized controlled trial of Students for Nutrition and eXercise (SNaX), a 5-week middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education. Methods We randomly selected schools (five intervention, five wait-list control) from the Los Angeles Unified School District. School records were obtained for number of fruits and vegetables served, students served lunch, and snacks sold per attending student, representing an average of 1,515 students (SD=323) per intervention school and 1,524 students (SD=266) per control school. A total of 2,997 seventh-graders (75% of seventh-graders across schools) completed pre-and post-intervention surveys assessing psychosocial variables. Consistent with community-based participatory research principles, the school district was an equal partner and a community advisory board provided critical input. Results Relative to control schools, intervention schools showed significant increases in the proportion of students served fruit and lunch and a significant decrease in proportion of students buying snacks at school. Specifically, the intervention was associated with relative increases of 15.3% more fruit served (p=0.006), 10.4% more lunches served (p<0.001), and 11.9% fewer snacks sold (p<0.001) than would have been expected in its absence. Pre-to-post intervention, intervention school students reported more positive attitudes about cafeteria food (p=0.02) and tap water (p=0.03), greater obesity-prevention knowledge (p=0.006), increased intentions to drink water from the tap (p=0.04) or a refillable bottle (p=0.02), and greater tap water consumption (p=0.04) compared to control school students. Conclusions Multi-level school-based interventions may promote healthy adolescent dietary behaviors. PMID:24784545

Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

PubMed

Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

2015-12-01

Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. 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.

Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

PubMed Central

2012-01-01

Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12612000909820) PMID:23110608

An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia.

PubMed

Montgomery, John H; Byerly, Matthew; Carmody, Thomas; Li, Baitao; Miller, Daniel R; Varghese, Femina; Holland, Rhiannon

2004-12-01

The effect of funding source on the outcome of randomized controlled trials has been investigated in several medical disciplines; however, psychiatry has been largely excluded from such analyses. In this article, randomized controlled trials of second generation antipsychotics in schizophrenia are reviewed and analyzed with respect to funding source (industry vs. non-industry funding). A literature search was conducted for randomized, double-blind trials in which at least one of the tested treatments was a second generation antipsychotic. In each study, design quality and study outcome were assessed quantitatively according to rating scales. Mean quality and outcome scores were compared in the industry-funded studies and non-industry-funded studies. An analysis of the primary author's affiliation with industry was similarly performed. Results of industry-funded studies significantly favored second generation over first generation antipsychotics when compared to non-industry-funded studies. Non-industry-funded studies showed a trend toward higher quality than industry-funded studies; however, the difference between the two was not significant. Also, within the industry-funded studies, outcomes of trials involving first authors employed by industry sponsors demonstrated a trend toward second generation over first generation antipsychotics to a greater degree than did trials involving first authors employed outside the industry (p=0.05). While the retrospective design of the study limits the strength of the findings, the data suggest that industry bias may occur in randomized controlled trials in schizophrenia. There appears to be several sources by which bias may enter clinical research, including trial design, control of data analysis and multiplicity/redundancy of trials.

A systematic review and meta-analysis of randomized controlled trials of adjunctive ketamine in electroconvulsive therapy: efficacy and tolerability.

PubMed

McGirr, Alexander; Berlim, Marcelo T; Bond, David J; Neufeld, Nicholas H; Chan, Peter Y; Yatham, Lakshmi N; Lam, Raymond W

2015-03-01

Electroconvulsive therapy (ECT) remains one of the most effective tools in the psychiatric treatment armamentarium, particularly for refractory depression. Yet, there remains a subset of patients who do not respond to ECT or for whom clinically adequate seizures cannot be elicited, for whom ketamine has emerged as a putative augmentation agent. We searched EMBASE, PsycINFO, CENTRAL, and MEDLINE from 1962 to April 2014 to identify randomized controlled trials evaluating ketamine in ECT (PROSPERO #CRD42014009035). Clinical remission, response, and change in depressive symptom scores were extracted by two independent raters. Adverse events were recorded. Drop-outs were assessed as a proxy for acceptability. Meta-analyses employed a random effects model. Data were synthesized from 5 RCTs, representing a total of 182 patients with major depressive episodes (n = 165 Major Depressive Disorder, n = 17 Bipolar Disorder). ECT with ketamine augmentation was not associated with higher rates of clinical remission (Risk Difference (RD) = 0.00; 95%CI = -0.08 to 0.10), response (RD = -0.01; 95%CI = -0.11 to 0.08), or improvements in depressive symptoms (SMD = 0.38; 95%CI = -0.41 to 1.17). Ketamine augmentation was associated with higher rates of confusion/disorientation/prolonged delirium (OR = 6.59, 95%CI: 1.28-33.82, NNH = 3), but not agitation, hypertension or affective switches. Our meta-analysis of randomized controlled trials of ketamine augmentation in the ECT setting suggests a lack of clinical efficacy, and an increased likelihood of confusion. Individuals for whom adequate seizures or therapeutic response cannot be obtained have not been studied using randomized controlled designs. Additional research is required to address the role of ketamine in this population. Copyright © 2015 Elsevier Ltd. All rights reserved.

Immediate effect of a functional wrist orthosis for children with cerebral palsy or brain injury: A randomized controlled trial.

PubMed

Jackman, Michelle; Novak, Iona; Lannin, Natasha; Galea, Claire

2017-10-28

Two-group randomized controlled trial. Upper limb orthoses worn during functional tasks are commonly used in pediatric neurologic rehabilitation, despite a paucity of high-level evidence. The purpose of this study was to investigate if a customized functional wrist orthosis, when placed on the limb, leads to an immediate improvement in hand function for children with cerebral palsy or brain injury. A 2-group randomized controlled trial involving 30 children was conducted. Participants were randomized to either receive a customized functional wrist orthosis (experimental, n = 15) or not receive an orthosis (control, n = 15). The box and blocks test was administered at baseline and repeated 1 hour after experimental intervention, with the orthosis on if randomized to the orthotic group. After intervention, there were no significant differences on the box and blocks test between the orthotic group (mean, 10.13; standard deviation, 11.476) and the no orthotic group (mean, 14.07; standard deviation, 11.106; t[28], -0.954; P = .348; and 95% confidence interval, -12.380 to 4.513). In contrast to the findings of previous studies, our results suggest that a functional wrist orthosis, when supporting the joint in a 'typical' position, may not lead to an immediate improvement in hand function. Wearing a functional wrist orthosis did not lead to an immediate improvement in the ability of children with cerebral palsy or brain injury to grasp and release. Further research is needed combining upper limb orthoses with task-specific training and measuring outcomes over the medium to long term. Copyright © 2017 Hanley & Belfus. All rights reserved.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

PubMed

Price, Jameca Renee; Guran, Larissa A; Gregory, W Thomas; McDonagh, Marian S

2016-11-01

The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I 2 , 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I 2 , 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I 2 , 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I 2 , 8%). Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

PubMed

Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

2016-12-01

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Coaching to Augment Mentoring to Achieve Faculty Diversity: A Randomized Controlled Trial

PubMed Central

Williams, Simon N.; Thakore, Bhoomi K.; McGee, Richard

2015-01-01

Purpose The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students’ perceptions of the achievability and desirability of an academic career. Method The authors have tested (July 2012-July 2013), with Northwestern University ethical approval, the Academy via a longitudinal randomized controlled trial. Participants were 121 latter-stage biomedical PhD students. The authors collected data via questionnaires, interviews, and meeting recordings. Results The case study shows how group career coaching can effectively supplement traditional one-to-one research mentoring; provide new role models for underrepresented minority students; and provide theory-based lenses through which to engage in open conversations about race, gender, and science careers. Repeated-measures analysis of variances showed perceived achievability increased in the Academy group from baseline to 1-year follow-up (means, 5.75 vs. 6.39), but decreased in the control group (6.58 vs. 5.81). Perceived desirability decreased significantly less (P < 0.05) in the Academy group (7.00 vs. 6.36), than in the control group (7.83 vs. 5.97). Conclusions Early results suggest that an academic career-coaching model can effectively supplement traditional research mentoring and promote persistence towards academic careers. PMID:26675187

Modification of dry grain processing for rice nutrition produced

NASA Astrophysics Data System (ADS)

Rahman, A. N. F.; Genisa, J.; Dirpan, A.; Badani, A. A.

2018-05-01

Rice is a staple food for people in Indonesia that provides high energy and nutrients of up to 360 calories per 100 g. Based on the research it was known that the nutrient content in rice will increased by soaking. This is suspected because the nutrient content in the aleurone layer adsorbed to the endosperm. The purpose of this research was to know the effect of dry grain immersion on the nutrition of rice produced. The method of this research was conducted through some stages: 1. Preparation of raw materials, 2. Grain immersion, 3. Grain drying, 4. Peeling chaff, 5. Testing the nutritional value of rice. The research was processed by using factorial randomized complete random design (RCRD) with three replications. The result showed that soaking the grain for 12 hours has the highest nutritional value increases compared to the control. Proximate test resulted from the best treatment were: protein content of 8.26%, ash content of 0.42% and thiamine content of 0.023%.

Recruitment and Enrollment for the Simultaneous Conduct of 2 Randomized Controlled Trials for Patients with Subacute and Chronic Low Back Pain at a CAM Research Center

PubMed Central

Long, Cynthia R.; Haan, Andrea G.; Spencer, Lori Byrd; Meeker, William C.

2008-01-01

Abstract Objective To describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs). Design Descriptive report. Setting Chiropractic research center in the midwest United States that is not a fee-for-service clinic. Participants Both trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential participants to enroll 192 participants (89 women and 103 men), mean age 40.0 ± 9.4 years (range, 21–54 years). For study 2 we screened 1849 potential participants to enroll 240 participants (105 women and 135 men) at least 55 years old (mean, 63.1 ± 6.7 years). Interventions Study 1 randomly assigned participants to 2 weeks of 2 different chiropractic techniques or a wait list control group. Study 2 randomly assigned participants to 6 weeks of 2 different chiropractic techniques or medical care consisting of 3 provider visits for medications. Outcome measures Recruitment source costs and yield, and baseline characteristics of enrolled versus nonparticipants were recorded. Results We conducted 3789 telephone screens for both trials to enroll 432 (11%) participants, at a cost in excess of $156,000 for recruitment efforts. The cost per call for all callers averaged $41, ranging from $4 to $300 based on recruitment method; for enrolled participants, the cost per call was $361, ranging from $33 to $750. Direct mail efforts accounted for 62% of all callers, 57% for enrolled participants, and had the second lowest cost per call for recruitment efforts. Conclusions It is important that complementary and alternative medicine (CAM) research can be successfully conducted at CAM institutions. However, the costs associated with recruitment efforts for studies conducted at CAM institutions may be higher than expected and many self-identified participants are users of the CAM therapy. Therefore, strategies for efficient recruitment methods and targeting nonusers of CAM therapies should be developed early for CAM trials. PMID:18990046

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

PubMed

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

2016-05-01

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

Effects of lyric analysis interventions on treatment motivation in patients on a detoxification unit: a randomized effectiveness study.

PubMed

Silverman, Michael J

2015-01-01

Treatment motivation is a key component in the early rehabilitative stages for people with substance use disorders. To date, no music therapy researcher has studied how lyric analysis interventions might affect motivation in a randomized controlled design. The primary purpose of this study was to determine the effect of lyric analysis interventions on treatment motivation in patients on a detoxification unit using a single-session wait-list control design. A secondary purpose was to determine if there were between-group differences concerning two contrasting songs used for the lyric analyses. Participants (N=104) were cluster randomized to a group lyric analysis condition or a wait-list control condition. Participants received either a "Hurt" or a "How to Save a Life" lyric analysis treatment. The Texas Christian University Treatment Motivation Scale-Client Evaluation of Self at Intake (CESI) (Simpson, 2008[2005]) was used to measure aspects of treatment motivation: problem recognition, desire for help, treatment readiness, pressures for treatment, and total motivation. Results indicated significant between-group differences in measures of problem recognition, desire for help, treatment readiness, and total motivation, with experimental participants having higher treatment motivation means than control participants. There was no difference between the two lyric analysis interventions. Although the song used for lyric analysis interventions did not affect outcome, a single group-based music therapy lyric analysis session can be an effective psychosocial treatment intervention to enhance treatment motivation in patients on a detoxification unit. Limitations, implications for clinical practice, and suggestions for future research are provided. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa.

PubMed

Pallitto, Christina; García-Moreno, Claudia; Stöeckl, Heidi; Hatcher, Abigail; MacPhail, Catherine; Mokoatle, Keneoue; Woollett, Nataly

2016-11-05

Intimate partner violence (IPV) during or before pregnancy is associated with many adverse health outcomes. Pregnancy-related complications or poor infant health outcomes can arise from direct trauma as well as physiological effects of stress, both of which impact maternal health and fetal growth and development. Antenatal care can be a key entry point within the health system for many women, particularly in low-resource settings. Interventions to identify violence during pregnancy and offer women support and counselling may reduce the occurrence of violence and mitigate its consequences. Following a formative research phase, a randomized controlled trial will be conducted to test a nurse-led empowerment counselling intervention, originally developed for high-income settings and adapted for urban South Africa. The primary outcome is reduction of partner violence, and secondary outcomes include improvement in women's mental health, safety and self-efficacy. The study aims to recruit 504 pregnant women from three antenatal clinics in Johannesburg who will be randomized to the nurse-led empowerment arm (two 30-min counselling sessions) or enhanced control condition (a referral list) to determine whether participants in the intervention arm have better outcomes as compared to the those in the control arm. This research will provide much needed evidence on whether a short counselling intervention delivered by nurses is efficacious and feasible in low resource settings that have high prevalence of IPV and HIV. The study was registered in the South African Clinical Trials Registry (DOH-27-0414-4720) on 11 August 2014 and in the ISRCTN Registry ( ISRCTN35969343 ) on 23 May 2016).

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

PubMed Central

Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

2014-01-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history. PMID:25506545

The Effects of Mindfulness-Based Intervention on Children's Attention Regulation.

PubMed

Felver, Joshua C; Tipsord, Jessica M; Morris, Maxwell J; Racer, Kristina Hiatt; Dishion, Thomas J

2017-08-01

This article describes results from a randomized clinical trial of a mindfulness-based intervention for parents and children, Mindful Family Stress Reduction, on a behavioral measure of attention in youths, the Attention Network Task (ANT). Forty-one parent-child dyads were randomly assigned to either the mindfulness-based intervention condition or a wait-list control. School-age youths completed the ANT before and after the intervention. Results demonstrate significant, medium-size ( f 2 = -.16) intervention effects to the conflict monitoring subsystem of the ANT such that those in the intervention condition decreased in conflict monitoring more than those in the wait-list control. Youths in the intervention condition also showed improvements in their orienting subsystem scores, compared with controls. Mindfulness-based interventions for youths have potential utility to improve attentional self-regulation, and future research should consider incorporating measures of attention into interventions that use mindfulness training.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

PubMed

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

PubMed Central

Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

2015-01-01

Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

A randomized wait-list controlled analysis of the implementation integrity of team-initiated problem solving processes.

PubMed

Newton, J Stephen; Horner, Robert H; Algozzine, Bob; Todd, Anne W; Algozzine, Kate

2012-08-01

Members of Positive Behavior Interventions and Supports (PBIS) teams from 34 elementary schools participated in a Team-Initiated Problem Solving (TIPS) Workshop and follow-up technical assistance. Within the context of a randomized wait-list controlled trial, team members who were the first recipients of the TIPS intervention demonstrated greater implementation integrity in using the problem-solving processes during their team meetings than did members of PBIS Teams in the Wait-List Control group. The success of TIPS at improving implementation integrity of the problem-solving processes is encouraging and suggests the value of conducting additional research focused on determining whether there is a functional relation between use of these problem-solving processes and actual resolution of targeted student academic and social problems. Copyright © 2012 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial.

PubMed

Yadavaia, James E; Hayes, Steven C; Vilardaga, Roger

2014-10-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history.