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Sample records for randomized controlled experiment

  1. 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.…

  2. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    ERIC Educational Resources Information Center

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  3. Experience Sampling-Based Personalized Feedback and Positive Affect: A Randomized Controlled Trial in Depressed Patients

    PubMed Central

    Hartmann, Jessica A.; Wichers, Marieke; Menne-Lothmann, Claudia; Kramer, Ingrid; Viechtbauer, Wolfgang; Peeters, Frenk; Schruers, Koen R. J.; van Bemmel, Alex L.; Myin-Germeys, Inez; Delespaul, Philippe; van Os, Jim; Simons, Claudia J. P.

    2015-01-01

    Objectives Positive affect (PA) plays a crucial role in the development, course, and recovery of depression. Recently, we showed that a therapeutic application of the experience sampling method (ESM), consisting of feedback focusing on PA in daily life, was associated with a decrease in depressive symptoms. The present study investigated whether the experience of PA increased during the course of this intervention. Design Multicentre parallel randomized controlled trial. An electronic random sequence generator was used to allocate treatments. Settings University, two local mental health care institutions, one local hospital. Participants 102 pharmacologically treated outpatients with a DSM-IV diagnosis of major depressive disorder, randomized over three treatment arms. Intervention Six weeks of ESM self-monitoring combined with weekly PA-focused feedback sessions (experimental group); six weeks of ESM self-monitoring combined with six weekly sessions without feedback (pseudo-experimental group); or treatment as usual (control group). Main outcome The interaction between treatment allocation and time in predicting positive and negative affect (NA) was investigated in multilevel regression models. Results 102 patients were randomized (mean age 48.0, SD 10.2) of which 81 finished the entire study protocol. All 102 patients were included in the analyses. The experimental group did not show a significant larger increase in momentary PA during or shortly after the intervention compared to the pseudo-experimental or control groups (χ2 (2) =0.33, p=.846). The pseudo-experimental group showed a larger decrease in NA compared to the control group (χ2 (1) =6.29, p=.012). Conclusion PA-focused feedback did not significantly impact daily life PA during or shortly after the intervention. As the previously reported reduction in depressive symptoms associated with the feedback unveiled itself only after weeks, it is conceivable that the effects on daily life PA also evolve

  4. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial.

    PubMed

    Hunger, Christina; Bornhäuser, Annette; Link, Leoni; Schweitzer, Jochen; Weinhold, Jan

    2014-06-01

    This study examined the efficacy of family constellation seminars (FCSs) on individuals' experience in their personal social systems, especially the experience of belonging, autonomy, accord, and confidence. We conducted a single-blind, stratified and balanced, randomized controlled trial. Participants were 208 adults (M = 48 years, SD = 10, 79% women) who were randomly allocated either to the intervention group (3-day FCSs; 64 active participants, 40 observing participants) or to the wait-list group (64 active participants, 40 observing participants). Change was measured short-term (2-week and 4-month follow-up) using the Experience In Social Systems Questionnaire, personal domain (EXIS.pers). EXIS.pers is a new outcome measure being applied for the first time in evaluation research. In addition, we used interpersonal scales derived from established measures (Outcome Questionnaire, OQ-45; Tool for the Evaluation of the Psychotherapeutic Progress, FEP). The average person in the intervention group showed improved experience in personal social systems, as compared with approximately 73% of the wait-list group after 2 weeks (total score: Cohen's d = .61, p = .000) and 69% of the wait-list group after 4 months (total score: d = .53, p = .000). The results were confirmed in per-protocol analyses (n = 191) by the results of the EXIS.pers dimensions (Belonging, Autonomy, Accord, and Confidence) and the interpersonal scales derived from the OQ-45 and FEP. No adverse events were reported. This RCT provides first evidence that FCSs tend to positively influence participants' experience in their social systems.

  5. Effects of 25 mg oxazepam on emotional mimicry and empathy for pain: a randomized controlled experiment

    PubMed Central

    Sörman, Karolina; Olsson, Andreas; Petrovic, Predrag

    2017-01-01

    Emotional mimicry and empathy are mechanisms underlying social interaction. Benzodiazepines have been proposed to inhibit empathy and promote antisocial behaviour. First, we aimed to investigate the effects of oxazepam on emotional mimicry and empathy for pain, and second, we aimed to investigate the association of personality traits to emotional mimicry and empathy. Participants (n=76) were randomized to 25 mg oxazepam or placebo. Emotional mimicry was examined using video clips with emotional expressions. Empathy was investigated by pain stimulating the participant and a confederate. We recorded self-rated experience, activity in major zygomatic and superciliary corrugator muscles, skin conductance, and heart rate. In the mimicry experiment, oxazepam inhibited corrugator activity. In the empathy experiment, oxazepam caused increased self-rated unpleasantness and skin conductance. However, oxazepam specifically inhibited neither emotional mimicry nor empathy for pain. Responses in both experiments were associated with self-rated empathic, psychopathic and alexithymic traits. The present results do not support a specific effect of 25 mg oxazepam on emotional mimicry or empathy.

  6. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

  7. Improving Access to Online Health Information With Conversational Agents: A Randomized Controlled Experiment

    PubMed Central

    2016-01-01

    Background Conventional Web-based search engines may be unusable by individuals with low health literacy for finding health-related information, thus precluding their use by this population. Objective We describe a conversational search engine interface designed to allow individuals with low health and computer literacy identify and learn about clinical trials on the Internet. Methods A randomized trial involving 89 participants compared the conversational search engine interface (n=43) to the existing conventional keyword- and facet-based search engine interface (n=46) for the National Cancer Institute Clinical Trials database. Each participant performed 2 tasks: finding a clinical trial for themselves and finding a trial that met prespecified criteria. Results Results indicated that all participants were more satisfied with the conversational interface based on 7-point self-reported satisfaction ratings (task 1: mean 4.9, SD 1.8 vs mean 3.2, SD 1.8, P<.001; task 2: mean 4.8, SD 1.9 vs mean 3.2, SD 1.7, P<.001) compared to the conventional Web form-based interface. All participants also rated the trials they found as better meeting their search criteria, based on 7-point self-reported scales (task 1: mean 3.7, SD 1.6 vs mean 2.7, SD 1.8, P=.01; task 2: mean 4.8, SD 1.7 vs mean 3.4, SD 1.9, P<.01). Participants with low health literacy failed to find any trials that satisfied the prespecified criteria for task 2 using the conventional search engine interface, whereas 36% (5/14) were successful at this task using the conversational interface (P=.05). Conclusions Conversational agents can be used to improve accessibility to Web-based searches in general and clinical trials in particular, and can help decrease recruitment bias against disadvantaged populations. PMID:26728964

  8. Experiences recruiting Indian worksites for an integrated health protection and health promotion randomized control trial in Maharashtra, India.

    PubMed

    Cordeira, L Shulman; Pednekar, M S; Nagler, E M; Gautam, J; Wallace, L; Stoddard, A M; Gupta, P C; Sorensen, G C

    2015-06-01

    This article provides an overview of the recruitment strategies utilized in the Mumbai Worksites Tobacco Control Study, a cluster randomized trial testing the effectiveness of an integrated tobacco control and occupational safety and health program in Indian manufacturing worksites. From June 2012 to June 2013, 20 companies were recruited. Companies were identified using association lists, referrals, internet searches and visits to industrial areas. Four hundred eighty companies were contacted to validate information, introduce the study and seek an in-person meeting with a company representative. Eighty-three company representatives agreed to meet. Of those 83 companies, 55 agreed to a formal 'pitch meeting' with key decision makers at the company. Seventy-seven recruitment 'pitches' were given, including multiple meetings in the same companies. If the company was interested, we obtained a letter of participation and employee roster. Based on this experience, recommendations are made that can help inform future researchers and practitioners wishing to recruit Indian worksites. When compared with recruitment of US manufacturing worksites, recruitment of Indian worksites lacked current industrial lists of companies to serve as a sampling frame, and required more in-person visits, incentives for control companies and more assurances around confidentiality to allow occupational safety and health experts into their worksite.

  9. Experiences Recruiting Indian Worksites for an Integrated Health Protection and Health Promotion Randomized Control Trial in Maharashtra, India

    ERIC Educational Resources Information Center

    Shulman Cordeira, L.; Pednekar, M. S.; Nagler, E. M.; Gautam, J.; Wallace, L.; Stoddard, A. M.; Gupta, P. C.; Sorensen, G. C.

    2015-01-01

    This article provides an overview of the recruitment strategies utilized in the Mumbai Worksites Tobacco Control Study, a cluster randomized trial testing the effectiveness of an integrated tobacco control and occupational safety and health program in Indian manufacturing worksites. From June 2012 to June 2013, 20 companies were recruited.…

  10. Can Facebook Be Used for Research? Experiences Using Facebook to Recruit Pregnant Women for a Randomized Controlled Trial

    PubMed Central

    Adam, Laura M; Manca, Donna P

    2016-01-01

    Background Recruitment is often a difficult and costly part of any human research study. Social media and other emerging means of mass communication hold promise as means to complement traditional strategies used for recruiting participants because they can reach a large number of people in a short amount of time. With the ability to target a specified audience, paid Facebook advertisements have potential to reach future research participants of a specific demographic. This paper describes the experiences of a randomized controlled trial in Edmonton, Alberta, attempting to recruit healthy pregnant women between 8 and 20 weeks’ gestation for participation in a prenatal study. Various traditional recruitment approaches, in addition to paid Facebook advertisements were trialed. Objective To evaluate the effectiveness of paid advertisements on Facebook as a platform for recruiting pregnant women to a randomized controlled trial in comparison with traditional recruitment approaches. Methods Recruitment using traditional approaches occurred for 7 months, whereas Facebook advertisements ran for a total of 26 days. Interested women were prompted to contact the study staff for a screening call to determine study eligibility. Costs associated with each recruitment approach were recorded and used to calculate the cost to recruit eligible participants. Performance of Facebook advertisements was monitored using Facebook Ads Manager. Results Of the 115 women included, 39.1% (n=45) of the women who contacted study staff heard about the study through Facebook, whereas 60.9% (n=70) of them heard about it through traditional recruitment approaches. During the 215 days (~7 months) that the traditional approaches were used, the average rate of interest was 0.3 (0.2) women/day, whereas the 26 days of Facebook advertisements resulted in an average rate of interest of 2.8 (1.7) women/day. Facebook advertisements cost Can $506.91 with a cost per eligible participant of Cad $20.28. In

  11. After the Gold Rush: Questioning the "Gold Standard" and Reappraising the Status of Experiment and Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Thomas, Gary

    2016-01-01

    The past few years have seen a resurgence of faith in experimentation in education inquiry, and particularly in randomized controlled trials (RCTs). Proponents of such research have succeeded in bringing into common parlance the term "gold standard," which suggests that research emerging from any other design frame fails to achieve the…

  12. Theoretically Motivated Interventions for Reducing Sexual Risk Taking in Adolescence: A Randomized Controlled Experiment Applying Fuzzy-trace Theory

    PubMed Central

    Reyna, Valerie F.; Mills, Britain A.

    2014-01-01

    Fuzzy-trace theory is a theory of memory, judgment, and decision-making, and their development. We applied advances in this theory to increase the efficacy and durability of a multicomponent intervention to promote risk reduction and avoidance of premature pregnancy and STIs. 734 adolescents from high schools and youth programs in three states (Arizona, Texas, and New York) were randomly assigned to one of three curriculum groups: RTR (Reducing the Risk), RTR+ (a modified version of RTR using fuzzy-trace theory), and a control group. We report effects of curriculum on self-reported behaviors and behavioral intentions plus psychosocial mediators of those effects, namely, attitudes and norms, motives to have sex or get pregnant, self-efficacy and behavioral control, and gist/verbatim constructs. Among 26 outcomes, 19 showed an effect of at least one curriculum relative to the control group: RTR+ produced improvements for 17 outcomes and RTR produced improvements for 12 outcomes. For RTR+, two differences (for perceived parental norms and global benefit perception) were confined to age, gender, or racial/ethnic subgroups. Effects of RTR+ on sexual initiation emerged six months after the intervention, when many adolescents became sexually active. Effects of RTR+ were greater than RTR for nine outcomes, and remained significantly greater than controls at one-year follow-up for 12 outcomes. Consistent with fuzzy-trace theory, results suggest that, by emphasizing gist representations, which are preserved over long time periods and are key memories used in decision-making, the enhanced intervention produced larger and more sustained effects on behavioral outcomes and psychosocial mediators of adolescent risk-taking. PMID:24773191

  13. Does attention bias modification improve attentional control? A double-blind randomized experiment with individuals with social anxiety disorder.

    PubMed

    Heeren, Alexandre; Mogoaşe, Cristina; McNally, Richard J; Schmitz, Anne; Philippot, Pierre

    2015-01-01

    People with anxiety disorders often exhibit an attentional bias for threat. Attention bias modification (ABM) procedure may reduce this bias, thereby diminishing anxiety symptoms. In ABM, participants respond to probes that reliably follow non-threatening stimuli (e.g., neutral faces) such that their attention is directed away from concurrently presented threatening stimuli (e.g., disgust faces). Early studies showed that ABM reduced anxiety more than control procedures lacking any contingency between valenced stimuli and probes. However, recent work suggests that no-contingency training and training toward threat cues can be as effective as ABM in reducing anxiety, implying that any training may increase executive control over attention, thereby helping people inhibit their anxious thoughts. Extending this work, we randomly assigned participants with DSM-IV diagnosed social anxiety disorder to either training toward non-threat (ABM), training toward threat, or no-contingency condition, and we used the attention network task (ANT) to assess all three components of attention. After two training sessions, subjects in all three conditions exhibited indistinguishably significant declines from baseline to post-training in self-report and behavioral measures of anxiety on an impromptu speech task. Moreover, all groups exhibited similarly significant improvements on the alerting and executive (but not orienting) components of attention. Implications for ABM research are discussed.

  14. Experiments on passive hypersonic boundary layer control using ultrasonically absorptive carbon-carbon material with random microstructure

    NASA Astrophysics Data System (ADS)

    Wagner, Alexander; Kuhn, Markus; Martinez Schramm, Jan; Hannemann, Klaus

    2013-10-01

    For the first time, the influence of ultrasonically absorptive carbon-carbon material on hypersonic laminar to turbulent boundary layer transition was investigated experimentally. A 7° half-angle blunted cone with a nose radius of 2.5 mm and a total length of 1,077 mm was tested at zero angle of attack in the High Enthalpy Shock Tunnel Göttingen of the German Aerospace Center (DLR) at Mach 7.5. One-third of the metallic model surface in circumferential direction was replaced by DLR in-house manufactured ultrasonically absorptive carbon-carbon material with random microstructure for passive transition control. The remaining model surface consisted of polished steel and served as reference surface. The model was equipped with coaxial thermocouples to determine the transition location by means of surface heat flux distribution. Flush-mounted piezoelectric fast-response pressure transducers were used to measure the pressure fluctuations in the boundary layer associated with second-mode instabilities. The free-stream unit Reynolds number was varied over a range of Re m = 1.5 × 106 m-1 to Re m = 6.4 × 106 m-1 at a stagnation enthalpy of h 0 ≈ 3.2 MJ/kg and a wall temperature ratio of T w/ T 0 ≈ 0.1. The present study revealed a clear damping of the second-mode instabilities and a delay of boundary layer transition along the ultrasonically absorptive carbon-carbon insert.

  15. Learning to dislike safe water products: results from a randomized controlled trial of the effects of direct and peer experience on willingness to pay.

    PubMed

    Luoto, Jill; Mahmud, Minhaj; Albert, Jeff; Luby, Stephen; Najnin, Nusrat; Unicomb, Leanne; Levine, David I

    2012-06-05

    Low-cost point-of-use (POU) safe water products have the potential to reduce waterborne illness, but adoption by the global poor remains low. We performed an eight-month randomized trial of four low-cost household water treatment products in Dhaka, Bangladesh. Intervention households (n = 600) received repeated educational messages about the importance of drinking safe water along with consecutive two-month free trials with each of four POU products in random order. Households randomly assigned to the control group (n = 200) did not receive free products or repeated educational messages. Households' willingness to pay for these products was quite low on average (as measured by bids in an incentive-compatible real-money auction), although a modest share was willing to pay the actual or expected retail price for low-cost chlorine-based products. Furthermore, contrary to our hypotheses that both one's own personal experience and the influence of one's peers would increase consumers' willingness to pay, direct experience significantly decreased mean bids by 18-55% for three of the four products and had no discernible effect on the fourth. Neighbor experience also did not increase bids. Widespread dissemination of safe water products is unlikely until we better understand the preferences and aspirations of these at-risk populations.

  16. Effects of certain control-system nonlinearities on stability and pointing of an attached double-gimbal experiment package in presence of random crew-motion disturbances

    NASA Technical Reports Server (NTRS)

    Shaughnessy, J. D.; Groom, N. J.; Nene, V. D.

    1973-01-01

    The effects of two types of control-system nonlinearities, sensor deadband and actuator breakout torque, on the pointing capability of a Apollo Telescope Mount (ATM) double-gimbal experiment isolation and control system are investigated. A composite structural model of a flexible experiment package connected through frictionless double gimbals to a flexible carrier vehicle is used for this investigation. Contributions of the primary carrier control system to experiment pointing are neglected. Pointing errors onboard the experiment package due to random crew-motion input into the carrier vehicle are computed. A stability investigation is performed to verify control-system stability with nominal nonlinearities and gains. Indications are that there is no stability problem due to the nonlinearities. A nonlinearity sensitivity study is carried out to determine the effects on pointing accuracy. Its results indicate that nominal ATM control system nonlinearities limit the pointing accuracy to approximately 0.4 arc second in the presence of crew motion. Methods of reducing the error to less than 0.1 arc second are discussed.

  17. Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

    PubMed Central

    2012-01-01

    Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813 PMID:22225733

  18. Individual Differences Methods for Randomized Experiments

    ERIC Educational Resources Information Center

    Tucker-Drob, Elliot M.

    2011-01-01

    Experiments allow researchers to randomly vary the key manipulation, the instruments of measurement, and the sequences of the measurements and manipulations across participants. To date, however, the advantages of randomized experiments to manipulate both the aspects of interest and the aspects that threaten internal validity have been primarily…

  19. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    PubMed Central

    Hovi, Sirpa-Liisa; Veerus, Piret; Rahu, Mati; Hemminki, Elina

    2008-01-01

    Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT), originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM) in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT) on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI) in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old) drug for a new preventive indication? In preventive drug trials companies may donate drugs but they take a

  20. Random Assignment: Practical Considerations from Field Experiments.

    ERIC Educational Resources Information Center

    Dunford, Franklyn W.

    1990-01-01

    Seven qualitative issues associated with randomization that have the potential to weaken or destroy otherwise sound experimental designs are reviewed and illustrated via actual field experiments. Issue areas include ethics and legality, liability risks, manipulation of randomized outcomes, hidden bias, design intrusiveness, case flow, and…

  1. Treatment of central and sensorineural tinnitus with orally administered Melatonin and Sulodexide: personal experience from a randomized controlled study.

    PubMed

    Neri, G; De Stefano, A; Baffa, C; Kulamarva, G; Di Giovanni, P; Petrucci, G; Poliandri, A; Dispenza, F; Citraro, L; Croce, A

    2009-04-01

    Since very little is understood about the exact aetiology of tinnitus, this has made treatment of the condition difficult. Even though approximately 10-15% of the general population suffer from tinnitus, only 2% consider it serious enough to warrant any treatment. The main problem arising from tinnitus is the disturbance it causes not only in day to day life but also in sleep, leading to fatigue and general discomfort. The present study focused on the effect of Melatonin in conjunction with Sulodexide as a treatment method for tinnitus. Overall, 102 patients suffering from tinnitus were evaluated in a prospective randomised controlled study conducted in a tertiary care ENT department. After randomisation, 34 patients were treated with Melatonin and Sulodexide, another 34 were treated with Melatonin alone, while the remaining 34 (control group) were managed without treatment in order to evaluate spontaneous variations in the quality of tinnitus. Patients were assessed prospectively with the Tinnitus Handicap Inventory and Acufenometry, both pre- and post-treatment. Among the patients studied, better results with both Tinnitus Handicap Inventory and Acufenometry were found in the group who received Melatonin and Sulodexide compared to those receiving Melatonin alone. No improvement was observed in the control group. In conclusion, Melatonin in combination with Sulodexide is, in our opinion, a viable treatment option for patients suffering from central or sensorineural tinnitus.

  2. Effects of upward and downward social comparison information on the efficacy of an appearance-based sun protection intervention: a randomized, controlled experiment.

    PubMed

    Mahler, Heike I M; Kulik, James A; Gerrard, Meg; Gibbons, Frederick X

    2010-12-01

    This experiment examined the impact of adding upward and/or downward social comparison information on the efficacy of an appearance-based sun protection intervention (UV photos and photoaging information). Southern California college students (N = 126) were randomly assigned to one of four conditions: control, intervention, intervention plus upward social comparison, intervention plus downward social comparison. The results demonstrated that all those who received the basic UV photo/photoaging intervention reported greater perceived susceptibility to photoaging (d = .74), less favorable tanning cognitions (d = .44), and greater intentions to sun protect (d = 1.32) relative to controls. Of more interest, while the basic intervention increased sun protective behavior during the subsequent 5 weeks relative to controls (d = .44), the addition of downward comparison information completely negated this benefit. Upward comparison information produced sun protection levels that were only slightly (and nonsignificantly) greater than in the basic intervention condition and, as such, does not appear to be a cost-effective addition. Possible mechanisms that may have reduced the benefits of upward comparison information and contributed to the undermining effects of downward comparison information are discussed.

  3. Packet Randomized Experiments for Eliminating Classes of Confounders

    PubMed Central

    Pavela, Greg; Wiener, Howard; Fontaine, Kevin R.; Fields, David A.; Voss, Jameson D.; Allison, David B.

    2014-01-01

    Background Although randomization is considered essential for causal inference, it is often not possible to randomize in nutrition and obesity research. To address this, we develop a framework for an experimental design—packet randomized experiments (PREs), which improves causal inferences when randomization on a single treatment variable is not possible. This situation arises when subjects are randomly assigned to a condition (such as a new roommate) which varies in one characteristic of interest (such as weight), but also varies across many others. There has been no general discussion of this experimental design, including its strengths, limitations, and statistical properties. As such, researchers are left to develop and apply PREs on an ad hoc basis, limiting its potential to improve causal inferences among nutrition and obesity researchers. Methods We introduce PREs as an intermediary design between randomized controlled trials and observational studies. We review previous research that used the PRE design and describe its application in obesity-related research, including random roommate assignments, heterochronic parabiosis, and the quasi-random assignment of subjects to geographic areas. We then provide a statistical framework to control for potential packet-level confounders not accounted for by randomization. Results PREs have successfully been used to improve causal estimates of the effect of roommates, altitude, and breastfeeding on weight outcomes. When certain assumptions are met, PREs can asymptotically control for packet-level characteristics. This has the potential to statistically estimate the effect of a single treatment even when randomization to a single treatment did not occur. Conclusions Applying PREs to obesity-related research will improve decisions about clinical, public health, and policy actions insofar as it offers researchers new insight into cause and effect relationships among variables. PMID:25444088

  4. Efficacy of Web-Based Collection of Strength-Based Testimonials for Text Message Extension of Youth Suicide Prevention Program: Randomized Controlled Experiment

    PubMed Central

    Thiha, Phyo; Gurditta, Kunali; Cherry, Erin; Peterson, Derick R; Kautz, Henry; Wyman, Peter A

    2016-01-01

    Background Equipping members of a target population to deliver effective public health messaging to peers is an established approach in health promotion. The Sources of Strength program has demonstrated the promise of this approach for “upstream” youth suicide prevention. Text messaging is a well-established medium for promoting behavior change and is the dominant communication medium for youth. In order for peer ‘opinion leader’ programs like Sources of Strength to use scalable, wide-reaching media such as text messaging to spread peer-to-peer messages, they need techniques for assisting peer opinion leaders in creating effective testimonials to engage peers and match program goals. We developed a Web interface, called Stories of Personal Resilience in Managing Emotions (StoryPRIME), which helps peer opinion leaders write effective, short-form messages that can be delivered to the target population in youth suicide prevention program like Sources of Strength. Objective To determine the efficacy of StoryPRIME, a Web-based interface for remotely eliciting high school peer leaders, and helping them produce high-quality, personal testimonials for use in a text messaging extension of an evidence-based, peer-led suicide prevention program. Methods In a double-blind randomized controlled experiment, 36 high school students wrote testimonials with or without eliciting from the StoryPRIME interface. The interface was created in the context of Sources of Strength–an evidence-based youth suicide prevention program–and 24 ninth graders rated these testimonials on relatability, usefulness/relevance, intrigue, and likability. Results Testimonials written with the StoryPRIME interface were rated as more relatable, useful/relevant, intriguing, and likable than testimonials written without StoryPRIME, P=.054. Conclusions StoryPRIME is a promising way to elicit high-quality, personal testimonials from youth for prevention programs that draw on members of a target

  5. Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial.

    PubMed

    Corruble, Emmanuelle; de Bodinat, Christian; Belaïdi, Carole; Goodwin, Guy M

    2013-11-01

    In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.9 and 54.4%; week 24: 69.6 and 63.1% respectively). Over the 12 and 24-wk treatment periods, the 'global satisfaction on sleep' scores increased in both treatment groups and did not differ between groups. Satisfaction with sleep-wake quality was high in both groups; the 'wellness feeling on waking' was more improved with agomelatine than with escitalopram (p = 0.02). In patients with pronounced sleep complaints, quality of sleep and feeling on waking were significantly more improved with agomelatine than with escitalopram (p = 0.016 and p = 0.009, respectively). Emotional blunting was less frequent on agomelatine than on escitalopram. Indeed, 28% of patients on agomelatine vs. 60% on escitalopram felt that their emotions lacked intensity and 16% of patients on agomelatine vs. 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). The tolerability profile of agomelatine was found to be superior to that of escitalopram and the incidence of patients with at least one emergent adverse event leading to treatment discontinuation was lower in the agomelatine group than in the escitalopram group (5.5 vs. 10.6%). The findings suggest that agomelatine displays additional long-term clinical benefits on sleep-wake quality and emotional experiences over

  6. The Impact of Personality Factors and Preceding User Comments on the Processing of Research Findings on Deep Brain Stimulation: A Randomized Controlled Experiment in a Simulated Online Forum

    PubMed Central

    Feinkohl, Insa; Flemming, Danny; Cress, Ulrike

    2016-01-01

    Background Laypeople frequently discuss medical research findings on Web-based platforms, but little is known about whether they grasp the tentativeness that is inherent in these findings. Potential influential factors involved in understanding medical tentativeness have hardly been assessed to date. Objective The research presented here aimed to examine the effects of personality factors and of other users’ previous contributions in a Web-based forum on laypeople’s understanding of the tentativeness of medical research findings, using the example of research on deep brain stimulation. Methods We presented 70 university students with an online news article that reported findings on applying deep brain stimulation as a novel therapeutic method for depression, which participants were unfamiliar with. In a randomized controlled experiment, we manipulated the forum such that the article was either accompanied by user comments that addressed the issue of tentativeness, by comments that did not address this issue, or the article was accompanied by no comments at all. Participants were instructed to write their own individual user comments. Their scientific literacy, epistemological beliefs, and academic self-efficacy were measured. The outcomes measured were perceived tentativeness and tentativeness addressed in the participants’ own comments. Results More sophisticated epistemological beliefs enhanced the perception of tentativeness (standardized β=.26, P=.034). Greater scientific literacy (stand. β=.25, P=.025) and greater academic self-efficacy (stand. β=.31, P=.007) were both predictors of a more extensive discussion of tentativeness in participants’ comments. When forum posts presented in the experiment addressed the issue of tentativeness, participants’ subsequent behavior tended to be consistent with what they had read in the forum, F 2,63=3.66; P=.049, ηp 2=.092. Conclusions Students’ understanding of the tentativeness of research findings on deep

  7. Social influence bias: a randomized experiment.

    PubMed

    Muchnik, Lev; Aral, Sinan; Taylor, Sean J

    2013-08-09

    Our society is increasingly relying on the digitized, aggregated opinions of others to make decisions. We therefore designed and analyzed a large-scale randomized experiment on a social news aggregation Web site to investigate whether knowledge of such aggregates distorts decision-making. Prior ratings created significant bias in individual rating behavior, and positive and negative social influences created asymmetric herding effects. Whereas negative social influence inspired users to correct manipulated ratings, positive social influence increased the likelihood of positive ratings by 32% and created accumulating positive herding that increased final ratings by 25% on average. This positive herding was topic-dependent and affected by whether individuals were viewing the opinions of friends or enemies. A mixture of changing opinion and greater turnout under both manipulations together with a natural tendency to up-vote on the site combined to create the herding effects. Such findings will help interpret collective judgment accurately and avoid social influence bias in collective intelligence in the future.

  8. Lasso adjustments of treatment effect estimates in randomized experiments

    PubMed Central

    Bloniarz, Adam; Liu, Hanzhong; Zhang, Cun-Hui; Sekhon, Jasjeet S.; Yu, Bin

    2016-01-01

    We provide a principled way for investigators to analyze randomized experiments when the number of covariates is large. Investigators often use linear multivariate regression to analyze randomized experiments instead of simply reporting the difference of means between treatment and control groups. Their aim is to reduce the variance of the estimated treatment effect by adjusting for covariates. If there are a large number of covariates relative to the number of observations, regression may perform poorly because of overfitting. In such cases, the least absolute shrinkage and selection operator (Lasso) may be helpful. We study the resulting Lasso-based treatment effect estimator under the Neyman–Rubin model of randomized experiments. We present theoretical conditions that guarantee that the estimator is more efficient than the simple difference-of-means estimator, and we provide a conservative estimator of the asymptotic variance, which can yield tighter confidence intervals than the difference-of-means estimator. Simulation and data examples show that Lasso-based adjustment can be advantageous even when the number of covariates is less than the number of observations. Specifically, a variant using Lasso for selection and ordinary least squares (OLS) for estimation performs particularly well, and it chooses a smoothing parameter based on combined performance of Lasso and OLS. PMID:27382153

  9. Evaluation of an Online Campaign for Promoting Help-Seeking Attitudes for Depression Using a Facebook Advertisement: An Online Randomized Controlled Experiment

    PubMed Central

    2015-01-01

    Background A depression-awareness campaign delivered through the Internet has been recommended as a public health approach that would enhance mental health literacy and encourage help-seeking attitudes. However, the outcomes of such a campaign remain understudied. Objective The main aim of this study was to evaluate the effectiveness of an online depression awareness campaign, which was informed by the theory of planned behavior, to encourage help-seeking attitudes for depression and to enhance mental health literacy in Hong Kong. The second aim was to examine click-through behaviors by varying the affective facial expressions of people in the Facebook advertisements. Methods Potential participants were recruited through Facebook advertisements, using either a happy or sad face illustration. Volunteer participants registered for the study by clicking on the advertisement and were invited to leave their personal email addresses to receive educational content about depression. The participants were randomly assigned into two groups (campaign or control), and over a four consecutive week period, received either the campaign material or official information developed by the Hospital Authority in Hong Kong. Pretests and posttests were conducted before and after the campaign to measure the differences in help-seeking attitudes and mental health literacy among the campaign and control groups. Results Of the 199 participants that registered and completed the pretest, 116 (55 campaign and 62 control) completed the campaign and the posttest. At the posttest, we found no significant changes in help-seeking attitudes between the campaign and control groups, but the campaign group participants demonstrated a statistically significant improvement in mental health literacy (P=.031) and a higher willingness to access additional information (P<.001) than the control group. Moreover, the happy face Facebook advertisement attracted more click-throughs by users into the website than

  10. Optimal Quantum Control Using Randomized Benchmarking

    NASA Astrophysics Data System (ADS)

    Kelly, J.; Barends, R.; Campbell, B.; Chen, Y.; Chen, Z.; Chiaro, B.; Dunsworth, A.; Fowler, A. G.; Hoi, I.-C.; Jeffrey, E.; Megrant, A.; Mutus, J.; Neill, C.; O'Malley, P. J. J.; Quintana, C.; Roushan, P.; Sank, D.; Vainsencher, A.; Wenner, J.; White, T. C.; Cleland, A. N.; Martinis, John M.

    2014-06-01

    We present a method for optimizing quantum control in experimental systems, using a subset of randomized benchmarking measurements to rapidly infer error. This is demonstrated to improve single- and two-qubit gates, minimize gate bleedthrough, where a gate mechanism can cause errors on subsequent gates, and identify control crosstalk in superconducting qubits. This method is able to correct parameters so that control errors no longer dominate and is suitable for automated and closed-loop optimization of experimental systems.

  11. Usefulness of a disease severity staging classification system for IPF in Japan: 20 years of experience from empirical evidence to randomized control trial enrollment.

    PubMed

    Homma, Sakae; Sugino, Keishi; Sakamoto, Susumu

    2015-01-01

    Since 1991, the severity of idiopathic pulmonary fibrosis (IPF) has been classified into 4 stages-stage I (characterized by a resting PaO2 ≥ 80 Torr), stage II (70-79 Torr), stage III (60-69 Torr), or stage IV (<60 Torr)-to aid decisions on medical care subsidization in Japan. Among patients with stage II/III IPF, the severity should be increased by one stage if the lowest oxygen saturation on pulse oximetry (SpO2) is <90% during a 6-min walk test. Patients with stage III/IV IPF receive Japanese government subsidies for incurable diseases. This classification system highly correlates with serial changes in the percentage of vital capacity (%VC), the diffusing capacity for carbon monoxide, the incidence of acute exacerbation, and survival. A phase III trial of pirfenidone showed that IPF patients with an SpO2 on exertion of <90% and either a %VC ≥ 70% or a PaO2 ≥ 70 Torr (which includes most patients with stage III disease) at baseline would benefit from pirfenidone treatment. Recent post-marketing surveillance of 1370 patients--67.3% of whom had stage III/IV IPF--showed that pirfenidone was well-tolerated among those treated for longer than 6 months (63% of patients). A Japanese randomized controlled trial (RCT) demonstrated that inhaled N-acetylcysteine monotherapy benefitted patients with early IPF (stage I/II, with no desaturation on exertion). Thus, N-acetylcysteine monotherapy is suitable for early IPF, and pirfenidone is indicated for advanced disease. The classification of IPF severity is important in identifying clinically responsive patients and those suitable for RCT enrollment.

  12. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  13. Understanding and control of random lasing

    NASA Astrophysics Data System (ADS)

    Burin, Alexander L.; Cao, Hui; Ratner, Mark A.

    2003-10-01

    Random lasing attracts much attention because it helps to understand coherent phenomena in disordered media and can be used in optoelectronics due to easy preparation (no need in mirrors) and small size of random lasers down to few microns. Recently the remarkable progress in studying the material, geometry and external pumping dependences of laser properties and efficiency has been reached. Lasing emerges from the special random cavities of high quality formed within the active medium. They can be described as the decaying eigenoptical modes within the medium and the optical mode having the minimum decay rate is responsible for lasing. Numerical and analytical studies of the properties of these modes permit to interpret existing experiments and suggest the ways to optimize the performance of lasers.

  14. General Framework for Effect Sizes in Cluster Randomized Experiments

    ERIC Educational Resources Information Center

    VanHoudnos, Nathan

    2016-01-01

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

  15. Social Aggregation in Pea Aphids: Experiment and Random Walk Modeling

    PubMed Central

    Nilsen, Christa; Paige, John; Warner, Olivia; Mayhew, Benjamin; Sutley, Ryan; Lam, Matthew; Bernoff, Andrew J.; Topaz, Chad M.

    2013-01-01

    From bird flocks to fish schools and ungulate herds to insect swarms, social biological aggregations are found across the natural world. An ongoing challenge in the mathematical modeling of aggregations is to strengthen the connection between models and biological data by quantifying the rules that individuals follow. We model aggregation of the pea aphid, Acyrthosiphon pisum. Specifically, we conduct experiments to track the motion of aphids walking in a featureless circular arena in order to deduce individual-level rules. We observe that each aphid transitions stochastically between a moving and a stationary state. Moving aphids follow a correlated random walk. The probabilities of motion state transitions, as well as the random walk parameters, depend strongly on distance to an aphid's nearest neighbor. For large nearest neighbor distances, when an aphid is essentially isolated, its motion is ballistic with aphids moving faster, turning less, and being less likely to stop. In contrast, for short nearest neighbor distances, aphids move more slowly, turn more, and are more likely to become stationary; this behavior constitutes an aggregation mechanism. From the experimental data, we estimate the state transition probabilities and correlated random walk parameters as a function of nearest neighbor distance. With the individual-level model established, we assess whether it reproduces the macroscopic patterns of movement at the group level. To do so, we consider three distributions, namely distance to nearest neighbor, angle to nearest neighbor, and percentage of population moving at any given time. For each of these three distributions, we compare our experimental data to the output of numerical simulations of our nearest neighbor model, and of a control model in which aphids do not interact socially. Our stochastic, social nearest neighbor model reproduces salient features of the experimental data that are not captured by the control. PMID:24376691

  16. Social aggregation in pea aphids: experiment and random walk modeling.

    PubMed

    Nilsen, Christa; Paige, John; Warner, Olivia; Mayhew, Benjamin; Sutley, Ryan; Lam, Matthew; Bernoff, Andrew J; Topaz, Chad M

    2013-01-01

    From bird flocks to fish schools and ungulate herds to insect swarms, social biological aggregations are found across the natural world. An ongoing challenge in the mathematical modeling of aggregations is to strengthen the connection between models and biological data by quantifying the rules that individuals follow. We model aggregation of the pea aphid, Acyrthosiphon pisum. Specifically, we conduct experiments to track the motion of aphids walking in a featureless circular arena in order to deduce individual-level rules. We observe that each aphid transitions stochastically between a moving and a stationary state. Moving aphids follow a correlated random walk. The probabilities of motion state transitions, as well as the random walk parameters, depend strongly on distance to an aphid's nearest neighbor. For large nearest neighbor distances, when an aphid is essentially isolated, its motion is ballistic with aphids moving faster, turning less, and being less likely to stop. In contrast, for short nearest neighbor distances, aphids move more slowly, turn more, and are more likely to become stationary; this behavior constitutes an aggregation mechanism. From the experimental data, we estimate the state transition probabilities and correlated random walk parameters as a function of nearest neighbor distance. With the individual-level model established, we assess whether it reproduces the macroscopic patterns of movement at the group level. To do so, we consider three distributions, namely distance to nearest neighbor, angle to nearest neighbor, and percentage of population moving at any given time. For each of these three distributions, we compare our experimental data to the output of numerical simulations of our nearest neighbor model, and of a control model in which aphids do not interact socially. Our stochastic, social nearest neighbor model reproduces salient features of the experimental data that are not captured by the control.

  17. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  18. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents

    PubMed Central

    Wang, Hua; Calabro, Karen Sue; Mitra, Natasha; Shegog, Ross

    2017-01-01

    Background Web-based programs for smoking prevention are being increasingly used with some success among adolescents. However, little is known about the mechanisms that link the experience of such programs to intended nicotine or tobacco control outcomes. Objective Based on the experiential learning theory and extended elaboration likelihood model, this study aimed to evaluate the impact of a Web-based intervention, A Smoking Prevention Interactive Experience (ASPIRE), on adolescents’ intention to smoke, while considering the experience of interactivity and entertainment as predictors of reduced intention to smoke, under a transitional user experience model. Methods A total of 101 adolescents were recruited from after-school programs, provided consent, screened, and randomized in a single-blinded format to 1 of 2 conditions: the full ASPIRE program as the experimental condition (n=50) or an online , text-based version of ASPIRE as the control condition (n=51). Data were collected at baseline and immediate follow-up. Repeated-measures mixed-effects models and path analyses were conducted. Results A total of 82 participants completed the study and were included in the analysis. Participants in the experimental condition were more likely to show a decrease in their intention to smoke than those in the control condition (beta=−0.18, P=.008). Perceived interactivity (beta=−0.27, P=.004) and entertainment (beta=−0.20, P=.04) were each associated with a decrease in intention to smoke independently. Results of path analyses indicated that perceived interactivity and perceived entertainment mediated the relationship between ASPIRE use and emotional involvement. Furthermore, perceived presence mediated the relationship between perceived interactivity and emotional involvement. There was a direct relationship between perceived entertainment and emotional involvement. Emotional involvement predicted a decrease in intention to smoke (beta=−0.16, P=.04). Conclusions

  19. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p < 0.007) was found for "satisfaction with parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

  20. Sham Electroacupuncture Methods in Randomized Controlled Trials

    PubMed Central

    Chen, Zi-xian; Li, Yan; Zhang, Xiao-guang; Chen, Shuang; Yang, Wen-ting; Zheng, Xia-wei; Zheng, Guo-qing

    2017-01-01

    Sham electroacupuncture (EA) control is commonly used to evaluate the specific effects of EA in randomized-controlled trials (RCTs). However, establishing an inert and concealable sham EA control remains methodologically challenging. Here, we aimed to systematically investigate the sham EA methods. Eight electronic databases were searched from their inception to April 2015. Ten out of the 17 sham EA methods were identified from 94 RCTs involving 6134 participants according to three aspects: needle location, depth of needle insertion and electrical stimulation. The top three most frequently used types were sham EA type A, type L and type O ordinally. Only 24 out of the 94 trials reported credibility tests in six types of sham EA methods and the results were mainly as follows: sham EA type A (10/24), type B (5/24) and type Q (5/24). Compared with sham EA controls, EA therapy in 56.2% trials reported the specific effects, of which the highest positive rate was observed in type N (3/4), type F (5/7), type D (4/6) and type M (2/3). In conclusion, several sham EA types were identified as a promising candidate for further application in RCTs. Nonetheless, more evidence for inert and concealable sham EA control methods is needed. PMID:28106094

  1. Neighborhoods, Obesity, and Diabetes — A Randomized Social Experiment

    PubMed Central

    Ludwig, Jens; Sanbonmatsu, Lisa; Gennetian, Lisa; Adam, Emma; Duncan, Greg J.; Katz, Lawrence F.; Kessler, Ronald C.; Kling, Jeffrey R.; Lindau, Stacy Tessler; Whitaker, Robert C.; McDade, Thomas W.

    2012-01-01

    BACKGROUND The question of whether neighborhood environment contributes directly to the development of obesity and diabetes remains unresolved. The study reported on here uses data from a social experiment to assess the association of randomly assigned variation in neighborhood conditions with obesity and diabetes. METHODS From 1994 through 1998, the Department of Housing and Urban Development (HUD) randomly assigned 4498 women with children living in public housing in high-poverty urban census tracts (in which ≥40% of residents had incomes below the federal poverty threshold) to one of three groups: 1788 were assigned to receive housing vouchers, which were redeemable only if they moved to a low-poverty census tract (where <10% of residents were poor), and counseling on moving; 1312 were assigned to receive unrestricted, traditional vouchers, with no special counseling on moving; and 1398 were assigned to a control group that was offered neither of these opportunities. From 2008 through 2010, as part of a long-term follow-up survey, we measured data indicating health outcomes, including height, weight, and level of glycated hemoglobin (HbA1c). RESULTS As part of our long-term survey, we obtained data on body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) for 84.2% of participants and data on glycated hemoglobin level for 71.3% of participants. Response rates were similar across randomized groups. The prevalences of a BMI of 35 or more, a BMI of 40 or more, and a glycated hemoglobin level of 6.5% or more were lower in the group receiving the low-poverty vouchers than in the control group, with an absolute difference of 4.61 percentage points (95% confidence interval [CI], −8.54 to −0.69), 3.38 percentage points (95% CI, −6.39 to −0.36), and 4.31 percentage points (95% CI, −7.82 to −0.80), respectively. The differences between the group receiving traditional vouchers and the control group were not significant

  2. Vibration driven random walk in a Chladni experiment

    NASA Astrophysics Data System (ADS)

    Grabec, Igor

    2017-01-01

    Drifting of sand particles bouncing on a vibrating membrane of a Chladni experiment is characterized statistically. Records of trajectories reveal that bounces are circularly distributed and random. The mean length of their horizontal displacement is approximately proportional to the vibration amplitude above the critical level and amounts about one fourth of the corresponding bounce height. For the description of horizontal drifting of particles a model of vibration driven random walk is proposed that yields a good agreement between experimental and numerically simulated data.

  3. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

    Fennis, W.M.; Kuijs, R.H.; Roeters, F.J.; Creugers, N.H.; Kreulen, C.M.

    2014-01-01

    The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848). PMID:24155264

  4. Thermal Control Surfaces Experiment

    NASA Technical Reports Server (NTRS)

    Wilkes, D. R.

    1999-01-01

    This report is the final experiment report for the TCSE and summarizes many years of hardware development and analyses. Also included are analyses presented in a number of TCSE papers that were prepared and given at scientific conferences including three LDEF Post-Retrieval Symposiums.

  5. Automating quantum experiment control

    NASA Astrophysics Data System (ADS)

    Stevens, Kelly E.; Amini, Jason M.; Doret, S. Charles; Mohler, Greg; Volin, Curtis; Harter, Alexa W.

    2017-03-01

    The field of quantum information processing is rapidly advancing. As the control of quantum systems approaches the level needed for useful computation, the physical hardware underlying the quantum systems is becoming increasingly complex. It is already becoming impractical to manually code control for the larger hardware implementations. In this chapter, we will employ an approach to the problem of system control that parallels compiler design for a classical computer. We will start with a candidate quantum computing technology, the surface electrode ion trap, and build a system instruction language which can be generated from a simple machine-independent programming language via compilation. We incorporate compile time generation of ion routing that separates the algorithm description from the physical geometry of the hardware. Extending this approach to automatic routing at run time allows for automated initialization of qubit number and placement and additionally allows for automated recovery after catastrophic events such as qubit loss. To show that these systems can handle real hardware, we present a simple demonstration system that routes two ions around a multi-zone ion trap and handles ion loss and ion placement. While we will mainly use examples from transport-based ion trap quantum computing, many of the issues and solutions are applicable to other architectures.

  6. Random Experiment Program Resource Impact (REPRI) program: User's manual

    NASA Technical Reports Server (NTRS)

    Pease, W. T.; Alford, R. A.

    1972-01-01

    A complete user and programmer guide for the REPRI program is presented. This program was developed to perform mission concept, subsystem capability, and experiment support compatibility studies for a space station. The program utilizes Monte Carlo techniques to randomly schedule events in discrete intervals. Resources, logistics, cost, and space station volume are considered.

  7. Randomized Social Policy Experiments and Research on Child Development

    ERIC Educational Resources Information Center

    Romich, Jennifer L.

    2006-01-01

    Randomized social policy experiments (SPEs) are an important methodology for investigating topics in child development. This article provides a framework for understanding how evidence from SPEs can add to knowledge about child development. The use of SPEs for child development questions to date is summarized and lessons from the applied economics…

  8. Randomized controlled trials - a matter of design.

    PubMed

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

  9. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

    Yulmetyev, Renat M.; Yulmetyeva, Dinara; Gafarov, Fail M.

    2005-08-01

    We discuss the fundamental role that chaosity and randomness play in the determination of quality and efficiency of medical treatment. The statistical parameter of non-Markovity from non-equilibrium statistical physics of condensed matters is offered as a quantitative information measure of chaosity and randomness. The role of chaosity and randomness is determined by the phenomenological property, which includes quantitative informational measures of chaosity and randomness and pathology (disease) in a covariant form. Manifestations of the statistical informational behavior of chaosity and randomness are examined while analyzing the chaotic dynamics of RR intervals from human ECG's, the electric signals of a human muscle's tremor of legs in a normal state and at Parkinson disease, the electric potentials of the human brain core from EEG's during epileptic seizure and a human hand finger tremor in Parkinson's disease. The existence of the above stated informational measure allows to introduce the quantitative factor of the quality of treatment. The above-stated examples confirm the existence of new phenomenological property, which is important not only for the decision of medical problems, but also for the analysis of the wide range of problems of physics of complex systems of life and lifeless nature.

  10. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

    Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.

  11. Breakdown of statistical inference from some random experiments

    NASA Astrophysics Data System (ADS)

    Kupczynski, Marian; De Raedt, Hans

    2016-03-01

    Many experiments can be interpreted in terms of random processes operating according to some internal protocols. When experiments are costly or cannot be repeated only one or a few finite samples are available. In this paper we study data generated by pseudo-random computer experiments operating according to particular internal protocols. We show that the standard statistical analysis performed on a sample, containing 105 data points or more, may sometimes be highly misleading and statistical errors largely underestimated. Our results confirm in a dramatic way the dangers of standard asymptotic statistical inference if a sample is not homogeneous. We demonstrate that analyzing various subdivisions of samples by multiple chi-square tests and chi-square frequency graphs is very effective in detecting sample inhomogeneity. Therefore to assure correctness of the statistical inference the above mentioned chi-square tests and other non-parametric sample homogeneity tests should be incorporated in any statistical analysis of experimental data. If such tests are not performed the reported conclusions and estimates of the errors cannot be trusted.

  12. How Affiliation Disclosure and Control Over User-Generated Comments Affects Consumer Health Knowledge and Behavior: A Randomized Controlled Experiment of Pharmaceutical Direct-to-Consumer Advertising on Social Media

    PubMed Central

    Vendemia, Megan Ashley

    2016-01-01

    Background More people are seeking health information online than ever before and pharmaceutical companies are increasingly marketing their drugs through social media. Objective The aim was to examine two major concerns related to online direct-to-consumer pharmaceutical advertising: (1) how disclosing an affiliation with a pharmaceutical company affects how people respond to drug information produced by both health organizations and online commenters, and (2) how knowledge that health organizations control the display of user-generated comments affects consumer health knowledge and behavior. Methods We conducted a 2×2×2 between-subjects experiment (N=674). All participants viewed an infographic posted to Facebook by a health organization about a prescription allergy drug. Across conditions, the infographic varied in the degree to which the health organization and commenters appeared to be affiliated with a drug manufacturer, and the display of user-generated comments appeared to be controlled. Results Affiliation disclosure statements on a health organization’s Facebook post increased perceptions of an organization-drug manufacturer connection, which reduced trust in the organization (point estimate –0.45, 95% CI –0.69 to –0.24) and other users who posted comments about the drug (point estimate –0.44, 95% CI –0.68 to –0.22). Furthermore, increased perceptions of an organization-manufacturer connection reduced the likelihood that people would recommend the drug to important others (point estimate –0.35, 95% CI –0.59 to –0.15), and share the drug post with others on Facebook (point estimate –0.37, 95% CI –0.64 to –0.16). An affiliation cue next to the commenters' names increased perceptions that the commenters were affiliated with the drug manufacturer, which reduced trust in the comments (point estimate –0.81, 95% CI –1.04 to –0.59), the organization that made the post (point estimate –0.68, 95% CI –0.90 to –0.49), the

  13. Multiple Shaker Random Vibration Control--An Update

    SciTech Connect

    Smallwood, D.O.

    1999-02-18

    The theory of the control of multiple shakers driving a single test item is reviewed. Several improvements that have been introduced since the original papers on the subject will be discussed. The improvements include: (1) specification of the control spectra; (2) the control of non-square systems (the number of shakers does not have to be equal to the number of control points); (3) the connection between sine testing, waveform control, and random control; (4) improvements in feedback control; (5) overlap-add versus time domain randomization; and (6) reproduction of non-Gaussian waveforms.

  14. Automatic Generation of Randomized Trial Sequences for Priming Experiments

    PubMed Central

    Ihrke, Matthias; Behrendt, Jörg

    2011-01-01

    In most psychological experiments, a randomized presentation of successive displays is crucial for the validity of the results. For some paradigms, this is not a trivial issue because trials are interdependent, e.g., priming paradigms. We present a software that automatically generates optimized trial sequences for (negative-) priming experiments. Our implementation is based on an optimization heuristic known as genetic algorithms that allows for an intuitive interpretation due to its similarity to natural evolution. The program features a graphical user interface that allows the user to generate trial sequences and to interactively improve them. The software is based on freely available software and is released under the GNU General Public License. PMID:22007178

  15. Postoperative pain relief following hysterectomy: A randomized controlled trial

    PubMed Central

    Raghvendra, K. P.; Thapa, Deepak; Mitra, Sukanya; Ahuja, Vanita; Gombar, Satinder; Huria, Anju

    2016-01-01

    Background: Women experience moderate to severe postoperative pain following total abdominal hysterectomy (TAH). The transversus abdominis plane (TAP) block is a new modality for providing postoperative pain relief in these patients. Materials and Methods: The present study was a single center, prospective randomized trial. After the Institutional Ethics Committee approval and informed consent, patients were randomized to either epidural group: Epidural block placement + general anesthesia (GA) or TAP group: Single shot TAP block + GA. Patients in both the groups received standard general anesthetic technique and intravenous tramadol patient-controlled analgesia in the postoperative period. Patients were monitored for tramadol consumption, visual analog scale (VAS) both at rest and on coughing, hemodynamics, and side effects at 0, 2, 4, 6, 8, 12, and 24 h postoperatively. Results: The total consumption of tramadol in 24 h was greater in TAP group as compared to epidural group (68.8 [25.5] vs. 5.3 [11.6] mg, P < 0.001). The VAS scores at rest and on coughing were higher in TAP group as compared to the epidural group at 6, 8, 12, and 24 h postoperatively (P < 0.05). None of the patients in either group had any adverse effects. Conclusion: Epidural analgesia provided greater tramadol-sparing effect with superior analgesia postoperatively as compared to TAP block in patients up to 24 h following TAH. PMID:27499592

  16. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    DTIC Science & Technology

    2016-03-01

    of Defense (DoD) Telemedicine and Advanced Technology Research Center (TATRC) funded randomized controlled trial of the Caring Letters intervention to...AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release

  17. Active control of multi-dimensional random sound in ducts

    NASA Technical Reports Server (NTRS)

    Silcox, R. J.; Elliott, S. J.

    1990-01-01

    Previous work has demonstrated how active control may be applied to the control of random noise in ducts. These implementations, however, have been restricted to frequencies where only plane waves are propagating in the duct. In spite of this, the need for this technology at low frequencies has progressed to the point where commercial products that apply these concepts are currently available. Extending the frequency range of this technology requires the extension of current single channel controllers to multi-variate control systems as well as addressing the problems inherent in controlling higher order modes. The application of active control in the multi-dimensional propagation of random noise in waveguides is examined. An adaptive system is implemented using measured system frequency response functions. Experimental results are presented illustrating attained suppressions of 15 to 30 dB for random noise propagating in multiple modes.

  18. RANDOM ACCESS CONTROL OF ELECTROLUMINESCENT ELEMENTS.

    DTIC Science & Technology

    Cadmium selenide (CdSe) switches were devised to control the luminous emittance of electroluminescent cells in a solid-state display. The technique...purpose of this contract was to establish the feasibility of utilizing the hysteretic effect in cadmium selenide to provide switching and storage to an...array of electroluminescent cells by investigating the cadmium selenide material, by studying panel structure, and by investigating the addressing of

  19. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    PubMed Central

    2012-01-01

    Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes). However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-)environment interactions to obtain more insight into a) moderating effects of polymorphisms on the link between parenting and child behavior, and b) behavioral mechanisms that underlie these gene-(gene-)environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training). In a screening, families with children aged 4–8 who show mild to (sub)clinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest), after 6 months (i.e., posttest), and after 10 months (i.e., follow-up). Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-)environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s) received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and will manifest

  20. Meaninglessness in terminally ill cancer patients: a randomized controlled study.

    PubMed

    Morita, Tatsuya; Murata, Hisayuki; Kishi, Emi; Miyashita, Mitsunori; Yamaguchi, Takuhiro; Uchitomi, Yosuke

    2009-04-01

    Although recent empirical studies reveal that fostering patients' perception of meaning in their lives is an essential task for palliative care clinicians, few studies have reported the effects of training programs for nurses specifically aimed at improving these skills. The primary aim of this randomized controlled trial was to determine the effects of an educational workshop focusing on patients' feelings of meaninglessness on nurses' confidence, self-reported practice, and attitudes toward caring for such patients, in addition to burnout and meaning of life. The study was designed as a single-institution, randomized controlled trial using a waiting list control. The intervention consisted of eight 180-minute training sessions over four months, including lectures and exercises using structured assessment. A total of 41 nurses were randomly allocated to three groups, which were separately trained, and all were evaluated four times at three-month intervals (before intervention, between each intervention, and after the last intervention). Assessments included validated Confidence and Self-Reported Practice scales, the Attitudes Toward Caring for Patients Feeling Meaningless Scale (including willingness to help, positive appraisal, and helplessness items), the Maslach Burnout Scale, job satisfaction, and the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). One participant withdrew from the study before the baseline evaluation, and the remaining 40 nurses completed the study. The nurses were all female and had a mean age of 31+/-6.4, and mean clinical experience of 8.9+/-5.5 years. There were no significant differences in background among the groups. The intervention effects were statistically significant on the Confidence Scale, the Self-Reported Practice Scale, and the willingness to help, positive appraisal, and helplessness subscales, in addition to the overall levels of burnout, emotional exhaustion, personal accomplishment, job satisfaction

  1. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    PubMed

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  2. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial

    PubMed Central

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research. PMID:27703964

  3. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  4. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  5. Simulation of random wind fluctuations. [space shuttle ascent control

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

    A technique was developed for the simulation of random wind fluctuations for use in computer studies of the space shuttle ascent control. The simulated wind fluctuations were generated using the techniques of control theory that have statistical characteristics similar to the characteristics obtained from wind data at Kennedy Space Center.

  6. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    ERIC Educational Resources Information Center

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

  7. A delayed random choice quantum mechanics experiment using light quanta

    NASA Astrophysics Data System (ADS)

    Jakubowicz, O. G.

    1984-01-01

    Wheeler has often articulated during the past seven years several delayed choice Gendanken experiments which are intended to focus attention on the meaning of the elementary quantum phenomenon. Attempts to realize a delayed choice Gendanken xperiment in the spirit John Wheeler's thinking were undertaken. Short laser pulses attenuated to the single photon detection level are introduced into a Mach-Zehnder interferometer one at a time. There is a very fast completely random choice (yes/no) optical switch in one of the arms. Any photons in that arm would be reflected out and into a photomultiplier (PMT) if the optical switch decided to be closed. And any photon in the other arm would have equal probability of going into either of the PMTs that normally monitor interference. If the optical switch chooses to leave the pathway in its arm clear (open) then the photon must split at the beamsplitter and no photons will be detected in the PMT waiting for reflections out of that arm. Additionally, the phase of the interferometer may be set beforehand so that one PMT monitoring interference will register the photon and the other PMT monitoring interference will have zero probability of photon registration. The results are consistent with conventional quantum mechanics even if the decision to block or unblock one arm of the interferometer occurs after the single photon light pulse has passed the entrance beamsplitter of the interferometer.

  8. Strategies for Improving Precision in Group-Randomized Experiments

    ERIC Educational Resources Information Center

    Raudenbush, Stephen W.; Martinez, Andres; Spybrook, Jessaca

    2007-01-01

    Interest has rapidly increased in studies that randomly assign classrooms or schools to interventions. When well implemented, such studies eliminate selection bias, providing strong evidence about the impact of the interventions. However, unless expected impacts are large, the number of units to be randomized needs to be quite large to achieve…

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

    ERIC Educational Resources Information Center

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

    2017-01-01

    Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their…

  10. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  11. Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

    ERIC Educational Resources Information Center

    Hesse-Biber, Sharlene

    2013-01-01

    Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

  12. Sample Selection in Randomized Experiments: A New Method Using Propensity Score Stratified Sampling

    ERIC Educational Resources Information Center

    Tipton, Elizabeth; Hedges, Larry; Vaden-Kiernan, Michael; Borman, Geoffrey; Sullivan, Kate; Caverly, Sarah

    2014-01-01

    Randomized experiments are often seen as the "gold standard" for causal research. Despite the fact that experiments use random assignment to treatment conditions, units are seldom selected into the experiment using probability sampling. Very little research on experimental design has focused on how to make generalizations to well-defined…

  13. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  14. Randomized Control Trials on the Dynamic Geometry Approach

    ERIC Educational Resources Information Center

    Jiang, Zhonghong; White, Alexander; Rosenwasser, Alana

    2011-01-01

    The project reported here is conducting repeated randomized control trials of an approach to high school geometry that utilizes Dynamic Geometry (DG) software to supplement ordinary instructional practices. It compares effects of that intervention with standard instruction that does not make use of computer drawing/exploration tools. The basic…

  15. A Systematic Review of Randomized Controlled Studies of Art Therapy

    ERIC Educational Resources Information Center

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  16. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  17. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  18. Can the Randomized Controlled Trial Literature Generalize to Nonrandomized Patients?

    ERIC Educational Resources Information Center

    Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Crits-Christoph, Paul; Rothman, Allison

    2005-01-01

    To determine the extent to which published randomized controlled trials (RCTs) of psychotherapy can be generalized to a sample of outpatients, the authors matched information obtained from charts of patients who had been screened out of RCTs to inclusion and exclusion criteria from published RCT studies. Most of the patients in the sample who had…

  19. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  20. Impacts of Child Development Accounts on maternal depressive symptoms: evidence from a randomized statewide policy experiment.

    PubMed

    Huang, Jin; Sherraden, Michael; Purnell, Jason Q

    2014-07-01

    This study examines the impact of Child Development Accounts (CDAs)-asset-building accounts created for children at birth-on the depressive symptoms of mothers in a statewide randomized experiment conducted in the United States. The experiment identified the primary caregivers of children born in Oklahoma during 2007, and 2704 of the caregivers completed a baseline interview before random assignment to the treatment (n = 1358) or the control group (n = 1346). To treatment participants, the experiment offered CDAs built on the existing Oklahoma 529 College Savings Plan. The baseline and follow-up surveys measured the participants' depressive symptoms with a shortened version of the Center for Epidemiologic Studies Depression Scale (CES-D). In models that control for baseline CES-D scores, the mean follow-up score of treatment mothers is .17 lower than that of control mothers (p < .05). Findings suggest that CDAs have a greater impact among subsamples that reported lower income or lower education. Although designed as an economic intervention for children, CDAs may improve parents' psychological well-being. Findings also suggest that CDAs' impacts on maternal depressive symptoms may be partially mediated through children's social-emotional development.

  1. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  2. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    DTIC Science & Technology

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  3. Real time digital control and controlled structures experiments

    NASA Technical Reports Server (NTRS)

    Rossi, Michael J.; Knowles, Gareth J.; Rauch, Frank

    1991-01-01

    Viewgraphs covering the following topics are given: controlled structures technology at Grumman Corporate Research Center, active and passive control technology, experiment plans, and vacuum chamber test experiment objectives and setup.

  4. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  5. Extrinsic stain removal with a toothpowder: A randomized controlled trial

    PubMed Central

    Khan, Muhammad Khalil; Bokhari, Syed Akhtar Hussain; Haleem, Abdul; Kareem, Abdul; Khan, Ayyaz Ali; Hosein, Tasleem; Khan, Muhammad Usama

    2014-01-01

    Objectives The efficacy of a commercially available toothpowder was compared with toothpaste in removing extrinsic dental stains. Methods In this single-blind, randomized controlled trial, 77 volunteers were included from a residential professional college. All study subjects (control toothpaste users and test toothpowder users) plaque control measures. All study subjects were instructed to rinse with 5 ml 0.12% chlorhexidine mouthwash for 1 minute, twice and one cup of double tea bag solution three times daily for three weeks. Subjects were randomized into test (n=36) and control (n=36) groups. Toothpaste (control) and toothpowder (test) was used for two weeks to see the effects on removing stains on the labial surfaces of 12 anterior teeth. For measuring dental extrinsic stains Lobene Stain Index (SI) was used. Results The amount of stain following the use of toothpaste and toothpowder was more controlled with the experimental toothpowder. For all sites combined, there was evidence that the experimental toothpowder was significantly superior to toothpaste in reducing stain area (p<.001), stain intensity (p<.001) and composite/product (area × intensity) (p<.001). Conclusion Stain removing efficacy of toothpowder was significantly higher as compared with toothpaste. A toothpowder may be expected to be of benefit in controlling and removing extrinsic dental staining. PMID:25505862

  6. Review of Randomized Controlled Trials of Massage in Preterm Infants.

    PubMed

    Niemi, Anna-Kaisa

    2017-04-03

    Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  7. Nimbus 6 Random Access Measurement System applications experiments

    NASA Technical Reports Server (NTRS)

    Cote, C. E. (Editor); Taylor, R. (Editor); Gilbert, E. (Editor)

    1982-01-01

    The advantages of a technique in which data collection platforms randomly transmit signal to a polar orbiting satellite, thus eliminating satellite interrogation are demonstrated in investigations of the atmosphere; oceanographic parameters; Arctic regions and ice conditions; navigation and position location; and data buoy development.

  8. Effect Sizes in Three-Level Cluster-Randomized Experiments

    ERIC Educational Resources Information Center

    Hedges, Larry V.

    2011-01-01

    Research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Many of these designs involve two levels of clustering or nesting (students within classes and classes within schools). Researchers would like to compute effect size indexes based on the standardized mean difference to…

  9. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  10. [Randomized controlled trials terminated prematurely: beneficial therapy effects].

    PubMed

    Kluth, L A; Rink, M; Ahyai, S A; Fisch, M; Shariat, S F; Dahm, P

    2013-08-01

    Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.

  11. Randomized Algorithms for Systems and Control: Theory and Applications

    DTIC Science & Technology

    2008-05-01

    does not display a currently valid OMB control number . 1. REPORT DATE MAY 2008 2. REPORT TYPE 3. DATES COVERED 00-00-2008 to 00-00-2008 4...TITLE AND SUBTITLE Randomized Algorithms for Systems and Control: Theory and Applications 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT... NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) IEIIT-CNR

  12. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First-Grade Response to Intervention in Reading

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2014-01-01

    This randomized controlled experiment compared the efficacy of two response-to-intervention (RTI) models--typical RTI and dynamic RTI--and included 34 first-grade classrooms (n = 522 students) across 10 socioeconomically and culturally diverse schools. Typical RTI was designed to follow the two-stage RTI decision rules that wait to assess response…

  13. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  14. Field Experiments in Litter Control

    ERIC Educational Resources Information Center

    Finnie, William C.

    1973-01-01

    A series of urban and highway litter experiments in Richmond (Virginia), St. Louis, and Philadelphia indicated well-designed litter cans reduced littering about 15 percent along city streets and nearly 30 percent along highways. Also, the propensity to litter is critically affected by the characteristics of the individual and environmental…

  15. A short history of randomized experiments in criminology. A meager feast.

    PubMed

    Farrington, David P

    2003-06-01

    This article discusses advantages of randomized experiments and key issues raised in the following articles. The main concern is the growth and decrease in the use of randomized experiments by the California Youth Authority, the U.S. National Institute of Justice, and the British Home Office, although other experiments are also discussed. It is concluded that feast and famine periods are influenced by key individuals. It is recommended that policy makers, practitioners, funders, the mass media, and the general public need better education in research quality so that they can tell the difference between good and poor evaluation studies. They might then demand better evaluations using randomized experiments.

  16. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  17. Randomly Sampled-Data Control Systems. Ph.D. Thesis

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

    The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

  18. Validation of Placebo in a Manual Therapy Randomized Controlled Trial.

    PubMed

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-07-06

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment ("yes" or "no") and how strongly they believed that active treatment was received (numeric rating scale 0-10). The outcome measures included the rate of successful blinding and the certitude of the participants' beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months.

  19. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  20. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  1. Biomimetic propulsion under random heaving conditions, using active pitch control

    NASA Astrophysics Data System (ADS)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  2. Climate Change: A Controlled Experiment

    SciTech Connect

    Wullschleger, Stan D; Strahl, Maya

    2010-01-01

    Researchers are altering temperature, carbon dioxide and precipitation levels across plots of forests, grasses and crops to see how plant life responds. Warmer temperatures and higher CO{sub 2} concentrations generally result in more leaf growth or crop yield, but these factors can also raise insect infestation and weaken plants ability to ward off pests and disease. Future field experiments that can manipulate all three conditions at once will lead to better models of how long-term climate changes will affect ecosystems worldwide.

  3. Robustness of connectionist swimming controllers against random variation in neural connections.

    PubMed

    Or, Jimmy

    2007-06-01

    The ability to achieve high swimming speed and efficiency is very important to both the real lamprey and its robotic implementation. In previous studies, we used evolutionary algorithms to evolve biologically plausible connectionist swimming controllers for a simulated lamprey. This letter investigates the robustness and optimality of the best-evolved controllers as well as the biological controller hand-crafted by Ekeberg. Comparing cases of random variation in intrasegmental or intersegmental weights against each controller allows estimates of robustness to be made. We conduct experiments on the controllers' robustness at the excitation level, which corresponds to either the maximum swimming speed or efficiency by randomly varying the segmental connection weights and on some occasions also the intersegmental couplings, through varying noise ranges. Interestingly, although the swimming performance (in terms of maximum speed and efficiency) of the Ekeberg biological controller is not as good as that of the artificially evolved controllers, it is relatively robust against noise in the neural networks. This suggests that the natural evolutions have evolved a swimming controller that is good enough to survive in the real world. Our findings could inspire neurobiologists to conduct real physiological experiments to gain a better understanding on how neural connectivity affects behavior. The results can also be applied to control an artificial lamprey in simulation and possibly also a robotic one.

  4. Testimony Therapy With Ritual: A Pilot Randomized Controlled Trial.

    PubMed

    Esala, Jennifer J; Taing, Sopheap

    2017-02-01

    Testimony therapy can provide low-cost, brief, simple, and culturally adaptable psychosocial services in low-income countries (Agger, Raghuvanshi, Khan, Polatin, & Laursen, 2009). Nonetheless, there have been no well-controlled studies of testimony therapy. We report the analyses of a randomized controlled trial designed to assess the effectiveness of testimony therapy plus a culturally adapted ceremony in reducing mental health symptoms among Khmer Rouge torture survivors from across Cambodia. Using multilevel modeling, we compared symptoms of posttraumatic stress disorder, anxiety, and depression between a treatment (n = 45) and a control group (n = 43) at baseline, 3 months, and 6 months. We found that testimony therapy plus ceremony significantly reduced symptoms of posttraumatic stress disorder (d = 0.49), anxiety (d = 0.44), and depression (d = 0.53).

  5. Baseline experiments in teleoperator control

    NASA Technical Reports Server (NTRS)

    Hankins, W. W., III; Mixon, R. W.

    1986-01-01

    Studies have been conducted at the NASA Langley Research Center (LaRC) to establish baseline human teleoperator interface data and to assess the influence of some of the interface parameters on human performance in teleoperation. As baseline data, the results will be used to assess future interface improvements resulting from this research in basic teleoperator human factors. In addition, the data have been used to validate LaRC's basic teleoperator hardware setup and to compare initial teleoperator study results. Four subjects controlled a modified industrial manipulator to perform a simple task involving both high and low precision. Two different schemes for controlling the manipulator were studied along with both direct and indirect viewing of the task. Performance of the task was measured as the length of time required to complete the task along with the number of errors made in the process. Analyses of variance were computed to determine the significance of the influences of each of the independent variables. Comparisons were also made between the LaRC data and data taken earlier by Grumman Aerospace Corp. at their facilities.

  6. Medication reconciliation at patient admission: a randomized controlled trial

    PubMed Central

    Mendes, Antonio E.; Lombardi, Natália F.; Andrzejevski, Vânia S.; Frandoloso, Gibran; Correr, Cassyano J.; Carvalho, Mauricio

    2015-01-01

    Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety. PMID:27011775

  7. Randomized controlled trial design in rheumatoid arthritis: the past decade

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

    Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries. PMID:19232061

  8. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

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

  9. IS “RESCUE” THERAPY ETHICAL IN RANDOMIZED CONTROLLED TRIALS?

    PubMed Central

    Holubkov, Richard; Michael Dean, J.; Berger, John; Anand, K. J. S.; Carcillo, Joseph; Meert, Kathleen; Zimmerman, Jerry; Newth, Christopher; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

    2011-01-01

    Objective There is a commonly held belief that randomized, placebo-controlled trials in pediatric critical care should incorporate “rescue” therapy (open-label administration of active drug) when a child’s condition is deteriorating. The ethical, conceptual and analytic challenges related to “rescue” therapy in randomized trials can be misrepresented. Design Narrative review. Methods The ethical basis of “rescue” therapy, the equipoise concept, and intention-to-treat analysis are examined in the setting of a hypothetical randomized trial comparing corticosteroids versus placebo in pediatric septic shock. Findings The perceived need for “rescue” therapy may be partly motivated by the moral imperative to save a child’s life. However, allowing “rescue” therapy in a trial is misconceived and inconsistent with equipoise regarding the efficacy of the study drug. If “rescue” therapy is permitted, intention-to-treat analysis can only compare immediate versus delayed use of the study drug. When “rescue” therapy is beneficial, the observed treatment effect is substantially diminished from true effect of the study drug, leading to increased sample size and thereby placing more children at risk (18 “excess” placebo-arm deaths occur in our hypothetical example). Analysis of a trial incorporating “rescue” therapy cannot definitively assess overall efficacy of the agent, or distinguish beneficial or harmful treatment effects related to timing of drug use. Conclusions While a “rescue” therapy component in a randomized trial may be perceived as ethically desirable, inconsistency of “rescue” therapy with full equipoise may itself raise significant ethical concerns. Increased sample sizes expose more children to the risks of study participation, including death. Researchers should be aware that clinical trials designed with “rescue” therapy cannot definitively determine the beneficial or harmful effects of a treatment per se, and

  10. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  11. Barbed suture for gastrointestinal closure: a randomized control trial.

    PubMed

    Demyttenaere, Sebastian V; Nau, Peter; Henn, Matthew; Beck, Catherine; Zaruby, Jeffrey; Primavera, Michael; Kirsch, David; Miller, Jeffrey; Liu, James J; Bellizzi, Andrew; Melvin, W Scott

    2009-09-01

    In an effort to make laparoscopic suturing more efficient, the V-Loc advanced wound closure device (Covidien, Mansfield, MA) has been produced. This device is a self-anchoring barbed suture that obviates the need for knot tying. The goal of this initial feasibility study was to investigate the use of the barbed suture in gastrointestinal enterotomy closure. A randomized study of 12 pigs comparing enterotomy closure with barbed versus a nonbarbed suture of similar tensile strength was performed. To this end, 25 mm enterotomies were made in the stomach (1 control, 1 treatment), jejunum (2 controls, 2 treatments), and descending colon (1 control, 1 treatment). Animals were killed at 3, 7, and 14 days postoperatively (4 each group) and their gastrointestinal tracts harvested; 6 of the 8 enterotomies from each pig underwent burst strength testing. The remaining 2 were fixed in formalin and sent for histological examination. All 12 pigs survived until they were killed without any major complications. Enterotomy closure with barbed suture revealed adhesion scores, burst strength pressures, and histology scores that were similar to those for the control. Jejunal closures resulted in 6 failures at 7 days (3 control, 3 barbed) and 4 failures at 14 days (2 control, 2 barbed). The barbed suture significantly reduced suturing time in the stomach, jejunum, and colon. The V-Loc wound closure device appears to offer comparable gastrointestinal closure to 3-0 Maxon while being significantly faster. Further studies with V-Loc are required to assess its use in laparoscopic surgery.

  12. Child Health and Neighborhood Conditions: Results from a Randomized Housing Voucher Experiment

    ERIC Educational Resources Information Center

    Fortson, Jane G.; Sanbonmatsu, Lisa

    2010-01-01

    Using data from the Moving to Opportunity randomized housing voucher experiment, we estimate the direct effects of housing and neighborhood quality on child health. We show that, five years after random assignment, housing mobility has little impact on overall health status, asthma, injuries, and body mass index. The few effects that we observe…

  13. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials.

    PubMed

    Brown, Andrew W; Li, Peng; Bohan Brown, Michelle M; Kaiser, Kathryn A; Keith, Scott W; Oakes, J Michael; Allison, David B

    2015-08-01

    Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples.

  14. Standardization for subgroup analysis in randomized controlled trials.

    PubMed

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

    Randomized controlled trials (RCTs) emphasize the average or overall effect of a treatment (ATE) on the primary endpoint. Even though the ATE provides the best summary of treatment efficacy, it is of critical importance to know whether the treatment is similarly efficacious in important, predefined subgroups. This is why the RCTs, in addition to the ATE, also present the results of subgroup analysis for preestablished subgroups. Typically, these are marginal subgroup analysis in the sense that treatment effects are estimated in mutually exclusive subgroups defined by only one baseline characteristic at a time (e.g., men versus women, young versus old). Forest plot is a popular graphical approach for displaying the results of subgroup analysis. These plots were originally used in meta-analysis for displaying the treatment effects from independent studies. Treatment effect estimates of different marginal subgroups are, however, not independent. Correlation between the subgrouping variables should be addressed for proper interpretation of forest plots, especially in large effectiveness trials where one of the goals is to address concerns about the generalizability of findings to various populations. Failure to account for the correlation between the subgrouping variables can result in misleading (confounded) interpretations of subgroup effects. Here we present an approach called standardization, a commonly used technique in epidemiology, that allows for valid comparison of subgroup effects depicted in a forest plot. We present simulations results and a subgroup analysis from parallel-group, placebo-controlled randomized trials of antibiotics for acute otitis media.

  15. Exercise training in mitochondrial myopathy: a randomized controlled trial.

    PubMed

    Cejudo, Pilar; Bautista, Juan; Montemayor, Teodoro; Villagómez, Rafael; Jiménez, Luis; Ortega, Francisco; Campos, Yolanda; Sánchez, Hildegard; Arenas, Joaquín

    2005-09-01

    Patients with mitochondrial myopathies (MM) usually suffer from exercise intolerance due to their impaired oxidative capacity and physical deconditioning. We evaluated the effects of a 12-week supervised randomized rehabilitation program involving endurance training in patients with MM. Twenty MM patients were assigned to a training or control group. For three nonconsecutive days each week, patients combined cycle exercise at 70% of their peak work rate with three upper-body weight-lifting exercises performed at 50% of maximum capacity. Training increased maximal oxygen uptake (28.5%), work output (15.5%), and minute ventilation (40%), endurance performance (62%), walking distance in shuttle walking test (+95 m), and peripheral muscle strength (32%-62%), and improved Nottingham Health Profile scores (21.47%) and clinical symptoms. Control MM patients did not change from baseline. Results show that our exercise program is an adequate training strategy for patients with mitochondrial myopathy.

  16. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    PubMed Central

    Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

    2011-01-01

    Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

  17. Dynamic response analysis of closed-loop control system for random intelligent truss structure under random forces

    NASA Astrophysics Data System (ADS)

    Gao, Wei; Chen, Jianjun; Zhou, Yabin; Cui, Mingtao

    2004-07-01

    Considering the randomness of structural damping, physical parameters of structural materials, geometric dimensions of active bars and passive bars, applied loads and control forces simultaneously, the problems of dynamic response analysis of closed-loop control system based on probability for the random intelligent truss structures are studied in this paper. The computational expressions of numerical characteristics of structural dynamic response of closed-loop control system are derived by means of the mode superposition method. Through the engineering examples, the influences of the randomness of them on structural dynamic response are inspected and some significant conclusions are obtained.

  18. Thermal control surfaces experiment flight system performance

    NASA Technical Reports Server (NTRS)

    Wilkes, Donald R.; Hummer, Leigh L.; Zwiener, James M.

    1991-01-01

    The Thermal Control Surfaces Experiment (TCSE) is the most complex system, other than the LDEF, retrieved after long term space exposure. The TCSE is a microcosm of complex electro-optical payloads being developed and flow by NASA and the DoD including SDI. The objective of TCSE was to determine the effects of the near-Earth orbital environment and the LDEF induced environment on spacecraft thermal control surfaces. The TCSE was a comprehensive experiment that combined in-space measurements with extensive post flight analyses of thermal control surfaces to determine the effects of exposure to the low earth orbit space environment. The TCSE was the first space experiment to measure the optical properties of thermal control surfaces the way they are routinely measured in a lab. The performance of the TCSE confirms that low cost, complex experiment packages can be developed that perform well in space.

  19. A randomized controlled trial of financial incentives for weight loss

    PubMed Central

    Volpp, Kevin G.; John, Leslie K; Troxel, Andrea B; Norton, Laurie; Fassbender, Jennifer; Loewenstein, George

    2012-01-01

    Context Identifying effective strategies for treating obesity is both a clinical challenge and a public health priority due to the health consequences of obesity. Objective To determine whether common decision errors identified by behavioral economists such as prospect theory, loss aversion, and regret could be used to design an effective weight loss intervention. Design 3-arm randomized controlled trial in which participants were randomized to either usual care (weigh ins once a month) or one of two financial incentives arms. One incentive arm used deposit contracts in which participants put their own money at risk (matched 1:1 by the study) which they would lose if they failed to lose weight. The second used lottery-based incentives in which participants who met the weight loss target had each day a 1 in 5 chance of winning a small reward ($10) and a 1 in 100 chance of winning a large reward ($100). All participants were given a weight loss goal of 1 pound per week for 16 weeks, and results were analyzed using intention-to-treat analysis of variance models. Setting Philadelphia Veterans Affairs Medical Center. Patients 57 patients with BMIs between 30-40 aged between 30 and 70, with no contraindications for study participation. Main Outcome Measures Weight loss after 16 weeks. Results Participants in both incentive groups lost significantly more weight than participants in the control group (3.9 pounds); (Lottery = 13.1 lbs; p-value for lottery vs. control .014; deposit contract = 14.0 lbs, p-value vs. control .003). 47.4% of deposit contract participants and 52.6% of lottery arm participants met the 16-pound weight loss goal compared to 10.5% in the control group (p-value 0.014.). By the end of 7 months, substantial amounts of weight were regained; however, incentive participants weighed significantly less than they did at the study start whereas controls did not. Low lost to follow-up rates (7.0%) during the weight loss phase of the study suggest that both

  20. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  1. Experiments with the KITE attitude control simulator

    NASA Technical Reports Server (NTRS)

    Powell, J. David; Kline-Schoder, Robert

    1989-01-01

    Simulation experiments are conducted to test an attitude control technique for tethered satellites using the tether tension force to generate control torques by moving the tether attach point relative to the satellite center of mass. A scaled, one-dimensional, air-bearing supported laboratory simulation of the Kinetic Isolation Tether Experiment shows that the attitude of the simulator can be regulated to within 0.75 arcsec with a bandwidth of about 0.1 Hz. The control design includes a state estimator to calculate the vehicle mass center and to calculate the effect of the stepper motor dynamics on the state estimate. Results are presented from closed-loop attitude control experiments to verify the attitude control technique.

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

    PubMed Central

    2014-01-01

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

  3. Internet-enhanced management of fibromyalgia: a randomized controlled trial.

    PubMed

    Williams, David A; Kuper, David; Segar, Michelle; Mohan, Niveditha; Sheth, Manish; Clauw, Daniel J

    2010-12-01

    Both pharmacological and non-pharmacological interventions have demonstrated efficacy in the management of fibromyalgia (FM). Non-pharmacological interventions however are far less likely to be used in clinical settings, in part due to limited access. This manuscript presents the findings of a randomized controlled trail of an Internet-based exercise and behavioral self-management program for FM designed for use in the context of a routine clinical care. 118 individuals with FM were randomly assigned to either (a) standard care or (b) standard care plus access to a Web-Enhanced Behavioral Self-Management program (WEB-SM) grounded in cognitive and behavioral pain management principles. Individuals were assessed at baseline and again at 6 months for primary endpoints: reduction of pain and an improvement in physical functioning. Secondary outcomes included fatigue, sleep, anxiety and depressive symptoms, and a patient global impression of improvement. Individuals assigned to the WEB-SM condition reported significantly greater improvement in pain, physical functioning, and overall global improvement. Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period. A no-contact, Internet-based, self-management intervention demonstrated efficacy on key outcomes for FM. While not everyone is expected to benefit from this approach, this study demonstrated that non-pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes.

  4. Handling missing data in randomized experiments with noncompliance.

    PubMed

    Jo, Booil; Ginexi, Elizabeth M; Ialongo, Nicholas S

    2010-12-01

    Treatment noncompliance and missing outcomes at posttreatment assessments are common problems in field experiments in naturalistic settings. Although the two complications often occur simultaneously, statistical methods that address both complications have not been routinely considered in data analysis practice in the prevention research field. This paper shows that identification and estimation of causal treatment effects considering both noncompliance and missing outcomes can be relatively easily conducted under various missing data assumptions. We review a few assumptions on missing data in the presence of noncompliance, including the latent ignorability proposed by Frangakis and Rubin (Biometrika 86:365-379, 1999), and show how these assumptions can be used in the parametric complier average causal effect (CACE) estimation framework. As an easy way of sensitivity analysis, we propose the use of alternative missing data assumptions, which will provide a range of causal effect estimates. In this way, we are less likely to settle with a possibly biased causal effect estimate based on a single assumption. We demonstrate how alternative missing data assumptions affect identification of causal effects, focusing on the CACE. The data from the Johns Hopkins School Intervention Study (Ialongo et al., Am J Community Psychol 27:599-642, 1999) will be used as an example.

  5. Game-Based Learning as a Vehicle to Teach First Aid Content: A Randomized Experiment

    ERIC Educational Resources Information Center

    Charlier, Nathalie; De Fraine, Bieke

    2013-01-01

    Background: Knowledge of first aid (FA), which constitutes lifesaving treatments for injuries or illnesses, is important for every individual. In this study, we have set up a group-randomized controlled trial to assess the effectiveness of a board game for learning FA. Methods: Four class groups (120 students) were randomly assigned to 2…

  6. Randomized controlled trials in environmental health research: ethical issues.

    PubMed

    Resnik, David B

    2008-01-01

    Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.

  7. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  8. Patient agenda setting in respiratory outpatients: A randomized controlled trial.

    PubMed

    Early, Frances; Everden, Angharad Jt; O'Brien, Cathy M; Fagan, Petrea L; Fuld, Jonathan P

    2015-11-01

    Soliciting a patient's agenda (the reason for their visit, concerns and expectations) is fundamental to health care but if not done effectively outcomes can be adversely affected. Forms to help patients consider important issues prior to a consultation have been tested with mixed results. We hypothesized that using an agenda form would impact the extent to which patients felt their doctor discussed the issues that were important to them. Patients were randomized to receive an agenda form to complete whilst waiting or usual care. The primary outcome measure was the proportion of patients agreeing with the statement 'My doctor discussed the issues that were important to me' rated on a four-point scale. Secondary outcomes included other experience and satisfaction measures, consultation duration and patient confidence. There was no significant effect of agenda form use on primary or secondary outcomes. Post hoc exploratory analyses suggested possible differential effects for new compared to follow-up patients. There was no overall benefit from the form and a risk of detrimental impact on patient experience for some patients. There is a need for greater understanding of what works for whom in supporting patients to get the most from their consultation.

  9. Randomized controlled trial of Anticipatory and Preventive multidisciplinary Team Care

    PubMed Central

    Hogg, William; Lemelin, Jacques; Dahrouge, Simone; Liddy, Clare; Armstrong, Catherine Deri; Legault, Frances; Dalziel, Bill; Zhang, Wei

    2009-01-01

    ABSTRACT OBJECTIVE T o examine whether quality of care (QOC) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes. DESIGN Randomized controlled trial. SETTING A family health network with 8 family physicians, 5 nurses, and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa, Ont. PARTICIPANTS Patients 50 years of age and older at risk of experiencing adverse health outcomes (N = 241). INTERVENTIONS At-risk patients were randomly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care (APTCare) from a collaborative team composed of their physicians, 1 of 3 nurse practitioners, and a pharmacist. MAIN OUTCOME MEASURES Quality of care for chronic disease management (CDM) for diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. RESULTS Controlling for baseline demographic characteristics, the APTCare approach improved CDM QOC by 9.2% (P < .001) compared with traditional care. The APTCare intervention also improved preventive care by 16.5% (P < .001). We did not observe significant differences in other secondary outcome measures (intermediate clinical outcomes, quality of life [Short-Form 36 and health-related quality of life scales], functional status [instrumental activities of daily living scale] and service usage). CONCLUSION Additional resources in the form of collaborative multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients. The appropriateness of this intervention will depend on its cost-effectiveness. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT) PMID:20008582

  10. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  11. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching.

  12. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  13. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

    PubMed

    Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

    2016-08-03

    The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, <2 years recent running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period.

  14. 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.

  15. 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

  16. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.

    PubMed

    Davey, Richard T; Dodd, Lori; Proschan, Michael A; Neaton, James; Neuhaus Nordwall, Jacquie; Koopmeiners, Joseph S; Beigel, John; Tierney, John; Lane, H Clifford; Fauci, Anthony S; Massaquoi, Moses B F; Sahr, Foday; Malvy, Denis

    2016-10-13

    Background Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). Methods Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. Results A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, -15 percentage points; 95% confidence interval, -36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. Conclusions In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified

  17. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  18. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  19. The Effects of Attrition on Baseline Comparability in Randomized Experiments in Education: A Meta-Analysis

    ERIC Educational Resources Information Center

    Valentine, Jeffrey C.; McHugh, Cathleen M.

    2007-01-01

    Using meta-analysis, randomized experiments in education that either clearly did or clearly did not experience student attrition were examined for the baseline comparability of groups. Results from 35 studies suggested that after attrition, the observed measures of baseline comparability of groups did not differ more than would be expected given…

  20. Randomized Experiments for Planning and Testing Projects in Developing Countries: Threshold Conditions.

    ERIC Educational Resources Information Center

    Dennis, Michael L.; Boruch, Robert F.

    1989-01-01

    Determining which program evaluations in developing countries are appropriate/feasible for randomized experiments to plan and evaluate social programs is discussed. Five threshold conditions are defined. Reviews of experiments from Barbados, China, Colombia, Kenya, Israel, Nicaragua, Pakistan, Taiwan, and the United States illustrate the issues…

  1. Urban Poverty and Juvenile Crime: Evidence from a Randomized Housing-Mobility Experiment. JCPR Working Paper.

    ERIC Educational Resources Information Center

    Ludwig, Jens; Duncan, Greg J.; Hirschfield, Paul

    This paper uses data from a randomized housing-mobility experiment to study the effects on juvenile crime of relocating families from high- to low-poverty neighborhoods. Since 1994, the Department of Housing and Urban Development's Moving to Opportunity (MTO) experiment has assigned families from high-poverty Baltimore neighborhoods into three…

  2. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    PubMed

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P<0.001) during cognitive tasks. Among controls, high-frequency power was unchanged (P=0.29), and RR interval decreased (P=0.03). Neither intervention altered spontaneous baroreflex sensitivity (P>0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  3. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  4. Prevention of pathological gambling: a randomized controlled trial.

    PubMed

    Doiron, Jason P; Nicki, Richard M

    2007-01-01

    Although the gambling industry is expanding rapidly throughout North America and around the world, there are only a few empirically evaluated programs aimed at the prevention of pathological gambling (PG). The purpose of this study was to measure the effectiveness of a new prevention program aimed at PG. The Stop & Think! program was designed to teach at-risk video lottery terminal (VLT) gamblers cognitive restructuring and problem-solving skills that may help to prevent the development of PG. These skills were taught through a variety of methods - including an automated educational presentation, video and text vignettes, audio training tapes, and skill rehearsal. The program was evaluated using a randomized, 2-group experimental design with a wait-list control group and pre-, post-, and follow-up measures. Results indicated that, compared with the control group, the experimental group was less at risk for developing a gambling problem after the program. The experimental group endorsed fewer gambling-related cognitive distortions, engaged in less VLT gambling, and had lower scores on a measure of PG. The results of this study provide the basis for the implementation of the Stop & Think! program in the province of Prince Edward Island, Canada, and perhaps other jurisdictions too.

  5. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  6. A slewing control experiment for flexible structures

    NASA Technical Reports Server (NTRS)

    Juang, J.-N.; Horta, L. G.; Robertshaw, H. H.

    1985-01-01

    A hardware set-up has been developed to study slewing control for flexible structures including a steel beam and a solar panel. The linear optimal terminal control law is used to design active controllers which are implemented in an analog computer. The objective of this experiment is to demonstrate and verify the dynamics and optimal terminal control laws as applied to flexible structures for large angle maneuver. Actuation is provided by an electric motor while sensing is given by strain gages and angle potentiometer. Experimental measurements are compared with analytical predictions in terms of modal parameters of the system stability matrix and sufficient agreement is achieved to validate the theory.

  7. 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…

  8. Wavefront Control Testbed (WCT) Experiment Results

    NASA Technical Reports Server (NTRS)

    Burns, Laura A.; Basinger, Scott A.; Campion, Scott D.; Faust, Jessica A.; Feinberg, Lee D.; Hayden, William L.; Lowman, Andrew E.; Ohara, Catherine M.; Petrone, Peter P., III

    2004-01-01

    The Wavefront Control Testbed (WCT) was created to develop and test wavefront sensing and control algorithms and software for the segmented James Webb Space Telescope (JWST). Last year, we changed the system configuration from three sparse aperture segments to a filled aperture with three pie shaped segments. With this upgrade we have performed experiments on fine phasing with line-of-sight and segment-to-segment jitter, dispersed fringe visibility and grism angle;. high dynamic range tilt sensing; coarse phasing with large aberrations, and sampled sub-aperture testing. This paper reviews the results of these experiments.

  9. A Randomized Controlled Study of Neurofeedback for Chronic PTSD

    PubMed Central

    van der Kolk, Bessel A.; Hodgdon, Hilary; Gapen, Mark; Musicaro, Regina; Suvak, Michael K.; Hamlin, Ed; Spinazzola, Joseph

    2016-01-01

    Introduction Brain/Computer Interaction (BCI) devices are designed to alter neural signals and, thereby, mental activity. This study was a randomized, waitlist (TAU) controlled trial of a BCI, EEG neurofeedback training (NF), in patients with chronic PTSD to explore the capacity of NF to reduce PTSD symptoms and increase affect regulation capacities. Study Design 52 individuals with chronic PTSD were randomized to either NF (n = 28) or waitlist (WL) (n = 24). They completed four evaluations, at baseline (T1), after week 6 (T2), at post-treatment (T3), and at one month follow up (T4). Assessment measures were:1. Traumatic Events Screening Inventory (T1); 2. the Clinician Administered PTSD Scale (CAPS; T1, T3, T4); 3. the Davidson Trauma Scale (DTS; T1-T4) and 4. the Inventory of Altered Self-Capacities (IASC; T1-T4). NF training occurred two times per week for 12 weeks and involved a sequential placement with T4 as the active site, P4 as the reference site. Results Participants had experienced an average of 9.29 (SD = 2.90) different traumatic events. Post-treatment a significantly smaller proportion of NF (6/22, 27.3%) met criteria for PTSD than the WL condition (15/22, 68.2%), χ2 (n = 44, df = 1) = 7.38, p = .007. There was a significant treatment condition x time interaction (b = -10.45, t = -5.10, p< .001). Measures of tension reduction activities, affect dysregulation, and affect instability exhibited a significant Time x Condition interaction. The effect sizes of NF (d = -2.33 within, d = - 1.71 between groups) are comparable to those reported for the most effective evidence based treatments for PTSD. Discussion Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action. PMID:27992435

  10. Placebo Effects and the Common Cold: A Randomized Controlled Trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

    2011-01-01

    PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group

  11. Modular control system for optogenetic experiments

    NASA Astrophysics Data System (ADS)

    Sowiński, Mikołaj; Kulik, Paweł; Kasprowicz, Grzegorz; Mankiewicz, Lech; Krawczyk, Rafał D.; Jarosiński, Jakub; Czajkowski, Rafał; Knapska, Ewelina; Puścian, Alicja; Kowalski, Jakub; Rusakov, Konstantin; Przywózki, Tomasz; Rasiński, Paweł; Juszczyk, Bartłomiej

    2016-09-01

    This article presents a modular control system used in Eco-HAB experimentation system. Features specific to the solution are covered. Control system is described in details. The architecture is outlined in the context of requirements to be met. Modes of utilization of implantable device, time synchronization, localization service and antenna driving oscillation fine-tuning as well as preliminary experiments in preparation are described.

  12. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

    PubMed

    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

  13. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  14. Randomized controlled trials to assess therapies for multiple sclerosis.

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

    MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

  15. Randomized controlled trials – a matter of design

    PubMed Central

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  16. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    PubMed

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes.

  17. Validation of a MIMO Random Control Tool Using the CUBE™

    NASA Astrophysics Data System (ADS)

    Carrella, Alex; Janssens, Joris; Debille, Jan; Faignet, Eddy; Peetrs, Bart

    2012-07-01

    Environmental testing is an important engineering discipline which aims at simulating the effect of the environmnet on a given structure, item or system. A particular environment is the vibratory one. From development to qualification, engineering systems subject to harsh dynamic environments have to be tested in order to ensure their capability to withstand vibrations. To this end, there exist a wealth of test stadards which impose strict pass/fail criteria. However, these methods are rather dated and the testing community is constantly striving to update the standards to account for new technologies and ever more stringent requirements. Currently, the standard specify to carry out vibration tests along one axis at the time, that is using a Single-Input-Single-Ouput (SISO) or a Single-Input- Multiple-Ouput (SIMO) approach. However, there are a number of significant advanteges in using a Multiple- Input-Multiple-Ouput (MIMO) apporach. In this paper are presented the results of an experimental campaign aimed at assessing the capabilty of the new MIMO Random control developed at LMS.

  18. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    PubMed Central

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  19. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial

    PubMed Central

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer’s disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. Methods and findings This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Conclusions Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  20. Modifying Media Content for Preschool Children: A Randomized Controlled Trial

    PubMed Central

    Garrison, Michelle M.; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P.; Zhou, Chuan; Liekweg, Kimberly

    2013-01-01

    BACKGROUND: Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. METHODS: We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. RESULTS: At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78–3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06–1.30]) and the social competence subscale (1.04 [95% CI: 0.34–1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: −0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60–11.37]). CONCLUSIONS: An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior. PMID:23420911

  1. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    PubMed

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness

  2. Diffraction experiments with infrared remote controls

    NASA Astrophysics Data System (ADS)

    Kuhn, Jochen; Vogt, Patrik

    2012-02-01

    In this paper we describe an experiment in which radiation emitted by an infrared remote control is passed through a diffraction grating. An image of the diffraction pattern is captured using a cell phone camera and then used to determine the wavelength of the radiation.

  3. Distributed control network for optogenetic experiments

    NASA Astrophysics Data System (ADS)

    Kasprowicz, G.; Juszczyk, B.; Mankiewicz, L.

    2014-11-01

    Nowadays optogenetic experiments are constructed to examine social behavioural relations in groups of animals. A novel concept of implantable device with distributed control network and advanced positioning capabilities is proposed. It is based on wireless energy transfer technology, micro-power radio interface and advanced signal processing.

  4. Can Inner Peace be Improved by Mindfulness Training: A Randomized Controlled Trial.

    PubMed

    Liu, Xinghua; Xu, Wei; Wang, Yuzheng; Williams, J Mark G; Geng, Yan; Zhang, Qian; Liu, Xin

    2015-08-01

    This article reports a randomized controlled trial to investigate whether mindfulness training can successfully improve inner peace in participants with no known mental disorder. Fifty-seven participants were randomized to either mindfulness training (n = 29) or wait-list control (n = 28). The experience sampling method was used to measure the fleeting momentary experience of inner peace in participants. In addition, we used an experimental approach to assessing ability to focus attention: the Meditation Breath Attention Score, as well as the self-report Five-Facet Mindfulness Questionnaire (FFMQ). Compared with the wait-list control group, mindfulness training led to an increase in scores of inner peace, Meditation Breath Attention Score and FFMQ, using analysis of repeated measures analysis of variance. Change in inner peace was not, however, mediated by changes in self-rated mindfulness (FFMQ) nor by increased attentional focus. The findings provide first evidence suggesting that using mindfulness training improves the participants' inner peace. The focus here was on the immediate effects and future studies need to use follow-up.

  5. Decentralized control experiments on NASA's flexible grid

    NASA Technical Reports Server (NTRS)

    Ozguner, U.; Yurkowich, S.; Martin, J., III; Al-Abbass, F.

    1986-01-01

    Methods arising from the area of decentralized control are emerging for analysis and control synthesis for large flexible structures. In this paper the control strategy involves a decentralized model reference adaptive approach using a variable structure control. Local models are formulated based on desired damping and response time in a model-following scheme for various modal configurations. Variable structure controllers are then designed employing co-located angular rate and position feedback. In this scheme local control forces the system to move on a local sliding mode in some local error space. An important feature of this approach is that the local subsystem is made insensitive to dynamical interactions with other subsystems once the sliding surface is reached. Experiments based on the above have been performed for NASA's flexible grid experimental apparatus. The grid is designed to admit appreciable low-frequency structural dynamics, and allows for implementation of distributed computing components, inertial sensors, and actuation devices. A finite-element analysis of the grid provides the model for control system design and simulation; results of several simulations are reported on here, and a discussion of application experiments on the apparatus is presented.

  6. Middeck Active Control Experiment (MACE), phase A

    NASA Technical Reports Server (NTRS)

    Crawley, Edward F.; Deluis, Javier; Miller, David W.

    1989-01-01

    A rationale to determine which structural experiments are sufficient to verify the design of structures employing Controlled Structures Technology was derived. A survey of proposed NASA missions was undertaken to identify candidate test articles for use in the Middeck Active Control Experiment (MACE). The survey revealed that potential test articles could be classified into one of three roles: development, demonstration, and qualification, depending on the maturity of the technology and the mission the structure must fulfill. A set of criteria was derived that allowed determination of which role a potential test article must fulfill. A review of the capabilities and limitations of the STS middeck was conducted. A reference design for the MACE test article was presented. Computing requirements for running typical closed-loop controllers was determined, and various computer configurations were studied. The various components required to manufacture the structure were identified. A management plan was established for the remainder of the program experiment development, flight and ground systems development, and integration to the carrier. Procedures for configuration control, fiscal control, and safety, reliabilty, and quality assurance were developed.

  7. Progress on control experiments of flexible structures

    NASA Technical Reports Server (NTRS)

    Juang, Jer-Nan

    1990-01-01

    Progress at the NASA Langley Research Center in the area of control experiments for flexible structures is described. First the author presents the experimental results for a linear model which represents slewing maneuvers of a generic space station solar panel carried out to evaluate experimentally some control technologies. Then the status of the rotational/translational maneuvering experiment of a flexible steel panel carried by a translation cart is presented. Finally, experimental results of the NASA minimast testbed using velocity command stepper motors as reaction mass reactors are shown. All the test configurations are briefly described, including actuator and sensor, test setup, and test software. The status of some research activities oriented primarily to the experimental methods for control of flexible structures is presented.

  8. The Middeck Active Control Experiment (MACE)

    NASA Technical Reports Server (NTRS)

    Miller, David W.; Sepe, Raymond B.; Rey, Daniel; Saarmaa, Erik; Crawley, Edward F.

    1993-01-01

    The Middeck Active Control Experiment (MACE) is a NASA In-Step and Control Structure Interaction (CSI) Office funded Shuttle middeck experiment. The objective is to investigate the extent to which closed-loop behavior of flexible spacecraft in zero-gravity (0-g) can be predicted. This prediction becomes particularly difficult when dynamic behavior during ground testing exhibits extensive suspension and direct gravity coupling. On-orbit system identification and control reconfiguration is investigated to improve performance which would otherwise be limited due to errors in prediction. The program is presently in its preliminary design phase with launch expected in the summer of 1994. The MACE test article consists of three attitude control torque wheels, a two axis gimballing payload, inertial sensors and a flexible support structure. With the acquisition of a second payload, this will represent a multiple payload platform with significant structural flexibility. This paper presents on-going work in the areas of modelling and control of the MACE test article in the zero and one-gravity environments. Finite element models, which include suspension and gravity effects, and measurement models, derived from experimental data, are used as the basis for Linear Quadratic Gaussian controller designs. Finite element based controllers are analytically used to study the differences in closed-loop performance as the test article transitions between the 0-g and 1-g environments. Measurement based controllers are experimentally applied to the MACE test article in the 1-g environment and achieve over an order of magnitude improvement in payload pointing accuracy when disturbed by a broadband torque disturbance. The various aspects of the flight portion of the experiment are also discussed.

  9. The effect of financial incentives on chlamydia testing rates: evidence from a randomized experiment.

    PubMed

    Dolan, Paul; Rudisill, Caroline

    2014-03-01

    Financial incentives have been used in a variety of settings to motivate behaviors that might not otherwise be undertaken. They have been highlighted as particularly useful in settings that require a single behavior, such as appointment attendance or vaccination. They also have differential effects based on socioeconomic status in some applications (e.g. smoking). To further investigate these claims, we tested the effect of providing different types of non-cash financial incentives on the return rates of chlamydia specimen samples amongst 16-24 year-olds in England. In 2011 and 2012, we ran a two-stage randomized experiment involving 2988 young people (1489 in Round 1 and 1499 in Round 2) who requested a chlamydia screening kit from Freetest.me, an online and text screening service run by Preventx Limited. Participants were randomized to control, or one of five types of financial incentives in Round 1 or one of four financial incentives in Round 2. We tested the effect of five types of incentives on specimen sample return; reward vouchers of differing values, charity donation, participation in a lottery, choices between a lottery and a voucher and including vouchers of differing values in the test kit prior to specimen return. Financial incentives of any type, did not make a significant difference in the likelihood of specimen return. The more deprived individuals were, as calculated using Index of Multiple Deprivation (IMD), the less likely they were to return a sample. The extent to which incentive structures influenced sample return was not moderated by IMD score. Non-cash financial incentives for chlamydia testing do not seem to affect the specimen return rate in a chlamydia screening program where test kits are requested online, mailed to requestors and returned by mail. They also do not appear more or less effective in influencing test return depending on deprivation level.

  10. Reduction of neonatal pain following administration of 25% lingual dextrose: a randomized control trial.

    PubMed

    Nimbalkar, Somashekhar; Sinojia, Ankit; Dongara, Ashish

    2013-06-01

    Neonates experience painful procedures during routine care. Orally administered, sweet tasting solutions are commonly used in management of neonatal pain. We conducted a double-blind randomized control trial in neonates admitted to Neonatal Intensive Care Unit of Shri Krishna Hospital, Karamsad-Gujarat-India, of lingual administration of 25% dextrose vs. no intervention, to evaluate reduction of pain following oropharyngeal infant feeding tube insertions. Pain was assessed using Premature Infant Pain Profile score. Almost all the patients in the control group (98%) experienced moderate-to-severe pain as compared with the intervention group (71%). Mean Premature Infant Pain Profile score was statistically significantly lower in the intervention group (8.21) as compared with control group (10.31). (p < 0.001, 95% CI 1.090-3.102). Lingual 25% dextrose is an effective analgesic for relieving pain during orogastric tube insertion.

  11. Generating and controlling homogeneous air turbulence using random jet arrays

    NASA Astrophysics Data System (ADS)

    Carter, Douglas; Petersen, Alec; Amili, Omid; Coletti, Filippo

    2016-12-01

    The use of random jet arrays, already employed in water tank facilities to generate zero-mean-flow homogeneous turbulence, is extended to air as a working fluid. A novel facility is introduced that uses two facing arrays of individually controlled jets (256 in total) to force steady homogeneous turbulence with negligible mean flow, shear, and strain. Quasi-synthetic jet pumps are created by expanding pressurized air through small straight nozzles and are actuated by fast-response low-voltage solenoid valves. Velocity fields, two-point correlations, energy spectra, and second-order structure functions are obtained from 2D PIV and are used to characterize the turbulence from the integral-to-the Kolmogorov scales. Several metrics are defined to quantify how well zero-mean-flow homogeneous turbulence is approximated for a wide range of forcing and geometric parameters. With increasing jet firing time duration, both the velocity fluctuations and the integral length scales are augmented and therefore the Reynolds number is increased. We reach a Taylor-microscale Reynolds number of 470, a large-scale Reynolds number of 74,000, and an integral-to-Kolmogorov length scale ratio of 680. The volume of the present homogeneous turbulence, the largest reported to date in a zero-mean-flow facility, is much larger than the integral length scale, allowing for the natural development of the energy cascade. The turbulence is found to be anisotropic irrespective of the distance between the jet arrays. Fine grids placed in front of the jets are effective at modulating the turbulence, reducing both velocity fluctuations and integral scales. Varying the jet-to-jet spacing within each array has no effect on the integral length scale, suggesting that this is dictated by the length scale of the jets.

  12. Mortality in the randomized, controlled lung intergroup trial of isotretinoin.

    PubMed

    Lee, J Jack; Feng, Lei; Reshef, Daniel S; Sabichi, Anita L; Williams, Brendell; Rinsurongkawong, Waree; Wistuba, Ignacio I; Lotan, Reuben; Lippman, Scott M

    2010-06-01

    In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial. We report the overall and cause (cancer, cardiovascular disease, or other)-specific mortality associated with long-term isotretinoin after an extended median follow-up of 6.2 years that included the capture of cause-of-death data from 428 deceased patients. Overall mortality was 36.7% in each of the two trial arms, about two thirds related to cancer and one third to other or unknown causes. Overall and cancer deaths increased in current smokers in the isotretinoin arm during the treatment and the extended follow-up period. No mortality end point increased among never smokers and former smokers taking isotretinoin, and cancer deaths decreased marginally in this combined subgroup. Isotretinoin also increased deaths from cardiovascular disease in current smokers. The present analysis supports the safety of protracted isotretinoin use in the combined group of never smokers and former smokers, which has important public health implications, for example, for treating acne in young people. The increased mortality in current smokers in this study is further evidence of the multifaceted danger of active smoking. The overall indications of this study have public health implications for treating acne in young people and other uses of retinoids in smokers.

  13. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  14. Generation of complete coherence in Young's interference experiment with random mutually uncorrelated electromagnetic beams.

    PubMed

    Agarwal, G S; Dogariu, A; Visser, T D; Wolf, E

    2005-01-15

    The recently developed theory that unifies the treatments of polarization and coherence of random electromagnetic beams is applied to study field correlations in Young's interference experiment. It is found that at certain pairs of points the transmitted field is spatially fully coherent, irrespective of the state of coherence and polarization of the field that is incident on the two pinholes.

  15. The Effects of Student Coaching: An Evaluation of a Randomized Experiment in Student Advising

    ERIC Educational Resources Information Center

    Bettinger, Eric P.; Baker, Rachel B.

    2014-01-01

    College graduation rates often lag behind college attendance rates. One theory as to why students do not complete college is that they lack key information about how to be successful or fail to act on the information that they have. We present evidence from a randomized experiment which tests the effectiveness of individualized student coaching.…

  16. Motivational Interviewing May Improve Exercise Experience for People with Multiple Sclerosis: A Small Randomized Trial

    ERIC Educational Resources Information Center

    Smith, Douglas C.; Lanesskog, Deirdre; Cleeland, Leah; Motl, Robert; Weikert, Madeline; Dlugonski, Deirdre

    2012-01-01

    People with multiple sclerosis (MS) are likely to benefit from regular exercise, but physical inactivity is more common among people with MS than among the general population. This small randomized study evaluated whether motivational interviewing (MI) affects adherence to and personal experience in an exercise program. Inactive people with MS…

  17. Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

    2014-01-01

    Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

  18. Improving Learning in Primary Schools of Developing Countries: A Meta-Analysis of Randomized Experiments

    ERIC Educational Resources Information Center

    McEwan, Patrick J.

    2015-01-01

    I gathered 77 randomized experiments (with 111 treatment arms) that evaluated the effects of school-based interventions on learning in developing-country primary schools. On average, monetary grants and deworming treatments had mean effect sizes that were close to zero and not statistically significant. Nutritional treatments, treatments that…

  19. Economic Intervention and Parenting: A Randomized Experiment of Statewide Child Development Accounts

    ERIC Educational Resources Information Center

    Nam, Yunju; Wikoff, Nora; Sherraden, Michael

    2016-01-01

    Objective: We examine the effects of Child Development Accounts (CDAs) on parenting stress and practices. Methods: We use data from the SEED for Oklahoma Kids (SEED OK) experiment. SEED OK selected caregivers of infants from Oklahoma birth certificates using a probability sampling method, randomly assigned caregivers to the treatment (n = 1,132)…

  20. Effects of a Summer Mathematics Intervention for Low-Income Children: A Randomized Experiment

    ERIC Educational Resources Information Center

    Lynch, Kathleen; Kim, James S.

    2017-01-01

    Prior research suggests that summer learning loss among low-income children contributes to income-based gaps in achievement and educational attainment. We present results from a randomized experiment of a summer mathematics program conducted in a large, high-poverty urban public school district. Children in the third to ninth grade (N = 263) were…

  1. An Examination of the Benefits, Limitations, and Challenges of Conducting Randomized Experiments with Principals

    ERIC Educational Resources Information Center

    Camburn, Eric M.; Goldring, Ellen; Sebastian, James; May, Henry; Huff, Jason

    2016-01-01

    Purpose: The past decade has seen considerable debate about how to best evaluate the efficacy of educational improvement initiatives, and members of the educational leadership research community have entered the debate with great energy. Throughout this debate, the use of randomized experiments has been a particularly contentious subject. This…

  2. APECS - The Atacama Pathfinder Experiment Control System

    NASA Astrophysics Data System (ADS)

    Muders, D.; Hafok, H.; Wyrowski, F.; Polehampton, E.; Belloche, A.; König, C.; Schaaf, R.

    2006-07-01

    APECS is the CORBA based, distributed control system for the new Atacama Pathfinder EXperiment (APEX) Telescope located at the Llano de Chajnantor at an altitude of 5100m in the Atacama desert in northern Chile. The telescope has been operational since August 2005 and APECS is now being used for regular science observations. APECS employs a modern, object-oriented design. Generic interfaces facilitate adding new instruments. The IPython based observer command language allows using macros and creating more complex observing modes.

  3. Attendance at cultural events and physical exercise and health: a randomized controlled study.

    PubMed

    Konlaan, B B; Björby, N; Bygren, L O; Weissglas, G; Karlsson, L G; Widmark, M

    2000-09-01

    The aim of this study was to assess the specific biomedico-social effects of participating in cultural events and gentle physical exercise effects apart from the general effect of participating in group activities. This was a randomized controlled investigation using a factorial design, where attending cultural events and taking easy physical exercise were tested simultaneously. The 21 participants, aged between 18 and 74 y were from a simple random sample of people registered as residents in Umeå, a town in northern Sweden. Among the 1000 in the sample, 21 individuals (11 men, 10 women) were recruited into the experiment. Two out of the 21 subjects dropped out and were discounted from our analysis. Nine people were encouraged to engage in cultural activity for a two-month period. Diastolic blood pressure in eight of these nine was significantly reduced following the experiment. There were no marked changes observed in either systolic or diastolic blood pressure in those not required to engage in any form of extra-cultural activity. A decrease in the levels of both adrenocorticotropical hormone (ACTH) and s-prolactin was observed in culturally stimulated subjects, whereas the average baseline s-prolactin level of 7 ng/l for the non-culturally stimulated group was unchanged after the experiment. Physical exercise produced an increase in the high density lipoprotein (HDL) cholesterol level and in the ratio of HDL to LDL (low density lipoprotein). It was concluded that cultural stimulation may have specific effects on health related determinants.

  4. Using frames to influence consumer willingness to pay for the patient health record: a randomized experiment.

    PubMed

    Vishwanath, Arun

    2009-07-01

    The American College of Medical Informatics rated the lack of willingness to pay for the patient health record (PHR) as the biggest obstacles to its rapid diffusion. Extending research propositions from the decision sciences and political communication, this study tests the influence of different types of emphasis frames on increasing consumer willingness to pay for the PHR. Using a randomized experiment embedded within a probability survey, the effects of 3 different types of emphasis frames (individual-focused, collective-focused, and joint), along with a no-frames control, are tested on a sample of early and later technology adopters. The results indicate a significant relationship between the type of frame and the type of adopter. Early adopters were more susceptible to individual-focused frames that made causal attributions at the individual level, whereas later adopters were significantly influenced by collective-focused frames that made causal attributions at the societal level. Interestingly, the framing effect continued and significantly influenced both early and later adopters' willingness to pay for the PHR. The findings demonstrate the need to carefully communicate the value of a technology to adopters and suggest the possibility of using frames to spur the diffusion of PHRs.

  5. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    SciTech Connect

    Tuomi, Lisa; Andréll, Paulin

    2014-08-01

    Background: Patients treated with radiation therapy for laryngeal cancer often experience voice problems. The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist. Methods and Materials: Sixty-nine male patients irradiated for laryngeal cancer participated. Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy. Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group. Furthermore, comparisons with 23 healthy control individuals were made. Acoustic analyses were performed for all patients, including the healthy control individuals. The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function. Results: The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation. Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function, whereas the control group did not. Conclusion: Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements. The patients experienced better voice function after rehabilitation. Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes. Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy, particularly for patients with supraglottic tumors.

  6. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  7. Costing and cost analysis in randomized controlled trials: caveat emptor.

    PubMed

    Polsky, Daniel; Glick, Henry

    2009-01-01

    This article provides an overview of the central issues regarding cost valuation and analysis for a decision maker's evaluation of costing performed within randomized controlled trials (RCTs). Costing involves specific choices for valuation and analysis that involve trade-offs. Understanding these choices and their implications is necessary for proper evaluation of how costs are valued and analyzed within an RCT and cannot be assessed through a checklist of adherence to general principles. Resource costing, the most common method of costing, involves measuring medical service use in study case report forms and translating this use into a cost by multiplying the number of units of each medical service by price weights for those services. A choice must be made as to how detailed the measurement of resources will be. Micro-costing improves the specificity of the cost estimate, but it is often impractical to precisely measure resources at this level and the price weights for these micro-units may not be available. Gross-costing may be more practical, and price weights are often easier to find and are more reliable, but important resource differences between treatment groups may be lost in the bundling of resources. Price weights can either be nationally determined or centre specific, but the appropriate price weight will depend on perspective, convenience, completeness and accuracy. Identifying the resource types and the appropriate price weights for these resources are the essential elements to an accurate valuation of costs. Once medical services are valued, the resulting individual patient cost estimates must be analysed. The difference in the mean cost between treatment groups is the important summary statistic for cost-effectiveness analysis from both the budgetary and the social perspectives. The statistical challenges with cost data typically stem from its skewed distribution and the resulting possibility that the sample mean may be inefficient and possibly

  8. The Impact of Classroom Physical Activity Breaks on Middle School Students' Health-Related Fitness: An Xbox One Kinetic Delivered 4-Week Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Yli-Piipari, S.; Layne, T.; McCollins, T.; Knox, T.

    2016-01-01

    The aim of the study was to examine the effect of a 4-week classroom physical activity break intervention on middle school students' health-related physical fitness. The study was a randomized controlled trial with students assigned to the experiment and control conditions. A convenience sample comprised 94 adolescents (experiment group n = 52;…

  9. A Controlled Shear Decorrelation Experiment (CSDX)

    NASA Astrophysics Data System (ADS)

    Tynan, George

    1999-11-01

    The controlled shear de-correlation experiment (CSDX) is being designed to study the effect of sheared flows on: (1) known linear pressure gradient-driven drift and/or effective gravity-driven flute eigenmodes; (2) the nonlinear three-wave coupling of a finite number of large amplitude coherent modes; and (3) on the rate of electrostatic turbulent fluctuation energy cascades. This research is motivated by magnetic confinement experiments and theory which suggest that sheared E x B shear flows lead to a nonlinear de-correlation of plasma turbulence. The plasma state (i.e. quiescent, single small-amplitude drift wave, nonlinearly coupled modes, or strongly turbulent) will be controlled by varying the magnetic field strength, collisionality, parallel current, and/or effective gravity due to solid-body plasma rotation driven by azimuthal ExB drifts. The radial electric field strength and shear rate will be controlled independently of the plasma state by the application of externally controlled voltages to concentric annular rings which will form the ends of the experimental region. Diagnostics include azimuthal, radial, and axial Langmuir probe arrays, laser induced flourescence (LIF) for ion temperature and equilibrium ExB flow velocities. Bi-spectral analysis techniques will be used to measure k-space resolved linear growth rates and nonlinear energy cascading due to three-wave coupling in the presence of flow shear. Designs and experimental plans will be presented and discussed.

  10. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  11. 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

  12. 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, protocols, and procedures...Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine, and pill placebo in the...21702 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited The views, opinions

  13. Computer Control of a Random Access Slide Projector.

    ERIC Educational Resources Information Center

    Barker, Philip G.

    1982-01-01

    A description of a simple interface to enable the interconnection of a random access slide projector and a microcomputer is provided, as well as summaries of the role of slide images as a means of implementing graphic communication and the new activity in graphics as an area of information processing. The microcomputer interface is then detailed,…

  14. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small-group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to 1 of 3 groups (n = 44 in each…

  15. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  16. The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

  17. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  18. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

    ERIC Educational Resources Information Center

    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  19. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  20. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    ERIC Educational Resources Information Center

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  1. Key Items to Get Right When Conducting a Randomized Controlled Trial in Education

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2005

    2005-01-01

    This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…

  2. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  3. Basic radiological studies contamination control experiments

    SciTech Connect

    Duce, S.W.; Winberg, M.R.; Freeman, A.L.

    1989-09-01

    This report describes the results of experiments relating to contamination control performed in support of the Environmental Restoration Programs Retrieval Project. During the years 1950 to 1970 waste contaminated with plutonium and other transuranic radionuclides was disposed of in shallow land-filled pits and trenches at the Idaho National Engineering Laboratory. Due to potential for migration of radionuclides to an existing aquifer the feasibility of retrieving and repackaging the waste for placement in a final repository is being examined as part of a retrieval project. Contamination control experiments were conducted to determine expected respirable and nonrespirable plutonium contaminated dust fractions and the effectiveness of various dust suppression techniques. Three soil types were tested to determine respirable fractions: Rocky Flats Plant generic soil, Radioactive Waste Management Complex generic soil, and a 1:1 blend of the two soil types. Overall, the average respirable fraction of airborne dust was 5.4% by weight. Three contamination control techniques were studied: soil fixative sprays, misting agents, and dust suppression agents. All of the tested agents proved to be effective in reducing dust in the air. Details of product performance and recommended usage are discussed.

  4. Empowerment of personal injury victims through the internet: design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI) victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. Methods/design The study is a two armed, randomized controlled trial (RCT), in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1) an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2) an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old. The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization), at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention-to-treat principle. Discussion This

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

    DTIC Science & Technology

    2013-10-01

    AD_________________ Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure...SUBTITLE A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans 5a. CONTRACT NUMBER...will: 1) evaluate effects of Transcendental Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician

  6. Village sanitation and child health: Effects and external validity in a randomized field experiment in rural India.

    PubMed

    Hammer, Jeffrey; Spears, Dean

    2016-07-01

    Over a billion people worldwide defecate in the open, with important consequences for early-life health and human capital accumulation in developing countries. We report a cluster randomized controlled trial of a village sanitation intervention conducted in rural Maharashtra, India designed to identify an effect of village sanitation on average child height, an outcome of increasing importance to economists. We find an effect of approximately 0.3 height-for-age standard deviations, which is consistent with observations and hypotheses in economic and health literatures. We further exploit details of the planning and implementation of the experiment to study treatment heterogeneity and external validity.

  7. Laser acupuncture reduces pain in pediatric kidney biopsies: a randomized controlled trial.

    PubMed

    Oates, Aris; Benedict, Kelly A; Sun, Karen; Brakeman, Paul R; Lim, Jessica; Kim, Cynthia

    2017-01-01

    Evaluate laser acupuncture (LA) as an adjuvant therapy in pain management during percutaneous kidney biopsy procedure in children and adolescents. This prospective, double-blinded, randomized controlled trial enrolled patients aged 7 to 26 years admitted to a children's hospital for percutaneous kidney biopsy. Patients received LA to treatment points (acupuncture group) or sham points (control group) before the procedure. The laser delivered a dose of 42 J/cm over 10 acupoints. Patients and parents rated the pain during and after the biopsy, and change in pain scores were calculated for each patient. Anxiety, vital signs, sedation medication, and patient's biopsy experience were secondary outcomes. Sixty-nine treatments (33 in the acupuncture group and 36 in the control group) were eligible for analysis. Patients in the acupuncture group reported a significantly improved change in the pain score after the biopsy compared with the controls (0.8 vs -0.5, P = 0.044). Patients in the acupuncture group had a statistically significant decrease in procedure vital signs including heart rate (-1.8 vs 5.6, P = 0.043) and respiratory rate (-2.4 vs 0.4, P = 0.045) when compared with controls. Parents also perceived a correspondingly greater improvement in their child's pain for those in the acupuncture group compared with the controls (2.3 vs 0.3, P = 0.04). Adjunctive LA significantly improved pain after pediatric percutaneous kidney biopsies.

  8. APECS - the Atacama pathfinder experiment control system

    NASA Astrophysics Data System (ADS)

    Muders, D.; Hafok, H.; Wyrowski, F.; Polehampton, E.; Belloche, A.; König, C.; Schaaf, R.; Schuller, F.; Hatchell, J.; van der Tak, F.

    2006-08-01

    APECS is the distributed control system of the new Atacama Pathfinder EXperiment (APEX) telescope located on the Llano de Chajnantor at an altitude of 5107 m in the Atacama desert in northern Chile. APECS is based on Atacama Large Millimeter Array (ALMA) software and employs a modern, object-oriented design using the Common Object Request Broker Architecture (CORBA) as the middleware. New generic device interfaces simplify adding instruments to the control system. The Python based observer command scripting language allows using many existing software libraries and facilitates creating more complex observing modes. A new self-descriptive raw data format (Multi-Beam FITS or MBFITS) has been defined to store the multi-beam, multi-frequency data. APECS provides an online pipeline for initial calibration, observer feedback and a quick-look display. APECS is being used for regular science observations in local and remote mode since August 2005.

  9. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    PubMed Central

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel  only and plain gel with diclofenac suppository in a randomized control trial. METHODS:  A total of 60 male patients with an indication of flexible cystoscopy were enrolled in a prospective, randomized controlled study. Patients were randomized in two groups. In group “A”, patients received diclofenac suppository one hour prior to the procedure while group “B” did not receive diclofenac suppository. Both groups received 10 ml of intra-urethral  plain gel for lubrication during flexible cystoscopy. Pain score was recorded immediately after the procedure using the visual analogue scale (VAS). Pre- and post-procedure pulse rate and systolic blood pressure was also recorded. Statistical analyses were performed using chi-square test and student t-test. Regression analysis was performed to address the confounding variables. RESULTS: Both groups were comparable for variables including age, duration of procedure, level of operating surgeon and indication of procedure. Most common indication for flexible cystoscopy was removal of double J stent. There was a statistically significant difference in the mean pain score between two groups ( p = 0.012).  The difference in post-procedure mean pulse rate in the two groups was statistically significant ( p= 0.01) however there was no difference observed in mean post procedure systolic blood pressure. Regression analysis showed that none of the confounding variables were significantly affecting pain perception. CONCLUSIONS: Intra rectal diclofenac suppository is simple and effective pre-emptive analgesia. We recommend its routine use during flexible cystoscopy for better pain control.

  10. Low Dimension Dynamics in the EPRB Experiment with Random Variable Analyzers

    NASA Astrophysics Data System (ADS)

    Hnilo, Alejandro A.; Kovalsky, Marcelo G.; Santiago, Guillermo

    2007-01-01

    The Einstein Podolsky Rosen Bohm (EPRB) experiment performed with random variable and spatially separated analyzers is a milestone test in the controversy between Objective Local Theories (OLT) and Quantum Mechanics (QM). Only a few OLT are still possible. Some of the surviving OLT (specifically, the so called non-ergodic theories) would be undetectable in the averaged statistical values, but they may leave their trace in the time dynamics. For, while QM predicts random processes, the OLT of this kind predict the existence of regularities that may be revealed as a low dimensional object in the phase space. We perform a numerical analysis of the time-resolved data recorded in that experiment to unveil any hypothetical low dimensional dynamics that may be present. We find no consistent indication of such dynamics except for one data file, the longest of all in the real time. The possible causes of these dynamics are discussed.

  11. A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis.

    PubMed

    McCann, Terence V; Lubman, Dan I; Cotton, Sue M; Murphy, Brendan; Crisp, Kingsley; Catania, Lisa; Marck, Claudia; Gleeson, John F M

    2013-11-01

    Caring for young people with first-episode psychosis (FEP) is challenging and can adversely affect carer well-being, with limited evidence-based support materials available. We aimed to examine whether completion of a self-directed problem-solving bibliotherapy among carers of young people with FEP led to a better experience of caring, less distress and expressed emotion, and better general health than carers who only received treatment as usual (TAU). A randomized controlled trial was conducted across two early-intervention psychosis services in Melbourne, Australia. A total of 124 carers were randomized to problem-solving bibliotherapy intervention (PSBI) or TAU and assessed at baseline, 6-week and 16-week follow-up. Intent-to-treat analyses were carried out and indicated that recipients of PSBI had a more favorable experience of caring than those receiving TAU, and these effects were sustained at both follow-up time points. Across the other measures, both groups demonstrated improvements by week 16, although the PBSI group tended to improve earlier. The PSBI group experienced a greater reduction in negative emotional evaluations of the need to provide additional support to young people with FEP than the TAU group by week 6, while the level of psychological distress decreased at a greater rate from baseline to 6 weeks in the PSBI compared with the TAU group. These findings support the use of problem-solving bibliotherapy for first-time carers, particularly as a cost-effective adjunct to TAU.

  12. The debate: a case for randomized controls in invasive aspergillosis.

    PubMed

    Bennett, John E

    2006-09-01

    Randomized trials in invasive aspergillosis have evolved over the past decade. Definitions of disease now include specifics of the underlying disease and how this affects interpretation of certain tests, including high resolution computed tomography and smears or cultures of sputum and bronchoalveolar lavage. Study hypotheses have changed from underpowered superiority trials to adequately powered noninferiority trials. Consensus building between Europe and North America has allowed trials to be conducted with the same protocol in both regions, thereby increasing study enrollment. In aggregate, the following outcomes can be drawn from randomized trials: (i) Liposomal amphotericin B is possibly superior to conventional amphotericin B at 14 days and less toxic. Whether the dose of liposomal amphotericin is 1 or 4 mg/kg daily is not as important as other factors in determining outcome of possible aspergillosis; (ii) amphotericin B colloidal dispersion is less nephrotoxic but has more acute infusion-related reactions than conventional amphotericin B; (iii) starting treatment with voriconazole is superior to starting with conventional amphotericin B. In an era of increasing cost containment, it will be the randomized trials that provide the clinician with the information needed to avoid inappropriate use of expensive drugs and drug combinations.

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

    PubMed Central

    2014-01-01

    Background 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. Methods/Design 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. Discussion 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. Trial registration Current Controlled Trials ISRCTN52982308 (registered 27 June 2013). PMID:24965551

  14. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    PubMed Central

    2012-01-01

    Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost effectiveness of remifentanil as

  15. Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study

    PubMed Central

    Nidich, Sanford; Seng, Angela; Compton, Blaze; O’Connor, Tom; Salerno, John W; Nidich, Randi

    2017-01-01

    Context: Compared with the general population, trauma experiences are higher among incarcerated women. Objective: To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Design: Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Main Outcome Measures: Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Results: Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. Conclusion: The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted. PMID:28333611

  16. Enhancing Foster Parent Training with Parent-Child Interaction Therapy: Evidence from a Randomized Field Experiment

    PubMed Central

    Mersky, Joshua P.; Topitzes, James; Janczewski, Colleen E.; McNeil, Cheryl B.

    2015-01-01

    Objective Research indicates that foster parents often do not receive sufficient training and support to help them meet the demands of caring for foster children with emotional and behavioral disturbances. Parent-Child Interaction Therapy (PCIT) is a clinically efficacious intervention for child externalizing problems, and it also has been shown to mitigate parenting stress and enhance parenting attitudes and behaviors. However, PCIT is seldom available to foster families, and it rarely has been tested under intervention conditions that are generalizable to community-based child welfare service contexts. To address this gap, PCIT was adapted and implemented in a field experiment using 2 novel approaches—group-based training and telephone consultation—both of which have the potential to be integrated into usual care. Method This study analyzes 129 foster-parent-child dyads who were randomly assigned to 1 of 3 conditions: (a) waitlist control, (b) brief PCIT, and (c) extended PCIT. Self-report and observational data were gathered at multiple time points up to 14 weeks post baseline. Results Findings from mixed-model, repeated measures analyses indicated that the brief and extended PCIT interventions were associated with a significant decrease in self-reported parenting stress. Results from mixed-effects generalized linear models showed that the interventions also led to significant improvements in observed indicators of positive and negative parenting. The brief course of PCIT was as efficacious as the extended PCIT intervention. Conclusions The findings suggest that usual training and support services can be improved upon by introducing foster parents to experiential, interactive PCIT training. PMID:26977251

  17. Robotic Compared With Laparoscopic Sacrocolpopexy: A Randomized Controlled Trial

    PubMed Central

    Anger, Jennifer T.; Mueller, Elizabeth R.; Tarnay, Christopher; Smith, Bridget; Stroupe, Kevin; Rosenman, Amy; Brubaker, Linda; Bresee, Catherine; Kenton, Kimberly

    2014-01-01

    Objective: Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy. Methods: Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared surgical costs (including costs for robot, initial hospitalization) and re-hospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events. Results: We randomized 78 women [mean age 59 years]: laparoscopic (n=38), robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 vs. $11,573, p < 0.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 vs. $12,170, p < 0.001). When we excluded costs of robot purchase and maintenance, we did not detect a statistical difference in initial day of surgery costs of robotic vs. laparoscopic ($12,586 vs. $11,573; p = 0.160) or hospital costs over 6 weeks ($13,867 vs. $12,170; p = 0.060). The robotic group had longer operating room times (202.8 min vs. 178.4 min, p = 0.030) and higher pain scores 1-week after surgery (3.5 ± 2.1 vs. 2.6 ± 2.2; p = 0.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events. Conclusion: Costs of robotic sacrocolpopexy are higher than laparoscopic, while short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. PMID:24463657

  18. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

    PubMed

    Allison, David B; Gadde, Kishore M; Garvey, William Timothy; Peterson, Craig A; Schwiers, Michael L; Najarian, Thomas; Tam, Peter Y; Troupin, Barbara; Day, Wesley W

    2012-02-01

    A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.

  19. The effect of chest expansion resistance exercise in chronic stroke patients: a randomized controlled trial

    PubMed Central

    Kim, Chang-Beom; Shin, Jun-Ho; Choi, Jong-Duk

    2015-01-01

    [Purpose] The aim of this study was to examine the initial effects of chest expansion resistance exercise (CERE) applied to chronic stroke patients on their pulmonary functions, chest expansion, and functional gait ability. [Subjects] Forty chronic stroke patients without any respiration-related rehabilitation program experience (21 men and 19 women; times elapsed since occurrence of stroke: 21.8 ± 5.3 months) were randomly and equally allocated to a CERE group (experimental group) and a control group. [Methods] An ordinary stroke rehabilitation program was performed on the subjects. While the experimental group received a CERE intervention, the control group performed passive range of motion exercise with automatic instruments. [Results] The CERE group’s chest expansion significantly increased after the intervention, whereas the control group did not see any significant difference. As regards VC (vital capacity), FVC (forced vital capacity), and FEV1 (forced expiratory volume in one second), there were no significant changes in either the CERE or control group. In the 10MTWT (10-meter timed walking test), there were no significant changes in either group, but in the 6MWT (6-minute walk test), while there were no significant differences in the control group, the CERE group saw significant changes. [Conclusion] The results of application of CERE to chronic stroke patients demonstrated the importance of respiratory exercise in an approach to stroke rehabilitation treatment intervention and the need to add respiratory exercise to a rehabilitation intervention program. PMID:25729188

  20. Randomized controlled trial of benzocaine versus placebo spray for pain relief at hysterosalpingogram.

    PubMed

    Bachman, E A; Senapati, S; Sammel, M D; Kalra, S K

    2014-06-01

    Many women experience pain during hysterosalpingogram (HSG). This prospective, randomized, double-blinded, placebo-controlled study assessed whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, parity, pre-procedure oral analgesic use and history of dysmenorrhoea and/or chronic pelvic pain. Median change in pain score from baseline to procedure was 50.6mm (-7.4 to 98.8mm) in the benzocaine group and 70.4mm (19.8 to 100mm) in the placebo group. There was no difference between groups after adjusting for history of dysmenorrhoea. There was no difference in resolution of pain in benzocaine versus placebo groups at 5 min post procedure--median pain score difference -11.1 (-90.1 to 18.5) versus -37.0 (-100 to 1.2)--or at 30 min post procedure. Satisfaction scores did not differ by treatment and did not correlate with pain score during the procedure (rho=0.005). The use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Many women experience pain during hysterosalpingogram (HSG), which is a test used to evaluate the uterine cavity and fallopian tube. We conducted a prospective, randomized, double-blinded, placebo-controlled study to assess whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, previous pregnancies, pre-procedure oral analgesic use and history of dysmenorrhoea (painful periods) and/or chronic pelvic pain. There was no difference in pain scores or resolution of pain between the two groups. Satisfaction scores did not differ by treatment group

  1. Meaningful Effect Sizes, Intra-Class Correlations, and Proportions of Variance Explained by Covariates for Planning 3 Level Cluster Randomized Experiments in Prevention Science

    ERIC Educational Resources Information Center

    Dong, Nianbo; Reinke, Wendy M.; Herman, Keith C.; Bradshaw, Catherine P.; Murray, Desiree W.

    2015-01-01

    Cluster randomized experiments are now widely used to examine intervention effects in prevention science. It is meaningful to use empirical benchmarks for interpreting effect size in prevention science. The effect size (i.e., the standardized mean difference, calculated by the difference of the means between the treatment and control groups,…

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

    DTIC Science & Technology

    2014-10-01

    Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and...COVERED 30 Sep 2013 - 29 Sep 2014 4. TITLE AND SUBTITLE A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education... Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician Administered PTSD Scale (CAPS) (primary

  3. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention

    PubMed Central

    Bomyea, Jessica; Stein, Murray B.; Lang, Ariel J.

    2015-01-01

    Post-traumatic stress disorder (PTSD) is a chronic and debilitating condition characterized by persistent intrusive memories. Although effective treatments exist for PTSD, there is a need for development of alternative treatments. Diminished ability to control proactive interference may contribute to re-experiencing symptoms and may be a novel intervention target. The present study tested an intervention designed to modify proactive interference control. Forty-two women with PTSD were randomly assigned to a computerized cognitive training or a control condition. The impact of these programs on cognitive performance and symptoms was assessed. PTSD re-experiencing symptoms and interference control performance improved significantly more for individuals in the training group relative to those in the control group. Other PTSD and general distress symptoms improved equally over time in both groups. Cognitive training of this type may hold promise as a novel intervention for reducing PTSD symptoms, although the mechanism of action and implications for models of PTSD requires future study. PMID:26114901

  4. Experiment-Based Teaching in Advanced Control Engineering

    ERIC Educational Resources Information Center

    Precup, R.-E.; Preitl, S.; Radac, M.-B.; Petriu, E. M.; Dragos, C.-A.; Tar, J. K.

    2011-01-01

    This paper discusses an experiment-based approach to teaching an advanced control engineering syllabus involving controlled plant analysis and modeling, control structures and algorithms, real-time laboratory experiments, and their assessment. These experiments are structured around the representative case of the longitudinal slip control of an…

  5. Control problem for diffusion-type random fields

    SciTech Connect

    Knopov, P.S.; Derieva, E.N.

    1995-09-01

    Sufficient existence conditions are given for optimal control in a system described by a stochastic differential equations. These conditions are derived by Girsanov`s method of transformation of measures. Existence of {epsilon}-optimal controls is proved and a method of their construction is described.

  6. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    PubMed

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  7. Randomized controlled trial of sealed in-office bleaching effectiveness.

    PubMed

    Santana, Mário Artur Pereira; Nahsan, Flávia Pardo Salata; Oliveira, Alaíde Hermínia de Aguiar; Loguércio, Alessandro Dourado; Faria-e-Silva, André Luis

    2014-01-01

    Regardless of the high success rate, patients commonly report the occurrence of tooth sensitivity during the in-office bleaching procedures. Recently, it has been demonstrated that using a customized tray (called sealed in-office bleaching technique) reduces peroxide penetration. The aim of this randomized clinical study was to evaluate tooth sensitivity and bleaching efficacy of sealed bleaching, in comparison with a conventional in-office technique. Twenty patients were randomized allocated in two groups in which 35% hydrogen peroxide gel was used in a single 45-min application. For the sealed technique, a customized bleaching tray was fabricated and carefully positioned over the bleaching agent during the session. The color was recorded at a baseline, 7 and 28 days after the bleaching session, using Vita Easy Shade spectrophotometer. Tooth sensitivity was recorded during (20 and 40 min) and immediately after the treatment using a visual analogue scale. The bleaching efficacy was evaluated by repeated-measures ANOVA, while the absolute risk of tooth sensitivity and its intensity were evaluated by Fisher's exact and Mann-Whitney tests, respectively (α=0.05). No significant difference on bleaching efficacy was observed between the conventional (7.4 and 8.1 ΔE) and sealed techniques (7.8 and 8.3 ΔE) at both evaluation periods. No significant difference was observed regarding the absolute risk of tooth sensitivity (p=0.15). Sealed technique showed a significant decrease of sensitivity intensity after 40 min (p=0.03). Sealed bleaching technique was able to reduce the sensitivity intensity during the bleaching procedure, without jeopardizing the bleaching efficacy.

  8. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial

    PubMed Central

    Spillane, Nichea S.; Day, Anne M.; Cioe, Patricia A.; Parks, Acacia; Leventhal, Adam M.; Brown, Richard A.

    2015-01-01

    Objective: Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). Method: Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. Results: Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). Conclusion: This trial suggests substantial promise for incorporating PPT into smoking cessation treatment. PMID:25646352

  9. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

    PubMed Central

    Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

  10. Randomized controlled trials and challenge trials: design and criterion for validity.

    PubMed

    Sargeant, J M; Kelton, D F; O'Connor, A M

    2014-06-01

    This article is the third of six articles addressing systematic reviews in animal agriculture and veterinary medicine. This article provides an overview of clinical trials, both randomized controlled trials (RCTs) and challenge trials, where the disease outcome is deliberately induced by the investigator. RCTs are not the only study design used in systematic reviews, but are preferred when available as the gold standard for evaluating interventions under real-world conditions. RCTs are planned experiments, which involve diseased or at-risk study subjects and are designed to evaluate interventions (therapeutic treatments or preventive strategies, including antibiotics, vaccines, management practices, dietary changes, management changes or lifestyle changes). Key components of the RCT are the use of one or more comparison (control) groups and investigator control over intervention allocation. Important design features in RCTs include as follows: how the population is selected, approach to allocation of intervention and control group subjects, how allocation is concealed prior to enrolment of study subjects, how outcomes are defined, how allocation to group is concealed (blinding) and how withdrawals from the study are managed. Guidelines for reporting important features of RCTs have been published and are useful tools for writing, reviewing and reading reports of RCTs.

  11. Intradialytic Massage for Leg Cramps Among Hemodialysis Patients: a Pilot Randomized Controlled Trial

    PubMed Central

    Mastnardo, Diane; Lewis, Janice M.; Hall, Kristi; Sullivan, Catherine M.; Cain, Katrice; Theurer, Jacqueline; Huml, Anne; Sehgal, Ashwini R.

    2016-01-01

    Background Patients on hemodialysis often experience muscle cramps that result in discomfort, shortened treatment times, and inadequate dialysis dose. Cramps have been associated with adversely affecting sleep and health-related quality of life, depression and anxiety. There is limited evidence available about massage in dialysis; however, massage in cancer patients has demonstrated decreases in pain, inflammation, and feelings of anxiety. These correlations indicate massage may be an effective treatment modality for hemodialysis-related lower extremity cramping. Purpose To determine the effectiveness of intradialytic massage on the frequency of cramping among hemodialysis patients prone to lower extremity cramping. Participants 26 maintenance hemodialysis patients with frequent lower extremity cramps. Setting three outpatient hemodialysis centers in Northeast Ohio. Research Design randomized controlled trial. Intervention The intervention group received a 20-minute massage of the lower extremities during each treatment (three times per week) for two weeks. The control group received usual care by dialysis center staff. Main Outcome Measure change in frequency of lower leg cramping. Results Patient reported cramping at home decreased by 1.3 episodes per week in the intervention group compared to 0.2 episodes per week in the control group (p=.005). Patient reported cramping during dialysis decreased by 0.8 episodes in the intervention group compared to 0.4 episodes in the control group (p=0.44). Conclusion Intradialytic massage appears to be an effective way to address muscle cramping. Larger studies with longer duration should be conducted to further examine this approach. PMID:27257445

  12. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    ERIC Educational Resources Information Center

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  13. The Late Pretest Problem in Randomized Control Trials of Education Interventions

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2010-01-01

    Pretest-posttest experimental designs often are used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data often are collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  14. The Late Pretest Problem in Randomized Control Trials of Education Interventions. NCEE 2009-4033

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2008-01-01

    Pretest-posttest experimental designs are often used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data are often collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  15. Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

    2017-01-01

    Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

  16. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  17. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  18. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  19. Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

    2016-01-01

    This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

  20. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  1. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    ERIC Educational Resources Information Center

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  2. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  3. Preventing Relapse/Recurrence in Recurrent Depression With Cognitive Therapy: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bockting, Claudi L. H.; Schene, Aart H.; Spinhoven, Philip; Koeter, Maarten W. J.; Wouters, Luuk F.; Huyser, Jochanan; Kamphuis, Jan H.

    2005-01-01

    This article reports on the outcome of a randomized controlled trial of cognitive group therapy (CT) to prevent relapse/recurrence in a group of high-risk patients diagnosed with recurrent depression. Recurrently depressed patients (N = 187) currently in remission following various types of treatment were randomized to treatment as usual,…

  4. Randomized block experimental designs can increase the power and reproducibility of laboratory animal experiments.

    PubMed

    Festing, Michael F W

    2014-01-01

    Randomized block experimental designs have been widely used in agricultural and industrial research for many decades. Usually they are more powerful, have higher external validity, are less subject to bias, and produce more reproducible results than the completely randomized designs typically used in research involving laboratory animals. Reproducibility can be further increased by using time as a blocking factor. These benefits can be achieved at no extra cost. A small experiment investigating the effect of an antioxidant on the activity of a liver enzyme in four inbred mouse strains, which had two replications (blocks) separated by a period of two months, illustrates this approach. The widespread failure to use these designs more widely in research involving laboratory animals has probably led to a substantial waste of animals, money, and scientific resources and slowed down the development of new treatments for human and animal diseases.

  5. Short-term impact of Experience Corps participation on children and schools: results from a pilot randomized trial.

    PubMed

    Rebok, George W; Carlson, Michelle C; Glass, Thomas A; McGill, Sylvia; Hill, Joel; Wasik, Barbara A; Ialongo, Nicholas; Frick, Kevin D; Fried, Linda P; Rasmussen, Meghan D

    2004-03-01

    This article reports on the short-term impact of a school-based program using older adult volunteers and aimed at improved academic achievement and reduced disruptive classroom behavior in urban elementary school students. The Experience Corps Baltimore (Maryland) program places a critical mass of older adult volunteers, serving 15 hours or more per week, in public schools to perform meaningful and important roles to improve the educational outcomes of children and the health and well-being of the volunteers. This article reports on the preliminary impact of the program on children in grades K-3. A total of 1,194 children in grades K-3 from six urban elementary schools participated in this pilot trial. At follow-up, third grade children whose schools were randomly selected for the program had significantly higher scores on a standardized reading test than children in the control schools, and there was a nonsignificant trend for improvement in alphabet recognition and vocabulary ability among kindergarten children in the program. Office referrals for classroom misbehavior decreased by about half in the Experience Corps schools, but remained the same in the control schools. Teachers had somewhat more favorable attitudes toward senior volunteers as a result of having older volunteers in the classroom, although the difference between the intervention and control schools was not statistically significant. In this pilot trial, the Experience Corps program led to selective improvements in student reading/academic achievement and classroom behavior while not burdening the school staff.

  6. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    PubMed Central

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Results Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p < 0.001), desire (p < 0.001), arousal (p = 0.037), lubrication (p < 0.001), satisfaction (p < 0.001) and pain (p = 0.041) domains of FSFI. Frequency of side effects was similar between the two groups. Conclusions Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted. PMID:24773615

  7. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

    PubMed Central

    Zywiak, William H.; Edwards, Steven M.; Tidey, Jennifer W.; Swift, Robert M.; Kenna, George A.

    2014-01-01

    Rationale There is presently no approved single treatment for dual alcohol and nicotine dependencies. Objective This pilot study investigated baclofen effects in alcoholic smokers. Methods This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. Results Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. Conclusions This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies. PMID:24973894

  8. Laparoscopic Gastric Bypass for Morbid Obesity–a Randomized Controlled Trial Comparing Two Gastrojejunal Anastomosis Techniques

    PubMed Central

    Llopis, Salvador Navarrete; Isaac, Jose; Aulestia, Salvador Navarrete; Bravo, Carlos; Obregon, Francisco

    2008-01-01

    Objectives: We present a randomized controlled trial of laparoscopic gastric bypass comparing 2 techniques of gastrojejunostomy in patients with morbid obesity. Methods: Eighty consecutive patients underwent laparoscopic Roux-en-Y gastric bypass between September 2005 and August 2006. Patients were randomly assigned to 2 groups by the use of sealed envelopes. In group A, the gastrojejunal anastomosis was performed with a 21-mm circular-stapler, and in group B, this anastomosis was performed with a 45-mm linear-stapler. The rest of the procedure was identical in both groups. Variables evaluated were complications involving the gastrojejunostomy, operative time, length of stay, and percentage of excess weight loss. Results: Both groups were similar in age and body mass index. No patients experienced leakage or gastrojejunal anastomosis fistula, but group A patients had a more frequent stricture rate (P<0.05). Operative time and hospital stay were comparable in both groups (P>0.05). Percentage excess weight loss at one year following surgery was satisfactory in both groups, without a statistically significant difference (P>0.05). Conclusion: Gastrojejunal anastomosis does not seem to be a critical factor in excess weight loss for morbidly obese patients who underwent laparoscopic gastric bypass. The 2 techniques used in this experience are safe and effective; however, the 45-mm liner-stapler is preferable because it has a lower stricture rate. PMID:19275854

  9. Portraying mental illness and drug addiction as treatable health conditions: effects of a randomized experiment on stigma and discrimination.

    PubMed

    McGinty, Emma E; Goldman, Howard H; Pescosolido, Bernice; Barry, Colleen L

    2015-02-01

    Despite significant advances in treatment, stigma and discrimination toward persons with mental illness and drug addiction have remained constant in past decades. Prior work suggests that portraying other stigmatized health conditions (i.e., HIV/AIDS) as treatable can improve public attitudes toward those affected. Our study compared the effects of vignettes portraying persons with untreated and symptomatic versus successfully treated and asymptomatic mental illness and drug addiction on several dimensions of public attitudes about these conditions. We conducted a survey-embedded randomized experiment using a national sample (N = 3940) from an online panel. Respondents were randomly assigned to read one of ten vignettes. Vignette one was a control vignette, vignettes 2-5 portrayed individuals with untreated schizophrenia, depression, prescription pain medication addiction and heroin addiction, and vignettes 6-10 portrayed successfully treated individuals with the same conditions. After reading the randomly assigned vignette, respondents answered questions about their attitudes related to mental illness or drug addiction. Portrayals of untreated and symptomatic schizophrenia, depression, and heroin addiction heightened negative public attitudes toward persons with mental illness and drug addiction. In contrast, portrayals of successfully treated schizophrenia, prescription painkiller addiction, and heroin addiction led to less desire for social distance, greater belief in the effectiveness of treatment, and less willingness to discriminate against persons with these conditions. Portrayal of persons with successfully treated mental illness and drug addiction is a promising strategy for reducing stigma and discrimination toward persons with these conditions and improving public perceptions of treatment effectiveness.

  10. Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial

    PubMed Central

    Zheng, Cuihong; Ding, Pei; Tian, Man; Wang, Ying; Dong, Haoxu; Zhang, Mingmin; Wang, Wei; Xu, Shabei; Xie, Minjie

    2017-01-01

    Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p < 0.0001, all). HCI improved the quality of life better than mosapride (p < 0.05) and reduced the proportion of severe constipation more than LCI and mosapride (p < 0.05, both). Conclusions. EA is effective and safe at both current intensities for FC; therapeutic effects of LCI and HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride. PMID:28250788

  11. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... From the Federal Register Online via the Government Publishing Office ] INTERNATIONAL TRADE COMMISSION Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and Products Containing Same; Determination Rescinding the Exclusion Order and Cease and Desist Orders...

  12. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  13. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    PubMed Central

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  14. Comparing Adrenaline with Tranexamic Acid to Control Acute Endobronchial Bleeding: A Randomized Controlled Trial

    PubMed Central

    Fekri, Mitra Samareh; Hashemi-Bajgani, Seyed Mehdy; Shafahi, Ahmad; Zarshenas, Rozita

    2017-01-01

    Background: Hemoptysis occurs due to either pulmonary diseases or bronchoscopy interventions. The aim of the present study was to compare the efficacy of the endobronchial instillation of adrenaline with that of tranexamic acid. Methods: Fifty patients were randomly selected as 2 double-blinded sample groups (n=25). In these patients, bleeding could not be controlled with cold saline lavage during bronchoscopy and they, therefore, required prescription of another medicine. Adrenaline (1 mg) in one group and tranexamic acid (500 mg) in the other group were diluted in 20 mL of normal saline and instilled through the bronchoscope. This technique was repeated 3 times at 90-second intervals, if necessary. In the case of persistent bleeding, 90 seconds after the last dose, a second medicine was given for bleeding control. Observation of clot through the bronchoscope meant that the bleeding had stopped. The efficacy of tranexamic acid and adrenaline was evaluated and then compared using the Mann–Whitney test. Results: The time of bleeding control had no significant difference between tranexamic acid and adrenaline (P=0.908). Another analysis was done to evaluate bleeding control with a second medicine; the results showed that 1 (4%) patient in the tranexamic acid and 8 (32%) in the adrenaline group needed the second medicine and there was no significant difference between the 2 groups (P=0.609). Conclusion: Our results suggested that tranexamic acid by endobronchial instillation was as efficient as adrenaline in controlling hemoptysis and required less frequent use of a second medicine. Trial Registration Number: IRCT2014120220188 PMID:28360438

  15. Wavelength control of random polymer fiber laser based on adaptive disorder.

    PubMed

    Hu, Zhijia; Gao, Pengfei; Xie, Kang; Liang, Yunyun; Jiang, Haiming

    2014-12-15

    We demonstrate the realization of two different kinds of random polymer optical fiber lasers to control the random lasing wavelength by changing the disorder of polymer optical fibers (POFs). One is a long-range disorder POF based on copolymer refractive-index inhomogeneity, and the other is a short-range disorder POF based on polyhedral oligomeric silsesquioxanes scattering. By end pumped both disorder POFs, the coherent random lasing for both is observed. Meanwhile, the random lasing wavelength of the short-range disorder POF because of a small scattering mean-free path has been found to be blue shifted with respect to the long-range disorder POF, which will give a way to control the random lasing wavelength.

  16. Enhanced Attitude Control Experiment for SSTI Lewis Spacecraft

    NASA Technical Reports Server (NTRS)

    Maghami, Peoman G.

    1997-01-01

    The enhanced attitude control system experiment is a technology demonstration experiment on the NASA's small spacecraft technology initiative program's Lewis spacecraft to evaluate advanced attitude control strategies. The purpose of the enhanced attitude control system experiment is to evaluate the feasibility of designing and implementing robust multi-input/multi-output attitude control strategies for enhanced pointing performance of spacecraft to improve the quality of the measurements of the science instruments. Different control design strategies based on modern and robust control theories are being considered for the enhanced attitude control system experiment. This paper describes the experiment as well as the design and synthesis of a mixed H(sub 2)/H(sub infinity) controller for attitude control. The control synthesis uses a nonlinear programming technique to tune the controller parameters and impose robustness and performance constraints. Simulations are carried out to demonstrate the feasibility of the proposed attitude control design strategy. Introduction

  17. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial

    PubMed Central

    Chi, Lee-Mei; Lin, Li-Mei; Chen, Chien-Lin; Wang, Shu-Fang; Lai, Hui-Ling; Peng, Tai-Chu

    2016-01-01

    The research aimed to investigate the effectiveness of cupping therapy (CT) in changes on skin surface temperature (SST) for relieving chronic neck and shoulder pain (NSP) among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS), and blood pressure (BP). The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI) severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001). One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT. PMID:27073404

  18. Model predictive control for tracking randomly varying references

    NASA Astrophysics Data System (ADS)

    Falugi, Paola

    2015-04-01

    This paper proposes a model predictive control scheme for tracking a-priori unknown references varying in a wide range and analyses its performance. It is usual to assume that the reference eventually converges to a constant in which case convergence to zero of the tracking error can be established. In this note we remove this simplifying assumption and characterise the set to which the tracking error converges and the associated region of convergence.

  19. Surface segregation of fluorinated moieties on random copolymer films controlled by random-coil conformation of polymer chains in solution.

    PubMed

    Xue, Dongwu; Wang, Xinping; Ni, Huagang; Zhang, Wei; Xue, Gi

    2009-02-17

    The relationship between solution properties, film-forming methods, and the solid surface structures of random copolymers composed of butyl methacrylate and dodecafluorheptyl methylacrylate (DFHMA) was investigated by contact angle measurements, X-ray photoelectron spectroscopy, sum frequency generation vibrational spectroscopy, and surface tension measurements. The results, based on thermodynamic considerations, demonstrated that the random copolymer chain conformation at the solution/air interface greatly affected the surface structure of the resulting film, thereby determining the surface segregation of fluorinated moieties on films obtained by various film-forming techniques. When the fluorinated monomer content of the copolymer solution was low, entropic forces dominated the interfacial structure, with the perfluoroalkyl groups unable to migrate to the solution/air interface and thus becoming buried in a random-coil chain conformation. When employing this copolymer solution for film preparation by spin-coating, the copolymer chains in solution were likely extended due to centrifugal forces, thereby weakening the entropy effect of the polymer chains. Consequently, this resulted in the segregation of the fluorinated moieties on the film surface. For the films prepared by casting, the perfluoroalkyl groups were, similar to those in solution, incapable of segregating at the film surface and were thus buried in the random-coil chains. When the copolymers contained a high content of DFHMA, the migration of perfluoroalkyl groups at the solution/air interface was controlled by enthalpic forces, and the perfluoroalkyl groups segregated at the surface of the film regardless of the film-forming technique. The aim of the present work was to obtain an enhanced understanding of the formation mechanism of the chemical structure on the surface of the polymer film, while demonstrating that film-forming methods may be used in practice to promote the segregation of fluorinated

  20. Controlled Space Physics Experiments using Laboratory Magnetospheres

    NASA Astrophysics Data System (ADS)

    Mauel, M. E.; Kesner, J.; Garnier, D.

    2013-12-01

    Modern society's reliance on space-based platforms for a variety of economic and geopolitical purposes makes understanding the physics of the magnetosphere and "space weather'' one of the most important applications of plasma science. During the past decade, results from the CTX and LDX laboratory magnetospheres and from the RT-1 device at University of Tokyo, we have developed techniques to explore space physics using controlled experiments in laboratory magnetospheres. This presentation briefly reviews observations from the laboratory magnetospheres at Columbia University and MIT, including adiabatic drift-resonant transport, low-frequency MHD turbulence, and the formation of high-beta plasmas with profiles similar to Earth's inner magnetosphere. First principle validation of ``whole plasma'' space weather models have been completed in relevant magnetic geometry, including the spectrum and dynamics of turbulence successfully modeled with nonlinear bounce-averaged gyrokinetic simulations. Plans to explore Alfvénic dynamics and whistler wave trapping are discussed through the achievement of higher-density plasmas using radio-frequency heating. Photographs of the laboratory magnetospheres located at MIT (top) and Columbia University (bottom).

  1. Controlled Space Physics Experiments using Laboratory Magnetospheres

    NASA Astrophysics Data System (ADS)

    Mauel, Michael; Davis, M.; Garnier, D.; Roberts, T. M.; Worstell, M.; Kesner, J.

    2013-10-01

    Modern society's reliance on space-based platforms for a variety of economic and geopolitical purposes makes understanding the physics of the magnetosphere and ``space weather'' one of the most important applications of plasma science. During the past decade, results from the CTX and LDX laboratory magnetospheres and from the RT-1 device at University of Tokyo, we have developed techniques to explore space physics using controlled experiments in laboratory magnetospheres. This presentation briefly reviews observations from the laboratory magnetospheres at Columbia University and MIT, including adiabatic drift-resonant transport, low-frequency MHD turbulence, and the formation of high-beta plasmas with profiles similar to Earth's inner magnetosphere. First principle validation of ``whole plasma'' space weather models have been completed in relevant magnetic geometry, including the spectrum and dynamics of turbulence successfully modeled with nonlinear bounce-averaged gyrokinetic simulations. Plans to explore Alfvénic dynamics and whistler wave trapping are discussed through the achievement of higher-density plasmas using radio-frequency heating. Supported by the NSF-DOE Partnership in Plasma Science.

  2. Effects of Guideline-Based Training on the Quality of Formal Ontologies: A Randomized Controlled Trial

    PubMed Central

    Boeker, Martin; Jansen, Ludger; Grewe, Niels; Röhl, Johannes; Schober, Daniel; Seddig-Raufie, Djamila; Schulz, Stefan

    2013-01-01

    Background The importance of ontologies in the biomedical domain is generally recognized. However, their quality is often too poor for large-scale use in critical applications, at least partially due to insufficient training of ontology developers. Objective To show the efficacy of guideline-based ontology development training on the performance of ontology developers. The hypothesis was that students who received training on top-level ontologies and design patterns perform better than those who only received training in the basic principles of formal ontology engineering. Methods A curriculum was implemented based on a guideline for ontology design. A randomized controlled trial on the efficacy of this curriculum was performed with 24 students from bioinformatics and related fields. After joint training on the fundamentals of ontology development the students were randomly allocated to two groups. During the intervention, each group received training on different topics in ontology development. In the assessment phase, all students were asked to solve modeling problems on topics taught differentially in the intervention phase. Primary outcome was the similarity of the students’ ontology artefacts compared with gold standard ontologies developed by the authors before the experiment; secondary outcome was the intra-group similarity of group members’ ontologies. Results The experiment showed no significant effect of the guideline-based training on the performance of ontology developers (a) the ontologies developed after specific training were only slightly but not significantly closer to the gold standard ontologies than the ontologies developed without prior specific training; (b) although significant differences for certain ontologies were detected, the intra-group similarity was not consistently influenced in one direction by the differential training. Conclusion Methodologically limited, this study cannot be interpreted as a general failure of a guideline

  3. Affect-focused psychodynamic psychotherapy for depression and anxiety through the Internet: a randomized controlled trial

    PubMed Central

    Björklund, Martin; Hornborg, Christoffer; Karlsson, Stina; Hesser, Hugo; Ljótsson, Brjánn; Rousseau, Andréas; Frederick, Ronald J.; Andersson, Gerhard

    2013-01-01

    Background. Psychodynamic psychotherapy is a psychological treatment approach that has a growing empirical base. Research has indicated an association between therapist-facilitated affective experience and outcome in psychodynamic therapy. Affect-phobia therapy (APT), as outlined by McCullough et al., is a psychodynamic treatment that emphasizes a strong focus on expression and experience of affect. This model has neither been evaluated for depression nor anxiety disorders in a randomized controlled trial. While Internet-delivered psychodynamic treatments for depression and generalized anxiety disorder exist, they have not been based on APT. The aim of this randomized controlled trial was to investigate the efficacy of an Internet-based, psychodynamic, guided self-help treatment based on APT for depression and anxiety disorders. Methods. One hundred participants with diagnoses of mood and anxiety disorders participated in a randomized (1:1 ratio) controlled trial of an active group versus a control condition. The treatment group received a 10-week, psychodynamic, guided self-help treatment based on APT that was delivered through the Internet. The treatment consisted of eight text-based treatment modules and included therapist contact (9.5 min per client and week, on average) in a secure online environment. Participants in the control group also received online therapist support and clinical monitoring of symptoms, but received no treatment modules. Outcome measures were the 9-item Patient Health Questionnaire Depression Scale (PHQ-9) and the 7-item Generalized Anxiety Disorder Scale (GAD-7). Process measures were also included. All measures were administered weekly during the treatment period and at a 7-month follow-up. Results. Mixed models analyses using the full intention-to-treat sample revealed significant interaction effects of group and time on all outcome measures, when comparing treatment to the control group. A large between-group effect size of Cohen

  4. Sham Control Methods Used in Ear-Acupuncture/Ear-Acupressure Randomized Controlled Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Yang, Angela Weihong; Zhang, Anthony Lin; May, Brian H.

    2014-01-01

    Abstract Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL®) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo ear-acupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were “high risk” in terms of participants blinding, and 45 RCTs were “high risk” in terms of personnel blinding. Meta-analysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review. PMID:24138333

  5. Improving the Productivity of Education Experiments: Lessons from a Randomized Study of Need-Based Financial Aid

    ERIC Educational Resources Information Center

    Harris, Douglas N.; Goldrick-Rab, Sara

    2012-01-01

    Given scarce resources for evaluation, we recommend that education researchers more frequently conduct comprehensive randomized trials that generate evidence on how, why, and under what conditions interventions succeed or fail in producing effects. Recent experience evaluating a randomized need-based financial aid intervention highlights some of…

  6. Temperature-Controlled Continuous Cold Flow Device after Total Knee Arthroplasty: A Randomized Controlled Trial Study.

    PubMed

    Ruffilli, Alberto; Castagnini, Francesco; Traina, Francesco; Corneti, Isabella; Fenga, Domenico; Giannini, Sandro; Faldini, Cesare

    2016-11-30

    Total knee arthroplasty (TKA) is a widely accepted and successful procedure for end-stage arthritis. Nevertheless, fast-track may be compromised by many factors, such as pain, edema, and blood loss. Cryotherapy has been advocated as a safe and effective strategy to improve the postoperative results, acting on pain, edema, and blood loss. This study is a prospective randomized controlled study, involving 50 patients after primary TKA. A power analysis was performed preoperatively. Twenty-four patients were addressed to a postoperative treatment with a continuous cold flow device (Hilotherm, Hilotherm GmbH, Germany). Twenty-six patients represented the control group, treated with crushed ice packs. All the patients shared the same analgesic strategy and the same rehabilitation protocol. Pain, analgesic consumption, active knee range of motion, drain output, transfusion requirement, and total blood loss were evaluated at different follow-ups (postoperative first, third, and seventh days). The two groups were homogenous for preoperative and intraoperative features. The groups showed no statistically significant differences in all the evaluated parameters. A modest reduction of knee volume was evident after 7 days from surgery (trend). No differences in blood loss were noticed. Continuous cold flow device in the acute postoperative setting after TKA did not show superiority in reducing edema, pain, and blood loss, compared with traditional icing regimen. Thus, due to the costs, it should be reserved to selected cases.

  7. The next step in translational research: lessons learned from the first preclinical randomized controlled trial.

    PubMed

    Llovera, Gemma; Liesz, Arthur

    2016-10-01

    For years, low reproducibility of preclinical trials and poor translation of promising preclinical therapies to the clinic have posed major challenges to translational research in most biomedical fields. To overcome the limitations that stand between experimental and clinical research, international consortia have attempted to establish standardized guidelines for study design and for reporting the resulting data. In addition, multicenter preclinical randomized controlled trials (pRCTs) have been proposed as a suitable tool for 'bridging the gap' between experimental research and clinical trials. We recently reported the design and results of the first such pRCT in which we confirmed the feasibility of using a coordinated approach with standardized protocols in collaboration with independent multinational research centers. However, despite its successes, this first pRCT also had several difficulties, particularly with respect to following the protocols established in the study design and analyzing the data. Here, we review our experiences performing the study, and we analyze and discuss the lessons learned from performing the first pRCT. Moreover, we provide suggestions regarding how obstacles can be overcome to improve the performance and outcome of future pRCT studies. Translational research is hampered by low reproducibility of preclinical studies and countless failed clinical trials. International consortia have proposed preclinical multicenter trials as an intermediate step to overcome this 'translational roadblock'. We have recently performed the first such preclinical randomized controlled trial (pRCT) by adopting key elements of clinical study design to preclinical research. In this review, we discuss the lessons learned from this trial and provide suggestions how to optimize future pRCTs. This article is part of the 60th Anniversary special issue.

  8. A random cell motility gradient downstream of FGF controls elongation of an amniote embryo

    PubMed Central

    Bénazéraf, Bertrand; Francois, Paul; Baker, Ruth E.; Denans, Nicolas; Little, Charles D.; Pourquie, Olivier

    2011-01-01

    Vertebrate embryos are characterized by an elongated antero-posterior (AP) body axis, which forms by progressive cell deposition from a posterior growth zone in the embryo. Here, we used tissue ablation in the chicken embryo to demonstrate that the caudal presomitic mesoderm (PSM) plays a key role in axis elongation. Using time-lapse microscopy, we analysed the movements of fluorescently labelled cells in the PSM during embryo elongation which revealed a clear posterior-to-anterior gradient of cell motility and directionality in the PSM. We tracked the movement of the PSM extracellular matrix in parallel with the labelled cells and subtracted the extracellular matrix movement from the global motion of cells. After subtraction, cell motility remained graded but lacked directionality, indicating that the posterior cell movements associated with axis elongation in the PSM are not intrinsic but reflect tissue deformation. The gradient of cell motion along the PSM parallels the fibroblast growth factor (FGF)/mitogen-activated protein kinase (MAPK) gradient 1, which has been implicated in the control of cell motility in this tissue2. Both FGF signalling gain- and loss-of-function experiments lead to disruption of the motility gradient and a slowing down of axis elongation. Furthermore, embryos treated with cell movement inhibitors (Blebbistatin or RhoK inhibitor), but not cell cycle inhibitors, show a slower axis elongation rate. We propose that the gradient of random cell motility downstream of FGF signalling in the PSM controls posterior elongation in the amniote embryo. Our data suggest that tissue elongation is an emergent property that arises from the collective regulation of graded, random cell motion rather than by the regulation of directionality of individual cellular movements. PMID:20613841

  9. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study.

    PubMed

    De Vito, Andrea; Agnoletti, Vanni; Berrettini, Stefano; Piraccini, Emanuele; Criscuolo, Armando; Corso, Ruggero; Campanini, Aldo; Gambale, Giorgio; Vicini, Claudio

    2011-03-01

    Understanding the sites of pharyngeal collapse is mandatory for surgical treatment decision-making in obstructive sleep-apnea-hypopnea syndrome patients. Drug-induced sleep endoscopy (DISE) allows for the direct observation of the upper airway during sedative-induced sleep. In order to re-create snoring and apnea patterns related to a spontaneous sleep situation, the authors used a target-controlled infusion (TCI) sleep endoscopy (DISE-TCI), comparing this technique to conventional DISE, in which sedation was reached by a manual bolus injection. The authors conducted a prospective, randomized, unicenter study. The apneic event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plans of DISE-TCI technique. From January 2009 to June 2009, 40 OSAHS patients were included in the study and randomized allocated in two groups: the bolus injection conventional DISE group and the DISE-TCI group. We recorded the complete apnea event at the oropharynx and hypopharynx levels in 4 patients of the conventional DISE group (20%) and in 17 patients of the DISE-TCI group (85%) (P < 0.0001). Two patients needed oxygen in the conventional DISE group because of severe desaturation that resulted from the first bolus of propofol (1 mg/kg) (P = 0.4872 ns). We recorded the instability of the sedation plan in 13 patients from the conventional DISE group (65%) and 1 patient from the DISE-TCI group (5%) (P = 0.0001). Our results suggest that the DISE-TCI technique should be the first choice in performing sleep endoscopy because of its increased accuracy, stability and safety.

  10. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  11. Distributed reservation control protocols for random access broadcasting channels

    NASA Astrophysics Data System (ADS)

    Greene, E. P.; Ephremides, A.

    1981-05-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  12. Distributed reservation control protocols for random access broadcasting channels

    NASA Technical Reports Server (NTRS)

    Greene, E. P.; Ephremides, A.

    1981-01-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  13. Worksite intervention effects on sleep quality: a randomized controlled trial.

    PubMed

    Atlantis, Evan; Chow, Chin-Moi; Kirby, Adrienne; Singh, Maria A Fiatarone

    2006-10-01

    Employees with sleep disturbance are at increased risk of disease. Exercise is believed to be effective for improving sleep quality, but few studies have been conducted. This study investigated the effects of a 24-week worksite exercise/behavioral intervention on self-rated sleep quality, via the Pittsburgh Sleep Quality Index (PSQI), in 73 employees. Greater post-test improvements in the PSQI (-2.0 +/- 2.6 vs. -1.3 +/- 2.7 points, p = .006, and -16 +/- 61 vs. -1 +/- 76%, p = .02) were found in treatment versus controls, and in women versus men (by -2.7 points [-5.0 to -0.3 points, p = .03], and by -72% [-142 to -2%, p = .04]). Similar results were found in the shift worker subgroup. Changes in sleep scores were not significantly related to baseline characteristics, changes in psychological health or quality-of-life scores, or level of exercise compliance.

  14. An Experiment in Linguistic Synthesis with a Fuzzy Logic Controller

    ERIC Educational Resources Information Center

    Mamdani, E. H.; Assilian, S.

    1975-01-01

    This paper describes an experiment on the "linguistic" synthesis of a controller for a model industrial plant (a steam engine). Fuzzy logic is used to convert heuristic control rules stated by a human operator into an automatic control strategy. (Author)

  15. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  16. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial

    PubMed Central

    Klest, Sihu K.; Sandoy, Tróndur Møller

    2016-01-01

    Introduction Infancy is an important period of life; adverse experiences during this stage can have both immediate and lifelong impacts on the child’s mental health and well-being. This study evaluates the effects of offering the Incredible Years Parents and Babies (IYPB) program as a universal intervention. Method We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to the IYPB program (76) or usual care (36) with a 2:1 allocation ratio. The primary outcome was parenting confidence at 20 weeks(Karitane Parenting Confidence Scale and Parental Stress Scale). Secondary outcomes include measures of parent health, parent-child relationship, infant development, parent-child activities, and network. Interviewers and data analysts were blind to allocation status. Multiple linear-regression analyses were used for evaluating the effects of the intervention. Results There were no intervention effects on the primary outcomes. Only one effect was detected for secondary outcomes, intervention mothers reported a significantly smaller network than control mothers (β = -0.15 [-1.85,-0.28]). When examining the lowest-functioning mothers in moderator analyses, we found that intervention mothers reported significantly higher parent stress (β = 5.33 [0.27,10.38]), lower parenting confidence (β = -2.37 [-4.45,-0.29]), and worse mental health than control mothers (β = -18.62 [-32.40,-4.84]). In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (β = -6.11 [-11.07,-1.14]). Conclusion Overall, we found no effects of the IYPB as a universal intervention for parents with infants. The intervention was developed to be used with groups of low functioning families and may need to be adapted to be effective with universal parent groups. The differential outcomes for the lowest and highest functioning families suggest that future research should evaluate the

  17. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial.

    PubMed

    Hume, Megan P; Nicolucci, Alissa C; Reimer, Raylene A

    2017-02-22

    Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk. Objective measures of appetite included energy intake at an ad libitum breakfast buffet, 3-d food records, and fasting satiety hormone concentrations. Subjective appetite ratings were obtained from visual analog scales before and after the breakfast. Children's Eating Behavior Questionnaires were also completed by caregivers.Results: Compared with placebo, prebiotic intake resulted in significantly higher feelings of fullness (P = 0.04) and lower prospective food consumption (P = 0.03) at the breakfast buffet at 16 wk compared with baseline. Compared with placebo, prebiotic supplementation significantly reduced energy intake at the week 16 breakfast buffet in 11- and 12-y-olds (P = 0.04) but not in 7- to 10-y-olds. Fasting adiponectin (P = 0.04) and ghrelin (P = 0.03) increased at 16 wk with the prebiotic compared with placebo. In intent-to-treat analysis, there was a trend for prebiotic supplementation to reduce BMI z score to a greater extent than placebo (-3.4%; P = 0.09) and a significant -3.8% reduction in per-protocol analysis (P = 0.043).Conclusions: Independent of other lifestyle changes, prebiotic supplementation in children with overweight and obesity improved subjective appetite ratings. This translated into reduced energy intake in a breakfast buffet in older but not in younger children. This simple dietary change has the potential to help with appetite regulation in children with obesity. This trial was registered at

  18. The Effect of Cold Showering on Health and Work: A Randomized Controlled Trial

    PubMed Central

    Sierevelt, Inger N.; van der Heijden, Bas C. J. M.; Dijkgraaf, Marcel G.; Frings-Dresen, Monique H. W.

    2016-01-01

    Purpose The aim of this study was to determine the cumulative effect of a routine (hot-to-) cold shower on sickness, quality of life and work productivity. Methods Between January and March 2015, 3018 participants between 18 and 65 years without severe comorbidity and no routine experience of cold showering were randomized (1:1:1:1) to a (hot-to-) cold shower for 30, 60, 90 seconds or a control group during 30 consecutive days followed by 60 days of showering cold at their own discretion for the intervention groups. The primary outcome was illness days and related sickness absence from work. Secondary outcomes were quality of life, work productivity, anxiety, thermal sensation and adverse reactions. Results 79% of participants in the interventions groups completed the 30 consecutive days protocol. A negative binomial regression model showed a 29% reduction in sickness absence for (hot-to-) cold shower regimen compared to the control group (incident rate ratio: 0.71, P = 0.003). For illness days there was no significant group effect. No related serious advents events were reported. Conclusion A routine (hot-to-) cold shower resulted in a statistical reduction of self-reported sickness absence but not illness days in adults without severe comorbidity. Trial Registration Netherlands National Trial Register NTR5183 PMID:27631616

  19. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    PubMed Central

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min

    2017-01-01

    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  20. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  1. Physics Experiments with Nintendo Wii Controllers

    ERIC Educational Resources Information Center

    Wheeler, Martyn D.

    2011-01-01

    This article provides a detailed description of the use of Nintendo Wii game controllers in physics demonstrations. The main features of the controller relevant to physics are outlined and the procedure for communicating with a PC is described. A piece of software written by the author is applied to gathering data from a controller suspended from…

  2. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  3. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  4. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  5. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  6. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  7. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. Objective This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Methods Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant’s experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. Results In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More

  8. [Randomized controlled trials for the prevention and treatment of glucocorticoid-induced osteoporosis].

    PubMed

    Suzuki, Yasuo

    2006-11-01

    The effectiveness of drug therapy for the prevention or treatment of glucocorticoid-induced osteoporosis has been reported. Especially, the beneficial effects of bisphosphonates (etidoronate, alendronate, and risedronate) to prevent bone loss and fractures have been confirmed by the large-scale, multicenter, double-blind, randomized controlled trials in terms of both primary and secondary prevention. This article reviews the results of recent randomized prospective trials using bisphosphonates in glucocorticoid-induced osteoporosis.

  9. A Spanish Pillbox App for Elderly Patients Taking Multiple Medications: Randomized Controlled Trial

    PubMed Central

    Mira, José Joaquín; Navarro, Isabel; Botella, Federico; Borrás, Fernando; Orozco, Domingo; Iglesias-Alonso, Fuencisla; Pérez-Pérez, Pastora; Lorenzo, Susana; Toro, Nuria

    2014-01-01

    Background Nonadherence and medication errors are common among patients with complex drug regimens. Apps for smartphones and tablets are effective for improving adherence, but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology. Objective The objective of this study was to design, implement, and evaluate a medication self-management app (called ALICE) for elderly patients taking multiple medications with the intention of improving adherence and safe medication use. Methods A single-blind randomized controlled trial was conducted with a control and an experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals. ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice, showing images of each of the medications (the packaging and the medication itself) together with alerts and multiple reminders for each alert. The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for 3 months. Pre and post measures included rate of missed doses and medication errors reported by patients, scores from the 4-item Morisky Medication Adherence Scale (MMAS-4), level of independence, self-perceived health status, and biochemical test results. In the experimental group, data were collected on their previous experience with information and communication technologies, their rating of ALICE, and their perception of the level of independence they had achieved. The intergroup intervention effects were calculated by univariate linear models and ANOVA, with the pre to post intervention differences as the dependent variables. Results Data were obtained from 99 patients (48 and 51 in the control

  10. Experiments on the rarefaction wave driven Rayleigh-Taylor instability initiated with a random initial perturbation

    NASA Astrophysics Data System (ADS)

    Morgan, Robert; Jacobs, Jeffrey

    2014-11-01

    Experiments are presented in which a diffuse interface between two gases is accelerated to become Rayleigh-Taylor unstable. The initially flat interface is generated by the opposing flow of two test gases at matched volumetric flow rates exiting through small holes in the test section. A random, three-dimensional interface perturbation is forced using a loudspeaker. The interface is then accelerated by an expansion wave which is generated by the rupturing of a diaphragm separating the heavy gas from a vacuum tank evacuated to ~0.01 atm. The expansion wave generates a large (of order 1000 g), non-constant acceleration acting on the interface causing the Rayleigh-Taylor instability to develop. Planar Mie scattering is employed to visualize the flow using a planar laser sheet generated at the top of the apparatus, which illuminates smoke particles seeded in the heavy gas. The scattered light is then recorded using a CMOS camera operating at 12 kHz. The mixing layer width is obtained from an ensemble of experiments and the turbulent growth parameter α is extracted and compared with previous experiments and simulations.

  11. Experiments on the Richtmyer-Meshkov instability with an imposed, random initial perturbation

    NASA Astrophysics Data System (ADS)

    Jacobs, J. W.; Krivets, V. V.; Tsiklashvili, V.; Likhachev, O. A.

    2013-07-01

    A vertical shock tube is used to perform experiments on the Richtmyer-Meshkov instability with a three-dimensional random initial perturbation. A membraneless flat interface is formed by opposed gas flows in which the light and heavy gases enter the shock tube from the top and from the bottom of the shock tube driven section. An air/SF6 gas combination is used and a Mach number M = 1.2 incident shock wave impulsively accelerates the interface. Initial perturbations on the interface are created by vertically oscillating the gas column within the shock tube to produce Faraday waves on the interface resulting in a short wavelength, three-dimensional perturbation. Planar Mie scattering is used to visualize the flow in which light from a laser sheet is scattered by smoke seeded in the air, and image sequences are captured using three high-speed video cameras. Measurements of the integral penetration depth prior to reshock show two growth behaviors, both having power law growth with growth exponents in the range found in previous experiments and simulations. Following reshock, all experiments show very consistent linear growth with a growth rate in good agreement with those found in previous studies.

  12. Evaluating Consumer m-Health Services for Promoting Healthy Eating: A Randomized Field Experiment.

    PubMed

    Kato-Lin, Yi-Chin; Padman, Rema; Downs, Julie; Abhishek, Vibhanshu

    2015-01-01

    Mobile apps have great potential to deliver promising interventions to engage consumers and change their health-related behaviors, such as healthy eating. Currently, the interventions for promoting healthy eating are either too onerous to keep consumers engaged or too restrictive to keep consumers connected with healthcare professionals. In addition, while social media allows individuals to receive information from many sources, it is unclear how peer support interacts with professional support in the context of such interventions. This study proposes and evaluates three mobile-enabled interventions to address these challenges. We examine their effects on user engagement and food choices via a 4-month randomized field experiment. Mixed models provide strong evidence of the positive effect of image-based dietitian support and negative effects of peer support, and moderate evidence of the positive effects of mobile-based visual diary, highlighting the value of mobile apps for delivering advanced interventions to engage users and facilitate behavior change.

  13. Evaluating Consumer m-Health Services for Promoting Healthy Eating: A Randomized Field Experiment

    PubMed Central

    Kato-Lin, Yi-Chin; Padman, Rema; Downs, Julie; Abhishek, Vibhanshu

    2015-01-01

    Mobile apps have great potential to deliver promising interventions to engage consumers and change their health-related behaviors, such as healthy eating. Currently, the interventions for promoting healthy eating are either too onerous to keep consumers engaged or too restrictive to keep consumers connected with healthcare professionals. In addition, while social media allows individuals to receive information from many sources, it is unclear how peer support interacts with professional support in the context of such interventions. This study proposes and evaluates three mobile-enabled interventions to address these challenges. We examine their effects on user engagement and food choices via a 4-month randomized field experiment. Mixed models provide strong evidence of the positive effect of image-based dietitian support and negative effects of peer support, and moderate evidence of the positive effects of mobile-based visual diary, highlighting the value of mobile apps for delivering advanced interventions to engage users and facilitate behavior change. PMID:26958294

  14. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patients with bipolar disorder experience sleep disturbance, even in euthymic phases. Changes in sleep pattern are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for primary insomnia, but there are no published results on the effects of CBT-I in patients with bipolar disorder. In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood variations and preventing new mood episodes in euthymic patients with bipolar disorder and comorbid insomnia. Methods Patients with euthymic bipolar I or II disorder and insomnia, as verified by the Structured Clinical Interview for DSM Disorders (SCID-1) assessment, will be included. The patients enter a three-week run-in phase in which they complete a sleep diary and a mood diary, are monitored for seven consecutive days with an actigraph and on two of these nights with polysomnography in addition before randomization to an eight-week treatment trial. Treatment as usual consists of pharmacological and supportive psychosocial treatment. In this trial, CBT-I will consist of sleep restriction, psychoeducation about sleep, stabilization of the circadian rhythm, and challenging and correcting sleep state misperception, in three to eight sessions. Discussion This trial could document a new treatment for insomnia in bipolar disorder with possible effects on sleep and on stability of mood. In addition, more precise information can be obtained about the character of sleep disturbance in bipolar disorder. Trial registration ClinicalTrials.gov: NCT01704352. PMID:24433249

  15. Does Reviewing Lead to Better Learning and Decision Making? Answers from a Randomized Stock Market Experiment

    PubMed Central

    Wessa, Patrick; Holliday, Ian E.

    2012-01-01

    Background The literature is not univocal about the effects of Peer Review (PR) within the context of constructivist learning. Due to the predominant focus on using PR as an assessment tool, rather than a constructivist learning activity, and because most studies implicitly assume that the benefits of PR are limited to the reviewee, little is known about the effects upon students who are required to review their peers. Much of the theoretical debate in the literature is focused on explaining how and why constructivist learning is beneficial. At the same time these discussions are marked by an underlying presupposition of a causal relationship between reviewing and deep learning. Objectives The purpose of the study is to investigate whether the writing of PR feedback causes students to benefit in terms of: perceived utility about statistics, actual use of statistics, better understanding of statistical concepts and associated methods, changed attitudes towards market risks, and outcomes of decisions that were made. Methods We conducted a randomized experiment, assigning students randomly to receive PR or non–PR treatments and used two cohorts with a different time span. The paper discusses the experimental design and all the software components that we used to support the learning process: Reproducible Computing technology which allows students to reproduce or re–use statistical results from peers, Collaborative PR, and an AI–enhanced Stock Market Engine. Results The results establish that the writing of PR feedback messages causes students to experience benefits in terms of Behavior, Non–Rote Learning, and Attitudes, provided the sequence of PR activities are maintained for a period that is sufficiently long. PMID:22666385

  16. Impact of a Collective Intelligence Tailored Messaging System on Smoking Cessation: The Perspect Randomized Experiment

    PubMed Central

    Borglund, Erin M; Adams, Roy; Marlin, Benjamin M; Houston, Thomas K

    2016-01-01

    Background Outside health care, content tailoring is driven algorithmically using machine learning compared to the rule-based approach used in current implementations of computer-tailored health communication (CTHC) systems. A special class of machine learning systems (“recommender systems”) are used to select messages by combining the collective intelligence of their users (ie, the observed and inferred preferences of users as they interact with the system) and their user profiles. However, this approach has not been adequately tested for CTHC. Objective Our aim was to compare, in a randomized experiment, a standard, evidence-based, rule-based CTHC (standard CTHC) to a novel machine learning CTHC: Patient Experience Recommender System for Persuasive Communication Tailoring (PERSPeCT). We hypothesized that PERSPeCT will select messages of higher influence than our standard CTHC system. This standard CTHC was proven effective in motivating smoking cessation in a prior randomized trial of 900 smokers (OR 1.70, 95% CI 1.03-2.81). Methods PERSPeCT is an innovative hybrid machine learning recommender system that selects and sends motivational messages using algorithms that learn from message ratings from 846 previous participants (explicit feedback), and the prior explicit ratings of each individual participant. Current smokers (N=120) aged 18 years or older, English speaking, with Internet access were eligible to participate. These smokers were randomized to receive either PERSPeCT (intervention, n=74) or standard CTHC tailored messages (n=46). The study was conducted between October 2014 and January 2015. By randomization, we compared daily message ratings (mean of smoker ratings each day). At 30 days, we assessed the intervention’s perceived influence, 30-day cessation, and changes in readiness to quit from baseline. Results The proportion of days when smokers agreed/strongly agreed (daily rating ≥4) that the messages influenced them to quit was significantly

  17. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    PubMed

    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

  18. Intraclass Correlations and Covariate Outcome Correlations for Planning 2 and 3 Level Cluster Randomized Experiments in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, Eric C.

    2013-01-01

    Background: Cluster randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

  19. Intraclass Correlations and Covariate Outcome Correlations for Planning Two-and Three-Level Cluster-Randomized Experiments in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2013-01-01

    Background: Cluster-randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

  20. Long-Term Effects of Individual Development Accounts on Postsecondary Education: Follow-Up Evidence from a Randomized Experiment

    ERIC Educational Resources Information Center

    Grinstein-Weiss, Michal; Sherraden, Michael; Gale, William G.; Rohe, William M.; Schreiner, Mark; Key, Clinton

    2013-01-01

    This paper presents evidence from a randomized field experiment testing the impact of a 3-year matched savings program on educational outcomes 10 years after the start of the experiment. We examine the effect of an Individual Development Account (IDA) program on (1) educational enrollment, (2) degree completion, and (3) increased education level.…

  1. Differentiating emotions across contexts: comparing adults with and without social anxiety disorder using random, social interaction, and daily experience sampling.

    PubMed

    Kashdan, Todd B; Farmer, Antonina S

    2014-06-01

    The ability to recognize and label emotional experiences has been associated with well-being and adaptive functioning. This skill is particularly important in social situations, as emotions provide information about the state of relationships and help guide interpersonal decisions, such as whether to disclose personal information. Given the interpersonal difficulties linked to social anxiety disorder (SAD), deficient negative emotion differentiation may contribute to impairment in this population. We hypothesized that people with SAD would exhibit less negative emotion differentiation in daily life, and these differences would translate to impairment in social functioning. We recruited 43 people diagnosed with generalized SAD and 43 healthy adults to describe the emotions they experienced over 14 days. Participants received palmtop computers for responding to random prompts and describing naturalistic social interactions; to complete end-of-day diary entries, they used a secure online website. We calculated intraclass correlation coefficients to capture the degree of differentiation of negative and positive emotions for each context (random moments, face-to-face social interactions, and end-of-day reflections). Compared to healthy controls, the SAD group exhibited less negative (but not positive) emotion differentiation during random prompts, social interactions, and (at trend level) end-of-day assessments. These differences could not be explained by emotion intensity or variability over the 14 days, or to comorbid depression or anxiety disorders. Our findings suggest that people with generalized SAD have deficits in clarifying specific negative emotions felt at a given point of time. These deficits may contribute to difficulties with effective emotion regulation and healthy social relationship functioning.

  2. Differentiating Emotions Across Contexts: Comparing Adults with and without Social Anxiety Disorder Using Random, Social Interaction, and Daily Experience Sampling

    PubMed Central

    Kashdan, Todd B.; Farmer, Antonina S.

    2014-01-01

    The ability to recognize and label emotional experiences has been associated with well-being and adaptive functioning. This skill is particularly important in social situations, as emotions provide information about the state of relationships and help guide interpersonal decisions, such as whether to disclose personal information. Given the interpersonal difficulties linked to social anxiety disorder (SAD), deficient negative emotion differentiation may contribute to impairment in this population. We hypothesized that people with SAD would exhibit less negative emotion differentiation in daily life, and these differences would translate to impairment in social functioning. We recruited 43 people diagnosed with generalized SAD and 43 healthy adults to describe the emotions they experienced over 14 days. Participants received palmtop computers for responding to random prompts and describing naturalistic social interactions; to complete end-of-day diary entries, they used a secure online website. We calculated intraclass correlation coefficients to capture the degree of differentiation of negative and positive emotions for each context (random moments, face-to-face social interactions, and end-of-day reflections). Compared to healthy controls, the SAD group exhibited less negative (but not positive) emotion differentiation during random prompts, social interactions, and (at trend level) end-of-day assessments. These differences could not be explained by emotion intensity or variability over the 14 days, or to comorbid depression or anxiety disorders. Our findings suggest that people with generalized SAD have deficits in clarifying specific negative emotions felt at a given point of time. These deficits may contribute to difficulties with effective emotion regulation and healthy social relationship functioning. PMID:24512246

  3. Mobile Technology for Vegetable Consumption: A Randomized Controlled Pilot Study in Overweight Adults

    PubMed Central

    Mathur, Maya; King, Abby C

    2016-01-01

    Background Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale, but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults. Objective The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption. Methods A total of 17 overweight adults aged 42.0 (SD 7.3) years with a body mass index (BMI) of 32.0 (SD 3.5) kg/m2 were randomized to the use of Vegethon (a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption, goal setting, feedback, and social comparison) or a wait-listed control condition. All participants were recruited from an ongoing 12-month weight loss trial (parent trial). Researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire administered at baseline and 12 weeks after randomization. An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions, controlling for baseline. App usability and satisfaction were measured via a 21-item post-intervention questionnaire. Results Using intention-to-treat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD 0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it. Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study (adjusted mean difference: 7.4 servings; 95% CI 1.4-13.5; P=.02). Among secondary outcomes defined a priori, there was significantly greater

  4. A simple heuristic for Internet-based evidence search in primary care: a randomized controlled trial

    PubMed Central

    Eberbach, Andreas; Becker, Annette; Rochon, Justine; Finkemeler, Holger; Wagner, Achim; Donner-Banzhoff, Norbert

    2016-01-01

    Background General practitioners (GPs) are confronted with a wide variety of clinical questions, many of which remain unanswered. Methods In order to assist GPs in finding quick, evidence-based answers, we developed a learning program (LP) with a short interactive workshop based on a simple three-step-heuristic to improve their search and appraisal competence (SAC). We evaluated the LP effectiveness with a randomized controlled trial (RCT). Participants (intervention group [IG] n=20; control group [CG] n=31) rated acceptance and satisfaction and also answered 39 knowledge questions to assess their SAC. We controlled for previous knowledge in content areas covered by the test. Results Main outcome – SAC: within both groups, the pre–post test shows significant (P=0.00) improvements in correctness (IG 15% vs CG 11%) and confidence (32% vs 26%) to find evidence-based answers. However, the SAC difference was not significant in the RCT. Other measures Most workshop participants rated “learning atmosphere” (90%), “skills acquired” (90%), and “relevancy to my practice” (86%) as good or very good. The LP-recommendations were implemented by 67% of the IG, whereas 15% of the CG already conformed to LP recommendations spontaneously (odds ratio 9.6, P=0.00). After literature search, the IG showed a (not significantly) higher satisfaction regarding “time spent” (IG 80% vs CG 65%), “quality of information” (65% vs 54%), and “amount of information” (53% vs 47%). Conclusion Long-standing established GPs have a good SAC. Despite high acceptance, strong learning effects, positive search experience, and significant increase of SAC in the pre–post test, the RCT of our LP showed no significant difference in SAC between IG and CG. However, we suggest that our simple decision heuristic merits further investigation. PMID:27563264

  5. Flexible manipulator control experiments and analysis

    NASA Technical Reports Server (NTRS)

    Yurkovich, S.; Ozguner, U.; Tzes, A.; Kotnik, P. T.

    1987-01-01

    Modeling and control design for flexible manipulators, both from an experimental and analytical viewpoint, are described. From the application perspective, an ongoing effort within the laboratory environment at the Ohio State University, where experimentation on a single link flexible arm is underway is described. Several unique features of this study are described here. First, the manipulator arm is slewed by a direct drive dc motor and has a rigid counterbalance appendage. Current experimentation is from two viewpoints: (1) rigid body slewing and vibration control via actuation with the hub motor, and (2) vibration suppression through the use of structure-mounted proof-mass actuation at the tip. Such an application to manipulator control is of interest particularly in design of space-based telerobotic control systems, but has received little attention to date. From an analytical viewpoint, parameter estimation techniques within the closed-loop for self-tuning adaptive control approaches are discussed. Also introduced is a control approach based on output feedback and frequency weighting to counteract effects of spillover in reduced-order model design. A model of the flexible manipulator based on experimental measurements is evaluated for such estimation and control approaches.

  6. Digital servo control of random sound test excitation. [in reverberant acoustic chamber

    NASA Technical Reports Server (NTRS)

    Nakich, R. B. (Inventor)

    1974-01-01

    A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

  7. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  8. Planning and self-efficacy can increase fruit and vegetable consumption: a randomized controlled trial.

    PubMed

    Kreausukon, Pimchanok; Gellert, Paul; Lippke, Sonia; Schwarzer, Ralf

    2012-08-01

    Fruit and vegetable consumption represents a nutritional goal to prevent obesity and chronic illness. To change dietary behaviors, people must be motivated to do so, and they must translate their motivation into actual behavior. The present experiment aims at the psychological mechanisms that support such changes, with a particular focus on dietary self-efficacy and planning skills. A randomized controlled trial compared a theory-based psychological intervention with a health education session in 114 participants. Dependent variables were fruit and vegetable consumption, intention to consume more fruit and vegetables, planning to consume more, and dietary self-efficacy, assessed before the intervention, 1 week afterwards, and at 6-week follow up. Significant group by time interactions for all four dependent variables documented superior treatment effects for the psychological intervention group, with substantially higher scores at posttest and follow-up for the experimental group, although all students benefited from participation. To identify the contribution of the main intervention ingredients (self-efficacy and planning), regression analyses yielded mediator effects for these two factors. A social-cognitive intervention to improve fruit and vegetable consumption was superior to a knowledge-based education session. Self-efficacy and planning seem to play a major role in the mechanisms that facilitate dietary changes.

  9. Hygienic-dietary recommendations for major depression treatment: Study protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice. Methods Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up. Discussion We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs. Trial registration ISRCTN73931675 PMID:23158080

  10. Polyprenyl Immunostimulant in Feline Rhinotracheitis: Randomized Placebo-Controlled Experimental and Field Safety Studies

    PubMed Central

    Legendre, Alfred M.; Kuritz, Tanya; Heidel, Robert Eric; Baylor, Vivian M.

    2017-01-01

    Feline rhinotracheitis is a ubiquitous disease caused by feline herpesvirus type 1 (FHV-1). The disease is easily transmissible and common in multi-cat environments where even vaccinated cats can develop clinical signs of respiratory or ocular disease or both when exposed to the virus. Prior to the work reported here, there was no licensed treatment for the disease on the market. We hypothesized that polyprenyl immunostimulant (PI), an immunomodulatory veterinary biologic, would be useful in treating feline rhinotracheitis by reducing the severity of respiratory or/and ocular disease. We conducted double-blinded, randomized, placebo-controlled clinical trials in experimentally infected cats to establish the efficacy of PI. Specific pathogen-free cats were administered a placebo (n = 20) or PI (n = 20) starting on the day of FHV-1 experimental challenge. Trained, masked observers applied a standardized scoring system daily in clinical examinations for 14 days after the FHV-1 challenge. The cats treated with PI had significantly lower disease severity scores over the course of the experiment compared to the cats in the placebo group (p = 0.05). The safety studies, including a field safety study involving 390 owned cats in 10 states, showed that PI was safe to use in cats as young as 8 weeks of age. PMID:28289684

  11. Power and control choice in aquatic experiments with solvents.

    PubMed

    Green, John W

    2014-04-01

    Aquatic toxicology experiments to determine the effects of chemicals sometimes require the use of a carrier solvent. Such experiments typically include both a negative (water) control group and a solvent control group. False positive rates and power to detect treatment effects in such experiments are compared for six possible strategies for deciding the appropriate control or controls for comparison. The main purpose of the present study is to determine the best use of the two controls in statistical analysis. A secondary purpose is to determine purely on statistical grounds whether both controls are actually needed. The evidence supports using either the solvent control only in all cases or a sequential strategy of combining the water and solvent controls unless the two controls are found to be statistically significantly different, in which case only the solvent control should be used. These results extend, and in some ways contradict, a recently published simulation study.

  12. Millikan's oil-drop experiment as a remotely controlled laboratory

    NASA Astrophysics Data System (ADS)

    Eckert, Bodo; Gröber, Sebastian; Vetter, Martin; Jodl, Hans-Jörg

    2012-09-01

    The Millikan oil-drop experiment, to determine the elementary electrical charge e and the quantization of charge Q = n · e, is an essential experiment in physics teaching but it is hardly performed in class for several reasons. Therefore, we offer this experiment as a remotely controlled laboratory (RCL). We describe the interactivity of the experiment and the quality of measurements. The added value to offer the Millikan experiment as an RCL is pointed out.

  13. Skylab experiment performance evaluation manual. Appendix R: Experiment T020 foot controlled maneuvering unit (MSFC)

    NASA Technical Reports Server (NTRS)

    Tonetti, B. B.

    1972-01-01

    A series of analyses for experiment T020, foot controlled maneuvering unit (MSFC), to be used for evaluating the performance of the Skylab corollary experiments under preflight, inflight and post-flight conditions is reported. Experiment contingency plan procedure and malfunction analyses are presented in order to assist in making the experiment operationally successful.

  14. Electrically controllable liquid crystal random lasers below the Fréedericksz transition threshold.

    PubMed

    Lee, Chia-Rong; Lin, Jia-De; Huang, Bo-Yuang; Lin, Shih-Hung; Mo, Ting-Shan; Huang, Shuan-Yu; Kuo, Chie-Tong; Yeh, Hui-Chen

    2011-01-31

    This investigation elucidates for the first time electrically controllable random lasers below the threshold voltage in dye-doped liquid crystal (DDLC) cells with and without adding an azo-dye. Experimental results show that the lasing intensities and the energy thresholds of the random lasers can be decreased and increased, respectively, by increasing the applied voltage below the Fréedericksz transition threshold. The below-threshold-electric-controllability of the random lasers is attributable to the effective decrease of the spatial fluctuation of the orientational order and thus of the dielectric tensor of LCs by increasing the electric-field-aligned order of LCs below the threshold, thereby increasing the diffusion constant and decreasing the scattering strength of the fluorescence photons in their recurrent multiple scattering. This can result in the decrease in the lasing intensity of the random lasers and the increase in their energy thresholds. Furthermore, the addition of an azo-dye in DDLC cell can induce the range of the working voltage below the threshold for the control of the random laser to reduce.

  15. Description of the Spacecraft Control Laboratory Experiment (SCOLE) facility

    NASA Technical Reports Server (NTRS)

    Williams, Jeffrey P.; Rallo, Rosemary A.

    1987-01-01

    A laboratory facility for the study of control laws for large flexible spacecraft is described. The facility fulfills the requirements of the Spacecraft Control Laboratory Experiment (SCOLE) design challenge for laboratory experiments, which will allow slew maneuvers and pointing operations. The structural apparatus is described in detail sufficient for modelling purposes. The sensor and actuator types and characteristics are described so that identification and control algorithms may be designed. The control implementation computer and real-time subroutines are also described.

  16. Description of the Spacecraft Control Laboratory Experiment (SCOLE) facility

    NASA Technical Reports Server (NTRS)

    Williams, Jeffrey P.; Rallo, Rosemary A.

    1987-01-01

    A laboratory facility for the study of control laws for large flexible spacecraft is described. The facility fulfills the requirements of the Spacecraft Control Laboratory Experiment (SCOLE) design challenge for a laboratory experiment, which will allow slew maneuvers and pointing operations. The structural apparatus is described in detail sufficient for modelling purposes. The sensor and actuator types and characteristics are described so that identification and control algorithms may be designed. The control implementation computer and real-time subroutines are also described.

  17. Use of Kampo Diagnosis in Randomized Controlled Trials of Kampo Products in Japan: A Systematic Review

    PubMed Central

    Motoo, Yoshiharu; Arai, Ichiro; Tsutani, Kiichiro

    2014-01-01

    Background The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is “How frequently is Kampo diagnosis used in RCTs of Kampo medicines?” The secondary research question is “When is Kampo diagnosis used in RCTs?” Materials and Methods The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process. Results Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs. Conclusions Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis. PMID:25119187

  18. The Effect of Intensive Education On Urinary Incontinence Following Radical Prostatectomy: A Randomized Control Trial.

    PubMed

    Novick, Besma Jassani; Angie, Michelle; Walker, Esteban; Kitay, Renee; Monday, Kathryn; Albert, Nancy M

    2014-01-01

    Intense bladder control education failed to improve bladder control among patients who underwent a radical prostatectomy as treatment of their prostate cancer. Despite this educational intervention, participants continued to experience post-operative bladder control problems. Nurses need to develop and implement novel interventions that might enhance bladder control.

  19. Dawn Spacecraft Reaction Control System Flight Experience

    NASA Technical Reports Server (NTRS)

    Mizukami, Masashi; Nakazono, Barry

    2014-01-01

    The NASA Dawn spacecraft mission is studying conditions and processes of the solar system's earliest epoch by investigating two protoplanets remaining intact since their formations, Ceres and Vesta. Launch was in 2007. Ion propulsion is used to fly to and enter orbit around Vesta, depart Vesta and fly to Ceres, and enter orbit around Ceres. A conventional blowdown hydrazine reaction control system (RCS) is used to provide external torques for attitude control. Reaction wheel assemblies were intended to provide attitude control in most cases. However, the spacecraft experienced one, then two apparent failures of reaction wheels. Also, similar thrusters experienced degradation in a long life application on another spacecraft. Those factors led to RCS being operated in ways completely different than anticipated prior to launch. Numerous mitigations and developments needed to be implemented. The Vesta mission was fully successful. Even with the compromises necessary due to those anomalies, the Ceres mission is also projected to be feasible.

  20. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    PubMed

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  1. Circulation control lift generation experiment: Hardware development

    NASA Technical Reports Server (NTRS)

    Panontin, T. L.

    1985-01-01

    A circulation control airfoil and its accompanying hardware were developed to allow the investigation of lift generation that is independent of airfoil angle of attack and relative flow velocity. The test equipment, designed for use in a water tunnel, includes the blown airfoil, the support systems for both flow visualization and airfoil load measurement, and the fluid control system, which utilizes hydraulic technology. The primary design tasks, the selected solutions, and the unforseen problems involved in the development of these individual components of hardware are described.

  2. Genetically controlled random search: a global optimization method for continuous multidimensional functions

    NASA Astrophysics Data System (ADS)

    Tsoulos, Ioannis G.; Lagaris, Isaac E.

    2006-01-01

    A new stochastic method for locating the global minimum of a multidimensional function inside a rectangular hyperbox is presented. A sampling technique is employed that makes use of the procedure known as grammatical evolution. The method can be considered as a "genetic" modification of the Controlled Random Search procedure due to Price. The user may code the objective function either in C++ or in Fortran 77. We offer a comparison of the new method with others of similar structure, by presenting results of computational experiments on a set of test functions. Program summaryTitle of program: GenPrice Catalogue identifier:ADWP Program summary URL:http://cpc.cs.qub.ac.uk/summaries/ADWP Program available from: CPC Program Library, Queen's University of Belfast, N. Ireland Computer for which the program is designed and others on which it has been tested: the tool is designed to be portable in all systems running the GNU C++ compiler Installation: University of Ioannina, Greece Programming language used: GNU-C++, GNU-C, GNU Fortran-77 Memory required to execute with typical data: 200 KB No. of bits in a word: 32 No. of processors used: 1 Has the code been vectorized or parallelized?: no No. of lines in distributed program, including test data, etc.:13 135 No. of bytes in distributed program, including test data, etc.: 78 512 Distribution format: tar. gz Nature of physical problem: A multitude of problems in science and engineering are often reduced to minimizing a function of many variables. There are instances that a local optimum does not correspond to the desired physical solution and hence the search for a better solution is required. Local optimization techniques are frequently trapped in local minima. Global optimization is hence the appropriate tool. For example, solving a nonlinear system of equations via optimization, employing a "least squares" type of objective, one may encounter many local minima that do not correspond to solutions, i.e. minima with values

  3. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. Methods/design The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. Discussion This study promises to be the first trial to provide a novel

  4. Experiments with a Magnetically Controlled Pendulum

    ERIC Educational Resources Information Center

    Kraftmakher, Yaakov

    2007-01-01

    A magnetically controlled pendulum is used for observing free and forced oscillations, including nonlinear oscillations and chaotic motion. A data-acquisition system stores the data and displays time series of the oscillations and related phase plane plots, Poincare maps, Fourier spectra and histograms. The decay constant of the pendulum can be…

  5. A Randomized Controlled Trial of the Impact of Therapeutic Horse Riding on the Quality of Life, Health, and Function of Children with Cerebral Palsy

    ERIC Educational Resources Information Center

    Davis, E.; Davies, B.; Wolfe, R.; Raadsveld, R.; Heine, B.; Thomason, P.; Dobson, Fiona; Graham, H. K.

    2009-01-01

    This randomized controlled trial examined whether therapeutic horse riding has a clinically significant impact on the physical function, health and quality of life (QoL) of children with cerebral palsy (CP). Ninety-nine children aged 4 to 12 years with no prior horse riding experience and various levels of impairment (Gross Motor Function…

  6. Aeroassist flight experiment guidance, navigation and control

    NASA Technical Reports Server (NTRS)

    Brand, Timothy J.; Engel, Albert G.

    1986-01-01

    The Aeroassist Flight Experiment scheduled for the early 1990's will demonstrate the use of a low L/D lifting brake using aerodynamic drag to return a spacecraft from a high energy to a low earth orbit. The experimental vehicle will be deployed and retrieved by the Shuttle Orbiter. This paper reviews some of the challenges, problems, and solutions encountered to date during guidance system development, with emphasis on technology advances which will benefit an operational Orbit Transfer Vehicle (OTV). Key factors to be discussed include guidance alternatives, aerodynamic modeling, navigation requirements, the impact of atmospheric uncertainties, and flight profile alternatives considered during initial planning.

  7. Virtual Reality for Pediatric Sedation: A Randomized Controlled Trial Using Simulation

    PubMed Central

    Davis, Aisha B; O'Connell, Karen J; Willner, Emily; Aronson Schinasi, Dana A; Ottolini, Mary

    2016-01-01

    Introduction: Team training for procedural sedation for pediatric residents has traditionally consisted of didactic presentations and simulated scenarios using high-fidelity mannequins. We assessed the effectiveness of a virtual reality module in teaching preparation for and management of sedation for procedures. Methods: After developing a virtual reality environment in Second Life® (Linden Lab, San Francisco, CA) where providers perform and recover patients from procedural sedation, we conducted a randomized controlled trial to assess the effectiveness of the virtual reality module versus a traditional web-based educational module. A 20 question pre- and post-test was administered to assess knowledge change. All subjects participated in a simulated pediatric procedural sedation scenario that was video recorded for review and assessed using a 32-point checklist. A brief survey elicited feedback on the virtual reality module and the simulation scenario. Results: The median score on the assessment checklist was 75% for the intervention group and 70% for the control group (P = 0.32). For the knowledge tests, there was no statistically significant difference between the groups (P = 0.14). Users had excellent reviews of the virtual reality module and reported that the module added to their education. Conclusions: Pediatric residents performed similarly in simulation and on a knowledge test after a virtual reality module compared with a traditional web-based module on procedural sedation. Although users enjoyed the virtual reality experience, these results question the value virtual reality adds in improving the performance of trainees. Further inquiry is needed into how virtual reality provides true value in simulation-based education. PMID:27014520

  8. Heated carrier fluids in decreasing propofol injection pain: a randomized, controlled trial

    PubMed Central

    Hsu, Tzung-Min

    2017-01-01

    Background Propofol is a commonly used intravenous drug during anesthetic induction because of its rapid onset and short duration. However, the injection pain that patients experience is so severe that they recall the induction of anesthesia as the most painful part of the perioperative period. Therefore, the objective of this study was to determine the effect of heated carrier fluids (40℃) in decreasing propofol injection pain. Methods A randomized, controlled clinical trial was conducted in 90 patients aged 18 to 65 who were scheduled for either elective or urgent surgery under general anesthesia classified as American Society of Anesthesiologists physical status I or II. Patients were allocated into the following 3 groups: 1) Group W (n = 30) who received 200 ml of heated carrier fluids for 20 minutes prior to propofol injection; 2) Group L (n = 30) who received 200 ml of heated carrier fluids for 20 minutes prior to 0.5 mg/kg 1%lidocaine 1 minute before propofol injection; 3) Group C (control group, n = 30) who received 200 ml of room temperature fluids prior to propofol injection. Pain was evaluated using verbal pain score (VPS). Results Group W and Group L showed significant reduction (P = 0.001) in the incidence and severity of injection pain compared to Group C. VPS scores were significantly lower in Group W and Group L compared to those of Group C. Incidence of propofol injection pain was statistically different between Group W (P = 0.005) and Group L (P = 0.037) compared to Group C, but not statistically different between Group W and Group L (P = 0.432). Conclusions Both sole injection of heated carrier fluids and the combination of 0.5 mg/kg 1%lidocaine pretreatment effectively reduced propofol injection pain. PMID:28184264

  9. 2. VIEW OF THE EXPERIMENT CONTROL PANEL IN 1970. THE ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    2. VIEW OF THE EXPERIMENT CONTROL PANEL IN 1970. THE NUCLEAR SAFETY GROUP CONDUCTED ABOUT 1,700 CRITICAL MASS EXPERIMENTS USING URANIUM AND PLUTONIUM IN SOLUTIONS (900 TESTS), COMPACTED POWDER (300), AND METALLIC FORMS (500). ALL 1,700 CRITICALITY ASSEMBLIES WERE CONTROLLED FROM THIS PANEL. - Rocky Flats Plant, Critical Mass Laboratory, Intersection of Central Avenue & 86 Drive, Golden, Jefferson County, CO

  10. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  11. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  12. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  13. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  14. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  15. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  16. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    ERIC Educational Resources Information Center

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  17. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  18. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  19. An Empirical Comparison of Randomized Control Trials and Regression Discontinuity Estimations

    ERIC Educational Resources Information Center

    Barrera-Osorio, Felipe; Filmer, Deon; McIntyre, Joe

    2014-01-01

    Randomized controlled trials (RCTs) and regression discontinuity (RD) studies both provide estimates of causal effects. A major difference between the two is that RD only estimates local average treatment effects (LATE) near the cutoff point of the forcing variable. This has been cited as a drawback to RD designs (Cook & Wong, 2008).…

  20. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    ERIC Educational Resources Information Center

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  1. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  2. Scaling Academic Planning in Community College: A Randomized Controlled Trial. REL 2017-204

    ERIC Educational Resources Information Center

    Visher, Mary G.; Mayer, Alexander K.; Johns, Michael; Rudd, Timothy; Levine, Andrew; Rauner, Mary

    2016-01-01

    Community college students often lack an academic plan to guide their choices of coursework to achieve their educational goals, in part because counseling departments typically lack the capacity to advise students at scale. This randomized controlled trial tests the impact of guaranteed access to one of two alternative counseling sessions (group…

  3. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  4. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial

    DTIC Science & Technology

    2013-10-01

    Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Henry W. Mahncke, Ph.D. CONTRACTING ORGANIZATION: Brain Plasticity, Inc...WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Brain Plasticity Inc. AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT...TERMS traumatic brain injury, tbi, concussion, persistent post-concussive symptoms, cognition, cognitive function, cognitive rehabilitation

  5. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial

    DTIC Science & Technology

    2012-10-01

    Veterans: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Henry W. Mahncke, Ph.D. CONTRACTING ORGANIZATION: Brain Plasticity...7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Brain Plasticity Inc., San Francisco, CA 94105 ES) 8. PERFORMING ORGANIZATION REPORT...SUBJECT TERMS traumatic brain injury, tbi, concussion, persistent post-concussive symptoms, cognition, cognitive function, cognitive rehabilitation

  6. 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…

  7. 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…

  8. Determinants of glycemic control in youth with type 2 diabetes at randomization in the TODAY study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The purpose of this study was to investigate insulin sensitivity and secretion indices and determinants of glycemic control in youth with recent-onset type 2 diabetes (T2DM) at randomization in the TODAY study, the largest study of youth with T2DM to date. We examined estimates of insulin sensitivit...

  9. 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…

  10. 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…

  11. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  12. Randomized controlled trials of antibiotics for neonatal infections: a systematic review

    PubMed Central

    Kaguelidou, Florentia; Turner, Mark A; Choonara, Imti; van Anker, John; Manzoni, Paolo; Alberti, Corinne; Langhendries, Jean-Paul; Jacqz-Aigrain, Evelyne

    2013-01-01

    Aims Antibiotics are a key resource for the management of infectious diseases in neonatology and their evaluation is particularly challenging. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials on antibiotics in neonatal infections. Methods We performed a systematic search of PubMed, Embase and the Cochrane Library from January 1995 to March 2010. Bibliographies of relevant articles were also hand-searched. We included all randomized controlled trials that involved neonates and evaluated the use of an antibiotic agent in the context of a neonatal infectious disease. Methodological quality was evaluated using the Jadad scale and the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality. Results A total of 35 randomized controlled trials were evaluated. The majority were conducted in a single hospital institution, without funding. Median sample size was 63 (34–103) participants. The most frequently evaluated antibiotic was gentamicin. Respectively, 18 (51%) and 17 (49%) trials evaluated the therapeutic or prophylactic use of antibiotics in various neonatal infections. Overall, the methodological quality was poor and did not improve over the years. Risk of bias was high in 66% of the trials. Conclusions Design and reporting of randomized controlled trials of antibacterial agents in neonates should be improved. Nevertheless, the necessity of implementing such trials when antibacterial efficacy has already been established in other age groups may be questioned and different methods of evaluation should be further developed. PMID:23488627

  13. 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,…

  14. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  15. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    ERIC Educational Resources Information Center

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

    2016-01-01

    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

  16. A Randomized Placebo-Controlled Trial of a School-Based Depression Prevention Program.

    ERIC Educational Resources Information Center

    Merry, Sally; McDowell, Heather; Wild, Chris J.; Bir, Julliet; Cunliffe, Rachel

    2004-01-01

    Objective: To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program. Method: Three hundred ninety-two students age 13 to 15 from two schools were randomized to intervention (RAP-Kiwi) and placebo programs run by teachers. RAP-Kiwi was an 11-session manual-based program derived from…

  17. Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

    2008-01-01

    This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

  18. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    ERIC Educational Resources Information Center

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  19. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  20. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

  1. 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…

  2. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Young, Helen E.; Falco, Ruth A.; Hanita, Makoto

    2016-01-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement…

  3. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  4. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  5. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  7. 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…

  8. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  9. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  10. Searching for Control: Priming Randomness Increases the Evaluation of Ritual Efficacy

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, André L.

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual…

  11. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  12. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  13. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  14. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  15. Methodology for conduct of epidemiologic surveys and randomized controlled trials of diabetic polyneuropathy.

    PubMed

    Dyck, Peter James

    2014-01-01

    This chapter outlines: (1) the reasons why epidemiologic surveys and randomized controlled clinical trials (RCTs) of diabetic polyneuropathy (DPN) are difficult and expensive, and often poorly done, (2) primary and secondary neuropathy end points, (3) single versus composite neuropathic end points, (4) adequate reference values from study of population representative cohorts, and (5) the issue of clinical proficiency.

  16. Evaluation of Parent and Child Enhancement (PACE) Program: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Lo, Cyrus

    2017-01-01

    Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or…

  17. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    ERIC Educational Resources Information Center

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

  18. Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Beard, Courtney; Taylor, Charles T.; Klumpp, Heide; Elias, Jason; Burns, Michelle; Chen, Xi

    2009-01-01

    The authors conducted a randomized, double-blind placebo-controlled trial to examine the efficacy of an attention training procedure in reducing symptoms of social anxiety in 44 individuals diagnosed with generalized social phobia (GSP). Attention training comprised a probe detection task in which pictures of faces with either a threatening or…

  19. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  20. Benefits and Harms of Sick Leave: Lack of Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Axelsson, Inge; Marnetoft, Sven-Uno

    2010-01-01

    The aim of this study was to try to identify those randomized controlled trials that compare sick leave with no sick leave or a different duration or degree of sick leave. A comprehensive, systematic, electronic search of Clinical Evidence, the Cochrane Library and PubMed, and a manual search of the Campbell Library and a journal supplement was…

  1. 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…

  2. Involving Parents in Paired Reading with Preschoolers: Results from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lam, Shui-fong; Chow-Yeung, Kamfung; Wong, Bernard P. H.; Lau, Kwok Kiu; Tse, Shuk In

    2013-01-01

    A paired reading program was implemented for 195 Hong Kong preschoolers (mean age = 4.7 years) and their parents from families with a wide range of family income. The preschoolers were randomly assigned to experimental or waitlist control groups. The parents in the experimental group received 12 sessions of school-based training on paired reading…

  3. Targeting Children's Behavior Problems in Preschool Classrooms: A Cluster-Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Raver, C. Cybele; Jones, Stephanie M.; Li-Grining, Christine; Zhai, Fuhua; Metzger, Molly W.; Solomon, Bonnie

    2009-01-01

    The present study evaluated the efficacy of a multicomponent, classroom-based intervention in reducing preschoolers' behavior problems. The Chicago School Readiness Project model was implemented in 35 Head Start classrooms using a clustered-randomized controlled trial design. Results indicate significant treatment effects (ds = 0.53-0.89) for…

  4. Fluoxetine, Smoking, and History of Major Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; McChargue, Dennis; Cook, Jessica Werth; Bailey, Katherine; Crayton, John; Hedeker, Donald

    2007-01-01

    The study was a randomized placebo-controlled trial testing whether fluoxetine selectively enhances cessation for smokers with a history of depression. Euthymic smokers with (H+, n = 109) or without (H-, n = 138) a history of major depression received 60 mg fluoxetine or placebo plus group behavioral quit-smoking treatment for 12 weeks. Fluoxetine…

  5. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  6. Working Memory Training in Young Children with ADHD: A Randomized Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Dongen-Boomsma, Martine; Vollebregt, Madelon A.; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training…

  7. Search Control Algorithm Based on Random Step Size Hill-Climbing Method for Adaptive PMD Compensation

    NASA Astrophysics Data System (ADS)

    Tanizawa, Ken; Hirose, Akira

    Adaptive polarization mode dispersion (PMD) compensation is required for the speed-up and advancement of the present optical communications. The combination of a tunable PMD compensator and its adaptive control method achieves adaptive PMD compensation. In this paper, we report an effective search control algorithm for the feedback control of the PMD compensator. The algorithm is based on the hill-climbing method. However, the step size changes randomly to prevent the convergence from being trapped at a local maximum or a flat, unlike the conventional hill-climbing method. The randomness depends on the Gaussian probability density functions. We conducted transmission simulations at 160Gb/s and the results show that the proposed method provides more optimal compensator control than the conventional hill-climbing method.

  8. Millikan's Oil-Drop Experiment as a Remotely Controlled Laboratory

    ERIC Educational Resources Information Center

    Eckert, Bodo; Grober, Sebastian; Vetter, Martin; Jodl, Hans-Jorg

    2012-01-01

    The Millikan oil-drop experiment, to determine the elementary electrical charge e and the quantization of charge Q = n [middle dot] e, is an essential experiment in physics teaching but it is hardly performed in class for several reasons. Therefore, we offer this experiment as a remotely controlled laboratory (RCL). We describe the interactivity…

  9. Wood smoke in a controlled exposure experiment with human volunteers.

    PubMed

    Riddervold, I S; Bønløkke, J H; Mølhave, L; Massling, A; Jensen, B; Grønborg, T K; Bossi, R; Forchhammer, L; Kjærgaard, S K; Sigsgaard, T

    2011-04-01

    Exposure to wood smoke in the general population is increasing and concurrently, also our awareness. This article describes a wood-smoke generating system for studying human exposure to wood smoke and symptoms related to this exposure. Twenty nonsmoking atopic human participants with normal lung function and normal bronchial reactivity were randomly exposed for 3 h at three different exposure conditions; clean filtered air (control exposure) and wood smoke with a characteristic particulate matter (PM) concentration of 200 µg/m³ (low) and 400 µg/m³ (high) under controlled environmental conditions. The range for PM₂.₅ load observed for single experiments was 165-303 µg/m³ for the low exposure and 205-662 µg/m³ for the high exposure, whereas particle loads during clean air exposure most often were below the detection limit (< 20 µg/m³). Health effects were evaluated in relation to rated changes in symptoms and environmental perception using a computerized questionnaire and a potentiometer. Subjective symptoms were generally weak, but when combining the effect of each of the symptoms into categorical symptom indices, significant effects were found for "environmental perception" (p = 0.0007), "irritative body perceptions" (p = 0.0127), "psychological/neurological effects" (p = 0.0075) and "weak inflammatory responses" (p = 0.0003). Furthermore, significant effects (p = 0.0192) on self-reported general mucosa irritation were found. In conclusion, exposure to wood smoke affected symptom rating and caused irritated mucosas in humans. The knowledge gained in this study on subjective-rated symptoms may be important for understanding human response to wood-smoke exposure.

  10. Tuning of an optimal fuzzy PID controller with stochastic algorithms for networked control systems with random time delay.

    PubMed

    Pan, Indranil; Das, Saptarshi; Gupta, Amitava

    2011-01-01

    An optimal PID and an optimal fuzzy PID have been tuned by minimizing the Integral of Time multiplied Absolute Error (ITAE) and squared controller output for a networked control system (NCS). The tuning is attempted for a higher order and a time delay system using two stochastic algorithms viz. the Genetic Algorithm (GA) and two variants of Particle Swarm Optimization (PSO) and the closed loop performances are compared. The paper shows that random variation in network delay can be handled efficiently with fuzzy logic based PID controllers over conventional PID controllers.

  11. Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses

    PubMed Central

    Wallach, Joshua D; Sullivan, Patrick G; Trepanowski, John F; Steyerberg, Ewout W

    2016-01-01

    Objective To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses. Design Meta-epidemiological study. Data sources Cochrane Database of Systematic Reviews (CDSR) and PubMed. Eligibility criteria for study selection Reviews published in the CDSR with sex-treatment subgroup analyses in the forest plots, using data from randomized controlled trials. Data extraction Information on the study design and sex subgroup data were extracted from reviews and forest plots that met inclusion criteria. For each statistically significant sex-treatment interaction, the potential for biological plausibility and clinical significance was considered. Results Among the 41 reviews with relevant data, there were 109 separate treatment-outcome analyses (“topics”). Among the 109 topics, eight (7%) had a statistically significant sex-treatment interaction. The 109 topics included 311 randomized controlled trials (162 with both sexes, 46 with males only, 103 with females only). Of the 162 individual randomized controlled trials that included both sexes, 15 (9%) had a statistically significant sex-treatment interaction. Of four topics where the first published randomized controlled trial had a statistically significant sex-treatment interaction, no meta-analyses that included other randomized controlled trials retained the statistical significance and no meta-analyses showed statistical significance when data from the first published randomized controlled trial were excluded. Of the eight statistically significant sex-treatment interactions from the overall analyses, only three were discussed by the CDSR reviewers for a potential impact on different clinical management for males compared with females. None of these topics had a sex-treatment interaction that influenced treatment recommendations in recent guidelines. UpToDate, an online physician-authored clinical

  12. Using random proportional pulse feedback of system variables to control chaos and hyperchaos

    NASA Astrophysics Data System (ADS)

    Luo, Xiao-shu; Wang, Bing-hong; Jiang, Feng; Gao, Yuan

    2001-01-01

    A method that allows one to control chaotic and hyperchaotic systems by a random proportional pulse feedback of system variables is proposed. This method is illustrated with the Rossler chaotic and the complex Lorenz-Harken hyperchaotic systems and a better control result is obtained. The advantage of this method is that just one perturbed system variable is enough to obtain a stabilized periodic orbit.

  13. The run control and monitoring system of the CMS experiment

    SciTech Connect

    Bauer, Gerry; Boyer, Vincent; Branson, James; Brett, Angela; Cano, Eric; Carboni, Andrea; Ciganek, Marek; Cittolin, Sergio; O'Dell, Vivian; Erhan, Samim; Gigi, Dominique; /CERN /Kyungpook Natl. U. /MIT /UCLA /CERN /INFN, Legnaro

    2007-10-01

    The CMS experiment at the LHC at CERN will start taking data in 2008. To configure, control and monitor the experiment during data-taking the Run Control and Monitoring System (RCMS) was developed. This paper describes the architecture and the technology used to implement the RCMS, as well as the deployment and commissioning strategy of this important component of the online software for the CMS experiment.

  14. Experiments on the Richtmyer-Meshkov instability with an imposed, random initial perturbation

    NASA Astrophysics Data System (ADS)

    Tsiklashvili, Vladimer

    The Richtmyer-Meshkov instability is studied in vertical shock tube experiment. The instability is initiated by the passage of an incident shock wave over an interface between two dissimilar gases. The interface is formed by opposed gas flows in which air and SF6 enter the shock tube from the top and from the bottom of the shock tube driven section. The gases exit the test section through a series of small holes in the test section side walls, leaving behind a flat, diffuse membrane-free interface at that location. Random three-dimensional perturbations are imposed on the interface by oscillating the column of gases in the vertical direction, using two loud speakers mounted in the shock tube wall. The development of the turbulent mixing is observed as a result of the shock-interface interaction. The flow is visualized using planar Mie scattering in which the light from a laser sheet is scattered by smoke particles seeded in one of the experimental gases and image sequences are captured using high-speed CMOS cameras. The primary interest of the study is the determination of the growth rate of the turbulent mixing layer that develops after an impulsive acceleration of the perturbed interface between the two gases (air/SF6) by a weak M=1.2 incident shock wave. Measurements of the mixing layer width following the initial shock interaction show a power law growth h˜ tthetasimilar to the those observed in previous experiments and simulations with theta ≈ 0.40. The experiments reveal that the growth rate of the mixing width significantly varies from one experiment to another. This is attributed to the influence of initial perturbations imposed on the interface. However, better consistency for the mixing layer growth rate is obtained from the mixing generated by the reflected shock wave. A novel approach that is based on mass and linear momentum conservation laws in the moving reference frame leads to a new definition of the spike and bubble mixing layer widths, which

  15. COMBAT: Initial experience with a randomized clinical trial of plasma-based resuscitation in the field for traumatic hemorrhagic shock

    PubMed Central

    Chapman, Michael P.; Moore, Ernest E.; Chin, Theresa L; Ghasabyan, Arsen; Chandler, James; Stringham, John; Gonzalez, Eduardo; Moore, Hunter B.; Banerjee, Anirban; Silliman, Christopher C; Sauaia, Angela

    2015-01-01

    The existing evidence shows great promise for plasma as the first resuscitation fluid in both civilian and military trauma. We embarked on the Control of Major Bleeding After Trauma (COMBAT) trial with the support of the Department of Defense, in order to determine if plasma-first resuscitation yields hemostatic and survival benefits. The methodology of the COMBAT study represents not only three years of development work, but the integration of nearly two-decades of technical experience with the design and implementation of other clinical trials and studies. Herein, we describe the key features of the study design, critical personnel and infrastructural elements, and key innovations. We will also briefly outline the systems engineering challenges entailed by this study. COMBAT is a randomized, placebo controlled, semi-blinded prospective Phase IIB clinical trial, conducted in a ground ambulance fleet based at a Level I trauma center, and part of a multicenter collaboration. The primary objective of COMBAT is to determine the efficacy of field resuscitation with plasma first, compared to standard of care (normal saline). To date we have enrolled 30 subjects in the COMBAT study. The ability to achieve intervention with a hemostatic resuscitation agent in the closest possible temporal proximity to injury is critical and represents an opportunity to forestall the evolution of the “bloody vicious cycle”. Thus, the COMBAT model for deploying plasma in first response units should serve as a model for RCTs of other hemostatic resuscitative agents. PMID:25784527

  16. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities.

    PubMed

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R; Platt, Robert; Toh, Sengwee

    2015-11-05

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up time, small sample size, highly selected population, high cost, and ethical restrictions. In this paper, we discuss the challenges and opportunities of incorporating both RCTs and non-randomized comparative cohort studies into network meta-analysis for assessing the safety and effectiveness of medical treatments. Non-randomized studies with inadequate control of biases such as confounding may threaten the validity of the entire network meta-analysis. Therefore, identification and inclusion of non-randomized studies must balance their strengths with their limitations. Inclusion of both RCTs and non-randomized studies in network meta-analysis will likely increase in the future due to the growing need to assess multiple treatments simultaneously, the availability of higher quality non-randomized data and more valid methods, and the increased use of progressive licensing and product listing agreements requiring collection of data over the life cycle of medical products. Inappropriate inclusion of non-randomized studies could perpetuate the biases that are unknown, unmeasured, or uncontrolled. However, thoughtful integration of randomized and non-randomized studies may offer opportunities to provide more timely, comprehensive, and generalizable evidence about the comparative safety and effectiveness of medical treatments.

  17. Experience with subsea well control systems

    SciTech Connect

    Coltharp, E.D.; Coffelt, D.E.

    1981-01-01

    Since 1969, Conoco Inc. has installed ten offshore wells and one land test of subsea completion systems. These wells consist of four single zone oil wells plus one water injection well with Thru Flowline (TFL) pumpdown capability and three single zone gas wells plus three dual zone gas wells utilizing the ''Plain Jane'' wellheads without TFL capability. The control systems for these wells have varied from an electro-hydraulic sequential system to a straight discrete hydraulic system. This paper deals with the design, installation, and operational problems encountered and the remedial procedures taken to solve the problems to date.

  18. Computerized monitoring and control of experiments in space

    NASA Technical Reports Server (NTRS)

    Janisch, Thomas V.

    1988-01-01

    The computer subsystem of the Villanova University GAS (Get Away Special) experiment apparatus is discussed. The function of the computer subsystem is to provide data acquisition and control system support to the experiments. The computer subsystem will provide high availability, low power consumption and highly reliable data retention. The general layout of the subsystem provides for redundant processing units, control modules, and multiple data acquisition modules. Each of the two redundant processing units will be composed of a microprocessor, control logic, PROM, RAM, non-volitile memory, timers, self-check logic and data ports to the data acquisition and control modules. One unit will control the experiment while the other shadows the primary unit operation. The data acquisition module gathers data from the experiment. The data is transfered to the processing unit in digital form. The control module validates the data, decodes it and executes the command.

  19. Differential effect of Taekwondo training on knee muscle strength and reactive and static balance control in children with developmental coordination disorder: a randomized controlled trial.

    PubMed

    Fong, Shirley S M; Chung, Joanne W Y; Chow, Lina P Y; Ma, Ada W W; Tsang, William W N

    2013-05-01

    This randomized controlled trial aimed to investigate the effect of short-term intensive TKD training on the isokinetic knee muscle strength and reactive and static balance control of children with developmental coordination disorder (DCD). Among the 44 children with DCD (mean age: 7.6 ± 1.3 years) recruited, 21 were randomly assigned to undergo daily TKD training for 1h over three consecutive months, with the remaining 23 children being assigned to the DCD control group. Eighteen typically developing children (mean age: 7.2 ± 1.0 years) received no training as normal controls. Knee extensor and flexor muscle strength and reactive and static balance control were assessed using an isokinetic machine (with low, moderate and high movement velocities), a motor control test (MCT) and a unilateral stance test (UST), respectively. A repeated measures MANCOVA revealed a significant group through time interaction effect in isokinetic outcomes at 180°/s and in the UST outcome. Post hoc analysis demonstrated that DCD-TKD children's isokinetic knee muscle strength, specifically at 180°/s, was as high as that of the normal control children (p>0.0083) after TKD training. Moreover, UST body sway velocity was slower in the DCD-TKD group than in the DCD control group (p<0.001), and was comparable to that of the normal control group (p>0.05) after TKD training. However, no such improvement in balance was observed in the MCT (p>0.025). The results show that children with DCD who undergo a 3-month program of intensive TKD training experience improvements in isokinetic knee muscle strength at 180°/s and static single-leg standing balance control, but do not benefit from improved reactive balance control.

  20. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

    ERIC Educational Resources Information Center

    Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

    2004-01-01

    The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

  1. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial.

    PubMed

    Springer, Bryan D; Beaver, Walter B; Griffin, William L; Mason, J Bohannon; Odum, Susan M

    2015-09-01

    We conducted a randomized controlled trial to compare efficacy of an occlusive antimicrobial barrier dressing and a standard surgical dressing in patients who underwent primary total joint arthroplasty. Two hundred sixty-two patients were randomized to receive either an occlusive dressing or a standard dressing. Wounds were closed in identical fashion. Outcomes included wound complications, dressing changes, and patient satisfaction. With use of occlusive dressing (vs standard dressing), wound complications (including skin blistering) were significantly (P = 0.15) reduced; there were significantly (P < .0001) fewer dressing changes; and patient satisfaction was significantly (P < .0001) higher. Use of occlusive dressings can reduce wound complications and promote wound healing after total joint arthroplasty.

  2. Double threshold behavior in a resonance-controlled ZnO random laser

    NASA Astrophysics Data System (ADS)

    Niyuki, Ryo; Fujiwara, Hideki; Nakamura, Toshihiro; Ishikawa, Yoshie; Koshizaki, Naoto; Tsuji, Takeshi; Sasaki, Keiji

    2017-03-01

    We observed unusual lasing characteristics, such as double thresholds and blue-shift of lasing peak, in a resonance-controlled ZnO random laser. From the analysis of lasing threshold carrier density, we found that the lasing at 1st and 2nd thresholds possibly arises from different mechanisms; the lasing at 1st threshold involves exciton recombination, whereas the lasing at 2nd threshold is caused by electron-hole plasma recombination, which is the typical origin of conventional random lasers. These phenomena are very similar to the transition from polariton lasing to photon lasing observed in a well-defined cavity laser.

  3. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  4. Effectiveness of Cognitive Behavioral Therapy on the Quality of Sleep in Women with Multiple Sclerosis: A Randomized Controlled Trial Study

    PubMed Central

    Abbasi, Samira; Alimohammadi, Nasrollah; Pahlavanzadeh, Saeid

    2016-01-01

    ABSTRACT Background: Multiple sclerosis is accompanied by secondary clinical signs such as insomnia. Considering the side effects of drugs and also increasing acceptability of psychotherapy methods in health systems, we aimed to determine the effect of group cognitive behavioral therapy on the quality of sleep in women with multiple sclerosis in 2014. Methods: This study is a randomized controlled clinical conducted on 72 women with multiple sclerosis who referred to medical centers of Isfahan. After convenience sampling, participants were randomly allocated into two equal groups of control (n=36) and intervention (n=36). In the intervention group, cognitive behavioral therapy was performed in 8 sessions. The control group, along with receiving the common drugs, participated in 3 group sessions and talked about their feelings and experiences. Data were gathered using Pittsburgh Sleep Quality Index (PSQI) and analyzed through independent t-test, Chi-square, Mann Whitney, ANOVA with repeated measure, using SPSS 18. Results: There was a significant difference between the mean score of sleep quality of the control and intervention groups immediately and one month after the intervention (P<0.001). ANOVA with repeated measure test showed that the mean score of sleep quality of patients in the intervention group had a significant difference at three stages of before, immediately and one month after the intervention. Conclusions: According to the results of this study, cognitive behavioral therapy, as an effective and cost-effective therapy, could improve sleep quality in patients with multiple sclerosis. Trial Registration Number: IRCT2015012720833N1 PMID:27713895

  5. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

    PubMed Central

    2012-01-01

    Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i) trial, (ii) site, (iii) patient, (iv) clinical team, (v) information and consent and (vi) study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using this tool with

  6. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

    PubMed

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study.

  7. A randomized controlled trial of solcoseryl and duoderm in chronic sickle-cell ulcers.

    PubMed

    La Grenade, L; Thomas, P W; Serjeant, G R

    1993-09-01

    A randomized controlled trial of Solcoseryl, DuoDerm and conventional conservative therapy with Eusol has been performed in 32 patients with homozygous sickle-cell (SS) disease. After 12 weeks' baseline observation, patients were randomized to one of three therapies and monitored for a further 12 weeks. Of 44 ulcerated legs, 20 received control treatment, 12 Solcoseryl and 12 DuoDerm. DuoDerm was generally unacceptable, and two-thirds of the patients defaulted from this treatment. Solcoseryl increased ulcer healing compared to the controls but the difference was not significant. Solcoseryl was well tolerated and may have a role in the treatment of chronic leg ulcers of sickle-cell disease.

  8. Pseudo-random Spray Release to Measure World-wide Transfer Functions of Cloud Albedo Control.

    NASA Astrophysics Data System (ADS)

    Salter, Stephen

    2010-05-01

    Institute for Energy Systems, School of Engineering, University of Edinburgh. S.Salter@ed.ac.uk Previous climate models of Latham's proposal to reverse global warming by using sub-micron sea spray to increase cloud albedo have used a variety of spray patterns. Kettles forced CCN concentration to be 375/cm3 everywhere. Rasch et al used the 20% and 70% most susceptible regions. Bala and Caldeira used an even spread. Jones et al. concentrated spray in the 3.3% oceans with the highest susceptibility All used the same rate through the year. We want to choose a scheme for a climate-modelling experiment designed to identify simultaneously the effects of cloud albedo control at various seasons of the year from spray at all regions of the world on climates of all other regions the world. In particular we want to know seasons and spray places which might have an undesirable effect on precipitation. The spray systems in various regions of a numerical climate model will be modulated on an off with different but known pseudo-random sequences and a selection of seasons. The mean value of the resulting weather records of the parameters of interest, mainly temperature and water run-off, at each region will be subtracted from each value of the record so as to give just the alternating component with an average value of zero. This will be correlated with each of the chosen pseudo-random sequences to give the magnitude and polarity of the effect of a treatment at each input area and selected seasons of the year with the resulting effects on all regions. By doing a time-shifted correlation we can account for phase-shift and time delay. The signal-to-noise ratio should improve with the square root of the analysis time and so we may be able to measure the transfer function with quite a small stimulus. The results of a Mathcad simulation of the process with statistical distributions approximating to natural variations temperature and precipitation show that a single run of a climate

  9. Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

    PubMed Central

    Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark

    2012-01-01

    Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters

  10. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  11. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    PubMed Central

    2014-01-01

    Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically

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

    PubMed

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

    2016-02-01

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

  13. A Randomized Control Trial Exploring the Effect of Mental Rehearsal and Cognitive Visualization on Microsurgery Skills.

    PubMed

    Chadha, Priyanka; Hachach-Haram, Nadine; Shurey, Sandra; Mohanna, Pari-Naz

    2016-09-01

    Background Many factors are known to influence the performance of surgeons within the operating theater, including tiredness, previous experience, and stress levels. The effects of mental rehearsal and cognitive visualization on microsurgical skills have not been assessed. Methods Thirty-six subjects recruited from the Northwick Park Microsurgery Skills Course were randomized into three groups; (1) a control group (C) with no mental rehearsal script, (2) a visual anastomosis group (VA), with a detailed rat anastomosis script, and (3) a visual relaxation (VR) group with a relaxation script, unrelated to the anastomosis. Participants ran through relevant scripts from day 2 to 5 and were assessed through recorded arterial rat anastomosis, scored using the structured assessment of microsurgery skills. Results Results were analyzed by double-blinded assessors. No statistical significance was found on Monday and Tuesday (first day post intervention), p = 0.326 (VA vs. C) and p = 0.283 (VR vs. C). A statistically significant difference was noted at the end of day 4; p < 0.001 (VA vs. VR) and p = 0.001 (VA vs. C). Further analysis demonstrated that domains within the global rating scoring system showed statistical significance for (1) dexterity: VA versus VR, p = 0.001, (2) visuospatial skills: VA versus VR, p = 0.001, and VA versus C, p = 0.002, and (3) operative flow: VA versus VR, p = 0.044, and VA versus C, p = 0.026. Conclusion The benefits of cognitive visualization and mental rehearsal in microsurgery may result in fewer complications from errors and thus lead to enhanced patient safety and better operative outcomes.

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  16. Assessing Fun Items' Effectiveness in Increasing Learning of College Introductory Statistics Students: Results of a Randomized Experiment

    ERIC Educational Resources Information Center

    Lesser, Lawrence M.; Pearl, Dennis K.; Weber, John J., III

    2016-01-01

    There has been a recent emergence of scholarship on the use of fun in the college statistics classroom, with at least 20 modalities identified. While there have been randomized experiments that suggest that fun can enhance student achievement or attitudes in statistics, these studies have generally been limited to one particular fun modality or…

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  18. Is Identification with School the Key Component in the "Black Box" of Education Outcomes? Evidence from a Randomized Experiment

    ERIC Educational Resources Information Center

    Fletcher, Jason M.

    2009-01-01

    In this paper, we follow up the important class size reduction randomized experiment in Tennessee in the mid 1980s (Project STAR) to attempt to further understand the long-lasting influences of early education interventions. While STAR led to large test score benefits during the intervention, these benefits quickly faded at its conclusion.…

  19. Effects of Practice on Task Architecture: Combined Evidence from Interference Experiments and Random-Walk Models of Decision Making

    ERIC Educational Resources Information Center

    Kamienkowski, Juan E.; Pashler, Harold; Dehaene, Stanislas; Sigman, Mariano

    2011-01-01

    Does extensive practice reduce or eliminate central interference in dual-task processing? We explored the reorganization of task architecture with practice by combining interference analysis (delays in dual-task experiment) and random-walk models of decision making (measuring the decision and non-decision contributions to RT). The main delay…

  20. Examining the Internal Validity and Statistical Precision of the Comparative Interrupted Time Series Design by Comparison with a Randomized Experiment

    ERIC Educational Resources Information Center

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

    2014-01-01

    Although evaluators often use an interrupted time series (ITS) design to test hypotheses about program effects, there are few empirical tests of the design's validity. We take a randomized experiment on an educational topic and compare its effects to those from a comparative ITS (CITS) design that uses the same treatment group as the experiment…

  1. Randomized Impact Evaluation of Education Interventions: Experiences and Lessons from a Reading to Learn Intervention in East Africa

    ERIC Educational Resources Information Center

    Ngware, Moses Waithanji; Abuya, Benta; Oketch, Moses; Admassu, Kassahun; Mutisya, Maurice; Musyoka, Peter

    2015-01-01

    This paper presents the experiences and lessons learnt during the design and implementation of the randomized impact evaluation (IE) of a reading to learn (RtL) intervention in early primary grades. The study was to assess the impact of RtL on literacy and numeracy among pupils in low-performing districts in East Africa. The intervention was…

  2. Use of antibacterial sutures for skin closure in controlling surgical site infections: a systematic review of published randomized, controlled trials

    PubMed Central

    Sajid, Muhammad S.; Craciunas, L.; Sains, P.; Singh, K.K.; Baig, M.K.

    2013-01-01

    Objective: The objective of this article is to systematically analyse the randomized, controlled trials that compare the use of antibacterial sutures (ABS) for skin closure in controlling surgical site infections. Methods: Randomized, controlled trials on surgical patients comparing the use of ABS for skin closure in controlling the surgical site infections were analysed systematically using RevMan® and combined outcomes were expressed as odds ratios (OR) and standardized mean differences (SMD). Results: Seven randomized, controlled trials evaluating 1631 patients were retrieved from electronic databases. There were 760 patients in the ABS group and 871 patients in the simple suture group. There was moderate heterogeneity among trials (Tau2 = 0.12; chi2 = 8.40, df = 6 [P < 0.01]; I2 = 29%). Therefore in the random-effects model, the use of ABS for skin closure in surgical patients was associated with a reduced risk of developing surgical site infections (OR, 0.16; 95% CI, 0.37, 0.99; z = 2.02; P < 0.04) and postoperative complications (OR, 0.56; 95% CI, 0.32, 0.98 z = 2.04; P = 0.04). The durations of operation and lengths of hospital stay were similar following the use of ABS and SS for skin closure in patients undergoing various surgical procedures. Conclusion: Use of ABS for skin closure in surgical patients is effective in reducing the risk of surgical site infection and postoperative complications. ABS is comparable with SS in terms of length of hospital stay and duration of operation. PMID:24759666

  3. Endoscopic versus microscopic transsphenoidal surgery in the treatment of pituitary tumors: systematic review and meta-analysis of randomized and non-randomized controlled trials.

    PubMed

    Bastos, Rodrigo V S; Silva, Carla Maria D M; Tagliarini, Jose Vicente; Zanini, Marco Antonio; Romero, Flavio R; Boguszewski, Cesar Luiz; Nunes, Vania Dos Santos

    2016-10-01

    We conducted a systematic review and meta-analysis of randomized and non-randomized controlled trials that compared pure endoscopic with microscopic transsphenoidal surgery (TSS) in the resection of pituitary tumors. Embase, PubMed, Lilacs, and Central Cochrane were used as our data sources. The outcomes were total tumor resection, achievement of biochemical control of functioning adenomas, hospital stay and surgery complications. The randomized trials were analyzed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Two randomized and three prospective controlled non-randomized studies were included. Two studies, including 68 patients, evaluated total tumor resection and the meta-analysis did not show differences between the groups [RR: 1.45 (95% CI: 0.87, 2.44)]. Three studies involving 65 patients analyzed the achievement of biochemical control and no statistical difference was found [RR: 0.94 (95% CI: 0.7, 1.26)]. All five studies compared the frequency of postoperative complications between intervention and control group and meta-analysis favored for a low rate of postoperative complications in the endoscopic TSS group [(RR: 0.37 (95% CI: 0.16, 0.83)]. Due to the low evidence level and low number of observations, the results of our meta-analysis should not be viewed as a final proof of inferiority or superiority of one approach in relation to the other. More data including higher numbers of observations are needed.

  4. A systematic review of randomized controlled trials on sterilization methods of extracted human teeth

    PubMed Central

    Western, J. Sylvia; Dicksit, Daniel Devaprakash

    2016-01-01

    Aim of this Study: The aim was to evaluate the efficiency of different sterilization methods on extracted human teeth (EHT) by a systematic review of in vitro randomized controlled trials. Methodology: An extensive electronic database literature search concerning the sterilization of EHT was conducted. The search terms used were “human teeth, sterilization, disinfection, randomized controlled trials, and infection control.” Randomized controlled trials which aim at comparing the efficiency of different methods of sterilization of EHT were all included in this systematic review. Results: Out of 1618 articles obtained, eight articles were selected for this systematic review. The sterilization methods reviewed were autoclaving, 10% formalin, 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C. Data were extracted from the selected individual studies and their findings were summarized. Conclusion: Autoclaving and 10% formalin can be considered as 100% efficient and reliable methods. While the use of 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C was inefficient and unreliable methods of sterilization of EHT. PMID:27563183

  5. 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

  6. 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

    2015-08-06

    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.

  7. 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

  8. Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial

    PubMed Central

    Mohammed, Shama; Glennerster, Rachel; Khan, Aamir J.

    2016-01-01

    Importance The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes. Objective To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. Design We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day. Setting Public and private sector tuberculosis clinics in Karachi, Pakistan. Participants Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group. Main Outcome The primary outcome was clinically recorded treatment success based upon intention-to-treat. Results We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment. Conclusion In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. Trial Registration The trial was registered with ClinicalTrials.gov, NCT

  9. Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial

    PubMed Central

    2014-01-01

    Background Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. Methods/Design The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). Discussion This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low

  10. Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

    PubMed Central

    Yektatalab, Shahrzad; Alipour, Abdolrasool; Edraki, Mitra; Tavakoli, Pouran

    2016-01-01

    Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01), verbal (P=0.02) and physical (P=0.01) aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09) and impulsive anger (P=0.08) subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers. Trial Registration Number: IRCT2014042617436N1 PMID:26793733

  11. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  12. On the repeated measures designs and sample sizes for randomized controlled trials.

    PubMed

    Tango, Toshiro

    2016-04-01

    For the analysis of longitudinal or repeated measures data, generalized linear mixed-effects models provide a flexible and powerful tool to deal with heterogeneity among subject response profiles. However, the typical statistical design adopted in usual randomized controlled trials is an analysis of covariance type analysis using a pre-defined pair of "pre-post" data, in which pre-(baseline) data are used as a covariate for adjustment together with other covariates. Then, the major design issue is to calculate the sample size or the number of subjects allocated to each treatment group. In this paper, we propose a new repeated measures design and sample size calculations combined with generalized linear mixed-effects models that depend not only on the number of subjects but on the number of repeated measures before and after randomization per subject used for the analysis. The main advantages of the proposed design combined with the generalized linear mixed-effects models are (1) it can easily handle missing data by applying the likelihood-based ignorable analyses under the missing at random assumption and (2) it may lead to a reduction in sample size, compared with the simple pre-post design. The proposed designs and the sample size calculations are illustrated with real data arising from randomized controlled trials.

  13. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

    PubMed

    Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

    2017-04-01

    The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record

  14. Decoupling gain and feedback in coherent random lasers: experiments and simulations.

    PubMed

    Consoli, Antonio; López, Cefe

    2015-11-18

    We propose and demonstrate a coherent random laser in which the randomly distributed scattering centres are placed outside the active region. This architecture is implemented by enclosing a dye solution between two agglomerations of randomly positioned titanium dioxide nanoparticles. The same spectral signature, consisting of sharp spikes with random spectral positions, is detected emerging from both ensembles of titanium dioxide nanoparticles. We interpret this newly observed behaviour as due to the optical feedback given by back-scattered light from the scattering agglomerations, which also act as output couplers. A simple model is presented to simulate the observed behaviour, considering the amplitude and phase round trip conditions that must be satisfied to sustain lasing action. Numerical simulations reproduce the experimental reports, validating our simple model. The presented results suggest a new theoretical and experimental approach for studying the complex behavior of coherent random lasers and stimulate the realization of new devices based on the proposed architecture, with different active and scattering materials.

  15. Decoupling gain and feedback in coherent random lasers: experiments and simulations

    NASA Astrophysics Data System (ADS)

    Consoli, Antonio; López, Cefe

    2015-11-01

    We propose and demonstrate a coherent random laser in which the randomly distributed scattering centres are placed outside the active region. This architecture is implemented by enclosing a dye solution between two agglomerations of randomly positioned titanium dioxide nanoparticles. The same spectral signature, consisting of sharp spikes with random spectral positions, is detected emerging from both ensembles of titanium dioxide nanoparticles. We interpret this newly observed behaviour as due to the optical feedback given by back-scattered light from the scattering agglomerations, which also act as output couplers. A simple model is presented to simulate the observed behaviour, considering the amplitude and phase round trip conditions that must be satisfied to sustain lasing action. Numerical simulations reproduce the experimental reports, validating our simple model. The presented results suggest a new theoretical and experimental approach for studying the complex behavior of coherent random lasers and stimulate the realization of new devices based on the proposed architecture, with different active and scattering materials.

  16. CR-Calculus and adaptive array theory applied to MIMO random vibration control tests

    NASA Astrophysics Data System (ADS)

    Musella, U.; Manzato, S.; Peeters, B.; Guillaume, P.

    2016-09-01

    Performing Multiple-Input Multiple-Output (MIMO) tests to reproduce the vibration environment in a user-defined number of control points of a unit under test is necessary in applications where a realistic environment replication has to be achieved. MIMO tests require vibration control strategies to calculate the required drive signal vector that gives an acceptable replication of the target. This target is a (complex) vector with magnitude and phase information at the control points for MIMO Sine Control tests while in MIMO Random Control tests, in the most general case, the target is a complete spectral density matrix. The idea behind this work is to tailor a MIMO random vibration control approach that can be generalized to other MIMO tests, e.g. MIMO Sine and MIMO Time Waveform Replication. In this work the approach is to use gradient-based procedures over the complex space, applying the so called CR-Calculus and the adaptive array theory. With this approach it is possible to better control the process performances allowing the step-by-step Jacobian Matrix update. The theoretical bases behind the work are followed by an application of the developed method to a two-exciter two-axis system and by performance comparisons with standard methods.

  17. In silico pooling of ChIP-seq control experiments.

    PubMed

    Sun, Guannan; Srinivasan, Rajini; Lopez-Anido, Camila; Hung, Holly A; Svaren, John; Keleş, Sündüz

    2014-01-01

    As next generation sequencing technologies are becoming more economical, large-scale ChIP-seq studies are enabling the investigation of the roles of transcription factor binding and epigenome on phenotypic variation. Studying such variation requires individual level ChIP-seq experiments. Standard designs for ChIP-seq experiments employ a paired control per ChIP-seq sample. Genomic coverage for control experiments is often sacrificed to increase the resources for ChIP samples. However, the quality of ChIP-enriched regions identifiable from a ChIP-seq experiment depends on the quality and the coverage of the control experiments. Insufficient coverage leads to loss of power in detecting enrichment. We investigate the effect of in silico pooling of control samples within multiple biological replicates, multiple treatment conditions, and multiple cell lines and tissues across multiple datasets with varying levels of genomic coverage. Our computational studies suggest guidelines for performing in silico pooling of control experiments. Using vast amounts of ENCODE data, we show that pairwise correlations between control samples originating from multiple biological replicates, treatments, and cell lines/tissues can be grouped into two classes representing whether or not in silico pooling leads to power gain in detecting enrichment between the ChIP and the control samples. Our findings have important implications for multiplexing samples.

  18. The Sexunzipped Trial: Young People’s Views of Participating in an Online Randomized Controlled Trial

    PubMed Central

    Nicholas, Angela; Stevenson, Fiona; Murray, Elizabeth

    2013-01-01

    Background Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants’ experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Objective Our goal was to determine participants’ views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. Methods We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Results Interview participants found the trial design, including online recruitment via Facebook, online registration, email

  19. Effects of an Interactive School-Based Program for Preventing Adolescent Sexual Harassment: A Cluster-Randomized Controlled Evaluation Study.

    PubMed

    de Lijster, Gaby P A; Felten, Hanneke; Kok, Gerjo; Kocken, Paul L

    2016-05-01

    Many adolescents experience sexual harassment and victims of sexual harassment have higher risks regarding well-being and health behaviors such as higher risks of suicidal thoughts, suicidal ideation and feeling unsafe at school. A peer-performed play and school lessons on preventing sexual harassment behavior were presented to secondary school students. We evaluated its effectiveness, using a cluster-randomized controlled design to assign schools to an experimental condition [n = 14 schools; 431 students (51 % female)] and a control condition [n = 11 schools; 384 students (51 % female)]. To measure the effects of the intervention at first post-test and 6-month follow-up, our multilevel analyses used a two-level random intercept model. Outcome measures were sexual harassment behaviors, behavioral determinants and distal factors influencing these behaviors. At post-test, students in the experimental group reported a reduced intention to commit sexual harassment behavior and higher self-efficacy in rejecting it. At post-test and follow-up there was a significant positive effect on social norms for rejecting sexual harassment behavior. At follow-up, sexual self-esteem was higher in students in the experimental group than in the control group. Effects on these determinants will benefit adolescents' future sexual behaviors. In combination, the play and lessons, possibly together with continued sexual health education and skills programs on social-emotional learning in subsequent school years, have potential for preventing sexual harassment behavior.

  20. Problem-solving education to prevent depression among low-income mothers of preterm infants: a randomized controlled pilot trial.

    PubMed

    Silverstein, Michael; Feinberg, Emily; Cabral, Howard; Sauder, Sara; Egbert, Lucia; Schainker, Elisabeth; Kamholz, Karen; Hegel, Mark; Beardslee, William

    2011-08-01

    We sought to assess the feasibility and document key study processes of a problem-solving intervention to prevent depression among low-income mothers of preterm infants. A randomized controlled pilot trial (n = 50) of problem-solving education (PSE) was conducted. We assessed intervention provider training and fidelity; recruitment and retention of subjects; intervention acceptability; and investigators' ability to conduct monthly outcome assessments, from which we could obtain empirical estimates of depression symptoms, stress, and functioning over 6 months. Four of four bachelor-level providers were able to deliver PSE appropriately with standardized subjects within 4 weeks of training. Of 12 randomly audited PSE sessions with actual subjects, all met treatment fidelity criteria. Nineteen of 25 PSE subjects (76%) received full four-session courses; no subjects reported negative experiences with PSE. Eighty-eight percent of scheduled follow-up assessments were completed. Forty-four percent of control group mothers experienced an episode of moderately severe depression symptoms over the follow-up period, compared to 24% of PSE mothers. Control mothers experienced an average 1.19 symptomatic episodes over the 6 months of follow-up, compared to 0.52 among PSE mothers. PSE appears feasible and may be a promising strategy to prevent depression among mothers of preterm infants.

  1. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

  2. Speed synchronization control for integrated automotive motor-transmission powertrain system with random delays

    NASA Astrophysics Data System (ADS)

    Zhu, Xiaoyuan; Zhang, Hui; Fang, Zongde

    2015-12-01

    This paper presents a robust speed synchronization controller design for an integrated motor-transmission powertrain system in which the driving motor and multi-gearbox are directly coupled. As the controller area network (CAN) is commonly used in the vehicle powertrain system, the possible network-induced random delays in both feedback and forward channel are considered and modeled by using two Markov chains in the controller design process. For the application perspective, the control law adopted here is a generalized proportional-integral (PI) control. By employing the system-augmentation technique, a delay-free stochastic closed-loop system is obtained and the generalized PI controller design problem is converted to a static output feedback (SOF) controller design problem. Since there are external disturbances involved in the closed-loop system, the energy-to-peak performance is considered to guarantee the robustness of the controller. And the controlled output is chosen as the speed synchronization error. To further improve the transient response of the closed-loop system, the pole placement is also employed in the energy-to-peak performance based speed synchronization control. The mode-dependent control gains are obtained by using an iterative linear matrix inequality (LMI) algorithm. Simulation results show the effectiveness of the proposed control approach.

  3. Control of large collector arrays: The SSPS experience

    NASA Astrophysics Data System (ADS)

    Carmona, R.; Martin, J. G.

    Experience gained in the control of the distributed collector fields at the IEA Small Solar Power Systems project may be of value in the design of control systems for future large arrays. The project experience with analog and digital systems is discussed, as are details on the improvements that were made and the lessons learned. A priority item in this year's efforts on site is the evaluation of the potential for fully automatic operation, with a suitable control algorithm, of a reliable collector array. Preliminary results from dynamic models of the fields in terms of lumped and distributed parameters are given. Adaptive controls are discussed.

  4. Alkylation of Chlorobenzene. An Experiment Illustrating Kinetic versus Thermodynamic Control.

    ERIC Educational Resources Information Center

    Kolb, Kenneth; And Others

    1988-01-01

    Describes an experiment which illustrates the kinetic versus thermodynamic control of chemical reactions for organic chemistry students. Considers the laboratory procedures including the isolation of both the kinetic and thermodynamic products. (CW)

  5. Sexual Experience and Responses to a Birth Control Film.

    ERIC Educational Resources Information Center

    Herold, Edward S.; Thomas, Roger E.

    1980-01-01

    The relationship between sexual experience and contraceptive attitudinal responses to a birth control film is examined. Significant group differences were found regarding reinforcement of sexual attitudes but not for contraceptive attitudes. (JMF)

  6. Controlling dispersion forces between small particles with artificially created random light fields.

    PubMed

    Brügger, Georges; Froufe-Pérez, Luis S; Scheffold, Frank; José Sáenz, Juan

    2015-06-22

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with optical tweezers as well as to induce significant optical binding forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir-Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as a gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light-induced interactions open a path towards the control of translationally invariant interactions with tuneable strength and range in colloidal systems.

  7. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    PubMed

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

  8. Prayer and healing: A medical and scientific perspective on randomized controlled trials

    PubMed Central

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect on outcomes, to worsen outcomes and to have retrospective healing effects. For a multitude of reasons, research on the healing effects of prayer is riddled with assumptions, challenges and contradictions that make the subject a scientific and religious minefield. We believe that the research has led nowhere, and that future research, if any, will forever be constrained by the scientific limitations that we outline. PMID:20048448

  9. Controlling dispersion forces between small particles with artificially created random light fields

    PubMed Central

    Brügger, Georges; Froufe-Pérez, Luis S.; Scheffold, Frank; José Sáenz, Juan

    2015-01-01

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with optical tweezers as well as to induce significant optical binding forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir–Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as a gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light-induced interactions open a path towards the control of translationally invariant interactions with tuneable strength and range in colloidal systems. PMID:26096622

  10. Can Modifications to the Bedroom Environment Improve the Sleep of New Parents? Two Randomized Controlled Trials

    PubMed Central

    Gay, Caryl L.

    2011-01-01

    Postpartum sleep disruption is common among new parents. In this randomized controlled trial we evaluated a modified sleep hygiene intervention for new parents (infant proximity, noise masking, and dim lighting) in anticipation of night-time infant care. Two samples of new mothers (n = 118 and 122) were randomized to the experimental intervention or attention control, and sleep was assessed in late pregnancy and first 3 months postpartum using actigraphy and the General Sleep Disturbance Scale. The sleep hygiene strategies evaluated did not benefit the more socioeconomically advantaged women or their partners in Sample 1, but did improve postpartum sleep among the less advantaged women of Sample 2. Simple changes to the bedroom environment can improve sleep for new mothers with few resources. PMID:21243655

  11. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials.

    PubMed

    Lee, Kathryn A; Gay, Caryl L

    2011-02-01

    Postpartum sleep disruption is common among new parents. In this randomized controlled trial we evaluated a modified sleep hygiene intervention for new parents (infant proximity, noise masking, and dim lighting) in anticipation of night-time infant care. Two samples of new mothers (n = 118 and 122) were randomized to the experimental intervention or attention control, and sleep was assessed in late pregnancy and first 3 months postpartum using actigraphy and the General Sleep Disturbance Scale. The sleep hygiene strategies evaluated did not benefit the more socioeconomically advantaged women or their partners in Sample 1, but did improve postpartum sleep among the less advantaged women of Sample 2. Simple changes to the bedroom environment can improve sleep for new mothers with few resources.

  12. Building social resilience in soldiers: A double dissociative randomized controlled study.

    PubMed

    Cacioppo, John T; Adler, Amy B; Lester, Paul B; McGurk, Dennis; Thomas, Jeffrey L; Chen, Hsi-Yuan; Cacioppo, Stephanie

    2015-07-01

    Can social resilience be trained? We report results of a double-dissociative randomized controlled study in which 48 Army platoons were randomly assigned to social resilience training (intervention condition) or cultural awareness training (active control group). The same surveys were administered to all platoons at baseline and after the completion of training to determine the short-term training effects, generalization effects beyond training, and possible adverse effects. Multilevel modeling analyses indicated that social resilience, compared with cultural awareness, training produced small but significant improvements in social cognition (e.g., increased empathy, perspective taking, & military hardiness) and decreased loneliness, but no evidence was found for social resilience training to generalize beyond these training foci nor to have adverse effects. Moreover, as predicted, cultural awareness, compared with social resilience, training produced increases in knowledge about and decreases in prejudice toward Afghans. Additional research is warranted to determine the long-term durability, safety, and generalizability of social resilience training.

  13. Feasibility, safety, and compliance in a randomized controlled trial of physical therapy for Parkinson's disease.

    PubMed

    McGinley, Jennifer L; Martin, Clarissa; Huxham, Frances E; Menz, Hylton B; Danoudis, Mary; Murphy, Anna T; Watts, Jennifer J; Iansek, Robert; Morris, Meg E

    2012-01-01

    Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD) (n = 210) were randomized into three groups: (1) progressive strength training (PST); (2) movement strategy training (MST); or (3) control ("life skills"). PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance >80%) did not differ between groups (P = .435). Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.

  14. Mindfulness training for loneliness among Chinese college students: A pilot randomized controlled trial.

    PubMed

    Zhang, Na; Fan, Fu-Min; Huang, Si-Yuan; Rodriguez, Marcus A

    2016-10-05

    Loneliness has been found to predict a wide range of physical and mental health problems. It is suggested that China's One-Child Policy places young Chinese people at a particularly high risk for loneliness. Although loneliness is most prevalent in late adolescence and early adulthood, interventions have primarily targeted children or older adults with limited success. The current study examines a pilot randomized controlled trial of a mindfulness training program among Chinese college students. Participants with elevated loneliness (N = 50, ages 17-25) were randomized into either an 8-week mindfulness training or a control group. Self-reported measures of loneliness and mindfulness were administered at baseline and posttest. The training group also completed a program evaluation form and a 3-month follow-up assessment. Results provided preliminary evidence indicating that the intervention was feasible and effective at reducing loneliness among Chinese college students. Limitations and future directions were discussed.

  15. Geometry controlled anomalous diffusion in random fractal geometries: looking beyond the infinite cluster.

    PubMed

    Mardoukhi, Yousof; Jeon, Jae-Hyung; Metzler, Ralf

    2015-11-28

    We investigate the ergodic properties of a random walker performing (anomalous) diffusion on a random fractal geometry. Extensive Monte Carlo simulations of the motion of tracer particles on an ensemble of realisations of percolation clusters are performed for a wide range of percolation densities. Single trajectories of the tracer motion are analysed to quantify the time averaged mean squared displacement (MSD) and to compare this with the ensemble averaged MSD of the particle motion. Other complementary physical observables associated with ergodicity are studied, as well. It turns out that the time averaged MSD of individual realisations exhibits non-vanishing fluctuations even in the limit of very long observation times as the percolation density approaches the critical value. This apparent non-ergodic behaviour concurs with the ergodic behaviour on the ensemble averaged level. We demonstrate how the non-vanishing fluctuations in single particle trajectories are analytically expressed in terms of the fractal dimension and the cluster size distribution of the random geometry, thus being of purely geometrical origin. Moreover, we reveal that the convergence scaling law to ergodicity, which is known to be inversely proportional to the observation time T for ergodic diffusion processes, follows a power-law ∼T(-h) with h < 1 due to the fractal structure of the accessible space. These results provide useful measures for differentiating the subdiffusion on random fractals from an otherwise closely related process, namely, fractional Brownian motion. Implications of our results on the analysis of single particle tracking experiments are provided.

  16. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading.

    PubMed

    Al Otaiba, Stephanie; Connor, Carol M; Folsom, Jessica S; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K

    2014-10-01

    This randomized controlled experiment compared the efficacy of two Response to Intervention (RTI) models - Typical RTI and Dynamic RTI - and included 34 first-grade classrooms (n = 522 students) across 10 socio-economically and culturally diverse schools. Typical RTI was designed to follow the two-stage RTI decision rules that wait to assess response to Tier 1 in many districts, whereas Dynamic RTI provided Tier 2 or Tier 3 interventions immediately according to students' initial screening results. Interventions were identical across conditions except for when intervention began. Reading assessments included letter-sound, word, and passage reading, and teacher-reported severity of reading difficulties. An intent-to-treat analysis using multi-level modeling indicated an overall effect favoring the Dynamic RTI condition (d = .36); growth curve analyses demonstrated that students in Dynamic RTI showed an immediate score advantage, and effects accumulated across the year. Analyses of standard score outcomes confirmed that students in the Dynamic condition who received Tier 2 and Tier 3 ended the study with significantly higher reading performance than students in the Typical condition. Implications for RTI implementation practice and for future research are discussed.

  17. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading

    PubMed Central

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2014-01-01

    This randomized controlled experiment compared the efficacy of two Response to Intervention (RTI) models – Typical RTI and Dynamic RTI - and included 34 first-grade classrooms (n = 522 students) across 10 socio-economically and culturally diverse schools. Typical RTI was designed to follow the two-stage RTI decision rules that wait to assess response to Tier 1 in many districts, whereas Dynamic RTI provided Tier 2 or Tier 3 interventions immediately according to students’ initial screening results. Interventions were identical across conditions except for when intervention began. Reading assessments included letter-sound, word, and passage reading, and teacher-reported severity of reading difficulties. An intent-to-treat analysis using multi-level modeling indicated an overall effect favoring the Dynamic RTI condition (d = .36); growth curve analyses demonstrated that students in Dynamic RTI showed an immediate score advantage, and effects accumulated across the year. Analyses of standard score outcomes confirmed that students in the Dynamic condition who received Tier 2 and Tier 3 ended the study with significantly higher reading performance than students in the Typical condition. Implications for RTI implementation practice and for future research are discussed. PMID:25530622

  18. A Data Management System Integrating Web-based Training and Randomized Trials: Requirements, Experiences and Recommendations.

    PubMed

    Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D

    2011-01-01

    This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance of web-course-trained participants (intervention group) and printed-manual-trained participants (comparison group) to determine the effectiveness of the web-course in teaching CBT skills. A single DMS was needed to support all aspects of the study: web-course delivery and management, as well as randomized trial management. The authors briefly reviewed several other systems that were described as built either to handle randomized trials or to deliver and evaluate web-based training. However it was clear that these systems fell short of meeting our needs for simultaneous, coordinated management of the web-course and the randomized trial. New England Research Institute's (NERI) proprietary Advanced Data Entry and Protocol Tracking (ADEPT) system was coupled with the web-programmed course and customized for our purposes. This article highlights the requirements for a DMS that operates at the intersection of web-based course management systems and randomized clinical trial systems, and the extent to which the coupled, customized ADEPT satisfied those requirements. Recommendations are included for institutions and individuals considering conducting randomized trials and web-based training programs, and seeking a DMS that can meet similar requirements.

  19. A feasibility study of orbiter flight control experiments

    NASA Technical Reports Server (NTRS)

    Geissler, W. H.

    1978-01-01

    The results of a feasibility study of orbiter flight control experiments performed are summarized. Feasibility studies were performed on a group of 14 experiments selected from a candidate list of 35 submitted to the study contractor by the flight control community. Concepts and requirements were developed for the 14 selected experiments and they were ranked on a basis of technical value, feasibility, and cost. It was concluded that all the selected experiments can be considered as potential candidates for the Orbiter Experiment program, which is being formulated for the Orbiter Flight Tests and subsequent operational flights, regardless of the relative ranking established during the study. None of the selected experiments has significant safety implications and the cost of most was estimated to be less than $200K.

  20. Direct Numerical Simulation of Fracture Behaviour for Random Short Wood Fibres Reinforced Composites, Comparison with Digital Image Correlation Experiments

    NASA Astrophysics Data System (ADS)

    Shen, M.; Touchard, F.; Bezine, G.; Brillaud, J.

    2010-06-01

    The work is to predict fracture behaviour of bio-composites from the tensile properties of its components. In this work, we have realized a direct numerical simulation of fracture behaviour for random short spruce fibers reinforced composites. For calculations, wood fibers have been considered as linear elastic bodies, polypropylene matrix as an elastic-plastic material. Then, numerical results have been compared with experimental results that have been obtained by digital image correlation. This comparison indicates that random fiber FE model of random short spruce fibers reinforced composites can be able to fairly reflect the influence of random fibers microstructure in the composite on its fracture behavior. The calculation of both random fiber and homogeneous FE model and their comparison with experiments show that the average values of J-integral in a region in the front of the crack tip from both numerical FE models are in good agreement with the average J value of DIC experiment in the same region when the numerical and experimental CT specimens of the short spruce fiber reinforced composite are subjected to the same extension at their loading point.

  1. Frontostriatal and behavioral adaptations to daily sugar-sweetened beverage intake: a randomized controlled trial.

    PubMed

    Burger, Kyle S

    2017-03-01

    Background: Current obesity theories suggest that the repeated intake of highly palatable high-sugar foods causes adaptions in the striatum, parietal lobe, and prefrontal and visual cortices in the brain that may serve to perpetuate consumption in a feed-forward manner. However, the data for humans are cross-sectional and observational, leaving little ability to determine the temporal precedence of repeated consumption on brain response.Objective: We tested the impact of regular sugar-sweetened beverage intake on brain and behavioral responses to beverage stimuli.Design: We performed an experiment with 20 healthy-weight individuals who were randomly assigned to consume 1 of 2 sugar-sweetened beverages daily for 21 d, underwent 2 functional MRI sessions, and completed behavioral and explicit hedonic assessments.Results: Consistent with preclinical experiments, daily beverage consumption resulted in decreases in dorsal striatal response during receipt of the consumed beverage (r = -0.46) and decreased ventromedial prefrontal response during logo-elicited anticipation (r = -0.44). This decrease in the prefrontal response correlated with increases in behavioral disinhibition toward the logo of the consumed beverage (r = 0.54; P = 0.02). Daily beverage consumption also increased precuneus response to both juice logos compared with a tasteless control (r = 0.45), suggesting a more generalized effect toward beverage cues. Last, the repeated consumption of 1 beverage resulted in an explicit hedonic devaluation of a similar nonconsumed beverage (P < 0.001).Conclusions: Analogous to previous reports, these initial results provide convergent data for a role of regular sugar-sweetened beverage intake in altering neurobehavioral responses to the regularly consumed beverage that may also extend to other beverage stimuli. Future research is required to provide evidence of replication in a larger sample and to establish whether the neurobehavioral adaptations observed herein are

  2. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    PubMed

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  3. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  4. A systematic mapping review of Randomized Controlled Trials (RCTs) in care homes

    PubMed Central

    2012-01-01

    Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated. PMID:22731652

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

    PubMed Central

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

    2013-01-01

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

  6. Contamination by an Active Control Condition in a Randomized Exercise Trial

    PubMed Central

    Kramer, Arthur F.; McAuley, Edward

    2016-01-01

    Contamination is commonly overlooked in randomized trials. The present study examined contamination (minutes of aerobic activity outside of exercise sessions) within an active control condition in a 6-month randomized exercise trial for older adults. We hypothesized that outside aerobic activity would be greater in the control condition compared to the intervention conditions. Participants (mean age = 65.06 years, 66.2% female) were randomly assigned to: Dance (n = 50), Walking, (n = 108), or Strength/Stretching/Stability (SSS; n = 48). Dance and Walking represented the experimental conditions and SSS the control condition. Participants attended exercise sessions three times weekly for 24 weeks. Participants recorded their physical activity outside of class on a weekly home log. Group assignment and covariates (age, gender, body mass index, exercise session intensity and enjoyment, and program adherence) were examined as predictors of weekly aerobic activity outside of exercise sessions. Participants who returned zero home logs were removed from the dataset (final N = 195). Out-of-class aerobic activity was lowest in the Walking group. Significant effects of gender, group, enjoyment, and intensity on out-of-class weekly aerobic activity were observed, all p<0.003. Higher perceived enjoyment of exercise sessions was associated with more out-of-class aerobic activity, while higher perceived intensity was associated with less out-of-class aerobic activity. A group x intensity interaction, p = 0.002, indicated that group differences in out-of-class aerobic activity were evident only among those with lower intensity perceptions. Walkers may have perceived exercise sessions as sufficient weekly exercise, while the Dance and SSS groups may have perceived the sessions as necessary, but insufficient. The lower aerobic intensity Dancers attributed to exercise sessions and non-aerobic nature of SSS may partially explain contamination observed in this study. Further

  7. Low-dose Ketamine Versus Morphine for Acute Pain In the ED: A Randomized Controlled Trial

    DTIC Science & Technology

    2015-03-01

    Original Contribution Low-dose ketamine vs morphine for acute pain in the ED: a randomized controlled trial☆,☆☆ Joshua P. Miller, MD a,b,⁎, Steven G...numeric rating scale (NRS) pain scores, in patients receiving low-dose ketamine (LDK) or morphine (MOR) for acute pain in the emergency department...convenience sample of patients aged 18 to 59 years with acute abdominal, flank, low back, or extremity pain were enrolled. Subjects were consented and

  8. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2010-05-01

    trial is being conducted to evaluate the effectiveness of propranolol , topiramate, and amitriptyline as treatments for chronic post-traumatic headaches...effectiveness of propranolol , amitriptyline, and topiramate as treatments for chronic PTHAs. We are conducting a single-center, prospective, randomized...double-blind, placebo-controlled, multi-arm trial to evaluate propranolol , amitriptyline, and topiramate for treatment of chronic PTHAs. A total of

  9. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    ERIC Educational Resources Information Center

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  10. Experience of Control and Student Satisfaction with Higher Education Services

    ERIC Educational Resources Information Center

    Lee, Jungki; Anantharaman, Sekhar

    2013-01-01

    Although the delivery of satisfactory services is an important strategic goal in many colleges, students are known to face challenges and experience a significant amount of stress during their school life. This study proposes and tests students' experience of control over their college life as a promising factor that would enhance their…

  11. Control of Physiological Experiments Using a Hybrid Computer.

    ERIC Educational Resources Information Center

    Jermann, William H.; Watkins, Melinda G.

    1980-01-01

    Described is the use of a general purpose hybrid computer in controlling and monitoring certain experiments on human subjects. In these investigations, researchers produce various sensory stimuli and measure participants' responses as voltage produced at a scalp node. The computer system discussed facilitates implementation of these experiments as…

  12. Reliable H∞ control of discrete-time systems against random intermittent faults

    NASA Astrophysics Data System (ADS)

    Tao, Yuan; Shen, Dong; Fang, Mengqi; Wang, Youqing

    2016-07-01

    A passive fault-tolerant control strategy is proposed for systems subject to a novel kind of intermittent fault, which is described by a Bernoulli distributed random variable. Three cases of fault location are considered, namely, sensor fault, actuator fault, and both sensor and actuator faults. The dynamic feedback controllers are designed not only to stabilise the fault-free system, but also to guarantee an acceptable performance of the faulty system. The robust H∞ performance index is used to evaluate the effectiveness of the proposed control scheme. In terms of linear matrix inequality, the sufficient conditions of the existence of controllers are given. An illustrative example indicates the effectiveness of the proposed fault-tolerant control method.

  13. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    PubMed

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-03

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children.

  14. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial.

    PubMed

    Kiely, Daniel J; Gotlieb, Walter H; Lau, Susie; Zeng, Xing; Samouelian, Vanessa; Ramanakumar, Agnihotram V; Zakrzewski, Helena; Brin, Sonya; Fraser, Shannon A; Korsieporn, Pira; Drudi, Laura; Press, Joshua Z

    2015-09-01

    The objective of this randomized, controlled trial was to assess whether voluntary participation in a proctored, proficiency-based, virtual reality robotic suturing curriculum using the da Vinci(®) Skills Simulator™ improves robotic suturing performance. Residents and attending surgeons were randomized to participation or non-participation during a 5 week training curriculum. Robotic suturing skills were evaluated before and after training using an inanimate vaginal cuff model, which participants sutured for 10 min using the da Vinci(®) Surgical System. Performances were videotaped, anonymized, and subsequently graded independently by three robotic surgeons. 27 participants were randomized. 23 of the 27 completed both the pre- and post-test, 13 in the training group and 10 in the control group. Mean training time in the intervention group was 238 ± 136 min (SD) over the 5 weeks. The primary outcome (improvement in GOALS+ score) and the secondary outcomes (improvement in GEARS, total knots, satisfactory knots, and the virtual reality suture sponge 1 task) were significantly greater in the training group than the control group in unadjusted analysis. After adjusting for lower baseline scores in the training group, improvement in the suture sponge 1 task remained significantly greater in the training group and a trend was demonstrated to greater improvement in the training group for the GOALS+ score, GEARS score, total knots, and satisfactory knots.

  15. Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial

    PubMed Central

    2013-01-01

    Background Menstrual-related migraine is a common form of migraine affecting >50% of female migraineurs. Acupuncture may be a choice for menstrual-related migraine, when pharmacological prophylaxis is not suitable. However, the efficacy of acupuncture has not been confirmed. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with naproxen in menstrual-related migraine patients. Methods/Design This is a multicenter, single blind, randomized controlled clinical trial. A total of 184 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and medicine (Naproxen Sustained Release Tablets). All treatments will be given for 3 months (menstrual cycles). The primary outcome measures are the change of migraine days inside the menstrual cycle and the proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days). The secondary outcome measures are the change of migraine days outside the menstrual cycle, duration of migraine attack, the Visual Analogue Scale (VAS), and intake of acute medication. The assessment will be made at baseline (before treatment), 3 months (menstrual cycles), and 4 months (menstrual cycles) after the first acupuncture session. Discussion The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis. Trial registration ISRCTN: ISRCTN57133712 PMID:24195839

  16. Evidence-based medicine training during residency: a randomized controlled trial of efficacy

    PubMed Central

    2010-01-01

    Background Evidence-based medicine (EBM) has been widely integrated into residency curricula, although results of randomized controlled trials and long term outcomes of EBM educational interventions are lacking. We sought to determine if an EBM workshop improved internal medicine residents' EBM knowledge and skills and use of secondary evidence resources. Methods This randomized controlled trial included 48 internal medicine residents at an academic medical center. Twenty-three residents were randomized to attend a 4-hour interactive workshop in their PGY-2 year. All residents completed a 25-item EBM knowledge and skills test and a self-reported survey of literature searching and resource usage in their PGY-1, PGY-2, and PGY-3 years. Results There was no difference in mean EBM test scores between the workshop and control groups at PGY-2 or PGY-3. However, mean EBM test scores significantly increased over time for both groups in PGY-2 and PGY-3. Literature searches, and resource usage also increased significantly in both groups after the PGY-1 year. Conclusions We were unable to detect a difference in EBM knowledge between residents who did and did not participate in our workshop. Significant improvement over time in EBM scores, however, suggests EBM skills were learned during residency. Future rigorous studies should determine the best methods for improving residents' EBM skills as well as their ability to apply evidence during clinical practice. PMID:20807453

  17. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  18. Aerobic Exercise and Neurocognitive Performance: a Meta-Analytic Review of Randomized Controlled Trials

    PubMed Central

    Smith, Patrick J.; Blumenthal, James A.; Hoffman, Benson M.; Cooper, Harris; Strauman, Timothy A.; Welsh-Bohmer, Kathleen; Browndyke, Jeffrey N.; Sherwood, Andrew

    2010-01-01

    Objectives Although the effects of exercise on neurocognition have been the subject of several previous reviews and meta-analyses, they have been hampered by methodological shortcomings and are now outdated as a result of the recent publication of several large-scale randomized controlled trials (RCTs). Methods We conducted a systematic literature review of RCTs examining the association between aerobic exercise training on neurocognitive performance conducted between January, 1966 and July, 2009. Suitable studies were selected for inclusion according to the following criteria: randomized treatment allocation, mean age ≥ 18 years of age, duration of treatment > 1 month, incorporated aerobic exercise components, exercise training was supervised, the presence of a non-aerobic-exercise control group, and sufficient information to derive effect size (ES) data. Results Twenty-nine studies met inclusion criteria and were included in our analyses, representing data from 2,049 participants and 234 effect sizes. Individuals randomly assigned to receive aerobic exercise training demonstrated modest improvements in attention and processing speed (g = .158 [95% CI: .055 to .260], P = .003), executive function (g = .123 [95% CI: .021 to .225], P = .018), and memory (g = .128 [95% CI: .015 - .241], P = .026). Conclusions Aerobic exercise training is associated with modest improvements in attention and processing speed, executive function, and memory, although the effects of exercise on working memory are less consistent. Rigorous RCTs are needed with larger samples, appropriate controls, and longer follow-up periods. PMID:20223924

  19. Insights Into the Impact of Online Physician Reviews on Patients’ Decision Making: Randomized Experiment

    PubMed Central

    Waiguny, Martin KJ

    2015-01-01

    Background Physician-rating websites combine public reporting with social networking and offer an attractive means by which users can provide feedback on their physician and obtain information about other patients’ satisfaction and experiences. However, research on how users evaluate information on these portals is still scarce and only little knowledge is available about the potential influence of physician reviews on a patient’s choice. Objective Starting from the perspective of prospective patients, this paper sets out to explore how certain characteristics of physician reviews affect the evaluation of the review and users’ attitudes toward the rated physician. We propose a model that relates review style and review number to constructs of review acceptance and check it with a Web-based experiment. Methods We employed a randomized 2x2 between-subject, factorial experiment manipulating the style of a physician review (factual vs emotional) and the number of reviews for a certain physician (low vs high) to test our hypotheses. A total of 168 participants were presented with a Web-based questionnaire containing a short description of a dentist search scenario and the manipulated reviews for a fictitious dental physician. To investigate the proposed hypotheses, we carried out moderated regression analyses and a moderated mediation analysis using the PROCESS macro 2.11 for SPSS version 22. Results Our analyses indicated that a higher number of reviews resulted in a more positive attitude toward the rated physician. The results of the regression model for attitude toward the physician suggest a positive main effect of the number of reviews (mean [low] 3.73, standard error [SE] 0.13, mean [high] 4.15, SE 0.13). We also observed an interaction effect with the style of the review—if the physician received only a few reviews, fact-oriented reviews (mean 4.09, SE 0.19) induced a more favorable attitude toward the physician compared to emotional reviews (mean 3

  20. Pretravel Health Advice Among Australians Returning From Bali, Indonesia: A Randomized Controlled Trial Protocol

    PubMed Central

    Gibbs, Robyn A; Heyworth, Jane S; Giele, Carolien; Firth, Martin J; Effler, Paul V

    2016-01-01

    Background The effect of pretravel health advice (PTHA) on travel-related illness rates is poorly understood, and to date there are no published randomized controlled trials evaluating the impact of PTHA outcomes. Objective This study aims to determine the effect of an online PTHA intervention on travel-related illness rates in Western Australians visiting Bali, Indonesia. Methods Western Australian travelers to Bali will be recruited online before departure and will be randomly allocated to an intervention or control group by computer algorithm. The intervention in this study is a short animated video, with accompanying text, containing PTHA relevant to Bali. An online posttravel survey will be administered to all participants within two weeks of their return from Bali. The primary outcome is the difference in self-reported travel-related illness rates between control and intervention groups. Secondary outcomes include the difference in risk prevention behaviors and health risk knowledge between the control and intervention groups. Further secondary outcomes include whether individuals in the control group who sought external PTHA differ from those who did not with respect to risk prevention behaviors, health risk knowledge, and health risk perception, as well as the rate of self-reported travel-related illness. Results The study began recruitment in September 2016 and will conclude in September 2017. Data analysis will take place in late 2017, with results disseminated via peer-reviewed journals in early 2018. Conclusions This will be the first randomized controlled trial to examine the effect of a novel PTHA intervention upon travel-related illness. In addition, this study builds upon the limited existing data on the effectiveness of PTHA on travel-related illness. ClinicalTrial Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12615001230549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369567 (Archived by WebCite at http

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

    PubMed Central

    Cunningham, Michael R.; van Zyl, Michiel A.; Antle, Becky F.; Langley, Cheri N.

    2016-01-01

    Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. PMID:27689500

  2. A Chinese Mind-Body Exercise Improves Self-Control of Children with Autism: A Randomized Controlled Trial

    PubMed Central

    Chan, Agnes S.; Sze, Sophia L.; Siu, Nicolson Y.; Lau, Eliza M.; Cheung, Mei-chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants’ self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants’ brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org. PMID:23874533

  3. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial.

    PubMed

    Chan, Agnes S; Sze, Sophia L; Siu, Nicolson Y; Lau, Eliza M; Cheung, Mei-Chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants' self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants' brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org.

  4. A Prospective Randomized Controlled Trial of an Interpersonal Violence Prevention Program With a Mexican American Community

    PubMed Central

    Kelly, Patricia J.; Lesser, Janna; Cheng, An-Lin; Osóos-Sánchez, Manuel; Martinez, Elisabeth; Pineda, Daniel; Mancha, Juan

    2014-01-01

    Using methods of community-based participatory research, a prospective randomized controlled trial of a violence prevention program based on Latino cultural values was implemented with elementary school children in a Mexican American community. Community members participated in intervention program selection, implementation, and data collection. High-risk students who participated in the program had greater nonviolent self-efficacy and demonstrated greater endorsement of program values than did high-risk students in the control group. This collaborative partnership was able to combine community-based participatory research with a rigorous study design and provide sustained benefit to community partners. PMID:20531101

  5. Humour-related interventions for people with mental illness: a randomized controlled pilot study.

    PubMed

    Rudnick, Abraham; Kohn, Paul M; Edwards, Kim R; Podnar, David; Caird, Sara; Martin, Rod

    2014-08-01

    This study explored the feasibility and effects of humour-related interventions for mentally ill adults. Twelve, randomly assigned, participated in each of 3 arms--stand up comedy training (the experimental arm), discussing comedy videos (the active control arm), and no humour-related intervention (the passive control arm). Quantitative and qualitative data were collected at baseline, end of interventions (3 months) and follow up (after another 3 months). Scale comparisons were largely negative, although self-esteem marginally increased in the experimental arm. Interview responses indicated benefits for the interventions, including improved self-esteem in the experimental arm. These results, though mixed, justify further study.

  6. Brief intervention to promote smoking cessation and improve glycemic control in smokers with type 2 diabetes: a randomized controlled trial

    PubMed Central

    Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.

    2017-01-01

    The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764

  7. Randomized controlled trials of psychological and pharmacological treatments for nightmares: a meta-analysis.

    PubMed

    Augedal, Aslak Wøien; Hansen, Kenneth Schøld; Kronhaug, Christian Robstad; Harvey, Allison G; Pallesen, Ståle

    2013-04-01

    A meta-analysis of treatments for nightmares is reported. The studies were identified by database searches and by an inspection of relevant reference lists. The inclusion criteria were: nightmares as a target problem, studies published in English, use of a randomized controlled trials and reporting of nightmare-relevant outcomes. A total of 19 studies, published between 1978 and 2012 were identified, which included 1285 participants. Effect sizes were calculated as Cohen's d. A statistically significant improvement for all studies combined (d = 0.47, 95% CI = 0.33-0.60, fixed effects model; d = 0.49, 95% CI = 0.32-0.66, random effects model) and for psychological treatments alone (d = 0.48, 95% CI = 0.36-0.60, random) and for prazosin alone (d = 0.50, 95% CI = 0.03-0.96, random) was found. Individual therapy format yielded a higher effect size than a self-help format (p = 0.03). Minimal interventions (relaxation, recording) yielded lower overall effect size than studies offering more extensive interventions (p = 0.02). It is concluded that there are both psychological and pharmacological interventions which have documented effects for the treatment of nightmares.

  8. Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Rozental, Alexander

    2013-01-01

    Background Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment

  9. Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention.

    PubMed

    Burkert, Silke; Scholz, Urte; Gralla, Oliver; Roigas, Jan; Knoll, Nina

    2011-09-01

    In this study, we investigated the role of dyadic planning for health-behavior change. Dyadic planning refers to planning health-behavior change together with a partner. We assumed that dyadic planning would affect the implementation of regular pelvic-floor exercise (PFE), with other indicators of social exchange and self-regulation strategies serving as mediators. In a randomized-controlled trial at a German University Medical Center, 112 prostatectomy-patients with partners were randomly assigned to a dyadic PFE-planning condition or one of three active control conditions. Questionnaire data were assessed at multiple time points within six months post-surgery, measuring self-reported dyadic PFE-planning and pelvic-floor exercise as primary outcomes and social exchange (support, control) and a self-regulation strategy (action control) as mediating mechanisms. There were no specific intervention effects with regard to dyadic PFE-planning or pelvic-floor exercise, as two active control groups also showed increases in either of these variables. However, results suggested that patients instructed to plan dyadically still benefited from self-reported dyadic PFE-planning regarding pelvic-floor exercise. Cross-sectionally, received negative control from partners was negatively related with PFE only in control groups and individual action control mediated between self-reported dyadic PFE-planning and PFE for participants instructed to plan PFE dyadically. Longitudinally, action control mediated between self-reported dyadic PFE-planning and pelvic-floor exercise for all groups. Findings provide support for further investigation of dyadic planning in health-behavior change with short-term mediating effects of behavior-specific social exchange and long-term mediating effects of better self-regulation.

  10. A Process Dynamics and Control Experiment for the Undergraduate Laboratory

    ERIC Educational Resources Information Center

    Spencer, Jordan L.

    2009-01-01

    This paper describes a process control experiment. The apparatus includes a three-vessel glass flow system with a variable flow configuration, means for feeding dye solution controlled by a stepper-motor driven valve, and a flow spectrophotometer. Students use impulse response data and nonlinear regression to estimate three parameters of a model…

  11. Expectations and Experience: Dissociable Bases for Cognitive Control?

    ERIC Educational Resources Information Center

    Bugg, Julie M.; Diede, Nathaniel T.; Cohen-Shikora, Emily R.; Selmeczy, Diana

    2015-01-01

    Classic theories emphasized the role of expectations in the intentional control of attention and action. However, recent theorizing has implicated experience-dependent, online adjustments as the primary basis for cognitive control--adjustments that appear to be implicit (Blais, Harris, Guerrero, & Bunge, 2012). The purpose of the current study…

  12. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    PubMed Central

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  13. Supported Employment for the Reintegration of Disability Pensioners with Mental Illnesses: A Randomized Controlled Trial

    PubMed Central

    Viering, Sandra; Jäger, Matthias; Bärtsch, Bettina; Nordt, Carlos; Rössler, Wulf; Warnke, Ingeborg; Kawohl, Wolfram

    2015-01-01

    Work is beneficial for the recovery from mental illness. Although the approach of individual placement and support (IPS) has been shown to be effective in Europe, it has not yet been widely implemented in European health care systems. The aim of this randomized controlled trial was to assess the effectiveness of IPS for disability pensioners with mental illnesses new on disability benefits in Switzerland. In the study at hand, 250 participants were randomly assigned to either the control or the intervention group. The participants in the intervention group received job coaching according to IPS during 2 years. The control group received no structured support. Both groups were interviewed at baseline and followed up every 6 months (baseline, 6, 12, 16, 18, 24 months) for 2 years. Primary outcome was to obtain a job in the competitive employment. IPS was more effective for the reintegration into the competitive employment market for disability pensioners than the control condition. Thirty-two percent of the participants of the intervention group and 12% of the control group obtained new jobs in the competitive employment. IPS is also effective for the reintegration into competitive employment of people with mental illness receiving disability pensions. PMID:26539425

  14. Supported Employment for the Reintegration of Disability Pensioners with Mental Illnesses: A Randomized Controlled Trial.

    PubMed

    Viering, Sandra; Jäger, Matthias; Bärtsch, Bettina; Nordt, Carlos; Rössler, Wulf; Warnke, Ingeborg; Kawohl, Wolfram

    2015-01-01

    Work is beneficial for the recovery from mental illness. Although the approach of individual placement and support (IPS) has been shown to be effective in Europe, it has not yet been widely implemented in European health care systems. The aim of this randomized controlled trial was to assess the effectiveness of IPS for disability pensioners with mental illnesses new on disability benefits in Switzerland. In the study at hand, 250 participants were randomly assigned to either the control or the intervention group. The participants in the intervention group received job coaching according to IPS during 2 years. The control group received no structured support. Both groups were interviewed at baseline and followed up every 6 months (baseline, 6, 12, 16, 18, 24 months) for 2 years. Primary outcome was to obtain a job in the competitive employment. IPS was more effective for the reintegration into the competitive employment market for disability pensioners than the control condition. Thirty-two percent of the participants of the intervention group and 12% of the control group obtained new jobs in the competitive employment. IPS is also effective for the reintegration into competitive employment of people with mental illness receiving disability pensions.

  15. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2015-01-01

    This randomized control study compares the efficacy of two response-to-intervention (RTI) models: (1) Dynamic RTI, which immediately refers grade 1 students with the weakest skills to the most intensive intervention supports (Tier 2 or Tier 3); and (2) Typical RTI, which starts all students in Tier 1 and after 8 weeks, decides whether students who…

  16. Home Computers and Child Outcomes: Short-Term Impacts from a Randomized Experiment in Peru. NBER Working Paper No. 18818

    ERIC Educational Resources Information Center

    Beuermann, Diether W.; Cristia, Julian P.; Cruz-Aguayo, Yyannu; Cueto, Santiago; Malamud, Ofer

    2013-01-01

    This paper presents results from a randomized control trial in which approximately 1,000 OLPC XO laptops were provided for home use to children attending primary schools in Lima, Peru. The intervention increased access and use of home computers, with some substitution away from computer use outside the home. Beneficiaries were more likely to…

  17. A deployable structure and solar array controls experiment for STEP

    NASA Technical Reports Server (NTRS)

    Nishimoto, T. S.

    1984-01-01

    A candidate configuration for a controls experiment on the Space Technology Experiments Platform (STEP) is described. The elements of the experiment are the mast, the solar array, and an articulation module between the two. The characteristic dimensions are very compatible for integration on a pallet such a STEP's proposed configuration. The controls' objective would be the measurement of orbiter interaction as well as the system identification of the appendages. The flight experiment configuration would also provide a test bed for various active vibration controls concepts. The instrumentation being considered would measure accelerations, strains, displacements, and temperatures. The deployable mast has eight elements defining a structural bay. Uniaxial measurements would be required to define loads at a cross section of the structure. Displacements due to thermal distortion of the mast and the local state of the solar concentrator may be measured by an optical ranging technique from the orbiter aft flight deck.

  18. Thermal control surfaces experiment: Initial flight data analysis

    NASA Technical Reports Server (NTRS)

    Wilkes, Donald R.; Hummer, Leigh L.

    1991-01-01

    The behavior of materials in the space environment continues to be a limiting technology for spacecraft and experiments. The thermal control surfaces experiment (TCSE) aboard the Long Duration Exposure Facility (LDEF) is the most comprehensive experiment flown to study the effects of the space environment on thermal control surfaces. Selected thermal control surfaces were exposed to the LDEF orbital environment and the effects of this exposure were measured. The TCSE combined in-space orbital measurements with pre and post-flight analyses of flight materials to determine the effects of long term space exposure. The TCSE experiment objective, method, and measurements are described along with the results of the initial materials analysis. The TCSE flight system and its excellent performance on the LDEF mission is described. A few operational anomalies were encountered and are discussed.

  19. Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

    PubMed Central

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-01-01

    Background & objectives: Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 200 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results: Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001) compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions: Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group. PMID:24820831

  20. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    PubMed Central

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724