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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. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    PubMed

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  3. Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment.

    PubMed

    Yin, H Shonna; Parker, Ruth M; Sanders, Lee M; Dreyer, Benard P; Mendelsohn, Alan L; Bailey, Stacy; Patel, Deesha A; Jimenez, Jessica J; Kim, Kwang-Youn A; Jacobson, Kara; Hedlund, Laurie; Smith, Michelle C J; Maness Harris, Leslie; McFadden, Terri; Wolf, Michael S

    2016-10-01

    Poorly designed labels and packaging are key contributors to medication errors. To identify attributes of labels and dosing tools that could be improved, we examined the extent to which dosing error rates are affected by tool characteristics (ie, type, marking complexity) and discordance between units of measurement on labels and dosing tools; along with differences by health literacy and language. Randomized controlled experiment in 3 urban pediatric clinics. English- or Spanish-speaking parents (n = 2110) of children ≤8 years old were randomly assigned to 1 of 5 study arms and given labels and dosing tools that varied in unit pairings. Each parent measured 9 doses of medication (3 amounts [2.5, 5, and 7.5 mL] and 3 tools [1 cup, 2 syringes (0.2- and 0.5-mL increments)]), in random order. Outcome assessed was dosing error (>20% deviation; large error defined as > 2 times the dose). A total of 84.4% of parents made ≥1 dosing error (21.0% ≥1 large error). More errors were seen with cups than syringes (adjusted odds ratio = 4.6; 95% confidence interval, 4.2-5.1) across health literacy and language groups (P < .001 for interactions), especially for smaller doses. No differences in error rates were seen between the 2 syringe types. Use of a teaspoon-only label (with a milliliter and teaspoon tool) was associated with more errors than when milliliter-only labels and tools were used (adjusted odds ratio = 1.2; 95% confidence interval, 1.01-1.4). Recommending oral syringes over cups, particularly for smaller doses, should be part of a comprehensive pediatric labeling and dosing strategy to reduce medication errors. Copyright © 2016 by the American Academy of Pediatrics.

  4. 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…

  5. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    PubMed

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  6. 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

  7. 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. © 2013 FPI, Inc.

  8. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    PubMed

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  9. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

    PubMed Central

    Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-01-01

    Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

  10. "Maybe I made up the whole thing": placebos and patients' experiences in a randomized controlled trial.

    PubMed

    Kaptchuk, Ted J; Shaw, Jessica; Kerr, Catherine E; Conboy, Lisa A; Kelley, John M; Csordas, Thomas J; Lembo, Anthony J; Jacobson, Eric E

    2009-09-01

    Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such "placebo effects" exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed "expectation" of improvement but spoke of "hope" instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo--e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment--provides an inadequate model to explain its salubrious benefits.

  11. Randomized controlled experiments in health and social sciences: some conceptual issues.

    PubMed

    Bhargava, Alok

    2008-07-01

    This brief article outlines some difficulties as well as benefits in conducting randomized controlled trials in social science settings especially in developing countries. Some of the historical developments are summarized and certain applications in health sciences are discussed from methodological and policy standpoints.

  12. Do Motion Controllers Make Action Video Games Less Sedentary? A Randomized Experiment

    PubMed Central

    Lyons, Elizabeth J.; Tate, Deborah F.; Ward, Dianne S.; Ribisl, Kurt M.; Bowling, J. Michael; Kalyanaraman, Sriram

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0.96 [0.20] kcal · kg−1 · hr−1) produced 0.10 kcal · kg−1 · hr−1 (95% confidence interval 0.03 to 0.17) greater energy expenditure than traditional control (0.86 [0.17] kcal · kg−1 · hr−1, P = .048). All games were sedentary. As currently implemented, motion control is unlikely to produce moderate intensity physical activity in action games. However, some games produce small but significant increases in energy expenditure, which may benefit health by decreasing sedentary behavior. PMID:22028959

  13. 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. PMID:28405353

  14. A practical limit to trials needed in one-person randomized controlled experiments.

    PubMed

    Alemi, Roshan; Alemi, Farrokh

    2007-01-01

    Recently in this journal, J. Olsson and colleagues suggested the use of factorial experimental designs to guide a patient's efforts to choose among multiple interventions. These authors argue that factorial design, where every possible combination of the interventions is tried, is superior to sequential trial and errors. Factorial design is efficient in identifying the effectiveness of interventions (factor effect). Most patients care only about feeling better and not why their conditions are improving. If the goal of the patient is to get better and not to estimate the factor effect, then no control groups are needed. In this article, we show a modification in the factorial design of experiments proposed by Olsson and colleagues where a full-factorial design is planned, but experimentation is stopped when the patient's condition improves. With this modification, the number of trials is radically fewer than those needed by factorial design. For example, a patient trying out 4 different interventions with a median probability of success of .50 is expected to need 2 trials before stopping the experimentation in comparison with 32 in a full-factorial design.

  15. Women's experiences after early versus postponed oxytocin treatment of slow progress in first childbirth--a randomized controlled trial.

    PubMed

    Bergqvist, Liselotte; Dencker, Anna; Taft, Charles; Lilja, Håkan; Ladfors, Lars; Skaring-Thorsén, Lena; Berg, Marie

    2012-06-01

    The aim was to compare the childbirth experiences of primiparous women with slow labour progress who had received early versus postponed oxytocin augmentation. The population included healthy primiparous women with slow labour progress after a normal pregnancy and spontaneous onset of active labour at term who had taken part in a randomized controlled trial at two delivery units in Sweden comparing early versus postponed oxytocin augmentation. A total of 536 women were sent the Childbirth Experience Questionnaire (CEQ) one month postpartum. The 22-item questionnaire assesses four domains of the childbirth experience. Main outcomes were the four domains of the CEQ: Own capacity, Professional support, Perceived safety and Participation. There were no significant differences between the women in the early and expectant oxytocin treatment groups in any of the four domains; however, operative births were associated with significantly worse childbirth experiences. Almost every third woman in both groups had negative and depressing memories from the childbirth process. Early oxytocin augmentation for slow labour progress does not appear to be more beneficial than expectant management regarding women's perceptions of childbirth one month postpartum. Given the risks for the foetus associated with oxytocin treatment, prudent expectant management seems to be a safe and viable alternative. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. Audiovisual information affects informed choice and experience of information in antenatal Down syndrome screening--a randomized controlled trial.

    PubMed

    Björklund, Ulla; Marsk, Anna; Levin, Charlotta; Öhman, Susanne Georgsson

    2012-03-01

    To evaluate the effects of an information film on making an informed choice regarding Down syndrome screening, and women's knowledge and experiences of information. Randomized controlled trial including 184 women in the intervention group and 206 controls recruited from maternity units in Stockholm, Sweden. The intervention was an information film presented as a complement to written and verbal information. Data were collected via a questionnaire in gestational week 27. Three different measures were combined to measure informed choice: attitudes towards Down syndrome screening, knowledge about Down syndrome and Down syndrome screening, and uptake of CUB (combined ultrasound and biochemical screening). In the intervention group 71.5% made an informed choice versus 62.4% in the control group. Women in the intervention group had significantly increased knowledge, and to a greater extent than the control group, experienced the information as being sufficient, comprehensible, and correct. An information film tended to increase the number of women who made an informed choice about Down syndrome screening. Participants were more satisfied with the information received. Access to correct, nondirective, and sufficient information is essential when making a choice about prenatal diagnostics. It is essential with equivalent information to all women. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  17. Therapist experience and knowledge acquisition in internet-delivered CBT for social anxiety disorder: a randomized controlled trial.

    PubMed

    Andersson, Gerhard; Carlbring, Per; Furmark, Tomas

    2012-01-01

    Guided internet-delivered cognitive behavior therapy (ICBT) has been tested in several trials on social anxiety disorder (SAD) with moderate to large effects. The aims of this study were threefold. First, to compare the effects of ICBT including online discussion forum with a moderated online discussion forum only. Second, to investigate if knowledge about SAD increased following treatment and third to compare the effects of inexperienced versus experienced therapists on patient outcomes. A total of 204 participants with a primary diagnosis of SAD were included and randomized to either guided ICBT or the control condition. ICBT consisted of a 9-week treatment program which was guided by either psychology students at MSc level (n = 6) or by licensed psychologists with previous experience of ICBT (n = 7). A knowledge test dealing with social anxiety was administered before and after treatment. Measures of social anxiety and secondary outcomes dealing with general anxiety, depression, and quality of life were administered before and after treatment. In addition, a 1-year follow-up was conducted on the treated individuals. Immediately following treatment, the ICBT group showed superior outcome on the Liebowitz Social Anxiety Scale self-report version with a between group posttreatment Hedges g effect size of g = 0.75. In addition, significant differences on all the secondary outcomes were observed. Gains were well maintained one year later. Knowledge, as assessed by the knowledge test, increased following treatment with little gain in the control group. Therapist experience did not result in different outcomes, but experienced therapists logged in less frequently compared to the inexperienced therapists, suggesting that they needed less time to support patients. We conclude that guided ICBT reduce symptoms of SAD, increase knowledge about SAD and that therapist experience does not make a difference apart from the finding that experienced therapist may

  18. 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.…

  19. 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

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

    PubMed

    Adam, Laura M; Manca, Donna P; Bell, Rhonda C

    2016-09-21

    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. 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. 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. 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 comparison, the traditional approaches

  1. 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…

  2. Personal experiences and emotionality in health-related knowledge exchange in Internet forums: a randomized controlled field experiment comparing responses to facts vs personal experiences.

    PubMed

    Kimmerle, Joachim; Bientzle, Martina; Cress, Ulrike

    2014-12-04

    On the Internet, people share personal experiences as well as facts and objective information. This also holds true for the exchange of health-related information in a variety of Internet forums. In online discussions about health topics, both fact-oriented and strongly personal contributions occur on a regular basis. In this field experiment, we examined in what way the particular type of contribution (ie, factual information vs personal experiences) has an impact on the subsequent communication in health-related Internet forums. For this purpose, we posted parallelized queries to 28 comparable Internet forums; queries were identical with regard to the information contained but included either fact-oriented descriptions or personal experiences related to measles vaccination. In the factual information condition, we posted queries to the forums that contained the neutral summary of a scientific article. In the personal experiences condition, we posted queries to the forums that contained the same information as in the first condition, but were framed as personal experiences We found no evidence that personal experiences evoked more responses (mean 3.79, SD 3.91) from other members of the Internet forums than fact-oriented contributions (mean 2.14, SD 2.93, t26=0.126, P=.219). But personal experiences elicited emotional replies (mean 3.17, SD 1.29) from other users to a greater extent than fact-oriented contributions (mean 2.13, SD 1.29, t81=3.659, P<.001). We suggest that personal experiences elicited more emotional replies due to the process of emotional anchoring of people's own style of communication. We recommend future studies should aim at testing the hypotheses with more general and with less emotionally charged topics, constructing different fact-oriented posts, and examining additional potential factors of influence such as personality factors or particular communication situations.

  3. IMPROVE trial: a randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies.

    PubMed

    Dampier, Carlton D; Smith, Wally R; Wager, Carrie G; Kim, Hae-Young; Bell, Margaret C; Miller, Scott T; Weiner, Debra L; Minniti, Caterina P; Krishnamurti, Lakshmanan; Ataga, Kenneth I; Eckman, James R; Hsu, Lewis L; McClish, Donna; McKinlay, Sonja M; Molokie, Robert; Osunkwo, Ifeyinwa; Smith-Whitley, Kim; Telen, Marilyn J

    2013-04-01

    The hallmark of sickle cell disease (SCD) is pain from a vaso-occlusive crisis. Although ambulatory pain accounts for most days in pain, pain is also the most common cause of hospitalization and is typically treated with parenteral opioids. The evidence base is lacking for most analgesic practice in SCD, particularly for the optimal opioid dosing for patient-controlled analgesia (PCA), in part because of the challenges of the trial design and conduct for this rare disease. The purpose of this report is to describe our Network's experiences with protocol development, implementation, and analysis, including overall study design, the value of pain assessments rather than 'crisis' resolution as trial endpoints, and alternative statistical analysis strategies. The Improving Pain Management and Outcomes with Various Strategies (IMPROVE) PCA trial was a multisite inpatient randomized controlled trial comparing two PCA-dosing strategies in adults and children with SCD and acute pain conducted by the SCD Clinical Research Network. The specified primary endpoint was a 25-mm change in a daily average pain intensity using a Visual Analogue Scale, and a number of related pain intensity and pain interference measures were selected as secondary efficacy outcomes. A time-to-event analysis strategy was planned for the primary endpoint. Of 1116 individuals admitted for pain at 31 participating sites over a 6-month period, 38 were randomized and 4 withdrawn. The trial was closed early due to poor accrual, reflecting a substantial number of challenges encountered during trial implementation. While some of the design issues were unique to SCD or analgesic studies, many of the trial implementation challenges reflected the increasing complexity of conducting clinical trials in the inpatient setting with multiple care providers and evolving electronic medical record systems, particularly in the context of large urban academic medical centers. Complicated clinical organization of many

  4. Nonresponse bias in randomized controlled experiments in criminology: Putting the Queensland Community Engagement Trial (QCET) under a microscope.

    PubMed

    Antrobus, Emma; Elffers, Henk; White, Gentry; Mazerolle, Lorraine

    2013-01-01

    The goal of this article is to examine whether or not the results of the Queensland Community Engagement Trial (QCET)-a randomized controlled trial that tested the impact of procedural justice policing on citizen attitudes toward police-were affected by different types of nonresponse bias. We use two methods (Cochrane and Elffers methods) to explore nonresponse bias: First, we assess the impact of the low response rate by examining the effects of nonresponse group differences between the experimental and control conditions and pooled variance under different scenarios. Second, we assess the degree to which item response rates are influenced by the control and experimental conditions. Our analysis of the QCET data suggests that our substantive findings are not influenced by the low response rate in the trial. The results are robust even under extreme conditions, and statistical significance of the results would only be compromised in cases where the pooled variance was much larger for the nonresponse group and the difference between experimental and control conditions was greatly diminished. We also find that there were no biases in the item response rates across the experimental and control conditions. RCTs that involve field survey responses-like QCET-are potentially compromised by low response rates and how item response rates might be influenced by the control or experimental conditions. Our results show that the QCET results were not sensitive to the overall low response rate across the experimental and control conditions and the item response rates were not significantly different across the experimental and control groups. Overall, our analysis suggests that the results of QCET are robust and any biases in the survey responses do not significantly influence the main experimental findings.

  5. Parent reflections of experiences of participating in a randomized controlled trial of a behavioral intervention for infants at risk of autism spectrum disorders.

    PubMed

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

    2014-07-01

    Despite the mounting evidence of efficacy of early intervention for children with autism spectrum disorders, there is little research that considers the various perceptions and resources with which parents respond to the pressures and opportunities associated with participation in early intervention. Research is particularly lacking surrounding experiences of parents with infants who are at risk of autism spectrum disorders but do not (yet) have a diagnosed condition. This qualitative study aimed to explore the experiences of caregivers following their participation in a randomized controlled trial of Adapted Responsive Teaching, a parent-infant relationship-focused intervention for infants at risk of autism spectrum disorders in a community sample. Parents were randomized into either the treatment group, in which they participated in the Adapted Responsive Teaching intervention, or the community services group, in which they were provided with information regarding local early intervention services and were encouraged, but not required to, seek community services as part of their inclusion in the randomized controlled trial. Semistructured interviews were conducted with families following the completion of the randomized controlled trial. Participants consisted of 13 mothers and 4 fathers. Five dyads were interviewed together for a total of 14 families. Child ages ranged from 39 to 46 months at the time of interview. Analysis was conducted on 14 interviews from 10 families who were randomized into the treatment group and 4 families randomized into the community services group. Analysis was informed by a thematic analysis approach, which involved a systematic process of coding and theme identification both across and within groups. Themes that emerged across groups included Working against all odds, Value of the personal relationship, Getting the ball rolling, and Getting dad on board. One broad theme represented the data within the groups: Win-win (Adapted

  6. Fear of childbirth in expectant fathers, subsequent childbirth experience and impact of antenatal education: subanalysis of results from a randomized controlled trial.

    PubMed

    Bergström, Malin; Rudman, Ann; Waldenström, Ulla; Kieler, Helle

    2013-08-01

    To explore if antenatal fear of childbirth in men affects their experience of the birth event and if this experience is associated with type of childbirth preparation. Data from a randomized controlled multicenter trial on antenatal education. 15 antenatal clinics in Sweden between January 2006 and May 2007. 762 men, of whom 83 (10.9%) suffered from fear of childbirth. Of these 83 men, 39 were randomized to psychoprophylaxis childbirth preparation where men were trained to coach their partners during labor and 44 to standard care antenatal preparation for childbirth and parenthood without such training. Experience of childbirth was compared between men with and without fear of childbirth regardless of randomization, and between fearful men in the randomized groups. Analyses by logistic regression adjusted for sociodemographic variables. Self-reported data on experience of childbirth including an adapted version of the Wijma Delivery Experience Questionnaire (W-DEQ B). Men with antenatal fear of childbirth more often experienced childbirth as frightening than men without fear: adjusted odds ratio 4.68, 95% confidence interval 2.67-8.20. Men with antenatal fear in the psychoprophylaxis group rated childbirth as frightening less often than those in standard care: adjusted odds ratio 0.30, 95% confidence interval 0.10-0.95. Men who suffer from antenatal fear of childbirth are at higher risk of experiencing childbirth as frightening. Childbirth preparation including training as a coach may help fearful men to a more positive childbirth experience. Additional studies are needed to support this conclusion. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

  7. 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

  8. 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. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Learning to experience side effects after antidepressant intake - Results from a randomized, controlled, double-blind study.

    PubMed

    Rheker, Julia; Winkler, Alexander; Doering, Bettina K; Rief, Winfried

    2017-02-01

    Side effects play a key role in patients' failure to take antidepressants. There is evidence that verbal suggestions and informed consent elicit expectations that can in turn trigger the occurrence of side effects. Prior experience or learning mechanisms are also assumed to contribute to the development of side effects, although their role has not been thoroughly investigated. In this study, we examined whether an antidepressant's side effects can be learned via Pavlovian conditioning. Participants (n = 39) were randomly allocated to one of two groups and were exposed to a classical conditioning procedure. During acquisition, 19 participants received amitriptyline and 20 participants received a placebo pill. Pills were taken for four nights together with a novel-tasting drink. After a washout phase, both groups received a placebo pill together with the novel-tasting drink (evocation). Side effects were assessed via the Generic Assessment of Side Effects Scale prior to acquisition (baseline), after acquisition, and after evocation. A score of antidepressant-specific side effects was calculated. Participants taking amitriptyline reported significantly more antidepressant-specific side effects after acquisition compared to both baseline and the placebo group. After evocation, participants who underwent the conditioning procedure with amitriptyline reported significantly more antidepressant-specific side effects than those who never received amitriptyline, even though both groups received a placebo. Our results indicate that antidepressant side effects can be learned using a conditioning paradigm and evoked via a placebo pill when applied with the same contextual factors as the verum.

  10. 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.

  11. 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.

  12. 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.

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

    PubMed

    Zielinski, Stephanie M; Viveiros, Helena; Heetveld, Martin J; Swiontkowski, Marc F; Bhandari, Mohit; Patka, Peter; Van Lieshout, Esther M M

    2012-01-08

    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. 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. 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). 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. ClinicalTrials.gov: NCT00761813.

  14. Effect of oral administration of a continuous 18 day regimen of meloxicam on ovulation: experience of a randomized controlled trial.

    PubMed

    Jesam, C; Salvatierra, A M; Schwartz, J L; Fuentes, A; Croxatto, H B

    2014-08-01

    Cyclooxygenase-2 (COX-2) is expressed in all female reproductive organs. Therefore, inhibitors of COX-2 may affect reproductive function. We evaluated the effect of extended administration of meloxicam on ovulation and the menstrual cycle. Our hypothesis was that meloxicam administered from menstrual cycle day 5- 22 could interfere with follicular rupture, without disrupting the menstrual cycle, and could be a potential non-hormonal contraceptive method. The study was conducted in 56 healthy sterilized women. Before the onset of treatment and after the end of treatment, participants were observed during a control cycle to ensure that they had progesterone (P₄) serum levels (>12 nmol/l) consistent with ovulation. Participants were treated for 18 days, during three consecutive cycles. They were randomized to 15 or 30 mg/day. The menstrual cycle was monitored with serial ultrasound and hormone assays in blood. Fifty-six volunteers completed the study. In 55% of cycles treated with 15 mg/day and in 78% of cycles treated with 30 mg/day (p<0.001) we observed dysfunctional ovulation defined as follicular rupture not preceded 24-48 h earlier by an LH peak or preceded by a blunted LH peak (<21 IU/l) or not followed by an elevated serum P₄ level >12 nmol/l. Ovulation was observed in 44.6% and in 21.7% of women in the lower dose group and the higher dose group, respectively. There were no differences between the two doses in other parameters measured. There were no serious adverse events and adverse events were not different between doses or between control and treated cycles. Although administration of meloxicam on menstrual cycle days 5- 22 resulted in a dose-dependent inhibition of ovulation, more than 20% of subjects had normal ovulation with the highest dose. Previous studies have shown that oral meloxicam can delay follicle rupture. This study investigated daily oral meloxicam as a non-hormonal contraceptive. Since ovulation occurs in over 20% of cycles even with a

  15. 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

  16. Mindfulness Training Increases Momentary Positive Emotions and Reward Experience in Adults Vulnerable to Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Geschwind, Nicole; Peeters, Frenk; Drukker, Marjan; van Os, Jim; Wichers, Marieke

    2011-01-01

    Objective: To examine whether mindfulness-based cognitive therapy (MBCT) increases momentary positive emotions and the ability to make use of natural rewards in daily life. Method: Adults with a life-time history of depression and current residual depressive symptoms (mean age = 43.9 years, SD = 9.6; 75% female; all Caucasian) were randomized to…

  17. 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…

  18. The impact of Professional Boundaries for Health Professionals (PBHP) training on knowledge, comfort, experience, and ethical decision-making: a longitudinal randomized controlled trial.

    PubMed

    Fronek, Patricia; Kendall, Melissa B

    2017-12-01

    A randomized controlled trial was conducted to evaluate the impact of Professional Boundaries for Health Professionals (PBHP) training program on the knowledge, comfort, experience, and ethical decision-making of multidisciplinary practitioners facing client-practitioner boundary dilemmas. In all, 36 rehabilitation practitioners from an Australian state-wide spinal cord injuries service were assigned to experimental and control groups. The Boundaries in Practice (BIP) Scale measured outcomes at four points: pre, post, 3 months, and 1 year. The control group received the training after 3 months. Nonparametric Friedman's two-way analysis of variance was used to examine the trajectories over time. Analysis was conducted using the data of 10 experimental and 13 control group participants who responded at four data collection points. The experimental group showed significant improvement in knowledge (χ 2  = 10.673, p = 0.014) and comfort (χ 2  = 9.727, p = 0.021) managing professional boundaries post-training. The control group showed no significant change in knowledge or comfort. No significant change was seen in experience across either experimental (χ 2  = 3.609, p = 0.307) or control group (χ 2  = 7.800, p = 0.050). Ethical decision-making improved in the control group (χ 2  = 13.188, p = 0.004) following training, however remained unchanged in the experimental group. The findings do not definitively support this training approach. Ethical decision-making may improve more substantially within the practice context and organizational culture change. Multifaceted approaches are indicated. Implications for Rehabilitation Ethical dilemmas related to boundaries between clients and practitioners are a frequent occurrence in the rehabilitation setting. In a relatively small sample, the current randomized trial provided inconclusive evidence on the benefit of a 1-day needs-oriented training program to improve knowledge, comfort

  19. Stent and Dual Antiplatelet Therapy Duration Comparisons in the Setting of a Multicenter Randomized Controlled Trial: Can the Operator Experience Affect the Study Results?

    PubMed

    Gargiulo, Giuseppe; Heg, Dik; Ferrari, Fabrizio; Percoco, Gianfranco; Campo, Gianluca; Tumscitz, Carlo; Colombo, Federico; Zuffi, Andrea; Castriota, Fausto; Cremonesi, Alberto; Windecker, Stephan; Valgimigli, Marco

    2017-12-23

    Operator experience influences outcomes after percutaneous coronary intervention, but this association in the controlled setting of a randomized, clinical trial is unclear. We investigated operator-related outcomes (30-day and 2-year efficacy and safety end points) among patients undergoing percutaneous coronary intervention and randomized to different dual antiplatelet therapy durations and stent types. A total of 2003 patients were analyzed, and 7 operator groups were compared. The majority of preprocedural and postprocedural characteristics were imbalanced. The primary end point of the study, the composite of death, myocardial infarction, or cerebrovascular accidents, did not differ among operators at 30 days or 2 years. There were no significant differences also for all other individual and composite end points analyzed at 30 days and 2 years, except for 2-year stent thrombosis (P=0.048) and bleeding events (P=0.022 for Bleeding Academic Research Consortium type 2, 3, or 5). Adjusted comparisons for the main end points showed slight differences among operators at 30 days, but not at 2 years. There was no interaction of operator with dual antiplatelet therapy duration (P=0.112) or stent type (P=0.300). Results remained entirely consistent when operators were stratified by their experience. There was a weak signal of heterogeneity across study operators for the 30-day, but not the 2-year, main study outcomes. No clear effect of operator or operator experience was observed for the comparative efficacy and safety profile of the randomized stent types or dual antiplatelet therapy duration regimens. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00611286. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  20. Pain experience and functional outcome of inpatient versus outpatient anterior cruciate ligament reconstruction, an equivalence randomized controlled trial with 12 months follow-up.

    PubMed

    Valkering, K P; van Bergen, C J A; Buijze, G A; Nagel, P H A F; Tuinebreijer, W E; Breederveld, R S

    2015-03-01

    Arthroscopic reconstruction of the anterior cruciate ligament (ACL) has traditionally been performed in an inpatient setting. Outpatient treatment may offer the advantages of cost reduction and higher patient satisfaction. We investigated whether ACL reconstruction in an outpatient setting is equally safe as in an inpatient setting and whether comparable functional outcomes can be achieved. We hypothesized that the outcomes of outpatient ACL reconstruction result in similar outcomes as inpatient ACL reconstruction. A prospective randomized controlled trial was conducted at one centre. Forty-six patients were randomized to outpatient treatment or a 2-day admission after ACL reconstruction. The functional outcome was evaluated with the Lysholm, Tegner and International Knee Documentation Committee scores. Safety of the procedures was judged according to pain experience and readmission rate. The duration of follow-up was 1 year after ACL reconstruction. The patients were provided with a simple postoperative analgesic protocol. The linear mixed effect model for repeated measures was used for testing the differences between the study groups. No significant differences were found between the study groups in all the outcome measures. No readmissions were recorded related to pain. One complication was recorded in the outpatient group versus three in the inpatient group. This study indicates that outpatient care after ACL reconstruction yields comparable functional results and postoperative pain experience as inpatient care and is a safe option. A simple analgesic protocol provides adequate pain relief during the postoperative phase. I. Copyright © 2014 Elsevier B.V. All rights reserved.

  1. Effect of a Website That Presents Patients’ Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial

    PubMed Central

    Giesler, Jürgen M; Keller, Bettina; Repke, Tim; Leonhart, Rainer; Weis, Joachim; Muckelbauer, Rebecca; Rieckmann, Nina; Müller-Nordhorn, Jacqueline; Lucius-Hoene, Gabriele

    2017-01-01

    Background Patients often seek other patients’ experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people’s health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients’ Experiences) aims to provide scientifically based online information on people’s experiences with health and illness to fulfill patients’ needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences. Objective The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence. Methods In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks Results The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the

  2. Effect of a Website That Presents Patients' Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial.

    PubMed

    Giesler, Jürgen M; Keller, Bettina; Repke, Tim; Leonhart, Rainer; Weis, Joachim; Muckelbauer, Rebecca; Rieckmann, Nina; Müller-Nordhorn, Jacqueline; Lucius-Hoene, Gabriele; Holmberg, Christine

    2017-10-13

    Patients often seek other patients' experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people's health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients' Experiences) aims to provide scientifically based online information on people's experiences with health and illness to fulfill patients' needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences. The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence. In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks. The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the colorectal cancer module on

  3. Randomized controlled trials 1: Design.

    PubMed

    Curtis, Bryan M; Barrett, Brendan J; Parfrey, Patrick S

    2015-01-01

    Today's clinical practice relies on the application of well-designed clinical research, the gold standard test of an intervention being the randomized controlled trial. Principles of the randomized control trial include emphasis on the principal research question, randomization, blinding; definitions of outcome measures, of inclusion and exclusion criteria, and of comorbid and confounding factors; enrolling an adequate sample size; planning data management and analysis; preventing challenges to trial integrity such as drop-out, drop-in, and bias. The application of pretrial planning is stressed to ensure the proper application of epidemiological principles resulting in clinical studies that are feasible and generalizable. In addition, funding strategies and trial team composition are discussed.

  4. Improving Anesthesiologists' Ability to Speak Up in the Operating Room: A Randomized Controlled Experiment of a Simulation-Based Intervention and a Qualitative Analysis of Hurdles and Enablers.

    PubMed

    Raemer, Daniel B; Kolbe, Michaela; Minehart, Rebecca D; Rudolph, Jenny W; Pian-Smith, May C M

    2016-04-01

    The authors addressed three questions: (1) Would a realistic simulation-based educational intervention improve speaking-up behaviors of practicing nontrainee anesthesiologists? (2) What would those speaking-up behaviors be when the issue emanated from a surgeon, a circulating nurse, or an anesthesiologist colleague? (3) What were the hurdles and enablers to speaking up in those situations? The authors conducted a simulation-based randomized controlled experiment from March 2008-February 2011 at the Center for Medical Simulation, Boston, Massachusetts. During a mandatory crisis management course for practicing nontrainee anesthesiologists from five Boston institutions, a 50-minute workshop on speaking up was conducted for intervention (n = 35) and control (n = 36) groups before or after, respectively, an experimental scenario with three events. The authors analyzed videos of the experimental scenarios and debriefing sessions. No statistically significant differences between the intervention and control group subjects with respect to speaking-up actions were observed in any of the three events. The five most frequently mentioned hurdles to speaking up were uncertainty about the issue, stereotypes of others on the team, familiarity with the individual, respect for experience, and the repercussion expected. The five most frequently mentioned enablers were realizing the speaking-up problem, having a speaking-up rubric, certainty about the consequences of speaking up, familiarity with the individual, and having a second opinion or getting help. An educational intervention alone was ineffective in improving the speaking-up behaviors of practicing nontrainee anesthesiologists. Other measures to change speaking-up behaviors could be implemented and might improve patient safety.

  5. A Randomized Experiment Comparing Random and Cutoff-Based Assignment

    ERIC Educational Resources Information Center

    Shadish, William R.; Galindo, Rodolfo; Wong, Vivian C.; Steiner, Peter M.; Cook, Thomas D.

    2011-01-01

    In this article, we review past studies comparing randomized experiments to regression discontinuity designs, mostly finding similar results, but with significant exceptions. The latter might be due to potential confounds of study characteristics with assignment method or with failure to estimate the same parameter over methods. In this study, we…

  6. Effects of a Cognitive Rehearsal Program on Interpersonal Relationships, Workplace Bullying, Symptom Experience, and Turnover Intention among Nurses: A Randomized Controlled Trial.

    PubMed

    Kang, Jiyeon; Kim, Jeung Im; Yun, Seonyoung

    2017-10-01

    This research aimed to investigate the effects of a cognitive rehearsal program (CRP) on workplace bullying among nurses. A randomized controlled trial was performed. Participants were 40 nurses working in different university hospitals in B city, South Korea. The experimental group was provided with a 20-hour CRP comprising scenarios on bullying situations, standard communication, and role-playing. To evaluate effects of the CRP, we measured interpersonal relationships, workplace bullying, symptom experience, and turnover intention at preand post-intervention. Follow-up effect was measured in the experimental group only at 4 weeks after the intervention. After the intervention, there were significant differences in interpersonal relationships (F=6.21, p=.022) and turnover intention (F=5.55, p=.024) between experimental and wait-list groups. However, there was no significant difference in workplace bullying or symptom experience between the 2 groups. The beneficial effects on interpersonal relationships and turnover intention lasted at least up to 4 weeks after CRP. The CRP for workplace bullying improves interpersonal relationships and decreases turnover intention. So it can be utilized as one of the personal coping strategies to reduce the the turnover among nurses. Further studies on the effects of unit- or hospital-based CRP and on the long-term effects of CRP are necessary.

  7. Microcomputer Controlled Experiments.

    ERIC Educational Resources Information Center

    Kirkman, John; Knaggs, David

    1982-01-01

    Describes a microcomputer-controlled system which determines the current/voltage characteristics of a resistor, lamp, and diode, detailing system elements, construction, and providing printout of the program developed to provide control and arithmetic functions necessary to complete the experiment. (SK)

  8. An Online Health Prevention Intervention for Youth with Addicted or Mentally Ill Parents: Experiences and Perspectives of Participants and Providers from a Randomized Controlled Trial.

    PubMed

    Woolderink, Marla; Bindels, Jill A P M; Evers, Silvia M A A; Paulus, Aggie T G; van Asselt, Antoinette D I; van Schayck, Onno C P

    2015-12-02

    Mental illnesses affect many people around the world, either directly or indirectly. Families of persons suffering from mental illness or addiction suffer too, especially their children. In the Netherlands, 864,000 parents meet the diagnostic criteria for a mental illness or addiction. Evidence shows that offspring of mentally ill or addicted parents are at risk for developing mental disorders or illnesses themselves. The Kopstoring course is an online 8-week group course with supervision by 2 trained psychologists or social workers, aimed to prevent behavioral and psychological problems for children (aged 16 to 25 years) of parents with mental health problems or addictions. The course addresses themes such as roles in the family and mastery skills. An online randomized controlled trial (RCT) was conducted to assess the effectiveness of the Kopstoring course. The aim was to gain knowledge about expectations, experiences, and perspectives of participants and providers of the online Kopstoring course. A process evaluation was performed to evaluate the online delivery of Kopstoring and the experiences and perspectives of participants and providers of Kopstoring. Interviews were performed with members from both groups. Participants were drawn from a sample from the Kopstoring RCT. Thirteen participants and 4 providers were interviewed. Five main themes emerged from these interviews: background, the requirements for the intervention, experience with the intervention, technical aspects, and research aspects. Overall, participants and providers found the intervention to be valuable because it was online; therefore, protecting their anonymity was considered a key component. Most barriers existed in the technical sphere. Additional barriers existed with conducting the RCT, namely gathering informed consent and gathering parental consent in the case of minors. This study provides valuable insight into participants' and providers' experiences and expectations with the online

  9. The Home Office and Random Allocation Experiments.

    ERIC Educational Resources Information Center

    Nuttall, Christopher

    2003-01-01

    Describes the history of the random experiment in the Home Office in the United Kingdom and demonstrates that research and the conduct of research is not an altogether rational process and that fashion, personality, and politics play a role in research policy and methodology choice. (SLD)

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  11. 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

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

    PubMed

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

    2016-11-09

    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. 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. 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. Testimonials written with the StoryPRIME interface were rated as more relatable, useful/relevant, intriguing, and likable than testimonials written without StoryPRIME, P=.054. StoryPRIME is a promising way to elicit high-quality, personal testimonials from youth for prevention programs that draw on members of a target population to spread public health messages.

  13. 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

  14. 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

    Feinkohl, Insa; Flemming, Danny; Cress, Ulrike; Kimmerle, Joachim

    2016-03-03

    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. 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. 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. 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, F2,63=3.66; P=.049, ηp(2)=.092. Students' understanding of the tentativeness of research findings on deep brain stimulation in an online forum is influenced by a

  15. Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

    PubMed

    Kentish-Barnes, Nancy; Chevret, Sylvie; Azoulay, Elie

    2016-02-20

    As intensive care mortality is high, end of life is a subject of major concern for intensivists. In this context, relatives are particularly vulnerable and prone to post-ICU syndrome, in the form of high levels of anxiety, depression, post-traumatic stress, and complicated grief. Grieving families suffer from a feeling of abandonment and evoke the need to get back in touch with the team to ask questions and remove doubts, but very few actually do. Aiding families during the grieving process is an important aspect of palliative care. A condolence letter represents an opportunity to recognize the pain of the family member and the strong tie that linked the family member to the ICU team, and to offer additional information if necessary. The goal of the study is to measure the impact of the condolence letter on the experience of bereaved families after a death in the ICU. Our hypothesis is that a post-death follow-up in the form of a condolence letter sent by the ICU physician who was in charge of the patient may help to reduce the risks of presenting symptoms of anxiety/depression, post-traumatic stress, and complicated grief. This is a randomized, controlled, multicenter study. Research will compare two groups of bereaved family members: one group that does not receive a condolence letter (control) and one group that receives a condolence letter 15 days after the death (intervention). Each of the 22 participating centers will include 12 relatives. Participating relatives will be followed up by phone with a call at 1 month and one at 6 months to complete questionnaires, permitting evaluation of post-ICU burden. The main outcome is anxiety and depression measured at 1 month. Other outcomes include evaluation of quality of dying and death, post-traumatic stress, and complicated grief. This study will allow us to assess if sending a condolence letter can reduce the risks of presenting symptoms of anxiety and depression, complicated grief, and symptoms of post

  16. How breast cancer patients want to search for and retrieve information from stories of other patients on the internet: an online randomized controlled experiment.

    PubMed

    Overberg, Regina; Otten, Wilma; de Man, Andries; Toussaint, Pieter; Westenbrink, Judith; Zwetsloot-Schonk, Bertie

    2010-03-09

    Other patients' stories on the Internet can give patients information, support, reassurance, and practical advice. We examined which search facility for online stories resulted in patients' satisfaction and search success. This study was a randomized controlled experiment with a 2x2 factorial design conducted online. We facilitated access to 170 stories of breast cancer patients in four ways based on two factors: (1) no versus yes search by story topic, and (2) no versus yes search by writer profile. Dutch speaking women with breast cancer were recruited. Women who gave informed consent were randomly assigned to one of four groups. After searching for stories, women were offered a questionnaire relating to satisfaction with the search facility, the stories retrieved, and impact of the stories on coping with breast cancer. Of 353 enrolled women, 182 (51.6%) completed the questionnaire: control group (n = 37), story topics group (n = 49), writer profile group (n = 51), and combination group (n = 45). Questionnaire completers were evenly distributed over the four groups (chi(2) (3) = 3.7, P = .30). Women who had access to the story topics search facility (yes vs no): were more positive about (mean scores 4.0 vs 3.6, P = .001) and more satisfied with the search facility (mean scores 7.3 vs 6.3, P < .001); were more positive about the number of search options (mean scores 2.3 vs 2.1, P = .04); were better enabled to find desired information (mean scores 3.3 vs 2.8, P = .001); were more likely to recommend the search facility to others or intend to use it themselves (mean scores 4.1 vs 3.5, P < .001); were more positive about how retrieved stories were displayed (mean scores 3.6 vs 3.2, P = .001); retrieved stories that better covered their information needs (mean scores 3.0 vs 2.6, P = .02); were more satisfied with the stories retrieved (mean scores 7.1 vs 6.4, P = .002); and were more likely to report an impact of the stories on coping with breast cancer (mean scores

  17. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo.

    PubMed

    Barlow, D H; Lumsden, M A; Fauser, B C J M; Terrill, P; Bestel, E

    2014-03-01

    What is the individualized bleeding experience of women with fibroids and anaemia in a 3 month randomized placebo controlled trial (PEARL I) of the selective progesterone receptor modulator (SPRM), ulipristal acetate (UPA)? In contrast to continuing excessive regular menstruation in the placebo group, a majority of women treated with UPA (63.1% of those on 5 mg/day and 71.3% of those on 10 mg/day) experienced the rapid onset of amenorrhoea or minimal blood loss [pictorial blood loss assessment chart (PBAC) < 12]. The remainder experienced various patterns of bleeding and intensity of blood loss that are described for the first time, including an association of irregular bleeding on UPA with sub-mucous fibroids. The majority experience on UPA is amenorrhoea but the bleeding experience of the others has not been characterized. A 13 week randomized controlled trial in women, eligible for surgery for uterine fibroids and anaemia, comparing placebo (n = 48), UPA 5 mg (n = 95) or UPA 10 mg (n = 94). The treatment aim was fibroid shrinkage and the primary definitions and outcomes are published elsewhere; here the secondary outcome measure of vaginal bleeding pattern is described. Women, 18-50 years old, with fibroids and haemoglobin ≤10.2 g/dl, justifying surgery. At least one fibroid was 3-10 cm diameter and uterus ≤16 weeks pregnancy size. All used the daily PBAC methodology in a screening cycle (Ps) and throughout treatment, and for the 4 weeks preceding Week 26 and Week 38 in those who did not have surgery. An excessive menstruation is PBAC > 100. The bleeding patterns were characterized using the classification of Belsey, developed under auspices of WHO. In the placebo group, all women had an excessive screening PBAC [median 376; interquartile range (IQR) 241-574]; 81.3% of them had regular menstrual bleeding and the intensity of bleeding remained similar, so that the median PBAC in the next three periods was 90, 92 and 93% of the screening value. Four of the 48

  18. 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

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

    PubMed

    Hui, Alison; Wong, Paul Wai-Ching; Fu, King-Wa

    2015-01-01

    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. 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. 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. 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 did the sad face advertisement (P=.03

  20. 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

  1. 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.

  2. 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

  3. Lasso adjustments of treatment effect estimates in randomized experiments.

    PubMed

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

    2016-07-05

    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.

  4. 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.

  5. Networked Dynamic Systems: Identification, Controllability, and Randomness

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

    The presented dissertation aims to develop a graph-centric framework for the analysis and synthesis of networked dynamic systems (NDS) consisting of multiple dynamic units that interact via an interconnection topology. We examined three categories of network problems, namely, identification, controllability, and randomness. In network identification, as a subclass of inverse problems, we made an explicit relation between the input-output behavior of an NDS and the underlying interacting network. In network controllability, we provided structural and algebraic insights into features of the network that enable external signal(s) to control the state of the nodes in the network for certain classes of interconnections, namely, path, circulant, and Cartesian networks. We also examined the relation between network controllability and the symmetry structure of the graph. Motivated by the analysis results for the controllability and observability of deterministic networks, a natural question is whether randomness in the network layer or in the layer of inputs and outputs generically leads to favorable system theoretic properties. In this direction, we examined system theoretic properties of random networks including controllability, observability, and performance of optimal feedback controllers and estimators. We explored some of the ramifications of such an analysis framework in opinion dynamics over social networks and sensor networks in estimating the real-time position of a Seaglider from experimental data.

  6. 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…

  7. 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

    Khalil, Georges Elias; Wang, Hua; Calabro, Karen Sue; Mitra, Natasha; Shegog, Ross; Prokhorov, Alexander V

    2017-02-16

    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. 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. 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. 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). Adolescents' experience of interactivity and entertainment

  8. 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…

  9. Menopausal Symptom Experience Before and After Stopping Estrogen Therapy in the Women’s Health Initiative Randomized Placebo-Controlled Trial

    PubMed Central

    Aragaki, Aaron; Barnabei, Vanessa; Cochrane, Barbara B.; Gass, Margery; Hendrix, Susan; Lane, Dorothy; Ockene, Judith; Stefanick, Marcia; Woods, Nancy F.; Yasmeen, Shagufta

    2010-01-01

    Objective To assess vasomotor and other menopausal symptoms before, one year later, again at trial closure and after stopping estrogens or placebo. The role of baseline symptoms and age was examined as was the frequency and determinants of hormone use and symptom management strategies after discontinuing conjugated equine estrogens or placebo. Methods Intention-to-treat analyses of 10,739 postmenopausal women before and one year after randomization to conjugated equine estrogens (CEE) or placebo at 40 clinical centers, and a cohort analysis of participants (n=3496) who continued taking assigned study pills up to trial closure and completed symptom surveys shortly before (mean 7.4 + 1.1 years from baseline) and after stopping pills (mean 306 + 55 days after trial closure). Generalized linear regression modeled vasomotor symptoms, vaginal dryness, breast tenderness, pain/stiffness and mood swings, as a function of treatment assignment and baseline symptoms, before and after stopping study pills. Results Approximately one-third of participants reported at least one moderate-to-severe symptom at baseline. Fewer symptoms were reported with increasing age, except joint pain/stiffness, which was similar among age groups. At one year, hot flashes, night sweats and vaginal dryness were reduced by CEE, whereas, breast tenderness was increased. Breast tenderness was also significantly higher in the CEE group at trial closure. Post-stopping, vasomotor symptoms were reported by significantly more women who had reported symptoms at baseline, compared to those who had not, and by significantly more participants assigned to CEE (9.8%) versus placebo (3.2%); however, among women with no moderate or severe symptoms at baseline, over 5 times as many reported hot flashes after stopping CEE (7.2%) versus placebo (1.5%). Conclusions CEE significantly reduced vasomotor symptoms and vaginal dryness in women with baseline symptoms, but increased breast tenderness. The likelihood of

  10. Dealing with daily challenges in dementia (deal-id study): effectiveness of the experience sampling method intervention 'Partner in Sight' for spousal caregivers of people with dementia: design of a randomized controlled trial.

    PubMed

    van Knippenberg, Rosalia J M; de Vugt, Marjolein E; Ponds, Rudolf W; Myin-Germeys, Inez; Verhey, Frans R J

    2016-05-11

    There is an urgent need for psychosocial interventions that effectively support dementia caregivers in daily life. The Experience Sampling Methodology (ESM) offers the possibility to provide a more dynamic view of caregiver functioning. ESM-derived feedback may help to redirect caregivers' behavior towards situations that elicit positive emotions and to increase their feelings of competence in the caretaking process. This paper presents the design of a study that evaluates the process characteristics and effects of the ESM-based intervention 'Partner in Sight'. A randomized controlled trial with 90 spousal caregivers of people with dementia will be conducted. Participants will be randomly assigned to the experimental (6-week ESM intervention including feedback), pseudo-experimental (6-week ESM intervention without feedback), or control group (care as usual). Assessments will be performed pre- and post-intervention and at 2-, and 6-month follow-up. Main outcomes will be sense of competence, perceived control, momentary positive affect, and psychological complaints (depressive symptoms, perceived stress, anxiety, momentary negative affect). In addition to the effect evaluation, a process and economic evaluation will be conducted to investigate the credibility and generalizability of the intervention, and its cost-effectiveness. The potential effects of the ESM intervention may help caregivers to endure their care responsibilities and prevent them from becoming overburdened. This is the first ESM intervention for caregivers of people with dementia. The results of this study, therefore, provide a valuable contribution to the growing knowledge on m-health interventions for dementia caregivers. Dutch Trial Register NTR4847 ; date registered Oct 9, 2014.

  11. Recent randomized controlled trials in otolaryngology.

    PubMed

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

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

    DTIC Science & Technology

    2008-05-01

    Preliminaries Randomized Algorithms for Analysis Probabilistic Robust Synthesis Randomized Algorithms for Optimal Control (LQR) Extensions Applications ...Randomized Algorithms (RAs) Randomized algorithms are frequently used in many areas of engineering, computer science, physics, finance , optimization ,…but...Uncertainty has been always a critical issue in control theory and applications First methods to deal with uncertainty were based on a stochastic

  13. Low degree of formal education and musical experience predict degree of music-induced stress reduction in relatives and friends of patients: a single-center, randomized controlled trial.

    PubMed

    Tilt, Alexandra C; Werner, Paul D; Brown, David F; Alam, Hassan B; Warshaw, Andrew L; Parry, Blair A; Jazbar, Brigita; Booker, Abigail; Stangenberg, Lars; Fricchione, Gregory L; Benson, Herbert; Lillemoe, Keith D; Conrad, Claudius

    2013-05-01

    To determine the factors that may predict music-induced relaxation in friends and family of patients in the emergency department. It remains unclear to date which demographic and experiential factors predict the effectiveness of music-induced relaxation. Furthermore, in-hospital stressors for friends and family of patients rather than patients themselves are underresearched and deserve in-depth investigation to improve this group's experience in health care environments. A total of 169 relatives and friends of patients in the emergency department-waiting area completed a series of questionnaires, including the Spielberger State-Trait Anxiety Inventory (STAI), the Music Experience Questionnaire (MEQ), and a demographic survey. They were then randomly assigned to either Case Group (1 hour in the waiting area with classical music in the background) or Control Group (1 hour with no music) before completing a second, identical copy of the STAI to measure change from baseline. Data were analyzed for associations between music intervention, change in STAI scores, MEQ scores, and demographic characteristics. Participants who underwent the music intervention experienced a 9.8% decrease in overall mean State Anxiety, whereas those in the Control Group experienced no change over time (P = 0.001). Higher education significantly inversely correlated with the effectiveness of music intervention: participants with no formal education beyond high school showed a greater overall mean decrease in State Anxiety than those with a college education or beyond in response to classical music (P = 0.006). Furthermore, MEQ scores indicated that the Social Uplift scale (a measure of one's tendency to be uplifted in a group-oriented manner by music) was highly predictive of the effectiveness of music intervention. Music is an effective and inexpensive means of reducing anxiety in friends and family of patients, who are underresearched in medicine. Moreover, low educational attainment and

  14. Individuals with tension and migraine headaches exhibit increased heart rate variability during post-stress mindfulness meditation practice but a decrease during a post-stress control condition - A randomized, controlled experiment.

    PubMed

    Azam, Muhammad Abid; Katz, Joel; Mohabir, Vina; Ritvo, Paul

    2016-12-01

    Current research suggests that associations between headache conditions (migraine, tension) and imbalances in the autonomic nervous system (ANS) are due to stress-related dysregulation in the activity of the parasympathetic-sympathetic branches. Mindfulness meditation has demonstrated effectiveness in reducing pain-related distress, and in enhancing heart rate variability-a vagal-mediated marker of ANS balance. This study examined HRV during cognitive stress and mindfulness meditation in individuals with migraine and tension headaches. Undergraduate students with tension and migraine headaches (n=36) and headache-free students (n=39) were recruited for an experiment involving HRV measurement during baseline, cognitive stress-induction, and after randomization to post-stress conditions of audio-guided mindfulness meditation practice (MMP) or mindfulness meditation description (MMD). HRV was derived using electrocardiograms as the absolute power in the high frequency bandwidth (ms 2 ). A three-way ANOVA tested the effects of Group (headache vs. headache-free), Phase (baseline, stress, & post-stress), and Condition (MMP vs. MMD) on HRV. ANOVA revealed a significant three-way interaction. Simple effects tests indicated: 1) HRV increased significantly from stress to MMP for headache and headache-free groups (p<0.001), 2) significantly greater HRV for headache (p<0.001) and headache-free (p<0.05) groups during MMP compared to MMD, and 3) significantly lower HRV in the headache vs. headache-free group during the post-stress MMD condition (p<0.05). Results suggest mindfulness practice can promote effective heart rate regulation, and thereby promote effective recovery after a stressful event for individuals with headache conditions. Moreover, headache conditions may be associated with dysregulated stress recovery, thus more research is needed on the cardiovascular health and stress resilience of headache sufferers. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. RANDOMIZATION PROCEDURES FOR THE ANALYSIS OF EDUCATIONAL EXPERIMENTS.

    ERIC Educational Resources Information Center

    COLLIER, RAYMOND O.

    CERTAIN SPECIFIC ASPECTS OF HYPOTHESIS TESTS USED FOR ANALYSIS OF RESULTS IN RANDOMIZED EXPERIMENTS WERE STUDIED--(1) THE DEVELOPMENT OF THE THEORETICAL FACTOR, THAT OF PROVIDING INFORMATION ON STATISTICAL TESTS FOR CERTAIN EXPERIMENTAL DESIGNS AND (2) THE DEVELOPMENT OF THE APPLIED ELEMENT, THAT OF SUPPLYING THE EXPERIMENTER WITH MACHINERY FOR…

  16. A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults.

    PubMed

    Dolovich, Lisa; Oliver, Doug; Lamarche, Larkin; Agarwal, Gina; Carr, Tracey; Chan, David; Cleghorn, Laura; Griffith, Lauren; Javadi, Dena; Kastner, Monika; Longaphy, Jennifer; Mangin, Dee; Papaioannou, Alexandra; Ploeg, Jenny; Raina, Parminder; Richardson, Julie; Risdon, Cathy; Santaguida, P Lina; Straus, Sharon; Thabane, Lehana; Valaitis, Ruta; Price, David

    2016-04-05

    Healthcare systems are not well designed to help people maintain or improve their health. They are generally not person-focused or well-coordinated. The objective of this study is to evaluate the effectiveness of the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) approach in older adults. The overarching hypothesis is that using the Health TAPESTRY approach to achieve better integration of the health and social care systems into a person's life that centers on meeting a person's health goals and needs will result in optimal aging. This is a 12-month delayed intervention pragmatic randomized controlled trial. The study will be performed in Hamilton, Ontario, Canada in the two-site McMaster Family Health Team. Participants will include 316 patients who are 70 years of age or older. Participants will be randomized to the Health TAPESTRY approach or control group. The Health TAPESTRY approach includes intentional, proactive conversations about a person's life and health goals and health risks and then initiation of congruent tailored interventions that support achievement of those goals and addressing of risks through (1) trained volunteers visiting clients in their homes to serve as a link between the primary care team and the client; (2) the use of novel technology including a personal health record from the home to link directly with the primary healthcare team; and (3) improved processes for connections, system navigation, and care delivery among interprofessional primary care teams, community service providers, and informal caregivers. The primary outcome will be the goal attainment scaling score. Secondary outcomes include self-efficacy for managing chronic disease, quality of life, the participant perspective on their own aging, social support, access to health services, comprehensiveness of care, patient empowerment, patient-centeredness, caregiver strain, satisfaction with care, healthcare resource utilization, and cost

  17. To vape or not to vape? Effects of exposure to conflicting news headlines on beliefs about harms and benefits of electronic cigarette use: Results from a randomized controlled experiment.

    PubMed

    Tan, Andy S L; Lee, Chul-Joo; Nagler, Rebekah H; Bigman, Cabral A

    2017-12-01

    News coverage of novel tobacco products including e-cigarettes has framed the use of these products with both positive and negative slants. Conflicting information may shape public knowledge, perceptions of e-cigarettes, and their harms. The objective of this study is to assess effects of exposure to conflicting news coverage on US adults' beliefs about harms and benefits of e-cigarette use. We conducted a one-way between-subjects randomized controlled experiment in 2016 to compare the effects of viewing either 1) positive, 2) negative, 3) both positive and negative (conflicting) news headlines about the safety of using e-cigarettes, or 4) no-message. Participants were 2056 adults aged 18 and older from an online survey panel. Outcomes were beliefs about harms (3-item scale, α=0.76) and benefits (3-item scale, α=0.82) of using e-cigarettes. Participants who viewed negative headlines reported increased beliefs about harms (B=0.164, p=0.039) and lower beliefs about benefits of e-cigarette use (B=-0.216, p=0.009), compared with those in the positive headlines condition. These differences were replicated in subgroup analyses among never e-cigarette users. In addition, never e-cigarette users who viewed conflicting headlines reported lower beliefs about benefits of e-cigarette use (B=-0.221, p=0.030) than the positive headlines condition. Valence of news coverage about e-cigarettes (positive, negative, or conflicting) could influence people's beliefs about harms and benefits of e-cigarette use. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. 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

  19. 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

    DeAndrea, David Christopher; Vendemia, Megan Ashley

    2016-07-19

    More people are seeking health information online than ever before and pharmaceutical companies are increasingly marketing their drugs through social media. 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. 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. 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 likelihood of participants recommending the drug (point estimate -0.61, 95% CI -0

  20. Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

    ERIC Educational Resources Information Center

    Lohr, Sharon L.; Zhu, Xiaoshu

    2017-01-01

    Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

  1. Nurse navigators in early cancer care: a randomized, controlled trial.

    PubMed

    Wagner, Edward H; Ludman, Evette J; Aiello Bowles, Erin J; Penfold, Robert; Reid, Robert J; Rutter, Carolyn M; Chubak, Jessica; McCorkle, Ruth

    2014-01-01

    To determine whether a nurse navigator intervention improves quality of life and patient experience with care for people recently given a diagnosis of breast, colorectal, or lung cancer. Adults with recently diagnosed primary breast, colorectal, or lung cancer (n = 251) received either enhanced usual care (n = 118) or nurse navigator support for 4 months (n = 133) in a two-group cluster randomized, controlled trial with primary care physicians as the units of randomization. Patient-reported measures included the Functional Assessment of Cancer Therapy-General (FACT-G) Quality of Life scale, three subscales of the Patient Assessment of Chronic Illness Care (PACIC), and selected subscales from a cancer adaptation of the Picker Institute's patient experience survey. Self-report measures were collected at baseline, 4 months, and 12 months. Automated administrative data were used to assess time to treatment and total health care costs. There were no significant differences between groups in FACT-G scores. Nurse navigator patients reported significantly higher scores on the PACIC and reported significantly fewer problems with care, especially psychosocial care, care coordination, and information, as measured by the Picker instrument. Cumulative costs after diagnosis did not differ significantly between groups, but lung cancer costs were $6,852 less among nurse navigator patients. Compared with enhanced usual care, nurse navigator support for patients with cancer early in their course improves patient experience and reduces problems in care, but did not differentially affect quality of life.

  2. 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.

  3. The Middeck Active Control Experiment (MACE)

    NASA Technical Reports Server (NTRS)

    Miller, David W.

    1992-01-01

    Viewgraphs on the Middeck Active Control Experiment (MACE) are presented. Topics covered include: program objectives; program features; flight experiment features; current activities; MACE development model lab testing; MACE test article deployed on STS middeck; and development model testing.

  4. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  5. 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…

  6. Viscosity Control Experiment Feasibility Study

    SciTech Connect

    Morris, Heidi E.; Bradley, Paul Andrew

    2018-01-31

    Turbulent mix has been invoked to explain many results in Inertial Confinement Fusion (ICF) and High Energy Density (HED) physics, such as reduced yield in capsule implosions. Many ICF capsule implosions exhibit interfacial instabilities seeded by the drive shock, but it is not clear that fully developed turbulence results from this. Many simulations use turbulent mix models to help match simulation results to data, but this is not appropriate if turbulence is not present. It would be useful to have an experiment where turbulent mixing could be turned on or off by design. The use of high-Z dopants to modifymore » viscosity and the resulting influence on turbulence is considered here. A complicating factor is that the plasma in some implosions can become strongly coupled, which makes the Spitzer expression for viscosity invalid. We first consider equations that cover a broad parameter space in temperature and density to address regimes for various experimental applications. Next, a previous shock-tube and other ICF experiments that investigate viscosity or use doping to examine the effects on yield are reviewed. How viscosity and dopants play a role in capsule yield depends on the region and process under consideration. Experiments and simulations have been performed to study the effects of viscosity on both the hot spot and the fuel/ablator mix. Increases in yield have been seen for some designs, but not all. We then discuss the effect of adding krypton dopant to the gas region of a typical OMEGA and a 2-shock NIF implosion to determine approximately the effect of adding dopant on the computed Reynolds number. Recommendations for a path forward for possible experiments using high-Z dopants to affect viscosity and turbulence are made.« less

  7. Receipt of Preventive Services After Oregon's Randomized Medicaid Experiment.

    PubMed

    Marino, Miguel; Bailey, Steffani R; Gold, Rachel; Hoopes, Megan J; O'Malley, Jean P; Huguet, Nathalie; Heintzman, John; Gallia, Charles; McConnell, K John; DeVoe, Jennifer E

    2016-02-01

    It is predicted that gaining health insurance via the Affordable Care Act will result in increased rates of preventive health services receipt in the U.S., primarily based on self-reported findings from previous health insurance expansion studies. This study examined the long-term (36-month) impact of Oregon's 2008 randomized Medicaid expansion ("Oregon Experiment") on receipt of 12 preventive care services in community health centers using electronic health record data. Demographic data from adult (aged 19-64 years) Oregon Experiment participants were probabilistically matched to electronic health record data from 49 Oregon community health centers within the OCHIN community health information network (N=10,643). Intent-to-treat analyses compared receipt of preventive services over a 36-month (2008-2011) period among those randomly assigned to apply for Medicaid versus not assigned, and instrumental variable analyses estimated the effect of actually gaining Medicaid coverage on preventive services receipt (data collected in 2012-2014; analysis performed in 2014-2015). Intent-to-treat analyses revealed statistically significant differences between patients randomly assigned to apply for Medicaid (versus not assigned) for 8 of 12 assessed preventive services. In intent-to-treat analyses, Medicaid coverage significantly increased the odds of receipt of most preventive services (ORs ranging from 1.04 [95% CI=1.02, 1.06] for smoking assessment to 1.27 [95% CI=1.02, 1.57] for mammography). Rates of preventive services receipt will likely increase as community health center patients gain insurance through Affordable Care Act expansions. Continued effort is needed to increase health insurance coverage in an effort to decrease health disparities in vulnerable populations. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  8. A Short History of Randomized Experiments in Criminology: A Meager Feast.

    ERIC Educational Resources Information Center

    Farrington, David P.

    2003-01-01

    Discusses advantages of randomized experiments and key issues raised in this special issue. Focuses on 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. Calls for increased recognition of the importance of randomized experiments. (SLD)

  9. Fluid dynamics during Random Positioning Machine micro-gravity experiments

    NASA Astrophysics Data System (ADS)

    Leguy, Carole A. D.; Delfos, René; Pourquie, Mathieu J. B. M.; Poelma, Christian; Westerweel, Jerry; van Loon, Jack J. W. A.

    2017-06-01

    A Random Positioning Machine (RPM) is a device used to study the role of gravity on biological systems. This is accomplished through continuous reorientation of the sample such that the net influence of gravity is randomized over time. The aim of this study is to predict fluid flow behavior during such RPM simulated microgravity studies, which may explain differences found between RPM and space flight experiments. An analytical solution is given for a cylinder as a model for an experimental container. Then, a dual-axis rotating frame is used to mimic the motion characteristics of an RPM with sinusoidal rotation frequencies of 0.2 Hz and 0.1 Hz while Particle Image Velocimetry is used to measure the velocity field inside a flask. To reproduce the same experiment numerically, a Direct Numerical Simulation model is used. The analytical model predicts that an increase in the Womersley number leads to higher shear stresses at the cylinder wall and decrease in fluid angular velocity inside the cylinder. The experimental results show that periodic single-axis rotation induces a fluid motion parallel to the wall and that a complex flow is observed for two-axis rotation with a maximum wall shear stress of 8.0 mPa (80 mdyne /cm2). The experimental and numerical results show that oscillatory motion inside an RPM induces flow motion that can, depending on the experimental samples, reduce the quality of the simulated microgravity. Thus, it is crucial to determine the appropriate oscillatory frequency of the axes to design biological experiments.

  10. Analyzing Randomized Controlled Interventions: Three Notes for Applied Linguists

    ERIC Educational Resources Information Center

    Vanhove, Jan

    2015-01-01

    I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a) checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b) using repeated measures ANOVA to analyze pretest-posttest designs, and…

  11. 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.

  12. Application of one-way ANOVA in completely randomized experiments

    NASA Astrophysics Data System (ADS)

    Wahid, Zaharah; Izwan Latiff, Ahmad; Ahmad, Kartini

    2017-12-01

    This paper describes an application of a statistical technique one-way ANOVA in completely randomized experiments with three replicates. This technique was employed to a single factor with four levels and multiple observations at each level. The aim of this study is to investigate the relationship between chemical oxygen demand index and location on-sites. Two different approaches are employed for the analyses; critical value and p-value. It also presents key assumptions of the technique to be satisfied by the data in order to obtain valid results. Pairwise comparisons by Turkey method are also considered and discussed to determine where the significant differences among the means is after the ANOVA has been performed. The results revealed that there are statistically significant relationship exist between the chemical oxygen demand index and the location on-sites.

  13. 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.

  14. 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.

  15. 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…

  16. 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.

  17. The Middeck Active Control Experiment (MACE)

    NASA Technical Reports Server (NTRS)

    Miller, David W.

    1991-01-01

    Viewgraphs on the Middeck Active Control Experiment (MACE) are presented. Topics covered include: science program objectives and rationale; science requirements; capturing the essential physics; science development approach; development model hardware; development model test plan; and flight hardware and operations.

  18. A randomized controlled trial: child life services in pediatric imaging.

    PubMed

    Tyson, Mary E; Bohl, Daniel D; Blickman, Johan G

    2014-11-01

    Children undergoing procedures in pediatric health care facilities and their families have been shown to benefit from psychosocial services and interventions such as those provided by a Certified Child Life Specialist (CCLS). The comprehensive impact of a CCLS in a pediatric imaging department is well recognized anecdotally but has not been examined in a prospective or randomized controlled fashion. We prospectively assessed the impact of a CCLS on parent satisfaction, staff satisfaction, child satisfaction, and parent and staff perceptions of child pain and distress in a pediatric imaging department. Eligible children between 1 and 12 years of age (n = 137) presenting to the pediatric imaging department for an imaging procedure were randomly assigned to an intervention or control arm. Those assigned to the intervention received the comprehensive services of a CCLS. The control group received standard of care, which did not include any child life services. Quantitative measures of satisfaction and perception of child pain and distress were assessed by parents and staff using a written 5-point Likert scale questionnaire after the imaging procedure. Children 4 and older were asked to answer 3 questions on a 3-point scale. Statistically significant differences between the intervention and control groups were found in 19 out of 24 measures. Parents in the intervention group indicated higher satisfaction and a lower perception of their child's pain and distress. Staff in the intervention group indicated greater child cooperation and a lower perception of the child's pain and distress. Children in the intervention group indicated a better overall experience and less fear than those in the control group. Child life specialists have a quantifiably positive impact on the care of children in imaging departments. Measures of parent satisfaction, staff satisfaction, child satisfaction, child pain and child distress are shown to be positively impacted by the services of a

  19. 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.

  20. The Middeck Active Control Experiment (MACE): Identification for robust control

    NASA Technical Reports Server (NTRS)

    Karlov, Valery I.

    1992-01-01

    Viewgraphs on identification for robust control for the Middeck Active Control Experiment (MACE) are presented. Topics covered include: identification for robust control; three levels of identification; basic elements of the approach; advantages of 'post-ID' model of uncertainty; advantages of optimization; and practical realization.

  1. History of the Athens Canadian Random Bred and the Athens Random Bred control populations.

    PubMed

    Collins, K E; Marks, H L; Aggrey, S E; Lacy, M P; Wilson, J L

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. © 2016 Poultry Science Association Inc.

  2. 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…

  3. Infant video viewing and salivary cortisol responses: a randomized experiment.

    PubMed

    Christakis, Dimitri A; Liekweg, Kimberly; Garrison, Michelle M; Wright, Jeffrey A

    2013-05-01

    To test the hypothesis that salivary cortisol levels respond differently when infants play with blocks compared with watching a digital video disk (DVD). We conducted a randomized experiment in which 8- to 14-month-old infants either watched a DVD or played with blocks for 30 minutes. Serial salivary cortisol measurements were obtained and analyzed, and parental and infant responses and activities were recorded. Results were converted to standardized effect sizes (ESs) for clarity of presentation. A total of 49 infants (49% female, mean age 10.6 months) participated in the study. In linear regression analyses, there was a trend toward higher cortisol levels in the block group at the 35-minute collection point (ES = 0.47, P = .08) and significantly higher levels at 45 minutes (ES = 0.56, P = .04); these salivary cortisol levels reflect serum levels approximately 10 and 20 minutes into the activity period, respectively. The results were substantially the same in sensitivity analyses excluding the outliers. Viewing by infants of a DVD leads to different neuroendocrine responses than block play in a laboratory setting. The implications of these differences are currently unknown, but may suggest different means of cognitive engagement between interactive play and DVD viewing. Copyright © 2013 Mosby, Inc. All rights reserved.

  4. 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. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. 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…

  6. 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…

  7. 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…

  8. Open source software for experiment design and control.

    PubMed

    Hillenbrand, James M; Gayvert, Robert T

    2005-02-01

    The purpose of this paper is to describe a software package that can be used for performing such routine tasks as controlling listening experiments (e.g., simple labeling, discrimination, sentence intelligibility, and magnitude estimation), recording responses and response latencies, analyzing and plotting the results of those experiments, displaying instructions, and making scripted audio-recordings. The software runs under Windows and is controlled by creating text files that allow the experimenter to specify key features of the experiment such as the stimuli that are to be presented, the randomization scheme, interstimulus and intertrial intervals, the format of the output file, and the layout of response alternatives on the screen. Although the software was developed primarily with speech-perception and psychoacoustics research in mind, it has uses in other areas as well, such as written or auditory word recognition, written or auditory sentence processing, and visual perception.

  9. 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…

  10. Participation Bias among Suicidal Adults in a Randomized Controlled Trial

    PubMed Central

    Stirman, Shannon Wiltsey; Brown, Gregory K.; Ghahramanlou-Holloway, Marjan; Fox, Allison J.; Chohan, Mariam Zahid; Beck, Aaron T.

    2012-01-01

    Although individuals who attempt suicide have poor compliance rates with treatment recommendations, the nature and degree of participation bias in clinical treatment research among these individuals is virtually unknown. The purpose of this study was to examine participation bias by comparing the demographic and diagnostic characteristics of adult suicide attempters who participated in a randomized controlled trial to a sample of nonparticipants. Results indicated that males and individuals with a diagnosis of substance abuse or dependence were more likely to be participants in the randomized controlled trial. The implications of these findings for suicide intervention research are discussed. PMID:21470296

  11. 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.

  12. GEECS (Generalized Equipment and Experiment Control System)

    SciTech Connect

    GONSALVES, ANTHONY; DESHMUKH, AALHAD

    2017-01-12

    GEECS (Generalized Equipment and Experiment Control System) monitors and controls equipment distributed across a network, performs experiments by scanning input variables, and collects and stores various types of data synchronously from devices. Examples of devices include cameras, motors and pressure gauges. GEEKS is based upon LabView graphical object oriented programming (GOOP), allowing for a modular and scalable framework. Data is published for subscription of an arbitrary number of variables over TCP. A secondary framework allows easy development of graphical user interfaces for a combined control of any available devices on the control system without the need of programming knowledge. This allows for rapid integration of GEECS into a wide variety of systems. A database interface provides for devise and process configuration while allowing the user to save large quantities of data to local or network drives.

  13. GEECS (Generalized Equipment and Experiment Control System)

    SciTech Connect

    GONSALVES, ANTHONY; DESHMUKH, AALHAD

    2017-01-12

    GEECS (Generalized Equipment and Experiment Control System) monitors and controls equipment distributed across a network, performs experiments by scanning input variables, and collects and stores various types of data synchronously from devices. Examples of devices include cameras, motors and pressure gauges. GEEKS is based upon LabView graphical object oriented programming (GOOP), allowing for a modular and scalable framework. Data is published for subscription of an arbitrary number of variables over TCP. A secondary framework allows easy development of graphical user interfaces for a combined control of any available devices on the control system without the need of programming knowledge. Thismore » allows for rapid integration of GEECS into a wide variety of systems. A database interface provides for devise and process configuration while allowing the user to save large quantities of data to local or network drives.« less

  14. Lessons Learned from Large-Scale Randomized Experiments

    ERIC Educational Resources Information Center

    Slavin, Robert E.; Cheung, Alan C. K.

    2017-01-01

    Large-scale randomized studies provide the best means of evaluating practical, replicable approaches to improving educational outcomes. This article discusses the advantages, problems, and pitfalls of these evaluations, focusing on alternative methods of randomization, recruitment, ensuring high-quality implementation, dealing with attrition, and…

  15. Advanced Thermal control Flight Experiment (ATFE)

    NASA Technical Reports Server (NTRS)

    1979-01-01

    A comprehensive description of the design and performance of the Advanced Thermal Control Flight Experiment (ATFE) is presented. The ATFE studied in a space environment for five years the steady state, transient ground and flight performance of (1) a thermal diode heat pipe, (2) a phase change material, and (3) a feedback controlled variable conductance heat pipe. It was found that all were flight worthy and highly reliable.

  16. Challenges of maintaining research protocol fidelity in a clinical care setting: a qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial.

    PubMed

    Lawton, Julia; Jenkins, Nicholas; Darbyshire, Julie L; Holman, Rury R; Farmer, Andrew J; Hallowell, Nina

    2011-05-04

    Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during trial delivery. This study sought to understand why there was limited attainment of the glycaemic target (HbA(1c) ≤6.5%) among patients who participated in the Treating to Target in Type 2 Diabetes Trial (4-T). The objective was to inform interpretation of trial outcomes and provide recommendations for future trial delivery. In-depth interviews were conducted with 45 patients and 21 health professionals recruited from 11 of 58 trial centres in the UK. Patients were broadly representative of those in the main trial in terms of treatment allocation, demographics and glycaemic control. Both physicians and research nurses were interviewed. Most patients were committed to taking insulin as recommended by 4-T staff. To avoid hypoglycaemia, patients occasionally altered or skipped insulin doses, normally in consultation with staff. Patients were usually unaware of the trial's glycaemic target. Positive staff feedback could lead patients to believe they had been 'successful' trial participants even when their HbA(1c) exceeded 6.5%. While some staff felt that the 4-T automated insulin dose adjustment algorithm had increased their confidence to prescribe larger insulin doses than in routine clinical practice, all described situations where they had not followed its recommendations. Staff regarded the application of a 'one size fits all' glycaemic target during the trial as contradicting routine clinical practice where they would tailor treatments to individuals. Staff also expressed concerns that 'tight' glycaemic control might impose an unacceptably high risk of hypoglycaemia, thus compromising trust and safety, especially amongst older patients. To address these concerns, staff tended to adapt the trial protocol to align it with their clinical practices and

  17. Adaptive adjustment of the randomization ratio using historical control data.

    PubMed

    Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

    2013-01-01

    Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms

  18. Adaptive adjustment of the randomization ratio using historical control data

    PubMed Central

    Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

    2013-01-01

    Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal

  19. 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…

  20. 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…

  1. 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…

  2. 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…

  3. Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

    2011-01-01

    Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

  4. 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…

  5. 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

  6. Doing the Impossible: A Note on Induction and the Experience of Randomness.

    ERIC Educational Resources Information Center

    Lopes, Lola L.

    1982-01-01

    The process of induction is formulated as a problem in detecting nonrandomness, or pattern, against a background of randomness, or noise. Experimental and philosophical approaches to human conceptions of randomness are contrasted. The relation between induction and the experience of randomness is discussed in terms of signal-detection theory.…

  7. 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.

  8. Simulation and properties of randomly switched control systems

    NASA Astrophysics Data System (ADS)

    Allison, Andrew G.; Abbott, Derek

    1999-10-01

    Power electronics has made great advances since the introduction of the thyristor in 1958. Even a casual study of consumer electronics have steadily replaced passive circuits. Switched mode circuits can accommodate higher power densities, they are lighter, cheaper and easier to control. The use of microprocessors and microcontrollers can make switched mode circuits even more versatile. Unfortunately, there are some problems with switched mode circuits. The higher power densities handled by these circuits can cause catastrophic failure. Periodic switching can give rise to acoustic noise or undesirable electromagnetic radiation. These problems can be reduced through the use of random switching policies. One theoretical disadvantage of random switching policies is that the time averaged switched system is not strictly equivalent to the classical system with the same average parameters. The stability limits for the randomly switched and classical system are different. This is a possible area for concern, given the high power densities and the possibility of catastrophic failure. In this paper we examine the stability of randomly switched control systems. We provide simulations, some analysis and derive some practical rules for stability. We show that some randomness can be beneficial from the point of view of minimizing power spectral density of the noise waveforms in the output current.

  9. 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.

  10. 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.

  11. Patient satisfaction with different interpreting methods: a randomized controlled trial.

    PubMed

    Gany, Francesca; Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C; Changrani, Jyotsna

    2007-11-01

    Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health

  12. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  13. The Core Analytics of Randomized Experiments for Social Research. MDRC Working Papers on Research Methodology

    ERIC Educational Resources Information Center

    Bloom, Howard S.

    2006-01-01

    This chapter examines the core analytic elements of randomized experiments for social research. Its goal is to provide a compact discussion for faculty members, graduate students, and applied researchers of the design and analysis of randomized experiments for measuring the impacts of social or educational interventions. Design issues considered…

  14. Internet-based randomized controlled trials: a systematic review.

    PubMed

    Mathieu, Erin; McGeechan, Kevin; Barratt, Alexandra; Herbert, Robert

    2013-05-01

    The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods.

  15. Internet-based randomized controlled trials: a systematic review

    PubMed Central

    Mathieu, Erin; McGeechan, Kevin; Barratt, Alexandra; Herbert, Robert

    2013-01-01

    Background The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. Objective To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. Methods A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. Results 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). Conclusions It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods. PMID:23065196

  16. Flight experience with flight control redundancy management

    NASA Technical Reports Server (NTRS)

    Szalai, K. J.; Larson, R. R.; Glover, R. D.

    1980-01-01

    Flight experience with both current and advanced redundancy management schemes was gained in recent flight research programs using the F-8 digital fly by wire aircraft. The flight performance of fault detection, isolation, and reconfiguration (FDIR) methods for sensors, computers, and actuators is reviewed. Results of induced failures as well as of actual random failures are discussed. Deficiencies in modeling and implementation techniques are also discussed. The paper also presents comparison off multisensor tracking in smooth air, in turbulence, during large maneuvers, and during maneuvers typical of those of large commercial transport aircraft. The results of flight tests of an advanced analytic redundancy management algorithm are compared with the performance of a contemporary algorithm in terms of time to detection, false alarms, and missed alarms. The performance of computer redundancy management in both iron bird and flight tests is also presented.

  17. Attrition in randomized controlled trials for pediatric chronic conditions.

    PubMed

    Karlson, Cynthia W; Rapoff, Michael A

    2009-08-01

    To examine attrition variables in randomized controlled trials of cognitive behavioral interventions for children with chronic illnesses. We examined attrition rates reported on 40 randomized cognitive behavioral interventions published in six pediatric research journals, during the years 2002-2007. Intervention focus was limited to children with a chronic medical condition, such as asthma, obesity, arthritis, diabetes, cancer, sickle cell disease, and cystic fibrosis. Mean rate of enrollment refusal was 37% (range 0-75%). Mean attrition rate was 20% (range 0-54%) for initial follow-up and 32% (range 0-59%) for extended follow-up. Of the reviewed articles, 40% included a CONSORT diagram. Strategies that can be used to limit attrition include tailoring recruitment to the study population, providing personalized feedback, maintaining consistent study procedures, providing incentives, and using intensive tracking measures. There is a need for standardized definitions and reporting of attrition rates in randomized cognitive behavioral intervention studies.

  18. 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.

  19. What's in placebos: who knows? Analysis of randomized, controlled trials.

    PubMed

    Golomb, Beatrice A; Erickson, Laura C; Koperski, Sabrina; Sack, Deanna; Enkin, Murray; Howick, Jeremy

    2010-10-19

    No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting. To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials. 4 English-language general and internal medicine journals with high impact factors. 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009. Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus. Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002). Journals with high impact factors may not be representative. Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

  20. Density Matching for Better Ground Control Experiments

    NASA Technical Reports Server (NTRS)

    Kleis, S.; Rao, A.; Geffert, S.; Hudson, E.; Gonda, S.

    2004-01-01

    Increasing the culture media density to more closely match the density of cells on microcarriers can reduce the differences in shear level and mass transport coefficients between flight and ground control experiments. This could allow a more direct determination of the effects of micro gravity on cell cultures. However, care must be taken to use operating conditions that will properly support the culture. Results from numerical simulations and some possible density matching procedures will be discussed.

  1. Describing Typical Capstone Course Experiences from a National Random Sample

    ERIC Educational Resources Information Center

    Grahe, Jon E.; Hauhart, Robert C.

    2013-01-01

    The pedagogical value of capstones has been regularly discussed within psychology. This study presents results from an examination of a national random sample of department webpages and an online survey that characterized the typical capstone course in terms of classroom activities and course administration. The department webpages provide an…

  2. 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.

  3. 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…

  4. Acknowledgement based random access transmission control - An equilibrium analysis

    NASA Astrophysics Data System (ADS)

    Hajek, B.

    A study is conducted of a general class of retransmission policies called Acknowledgement Based Retransmission Control (ABRC) policies. Under an ABC policy stations wait random lengths of time between packet transmissions, as under the original ALOHA policy. A description is given of a multiaccess broadcast channel model. An important aspect of such a model is the feedback information available to the users. Two different models for the generation of new packets are considered. The first model is the infinite-user model for which the number of new packets transmitted in each slot is given by a sequence of independent Poisson random variables. The second model for packet generation considered is the finite-user population model with M users. The acknowledgement based retransmission control policy is discussed, and an equilibrium analysis of the ABRC policy is conducted.

  5. Randomized controlled trials in malignant pleural mesothelioma surgery-mistakes made and lessons learned.

    PubMed

    Waller, David A; Dawson, Alan G

    2017-06-01

    Randomized surgical trials are of the most difficult to design and recruit, however, they are the only robust method available to establish a new surgical procedure. Mesothelioma is a disease with a perceived poor prognosis for which surgical intervention has relatively high complications and not insignificant mortality. This review will consider the mesothelioma and radical surgery (MARS) 1 and 2 trials, SAKK 17/04 trial and the EORTC 1205 trial all aimed at assessing the potential benefit of radical surgery for malignant pleural mesothelioma. In addition, MesoVATS and MesoTRAP will be explored assessing the value of debulking surgery for malignant pleural mesothelioma. We also endeavour to identify the mistakes made and the lessons learned which will inform future randomized controlled clinical trials in the field of malignant pleural mesothelioma. Despite the insurmountable problems with randomized controlled clinical trials, we show that they are possible and continuing with uncontrolled experiments will perpetuate unproven and potentially harmful operations.

  6. Randomized controlled trials in malignant pleural mesothelioma surgery—mistakes made and lessons learned

    PubMed Central

    Waller, David A.

    2017-01-01

    Randomized surgical trials are of the most difficult to design and recruit, however, they are the only robust method available to establish a new surgical procedure. Mesothelioma is a disease with a perceived poor prognosis for which surgical intervention has relatively high complications and not insignificant mortality. This review will consider the mesothelioma and radical surgery (MARS) 1 and 2 trials, SAKK 17/04 trial and the EORTC 1205 trial all aimed at assessing the potential benefit of radical surgery for malignant pleural mesothelioma. In addition, MesoVATS and MesoTRAP will be explored assessing the value of debulking surgery for malignant pleural mesothelioma. We also endeavour to identify the mistakes made and the lessons learned which will inform future randomized controlled clinical trials in the field of malignant pleural mesothelioma. Despite the insurmountable problems with randomized controlled clinical trials, we show that they are possible and continuing with uncontrolled experiments will perpetuate unproven and potentially harmful operations. PMID:28706908

  7. A Randomized Controlled Trial of Storytelling as a Communication Tool

    PubMed Central

    Hartling, Lisa; Scott, Shannon D.; Johnson, David W.; Bishop, Ted; Klassen, Terry P.

    2013-01-01

    Introduction Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. Results There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Conclusions Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. Trial Registration Current Controlled

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

    DTIC Science & Technology

    2016-03-01

    instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information...of Defense (DoD) Telemedicine and Advanced Technology Research Center (TATRC) funded randomized controlled trial of the Caring Letters intervention to...follow-up procedures for LRMC. A project manager was hired at the main site and all necessary training was completed. 2. Equipment a. None required

  9. Controlling Large Fluctuations: Theory and Experiment

    NASA Astrophysics Data System (ADS)

    Dykman, Mark I.; Golding, Brage

    We review some recent results on large infrequent fluctuations in which a system moves far away from a metastable state or makes a transition between metastable states. Although fluctuations happen at random, the motion in a large fluctuation is essentially deterministic. This makes it possible to change fluctuation probabilities exponentially strongly by comparatively weak fields, paving the way for selective control of escape rates. To investigate large fluctuations experimentally, w e trap a dielectric Brownian particle in a double-well potential created by two independent Optical beams. By analyzing thermal fluctuations, we can fully map the three-dimensional potential. This has allowed us to put Kramers' theory of thermally activated transitions to a quantitative experimental test. A suitable periodic modulation of the optical intensity breaks the spatio-temporal symmetry of an otherwise spatially symmetric system. This has allowed us to localize a particle in one of the symmetr ic wells.

  10. Analysis of random drop for gateway congestion control. M.S. Thesis

    NASA Technical Reports Server (NTRS)

    Hashem, Emam Salaheddin

    1989-01-01

    Lately, the growing demand on the Internet has prompted the need for more effective congestion control policies. Currently No Gateway Policy is used to relieve and signal congestion, which leads to unfair service to the individual users and a degradation of overall network performance. Network simulation was used to illustrate the character of Internet congestion and its causes. A newly proposed gateway congestion control policy, called Random Drop, was considered as a promising solution to the pressing problem. Random Drop relieves resource congestion upon buffer overflow by choosing a random packet from the service queue to be dropped. The random choice should result in a drop distribution proportional to the bandwidth distribution among all contending TCP connections, thus applying the necessary fairness. Nonetheless, the simulation experiments demonstrate several shortcomings with this policy. Because Random Drop is a congestion control policy, which is not applied until congestion has already occurred, it usually results in a high drop rate that hurts too many connections including well-behaved ones. Even though the number of packets dropped is different from one connection to another depending on the buffer utilization upon overflow, the TCP recovery overhead is high enough to neutralize these differences, causing unfair congestion penalties. Besides, the drop distribution itself is an inaccurate representation of the average bandwidth distribution, missing much important information about the bandwidth utilization between buffer overflow events. A modification of Random Drop to do congestion avoidance by applying the policy early was also proposed. Early Random Drop has the advantage of avoiding the high drop rate of buffer overflow. The early application of the policy removes the pressure of congestion relief and allows more accurate signaling of congestion. To be used effectively, algorithms for the dynamic adjustment of the parameters of Early Random Drop

  11. Does Written Emotional Disclosure about Stress Improve College Students' Academic Performance? Results from Three Randomized, Controlled Studies

    ERIC Educational Resources Information Center

    Radcliffe, Alison M.; Stevenson, Jennifer K.; Lumley, Mark A.; D'Souza, Pamela J.; Kraft, Christina A.

    2011-01-01

    Several early studies and subsequent reviews suggested that written emotional disclosure (WED)--writing repeatedly about personal stressful experiences--leads to improved academic performance of college students. A critical review of available studies casts some doubt on this conclusion, so we conducted three randomized, controlled experiments of…

  12. Hospital chaplains' involvement in a randomized controlled multidisciplinary trial: implications for spiritual care and research.

    PubMed

    Piderman, Katherine M; Johnson, Mary E

    2009-01-01

    Chaplains' involvement in spirituality and health research can contribute something vital and unique to these investigations. It can also provide opportunity for professional growth and increased effectiveness. This article describes the authors' experience as co-investigators in a randomized controlled trial involving patients with a life expectancy of less than five years receiving radiation therapy for advanced cancer. It also discusses the application to clinical settings and other research.

  13. Moxibustion for correction of breech presentation: a randomized controlled trial.

    PubMed

    Cardini, F; Weixin, H

    1998-11-11

    Traditional Chinese medicine uses moxibustion (burning herbs to stimulate acupuncture points) of acupoint BL 67 (Zhiyin, located beside the outer corner of the fifth toenail), to promote version of fetuses in breech presentation. Its effect may be through increasing fetal activity. However, no randomized controlled trial has evaluated the efficacy of this therapy. To evaluate the efficacy and safety of moxibustion on acupoint BL 67 to increase fetal activity and correct breech presentation. Randomized, controlled, open clinical trial. Outpatient departments of the Women's Hospital of Jiangxi Province, Nanchang, and Jiujiang Women's and Children's Hospital in the People's Republic of China. Primigravidas in the 33rd week of gestation with normal pregnancy and an ultrasound diagnosis of breech presentation. The 130 subjects randomized to the intervention group received stimulation of acupoint BL 67 by moxa (Japanese term for Artemisia vulgaris) rolls for 7 days, with treatment for an additional 7 days if the fetus persisted in the breech presentation. The 130 subjects randomized to the control group received routine care but no interventions for breech presentation. Subjects with persistent breech presentation after 2 weeks of treatment could undergo external cephalic version anytime between 35 weeks' gestation and delivery. Fetal movements counted by the mother during 1 hour each day for 1 week; number of cephalic presentations during the 35th week and at delivery. The intervention group experienced a mean of 48.45 fetal movements vs 35.35 in the control group (P<.001; 95% confidence interval [CI] for difference, 10.56-15.60). During the 35th week of gestation, 98 (75.4%) of 130 fetuses in the intervention group were cephalic vs 62 (47.7%) of 130 fetuses in the control group (P<.001; relative risk [RR], 1.58; 95% CI, 1.29-1.94). Despite the fact that 24 subjects in the control group and 1 subject in the intervention group underwent external cephalic version, 98 (75

  14. Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial.

    PubMed

    Raith, Wolfgang; Schmölzer, Georg M; Resch, Bernhard; Reiterer, Fritz; Avian, Alexander; Koestenberger, Martin; Urlesberger, Berndt

    2015-11-01

    Neonatal abstinence syndrome (NAS) is usually treated with opiate derivatives and supported with nonpharmacological treatment. This prospective, randomized, controlled, blinded, single-center study was carried out between March 2009 and November 2014. Newborn infants diagnosed with NAS after maternal opioid substitution therapy were eligible for inclusion. Infants were randomly allocated to the acupuncture group (combining laser acupuncture and pharmacological therapy of morphine and phenobarbital) or control group (pharmacological therapy alone). Laser acupuncture was performed with a LABpen MED 10 (675 nm/10 mW) at 5 ear and 4 body acupuncture points, bilaterally, and sessions were repeated every day. The primary outcome measure was duration of oral morphine therapy for NAS. Secondary outcomes included highest single Finnegan score, time to highest single Finnegan score, maximum amount of oral morphine solution (in milliliters per kilogram and milligrams per kilogram), time to maximum amount of oral morphine solution, and length of hospital stay. Twenty-eight newborns (14 in each group) were eligible for analysis. Duration of oral morphine therapy was significantly reduced in the acupuncture group compared with the control group (28 vs 39 days, respectively, P = .019). In addition, we observed a significantly reduced length of hospital stay in the acupuncture group compared with the control group (35 days [interquartile range 25 to 47] vs 50 days [36 to 66], P = .048). Adjunctive laser acupuncture significantly reduced the duration of morphine therapy in newborns with NAS. Copyright © 2015 by the American Academy of Pediatrics.

  15. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    PubMed

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    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. 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). 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. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  16. 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

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

    PubMed

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

    2001-10-01

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

  18. 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.

  19. 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…

  20. Random Access: The Latino Student Experience with Prior Learning Assessment

    ERIC Educational Resources Information Center

    Klein-Collins, Rebecca; Olson, Richard

    2014-01-01

    Many Latinos come to higher education as adults. One degree completion strategy that is particularly suited to adult students in higher education is prior learning assessment (PLA). PLA provides opportunities to evaluate a student's learning from work or life experience for the purpose of awarding college credit. For students whose…

  1. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    PubMed

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  2. Recovery after minor traffic injuries: a randomized controlled trial.

    PubMed

    Ottosson, Carin; Pettersson, Hans; Johansson, Sven-Erik; Nyrén, Olof; Ponzer, Sari

    2007-03-23

    To assess the efficacy of an acute multidisciplinary group intervention on self-perceived recovery following minor traffic-related musculoskeletal injuries. Open, randomized controlled trial. A large inner-city hospital. 127 patients (> or = 15 y) with traffic-related acute minor musculoskeletal injuries and predicted to be at risk for delayed recovery were randomized into an intervention group (n = 65) or a control group (n = 62). Four 1 1/2-h sessions in open groups with the aim of providing information about injuries in general, calling attention to the importance of self-care and promoting physical activity. In addition, both groups received standard medical care by regular staff. The main outcome measure was self-reported recovery at 12 mo. Secondary outcome measures were ratings of functional health status (SF-36, SMFA), pain and mental distress on visual analog scales, and self-reported duration of sick leave. At 12 mo, there was a 21.9 percentage point difference: 52.4% of the patients in the intervention group and 30.5% in the control group reported self-perceived recovery (95% confidence interval for the difference 5%-38%; p = 0.03). There were no statistically significant differences between the groups regarding the secondary outcome measures. A simple group intervention may accelerate the self-perceived recovery in selected patients. As we did not find evidence of improvements in the secondary outcome measures, the clinical significance of the treatment benefit remains to be defined.

  3. 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. © 2015 American Society for Nutrition.

  4. Current Update on the Randomized Controlled Trials of Intracranial Aneurysms

    PubMed Central

    2011-01-01

    Endovascular coiling has become the primary treatment modality for the treatment of intracranial ruptured aneurysms in many centers. A multicenter randomized controlled trial (RCT), ISAT study, has demonstrated that endovascular coiling of ruptured intracranial aneurysms has benefits over surgical clipping in those patients suitable for either treatment. Because RCT comparing conservative management with surgical clipping and with endovascular coiling have not been performed to date for unruptured intracranial aneurysms, the best management for unruptured aneurysm remains unclear. A RCT is ongoing to answer the question whether active treatment can improve the outcome of patients with unruptured intracranial aneurysms as compared with observation. PMID:22125740

  5. Assertive community treatment in the Netherlands: a randomized controlled trial.

    PubMed

    Sytema, S; Wunderink, L; Bloemers, W; Roorda, L; Wiersma, D

    2007-08-01

    Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for other European countries with modern mental health services. Open randomized controlled trial of long-term severely mentally ill patients [Health of the Nation Outcome Scales (HoNOS) total score >or=15], assigned to assertive community treatment (n = 59) or to standard community mental health care (n = 59). sustained contact; housing stability and admission days. This trial is registered as an International Standard Randomized Clinical Trial, number ISRCTN 11281756. Assertive community treatment was significantly better in sustaining contact with patients, but not in reducing admission days. No differences in housing stability, psychopathology, social functioning or quality of life were found. The results are in agreement with UK studies. However, the sustained contact potential of assertive community treatment is important, as too many patients are lost in standard care.

  6. Design of load-control experiments for the Athens Automation and Control Experiment

    SciTech Connect

    Johnston, T.; Newton, B.; Smith, B.A.; Chan, M.L.; Grimsrud, G.P.

    1986-06-01

    The research assessed the load control experiments' design, examined the adequacy of the AACE load data monitoring strategy, developed preliminary experiments and developed analysis plans for the load control experiments' results. The volt/var and system reconfiguration experiments of the AACE were not examined in this project. The results of the experimental design assessment include the finding that the addition of end-use load monitoring will greatly enhance the load control experiments' worth, especially if the Athens data are to be used by other utilities. These analysis results led to the addition of end-use load data collection equipment in Athens. The report presents a detailed statistical model for assessing the adequacy of load data collection strategies, to ensure statistical validity of the experimental results. The model was developed on this project and applied to Athens in order to develop the required load monitoring sample size for these experiments. Sample sizes were developed for specified levels of statistical confidence, accuracy and load data sampling rates. This model facilitates data transferability to other utilities, since it defines a number of important parameters that may be considered in transferring the Athens data to other utilities.

  7. 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…

  8. Evidence-based Narratives to Improve Recall of Opioid Prescribing Guidelines: A Randomized Experiment

    PubMed Central

    Kilaru, Austin S.; Perrone, Jeanmarie; Auriemma, Catherine L.; Shofer, Frances S.; Barg, Frances K.; Meisel, Zachary F.

    2014-01-01

    Objectives Physicians adopt evidence-based guidelines with variable consistency. Narratives, or stories, offer a novel dissemination strategy for clinical recommendations. The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians (ACEP). Methods This was a prospective, randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline. The experiment was modeled after the free-recall test, an established technique in studies of memory. At a regional conference, emergency physicians were randomized to read either a summary of the guideline (control) or a narrative (intervention). The fictional narrative was constructed to match the summary in content and length. One hour after reading the text, participants listed all content that they could recall. Two reviewers independently scored the responses to assess recall of the six themes. The primary outcome was the total number of themes recalled per participant. Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information. Results Ninety-five physicians were randomized. Eighty-two physicians completed the experiment, for a response rate of 86%. The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm (difference = 1.1, 95% confidence interval [CI] = 0.6 to 1.7). For three themes, the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm, with the differences ranging from 20% to 51%. For one theme, recall was significantly greater in the summary arm. For two themes, there was no statistically significant difference in

  9. Genetic Susceptibility Testing and Readiness to Control Weight: Results from a Randomized Controlled Trial

    PubMed Central

    Meisel, Susanne F; Beeken, Rebecca J; van Jaarsveld, Cornelia H M; Wardle, Jane

    2015-01-01

    Objective To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. Methods Individually randomized controlled trial comparing the effect of: (i) simple weight control advice plus FTO feedback (FA) and (ii) simple weight control advice only (AO) on readiness to engage with weight control. Differences in stage of change by genotype and differential weight control behaviors were secondary outcomes. Results Of 1,016 participants randomized, only 279 completed follow-up, yielding 90% power to detect a small effect for readiness to control weight. As predicted, FA participants were more likely to be in the contemplation stage than AO participants (P = 0.023). Participants receiving higher-risk genetic results were at a higher stage of change than controls (P = 0.003), with a trend toward a higher stage of change than those getting lower-risk results (P = 0.051). Lower-risk results did not decrease weight control intentions compared with controls (P = 0.55). There were no group differences in adherence to recommended weight control behaviors (P = 0.87). Conclusions Adding FTO feedback to weight control advice enhanced readiness to control weight, without evidence for genetic determinism, but had no more effect on behavior than weight control advice alone. PMID:25522302

  10. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial.

    PubMed

    Meisel, Susanne F; Beeken, Rebecca J; van Jaarsveld, Cornelia H M; Wardle, Jane

    2015-02-01

    To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. Individually randomized controlled trial comparing the effect of: (i) simple weight control advice plus FTO feedback (FA) and (ii) simple weight control advice only (AO) on readiness to engage with weight control. Differences in stage of change by genotype and differential weight control behaviors were secondary outcomes. Of 1,016 participants randomized, only 279 completed follow-up, yielding 90% power to detect a small effect for readiness to control weight. As predicted, FA participants were more likely to be in the contemplation stage than AO participants (P = 0.023). Participants receiving higher-risk genetic results were at a higher stage of change than controls (P = 0.003), with a trend toward a higher stage of change than those getting lower-risk results (P = 0.051). Lower-risk results did not decrease weight control intentions compared with controls (P = 0.55). There were no group differences in adherence to recommended weight control behaviors (P = 0.87). Adding FTO feedback to weight control advice enhanced readiness to control weight, without evidence for genetic determinism, but had no more effect on behavior than weight control advice alone. © 2014 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  11. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial.

    PubMed

    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

    2014-04-01

    This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 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 the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; 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 the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

  12. 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

  13. Population Survey Features and Response Rates: A Randomized Experiment.

    PubMed

    Guo, Yimeng; Kopec, Jacek A; Cibere, Jolanda; Li, Linda C; Goldsmith, Charles H

    2016-08-01

    To study the effects of several survey features on response rates in a general population health survey. In 2012 and 2013, 8000 households in British Columbia, Canada, were randomly allocated to 1 of 7 survey variants, each containing a different combination of survey features. Features compared included administration modes (paper vs online), prepaid incentive ($2 coin vs none), lottery incentive (instant vs end-of-study), questionnaire length (10 minutes vs 30 minutes), and sampling frame (InfoCanada vs Canada Post). The overall response rate across the 7 groups was 27.9% (range = 17.1-43.4). All survey features except the sampling frame were associated with statistically significant differences in response rates. The survey mode elicited the largest effect on the odds of response (odds ratio [OR] = 2.04; 95% confidence interval [CI] = 1.61, 2.59), whereas the sampling frame showed the least effect (OR = 1.14; 95% CI = 0.98, 1.34). The highest response was achieved by mailing a short paper survey with a prepaid incentive. In a mailed general population health survey in Canada, a 40% to 50% response rate can be expected. Questionnaire administration mode, survey length, and type of incentive affect response rates.

  14. Random fiber lasers based on artificially controlled backscattering fibers

    NASA Astrophysics Data System (ADS)

    Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

    2017-10-01

    The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

  15. Family presence during brain death evaluation: a randomized controlled trial*.

    PubMed

    Tawil, Isaac; Brown, Lawrence H; Comfort, David; Crandall, Cameron S; West, Sonlee D; Rollstin, Amber D; Dettmer, Todd S; Malkoff, Marc D; Marinaro, Jonathan

    2014-04-01

    To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress. Randomized controlled trial. Four ICUs at an academic tertiary care center. Immediate family members of patients suspected to have suffered brain death. Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone. All randomized subjects were administered a validated "understanding brain death" survey before and after the intervention. Subjects were assessed for psychological well-being between 30 and 90 days after the intervention. Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire. Brain death understanding, Impact of Event Scale, and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests. Analyses were adjusted for within family correlation. Fifty-eight family members of 17 patients undergoing brain death evaluation were enrolled: 38 family members were present for 11 brain death evaluations and 20 family members were absent for six brain death evaluations. Baseline understanding scores were similar between groups (median 3.0 [presence group] vs 2.5 [control], p = 0.482). Scores increased by a median of 2 (interquartile range, 1-2) if present versus 0 (interquartile range, 0-0) if absent (p < 0.001). Sixty-six percent of those in the intervention group achieved perfect postintervention "understanding" scores, compared with 20% of subjects who were not present (p = 0.02). Median Impact of Event Scale and General Health Questionnaire scores were similar between groups at follow-up (Impact of Event Scale: present = 20.5, absent = 23.5, p = 0.211; General Health Questionnaire: present = 13.5, absent = 13.0, p = 0.250). Family presence during brain death evaluation improves understanding of brain death with no apparent adverse

  16. Neuromuscular Exercise post Partial Medial Meniscectomy: Randomized Controlled Trial.

    PubMed

    Hall, Michelle; Hinman, Rana S; Wrigley, Tim V; Roos, Ewa M; Hodges, Paul W; Staples, Margaret P; Bennell, Kim L

    2015-08-01

    This study aimed to evaluate the effects of a 12-wk, home-based, physiotherapist-guided neuromuscular exercise program on the knee adduction moment (an indicator of mediolateral knee load distribution) in people with a medial arthroscopic partial meniscectomy (APM) within the past 3-12 months. An assessor-blinded, randomized controlled trial including people age 30-50 yr with no to mild pain after medial APM was conducted. Participants were randomly allocated to either a 12-wk neuromuscular exercise program that targeted neutral lower limb alignment or a control group with no exercise. The exercise program included eight individual sessions with one of seven physiotherapists in private clinics, together with home exercises. Primary outcomes were the peak external knee adduction moment during normal-paced walking and during one-leg sit-to-stand. Secondary outcomes included additional measures of knee joint load distribution, patient-reported outcomes, maximal knee and hip muscle strength, and physical function measures. Of 62 randomized participants, 60 (97%) completed the trial. There were no significant between-group differences in the change in peak knee adduction moment during normal-paced walking (mean difference (95% confidence interval), 0.22 (-0.11 to 0.55) N·m/body weight × height %, P =0.19) or during one-leg sit-to-stand (-0.01 (-0.33 to 0.31) N·m/body weight × height %, P = 0.95). There were also no significant between-group differences for any of the secondary outcomes. In patients 3-12 months after a medial APM, a neuromuscular exercise program did not alter the peak knee adduction moment, a key predictor of osteoarthritis structural disease progression. (Australia and New Zealand Clinical Trials Registry, #ACTRN12612000542897.).

  17. 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.

  18. Random fiber laser based on artificially controlled backscattering fibers.

    PubMed

    Wang, Xiaoliang; Chen, Daru; Li, Haitao; She, Lijuan; Wu, Qiong

    2018-01-10

    The random fiber laser (RFL), which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previously reported RFLs are based on distributed feedback of Rayleigh scattering amplified through the stimulated Raman-Brillouin scattering effect in single-mode fibers, which require long-distance (tens of kilometers) single-mode fibers and high threshold, up to watt level, due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open-cavity RFL based on a segment of an artificially controlled backscattering single-mode fiber with a length of 210 m, 310 m, or 390 m. A fiber Bragg grating with a central wavelength of 1530 nm and a segment of artificially controlled backscattering single-mode fiber fabricated by using a femtosecond laser form the half-open cavity. The proposed RFL achieves thresholds of 25 mW, 30 mW, and 30 mW, respectively. Random lasing at a wavelength of 1530 nm and extinction ratio of 50 dB is achieved when a segment of 5 m erbium-doped fiber is pumped by a 980 nm laser diode in the RFL. A novel RFL with many short cavities has been achieved with low threshold.

  19. Testing Tele-Savvy: Protocol for a randomized controlled trial.

    PubMed

    Kovaleva, Mariya A; Bilsborough, Elizabeth; Griffiths, Patricia C; Nocera, Joe; Higgins, Melinda; Epps, Fayron; Kilgore, Katie; Lindauer, Allison; Morhardt, Darby; Shah, Raj C; Hepburn, Kenneth

    2018-02-05

    Many informal caregivers of persons with dementia suffer adverse health consequences. Although established psychoeducation programs are known to benefit caregivers, attending in-person programs is challenging for them. To address this challenge, the Savvy Caregiver Program, an evidence-based psychoeducation program with demonstrated effectiveness for caregiving and disease-related outcomes, was transformed into an on-line program, Tele-Savvy. This article describes the rationale for and design of a prospective longitudinal randomized controlled trial (targeted N = 215), currently underway. The trial aims to establish Tele-Savvy's efficacy in (i) reducing the negative effects of caregiving on caregivers; (ii) promoting care recipients' quality of life; (iii) improving caregiver mastery; and to explore (iv) Tele-Savvy's efficacy among caregivers of different races/ethnicities. The mediating role of mastery will be assessed. Participants are randomized to the active condition (immediate Tele-Savvy participation), attention control, or usual care. Participants in the two latter conditions will complete Tele-Savvy 6 months post-baseline. Multilevel mixed effects models will be used to examine changes in outcomes and to model group by time (months since baseline) interactions. The exploratory aim will be addressed using analysis of covariance and qualitative analysis. This trial's results may be used by healthcare and community organizations to implement Tele-Savvy in dementia care, increasing caregivers' access to this evidence-based intervention. © 2018 Wiley Periodicals, Inc.

  20. Effect of vitamin C on common cold: randomized controlled trial.

    PubMed

    Sasazuki, S; Sasaki, S; Tsubono, Y; Okubo, S; Hayashi, M; Tsugane, S

    2006-01-01

    To investigate the relationship between the common cold and vitamin C supplementation. A double-blind, 5-year randomized controlled trial. A village in Akita prefecture, one of the regions in Japan with the highest mortality from gastric cancer. Participants in annual screening programs for circulatory diseases conducted under the National Health and Welfare Services Law for the Aged, and diagnosed as having atrophic gastritis. Of the 439 eligible subjects, 144 and 161 were assigned to receive 50 or 500 mg of vitamin C, respectively, after protocol amendment. During the supplementation phase, 61 dropped out, and 244 completed the trial. Daily vitamin C supplementation of 50 mg (low-dose group) or 500 mg (high-dose group). Total number of common colds (per 1000 person-months) was 21.3 and 17.1 for the low- and high-dose groups, respectively. After adjustment for several factors, the relative risks (95% confidence interval (CI)) of suffering from a common cold three or more times during the survey period was 0.34 (0.12-0.97) for the high-dose group. No apparent reduction was seen for the severity and duration of the common cold. A randomized, controlled 5-year trial suggests that vitamin C supplementation significantly reduces the frequency of the common cold but had no apparent effect on the duration or severity of the common cold. However, considering several limitations due to protocol amendment, the findings should be interpreted with caution.

  1. Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

    PubMed

    Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

    2018-01-22

    Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p < .001, partial η 2  = 0.18) and in associated symptomatology, which persisted through 6 months of follow-up. There were no significant differences regarding symptom reduction between the treatment groups. Women benefited more compared to men irrespective of treatment group. Men showed the most pronounced changes under MAP. In the current study, MAP was not superior to PE regarding symptom reduction in adult ADHD. Both interventions, mindfulness meditation and PE, were efficacious in reducing symptom load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

  2. Microparticle driven by parametric and random forces: Theory and experiment

    NASA Astrophysics Data System (ADS)

    Izmailov, Alexander F.; Arnold, Stephen; Holler, Stephen; Myerson, Allan S.

    1995-08-01

    The confined motion of a charged microparticle within the Paul Trap (also known as the electrodynamic levitator trap) in an atmosphere near the standard temperature T and pressure Patm is studied both theoretically and experimentally. The suggested theoretical model is based on the Mathieu differential equation with damping term and stochastic source. This equation describes the damped microparticle motion subjected to the combined periodic parametric and random external excitations. To solve the equation in an experimentally investigated regime of extremely strong damping and periodic excitations, the singular perturbation theory (WKB theory) is applied. In order to compare experimental data obtained in the long-time imaging limit with an analytical solution obtained for the autocorrelation function, the last is averaged by employing the Bogoliubov general averaging principle. This comparison is performed in terms of the standard deviation of the microparticle confined stochastic motion. It results almost in the perfect agreement between the analytical result and the data obtained experimentally in an entire region of the investigated experimental parameters. The only theoretical restrictions imposed on the model parameters are 1/α<<1 and 4β/α2<<1 (where α and β are the dimensionless drag and drive parameters). It is discovered both experimentally and theoretically that there is a minimum equal to [8kT/(mω2)]1/2 in the standard deviation of the microparticle confined stochastic motion (m is the microparticle mass and ω is the drive force frequency). The presence of this minimum, which takes place at β~=1.518α, reduces the thermal noise effects, providing unique opportunities for the spectroscopic studies. Comparison with the numerical simulation schemes developed in papers [Arnold, Folan, and Korn, J. Appl. Phys. 74, 4291 (1993); Blatt et al., Z. Phys. D 4, 121 (1986); Zerbe, Jung, and Hanggi, Phys. Rev. E 49, 3626 (1994)] is discussed.

  3. Randomized controlled trial of computerized tailored physical activity reports

    PubMed Central

    Carroll, Jennifer K.; Lewis, Beth A.; Marcus, Bess H.; Lehman, Erik B.; Shaffer, Michele L.; Sciamanna, Christopher N.

    2010-01-01

    Background Computerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. To examine the effect of computerized tailored physical activity reports on primary care patients' physical activity at six months. Design Two-group randomized clinical trial with primary care physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment. Setting/Participants Primary care physicians (n=22) and their adult patients (n=394) from Philadelphia, PA. The study and analyses were conducted from 2004-2010. Intervention The intervention group completed physical activity surveys at baseline, one, three, and six months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to the participant's needs; they also included an activity prescription. The control group received identical procedures except they received general reports on preventive screening based on their responses to preventive screening questions. Main outcome measure Minutes of physical activity measured by the 7-Day Physical Activity Recall interview at six months. Results Participants were 69% female, 59% African American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, the intervention group increased their total minutes of physical activity by a mean of 133 minutes, while the control group had a mean increase of 99 minutes (p=0.39). Conclusions Although we saw an increase in physical activity within both groups, computerized tailored physical activity reports did not significantly increase physical activity levels beyond control among ethnically and socioeconomically diverse adults in primary care. PMID:20621262

  4. Cultural participation and health: a randomized controlled trial among medical care staff.

    PubMed

    Bygren, Lars Olov; Weissglas, Gösta; Wikström, Britt-Maj; Konlaan, Boinkum Benson; Grjibovski, Andrej; Karlsson, Ann-Brith; Andersson, Sven-Olof; Sjöström, Michael

    2009-05-01

    Population studies demonstrate that attending cultural events is conducive to improved health when baseline health, income, education, and health habits are taken into account. Animal experiments suggest possible mechanisms. We studied the link in humans between attending cultural events and health in a randomized controlled trial. Members of the local government officers' union in the health services in Umeå, Sweden, were invited to the experiment and 101 people registered for fine arts visits once a week for 8 weeks. They chose films, concerts, or art exhibitions visits, or singing in a choir and were then randomized into 51 cases, starting at once, and 50 controls starting after the trial. Health was assessed before randomization and after the experimental period using the instrument for perceived health, short form (SF)-36, and tests of episodic memory, saliva-cortisol and immunoglobulin. The results were analyzed using a mixed design analysis of variance. The SF-36 Composite Score called physical health improved in the intervention group and decreased among controls during the experiment (F(1,87) = 7.06, p = .009). The individual factor of the SF-36 called social functioning, improved more in the intervention group than among controls (F(1,98) = 8.11, p = .005) as well as the factor vitality (F(1,98) = 5.26, p = .024). The six other factors and the Mental Health Composite Score, episodic memory, cortisol and immunoglobulin levels did not change otherwise than among controls. Mechanisms are left to be identified. Fine arts stimulations improved perceived physical health, social functioning, and vitality.

  5. Improving preschoolers' mathematics achievement with tablets: a randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Schacter, John; Jo, Booil

    2017-09-01

    With a randomized field experiment of 433 preschoolers, we tested a tablet mathematics program designed to increase young children's mathematics learning. Intervention students played Math Shelf, a comprehensive iPad preschool and year 1 mathematics app, while comparison children received research-based hands-on mathematics instruction delivered by their classroom teachers. After 22 weeks, there was a large and statistically significant effect on mathematics achievement for Math Shelf students (Cohen's d = .94). Moderator analyses demonstrated an even larger effect for low achieving children (Cohen's d = 1.27). These results suggest that early education teachers can improve their students' mathematics outcomes by integrating experimentally proven tablet software into their daily routines.

  6. 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

  7. Encouraging Health Insurance for the Informal Sector: A Cluster Randomized Experiment in Vietnam.

    PubMed

    Wagstaff, Adam; Nguyen, Ha Thi Hong; Dao, Huyen; Bales, Sarah

    2016-06-01

    Subsidized voluntary enrollment in government-run health insurance schemes is often proposed as a way of increasing coverage among informal sector workers and their families. We report the results of a cluster randomized experiment, in which 3000 households in 20 communes in Vietnam were randomly assigned at baseline to a control group or one of three treatments: an information leaflet about Vietnam's government-run scheme and the benefits of health insurance, a voucher entitling eligible household members to 25% off their annual premium, and both. At baseline, the four groups had similar enrollment rates (4%) and were balanced on plausible enrollment determinants. The interventions all had small and insignificant effects (around 1 percentage point or ppt). Among those reporting sickness in the 12 months prior to the baseline survey the subsidy-only intervention raised enrollment by 3.5 ppts (p = 0.08) while the combined intervention raised enrollment by 4.5 ppts (p = 0.02); however, the differences in the effect sizes between the sick and non-sick were just shy of being significant. Our results suggest that information campaigns and subsidies may have limited effects on voluntary health insurance enrollment in Vietnam and that such interventions might exacerbate adverse selection. Copyright © The World Bank Health Economics © 2015 John Wiley & Sons, Ltd. Copyright © The World Bank Health Economics © 2015 John Wiley & Sons, Ltd.

  8. 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…

  9. 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…

  10. Computerized tailored physical activity reports. A randomized controlled trial.

    PubMed

    Carroll, Jennifer K; Lewis, Beth A; Marcus, Bess H; Lehman, Erik B; Shaffer, Michele L; Sciamanna, Christopher N

    2010-08-01

    Computerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. This study examined the effect of computerized tailored physical activity reports on primary care patients' physical activity at 6 months. Two-group randomized clinical trial with physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment. Primary care physicians (n=22) and their adult patients (n=394) from Philadelphia PA. The study and analyses were conducted from 2004 to 2010. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. Minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. Participants were 69% female, 59% African-American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, there were no differences in physical activity at 6 months. The intervention group increased their total physical activity by a mean of 139 minutes; the control group had a mean increase of 109 minutes (p=0.45). Although physical activity increased within both groups, computerized tailored physical activity reports did not significantly increase physical activity between groups at 6 months among ethnically and socioeconomically diverse adults in primary care. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  11. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    PubMed

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  12. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    PubMed

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p < .01). Furthermore, the experimental group achieved a larger reduction in body mass index than the control group at 3 months after completing the intervention (p = .001). The empowerment program was

  13. 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

  14. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

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

  15. Preconception maternal nutrition: a multi-site randomized controlled trial.

    PubMed

    Hambidge, K Michael; Krebs, Nancy F; Westcott, Jamie E; Garces, Ana; Goudar, Shivaprasad S; Kodkany, Balachandra S; Pasha, Omrana; Tshefu, Antoinette; Bose, Carl L; Figueroa, Lester; Goldenberg, Robert L; Derman, Richard J; Friedman, Jacob E; Frank, Daniel N; McClure, Elizabeth M; Stolka, Kristen; Das, Abhik; Koso-Thomas, Marion; Sundberg, Shelly

    2014-03-20

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

  16. Implant and prosthesis movement after enucleation: a randomized controlled trial.

    PubMed

    Shome, Debraj; Honavar, Santosh G; Raizada, Kuldeep; Raizada, Deepa

    2010-08-01

    To evaluate implant and prosthesis movement after myoconjunctival enucleation and subsequent polymethyl methacrylate (PMMA) implantation, compared with the traditional enucleation with muscle imbrication using a PMMA implant and with enucleation accompanied by porous polyethylene implantation. Randomized, controlled, observer-masked, interventional study. One hundred fifty patients, equally and randomly allocated to the 3 groups. Group 1 consisted of patients in whom a PMMA implant was used after enucleation with muscle imbrication (traditional PMMA group). Group 2 consisted of patients in whom a PMMA implant was used after enucleation with a myoconjunctival technique (myoconjunctival PMMA group). Group 3 consisted of patients in whom a porous polyethylene implant was used after enucleation by the scleral cap technique (porous polyethylene group). Fifty patients were included in each group. Patients were allocated to 1 of the 3 groups using stratified randomization. Informed consent was obtained. Acrylic prostheses custom made by a trained ocularist were fitted 6 weeks after surgery in all patients. A masked observer measured implant and prosthesis movement 6 weeks after surgery using a slit-lamp device with real-time video and still photographic documentation. Analysis of implant and prosthesis movement was carried out using the Mann-Whitney U test, and a P value of < or =0.03 was considered significant. Complications including implant displacement and exposure also were noted. Implant and prosthesis movement. Myoconjunctival PMMA implant movement was better than the traditional PMMA implant (P = 0.001), but was similar to that of the porous polyethylene implant. Prosthesis movement with the myoconjunctival PMMA implant was better than that of either the traditional PMMA (P = 0.001) or porous polyethylene (P = 0.002) implants. Myoconjunctival enucleation technique with a PMMA implant provides statistically and clinically significantly better implant and prosthesis

  17. Retrospective Consent in a Neonatal Randomized Controlled Trial.

    PubMed

    Songstad, Nils T; Roberts, Calum T; Manley, Brett J; Owen, Louise S; Davis, Peter G

    2018-01-01

    The requirement for prospective consent in clinical trials in acute settings may result in samples unrepresentative of the study population, potentially altering study findings. However, using retrospective consent may raise ethical issues. We assessed whether using retrospective consent affected recruitment, participant characteristics, and outcomes within a randomized controlled trial. We conducted a secondary analysis of a randomized trial, which compared nasal high flow (nHF) with nasal continuous positive airway pressure (CPAP) for primary respiratory support in preterm infants. In Era 1, all infants were consented prospectively; in Era 2, retrospective consent was available. We assessed inclusion rates of eligible infants, demographic data, and primary trial outcome (treatment failure within 72 hours). In Era 1, recruitment of eligible infants was lower than in Era 2: 111 of 220 (50%) versus 171 of 209 (82%), P < .001; intrapartum antibiotic administration was lower: 23 of 111 (21%) versus 84 of 165 (51%), P < .001; full courses of antenatal steroids were higher: 86 of 111 (78%) versus 103 of 170 (61%), P = .004; and more infants received pre-randomization CPAP: 77 of 111 (69%) versus 48 of 171 (28%), P < .001. In Era 1, nHF failure (15 of 56, 27%) and CPAP failure (14 of 55, 26%) rates were similar, P = .9. In Era 2, failure rates differed: 24 of 85 (28%) nHF infants versus 13 of 86 (15%) CPAP infants, P = .04. The χ2 interaction test was nonsignificant (P = .20). The use of retrospective consent resulted in greater recruitment and differences in risk factors between eras. Using retrospective consent altered the study sample, which may be more representative of the whole population. This may improve scientific validity but requires further ethical evaluation. Copyright © 2018 by the American Academy of Pediatrics.

  18. The Bonn Criteria: Minimal Experimental Parameter Reporting for Clinostat and Random Positioning Machine Experiments with Cells and Tissues

    NASA Astrophysics Data System (ADS)

    Hammond, Timothy; Allen, Patricia

    2011-02-01

    Published reports on studies in clinostats and random positioning machines frequently do not include adequate operational data on physical parameters of the culture device or cell culture conditions. This failure to report minimum physical and chemical data on how experiments are performed makes it impossible to determine specific hardware utilization or to calculate forces delivered. This makes experimental comparisons difficult and isolation of critical methodological differences between investigational results impossible. A minimum set of parameters to be reported in clinostat or random positioning machines is proposed to be known as the Bonn criteria. For random positioning machine experiments, the minimum experimental parameters to be reported should include angular velocity of rotation, highest angular acceleration, operating mode (random, centrifuge, or clinostat in rpm or freely programmable mode). For both clinostat and random positioning machines, experimental reporting should include the properties of the culture vessel, culture media and carrier beads. These should also include dimensions and rotation speed of vessel, chemical consistency including density and viscosity of media, size, density, and porosity of beads, size, density, and porosity of cells, whether cells are motile or non-motile, density of beads with cells attached, as well as time of rotation, nature of controls, operating temperature, and gas content.

  19. 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

  20. Reiki for the Treatment of Fibromyalgia: A Randomized Controlled Trial

    PubMed Central

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack

    2008-01-01

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

  1. Dry cupping for plantar fasciitis: a randomized controlled trial.

    PubMed

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  2. Dry cupping for plantar fasciitis: a randomized controlled trial

    PubMed Central

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested. PMID:28603360

  3. Control of false positives in randomized phase III clinical trials.

    PubMed

    Shen, Changyu; Liu, Ziyue; Xu, Huiping; Liu, Hai; Yue, Cynthia

    2016-08-12

    Randomized Phase III clinical trials serve as the gold-standard for the evaluation of the efficacy of a medical intervention. Although research and development in earlier stages together with rigorous statistical examination assure a small probability of false positive for a given trial, it is unclear how many false positives were generated from the large number of randomized Phase III trials from the biopharmaceutical industry in the United States. The proportion of comparisons in Phase III trials where the medical intervention has null or negative efficacy, or proportion of null or negative (PNN), is at the central position for the estimation and control of the number of false positives. We seek to estimate PNN using a new Bayesian deconvolution method. Using data from clinicaltrials.gov and other data sources, we identified 1393 trials completed in 2008-2012 that meet our study entry criteria, which are dominated by trials on drugs for treatment purpose. Among the 1221 trials with results available on the selected comparisons, 789 (64.6%) show statistically significant superiority of the intervention, with 561 (45.9%) having a two-sided p-value less than 0.001. The PNN is estimated to be no more than 7-9%. Based on the PNN, we estimated that 18-22% of the trials have at least one comparison with null or negative efficacy, leading to an expectation of no more than 6-8 trials with at least one false positive comparison over a 5-year period.

  4. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    PubMed

    Sawada, Hideyuki; Oeda, Tomoko; Kuno, Sadako; Nomoto, Masahiro; Yamamoto, Kenji; Yamamoto, Mitsutoshi; Hisanaga, Kinya; Kawamura, Takashi

    2010-12-31

    Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day) or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS) during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias), part IVb (motor fluctuations), and part III (motor function). RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores. Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. UMIN Clinical Trial Registry UMIN000000780.

  5. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    PubMed

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  6. Levocarnitine Decreases Intradialytic Hypotension Episodes: A Randomized Controlled Trial.

    PubMed

    Ibarra-Sifuentes, Héctor Raúl; Del Cueto-Aguilera, Ángel; Gallegos-Arguijo, Daniel Alberto; Castillo-Torres, Sergio Andres; Vera-Pineda, Raymundo; Martínez-Granados, Rolando Jacob; Atilano-Díaz, Alexandro; Cuellar-Monterrubio, Jesus Eduardo; Pezina-Cantú, Cesar Octaviano; Martínez-Guevara, Edgar de Jesús; Ortiz-Treviño, Juan Francisco; Delgado-García, Guillermo Rubén; Martínez-Jiménez, José Guadalupe; Cruz-Valdez, Jesús; Sánchez-Martínez, Concepción

    2017-10-01

    Intradialytic hypotension is common complication in stage 5 chronic kidney disease patients on hemodialysis. Incidence ranges from 15 to 30%. These patients have levocarnitine deficiency. A randomized, placebo-controlled quadruple-blinded trial was designed to demonstrate the levocarnitine efficiency on intradialytic hypotension prevention. Patients were randomized into four groups, to receive levocarnitine or placebo. During the intervention period, levocarnitine and placebo was administered 0 and 30 min before each hemodialysis session, respectively. During the trial, 33 patients received 1188 hemodialysis sessions. We identified 239 (21.3%) intradialytic hypotension episodes. The intradialytic hypotension episodes were less frequent in the levocarnitine group (9.3%, 60 IH events) (P < 0.001). Hemodialysis is frequently perplexed by intradialytic hypotension episodes. Levocarnitine supplementation before each hemodialysis session efficiently diminishes the intradialytic hypotension episodes. This is a new application method that must be considered and explored. © 2017 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy.

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

    PubMed

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

    2008-11-01

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

  8. Cognitive training in Alzheimer's disease: a controlled randomized study.

    PubMed

    Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

    2017-08-01

    This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

  9. Minimal stimulation IVF vs conventional IVF: a randomized controlled trial.

    PubMed

    Zhang, John J; Merhi, Zaher; Yang, Mingxue; Bodri, Daniel; Chavez-Badiola, Alejandro; Repping, Sjoerd; van Wely, Madelon

    2016-01-01

    Minimal stimulation in vitro fertilization (mini-in vitro fertilization) is an alternative in vitro fertilization treatment protocol that may reduce ovarian hyperstimulation syndrome, multiple pregnancy rates, and cost while retaining high live birth rates. We performed a randomized noninferiority controlled trial with a prespecified border of 10% that compared 1 cycle of mini-in vitro fertilization with single embryo transfer with 1 cycle of conventional in vitro fertilization with double embryo transfer. Five hundred sixty-four infertile women (<39 years old) who were undergoing their first in vitro fertilization cycle were allocated randomly to either mini-in vitro fertilization or conventional in vitro fertilization. The primary outcome was cumulative live birth rate per woman over a 6-month period. Secondary outcomes included ovarian hyperstimulation syndrome, multiple pregnancy rates, and gonadotropin use. The primary outcome was cumulative live birth per randomized woman within a time horizon of 6 months. Five hundred sixty-four couples were assigned randomly between February 2009 and August 2013 with 285 couples allocated to mini-in vitro fertilization and 279 couples allocated to conventional in vitro fertilization. The cumulative live birth rate was 49% (140/285) for mini-in vitro fertilization and 63% (176/279) for conventional in vitro fertilization (relative risk, 0.76; 95% confidence interval, 0.64-0.89). There were no cases of ovarian hyperstimulation syndrome after mini-in vitro fertilization compared with 16 moderate/severe ovarian hyperstimulation syndrome cases (5.7%) after conventional in vitro fertilization. The multiple pregnancy rates were 6.4% in mini-in vitro fertilization compared with 32% in conventional in vitro fertilization (relative risk, 0.25; 95% confidence interval, 0.14-0.46). Gonadotropin consumption was significantly lower with mini-in vitro fertilization compared with conventional in vitro fertilization (459

  10. Hypnosis versus diazepam for embryo transfer: a randomized controlled study.

    PubMed

    Catoire, Patrick; Delaunay, Laurent; Dannappel, Thomas; Baracchini, Dominique; Marcadet-Fredet, Sabine; Moreau, Olivier; Pacaud, Luc; Przyrowski, Daniel; Marret, Emmanuel

    2013-04-01

    Levitas et al. (2006) showed in a cohort study that hypnosis during embryo transfer (ET) increased pregnancy ratio by 76%. In order to evaluate hypnosis during ET in a general population, the authors performed a randomized prospective controlled study comparing diazepam (usual premedication) administered before ET plus muscle relaxation versus hypnosis plus placebo in 94 patients. Additionally, the authors studied anxiety pre and post ET. Anxiety scores were not different in the two groups before and after ET. No difference in pregnancy and birth ratio was found in the two groups. Hypnosis during ET is as effective as diazepam in terms of pregnancy ratio and anxiolytic effects, but with fewer side effects and should be routinely available.

  11. Randomized, controlled trial of compression gloves in rheumatoid arthritis.

    PubMed

    McKnight, P T; Kwoh, C K

    1992-12-01

    A randomized, controlled trial was conducted to determine efficacy of the Isotoner and the Futuro compression gloves in 39 patients with hand synovitis secondary to rheumatoid arthritis. After 7 days of nighttime treatment, both brands of gloves were found to decrease subjective symptoms of pain and stiffness (p < 0.05). In addition, swelling of the proximal interphalangeal joints decreased, while range of motion, rate of finger motion, and grip strength all increased (p < 0.05). Compression gloves should be used with caution in patients with bilateral carpal tunnel syndrome, because 12 of 13 such patients experienced worsening of their symptoms following one nighttime wearing of compression gloves. While both gloves were found to be efficacious in improving the signs and symptoms of hand synovitis, neither glove was found to be superior to the other. Patient preferences related to glove composition and fit may ultimately determine which glove to prescribe.

  12. A randomized controlled trial of paroxetine for noncardiac chest pain.

    PubMed

    Doraiswamy, P Murali; Varia, Indira; Hellegers, Caroline; Wagner, H Ryan; Clary, Greg L; Beyer, John L; Newby, L Kristin; O'Connor, John F; Beebe, Katherine L; O'Connor, Christopher; Krishnan, K Ranga

    2006-01-01

    Noncardiac chest pain occurs frequently in medical practice and is often difficult to treat. We conducted a randomized double-blind, placebo-controlled, 8-week trial of paroxetine in 50 patients with noncardiac chest pain. None of the patients met criteria for panic disorder or major depression. Paroxetine-treated patients showed greater (P < .05) improvements than placebo-treated patients on the Clinical Global Impressions (CGI) scale. Both paroxetine and placebo-treated patients improved to a similar extent on selfrated pain measures, although baseline differences limited the interpretation of this outcome variable. There were no differences on other outcome ratings. Treatment was well tolerated. These preliminary findings extend other data on the potential of selective serotonin reuptake inhibitors for the acute treatment of noncardiac chest pain. Some recommendations for future studies to definitively test this potential are presented.

  13. [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.

  14. Qigong and fibromyalgia: randomized controlled trials and beyond.

    PubMed

    Sawynok, Jana; Lynch, Mary

    2014-01-01

    Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6-8 weeks) produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function) that are maintained at 4-6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6-12 months) indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  15. 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.

  16. Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

    PubMed

    Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

    2017-06-01

    Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

  17. [Randomized controlled study on acupuncture treatment for chronic fatigue syndrome].

    PubMed

    Chen, Xing-Hua; Li, Lu-Qian; Zhang, Wen; Yang, Juan; Dai, Yi-Shuang; Xu, Dong-Hua; Tang, Chun-Zhi

    2010-07-01

    To observe the therapeutic effect of acpuncture treatment for chronic fatigue syndrome (CFS). Nighty cases of CFS were randomly divided into an observation group and a control group, 45 cases in each group. The observation group was treated with acupunture at Renying (ST 9), Fengfu (GV 16), Baihui (GV 20); the control group was treated with 250 mL 5% Glucose injectio combined with 20 mL Shenmai injectio. Fatigue Scale (FS) was used to compare the scores between the two groups after treatment. The total scores in the observation group were 9.37 +/- 2.33 and 5.41 +/- 1.96 before and after treatment respectively, and in the control group, they were 9.08 +/- 2.27 and 7.34 +/- 2.03 respectively. FS brainwork integral, physical fatigue integral, and total integral all decreased after treatment in two groups (all P < 0.001), and it decreased much more obviously in the observation group (P < 0.05, P < 0.01). Both of the acpuncture treatment and Shenmai injectio are able to decrease fatigue scale score, improve the fatigue symptoms of CFS patients, and the effect of acupucture treatment is obviously superior to that of Shenmai injectio.

  18. Control capacity and a random sampling method in exploring controllability of complex networks.

    PubMed

    Jia, Tao; Barabási, Albert-László

    2013-01-01

    Controlling complex systems is a fundamental challenge of network science. Recent advances indicate that control over the system can be achieved through a minimum driver node set (MDS). The existence of multiple MDS's suggests that nodes do not participate in control equally, prompting us to quantify their participations. Here we introduce control capacity quantifying the likelihood that a node is a driver node. To efficiently measure this quantity, we develop a random sampling algorithm. This algorithm not only provides a statistical estimate of the control capacity, but also bridges the gap between multiple microscopic control configurations and macroscopic properties of the network under control. We demonstrate that the possibility of being a driver node decreases with a node's in-degree and is independent of its out-degree. Given the inherent multiplicity of MDS's, our findings offer tools to explore control in various complex systems.

  19. Control Capacity and A Random Sampling Method in Exploring Controllability of Complex Networks

    PubMed Central

    Jia, Tao; Barabási, Albert-László

    2013-01-01

    Controlling complex systems is a fundamental challenge of network science. Recent advances indicate that control over the system can be achieved through a minimum driver node set (MDS). The existence of multiple MDS's suggests that nodes do not participate in control equally, prompting us to quantify their participations. Here we introduce control capacity quantifying the likelihood that a node is a driver node. To efficiently measure this quantity, we develop a random sampling algorithm. This algorithm not only provides a statistical estimate of the control capacity, but also bridges the gap between multiple microscopic control configurations and macroscopic properties of the network under control. We demonstrate that the possibility of being a driver node decreases with a node's in-degree and is independent of its out-degree. Given the inherent multiplicity of MDS's, our findings offer tools to explore control in various complex systems. PMID:23912679

  20. Dronabinol in severe, enduring anorexia nervosa: a randomized controlled trial.

    PubMed

    Andries, Alin; Frystyk, Jan; Flyvbjerg, Allan; Støving, René Klinkby

    2014-01-01

    The evidence for pharmacological treatment of severe, longstanding anorexia nervosa (AN) is sparse and the few controlled pharmacologic studies have focused on a narrow range of drugs. The aim of the present study was to investigate the effects of treatment with a synthetic cannabinoid agonist on body weight and eating disorder-related psychopathological personality traits in women with severe, enduring AN. This add-on, prospective, randomized, double blind, controlled crossover study was conducted between 2008 and 2011 at a specialized care center for eating disorders. Twenty-five women over 18 years with AN of at least 5 years duration were randomized to treatment with either dronabinol-placebo or placebo-dronabinol. In addition to the standardized baseline therapeutic regime, the participants received dronabinol, 2.5 mg twice daily for 4 weeks and matching placebo for 4 weeks, separated by a 4-week wash-out period. Primary outcome was the mean change in body weight. Secondary outcome was score changes on the Eating Disorder Inventory-2 (EDI-2). Data were analyzed for the 24 patients who completed the trial. During dronabinol treatment, participants gained 0.73 kg (t = 2.86, df = 22, p < 0.01) above placebo without significant psychotropic adverse events. Dronabinol significantly predicted weight gain in a multiple linear regression including EDI-2 body dissatisfaction score and leptin. EDI-2 subscale scores showed no significant changes over time. Dronabinol therapy was well tolerated. During four weeks of exposure it induced a small but significant weight gain in the absence of severe adverse events. Copyright © 2013 Wiley Periodicals, Inc.

  1. Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial.

    PubMed

    Laborie, Sophie; Denis, Angélique; Dassieu, Gilles; Bedu, Antoine; Tourneux, Pierre; Pinquier, Didier; Kermorvant, Elsa; Millet, Véronique; Klosowski, Serge; Patural, Hugues; Clamadieu, Catherine; Brunhes, Anne; Walther, Marie; Jaisson-Hot, Isabelle; Mandy, Bruno; Claris, Olivier

    2015-08-01

    Oxidant stress is implicated in the pathogenesis of bronchopulmonary dysplasia (BPD). Light induces peroxide generation in parenteral nutrition (PN) solutions, creating an oxidant stress. Shielding PN from light decreases its peroxide content, which has nutrition and biochemical benefits in animals and humans. This study aims at determining whether full light protection of PN decreases the rate of bronchopulmonary dysplasia and/or death in very low-birth-weight infants. Multicenter randomized controlled trial of photoprotection, using amber bags and tubing initiated during compounding of PN and maintained throughout infusion in the light-protected (LP) group. The control group (light exposed [LE]) received PN exposed to ambient light. Depending on centers, lipids were infused either separately or as all-in-one PN. In total, 590 infants born <30 weeks gestational age were included. At randomization, LE and LP groups did not differ clinically except for maximal FiO2 before 12 hours. The rate of BPD/death was not different between groups at 28 days (77% LP vs 72% LE, P = .16) or at 36 weeks corrected age (30% LP vs 27% LE, P = .55). Multivariate analysis showed no significant effect of photoprotection on BPD and/or death. The rate of BPD/death was significantly lower (odds ratio, 0.54; 95% confidence interval, 0.32-0.93; P = .02) in infants receiving all-in-one PN vs those who received lipids separately. This study did not show significant beneficial effects of photoprotection. Since the decreased rate of BPD/death found with all-in-one PN relates to a center-dependent variable, this warrants further investigation. © 2014 American Society for Parenteral and Enteral Nutrition.

  2. Physical activity and skills intervention: SCORES cluster randomized controlled trial.

    PubMed

    Cohen, Kristen E; Morgan, Philip J; Plotnikoff, Ronald C; Callister, Robin; Lubans, David R

    2015-04-01

    Physical activity (PA) declines dramatically during adolescence, and activity levels are consistently lower among children living in low-income communities. Competency in a range of fundamental movement skills (FMS) may serve as a protective factor against the decline in PA typically observed during adolescence. The purpose of this study was to evaluate the effect of a 12-month multicomponent PA and FMS intervention on children attending primary schools in low-income communities. The Supporting Children's Outcomes using Rewards, Exercise, and Skills intervention was evaluated using a cluster randomized controlled trial. The sample included 25 classes from eight primary schools located in low-income communities. Participants were 460 children (54.1% girls) age 8.5 ± 0.6 yr. Primary outcomes were objectively measured PA (ActiGraph GT3X and GT3X+ accelerometers), FMS competency (Test of Gross Motor Development 2, six locomotor and six object control skills), and cardiorespiratory fitness (20-m multistage fitness test) assessed at baseline, midprogram (6-months), and at posttest (12 months). Linear mixed models, adjusted for sex, age, body mass index z-score, socioeconomic status, ethnicity, and school class as a random factor, were used to assess the effect of the intervention. At midprogram, there were no significant intervention effects for any of the outcomes. At posttest (study's primary time point), there were intervention effects for daily moderate-to-vigorous PA (MVPA) (adjusted mean difference, 12.7 min·d of MVPA; 95% confidence interval (CI), 5.0-20.5), overall FMS competency (4.9 units; 95% CI, -0.04 to 9.8), and cardiorespiratory fitness (5.4 laps; 95% CI, 2.3-8.6). A school-based multicomponent PA and FMS intervention maintained daily MVPA, improved overall FMS competency, and increased cardiorespiratory fitness among children attending primary schools in low-income communities.

  3. Atropine drops for drooling: a randomized controlled trial.

    PubMed

    De Simone, Gustavo G; Eisenchlas, Jorge H; Junin, Marta; Pereyra, Facundo; Brizuela, Rafael

    2006-10-01

    Drooling occasionally occurs in cancer patients, impairing their quality of life. Recommended treatment includes the use of anticholinergic drugs, but there is a lack of scientific evidence supporting it; some recent reports tested the use of sublingual atropine, and further controlled studies have been recommended. To evaluate the effectiveness of sublingual atropine for the relief of drooling when compared with a placebo, in a population of patients with upper digestive cancer at the Gastroenterology 'Bonorino Udaondo' Hospital. From March 2002 to March 2003, 22 consecutive patients were enrolled in a prospective, randomized, placebo-controlled, double-blind, cross-over trial (gender: M/F=14/8; median age=66, range: 4887 years). Patients were randomly allocated to receive atropine or placebo for 48 hours (phase 1), followed by a wash-out period of 48 hours, and final cross-over during the next 48 hours (phase 2). We evaluated the impact on sialorrhoea, choking, interference with daily and social activities, and global impact from drooling by visual analogue scales (VAS) at the beginning and end of each phase, as well as patients' choice at the end of the study. Mean score for sialorrhoea was 59.6 (SD=28.5) at baseline and 34.9 (SD=27.7) after 48 hours of receiving atropine; 62.1 (SD=27.6) at baseline and 40.7 (SD=30.5) after 48 hours of placebo. Analysis of variance (ANOVA) for repeated measures and two factors was not significant for either the variable sialorrhoea (P=0.58) or any of the secondary outcomes measured. No severe toxicity was reported. This study failed to demonstrate the effectiveness of atropine over placebo in this population; we provide further discussion of results.

  4. Laparoscopic Versus Abdominal Sacrocolpopexy: A Randomized, Controlled Trial.

    PubMed

    Costantini, Elisabetta; Mearini, Luigi; Lazzeri, Massimo; Bini, Vittorio; Nunzi, Elisabetta; di Biase, Manuel; Porena, Massimo

    2016-07-01

    Few randomized, controlled trials have compared standard abdominal sacrocolpopexy and the laparoscopic approach. We tested the hypothesis that laparoscopic sacrocolpopexy could compete with abdominal sacrocolpopexy for pelvic organ prolapse repair. This randomized, controlled trial was done to compare laparoscopic sacrocolpopexy and abdominal sacrocolpopexy for pelvic organ prolapse repair in women referred to our tertiary Department of Urology for symptomatic stage 2 or greater pelvic organ prolapse. The primary outcome was quantitative evaluation by the POP-Q (Pelvic Organ Prolapse Quantification) system. Cure was defined as prolapse stage 1 or less, point C/D -5 or less at the apex and at least 7 cm total vaginal length. Secondary outcomes were the complication rate, operative time, intraoperative blood loss, hospital stay and PGI-I (Patient Global Impression of Improvement) scores. The Kaplan-Meier estimator with the log-rank test was used to estimate pelvic organ prolapse recurrence-free survival rates. A total of 200 patients were eligible for study. We compared 60 and 61 patients treated with abdominal and laparoscopic sacrocolpopexy, respectively. At a mean followup of 41.7 months the cure rate was of 100% for both approaches. Kaplan-Meier curves showed that overall pelvic organ prolapse recurrence-free survival was longer following the open approach. Patients treated with laparoscopic sacrocolpopexy showed significantly earlier recurrence (p = 0.030), mostly in the first 12 months after surgery. When evaluating the different compartments, a statistically significant difference was observed between the laparoscopic and abdominal approaches for anterior compartment descensus (11 vs 1, p = 0.004). Statistical results had high internal validity but may not be applicable to other populations or settings. Laparoscopic sacrocolpopexy provides outcomes as good as those of abdominal sacrocolpopexy for anatomical correction but not for anterior pelvic organ prolapse

  5. Improved Reporting of Randomized Controlled Trials in the Urologic Literature.

    PubMed

    Narayan, Vikram M; Cone, Eugene B; Smith, Daniel; Scales, Charles D; Dahm, Philipp

    2016-12-01

    Well-designed randomized controlled trials (RCTs) have the potential to provide high-quality evidence to inform questions of therapy and prevention, but this potential is contingent on the use of appropriate methods and transparent reporting. To systematically assess the quality of urology RCT reporting and identify trends over time. All RCTs published in four leading urology journals in 2013 were identified and compared to a prior analysis of studies from 1996 and 2004. Two reviewers abstracted data based on the Consolidated Standards of Reporting Trials (CONSORT) checklist. A summary reporting score (range: 0-22) for each study was determined. Mean overall scores for 1996, 2004, and 2013 were compared using analysis of variance. We used χ 2 to compare the reporting frequency of individual criteria. Mean CONSORT scores for RCTs were 15.6±2.0 in 2013 (n=82), 12.0±0.3 in 2004 (n=87), and 10.2±0.3 in 1996 (n=65); p<0.01. Key deficiencies remain in reporting methods of allocation concealment and group assignment (selection bias), and blinding of participants, personnel, and outcome assessors (performance and detection bias). Study limitations are potential reviewer bias resulting from lack of journal deidentification and the relatively low number of studies reviewed. There has been a substantial improvement in reporting quality of RCTs in urology since CONSORT. Some methodological criteria remain underreported, and increased efforts are necessary to further this improvement. Treatment decisions are often based on data from randomized controlled trials. We looked at whether these trials in urology are transparent in reporting their design and conduct using a framework known as the CONSORT criteria and found significant improvements over time. Some areas of deficiency remain, and our paper aimed to highlight these drawbacks to promote continued high-quality research. Published by Elsevier B.V.

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2011-05-01

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

  8. Randomized Controlled Trials: Ethical and Scientific Issues in the Choice of Placebo or Active Control

    PubMed Central

    Ovosi, Joseph Ogirima; Ibrahim, Muhammed Sani; Bello-Ovosi, Beatrice Ohunene

    2017-01-01

    The use of control group in clinical trials has been universally acclaimed by researchers to effectively help discriminate between the actual effects of an intervention and those arising from other factors. However, the choice of the control that provided both scientific and ethical acceptability among researchers has been a source of intense debate. We conducted a literature search on the use of placebo and active controls in clinical trials and X-ray the arguments for and against both choices in randomized control trials and concluded by highlighting the scenarios where the use of placebo is justified. PMID:28671148

  9. 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

  10. 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

    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). 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. 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. 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 statistical threshold for efficacy. (Funded

  11. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

  12. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies.

    PubMed

    Balasingam, Shobana; Wilder-Smith, Annelies

    2016-08-01

    Controlled human infection, the intentional infection of healthy volunteers, allows disease pathogenesis to be studied and vaccines and therapeutic interventions to be evaluated in a controlled setting. A systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform was performed. The primary objective was to document the scope of trials performed to date and the main efficacy outcome in the trials. The secondary objective was to assess safety and identify serious adverse events. The PubMed database was searched for randomized controlled influenza human challenge studies with predetermined search terms. Review papers, papers without outcomes, community-acquired infections, duplicated data, pathogenesis studies, and observational studies were excluded. Twenty-six randomized controlled trials published between 1947 and 2014 fit the study inclusion criteria. Two-thirds of these trials investigated antivirals and one-third investigated influenza vaccines. Among 2462 subjects inoculated with influenza virus, the incidence of serious adverse events was low (0.04%). These challenge studies helped to down-select three antivirals and one vaccine that were subsequently approved by the US Food and Drug Administration (FDA). Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. 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)

  14. 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

  15. Randomized controlled evaluation of an insulin pen storage policy.

    PubMed

    Gibbs, Haley G; McLernon, Tara; Call, Rosemary; Outten, Katie; Efird, Leigh; Doyle, Peter A; Stuart, Elizabeth A; Mathioudakis, Nestoras; Glasgow, Nicole; Joshi, Avadhut; George, Pravin; Feroli, Bob; Zink, Elizabeth K

    2017-12-15

    Results of a quality-improvement project to enhance safeguards against "wrong-pen-to-patient" insulin pen errors by permitting secure bedside storage of insulin pens are reported. A cluster-randomized controlled evaluation was conducted at an academic medical center to assess adherence with institutional policy on insulin pen storage before and after implementation of a revised policy allowing pen storage in locking boxes in patient rooms. In phase 1 of the study, baseline data on policy adherence were captured for 8 patient care units (4 designated as intervention units and 4 designated as control units). In phase 2, policy adherence was assessed through direct observation during weekly audits after lock boxes were installed on intervention units and education on proper insulin pen storage was provided to nurses in all 8 units. Phase 1 rates of adherence to insulin pen storage policy were 59% in the intervention units and 49% in the control units (p = 0.56). During phase 2, there was no significant change from baseline in control unit adherence (67%, p = 0.26), but adherence in intervention units improved significantly, to 89% (p = 0.005). Common types of observed nonadherence included pens being unsecured in patient rooms or nurses' pockets or left in patient-specific medication drawers after patient discharge. An institutional policy change permitting secure storage of insulin pens close to the point of care, paired with nurse education, increased adherence more than education alone. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  16. Multicenter, randomized controlled trial of pain-related behaviors following routine neutering in dogs.

    PubMed

    Wagner, Ann E; Worland, Grace A; Glawe, J Christopher; Hellyer, Peter W

    2008-07-01

    To evaluate the degree of postoperative pain in dogs undergoing elective castration or ovariohysterectomy (OHE); determine whether an association exists between surgeon experience, incision length, or surgery duration and degree of postoperative pain; and determine whether analgesic treatment decreases expression of postoperative pain behaviors. Randomized controlled clinical trial. 426 client-owned dogs undergoing OHE or castration. Dogs underwent OHE or castration performed by an experienced veterinarian or a fourth-year veterinary student. Dogs were randomly assigned to 1 of 4 treatment groups: no perioperative analgesic treatment (n = 44), preoperative administration of morphine (144), preoperative administration of nalbuphine (119), and postoperative administration of ketoprofen (119). Dogs were evaluated while in the hospital before anesthesia and for 4 hours after surgery and once a day at home for 3 days after surgery. Dogs in all 4 groups had significant increases in overall pain scores after surgery, compared with baseline scores. There were significant differences among groups, with control dogs having significantly higher increases in overall pain scores than dogs in the other groups. Factors that did not influence the frequency or severity of pain-related behaviors included breed, individual hospital, anesthetic induction protocol, surgeon experience, and duration of surgery. Results suggested that dogs expressed behaviors suggestive of pain following OHE and castration, that analgesic treatment mitigated the expression of pain-related behaviors, and that surgeon experience and surgery duration did not have any effect on expression of pain-related behaviors.

  17. Outpatient versus inpatient opioid detoxification: a randomized controlled trial.

    PubMed

    Day, Ed; Strang, John

    2011-01-01

    Opioid detoxification is not an effective stand-alone treatment for heroin dependence but is nevertheless an essential step in the path to recovery. There has been relatively little previous controlled research on the impact of treatment setting on the likelihood of successful completion of detoxification. In this study, 68 opioid-dependent patients receiving community treatment (predominantly with methadone) and requesting detoxification were randomly assigned to an inpatient versus outpatient setting. Both groups received the same medication (lofexidine), and the primary outcome measure was being opioid-free at detoxification completion. More inpatients (n = 18, 51.4%) than outpatients (n = 12, 36.4%) completed detoxification, but this difference was not statistically significant (χ(2) = 1.56, p = .21). However, the outpatient group received a significantly longer period of medication, and when the length of detoxification was controlled for, the results favored the inpatient setting (Exp(B) = 13.9, 95% confidence interval = 2.6-75.5, p = .002). Only 11 (16%) participants were opioid-free at the 1-month follow-up and 8 at the 6-month follow-up, with no between-group difference. Inpatient and outpatient opioid detoxification settings were not significantly different in completion or follow-up abstinence rates, but aspects of the study design may have favored the outpatient setting. Future studies should test patient characteristics that predict better outcomes in each setting. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Periodic salbutamol in facioscapulohumeral muscular dystrophy: a randomized controlled trial.

    PubMed

    Payan, C A; Hogrel, J Y; Hammouda, E H; Lacomblez, L; Ollivier, G; Doppler, V; Eymard, B; Attarian, S; Pouget, J; Desnuelle, C; Laforêt, P

    2009-07-01

    To evaluate the effects on muscle strength of salbutamol administered for 6 months using a periodic regimen in patients presenting with facioscapulohumeral muscular dystrophy (FSHD). Placebo-controlled double-blind randomized study. Three clinical centers involved in neuromuscular disorders. Ambulatory patients (N=112), 56 per group, with genetically confirmed FSHD, age 18 to 60 years. Salbutamol (sustained released formulation) administered orally at a daily dose of 16 mg using a periodic dosage regimen (3 wks on, 1 wk off). Muscle strength was assessed with quantitative muscle testing (QMT), manual muscle testing (MMT), and timed motor tests. Patients were evaluated at baseline, and 3 and 6 months later. Plasma drug assays were carried out at each visit. There was no significant change with periodic use of salbutamol in the total composite QMT z-score, MMT score, or timed motor tests. Salbutamol was well tolerated. Lack of efficacy did not seem to be related to plasma concentrations, which were within the expected range. Results from this study and previous controlled trials preclude at present the use of salbutamol as routine treatment for FSHD, even if we cannot exclude improvement from anabolic effects with a longer duration of treatment.

  19. A Randomization Test for Controlling Population Stratification in Whole-Genome Association Studies

    PubMed Central

    Kimmel, Gad ; Jordan, Michael I. ; Halperin, Eran ; Shamir, Ron ; Karp, Richard M. 

    2007-01-01

    Population stratification can be a serious obstacle in the analysis of genomewide association studies. We propose a method for evaluating the significance of association scores in whole-genome cohorts with stratification. Our approach is a randomization test akin to a standard permutation test. It conditions on the genotype matrix and thus takes into account not only the population structure but also the complex linkage disequilibrium structure of the genome. As we show in simulation experiments, our method achieves higher power and significantly better control over false-positive rates than do existing methods. In addition, it can be easily applied to whole-genome association studies. PMID:17924333

  20. A randomization test for controlling population stratification in whole-genome association studies.

    PubMed

    Kimmel, Gad; Jordan, Michael I; Halperin, Eran; Shamir, Ron; Karp, Richard M

    2007-11-01

    Population stratification can be a serious obstacle in the analysis of genomewide association studies. We propose a method for evaluating the significance of association scores in whole-genome cohorts with stratification. Our approach is a randomization test akin to a standard permutation test. It conditions on the genotype matrix and thus takes into account not only the population structure but also the complex linkage disequilibrium structure of the genome. As we show in simulation experiments, our method achieves higher power and significantly better control over false-positive rates than do existing methods. In addition, it can be easily applied to whole-genome association studies.

  1. Tetrahydrocannabinol for neuropsychiatric symptoms in dementia: A randomized controlled trial.

    PubMed

    van den Elsen, Geke A H; Ahmed, Amir I A; Verkes, Robbert-Jan; Kramers, Cees; Feuth, Ton; Rosenberg, Paul B; van der Marck, Marjolein A; Olde Rikkert, Marcel G M

    2015-06-09

    To study the efficacy and safety of low-dose oral tetrahydrocannabinol (THC) in the treatment of dementia-related neuropsychiatric symptoms (NPS). This is a randomized, double-blind, placebo-controlled study. Patients with dementia and clinically relevant NPS were randomly assigned to receive THC 1.5 mg or matched placebo (1:1) 3 times daily for 3 weeks. Primary outcome was change in Neuropsychiatric Inventory (NPI), assessed at baseline and after 14 and 21 days. Analyses were based on intention-to-treat. Twenty-four patients received THC and 26 received placebo. NPS were reduced during both treatment conditions. The difference in reduction from baseline between THC and placebo was not significant (mean difference NPItotal: 3.2, 95% confidence interval [CI] -3.6 to 10.0), nor were changes in scores for agitation (Cohen-Mansfield Agitation Inventory 4.6, 95% CI -3.0 to 12.2), quality of life (Quality of Life-Alzheimer's Disease -0.5, 95% CI -2.6 to 1.6), or activities of daily living (Barthel Index 0.6, 95% CI -0.8 to 1.9). The number of patients experiencing mild or moderate adverse events was similar (THC, n = 16; placebo, n = 14, p = 0.36). No effects on vital signs, weight, or episodic memory were observed. Oral THC of 4.5 mg daily showed no benefit in NPS, but was well-tolerated, which adds valuable knowledge to the scarce evidence on THC in dementia. The benign adverse event profile of this dosage allows study of whether higher doses are efficacious and equally well-tolerated. This study provides Class I evidence that for patients with dementia-related NPS, low-dose THC does not significantly reduce NPS at 21 days, though it is well-tolerated. © 2015 American Academy of Neurology.

  2. [Chuzhen therapy for sub-health: a randomized controlled study].

    PubMed

    Hu, You-Ping; Xu, Zhen-Jie; Wu, Jia; Xing, Lin; Zhang, Lei-Xiao; Zhang, Jin-Xing; Tan, Hui; Mao, Shi-Zhi; Zhou, Cong-Quan

    2012-11-01

    To observe the effect on intervention of sub-health with pestle needle (Chuzhen). Randomized controlled trail was adopted for this research. One hundred and fifty-three cases were randomly divided into two groups of a Chuzhen group (79 cases) and a massage group (74 cases). Acupoint of Bazhen (Baihui Bazhen, Shendao Bazhen, Zhiyang Bazhen, Mingmen Bazhen, Yaoyangguan Bazhen), Hechelu on the head, the neck and the lumbar area were adopted in Chuzhen group. While regular whole-body massage was applied in the massage group. The human sub-health score, the cornell medical index (CMI) and thermal texture maps system (TTM) technology of the two groups before and after the intervention were observed. 1) After treatment, sub-health condition score, the CMI score, the M-R score and the TTM index were all increased in both groups (all P<0.01) 2) Comparison of D-value of the two groups before and after the intervention: the level of the sub-health score, the total score of CMI, and the index of sleep, pressure, Governor Vessel, Hukou (first web), blood lipid, viscosity of blood, microcirculation of TTM index of the Chuzhen group changed more obvious (all P<0.01), but there was no statistic significances in the M-R score and blood sugar of the TTM (both P>0.05). 3) The sub-health condition score in Chuzhen group was higher than that in the massage group (P<0.01). Chuzhen therapy has definite effect on intervention of sub-health, which is better than regular general massage.

  3. Preventing alcohol-exposed pregnancies: a randomized controlled trial.

    PubMed

    Floyd, R Louise; Sobell, Mark; Velasquez, Mary M; Ingersoll, Karen; Nettleman, Mary; Sobell, Linda; Mullen, Patricia Dolan; Ceperich, Sherry; von Sternberg, Kirk; Bolton, Burt; Johnson, Kenneth; Skarpness, Bradley; Nagaraja, Jyothi

    2007-01-01

    Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. A brief motivational intervention can reduce the risk of an AEP.

  4. Amantadine for Dyskinesias in Parkinson's Disease: A Randomized Controlled Trial

    PubMed Central

    Sawada, Hideyuki; Oeda, Tomoko; Kuno, Sadako; Nomoto, Masahiro; Yamamoto, Kenji; Yamamoto, Mitsutoshi; Hisanaga, Kinya; Kawamura, Takashi

    2010-01-01

    Background Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. Methods In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg /day) or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS) during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias), part IVb (motor fluctuations), and part III (motor function). Results RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores. Conclusions Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60–70% of patients. Trial Registration UMIN Clinical Trial Registry UMIN000000780 PMID:21217832

  5. A randomized controlled trial of mindfulness meditation for chronic insomnia.

    PubMed

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

    2014-09-01

    To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial. Academic medical center. Fifty-four adults with chronic insomnia. Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. 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. Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781. © 2014 Associated Professional Sleep Societies, LLC.

  6. 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

  7. Methodological review: quality of randomized controlled trials in health literacy.

    PubMed

    Brainard, Julii; Wilsher, Stephanie Howard; Salter, Charlotte; Loke, Yoon Kong

    2016-07-11

    The growing move towards patient-centred care has led to substantial research into improving the health literacy skills of patients and members of the public. Hence, there is a pressing need to assess the methodology used in contemporary randomized controlled trials (RCTs) of interventions directed at health literacy, in particular the quality (risk of bias), and the types of outcomes reported. We conducted a systematic database search for RCTs involving interventions directed at health literacy in adults, published from 2009 to 2014. The Cochrane Risk of Bias tool was used to assess quality of RCT implementation. We also checked the sample size calculation for primary outcomes. Reported evidence of efficacy (statistical significance) was extracted for intervention outcomes in any of three domains of effect: knowledge, behaviour, health status. Demographics of intervention participants were also extracted, including socioeconomic status. We found areas of methodological strength (good randomization and allocation concealment), but areas of weakness regarding blinding of participants, people delivering the intervention and outcomes assessors. Substantial attrition (losses by monitoring time point) was seen in a third of RCTs, potentially leading to insufficient power to obtain precise estimates of intervention effect on primary outcomes. Most RCTs showed that the health literacy interventions had some beneficial effect on knowledge outcomes, but this was typically for less than 3 months after intervention end. There were far fewer reports of significant improvements in substantive patient-oriented outcomes, such as beneficial effects on behavioural change or health (clinical) status. Most RCTs featured participants from vulnerable populations. Our evaluation shows that health literacy trial design, conduct and reporting could be considerably improved, particularly by reducing attrition and obtaining longer follow-up. More meaningful RCTs would also result if health

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

    PubMed

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

    2014-06-25

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

  9. 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. © 2013 The Authors. Stress and Health published by John Wiley & Sons Ltd.

  10. Acupuncture in Menopause (AIM) Study: a Pragmatic, Randomized Controlled Trial

    PubMed Central

    Avis, Nancy E.; Coeytaux, Remy R.; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2015-01-01

    Objective to evaluate the short- and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. Methods A total of 209 perimenopausal and postmenopausal women aged 45-60 experiencing ≥4 VMS per day recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. Results VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (p<0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (p<0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained post treatment. Statistically significant clinical improvement was observed after 3 acupuncture treatments and maximum clinical effects occurred after a median of 8 treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. Conclusions We found that a course of acupuncture treatments was associated with significant reduction in VMS, as well as several quality of life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment. PMID:27023860

  11. Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

    PubMed

    Avis, Nancy E; Coeytaux, Remy R; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2016-06-01

    The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

  12. Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

    PubMed

    Huang, DeRen

    2015-12-01

    The remarkable global development of disease-modifying therapies (DMTs) specific for multiple sclerosis (MS) has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials (RCTs) for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica (NMO) and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

  13. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    PubMed

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (P<.01). The evidence provided by the present study does not support the hypothesis that treatment of periodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

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

    PubMed

    Dawson, J A; Kaiser, K A; Affuso, O; Cutter, G R; Allison, D B

    2016-06-01

    It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG)-randomized controlled trials (RCTs). We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework was used to model and understand the relationship between treatment effects and control group outcomes. Under the informed model, an increase in control group WL of 1 kg corresponds with an expected shrinkage of the treatment effect by 0.309 kg (95% confidence interval (-0.480, -0.138), P=0.00081); this result is robust against violations of the model assumptions. We find that control conditions with large WLs diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies.

  15. A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Cardiac surgery is one of the most commonly performed surgical procedures worldwide with >700,000 surgeries in 2006 in the US alone. Cardiac surgery results in a considerable exposure to physical and emotional stress; stress-related disorders such as depression or post-traumatic stress disorder are the most common adverse outcomes of cardiac surgery, seen in up to 20% of patients. Using information from a genome-wide association study to characterize genetic effects on emotional memory, we recently identified a single nucleotide polymorphism of the glucocorticoid receptor gene (the Bcll single nucleotide polymorphism) as a significant genetic risk factor for traumatic memories from cardiac surgery and symptoms of post-traumaticstress disorder. The Bcll high-risk genotype (Bcll GG) has a prevalence of 16.6% in patients undergoing cardiac surgery and is associated with increased glucocorticoid receptor signaling under stress. Concomitant animal experiments have confirmed an essential role of glucocorticoid receptor activation for traumatic memory formation during stressful experiences. Early cognitive behavioral intervention has been shown to prevent stress-related disorders after heart surgery. Methods/Design The proposed study protocol is based on the above mentioned earlier findings from animal experiments and preclinical studies in volunteers. Patients (n = 872) will be genotyped for the Bcll single nucleotide polymorphism before surgery, which should result in 120 homozygous high-risk carriers of the Bcll GG allele and 240 randomly selected low-risk heterozygous or non-carriers of the single nucleotide polymorphism. All patients will then undergo randomization to either cognitive behavioral intervention or a control intervention consisting of non-specific general information about the role of stress in heart disease. The primary efficacy endpoint will be post-traumatic stress levels at one year after surgery as determined by a standardized

  16. A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial.

    PubMed

    Hauer, Daniela; Kolassa, Iris-Tatjana; Laubender, Rüdiger Paul; Mansmann, Ulrich; Hagl, Christian; Roozendaal, Benno; de Quervain, Dominique J-F; Schelling, Gustav

    2013-04-01

    Cardiac surgery is one of the most commonly performed surgical procedures worldwide with >700,000 surgeries in 2006 in the US alone. Cardiac surgery results in a considerable exposure to physical and emotional stress; stress-related disorders such as depression or post-traumatic stress disorder are the most common adverse outcomes of cardiac surgery, seen in up to 20% of patients. Using information from a genome-wide association study to characterize genetic effects on emotional memory, we recently identified a single nucleotide polymorphism of the glucocorticoid receptor gene (the Bcll single nucleotide polymorphism) as a significant genetic risk factor for traumatic memories from cardiac surgery and symptoms of post-traumaticstress disorder. The Bcll high-risk genotype (Bcll GG) has a prevalence of 16.6% in patients undergoing cardiac surgery and is associated with increased glucocorticoid receptor signaling under stress. Concomitant animal experiments have confirmed an essential role of glucocorticoid receptor activation for traumatic memory formation during stressful experiences. Early cognitive behavioral intervention has been shown to prevent stress-related disorders after heart surgery. The proposed study protocol is based on the above mentioned earlier findings from animal experiments and preclinical studies in volunteers. Patients (n = 872) will be genotyped for the Bcll single nucleotide polymorphism before surgery, which should result in 120 homozygous high-risk carriers of the Bcll GG allele and 240 randomly selected low-risk heterozygous or non-carriers of the single nucleotide polymorphism. All patients will then undergo randomization to either cognitive behavioral intervention or a control intervention consisting of non-specific general information about the role of stress in heart disease. The primary efficacy endpoint will be post-traumatic stress levels at one year after surgery as determined by a standardized questionnaire that has been

  17. A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience

    PubMed Central

    Arun, Banu; Austin, Taylor; Babiera, Gildy V.; Basen-Engquist, Karen; Carmack, Cindy L.; Chaoul, Alejandro; Cohen, Lorenzo; Connelly, Lisa; Haddad, Robin; Harrison, Carol; Li, Yisheng; Mallaiah, Smitha; Nagarathna, Raghuram; Parker, Patricia A.; Perkins, George H.; Reuben, James M.; Shih, Ya-Chen Tina; Spelman, Amy; Sood, Anil; Yang, Peiying; Yeung, Sai-Ching J.

    2016-01-01

    Background: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). Methods: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. Results: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending

  18. Physics experiments with Nintendo Wii controllers

    NASA Astrophysics Data System (ADS)

    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 a spring undergoing simple harmonic motion, a pair of controllers mounted on colliding gliders on a linear air track, and a person jumping from a balance board.

  19. 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…

  20. A Randomized Controlled Study of Neurofeedback for Chronic PTSD.

    PubMed

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

    2016-01-01

    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. 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. 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. 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.

  1. Worksite intervention effects on physical health: a randomized controlled trial.

    PubMed

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

    2006-09-01

    Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure. Well-designed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors. This randomized controlled trial was conducted at one of Australia's casinos in 2002-2003, to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness. Only 6.4% of the workforce expressed interest in being study participants. Seventy-three employees (aged 32 +/- 8 years, 51% overweight/obese, 73% shift workers and 52% women) were recruited and randomized to treatment or wait-list control groups for 24 weeks, 44 of whom completed the intervention. Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic (at least 20 min duration 3 days/week) and weight-training (for an estimated 30 min completed 2-3 days/week), and dietary/health education (delivered via group seminars, one-on-one counselling and literature through the provision of a worksite manual). ANCOVA, by intention-to-treat and of study completers, found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake (VO2max), favouring the intervention, but effects were concentrated in one subject. For study completers, between-group differences in the mean waist circumference (82.3 +/- 9.2 versus 90.5 +/- 17.8 cm, p = 0.01) and predicted VO2max (47 versus 41 ml/kg/min, p < 0.001) remained significant without the outlier, favouring the intervention. Higher intervention compliance predicted greater improvements in physical fitness. No significant effects on body mass or body mass index were found. This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees, most of whom were shift workers. Worksite interventions have the potential to counter the increasing burden of

  2. 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;…

  3. Placebo effects and the common cold: a randomized controlled trial.

    PubMed

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

    2011-01-01

    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. 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. 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 blinded to echinacea, and 70 pg

  4. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

    PubMed

    Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

    2018-02-06

    Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety

  5. 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…

  6. 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…

  7. 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…

  8. 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)…

  9. What Works Clearinghouse Quick Review: "Information and College Access: Evidence from a Randomized Field Experiment"

    ERIC Educational Resources Information Center

    What Works Clearinghouse, 2013

    2013-01-01

    "Information and College Access: Evidence From a Randomized Field Experiment" examined the impact of offering an online informational video and financial aid materials to high school students on: (1) their postsecondary aspirations, (2) the accuracy of their understanding of financial aid availability, and (3) the accuracy of their…

  10. The Effect of Teacher-Family Communication on Student Engagement: Evidence from a Randomized Field Experiment

    ERIC Educational Resources Information Center

    Kraft, Matthew A.; Dougherty, Shaun M.

    2013-01-01

    In this study, we evaluate the efficacy of teacher communication with parents and students as a means of increasing student engagement. We estimate the causal effect of teacher communication by conducting a randomized field experiment in which sixth- and ninth-grade students were assigned to receive a daily phone call home and a text/written…

  11. 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…

  12. Dealing with Design Failures in Randomized Field Experiments: Analytic Issues Regarding the Evaluation of Treatment Effects.

    ERIC Educational Resources Information Center

    Gartin, Patrick R.

    1995-01-01

    Asserts that several analytical issues in randomized field experiments conducted by criminal justice scholars must be addressed more systematically. Notes that issues related to statistical power and desired sample size remain unresolved. Reviews related literature from the field of medicine to provide insights regarding the dilemmas created by…

  13. 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…

  14. Selecting a Sample for Your Experiment: A Non-Random Stratified Sampling Approach

    ERIC Educational Resources Information Center

    Tipton, Elizabeth

    2012-01-01

    The purpose of this paper is to develop a more general method for sample recruitment in experiments that is purposive (not random) and that results in a sample that is compositionally similar to the generalization population. This work builds on Tipton et al. (2011) by offering solutions to a larger class of problems than the non-overlapping…

  15. Hand splinting for poststroke spasticity: a randomized controlled trial.

    PubMed

    Basaran, Aynur; Emre, Ufuk; Karadavut, Kiymet Ikbal; Balbaloglu, Ozlem; Bulmus, Nercivan

    2012-01-01

    To determine the effect of volar and dorsal splinting on the spasticity of the wrist flexor muscles in patients who had stroke. Thirty-nine subjects were prospectively randomized to use a dorsal or volar splint or no splint (control group). All the patients underwent home-based exercise program, and the experimental groups used either dorsal or volar hand splints according to their distribution. The primary outcome measure was spasticity assessed clinically by the Modified Ashworth Scale (MAS) and electrophysiologically by H latency and Hmax:Mmax ratio of flexor carpi radialis. Secondary outcome measure was passive range of motion (PROM) of wrist extension. Spasticity parameters (MAS, H latency, Hmax:Mmax ratio) and wrist PROM were not significantly different among the groups. This study failed to demonstrate any statistically significant difference in spasticity or in wrist PROM of both the volar and dorsal splint groups. These splints could be recommended as part of an integrative approach without expecting a major clinical effect rather than as an alternative to other treatment.

  16. Quality of reporting randomized controlled trials in cancer nursing research.

    PubMed

    Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy

    2014-01-01

    Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.

  17. Impact of Killing in War: A Randomized, Controlled Pilot Trial.

    PubMed

    Maguen, Shira; Burkman, Kristine; Madden, Erin; Dinh, Julie; Bosch, Jeane; Keyser, Jessica; Schmitz, Martha; Neylan, Thomas C

    2017-09-01

    The purpose of this pilot study was to test the effectiveness of Impact of Killing (IOK), a novel, cognitive-behavioral treatment (CBT) aimed at reducing mental health symptoms and functional impairment. Participants were 33 combat Veterans with a posttraumatic stress disorder (PTSD) diagnosis who had completed trauma-focused psychotherapy and reported distress regarding killing or feeling responsible for the deaths of others in war. Veterans were randomized to either IOK treatment or a 6-week waitlist condition, after which Veterans could receive IOK. IOK is a 6- to 8-session, weekly, individual, CBT, lasting 60-90 minutes, and focused on key themes, including physiology of killing responses, moral injury, self-forgiveness, spirituality, making amends, and improved functioning. We found that compared to controls (N = 16), the IOK group (N = 17) experienced a significant improvement in PTSD symptoms, general psychiatric symptoms, and quality of life functional measures. Veterans who received IOK reported that the treatment was acceptable and feasible. These results provide preliminary evidence that Veterans can benefit from a treatment focused on the impact of killing after initial trauma therapy. © 2017 Wiley Periodicals, Inc.

  18. Prenatal emotion management improves obstetric outcomes: a randomized control study

    PubMed Central

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Introduction: Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. Methods: All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. Results: The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P < 0.01), and a lower EPDS score 42 days postpartum (P < 0.05). The rate of cesarean section in the EM group was lower than the UC group (P < 0.01), and the cesarean section rate without a medical indication was lower (P < 0.01). The duration of the second stage of labor in the EM group was shorter than the UC group (P < 0.01). Conclusions: Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China. PMID:26309641

  19. Custom-tailored spatial mode sorting by controlled random scattering

    NASA Astrophysics Data System (ADS)

    Fickler, Robert; Ginoya, Manit; Boyd, Robert W.

    2017-04-01

    The need to increase data transfer rates constitutes a key challenge in modern information-driven societies. Taking advantage of the transverse spatial modes of light to encode more information is a promising avenue for both classical and quantum photonics. However, to ease access to the encoded information, it is essential to be able to sort spatial modes into different output channels. Here, we introduce a way to customize the sorting of arbitrary spatial light modes. Our method relies on the high degree of control over random scattering processes by preshaping of the phase structure of the incident light. We demonstrate experimentally that various sets of modes, irrespective of their specific modal structure, can be transformed to a broad range of output channel arrangements. Thus, our method enables full access to all of the information encoded in the transverse structure of the field; for example, azimuthal and radial modes. We also demonstrate that coherence is retained in this complex mode transformation, which opens up applications in quantum and classical information science.

  20. Complementing the randomized controlled trial evidence base. Evolution not revolution.

    PubMed

    Price, David; Bateman, Eric D; Chisholm, Alison; Papadopoulos, Nikolaos G; Bosnic-Anticevich, Sinthia; Pizzichini, Emilio; Hillyer, Elizabeth V; Buist, A Sonia

    2014-02-01

    Observational studies and pragmatic trials can complement classical randomized controlled trials (RCTs) by providing data more relevant to the circumstances under which medicine is routinely practiced, thereby providing practical guidance for clinicians. The bearing of RCT findings on day-to-day practice can be weighted and the data more meaningfully interpreted by practicing clinicians if evidence is integrated from a variety of different study designs and methodologies. The advent of observational studies and pragmatic trials, often referred to as "real-life studies," has met with a degree of cynicism, but their role and value is gaining widespread recognition and support among clinicians. This article discusses where observational studies and pragmatic trials have utility, namely: in addressing clinical questions that are unanswered and/or unanswerable by RCTs; in testing new hypotheses and possible license extensions; and in helping to differentiate between available therapies for a given indication. Moreover, it seeks to highlight how the different approaches fit within a conceptual framework of evidence relevant to clinical practice, a step-change in the traditional view of medical evidence.

  1. Venlafaxine versus imipramine in painful polyneuropathy: a randomized, controlled trial.

    PubMed

    Sindrup, S H; Bach, F W; Madsen, C; Gram, L F; Jensen, T S

    2003-04-22

    Tricyclic antidepressants (TCA) are often used in the treatment of painful polyneuropathy. Venlafaxine is a serotonin and weak noradrenaline reuptake inhibitor antidepressant with a different profile of other pharmacologic actions from those of TCA. To test if venlafaxine would relieve painful polyneuropathy and compare its possible efficacy with that of the TCA imipramine. The study design was randomized, double blind, and placebo controlled, with a three-way crossover. Forty patients were assigned to one of the treatment sequences, and 29 completed all three study periods. The daily doses were venlafaxine 225 mg and imipramine 150 mg. During the three treatment periods, each of 4 weeks' duration, patients rated pain paroxysms, constant pain, and touch- and pressure-evoked pain by use of 0- to 10-point numeric rating scales. The sum of the individual pain scores during treatment week 4 was lower on venlafaxine (80% of baseline score; p = 0.006) and imipramine (77%; p = 0.001) than on placebo (100%) and did not show any statistical difference between venlafaxine and imipramine (p = 0.44). The individual pain scores for pain paroxysms, constant pain, and pressure-evoked pain showed a similar pattern, whereas touch-evoked pain was uncommon and was not altered by any of the drugs. Numbers needed to treat to obtain one patient with moderate or better pain relief were 5.2 for venlafaxine and 2.7 for imipramine. Venlafaxine relieves pain in polyneuropathy and may be as effective as imipramine.

  2. Randomized controlled trial on physical therapy for TMJ closed lock.

    PubMed

    Craane, B; Dijkstra, P U; Stappaerts, K; De Laat, A

    2012-04-01

    This study evaluated the one-year effect of physical therapy on pain and mandibular dysfunction associated with anterior disc displacement without reduction of the temporomandibular joint (closed lock). Forty-nine individuals were randomly assigned to either a physical therapy group [n = 23, mean age (SD) 34.7 (14.0) yrs] or a control group [n = 26, mean age 38.5 (15.1) yrs]. At baseline and after 3, 6, 12, 26, and 52 wks, pain and mandibular function were evaluated. All patients received extensive information about avoiding parafunctions and oral habits on all evaluation days. The physical therapy group received, in a 6-week period, 9 sessions of physical therapy, including joint mobilization, exercises, and massage, and the information on avoiding parafunctions and oral habits was repeated each time. All pain variables decreased, and all function variables increased significantly over time for both groups. The interaction between time and treatment group was not significant. Hence, physical therapy had no significant additional effect in patients with anterior disc displacement, without reduction, of the temporomandibular joint (ClinicalTrials.gov number, CT01475630).

  3. Outpatient treatment of pyelonephritis in pregnancy: a randomized controlled trial.

    PubMed

    Millar, L K; Wing, D A; Paul, R H; Grimes, D A

    1995-10-01

    To compare the safety and efficacy of outpatient and inpatient treatment of pyelonephritis in pregnancy. We performed a randomized controlled trial of pregnant women with pyelonephritis before 24 weeks' estimated gestational age, comparing inpatient and outpatient treatment. Sixty inpatients received cefazolin intravenously until afebrile for 48 hours, and 60 outpatients received two injections of ceftriaxone intramuscularly. All patients completed a 10-day course of oral cephalexin. We performed a urine culture 5-14 days after completion of therapy. The two groups were similar with respect to age, parity, temperature, estimated gestational age, initial white blood cell count, and incidence of bacteremia. Escherichia coli was the major uropathogen isolated (86% of cultures, 95 of 111). Twelve percent (13 of 111) of bacteria were resistant to cefazolin. Eleven outpatients and 12 inpatients had positive urine cultures after therapy (relative risk 0.9, 95% confidence interval 0.4-1.9). Three patients in each group had recurrent pyelonephritis. We switched six inpatients to gentamicin because of a worsening clinical picture (two) or a prolonged febrile course (four); no outpatients required a change in antibiotic (Fisher exact test, P = .03). One preterm delivery occurred in an inpatient with recurrent pyelonephritis. Outpatient antibiotic therapy is effective and safe in selected pregnant women with pyelonephritis.

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

    PubMed

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

    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. 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. 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. ClinicalTrials.gov NCT01128361.

  5. 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

  6. Modifying media content for preschool children: a randomized controlled trial.

    PubMed

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

    2013-03-01

    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. 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. 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]). An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior.

  7. Effectiveness of myofascial release: systematic review of randomized controlled trials.

    PubMed

    Ajimsha, M S; Al-Mudahka, Noora R; Al-Madzhar, J A

    2015-01-01

    Myofascial release (MFR) is a form of manual therapy that involves the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function. Anecdotal evidence shows great promise for MFR as a treatment for various conditions. However, research to support the anecdotal evidence is lacking. To critically analyze published randomized controlled trials (RCTs) to determine the effectiveness of MFR as a treatment option for different conditions. Electronic databases: MEDLINE, CINAHL, Academic Search Premier, Cochrane library, and Physiotherapy Evidence Database (PEDro), with key words myofascial release and myofascial release therapy. No date limitations were applied to the searches. Articles were selected based upon the use of the term myofascial release in the abstract or key words. The final selection was made by applying the inclusion and exclusion criteria to the full text. Studies were included if they were English-language, peer-reviewed RCTs on MFR for various conditions and pain. Data collected were number of participants, condition being treated, treatment used, control group, outcome measures and results. Studies were analyzed using the PEDro scale and the Center for Evidence-Based Medicine's Levels of Evidence scale. The literature regarding the effectiveness of MFR was mixed in both quality and results. Although the quality of the RCT studies varied greatly, the result of the studies was encouraging, particularly with the recently published studies. MFR is emerging as a strategy with a solid evidence base and tremendous potential. The studies in this review may help as a respectable base for the future trials. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. Cognitive behavioural treatment for the chronic post-traumatic headache patient: a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic post-traumatic headache (CPTH) after mild head injury can be difficult to manage. Research is scarce and successful interventions are lacking. To evaluate the effect of a group-based Cognitive Behavioural Therapy (CBT) intervention in relation to headache, pain perception, psychological symptoms and quality of life in patients with CPTH. Methods Ninety patients with CPTH according to ICHD-2 criteria were enrolled from the Danish Headache Center into a randomized, controlled trial. Patients were randomly assigned to either a waiting list group or to a nine-week CBT group intervention. At baseline and after 26 weeks all patients completed the Rivermead Post Concussion Symptoms Questionnaire, SF-36, SCL-90-R and a headache diary. Results The CBT had no effect on headache and pressure pain thresholds and only a minor impact on the CPTH patients’ quality of life, psychological distress, and the overall experience of symptoms. The waiting-list group experienced no change in headache but, opposed to the treatment group, a significant decrease in somatic and cognitive symptoms indicating a spontaneous remission over time. Conclusions Our primarily negative findings confirm that management of patients with CPTH still remains a considerable challenge. Psychological group therapy with CBT might be effective in an earlier stage of CPTH and in less severely affected patients but our findings strongly underline the need for randomized controlled studies to test the efficacy of psychological therapy. PMID:25441170

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

    PubMed

    Destin, Mesmin; Svoboda, Ryan C

    2017-04-01

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

  10. Pharmacist collaborative management of poorly controlled diabetes mellitus: a randomized controlled trial.

    PubMed

    Jameson, John P; Baty, Philip J

    2010-04-01

    To investigate the effect of pharmacist management of poorly controlled diabetes mellitus in a community-based primary care group. Randomized controlled trial of pharmacist management of diabetes compared with usual medical care. Patients 18 years or older with glycosylated hemoglobin (A1C) levels of 9.0% or higher were enrolled. Patients were randomly assigned to an intervention group (n = 52) or a control group (n = 51). Management in the control group included the use of registries and targeted patient outreach. The intervention group participated in the same outreach program plus medication management, patient education, and disease control by a pharmacist. Nonparametric data showed median A1C decreases of 1.50% for the intervention group and 0.40% for the control group (P = .06). Significantly more patients in the intervention group improved their A1C level by at least 1.0% relative to the control group (67.3% vs 41.2%, P = .02). Most of this benefit was seen for patients of nonwhite race/ethnicity compared with control subjects (56.3% vs 22.7%, P = .03). Male patients showed significantly greater benefit as well, with a median A1C decrease of 1.90% vs 0.15% for controls (P = .03). Patients with poorly controlled diabetes improved A1C levels significantly when pharmacist management was added to an aggressive organizational diabetes management program. Our results suggest that clinically trained pharmacists can help primary care providers improve diabetes management, especially among male patients and among patients of nonwhite race/ethnicity.

  11. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study.

    PubMed

    Goldstein, Rachel Y; Montero, Nicole; Jain, Sudheer K; Egol, Kenneth A; Tejwani, Nirmal C

    2012-10-01

    To compare postoperative pain control in patients treated surgically for ankle fractures who receive popliteal blocks with those who received general anesthesia alone. Institutional Review Board approved prospective randomized study. Metropolitan tertiary-care referral center. All patients being treated with open reduction internal fixation for ankle fractures who met inclusion criteria and consented to participate were enrolled. Patients were randomized to receive either general anesthesia (GETA) or intravenous sedation and popliteal block. Patients were assessed for duration of procedure, total time in the operating room, and postoperative pain at 2, 4, 8, 12, 24, and 48 hours after surgery using a visual analog scale. Fifty-one patients agreed to participate in the study. Twenty-five patients received popliteal block, while 26 patients received GETA. There were no anesthesia-related complications. At 2, 4, and 8 hours postoperatively, patients who underwent GETA demonstrated significantly higher pain. At 12 hours, there was no significant difference between the 2 groups with regard to pain control. However, by 24 hours, those who had received popliteal blocks had significantly higher pain with no difference by 48 hours. Popliteal block provides equivalent postoperative pain control to general anesthesia alone in patients undergoing operative fixation of ankle fractures. However, patients who receive popliteal blocks do experience a significant increase in pain between 12 and 24 hours. Recognition of this "rebound pain" with early narcotic administration may allow patients to have more effective postoperative pain control.

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

    PubMed

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

    2018-03-01

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

  13. Caffeine for treatment of Parkinson disease: a randomized controlled trial.

    PubMed

    Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit

    2012-08-14

    Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime

  14. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial.

    PubMed

    Liu-Ambrose, Teresa; Best, John R; Davis, Jennifer C; Eng, Janice J; Lee, Philip E; Jacova, Claudia; Boyd, Lara A; Brasher, Penelope M; Munkacsy, Michelle; Cheung, Winnie; Hsiung, Ging-Yuek R

    2016-11-15

    To assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI). This was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training. Primary outcomes assessed were general cognitive function (Alzheimer's Disease Assessment Scale-Cognitive subscale [ADAS-Cog]), executive functions (Executive Interview [EXIT-25]), and activities of daily living (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL]). Seventy adults randomized to aerobic exercise training or usual care were included in intention-to-treat analyses (mean age 74 years, 51% female, n = 35 per group). At the end of the intervention, the aerobic exercise training group had significantly improved ADAS-Cog performance compared with the usual care plus education group (-1.71 point difference, 95% confidence interval [CI] -3.15 to -0.26, p = 0.02); however, this difference was not significant at the 6-month follow-up (-0.63 point difference, 95% CI -2.34 to 1.07, p = 0.46). There were no significant between-group differences at intervention completion and at the 6-month follow-up in EXIT-25 or ADCS-ADL performance. Examination of secondary measures showed between-group differences at intervention completion favoring the AT group in 6-minute walk distance (30.35 meter difference, 95% CI 5.82 to 54.86, p = 0.02) and in diastolic blood pressure (-6.89 mm Hg difference, 95% CI -12.52 to -1.26, p = 0.02). This study provides preliminary evidence for the efficacy of 6 months of thrice-weekly progressive aerobic training in community-dwelling adults with mild SIVCI, relative to usual care plus education. NCT01027858. This study

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

    PubMed

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

    2013-09-20

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

  16. VNEC - A Virtual Network Experiment Controller

    NASA Astrophysics Data System (ADS)

    Gagnon, François; Dej, Tomas; Esfandiari, Babak

    This paper presents VNEC, a tool to specify and execute network experiments in a virtual environment. The user first formulates the network topology and then provides the tasks that should be performed by the computers together with their execution. Next, VNEC initializes the environment by powering up and configuring the virtual machines to match the desired network topology. Finally, commands are dispatched to the right virtual machines in the specified order. VNEC provides an environment for several types of research experiments such as virus propagation patterns and reactions of different targets against a given attack.

  17. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC).

    PubMed

    Andrade, Luis Angel Medina; Muñoz, Franz Yeudiel Pérez; Báez, María Valeria Jiménez; Collazos, Stephanie Serrano; de Los Angeles Martinez Ferretiz, Maria; Ruiz, Brenda; Montes, Oscar; Woolf, Stephanie; Noriega, Jessica Gonzalez; Aparicio, Uriel Maldonado; Gonzalez, Israel Gonzalez

    2016-11-01

    Appendectomy is the most frequent and urgent gastrointestinal surgery. Overtime, the surgical techniques have been improved upon, in order to reduce complications, get better cosmetic results, and limit the discomfort associated with this procedure, by its high impact in the surgery departments. The traditional skin closure is associated with a poor cosmetic result and it requires stitches removal, alongside the pain associated with this procedure, and no benefits were demonstrated in the literature regarding separated stitches over intradermic stitch. This is a randomized controlled trial, and our objective is to compare two different skin closure techniques in open appendectomy. A prospective randomized trial method was used, with a total number of 208 patients participating in the study, after acute appendicitis diagnosis in the emergency department. They were randomized into two groups: patients who would receive skin closure with a unique absorbable intradermic stitch (Group A) and another group that would receive the traditional closure technique, consistent in non-absorbable separated stitches (Group B). General characteristics like gender, age, Body Mass Index (BMI), comorbidities, and allergies were registered. Days of Evolution (DOE) until surgery, previous use of antibiotics, complicated or uncomplicated appendicitis, surgical time, and wound complications like skin infection, dehiscence, seroma or abscess were also registered in each case. 8 patients were excluded due to negative appendicitis during surgery and lack of follow-up. Two groups, each containing 100 patients, were formed. General characteristics and parity were compared, and no statistically significant differences were observed. Difference in the surgical time (Group A: 47.35 min vs Group B: 54.13 min, p < .001) and cases with complicated appendicitis (Group A: 58 and Group B:38, p = .005) were found to be statistically significant. Four wound complications were reported, and the

  18. A randomized controlled trial of birth simulation for medical students.

    PubMed

    DeStephano, Christopher C; Chou, Betty; Patel, Silka; Slattery, Rebecca; Hueppchen, Nancy

    2015-07-01

    The objective of the study was to evaluate the effectiveness of a high-fidelity birth simulator (Noelle; Gaumard Scientific, Coral Gables, FL) compared with a lower-cost, low-tech, birth simulator (MamaNatalie; Laerdal Medical, Stavanger, Norway) in teaching medical students how to perform a spontaneous vaginal delivery (SVD). Prior to the obstetrics-gynecology clerkship, students were randomly assigned to 2 groups. The MamaNatalie group (MG) completed 45 minutes of SVD simulation using an obstetrical abdominal-pelvic model worn by an obstetrics-gynecology faculty member. The Noelle group (NG) completed 45 minutes of SVD simulation using a high-fidelity, computer-controlled mannequin facilitated by an obstetrics-gynecology faculty member. The primary outcome was student performance during his or her first SVD as rated by supervising preceptors. Surveys were also completed by students on confidence in performing steps of a SVD (secondary outcome). One hundred ten medical students (95% of those eligible) participated in this research study. The final postclerkship survey was completed by 93 students (85% follow-up rate). There were no significant differences in performance of SVD steps between MG and NG students as rated by preceptors. The SVD step with the least involvement by students was controlling the head (20.5% in MG, 23.3% in NG performed step with hands-off supervision). Delivery of the placenta was the SVD step with the most involvement (65.9% in MG, 52.3% in NG performed step with hands-off supervision). Baseline presimulation confidence levels were similar between MG and NG. On the immediate postsimulation survey of confidence, MG students were significantly more confident in their ability to deliver the abdomen and legs and perform fundal massage with hands-off supervision (P < .05) than NG students. Following the clerkship, MG students were significantly more confident in their ability to control the head and deliver the abdomen and legs (P < .05) than

  19. 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.

  20. Slewing control experiment for a flexible panel

    NASA Technical Reports Server (NTRS)

    Juang, Jer-Nan

    1987-01-01

    Technology areas are identified in which better analytical and/or experimental methods are needed to adequately and accurately control the dynamic responses of multibody space platforms such as the space station. A generic space station solar panel is used to experimentally evaluate current control technologies. Active suppression of solar panel vibrations induced by large angle maneuvers is studied with a torque actuator at the root of the solar panel. These active suppression tests will identify the hardware requirements and adequacy of various controller designs.

  1. Apollo experience report guidance and control systems

    NASA Technical Reports Server (NTRS)

    Wilson, R. E., Jr.

    1976-01-01

    The Apollo guidance and control systems for both the command module and the lunar module are described in a summary report. General functional requirements are discussed, and general functional descriptions of the various subsystems and their interfaces are provided. The differences between the original in-flight maintenance concept and the final lunar-orbital-rendezvous concept are discussed, and the background in philosophy, the system development, and the reasons for the change in concept are chronologically presented. Block diagrams showing the command module guidance and control system under each concept are included. Significant conclusions and recommendations contained in more detailed reports on specific areas of the guidance and control systems are included.

  2. Executive Control and the Experience of Regret

    ERIC Educational Resources Information Center

    Burns, Patrick; Riggs, Kevin J.; Beck, Sarah R.

    2012-01-01

    The experience of regret rests on a counterfactual analysis of events. Previous research indicates that regret emerges at around 6 years of age, marginally later than the age at which children begin to answer counterfactual questions correctly. We hypothesized that the late emergence of regret relative to early counterfactual thinking is a result…

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

    SciTech Connect

    Tuomi, Lisa, E-mail: lisa.tuomi@vgregion.se; Andréll, Paulin; Finizia, Caterina

    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 withmore » 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.« less

  4. 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.

  5. Gastric endoscopic submucosal dissection under steady pressure automatically controlled endoscopy (SPACE); a multicenter randomized preclinical trial.

    PubMed

    Yamada, Takuya; Hirota, Masashi; Tsutsui, Shusaku; Kato, Motohiko; Takahashi, Tsuyoshi; Yasuda, Kazuhiro; Sumiyama, Kazuki; Tsujii, Masahiko; Takehara, Tetsuo; Mori, Masaki; Doki, Yuichiro; Nakajima, Kiyokazu

    2015-09-01

    Steady pressure automatically controlled endoscopy (SPACE) is a new modality that eliminates on-demand insufflation but enables automatic insufflation in the gastrointestinal tract. Though its use in porcine esophageal ESD was reported to be promising, its applicability and potential effectiveness to gastric procedures have not been evaluated. The aims were (1) to evaluate feasibility and safety of SPACE in the stomach, and (2) to assess its potential advantages over conventional endoscopy in preventing "blind insufflation"-related complications. A multicenter randomized preclinical animal study. Laboratories at three universities. Experiment 1: Gastric ESD was attempted in the swine (n = 17), under either SPACE or manual insufflation. Experiment 2: Gastroscopy was performed for 10 min in the perforated stomach (n = 10) under either SPACE or manual insufflation. Experiment 1: ESD time, energy device activation time, number of forceps exchanges, specimen size, en block resection rate, vital signs and any intraoperative adverse events. Experiment 2: Intra-gastric and intra-abdominal pressures, vital signs, and any adverse events. Experiment 1: Gastric ESD was completed in all animals. ESD time tended to be shorter in SPACE than in the control, though the difference was not significant (p = 0.18). Experiment 2: Although both intra-gastric and intra-abdominal pressures remained within preset values in SPACE, they showed excessive elevation in control. An animal study with small sample size. SPACE is feasible and safe for complicated and lengthy procedures such as gastric ESD, and is potentially effective in preventing serious consequences related to excessive blind insufflation.

  6. 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.

  7. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent versus Sequential Intervention

    PubMed Central

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; Schneider, Kristin; Pingitore, Regina; Hedeker, Don

    2014-01-01

    Prospects for changing multiple health behaviors conjointly remain controversial. We compared effects on tobacco abstinence and weight gain of adding diet and exercise concurrently or after smoking treatment. Female regular smokers (n=315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit at week 5, and were followed for 9 months after the quit date. Weight management was added to the first 8 weeks for Early Diet (ED), the final 8 weeks for Late Diet (LD), and omitted for Control. Both Diet groups tended to show greater bio-verified abstinence than Control although differences were nonsignificant. Compared to Control, ED initially suppressed weight gain but lost that effect over time, whereas LD initially lacked but gradually acquired a weight suppression effect that stabilized [p = .004]. Behavioral weight control did not undermine smoking cessation and slowed the rate of weight gain when initiated after the smoking quit date, supporting a sequential approach to multiple behavior change. PMID:15482037

  8. 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.

  9. Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial

    PubMed Central

    Imhoff-Kunsch, Beth; Stein, Aryeh D.; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle

    2011-01-01

    OBJECTIVE: Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. METHODS: In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. RESULTS: Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58–1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and “other illness,” respectively, but 74% longer duration of vomiting (all P < .05). CONCLUSIONS: DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months. PMID:21807696

  10. Personal health records and hypertension control: a randomized trial.

    PubMed

    Wagner, Peggy J; Dias, James; Howard, Shalon; Kintziger, Kristina W; Hudson, Matthew F; Seol, Yoon-Ho; Sodomka, Pat

    2012-01-01

    To examine the impact of a personal health record (PHR) in patients with hypertension measured by changes in biological outcomes, patient empowerment, patient perception of quality of care, and use of medical services. A cluster-randomized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics. 453 of 1686 (26.4%) patients approached were included in the analyses. A PHR tethered to the patient's electronic medical record (EMR) was the primary intervention and included security measures, patient control of access, limited transmission of EMR data, blood pressure (BP) tracking, and appointment assistance. BP was the main outcome measure. Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale. Quality of care was assessed using the Clinician and Group Assessment Score (CAHPS) and the Patient Assessment of Chronic Illness Care. Frequency of use of medical services was self-reported. No impact of the PHR was observed on BP, patient activation, patient perceived quality, or medical utilization in the intention-to-treat analysis. Sub-analysis of intervention patients self-identified as active PHR users (25.7% of those with available information) showed a 5.25-point reduction in diastolic BP. Younger age, self-reported computer skills, and more positive provider communication ratings were associated with frequency of PHR use. Few patients provided with a PHR actually used the PHR with any frequency. Thus simply providing a PHR may have limited impact on patient BP, empowerment, satisfaction with care, or use of health services without additional education or clinical intervention designed to increase PHR use. http://ClinicalTrials.gov Identifier: NCT01317537.

  11. Oxytocin and autism: a systematic review of randomized controlled trials.

    PubMed

    Preti, Antonio; Melis, Mariangela; Siddi, Sara; Vellante, Marcello; Doneddu, Giuseppe; Fadda, Roberta

    2014-03-01

    Little is known about the effectiveness of pharmacological interventions on autism spectrum disorder (ASD). This is a systematic review of the randomized controlled trials (RCTs) of oxytocin interventions in autism, made from January 1990 to September 2013. A search of computerized databases was supplemented by manual search in the bibliographies of key publications. The methodological quality of the studies included in the review was evaluated independently by two researchers, according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. The review yielded seven RCTs, including 101 subjects with ASD (males=95) and 8 males with Fragile X syndrome. The main categories of target symptoms tested in the studies were repetitive behaviors, eye gaze, and emotion recognition. The studies had a medium to high risk of bias. Most studies had small samples (median=15). All the studies but one reported statistically significant between-group differences on at least one outcome variable. Most findings were characterized by medium effect size. Only one study had evidence that the improvement in emotion recognition was maintained after 6 weeks of treatment with intranasal oxytocin. Overall, oxytocin was well tolerated and side effects, when present, were generally rated as mild; however, restlessness, increased irritability, and increased energy occurred more often under oxytocin. RCTs of oxytocin interventions in autism yielded potentially promising findings in measures of emotion recognition and eye gaze, which are impaired early in the course of the ASD condition and might disrupt social skills learning in developing children. There is a need for larger, more methodologically rigorous RCTs in this area. Future studies should be better powered to estimate outcomes with medium to low effect size, and should try to enroll female participants, who were rarely considered in previous studies. Risk of bias should be minimized. Human long

  12. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants

    PubMed Central

    Sherman, Michael P; Adamkin, David H; Niklas, Victoria; Radmacher, Paula; Sherman, Jan; Wertheimer, Fiona; Petrak, Karel

    2016-01-01

    Objective To evaluate safety and explore efficacy of recombinant human lactoferrin (talactoferrin, TLf) to reduce infection. Study design We conducted a randomized, double blind, placebo-controlled trial in 6 0 infants with birth weights of 750 to 1500 grams. Each infant received enteral TLf or placebo on day 1 through 28 days of life; TLf dose was 150 mg/kg/12 hour. Primary outcomes were bacteremia, pneumonia, urinary tract infection, meningitis and necrotizing enterocolitis. Secondary outcomes were sepsis syndrome and suspected NEC. We recorded clinical, laboratory and radiologic findings, diseases, and adverse events in a database used for statistical analyses. Results Infants in the two groups had similar demographics. We attributed no enteral or organ-specific adverse events to TLf. There were two deaths in the group with TLf (posterior fossa hemorrhage and post-discharge sudden infant death), and one infant given placebo died of necrotizing enterocolitis. Hospital-acquired infections in the group with Tlf were 50% of that observed in infants fed placebo (p<0.04), including fewer blood or line infections, urinary tract infections, and pneumonia. Fourteen infants treated with TLf-weighing <1 kg at birth weight had no Gram-negative infections versus three of 14 infants given placebo. Non-infectious outcomes did not differ statistically in the two arms. No differences in growth or neurodevelopment occurred among infants treated with TLf and placebo during a one-year, post-hospitalization period. Conclusion We found no clinical or laboratory toxicity and a trend towards less infectious morbidity in infants treated with TLf. Trial registration ClinicalTrials.gov: NCT00854633. PMID:27260839

  13. The HONEYPOT randomized controlled trial statistical analysis plan.

    PubMed

    Pascoe, Elaine Mary; Lo, Serigne; Scaria, Anish; Badve, Sunil V; Beller, Elaine Mary; Cass, Alan; Hawley, Carmel Mary; Johnson, David W

    2013-01-01

    The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial. Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes. A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

  14. 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.

  15. Psychosocial and cardiac outcomes of yoga for ICD patients: a randomized clinical control trial.

    PubMed

    Toise, Stefanie C F; Sears, Samuel F; Schoenfeld, Mark H; Blitzer, Mark L; Marieb, Mark A; Drury, John H; Slade, Martin D; Donohue, Thomas J

    2014-01-01

    Because as many as 46% of implantable cardioverter defibrillator (ICD) patients experience clinical symptoms of shock anxiety, this randomized controlled study evaluated the efficacy of adapted yoga (vs usual care) in reducing clinical psychosocial risks shown to impact morbidity and mortality in ICD recipients. Forty-six participants were randomized to a control group or an 8-week adapted yoga group that followed a standardized protocol with weekly classes and home practice. Medical and psychosocial data were collected at baseline and follow-up, then compared and analyzed. Total shock anxiety decreased for the yoga group and increased for the control group, t(4.43, 36), P < 0.0001, with significant differences between these changes. Similarly, consequential anxiety decreased for the yoga group but increased for the control group t(2.86,36) P = 0.007. Compared to the control, the yoga group had greater overall self-compassion, t(-2.84,37), P = 0.007, and greater mindfulness, t(-2.10,37) P = 0.04, at the end of the study. Exploratory analyses utilizing a linear model (R(2) = 0.98) of observed device-treated ventricular (DTV) events revealed that the expected number of DTV events in the yoga group was significantly lower than in the control group (P < 0.0001). Compared to the control, the yoga group had a 32% lower risk of experiencing device-related firings at end of follow-up. Our study demonstrated psychosocial benefits from a program of adapted yoga (vs usual care) for ICD recipients. These data support continued research to better understand the role of complementary medicine to address ICD-specific stress in cardiac outcomes. ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.

  16. 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

  17. Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

    PubMed

    Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

    2014-03-01

    Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  18. Telephone Intervention for Pregnant Smokers: A Randomized Controlled Trial.

    PubMed

    Cummins, Sharon E; Tedeschi, Gary J; Anderson, Christopher M; Zhu, Shu-Hong

    2016-09-01

    Pregnant smokers are advised to quit; however, many struggle to do so. Behavioral counseling can increase quitting success, but the efficacy of telephone counseling for pregnant smokers has not been established. This study tests the efficacy of pregnancy-specific counseling, embedded in the ongoing operations of a state quitline. In this two-group RCT, participants were randomly assigned to the intervention (telephone counseling plus self-help materials, n=584) or the control group (self-help materials only, n=589). Participants were pregnant smokers (N=1,173) in the first 27 weeks of gestation who called a state quitline between September 2000 and May 2003 for help with quitting. The primary component of the intervention was telephone counseling using a semi-structured protocol developed specifically for pregnant smokers. It drew its basic structure and clinical content from a previously tested counseling protocol for adult quitline callers, while including pregnancy-specific content and additional counseling sessions (nine rather than the standard five). Subjects were evaluated on prolonged abstinence at the third trimester (about 29 weeks' gestation) and at 2 and 6 months postpartum. Data were analyzed in 2015. Abstinence was higher for the intervention than the control group at the end of pregnancy (30-day abstinence, 29.6% vs 20.1%; p<0.001); 2 months postpartum (90-day abstinence, 22.1% vs 14.8%; p<0.001); and 6 months postpartum (180-day abstinence, 14.4% vs 8.2%; p<0.001). Cotinine-corrected (≤13 ng/mL) 7-day abstinence rates at the end of pregnancy supported the intervention effect (35.8% vs 22.5%, p<0.001). A pregnancy-specific counseling protocol, embedded in a state quitline, was effective in helping pregnant smokers quit and stay quit postpartum. Wide adoption of this intervention could help reduce the rate of maternal smoking and prevent its devastating health consequences. This study is registered at www.clinicaltrials.gov NCT02144883. Copyright

  19. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    PubMed Central

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  20. 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.

  1. A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

    PubMed

    Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

    2017-04-01

    The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.

  2. Physical activity and mental health outcomes during menopause: a randomized controlled trial.

    PubMed

    Elavsky, Steriani; McAuley, Edward

    2007-04-01

    Many women experience detriments in mental health during the menopausal transition. Physical activity may attenuate these adverse outcomes but few studies investigating such effects exist. This study examined the effects of a 4-month randomized controlled exercise trial on mental health outcomes in 164 previously low-active middle-aged women (M age = 49.9; SD = 3.6). Participants completed body composition and fitness assessment and a battery of psychological measures at the beginning and end of a 4-month randomized controlled exercise trial with three arms: walking, yoga, control. The results indicated that walking and yoga were effective in enhancing positive affect and menopause-related QOL and reducing negative affect. Women who experienced decreases in menopausal symptoms across the trial also experienced improvements in all positive mental health and QOL outcomes and reductions in negative mental health outcomes. Whether menopausal symptoms increased or decreased across the trial appeared to be determined in part by whether there were increases or decreases in cardiorespiratory fitness. Physical activity appears to enhance mood and menopause-related QOL during menopause, however, other aspects of mental health may be affected only as a result of reduction in menopausal symptoms. Increasing cardiorespiratory fitness could be one way to reduce menopausal symptoms.

  3. Internet delivered support for tobacco control in dental practice: randomized controlled trial.

    PubMed

    Houston, Thomas K; Richman, Joshua S; Ray, Midge N; Allison, Jeroan J; Gilbert, Gregg H; Shewchuk, Richard M; Kohler, Connie L; Kiefe, Catarina I

    2008-11-04

    The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized. To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings. Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention. Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices' mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK. This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit. clinicaltrials.gov NCT00627185, http://www.webcitation.org/5c5Kugvzj.

  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. Robust controllers for the Middeck Active Control Experiment using Popov controller synthesis

    NASA Technical Reports Server (NTRS)

    How, Jonathan P.; Hall, Steven R.

    1993-01-01

    Recent work in robust control with real parameter uncertainties has focused on absolute stability and its connections to real mu theory. In particular, the research has investigated the Popov stability criterion and its associated Lur'e-Postnikov Liapunov functions. State space representations of this Popov stability analysis tests are included in an H2 design formulation to provide a powerful technique for robust controller synthesis. This synthesis approach uses a state space optimization procedure to design controllers that minimize an overbound of an H2 cost functional and satisfy stability analysis tests based on the Popov multiplier. The controller and stability multiplier coefficients are optimized simultaneously, which avoids the iteration and curve-fitting procedures required by the D-K algorithm of mu synthesis. While previous work has demonstrated this synthesis approach on benchmark control problems, the purpose of this paper is to use Popov controller synthesis to design robust compensators for the Middeck Active Control Experiment (MACE).

  6. 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

  7. 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.

  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. Preoperative Femoral Nerve Block for Hip Arthroscopy: A Randomized, Triple-Masked Controlled Trial.

    PubMed

    Xing, Jerry G; Abdallah, Faraj W; Brull, Richard; Oldfield, Stephanie; Dold, Andrew; Murnaghan, M Lucas; Whelan, Daniel B

    2015-11-01

    Arthroscopy has become a standard method of treatment for a variety of intra-articular hip disorders. While most arthroscopic hip procedures are performed as outpatient surgeries, patients can still experience significant postoperative pain and opioid-associated side effects. The potential benefits of a preoperative femoral nerve block (FNB) in hip arthroscopy were explored in a previous retrospective review. The study objective was to confirm these findings in a prospective randomized study. Randomized controlled trial; Level of evidence, 1. Fifty patients undergoing hip arthroscopy were included in this prospective, single-center, randomized controlled trial that was patient-, operator-, and assessor-blinded. Patients received either a preoperative ultrasound-guided FNB with 20 mL of 0.5% bupivacaine (FNB group) or normal saline (control group). Nerve blockade was confirmed via standardized sensory testing before the induction of general anesthesia. The primary endpoint was cumulative consumption of oral morphine equivalent at 24 hours after discharge. Secondary endpoints included opioid use at various time points, pain scores, Quality of Recovery (QoR-27) score, incidence of nausea and vomiting, time to discharge, block-related complications, falls at 24 hours, and patient satisfaction. Fifty patients completed the study, including 27 in the FNB group and 23 in the control group. Most patient characteristics were statistically similar between groups except for operative time, which was longer in the control group. Cumulative oral morphine consumption was lower in the FNB group at 48 hours; there was no difference at 24 hours or 7 days postoperatively. Pain scores were significantly lower up to 6 hours postoperatively in the FNB group compared with control; however, rebound pain was observed at 24 hours after discharge in patients who received FNB. There was no difference in most secondary outcomes. Importantly, a total of 6 patients in the FNB group reported

  10. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

    PubMed

    Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

    2012-01-25

    Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

  11. Preventing Youth Violence and Dropout: A Randomized Field Experiment. NBER Working Paper No. 19014

    ERIC Educational Resources Information Center

    Heller, Sara; Pollack, Harold A.; Ander, Roseanna; Ludwig, Jens

    2013-01-01

    Improving the long-term life outcomes of disadvantaged youth remains a top policy priority in the United States, although identifying successful interventions for adolescents--particularly males--has proven challenging. This paper reports results from a large randomized controlled trial of an intervention for disadvantaged male youth grades 7-10…

  12. 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

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

    PubMed

    Elbers, Nieke A; Akkermans, Arno J; Cuijpers, Pim; Bruinvels, David J

    2011-02-02

    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. 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. This study evaluates the effectiveness of an

  14. Experiments with More Than One Random Factor: Designs, Analytic Models, and Statistical Power.

    PubMed

    Judd, Charles M; Westfall, Jacob; Kenny, David A

    2017-01-03

    Traditional methods of analyzing data from psychological experiments are based on the assumption that there is a single random factor (normally participants) to which generalization is sought. However, many studies involve at least two random factors (e.g., participants and the targets to which they respond, such as words, pictures, or individuals). The application of traditional analytic methods to the data from such studies can result in serious bias in testing experimental effects. In this review, we develop a comprehensive typology of designs involving two random factors, which may be either crossed or nested, and one fixed factor, condition. We present appropriate linear mixed models for all designs and develop effect size measures. We provide the tools for power estimation for all designs. We then discuss issues of design choice, highlighting power and feasibility considerations. Our goal is to encourage appropriate analytic methods that produce replicable results for studies involving new samples of both participants and targets.

  15. Heterogenic control groups in randomized, controlled, analgesic trials of total hip- and knee arthroplasty.

    PubMed

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2017-11-17

    Postoperative analgesic interventions are often tested adjunct to basic non- opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities varies between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0-24h postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where NSAID was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligi- ble for subgroup comparisons. These subgroups received: 'opioid', 'NSAID+opioid', 'acetamino- phen+opioid', or 'NSAID+acetaminophen+opioid'. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Addi- tionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  16. Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

    PubMed

    Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

    2016-03-01

    The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001). In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. 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,…

  18. Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

    PubMed

    Nagao, Mizuho; Ikeda, Masanori; Fukuda, Norimasa; Habukawa, Chizu; Kitamura, Tetsuro; Katsunuma, Toshio; Fujisawa, Takao

    2018-01-01

    While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β 2 -agonists in this population, we conducted a randomized controlled trial. Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β 2 -agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219. From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033). Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  19. "Congratulations, you have been randomized into the control group!(?)": issues to consider when recruiting schools for matched-pair randomized control trials of prevention programs.

    PubMed

    Ji, Peter; DuBois, David L; Flay, Brian R; Brechling, Vanessa

    2008-03-01

    Recruiting schools into a matched-pair randomized control trial (MP-RCT) to evaluate the efficacy of a school-level prevention program presents challenges for researchers. We considered which of 2 procedures would be most effective for recruiting schools into the study and assigning them to conditions. In 1 procedure (recruit and match/randomize), we would recruit schools and match them prior to randomization, and in the other (match/randomize and recruitment), we would match schools and randomize them prior to recruitment. We considered how each procedure impacted the randomization process and our ability to recruit schools into the study. After implementing the selected procedure, the equivalence of both treatment and control group schools and the participating and nonparticipating schools on school demographic variables was evaluated. We decided on the recruit and match/randomize procedure because we thought it would provide the opportunity to build rapport with the schools and prepare them for the randomization process, thereby increasing the likelihood that they would accept their randomly assigned conditions. Neither the treatment and control group schools nor the participating and nonparticipating schools exhibited statistically significant differences from each other on any of the school demographic variables. Recruitment of schools prior to matching and randomization in an MP-RCT may facilitate the recruitment of schools and thus enhance both the statistical power and the representativeness of study findings. Future research would benefit from the consideration of a broader range of variables (eg, readiness to implement a comprehensive prevention program) both in matching schools and in evaluating their representativeness to nonparticipating schools.

  20. 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.

  1. The reporting quality of randomized controlled trials in orthodontics.

    PubMed

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

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

    PubMed

    Moss, David A; Crawford, Paul

    2015-01-01

    Sore throat is a common cause of pain in outpatient encounters. Battlefield auricular acupuncture (the placing of needles in specific points in the ear) is a modality used to treat acute pain associated with a variety of ailments. The aim of our study was to determine whether auricular acupuncture reduces pain, medication usage, and missed work hours when added to standard therapy in adult patients with acute sore throat. We conducted an unblinded, pragmatic, randomized controlled trial among adult, nonpregnant patients presenting to an Air Force family medicine clinic with pain from acute sore throat. A total of 54 patients were followed for 48 hours after treatment. Patients receiving auricular acupuncture reported lower pain scores than those who did not at 15 minutes (6.0 [95% confidence interval (CI), 5.4-6.6] vs 2.6 [95% CI, 1.7-3.5]; P < .0001), 6 hours (4.8 [95% CI, 4.0-5.6] vs 2.5 [95% CI, 1.6-3.4]; P = .0005), and 24 hours (4.1 [95% CI, 3.3-4.9] vs 1.3 [95% CI, 1.0-2.8]; P = .0006). They also reported taking fewer cumulative doses of pain medication at 6 hours (1.07 [95% CI, 0.69-1.45] vs 0.39 [95% CI, 0.2-0.58]; P = .003), 24 hours (2.63 [95% CI, 1.95-3.31] vs 1.37 [95% CI, 0.92-1.82]; P = .004), and 48 hours (4.07 [95% CI, 2.9-5.24] vs 2.19 [95% CI, 1.44-2.94]; P = .009). There was no difference in time missed from work between the auricular acupuncture and standard therapy groups. Compared with usual treatment, battlefield auricular acupuncture was associated with reduced sore throat pain for 24 hours and decreased use of pain medication for up to 48 hours. There was no apparent effect on hours missed from work. © Copyright 2015 by the American Board of Family Medicine.

  3. Pediatric selective mutism therapy: a randomized controlled trial.

    PubMed

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (P<0.001), Withdrawn (P=0.007) and Internalizing problems (P=0.020). Regarding SM severity according to SMQ assessment, children of group A showed a reduction of SM symptoms in all situations (school, P=0.003; family, P=0.018; and social, P=0.030 situations) and in SMQ total score (P<0.001). Our preliminary results suggest the positive effect of the psychomotor treatment in rehabilitative program for children affected by selective mutism, even if further studies are needed. The present study

  4. Echinacea for treating the common cold: A randomized controlled trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Mundt, Marlon; Bone, Kerry; Barlow, Shari; Ewers, Tola

    2011-01-01

    Background Echinacea is widely used to treat common cold. Objective To assess potential benefits of echinacea as common cold treatment. Design Randomized controlled trial with four parallel groups: 1) no pills, 2) placebo pills (blinded), 3) echinacea pills (blinded), or 4) echinacea pills (open-label). (NCT00065715) Setting Community-based trial. Participants People aged 12 to 80 years with new onset common cold. Interventions Extracts of Echinacea purpurea and E. angustifolia root were used to make tablets standardized to alkamide content. Indistinguishable placebo tablets contained only inert ingredients. Measurements The primary outcome was area-under-the-curve global severity, with severity assessed twice daily by self report on the Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Secondary outcomes included interleukin-8 and neutrophil count from nasal wash assessed at intake and two days later. Results Of 719 enrolled, 713 completed the protocol. Participants were 64% female and 88% white, with mean age 33.7 years. Mean global severity was 236 and 258 for blinded and unblinded echinacea, 264 for blinded placebo, and 286 for those without pills. Contrasting the two blinded groups yields a 28 point (95% CI = −69 to 13) trend toward benefit for echinacea (p=0.089). Mean illness duration for the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared to 6.87 days for blinded placebo and 7.03 for no pills. Contrasting blinded groups yields a 0.53 day (95% CI = −1.25 to 0.19) trend toward benefit (p = 0.075). Median change interleukin-8 (pg/mL) and neutrophil cell count were: no pills (30, 1), blinded placebo (39, 1), blinded echinacea (58, 2), and open-label echinacea (70, 1), also not statistically significant. Limitations Higher-than-expected variability limited power to detect small-but-potentially-important benefits. Conclusions The observed shorter illness duration and lower severity seen in the echinacea groups were

  5. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

    PubMed

    Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael

    2016-04-01

    Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial.

    PubMed

    Farrehi, Peter M; Clore, Kristen R; Scott, J Ryan; Vanini, Giancarlo; Clauw, Daniel J

    2016-12-01

    Patients are commonly provided tools in the hospital to overcome poor sleep. Whether education on use of sleep tools can impact health outcomes from a patient perspective is not known. We recruited 120 adults admitted to a nonintensive care unit cardiac-monitored floor. All patients received a set of sleep-enhancing tools (eye mask, ear plugs, and a white noise machine) and were randomized to receive direct education on use of and benefit of these sleep-enhancing tools (intervention), or an equal amount of time was spent discussing general benefits of sleep (control). Measurement of several symptom domains was assessed daily by health outcome survey responses, and change from baseline was assessed for differences between groups. Inpatient opioid use and length of stay were also measured. Participants randomized to receive the education intervention had a significantly greater decrease in fatigue scores over the 3 days, compared with controls (5.30 ± 6.93 vs 1.81 ± 6.96, t = 2.32, P = .028). There was a trend toward improvements in multiple other sleep-related domains, including sleep disturbance, sleep-related impairment, physical functioning, pain severity, or pain interference (all P >.140). There was no difference in length of stay between intervention and control groups (7.40 ± 7.29 vs 7.71 ± 6.06 days, P = .996). The change in number of opioid equivalents taken did not differ use between the groups (P = .688). In a randomized trial of education in the use of sleep-enhancing tools while hospitalized, patient fatigue was significantly improved, whereas several other patient-reported outcomes showed a trend toward improvements. Implementation of this very low-cost approach to improving sleep and well-being could substantially improve the patient care experience. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Controllability of social networks and the strategic use of random information.

    PubMed

    Cremonini, Marco; Casamassima, Francesca

    2017-01-01

    This work is aimed at studying realistic social control strategies for social networks based on the introduction of random information into the state of selected driver agents. Deliberately exposing selected agents to random information is a technique already experimented in recommender systems or search engines, and represents one of the few options for influencing the behavior of a social context that could be accepted as ethical, could be fully disclosed to members, and does not involve the use of force or of deception. Our research is based on a model of knowledge diffusion applied to a time-varying adaptive network and considers two well-known strategies for influencing social contexts: One is the selection of few influencers for manipulating their actions in order to drive the whole network to a certain behavior; the other, instead, drives the network behavior acting on the state of a large subset of ordinary, scarcely influencing users. The two approaches have been studied in terms of network and diffusion effects. The network effect is analyzed through the changes induced on network average degree and clustering coefficient, while the diffusion effect is based on two ad hoc metrics which are defined to measure the degree of knowledge diffusion and skill level, as well as the polarization of agent interests. The results, obtained through simulations on synthetic networks, show a rich dynamics and strong effects on the communication structure and on the distribution of knowledge and skills. These findings support our hypothesis that the strategic use of random information could represent a realistic approach to social network controllability, and that with both strategies, in principle, the control effect could be remarkable.

  8. 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…

  9. 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…

  10. 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…

  11. 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…

  12. Randomized controlled trial: effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization.

    PubMed

    Moy, Irene; Milad, Magdy P; Barnes, Randall; Confino, Edmond; Kazer, Ralph R; Zhang, Xingqi

    2011-02-01

    To evaluate the influence of "true" versus "sham" acupuncture on pregnancy rates (PRs) in women undergoing IVF. Randomized controlled trial, double-blinded with independent observer. Academic infertility clinic. One hundred sixty patients <38 years old undergoing IVF with or without intracytoplasmic sperm injection. Subjects were randomly allocated to the true or sham group and underwent acupuncture 25 minutes before and after ET. Subjects completed a McGill Pain Questionnaire regarding their clinical symptoms during ET. Clinical PR and clinical symptoms during ET. While the overall clinical PR was 51.25%, there was no significant difference between the arms of the study (true = 45.3% vs. sham = 52.7%); 33.1% of the patients had ultrasound-documented singleton pregnancy, and 15% of patients had twin gestations, while one patient in the true arm had a triplet gestation. There were significant differences in the subjective, affective, and total pain experience between both arms. The subjects in the true arm described their acupuncture session as being more "tiring" and "fearful" and experienced more "achiness" compared with their sham counterparts. There was no statistically significant difference in the clinical or chemical PRs between both groups. Patients undergoing true acupuncture had differing sensory experiences compared with patients in the sham arm. There were no significant adverse effects observed during the study, suggesting that acupuncture is safe for women undergoing ET. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  13. 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.

  14. A Randomized Controlled Trial of Bibliotherapy for Carers of Young People With First-Episode Psychosis

    PubMed Central

    McCann, Terence V.

    2013-01-01

    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. PMID:23172001

  15. Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

    PubMed

    Silverman, Henry J; Miller, Franklin G

    2004-03-01

    Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be

  16. 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.

  17. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial.

    PubMed

    Meisel, Susanne F; Beeken, Rebecca J; van Jaarsveld, Cornelia H M; Wardle, Jane

    2012-12-06

    Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. First-year university students (n = 800) will be randomized to receive either 1) their personal genetic test result for a gene (FTO) related to weight gain susceptibility in addition to a leaflet with simple weight control advice ('Feedback + Advice' group, FA), or 2) only the leaflet containing simple weight control advice ('Advice Only' group, AO).Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Current controlled trials ISRCTN91178663.

  18. Effects of a Brief Psychosocial Intervention on Inpatient Satisfaction: A Randomized Controlled Trial.

    PubMed

    Pace, Emma J; Somerville, Nicholas J; Enyioha, Chineme; Allen, Joseph P; Lemon, Latrina C; Allen, Claudia W

    2017-10-01

    Increasing attention is being paid to patients’ experience of hospitalization. BATHE (a brief psychosocial intervention that addresses Background, Affect, Trouble, Handling, and Empathy) has been found to improve patients’ outpatient experiences but has not yet been studied in inpatient settings. This randomized controlled trial (RCT) examined whether daily administration of BATHE would improve patients’ satisfaction with their hospital experience. BATHE is a brief psychosocial intervention designed to reduce distress and strengthen the physician-patient relationship. In February through March 2015 and February through March 2016, 25 patients admitted to the University of Virginia Family Medicine inpatient service were randomized to usual care or to the BATHE intervention. Participants completed a baseline measure of satisfaction at enrollment. Those in the intervention group received the BATHE intervention daily for five days or until discharge. At completion, participants completed a patient satisfaction measure. Daily administration of BATHE had strong effects on patients’ likelihood of endorsing their medical care as “excellent.” BATHE did not improve satisfaction by making patients feel more respected, informed or attended to. Rather, effects on satisfaction were mediated by patients’ perception that their physician showed “a genuine interest in me as a person." Our study suggests that patients are more satisfied with their hospitalization experience when physicians take a daily moment to check in with the patient “as a person” and not just as a medical patient. The brevity of the BATHE intervention indicates that this check-in need not be lengthy or overly burdensome for the already busy inpatient physician.

  19. [Application of expertise-based randomized controlled trials in acupuncture studies].

    PubMed

    Wu, Xiao-Hong; Zhao, Xiao-Feng; Wang, Shu

    2010-04-01

    Conventional randomized controlled trial is considered as the gold standard of clinical trials in evalua ting pharmacologic effectiveness. Whereas, it still has some faults in the non-pharmacy interventions, such as surgery, acupuncture, massage, etc. Expertise-based randomized controlled trial makes up for some deficiencies of conventional randomized controlled trial, which has made better developments in the field of surgery, however, there is no any relevant retrieval literature found in the acupuncture field. It is feasible and practical of the expertise-based randomized controlled trial to be applied and promoted in the acupuncture-moxibustion clinical research for a further degree. Expertise-based randomized controlled trials might become the trend of acupuncture-moxibustion clinical stu dies in the future.

  20. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  1. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

    PubMed

    Pallavicini, Federica; Gaggioli, Andrea; Raspelli, Simona; Cipresso, Pietro; Serino, Silvia; Vigna, Cinzia; Grassi, Alessandra; Morganti, Luca; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2013-06-28

    Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health--Interreality--that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies

  2. 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

  3. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

    PubMed

    Bian, Zhao-Xiang; Moher, David; Dagenais, Simon; Li, You-Ping; Liu, Liang; Wu, Tai-Xiang; Miao, Jiang-Xia

    2006-03-01

    To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical

  4. 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

  5. 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

  6. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns.

    PubMed

    Schmitt, Yuko S; Hoffman, Hunter G; Blough, David K; Patterson, David R; Jensen, Mark P; Soltani, Maryam; Carrougher, Gretchen J; Nakamura, Dana; Sharar, Sam R

    2011-02-01

    This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6-19 years old) performed range-of-motion exercises under a therapist's direction for 1-5 days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects' perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27-44%) in pain ratings during virtual reality. They also reported improved affect ("fun") during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. Copyright © 2010 Elsevier Ltd and ISBI. All rights reserved.

  7. A Randomized, Controlled Trial of Immersive Virtual Reality Analgesia during Physical Therapy for Pediatric Burn Injuries

    PubMed Central

    Schmitt, Yuko S.; Hoffman, Hunter G.; Blough, David K.; Patterson, David R.; Jensen, Mark P.; Soltani, Maryam; Carrougher, Gretchen J.; Nakamura, Dana; Sharar, Sam R.

    2010-01-01

    This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6–19 years old) performed range-of-motion exercises under a therapist’s direction for one to five days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects’ perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27–44%) in pain ratings during virtual reality. They also reported improved affect (“fun”) during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. PMID:20692769

  8. Music therapy improves the mood of patients undergoing hematopoietic stem cells transplantation (controlled randomized study).

    PubMed

    Dóro, Carlos Antonio; Neto, José Zanis; Cunha, Rosemyriam; Dóro, Maribel Pelaez

    2017-03-01

    The allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a therapeutic medical treatment for various neoplastic hematologic, congenital, genetic, or acquired disorders. In this procedure which combines high-dose chemotherapy and/or radiotherapy and has a high degree of cytotoxicity, the patient experiences solitary confinement, which causes psychological distress, pain, anxiety, mood disorders and can lead him/her to depression. Music therapy was applied with the purpose of decreasing this social confinement. This is a randomized controlled trial. Patients (n = 100) were selected randomly. Patients (n = 50) were selected for the Experimental Music Therapy Group (EMG) and n = 50 for the control group (CG) who received the standard treatment. The intervention of live music was applied using music therapy techniques. Assessment and quantification were made using the visual analog scale (VAS). The dependent variables were pain, anxiety, and mood of patients. The Mann-Whitney test (p < 0.05) applied was considered statistically significant when comparing the groups, improving mood significantly (EMG). Music therapy proved to be a strong ally in the treatment of patients undergoing allo-HSCT, providing bio-psychosocial welfare.

  9. 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,…

  10. 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…

  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, 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

  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...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

  13. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2015-10-01

    Eye movement desensitization and reprocessing ( EMDR ): Basic principles, protocols, and procedures (2nd ed.) (2nd ed...A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine, and pill placebo in the treatment of...Ph.D. CONTRACTING ORGANIZATION: Palo Alto Veterans Institute for Research and Education Palo Alto, CA 94304-1290 REPORT DATE: October 2015

  14. Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review.

    PubMed

    Flory, James H; Mushlin, Alvin I; Goodman, Zachary I

    2016-12-01

    Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted. The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems.

  15. Environmental changes to control obesity: a randomized controlled trial in manufacturing companies.

    PubMed

    Brehm, Bonnie J; Gates, Donna M; Singler, Mary; Succop, Paul A; D'Alessio, David A

    2011-01-01

    To determine the effects of an environmental intervention on obesity, disease risk factors, and dietary intake in an employee population. Randomized controlled community trial. Eight manufacturing companies in Kentucky with ∼150 to 350 employees each. Randomly selected employees. Multicomponent environmental intervention that included employee advisory committees, point-of-decision prompts, walking paths, cafeteria/vending changes, and educational materials. Height; weight; body fat; blood pressure; fasting lipids, glucose and insulin; and dietary intake were assessed prior to and 3, 6, and 12 months after initiation of the intervention. Mixed-model repeat-measure analyses of covariance were used to analyze data collected over the study period. Categorical data were analyzed in contingency tables. A p value of .05 was used to judge statistical significance. There were no intervention effects for outcome variables, with the exception of lower intake of saturated fat and dietary cholesterol in the intervention group compared to the control group. Over the course of the study, changes in anthropometry and biomeasures were similar in both groups. Findings indicate that subtle environmental changes alone may not impact employees' weight and health; however, such institutional-level approaches may be essential to support healthy lifestyle habits that are initiated by more intensive efforts. Academic researchers should continue to partner with employers and practitioners to develop, implement, and evaluate innovative health promotion strategies including environmental interventions. Copyright © 2011 by American Journal of Health Promotion, Inc.

  16. Surgical Pain Control With Ropivacaine by Atomized Delivery (Spray): A Randomized Controlled Trial.

    PubMed

    Collins, Gretchen G; Gadzinski, Jill A; Fitzgerald, Garrett D; Sheran, Jordan; Wagner, Sarah; Edelstein, Steven; Mueller, Elizabeth R

    2016-01-01

    To investigate the role of intraoperative atomized intraperitoneal ropivacaine (AIR) as an adjuvant to anesthetic agents at the time of minimally invasive pelvic surgery. Double-blind, randomized controlled trial. Randomized controlled trial (Canadian Task Force classification I). Tertiary care teaching hospital. Fifty-five patients who underwent laparoscopic and robotic gynecologic procedures. Patients received AIR or atomized intraperitoneal saline (AIS) (dose, 2 mg/kg) immediately after the initiation of pneumoperitoneum. Visual analog scale (VAS) pain scores and narcotic use (in morphine equivalents) were collected and recorded at 2, 4, 8, and 12 hours postoperatively. Fifty-five patients completed the study protocol and data collection, with 30 patients allocated to the AIS group and 25 patients allocated to the AIR group. Demographic and surgical variables did not vary between the groups, with the exception of median operative duration. Postoperative VAS scores at 2, 4, 8, and 12 postoperative hours were higher in the AIS group, but the difference failed to reach statistical significance. Narcotic use was also similar in the 2 groups. The use of intraperitoneal ropivacaine was not associated with a statistically significant difference in patients' postoperative VAS scores. Thus, in contrast to findings of similar studies performed in general surgery, AIR might not confer a benefit in women undergoing minimally invasive gynecologic procedures. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

  17. The Effectiveness of Pregabalin for Post-Tonsillectomy Pain Control: A Randomized Controlled Trial

    PubMed Central

    Park, Soo Seog; Kim, Dong-Hyun; Nam, In-Chul; Lee, Il-Hwan; Hwang, Jae-Woong

    2015-01-01

    Background Although various analgesics have been used, postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients. Objective The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo (diazepam) on postoperative pain control in patients undergoing tonsillectomy. Methods Forty-eight adult patients were randomly divided into a control group and a pregabalin group. Preoperatively, patients in the control group received 4 mg diazepam orally as placebo, whereas those in the pregabalin group received 300 mg pregabalin orally. All participants were provided with patient-controlled analgesia using fentanyl for 24 hours after surgery. Postoperative pain treatment included acetaminophen 650 mg three times daily for 8 postoperative days. The primary outcome measure was the total amount of patient-controlled fentanyl consumption after tonsillectomy. Secondary outcome measures were the number of injections of ketorolac tromethamine (each 30 mg) requested by patients, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting after the surgery. P < 0.05 was considered statistically significant. Results The total amount of fentanyl demanded decreased significantly in the pregabalin group (P < 0.001). There were no significant differences in the number of ketorolac tromethamine injections, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting between the two groups. Conclusion Administration of 300 mg pregabalin prior to tonsillectomy decreases fentanyl consumption compared with that after 4 mg diazepam, without an increased incidence of adverse effects. Trial Registration KCT0001215 PMID:25706948

  18. Reproducible and controllable induction voltage adder for scaled beam experiments

    SciTech Connect

    Sakai, Yasuo; Nakajima, Mitsuo; Horioka, Kazuhiko

    2016-08-15

    A reproducible and controllable induction adder was developed using solid-state switching devices and Finemet cores for scaled beam compression experiments. A gate controlled MOSFET circuit was developed for the controllable voltage driver. The MOSFET circuit drove the induction adder at low magnetization levels of the cores which enabled us to form reproducible modulation voltages with jitter less than 0.3 ns. Preliminary beam compression experiments indicated that the induction adder can improve the reproducibility of modulation voltages and advance the beam physics experiments.

  19. Thermal control of the Lidar In-Space Technology Experiment

    NASA Technical Reports Server (NTRS)

    Carlson, Ann B.; Roettker, William A.

    1987-01-01

    The Lidar In-Space Technology Experiment (LITE) will employ lidar techniques to study the atmosphere from space. The LITE instrument will be flown in the Space Shuttle Payload Bay with an earth directed orientation. The experiment thermal control incorporates both active and passive techniques. The Laser Transmitter Module (LTM) and the system electronics will be actively cooled through the Shuttle pallet coolant loop. The receiver system and experiment platform will be passsively controlled through the use of insulation and component surface properties. This paper explains the thermal control techniques used and the analysis results, with primary focus on the receiver system.

  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. Experiments on individual strategy updating in iterated snowdrift game under random rematching.

    PubMed

    Qi, Hang; Ma, Shoufeng; Jia, Ning; Wang, Guangchao

    2015-03-07

    How do people actually play the iterated snowdrift games, particularly under random rematching protocol is far from well explored. Two sets of laboratory experiments on snowdrift game were conducted to investigate human strategy updating rules. Four groups of subjects were modeled by experience-weighted attraction learning theory at individual-level. Three out of the four groups (75%) passed model validation. Substantial heterogeneity is observed among the players who update their strategies in four typical types, whereas rare people behave like belief-based learners even under fixed pairing. Most subjects (63.9%) adopt the reinforcement learning (or alike) rules; but, interestingly, the performance of averaged reinforcement learners suffered. It is observed that two factors seem to benefit players in competition, i.e., the sensitivity to their recent experiences and the overall consideration of forgone payoffs. Moreover, subjects with changing opponents tend to learn faster based on their own recent experience, and display more diverse strategy updating rules than they do with fixed opponent. These findings suggest that most of subjects do apply reinforcement learning alike updating rules even under random rematching, although these rules may not improve their performance. The findings help evolutionary biology researchers to understand sophisticated human behavioral strategies in social dilemmas. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. A Randomized Controlled Trial of Listening to Recorded Music for Heart Failure Patients: Study Protocol.

    PubMed

    Burrai, Francesco; Hasan, Wohaib; Fancourt, Daisy; Luppi, Marco; Di Somma, Salvatore

    2016-01-01

    To describe a conceptual framework and to test the effectiveness of a recorded music-listening protocol on symptom burden and quality of life in heart failure (HF) patients. Heart failure is an important public health problem. Many HF patients experience symptoms burden and poor quality of life, even with current improvements in pharmacological treatments. Recorded music listening has been shown to improve outcomes in cardiovascular patients, but it has never been tested on HF patients and with a specific music protocol and a randomized controlled trial methodology. This study is a multicenter blinded randomized controlled trial that will involve 150 patients. Eligible patients will have a diagnosis of HF, in New York Heart Association functional classification of I to III, and will be recruited from 3 large hospitals in Northern Italy. Patients will be randomly allocated in a 1:1 ratio to receive recorded music-listening intervention with or without standard care for 3 months. Data will be collected at baseline and at the end of the first, second, and third month during the intervention, and at 6 months for follow-up. The following variables will be collected from HF patients with validated protocols: quality of life (primary endpoint), use of emergency services, rehospitalization rates, all cause mortality, self-care, somatic symptoms, quality of sleep, anxiety and depression symptoms, and cognitive function. This study will examine the effect of recorded music listening on HF patients and will inform clinical practice. If the findings are found to be positive, the protocol could be used as a tool for evidence-based applications of recorded music in HF patients. The framework developed in this study may be helpful for future research focused on the effects of music in HF patients.

  3. In Silico Pooling of ChIP-seq Control Experiments

    PubMed Central

    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. PMID:25380244

  4. Does peer use influence adoption of efficient cookstoves? Evidence from a randomized controlled trial in Uganda.

    PubMed

    Beltramo, Theresa; Blalock, Garrick; Levine, David I; Simons, Andrew M

    2015-01-01

    The authors examined the effect of peer usage on consumer demand for efficient cookstoves with a randomized controlled trial in rural Uganda. The authors tested whether the neighbors of buyers who ordered and received a stove are more likely to purchase an efficient cookstove than the neighbors of buyers who ordered but have not yet received a stove. The authors found that neighbors of buyers who have experience with the stove are not detectably more likely to purchase a stove than neighbors of buyers who have not yet received their stove. The authors found evidence of peer effects in opinions about efficient cookstoves. Knowing that a prominent member of the community has the efficient stove predicts 17-22 percentage points higher odds of strongly favoring the stove. However, this more favorable opinion seemingly has no effect on purchase decisions.

  5. Telehealth to improve asthma control in pregnancy: A randomized controlled trial.

    PubMed

    Zairina, Elida; Abramson, Michael J; McDonald, Christine F; Li, Jonathan; Dharmasiri, Thanuja; Stewart, Kay; Walker, Susan P; Paul, Eldho; George, Johnson

    2016-07-01

    Poorly controlled asthma during pregnancy is hazardous for both mother and foetus. Better asthma control may be achieved if patients are involved in regular self-monitoring of symptoms and self-management according to a written asthma action plan. Telehealth applications to optimize asthma management and outcomes in pregnant women have not yet been evaluated. This study evaluated the efficacy of a telehealth programme supported by a handheld respiratory device in improving asthma control during pregnancy. Pregnant women with asthma (n = 72) from two antenatal clinics in Melbourne, Australia, were randomized to one of two groups: (i) intervention-involving a telehealth programme (management of asthma with supportive telehealth of respiratory function in pregnancy (MASTERY(©) )) supported by a handheld respiratory device and an Android smart phone application (Breathe-easy(©) ) and written asthma action plan or (ii) control-usual care. The primary outcome was change in asthma control at 3 and 6 months (prenatal). Secondary outcomes included changes in quality of life and lung function, and perinatal/neonatal outcomes. At baseline, participants' mean (± standard deviation) age was 31.4 ± 4.5 years and gestational age 16.7 ± 3.1 weeks. At 6 months, the MASTERY group had better asthma control (P = 0.02) and asthma-related quality of life (P = 0.002) compared with usual care. There were no significant differences between groups in lung function, unscheduled health-care visits, days off work/study, oral corticosteroid use, or perinatal outcomes. Differences between groups were not significant at 3 months. Telehealth interventions supporting self-management are feasible and could potentially improve asthma control and asthma-related quality of life during pregnancy. © 2016 Asian Pacific Society of Respirology.

  6. A randomized controlled trial of simulation-based training for ear, nose, and throat emergencies.

    PubMed

    Smith, Matthew Edward; Navaratnam, Annakan; Jablenska, Lily; Dimitriadis, Panagiotis A; Sharma, Rishi

    2015-08-01

    Life-threatening ear, nose, and throat (ENT) emergencies are uncommon but require immediate skilled management. We investigated if traditional lecture-based teaching can be improved by a simulation and lecture hybrid approach. A single-blinded, prospective, randomized controlled trial. Two groups of interns with no previous ENT experience were randomized to one of two training groups: a simulation/lecture hybrid group or a lecture-only control group. Both groups received 90 minutes of training covering the assessment of critically ill patients and four ENT emergency topics. Both groups received the same initial lecture slides. The control group received additional slides, and the simulation group received simulated emergency scenario training using basic mannequins. Following the training, candidates were asked to provide feedback on their perception of training, and they were formally assessed with a standardized one-to-one viva. Thirty-eight interns were recruited: 18 in the control group and 20 in the simulation group. The candidates in the simulation group performed significantly better in all viva situations (P < .05) and had better perception of learning (P < .05). Additionally, the simulation group was more likely to recommend the training to a colleague (P < .05). We have demonstrated that replacing traditional lecture-based training with a mixture of lectures and emergency scenario simulation is more effective at preparing junior doctors for ENT emergencies, and better met their learning needs. Implementing this kind of teaching is feasible with a minimum of additional resources or time. 1b © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  7. Activity groups for people with schizophrenia: a randomized controlled trial.

    PubMed

    Dean, Madeleine; Weston, Adam R W; Osborn, David P; Willis, Suzie; Patterson, Sue; Killaspy, Helen; Leurent, Baptiste; Crawford, Mike J

    2014-08-01

    UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score = -6.0, 95% CI -2.3 to -9.8) but global functioning did not (change in GAF score = 0.8, 95% CI -1.7 to 3.3). No significant differences were found between treatment arms. Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.

  8. Controlling Random Waves with Digital Building Blocks Based on Supersymmetry

    NASA Astrophysics Data System (ADS)

    Yu, Sunkyu; Piao, Xianji; Park, Namkyoo

    2017-11-01

    Harnessing multimode waves allows high information capacity through modal expansions. Although passive multimode devices for broadband responses have been demonstrated in momentum or frequency domains, the difficulty in achieving collective manipulation of all eigenmodes has hindered the implementation of digital multimode devices such as switching. Here we propose building blocks for digital switching of spatially random waves based on parity-converted supersymmetric pairs of multimode potentials. We reveal that unbroken supersymmetric transformations of any parity-symmetric potential derive the parity reversal of all eigenmodes, which allows the complete isolation of random waves in the "off" state. With two representative solvable potentials, building blocks for binary and many-valued logics are then demonstrated for random waves: a harmonic pair for binary switching of arbitrary wave fronts and a Pöschl-Teller pair for multilevel switching which implements fuzzy membership functions. Our results realizing the transfer of arbitrary wave fronts between wave elements will lay the foundation of high-bandwidth data processing.

  9. Simulation training program for midwives to manage postpartum hemorrhage: A randomized controlled trial.

    PubMed

    Kato, Chiho; Kataoka, Yaeko

    2017-04-01

    To explore the effectiveness of a simulation training program for midwives in performance and knowledge for the management of postpartum hemorrhage (PPH). The study design was a randomized controlled trial. Midwives working at one obstetrics ward in an urban area were randomly assigned to simulation training program or no training. This "simulation program" included pre study e-learning and simulation. Inclusion criteria were midwives who: 1) had two or three years of clinical experience, 2) worked in an obstetrics ward, and 3) had experience with birth assistance. There was one exclusion criterion namely prior experience of simulation training for PPH. Change in performance was evaluated using a PPH scenario performance test at one month after the simulation training. Change in knowledge was evaluated by a 25-item multiple-choice questionnaire completed shortly before the training and one month after the training. The ethical review committee of St Luke's International University granted approval (No. 14-096). Eighty-one midwives were randomly assigned to either the intervention group (n=40) or the control group (n=41). Performance in the simulation training group was significantly better in comparison to the no training group; mean performance score was 23.85(SD 2.71) in the training group versus 18.00(SD 3.01) in the no training group (MD 5.85 95% CI 4.85-7.12, t=9.17, p<0.001). Knowledge was significantly increased in the simulation training group; amount of knowledge score was 3.65(SD 3.40) in the training group versus -0.02(SD 3.02) in the no training group (MD 3.67 95% CI 2.25-5.10, t=5.14, p<0.001). Both performance and knowledge about the management of PPH were significantly improved after simulation training. However, assessments of long-term effects on performance, and knowledge and the clinical outcomes in managing of obstetric complications are necessary to adequately evaluate the effectiveness of simulation training. Copyright © 2017 Elsevier Ltd

  10. Highlighting consensus among medical scientists increases public support for vaccines: evidence from a randomized experiment.

    PubMed

    van der Linden, Sander L; Clarke, Chris E; Maibach, Edward W

    2015-12-03

    A substantial minority of American adults continue to hold influential misperceptions about childhood vaccine safety. Growing public concern and refusal to vaccinate poses a serious public health risk. Evaluations of recent pro-vaccine health communication interventions have revealed mixed results (at best). This study investigated whether highlighting consensus among medical scientists about childhood vaccine safety can lower public concern, reduce key misperceptions about the discredited autism-vaccine link and promote overall support for vaccines. American adults (N = 206) were invited participate in an online survey experiment. Participants were randomly assigned to either a control group or to one of three treatment interventions. The treatment messages were based on expert-consensus estimates and either normatively described or prescribed the extant medical consensus: "90 % of medical scientists agree that vaccines are safe and that all parents should be required to vaccinate their children". Compared to the control group, the consensus-messages significantly reduced vaccine concern (M = 3.51 vs. M = 2.93, p < 0.01) and belief in the vaccine-autism-link (M = 3.07 vs M = 2.15, p < 0.01) while increasing perceived consensus about vaccine safety (M = 83.93 vs M = 89.80, p < 0.01) and public support for vaccines (M = 5.66 vs M = 6.22, p < 0.01). Mediation analysis further revealed that the public's understanding of the level of scientific agreement acts as an important "gateway" belief by promoting public attitudes and policy support for vaccines directly as well as indirectly by reducing endorsement of the discredited autism-vaccine link. These findings suggest that emphasizing the medical consensus about (childhood) vaccine safety is likely to be an effective pro-vaccine message that could help prevent current immunization rates from declining. We recommend that clinicians and public health officials

  11. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial.

    PubMed

    Mercier, Rebecca J; Liberty, Abigail

    2014-12-01

    To determine if intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block reduces pain during laminaria insertion, when compared with paracervical block and saline placebo. This was a randomized, double blind placebo-controlled trial. Women presenting for abortion by dilation and evacuation (D&E) at 14-24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2% lidocaine or 5 mL of normal saline, in addition to standard paracervical block with 20 cc of 0.25% bupivacaine. Our primary outcome was self-reported pain scores on a 100mm Visual Analogue Scale (VAS) immediately following laminaria insertion. Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48-h interval between laminaria insertion and D&E procedure. Seventy-two women were enrolled, and data for 67 women were analyzed, only two of whom were more than 21 weeks on gestation. The range of pain scores at both time points was large (1-90 mm at laminaria insertion; 0-100mm in laminaria-D&E interval). Mean pain scores were not different between treatment groups at laminaria insertion, (33 vs. 32, p=.8) or in the laminaria - D&E interval (43 vs. 44, p=.9). Intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo. Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo. Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. 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.

  13. Impact of a personalized versus moderate-intensity exercise prescription: a randomized controlled trial.

    PubMed

    Schneider, Margaret; Schmalbach, Priel; Godkin, Sophia

    2017-04-01

    Effective approaches to promote adolescent physical activity are needed. Moreover, a one-size-fits-all approach has been minimally successful to date. This randomized controlled trial evaluates a theory-based personalized exercise prescription to enhance motivation for being active and physical activity participation among adolescent reluctant exercisers. Adolescents were characterized by affective style as reluctant (predisposed to negative affect during exercise) or latent (predisposed to positive affect during exercise) exercisers based on their affective response to an acute exercise task, and then randomly assigned to an exercise prescription of either a personalized or a moderate intensity. Assignment was double-blind. Assessments were pre- and post- the 8-week intervention. Participants were an ethnically diverse group of adolescents (19 % non-Latino White) in a public middle-school. The exercise intensity manipulation and assessments took place at the school site during regular Physical Education. Participants were assigned to either a moderate-intensity exercise prescription [target heart rate (HR) range 60-80 % of HR max] or a personalized exercise prescription corresponding to an intensity that "feels good" to the individual for 8 weeks during daily Physical Education. Outcome measures included exercise-related intrinsic motivation (via questionnaire), and daily moderate-to-vigorous physical activity (MVPA; via accelerometer). The exercise intensity manipulation did not yield actual differences in exercise intensity during PE, and had no effect on either Intrinsic Motivation or MVPA. There was no significant interaction between affective style and group assignment in predicting Intrinsic Motivation or MVPA. This study did not find support for a link between affective experiences during exercise and physical activity participation. Providing adolescents with a personalized exercise intensity prescription and asking them to follow the prescription

  14. A controlled experiment to evaluate the impact of summer research experiences on attitudes towards science in high school aged students

    NASA Astrophysics Data System (ADS)

    White, M. A.; Tcherednichenko, I.; Hamar, M.; Taylor, M. J.; Litizzette, L.

    2006-12-01

    United States funding agencies increasingly are supporting activities designed to increase the enrollment of United States high school students in science, math, or engineering careers. However, in many cases, the likely outcomes of educational activities are unknown. A common approach within the physical and natural sciences is to provide high school aged students with a summer research experience, with the expectation that such experiences will increase student interest in science, possibly as a career choice. With funding support from the National Aeronautics and Space Administration New Investigator Grant program, we conducted a controlled experiment to test this assumption. In collaboration with Mountain Crest High School in Logan, UT, we recruited 40 students currently enrolled in science courses, assessed attitudes towards science (with informed consent), and randomly assigned 20 students to a control group and 20 students to an experimental group. Students in the experimental group were paired with faculty and graduate students in a wide range of field and laboratory research groups in natural resources and biology. Students were employed in at least two different research groups for an average of 30-40 hours per week for eight weeks in the summer of 2006. Following the completion of the summer work experience, we again assessed attitudes towards science in both groups and gathered additional information from the experimental group on satisfaction with the work experience and reasons for participating. Results are presented and discussed.

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

    PubMed

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

    2017-10-13

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

  16. Balance versus resistance training on postural control in patients with Parkinson's disease: a randomized controlled trial.

    PubMed

    Santos, Suhaila M; da Silva, Rubens A; Terra, Marcelle B; Almeida, Isabela A; de Melo, Lúcio B; Ferraz, Henrique B

    2017-04-01

    Evidences have shown that physiotherapy programs may improve the balance of individuals with Parkinson's disease (PD), although it is not clear which specific exercise program is better. The aim of this study was to compare the effectiveness of balance versus resistance training on postural control measures in PD patients. Randomized controlled trial. The study was conducted in a physiotherapy outpatient clinic of a university hospital. A total of 40 PD participants were randomly divided into two groups: balance training (BT) and resistance training (RT). The BT group focused on balance training, functional independence and gait while the RT group performed resistance exercises emphasizing the lower limbs and trunk, both supervised by trained physiotherapists. Therapy sessions were held twice a week (at 60 minutes), totaling 24 sessions. The primary outcome was evaluated by force platform with center of pressure sway measures in different balance conditions and the secondary outcome was evaluated by Balance Evaluation Systems Test (BESTest) scale to determine the effects of the intervention on postural control. Significant improvement of postural control (pre vs. post 15.1 vs. 9.6 cm2) was only reported in favor of BT group (d=1.17) for one-legged stand condition on force platform. The standardized mean difference between groups was significantly (P<0.02), with 36% of improvement for BT vs. 0.07% for RT on this condition. Significant improvement (P<0.05) was also observed in favor of BT (in mean 3.2%) for balance gains in some BESTest scores, when compared to RT group (-0.98%). Postural control in Parkinson's disease is improved when training by a directional and specific balance program than a resistance training program. Balance training is superior to resistance training in regard to improving postural control of individuals with PD. Gold standard instruments (high in cost and difficult to access) were used to assess balance, as well as scales with clinical

  17. A single blind randomized control trial on support groups for Chinese persons with mild dementia.

    PubMed

    Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

    2014-01-01

    Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

  18. A randomized controlled trial of mindfulness to reduce stress and burnout among intern medical practitioners.

    PubMed

    Ireland, Michael J; Clough, Bonnie; Gill, Kim; Langan, Fleur; O'Connor, Angela; Spencer, Lyndall

    2017-04-01

    Stress and burnout are highly prevalent among medical doctors, and are associated with negative consequences for doctors, patients, and organizations. The purpose of the current study was to examine the effectiveness of a mindfulness training intervention in reducing stress and burnout among medical practitioners, by means of a Randomised Controlled Trial design. Participants were 44 intern doctors completing an emergency department rotation in a major Australian hospital. Participants were randomly assigned to either an active control (one hour extra break per week) or the 10-week mindfulness training intervention. Measures of stress and burnout were taken pre-, mid- and post intervention. Participants undergoing the 10-week mindfulness training program reported greater improvements in stress and burnout relative to participants in the control condition. Significant reduction in stress and burnout was observed for participants in the mindfulness condition. No such reductions were observed for participants in the control condition. Mindfulness interventions may provide medical practitioners with skills to effectively manage stress and burnout, thereby reducing their experience of these symptoms. It is likely that doctors would benefit from the inclusion of such a training program as a part of their general medical education.

  19. 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

  20. 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…

  1. 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…

  2. NanoRacks Biorack Experiment Container and Controller Installation (Manual)

    NASA Image and Video Library

    2014-04-30

    ISS039-E-017566 (30 April 2014) --- NASA astronaut Steve Swanson, Expedition 39 flight engineer, works with NanoRacks hardware in the Kibo laboratory of the Japan Aerospace Exploration Agency (JAXA). He is about to insert BioRack experiment containers and experiment controllers into the BioRack frame.

  3. NanoRacks Biorack Experiment Container and Controller Installation (Manual)

    NASA Image and Video Library

    2014-04-30

    ISS039-E-017568 (30 April 2014) --- NASA astronaut Steve Swanson, Expedition 39 flight engineer, works with NanoRacks hardware in the Kibo laboratory of the Japan Aerospace Exploration Agency (JAXA). He is in the process of inserting BioRack experiment containers and experiment controllers into the BioRack frame. .

  4. Open Source Software for Experiment Design and Control. (tutorial)

    ERIC Educational Resources Information Center

    Hillenbrand, James M.; Gayvert, Robert T.

    2005-01-01

    The purpose of this paper is to describe a software package that can be used for performing such routine tasks as controlling listening experiments (e.g., simple labeling, discrimination, sentence intelligibility, and magnitude estimation), recording responses and response latencies, analyzing and plotting the results of those experiments,…

  5. Effects of an anger management and stress control program on smoking cessation: a randomized controlled trial.

    PubMed

    Yalcin, Bektas Murat; Unal, Mustafa; Pirdal, Hasan; Karahan, Tevfik Fikret

    2014-01-01

    The purpose of this study was to investigate the effects of a cognitive behavioral therapy-oriented anger management and stress control program on smokers' quit rates. Of 2348 smokers, 350 were randomly allocated into study and control groups (n = 175 each). An individualized therapy cessation technique was selected for each participant (combination of behavioral counseling, nicotine replacement therapy, and/or pharmacotherapy). The participants in the control group attended a standard quit program, whereas the study group also received an additional 5-session (90 minutes each) cognitive behavioral therapy-oriented program aimed at improving their anger and stress coping skills. At the beginning of the study, both groups were asked to complete the Trait Anger Scale (TAS) of the State and Trait Anger Scale and the Self-Confident (SCS) and Hopeless (HS) subscales of the Stress Coping Styles Inventory; pretest smoking status of both groups and their coping skills were compared with each other as soon as the program ended (post-test results) and after 3 and 6 months (first and second follow-up tests). Although there was no difference between pretest scores on the TAS (P = .234), SCS (P = .130), and HS (P = .148) subscales, post-test results indicate that the study groups' TAS and HS scores decreased and SCS scores increased (P < .001), whereas there was no change in the control group (P > .05). The study group had a better quit level after 6 months compared with the control group (44% vs 27.4%; P < .001). The anger management and stress control program was found to have a significant effect on cessation (odds ratio, 2.09; 95% confidence interval, 1.14-3.85). The anger and stress coping skills program may increase the success of quitting smoking. © Copyright 2014 by the American Board of Family Medicine.

  6. Adaptive control of the propagation of ultrafast light through random and nonlinear media

    NASA Astrophysics Data System (ADS)

    Moores, Mark David

    2001-12-01

    Ultrafast light sources generate coherent pulses with durations of less than one picosecond, and represent the next generation of illuminators for medical imaging and optical communications applications. Such sources are already widely used experimentally. Correction of temporal widths or pulse envelopes after traversal of optically non-ideal materials is critical for the delivery of optimal ultrashort pulses. It is important to investigate the physical mechanisms that distort pulses and to develop and implement methods for minimizing these effects. In this work, we investigate methods for characterizing and manipulating pulse propagation dynamics in random (scattering) and nonlinear optical media. In particular, we use pulse shaping to manipulate the light field of ultrashort infrared pulses. Application of spectral phase by a liquid crystal spatial light modulator is used to control the temporal pulse shape. The applied phase is controlled by a genetic algorithm that adaptively responds to the feedback from previous phase profiles. Experiments are detailed that address related aspects of the character of ultrafast pulses-the short timescales and necessarily wide frequency bandwidths. Material dispersion is by definition frequency dependent. Passage through an inhomogeneous system of randomly situated boundaries (scatterers) causes additional distortion of ballistic pulses due to multiple reflections. The reflected rays accumulate phase shifts that depend on the separation of the reflecting boundaries and the photon frequency. Ultrafast bandwidths present a wide range of frequencies for dispersion and interaction with macroscopic dielectric structure. The shaper and adaptive learning algorithm are used to reduce these effects, lessening the impact of the scattering medium on propagating pulses. The timescale of ultrashort pulses results in peak intensities that interact with the electronic structure of optical materials to induce polarization that is no longer

  7. Data acquisition and experiment control system of the project Maus (materials science experiments under weightlessness)

    NASA Astrophysics Data System (ADS)

    Lensch, D.

    In the context of Spacelab and Shuttle utilization, it is possible to conduct experiments in 'Small Self Contained Packages' (SSCP). This possibility exists primarily for experiments related to materials research/industrial processing engineering. The program involved is called 'get away special' (GAS). The project Maus was established in West Germany with the aim to participate in the program GAS. The autonomous design of the considered experiments made it necessary to develop an electronic unit for the control and the automatic conduction of the experiment. In addition, the process of the acquisition and the recording of the experimental data is also controlled.

  8. Reducing the stigma of depression through neurobiology-based psychoeducation: a randomized controlled trial.

    PubMed

    Han, Der-Yan; Chen, Sue-Huei

    2014-09-01

    Attribution theory claims that people who are stigmatized experience more negative emotional and behavioral reactions from others when they are thought to be responsible for their problems. Accordingly, this study proposed a neurobiology-based psychoeducational intervention, which attempted to reduce people's blameworthy attitudes toward and social distance from depressed individuals. One hundred and thirty-two college students were randomly assigned to an experimental and control group. Participants in the experimental group received a 30-min lecture on neurobiology-based psychoeducation for depressive disorders, and were asked to fill out questionnaires before and 2 weeks after the intervention. The control group, with no intervention, also filled out the same questionnaires before and 2 weeks after the experiment. The main contents of the neurobiology-based psychoeducation concerned the neurotransmission processes and biological mechanisms of depression, in order to emphasize the biological attribution of depression. An ancova indicated that the neurobiology-based psychoeducational intervention significantly elevated the biological attribution of depression and reduced the social distance from depressed individuals. Psychological blameworthy attitudes toward depression, however, did not significantly change. Through a brief psychoeducation program about depression, knowledge of neuroscience could lead to positive benefits. Public awareness that depression can be effectively prevented and treated may be a way in which people can accept depressed individuals. Further studies are needed to certify the mechanisms of the effect of neurobiology-based psychoeducation. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

  9. A randomized controlled trial of a correspondence-based intervention for carers of relatives with psychosis.

    PubMed

    Deane, Frank P; Marshall, Sarah; Crowe, Trevor; White, Angela; Kavanagh, David

    2015-01-01

    Family members play a crucial role in supporting the recovery of loved ones with psychosis. The journey of recovery is not only traversed by the person experiencing the mental illness but also by their family. Interventions to support these families have traditionally either focused on psychoeducation or addressed problematic interactions or expressed emotion. Family programmes have far less frequently emphasized supporting family members' adjustment to the challenges posed by their relative's disorder or their recovery from associated distress. The study compared a control condition that received only a psychoeducational booklet (Information) and a condition also receiving a correspondence-based interactive recovery-oriented intervention (Connections). The Connections group was expected to show greater improvements in recovery knowledge, well-being, experiences of caregiving, hopefulness and distress. A randomized controlled trial was conducted to evaluate the effectiveness of two correspondence-based family interventions delivered to 81 carers of relatives with psychosis. Intent-to-treat analyses showed no differential outcomes between conditions, but an analysis of participants who substantially completed their allocated treatment showed that carers receiving Connections had significantly more improvements in well-being, positive experiences of caregiving and distress. Correspondence interventions that support carer's recovery may result in more positive mental health for those who complete key elements of the programme compared with information alone. However, many carers do not complete a correspondence programme and this may limit its impact. Copyright © 2013 John Wiley & Sons, Ltd.

  10. Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial.

    PubMed

    Yuan, Fang; Yang, Fang; Xue, Changhu; Wang, Kangjun; Liu, Qiuwu; Zhou, Jun; Fu, Feng; Wang, Xiaocheng; Zhang, Wei; Liu, Yi; Huo, Kang; Lv, Hua; Jiang, Wen

    2018-02-21

    No ideal blood pressure (BP) range has been scientifically determined for acute stroke, and no studies on BP management have been carried out for patients with severe stroke. This trial aims to investigate whether individualized lowering of elevated BP would improve the outcome in patients with severe stroke. The CHASE trial is a multicenter, randomized, controlled study. A total of 500 adult patients with acute severe stroke will be enrolled in 18 study sites in China and randomized to individualized BP lowering (10-15% reduction from admission level) or guideline-recommended BP lowering. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ≥ 3) at day 90 of enrollment. Secondary outcomes include disability at hospital discharge and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics. The CHASE trial will be the first study to explore the optimum BP management for acute severe stroke. This trial potentially offers a strong argument for individualized target for lowering elevated BP in patients with severe stroke. ClinicalTrials.gov, NCT02982655 . Registered on 30 November 2016.

  11. Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

    PubMed

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

    2014-01-01

    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. 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 rehospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events. We randomized 78 women (mean age 59 years): laparoscopic (n=38) and robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 compared with $11,573, P<.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 compared with $12,170, P<.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 compared with laparoscopic ($12,586 compared with $11,573; P=.160) or hospital costs over 6 weeks ($13,867 compared with $12,170; P=.060). The robotic group had longer operating room times (202.8 minutes compared with 178.4 minutes, P=.030) and higher pain scores 1 week after surgery (3.5±2.1 compared with 2.6±2.2; P=.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events. Costs of robotic sacrocolpopexy are higher than laparoscopic, whereas short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. Clinicaltrials.gov, www.clinicaltrials.gov, NCT01124916. I.

  12. The Copenhagen Triage Algorithm: a randomized controlled trial.

    PubMed

    Hasselbalch, Rasmus Bo; Plesner, Louis Lind; Pries-Heje, Mia; Ravn, Lisbet; Lind, Morten; Greibe, Rasmus; Jensen, Birgitte Nybo; Rasmussen, Lars S; Iversen, Kasper

    2016-10-10

    Crowding in the emergency department (ED) is a well-known problem resulting in an increased risk of adverse outcomes. Effective triage might counteract this problem by identifying the sickest patients and ensuring early treatment. In the last two decades, systematic triage has become the standard in ED's worldwide. However, triage models are also time consuming, supported by limited evidence and could potentially be of more harm than benefit. The aim of this study is to develop a quicker triage model using data from a large cohort of unselected ED patients and evaluate if this new model is non-inferior to an existing triage model in a prospective randomized trial. The Copenhagen Triage Algorithm (CTA) study is a prospective two-center, cluster-randomized, cross-over, non-inferiority trial comparing CTA to the Danish Emergency Process Triage (DEPT). We include patients ≥16 years (n = 50.000) admitted to the ED in two large acute hospitals. Centers are randomly assigned to perform either CTA or DEPT triage first and then use the other triage model in the last time period. The CTA stratifies patients into 5 acuity levels in two steps. First, a scoring chart based on vital values is used to classify patients in an immediate category. Second, a clinical assessment by the ED nurse can alter the result suggested by the score up to two categories up or one down. The primary end-point is 30-day mortality and secondary end-points are length of stay, time to treatment, admission to intensive care unit, and readmission within 30 days. If proven non-inferior to standard DEPT triage, CTA will be a faster and simpler triage model that is still able to detect the critically ill. Simplifying triage will lessen the burden for the ED staff and possibly allow faster treatment. Clinicaltrials.gov: NCT02698319 , registered 24. of February 2016, retrospectively registered.

  13. Design of a factorial experiment with randomization restrictions to assess medical device performance on vascular tissue

    PubMed Central

    2011-01-01

    Background Energy-based surgical scalpels are designed to efficiently transect and seal blood vessels using thermal energy to promote protein denaturation and coagulation. Assessment and design improvement of ultrasonic scalpel performance relies on both in vivo and ex vivo testing. The objective of this work was to design and implement a robust, experimental test matrix with randomization restrictions and predictive statistical power, which allowed for identification of those experimental variables that may affect the quality of the seal obtained ex vivo. Methods The design of the experiment included three factors: temperature (two levels); the type of solution used to perfuse the artery during transection (three types); and artery type (two types) resulting in a total of twelve possible treatment combinations. Burst pressures of porcine carotid and renal arteries sealed ex vivo were assigned as the response variable. Results The experimental test matrix was designed and carried out as a split-plot experiment in order to assess the contributions of several variables and their interactions while accounting for randomization restrictions present in the experimental setup. The statistical software package SAS was utilized and PROC MIXED was used to account for the randomization restrictions in the split-plot design. The combination of temperature, solution, and vessel type had a statistically significant impact on seal quality. Conclusions The design and implementation of a split-plot experimental test-matrix provided a mechanism for addressing the existing technical randomization restrictions of ex vivo ultrasonic scalpel performance testing, while preserving the ability to examine the potential effects of independent factors or variables. This method for generating the experimental design and the statistical analyses of the resulting data are adaptable to a wide variety of experimental problems involving large-scale tissue-based studies of medical or experimental

  14. Material hardship and children's social-emotional development: Testing mitigating effects of Child Development Accounts in a randomized experiment.

    PubMed

    Huang, J; Kim, Y; Sherraden, M

    2017-01-01

    Research has established a negative association between household material hardship and children's mental health. This study examines whether Child Development Accounts (CDAs), an economic intervention that encourages families to accumulate assets for children's long-term development, mitigate the association between material hardship and children's social-emotional development. Researchers conducted a randomized experiment of CDAs in Oklahoma, USA, with a probability sample (N = 7328) of all infants born in two 3-month periods in 2007. After agreeing to participate in the experiment, caregivers of 2704 infants completed a baseline survey and were assigned randomly to the treatment (n = 1358) or control group (n = 1346). The intervention exposed the treatment group to a CDA, which consisted of an Oklahoma 529 College Savings Plan account, financial incentives and financial information. Material hardship has a negative association with the social-emotional development of children around the age of 4 years. Estimates from regression analysis indicate that CDAs mitigate about 50% of the negative association between material hardship and children's social-emotional development. Although they do not provide direct support for consumption in households experiencing material hardship, CDAs may improve child development by influencing parenting practices and parents' expectations for their children. We discuss the implications of using asset-building programmes to improve child development. © 2016 John Wiley & Sons Ltd.

  15. Telehealth Rehabilitation for Cognitive Impairment: Randomized Controlled Feasibility Trial.

    PubMed

    Burton, Rachel L; O'Connell, Megan E

    2018-02-08

    Nonpharmacological interventions are needed to support the function of older adults struggling with subjective cognitive impairment (SCI), mild cognitive impairment (MCI), and dementia due to Alzheimer disease (AD). Telerehabilitation aims to provide rehabilitation at a distance, but cognitive rehabilitation by videoconferencing has not been explored. The objective of this study was to compare goal-oriented cognitive rehabilitation delivered in-person with videoconferencing to determine whether telehealth cognitive rehabilitation appears feasible. Random assignment to in-person or telehealth videoconferencing cognitive rehabilitation with a combined between-subjects, multiple baseline single-case experimental design, cognitive rehabilitation was delivered by a therapist to 6 participants with SCI (n=4), MCI (n=1), or dementia due to AD (n=1). Two of the 6 participants randomly assigned to the telehealth condition withdrew before beginning the intervention. For those who participated in the intervention, 6 out of 6 goals measured with the Canadian Occupational Performance Measure improved for those in the in-person group, and 7 out of 9 goals improved for those in the telehealth group. Delivery of cognitive rehabilitation by telehealth appeared feasible but required modifications such as greater reliance on caregivers and clients for manipulating materials.

  16. Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial.

    PubMed

    Dundar, Umit; Solak, Ozlem; Yigit, Ilknur; Evcik, Deniz; Kavuncu, Vural

    2009-06-15

    This study was a prospective, randomized, controlled study. To compare the effectiveness of aquatic exercise interventions with land-based exercises in the treatment of chronic low back pain (CLBP). Land-based exercise and physiotherapy are the main treatment tools used for CLBP. Clinical experience indicates that aquatic exercise may have advantages for patients with musculoskeletal disorders. A total of 65 patients with CLBP were included in this study. Patients were randomly assigned to receive aquatic exercise or land-based exercise treatment protocol. Aquatic exercise program consisted of 20 sessions, 5 x per week for 4 weeks in a swimming pool at 33 degrees C. Land-based exercise (home-based exercise) program were demonstrated by a physiotherapist on one occasion and then they were given written advice The patients were assessed for spinal mobility, pain, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). In both groups, statistically significant improvements were detected in all outcome measures (except modified Schober test) compared with baseline. However, improvement in modified Oswestry Low Back Pain Disability questionnaire and physical function and role limitations due to physical functioning subpart of Short-Form 36 Health Survey were better in aquatic exercise group (P < 0.05). It is concluded that a water-based exercises produced better improvement in disability and quality of life of the patients with CLBP than land-based exercise.

  17. Intraoperative ice pack application for uvulopalatoplasty pain reduction: a randomized controlled trial.

    PubMed

    Rotenberg, Brian W; Wickens, Brandon; Parnes, Jason

    2013-02-01

    Pain after uvulopalatoplasty continues to cause patients significant morbidity, especially from the tonsillectomy portion. The literature describes multiple techniques to reduce post-tonsillectomy pain, none being definitive. The purpose of this study was to evaluate the effect of intraoperative ice pack application on post-uvulopalatoplasty pain. Single-blinded, randomized controlled trial. After inclusion and exclusion criteria were met, patients were enrolled and randomized, and subsequently underwent standard electrocautery uvulopalatoplasty. Packs were placed into the tonsillar fossae immediately following tonsil removal and into the palate after the palatoplasty. Patients then completed a questionnaire that evaluated their experience for 10 days following surgery. The primary outcome was pain rated on a visual analog scale. Return to work and return to normal diet were also assessed. T test and Mann-Whitney statistical analyses, as well as routine descriptive statistics, were conducted. Eighteen subjects were recruited. Patients that received intraoperative cold packs experienced a statistically significant change in VAS average pain [3.4 ± 1.1 cm (p = 0.00001)] when compared with patients receiving room temperature packs. No difference in return to work (p = 0.16) and return to normal diet (p = 0.12) was identified. Intraoperative ice pack administration results in significantly reduced pain following electrocautery uvulopalatoplasty. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

  18. Peer support for postpartum depression: volunteers' perceptions, recruitment strategies and training from a randomized controlled trial

    PubMed Central

    Dennis, Cindy-Lee

    2013-01-01

    A randomized controlled trial evaluated the effect of telephone-based peer support (mother-to-mother) on preventing postpartum depression among high-risk mothers. This paper reports volunteers' perceptions, which showed that peer support is an effective preventative intervention. Two-hundred and five (205) volunteers were recruited and trained to provide peer support to 349 mothers randomized to the intervention group. Volunteers' perceptions were measured at 12 weeks using the Peer Volunteer Experience Questionnaire, completed by 69% (121) of the 175 volunteers who provided support to at least one mother. Large majorities felt that the training session had prepared them for their role (94.2%), that volunteering did not interfere with their lives (81.8%) and that providing support helped them grow as individuals (87.8%). Over 90% stated that they would become a peer volunteer again, given the opportunity. Recruitment and retention of effective volunteers is essential to the success of any peer-support intervention. Results from this study can assist clinicians and program planners to provide effective training, sufficient on-going support and evaluation and appropriate matching of volunteers to mothers who desire peer support and are at high risk of postpartum depression. PMID:22388589

  19. Occlusive drainage system for split-thickness skin graft: A prospective randomized controlled trial.

    PubMed

    Hsiao, Sara Fu-Yin; Ma, Hsu; Wang, Yu-Hei; Wang, Tien-Hsiang

    2017-03-01

    Split-thickness skin grafts are widely used in reconstruction of large area defects. Conventional postoperative recipient site care includes saline-moistened gauze with a protective layer of petroleum gauze and splints for immobilization. This method causes pain while changing the dressing. We designed a better occlusive drainage system for split-thickness skin grafts. We compared the treatment effect and subjective evaluation of our occlusive drainage system with that of the conventional method for coverage of split-thickness skin grafts. A randomized controlled trial was carried out in patients who received split-thickness skin grafts. Patients aged 24-76 years were randomly assigned to the occlusive drainage system or the conventional indirect wet dressing method. The status of graft take, pain, and subjective evaluations were compared. Twenty-eight participants were enrolled, with 14 in each group. The percentage of graft take was no difference between the 2 groups. No wound infection developed. Patients in the occlusive drainage system group experienced less pain and greater satisfaction. All patients followed up for at least 3 months, and no hypertrophic scar formation was noted. Comparing with the indirect wet dressing method, this new method is practical for covering split-thickness skin grafts, causes less pain, and provides a better experience for patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  20. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial.

    PubMed

    Harada, Yoshihiro; Hirasawa, Dai; Fujita, Naotaka; Noda, Yutaka; Kobayashi, Go; Ishida, Kazuhiko; Yonechi, Makoto; Ito, Kei; Suzuki, Takashi; Sugawara, Toshiki; Horaguchi, Jun; Takasawa, Osamu; Obana, Takashi; Oohira, Tetsuya; Onochi, Kengo; Kanno, Yoshihide; Kuroha, Masatake; Iwai, Wataru

    2009-03-01

    Clinical demand for total colonoscopy (TCS) is increasing. Improvement of the cecal intubation rate and shortening of the examination time would expand the capacity for TCS. To assess the efficacy of a transparent hood attached to the tip of a colonoscope for cecal intubation in TCS. Prospective, randomized, controlled study. Single tertiary-referral center. TCS. Cecal intubation time and rate, complications, patient discomfort, and detection rate of colonic polyps. Patients who were to undergo screening and/or surveillance TCS for colorectal cancer were invited to participate in the study. Cecal intubation time and rate, complications, patient discomfort, and detection rate of colonic polyps were evaluated. A total of 592 patients enrolled in this study were randomly allocated to the hood group and no-hood group. The mean (SD) cecal intubation time in the hood group and the no-hood group was 10.2 +/- 12.5 minutes and 13.4 +/- 15.8 minutes, respectively (P = .0241). The effect of its use was more prominent in the expert endoscopists group compared with those with moderate experience. The cecal intubation rate and the detection rate of small polyps in the 2 groups were similar. The grade of patient discomfort was significantly lower in the hood group. No complications were encountered with the use of the hood. Use of a transparent hood on the tip of a colonoscope shortened the time required for cecal intubation and decreased patient discomfort; such use was more effective among experts in shortening the examination time.

  1. A health advocacy intervention for adolescents with intellectual disability: a cluster randomized controlled trial.

    PubMed

    Lennox, Nicholas; McPherson, Lyn; Bain, Chris; O'Callaghan, Michael; Carrington, Suzanne; Ware, Robert S

    2016-12-01

    Adolescents with intellectual disability experience poorer heath than their peers in the general population, partially due to communication barriers and knowledge gaps in their health history. This study aimed to test a health intervention package against usual care for a range of health promotion and disease detection outcomes. A parallel-group cluster randomized controlled trial was conducted with Australian adolescents with intellectual disability living in the community. Randomization occurred at school level. The intervention package consisted of classroom-based health education, a hand-held personalized health record, and a health check. Evidence of health promotion, disease prevention, and case-finding activities were extracted from general practitioners' records for 12 months post-intervention. Clinical data was available for 435 of 592 (73.5%) participants from 85 schools. Adolescents allocated to receive the health intervention were more likely to have their vision (odds ratio [OR] 3.3; 95% confidence interval [CI] 1.8-6.1) and hearing (OR 2.7; 95% CI 1.0-7.3) tested, their blood pressure checked (OR 2.4; 95% CI 1.6-3.7), and weight recorded (OR 4.8; 95% CI 3.1-7.6). There was no difference between health intervention and usual care for identification of new diseases. The school-based intervention package increased healthcare activity in adolescents with intellectual disability living in the community. © 2016 Mac Keith Press.

  2. 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

  3. Effect of different warm-up strategies on simulated laparoscopy performance: a randomized controlled trial.

    PubMed

    Brönnimann, Enrico; Hoffmann, Henry; Schäfer, Juliane; Hahnloser, Dieter; Rosenthal, Rachel

    2015-01-01

    The objective of this trial was to assess which type of warm-up has the highest effect on virtual reality (VR) laparoscopy performance. The following warm-up strategies were applied: a hands-on exercise (group 1), a cognitive exercise (group 2), and no warm-up (control, group 3). This is a 3-arm randomized controlled trial. The trial was conducted at the department of surgery of the University Hospital Basel in Switzerland. A total of 94 participants, all laypersons without any surgical or VR experience, completed the study. A total of 96 participants were randomized, 31 to group 1, 31 to group 2, and 32 to group 3. There were 2 postrandomization exclusions. In the multivariate analysis, we found no evidence that the intervention had an effect on VR performance as represented by 6 calculated subscores of accuracy, time, and path length for (1) camera manipulation and (2) hand-eye coordination combined with 2-handed maneuvers (p = 0.795). Neither the comparison of the average of the intervention groups (groups 1 and 2) vs control (group 3) nor the pairwise comparisons revealed any significant differences in VR performance, neither multivariate nor univariate. VR performance improved with increasing performance score in the cognitive exercise warm-up (iPad 3D puzzle) for accuracy, time, and path length in the camera navigation task. We were unable to show an effect of the 2 tested warm-up strategies on VR performance in laypersons. We are currently designing a follow-up study including surgeons rather than laypersons with a longer warm-up exercise, which is more closely related to the final task. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  4. A Randomized Controlled Trial of Cognitive Debiasing Improves Assessment and Treatment Selection for Pediatric Bipolar Disorder

    PubMed Central

    Jenkins, Melissa M.; Youngstrom, Eric A.

    2015-01-01

    Objective This study examined the efficacy of a new cognitive debiasing intervention in reducing decision-making errors in the assessment of pediatric bipolar disorder (PBD). Method The study was a randomized controlled trial using case vignette methodology. Participants were 137 mental health professionals working in different regions of the US (M=8.6±7.5 years of experience). Participants were randomly assigned to a (1) brief overview of PBD (control condition), or (2) the same brief overview plus a cognitive debiasing intervention (treatment condition) that educated participants about common cognitive pitfalls (e.g., base-rate neglect; search satisficing) and taught corrective strategies (e.g., mnemonics, Bayesian tools). Both groups evaluated four identical case vignettes. Primary outcome measures were clinicians’ diagnoses and treatment decisions. The vignette characters’ race/ethnicity was experimentally manipulated. Results Participants in the treatment group showed better overall judgment accuracy, p < .001, and committed significantly fewer decision-making errors, p < .001. Inaccurate and somewhat accurate diagnostic decisions were significantly associated with different treatment and clinical recommendations, particularly in cases where participants missed comorbid conditions, failed to detect the possibility of hypomania or mania in depressed youths, and misdiagnosed classic manic symptoms. In contrast, effects of patient race were negligible. Conclusions The cognitive debiasing intervention outperformed the control condition. Examining specific heuristics in cases of PBD may identify especially problematic mismatches between typical habits of thought and characteristics of the disorder. The debiasing intervention was brief and delivered via the Web; it has the potential to generalize and extend to other diagnoses as well as to various practice and training settings. PMID:26727411

  5. 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…

  6. 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,…

  7. 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,…

  8. 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…

  9. 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…

  10. 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,…

  11. 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…

  12. 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…

  13. 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…

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

    ERIC Educational Resources Information Center

    Shadish, William R.

    2011-01-01

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

  15. 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…

  16. 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.

  17. Cytokine inhibition in chronic fatigue syndrome patients: study protocol for a randomized controlled trial.

    PubMed

    Roerink, Megan E; Knoop, Hans; Bredie, Sebastian J H; Heijnen, Michael; Joosten, Leo A B; Netea, Mihai G; Dinarello, Charles A; van der Meer, Jos W M

    2015-10-05

    Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. The disturbances of the cytokine network detected in CFS patients are highly variable, in part due to the lack of adequate controls in many studies. Furthermore, all studies have been performed on peripheral venous blood of patients. As cytokines mainly act in tissues, for example, the brain, the information that can be derived from peripheral blood cells is limited. The information regarding the possible role of cytokines in the pathophysiology could come from intervention studies in which the activities of relevant cytokines are reduced, for example, reducing interleukin-1, interleukin-6 or tumor necrosis factor. In this study, the clinical usefulness of anakinra, an IL-1 antagonist, will be assessed in patients with CFS. A randomized placebo-controlled, double-blind trial will be conducted. Fifty adult female patients meeting the Centers for Disease Control (CDC) criteria for CFS and without psychiatric co-morbidity will be included. After inclusion, patients will be randomized between treatment with anakinra (recombinant human interleukin-1 receptor antagonist) or placebo. Each group will be treated for 4 weeks. Outcome measures will be assessed at baseline, after 4 weeks of intervention, and 6 months after baseline assessment. The primary outcome measure will be fatigue severity at 4 weeks, measured with the validated Checklist of Individual Strength (CIS). Secondary outcome measures are functional impairment, physical and social functioning, psychological distress, pain severity, presence of accompanying symptoms, and cytokine and cortisol concentrations. This is the first randomized placebo-controlled trial that will evaluate the effect of interference with IL-1 on the experience of fatigue in patients with CFS. The

  18. In-space technology flight experiments: Middeck 0-gravity Dynamics Experiment (MODE) and Middeck Active Control Experiment (MACE)

    NASA Technical Reports Server (NTRS)

    Venneri, Samuel L.

    1991-01-01

    The topics addressed are covered in viewgraph form. The objective of the Middeck 0-gravity Dynamics Experiment (MODE) programs is to study gravity dependent nonlinearities associated with fluid slosh and truss structure dynamics. MODE provides a reusable facility for on-orbit dynamics testing of small scale test articles in the shirt sleeve environment on the Shuttle middeck. Flight program objective of Middeck Active Control Experiment (MACE) is to study gravity effects on the performance and stability of controlled structures.

  19. Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial.

    PubMed

    Mistraletti, Giovanni; Mantovani, Elena S; Cadringher, Paolo; Cerri, Barbara; Corbella, Davide; Umbrello, Michele; Anania, Stefania; Andrighi, Elisa; Barello, Serena; Di Carlo, Alessandra; Martinetti, Federica; Formenti, Paolo; Spanu, Paolo; Iapichino, Gaetano

    2013-04-03

    A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. This 'educational research' project aims both to

  20. Treating depression in predominantly low-income young minority women: a randomized controlled trial.

    PubMed

    Miranda, Jeanne; Chung, Joyce Y; Green, Bonnie L; Krupnick, Janice; Siddique, Juned; Revicki, Dennis A; Belin, Tom

    2003-07-02

    Impoverished minority women experience a higher burden from depression than do white women because they are less likely to receive appropriate care. Little is known about the effectiveness of guideline-based care for depression with impoverished minority women, most of whom do not seek care. To determine the impact of an intervention to deliver guideline-based care for depression compared with referral to community care with low-income and minority women. A randomized controlled trial conducted in the Washington, DC, suburban area from March 1997 through May 2002 of 267 women with current major depression, who attended county-run Women, Infants, and Children food subsidy programs and Title X family planning clinics. Outcomes Hamilton Depression Rating Scale measured monthly from baseline through 6 months; instrumental role functioning (Social Adjustment Scale) and social functioning (Short Form 36-Item Health Survey) measured at baseline and 3 and 6 months. Participants were randomly assigned to an antidepressant medication intervention (trial of paroxetine switched to buproprion, if lack of response) (n = 88), a psychotherapy intervention (8 weeks of manual-guided cognitive behavior therapy) (n = 90), or referral to community mental health services (n = 89). Both the medication intervention (P<.001) and the psychotherapy intervention (P =.006) reduced depressive symptoms more than the community referral did. The medication intervention also resulted in improved instrumental role (P =.006) and social (P =.001) functioning. The psychotherapy intervention resulted in improved social functioning (P =.02). Women randomly assigned to receive medications were twice as likely (odds ratio, 2.04; 95% confidence interval, 0.98-4.27; P =.057) to achieve a Hamilton Depression Rating Scale score of 7 or less by month 6 as were those referred to community care. Guideline-concordant care for major depression is effective for these ethnically diverse and impoverished patients

  1. A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial.

    PubMed

    Vigod, Simone; Hussain-Shamsy, Neesha; Grigoriadis, Sophie; Howard, Louise M; Metcalfe, Kelly; Oberlander, Tim F; Schram, Carrie; Stewart, Donna E; Taylor, Valerie H; Dennis, Cindy-Lee

    2016-02-29

    Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy. This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms. Our PDA represents a key opportunity to optimize the decision-making process for women around

  2. 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.

  3. [A randomized controlled study of treating chronic rhinosinusitis with macrolides].

    PubMed

    Li, Yu; Wu, Tianjie

    2014-09-01

    Invastigation of macrolides in the treatment of drug effects in chronic rhinosinusit. The 165 patients with chronic rhinosinusit were randomly divided into 80 cases of macrolides drug group and 85 cases of cephalosporins group, and therapeutic effect was observed. The therapeutic effect of macrolides was also observed in refractory chronic rhinosinusit. Comparing macrolides group and cephalosporins group,there is not statistically significant (P > 0.05). Treatment with macrolides cefixime tablet ineffective treatment of patients for 3 months, compared before and after treatment was statistically significant (P < 0.01). Treatment with cefixime tablet macrolides ineffective treatment of patients for 3 months, compared before and after treatment was not statistically significant (P > 0.05). Long-term low-dose applications of macrolides have a good effect in patients with chronic rhinosinusit, particularly for refractory chronic rhinosinusit have a significant effect.

  4. 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

  5. Randomized Control Trial of the 3Rs Health Knowledge Training Program for Persons with Intellectual Disabilities.

    PubMed

    Feldman, Maurice A; Owen, Frances; Andrews, Amy E; Tahir, Munazza; Barber, Rachel; Griffiths, Dorothy

    2016-05-01

    Persons with intellectual disabilities (ID) experience a wide range of health problems. Research is needed on teaching persons with intellectual disabilities about their health to promote self-advocacy. This study used a RCT to evaluate a health knowledge training program for adults with intellectual disabilities and verbal skills. Participants were randomly assigned to training (n = 12) or no training control (n = 10) groups. Topics included key body organs, systems, functions, health maintenance and illnesses. Participants played a game answering questions (e.g. 'What does the heart do?'). Instruction involved visuals (e.g., PowerPoint slides), cueing, modelling and feedback. The control group received pre-, post- and follow-up tests as the training group. The training group had significantly higher overall post-test and follow-up health knowledge test scores than the control group. Health knowledge training is one step in promoting health self-advocacy and better health in persons with intellectual disabilities. © 2015 John Wiley & Sons Ltd.

  6. A quality assessment of randomized controlled trial reports in endodontics.

    PubMed

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  7. Progesterone Receptor Modulator for Emergency Contraception: A Randomized Controlled Trial

    PubMed Central

    Creinin, Mitchell D.; Schlaff, William; Archer, David F.; Wan, Livia; Frezieres, Ron; Thomas, Michael; Rosenberg, Michael; Higgins, James

    2010-01-01

    Objective Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. Methods We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum β-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. Results Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2–1.6%) and 13 (1.7%, 95% confidence interval 0.8–2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. Conclusion CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. PMID:17077229

  8. Complementary feeding: a Global Network cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale

  9. Complementary feeding: a Global Network cluster randomized controlled trial.

    PubMed

    Krebs, Nancy F; Hambidge, K Michael; Mazariegos, Manolo; Westcott, Jamie; Goco, Norman; Wright, Linda L; Koso-Thomas, Marion; Tshefu, Antoinette; Bose, Carl; Pasha, Omrana; Goldenberg, Robert; Chomba, Elwyn; Carlo, Waldemar; Kindem, Mark; Das, Abhik; Hartwell, Ty; McClure, Elizabeth

    2011-01-13

    Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local

  10. Sildenafil Citrate Therapy for Oligohydramnios: A Randomized Controlled Trial.

    PubMed

    Maher, Mohammad Ahmed; Sayyed, Tarek Mohammad; Elkhouly, Nabih

    2017-04-01

    To compare sildenafil plus hydration with hydration alone in improving the amniotic fluid index and neonatal outcomes in pregnancies complicated by idiopathic oligohydramnios ( amniotic fluid index less than 5 cm without underlying maternal or fetal causes and with normal fetal growth). This was an open-label randomized trial for women carrying singleton pregnancies at 30 weeks of gestation or more with idiopathic oligohydramnios detected during routine ultrasonogram. Women received either oral sildenafil citrate (25 mg every 8 hours) plus intravenous infusion of 2 L isotonic solution or fluids only until delivery. The primary study outcome was the amniotic fluid volume at 6 weeks of follow-up or the final volume before delivery, whichever occurred first. Secondary outcomes were duration of pregnancy prolongation, mode of delivery, and select neonatal outcomes. The study was powered to detect a 45% difference between groups, so, at an α level of 0.05 and 80% power, a sample size of 167 women was required. From February 24, 2015, through April 2016, 196 women were screened and 184 were randomized. Follow-up was completed in 166 (90%): 82 in the sildenafil group and 84 in the hydration group. Baseline characteristics were similar between groups. The amniotic fluid volume was higher in the sildenafil group at the final assessment (11.5 compared with 5.4 cm, P=.02). The sildenafil group delivered later (38.3 compared with 36.0 weeks of gestation, P=.001), had a lower rate of cesarean delivery (28% compared with 73%), and their neonates were less likely to be admitted to the neonatal intensive care unit (11% compared with 41%, P=.001). Sildenafil citrate increases amniotic fluid volume in pregnancies complicated by oligohydramnios. ClinicalTrials.gov, www.clinicaltrials.gov, NCT02372487.

  11. Effect of Medication Label Units of Measure on Parent Choice of Dosing Tool: A Randomized Experiment

    PubMed Central

    Yin, H. Shonna; Parker, Ruth M.; Sanders, Lee M.; Dreyer, Benard P.; Mendelsohn, Alan; Bailey, Stacy; Patel, Deesha A.; Jimenez, Jessica J.; Kim, Kwang-Youn A.; Jacobson, Kara; Hedlund, Laurie; Landa, Rosa; Maness, Leslie; Raythatha, Purvi Tailor; McFadden, Terri; Wolf, Michael S.

    2016-01-01

    OBJECTIVE Some experts recommend eliminating “teaspoon” and “tablespoon” terms from pediatric medication dosing instructions, as they may inadvertently encourage use of nonstandard tools (i.e. kitchen spoons), which are associated with dosing errors. We examined whether use of “teaspoon” or “tsp” on prescription labels affects parents’ choice of dosing tools, and the role of health literacy and language. METHODS Analysis of data collected as part of a controlled experiment (SAFE Rx for Kids study), which randomized English/Spanish-speaking parents (n=2110) of children ≤8 years old to 1 of 5 groups which varied in unit of measurement pairings on medication labels/dosing tools. Outcome assessed was parent self-reported choice of dosing tool. Parent health literacy measured using the Newest Vital Sign. RESULTS 77.0% had limited health literacy (36.0% low, 41.0% marginal); 35.0% completed assessments in Spanish. Overall, 27.7% who viewed labels containing either “tsp” or “teaspoon” units (alone or with “mL”) chose nonstandard dosing tools (i.e. kitchen teaspoon, kitchen tablespoon), compared to 8.3% who viewed “mL”-only labels (AOR=4.4[95%CI: 3.3–5.8]). Odds varied based on whether “teaspoon” was spelled out or abbreviated (“teaspoon”-alone: AOR=5.3[3.8–7.3]); “teaspoon” with mL: AOR=4.7[3.3–6.5]; “tsp” with mL (AOR=3.3[2.4–4.7]); p<0.001)). Similar findings were noted across health literacy and language groups. CONCLUSIONS Use of teaspoon units (“teaspoon” or “tsp) on prescription labels is associated with increased likelihood of parent choice of nonstandard dosing tools. Future studies may be helpful to examine the real-world impact of eliminating teaspoon units from medication labels, and identify additional strategies to promote the safe use of pediatric liquid medications. PMID:27155289

  12. Effect of Medication Label Units of Measure on Parent Choice of Dosing Tool: A Randomized Experiment.

    PubMed

    Yin, H Shonna; Parker, Ruth M; Sanders, Lee M; Dreyer, Benard P; Mendelsohn, Alan; Bailey, Stacy; Patel, Deesha A; Jimenez, Jessica J; Kim, Kwang-Youn A; Jacobson, Kara; Hedlund, Laurie; Landa, Rosa; Maness, Leslie; Tailor Raythatha, Purvi; McFadden, Terri; Wolf, Michael S

    Some experts recommend eliminating "teaspoon" and "tablespoon" terms from pediatric medication dosing instructions, because these terms could inadvertently encourage use of nonstandard tools (ie, kitchen spoons), which are associated with dosing errors. We examined whether use of "teaspoon" or "tsp" on prescription labels affects parents' choice of dosing tools, and the role of health literacy and language. Analysis of data collected as part of a controlled experiment (SAFE Rx for Kids [Safe Administration For Every Prescription for Kids] study), which randomized English- and Spanish-speaking parents (n = 2110) of children 8 years of age and younger to 1 of 5 groups, which varied in unit of measurement pairings on medication labels and dosing tools. Outcome assessed was parent self-reported choice of dosing tool. Parent health literacy was measured using the Newest Vital Sign. Seventy-seven percent had limited health literacy (36.0% low, 41.0% marginal); 35.0% completed assessments in Spanish. Overall, 27.7% who viewed labels containing either "tsp" or "teaspoon" units (alone or with "mL") chose nonstandard dosing tools (ie, kitchen teaspoon, kitchen tablespoon), compared with 8.3% who viewed "mL"-only labels (adjusted odds ratio [AOR] = 4.4 [95% confidence interval (CI), 3.3-5.8]). Odds varied based on whether "teaspoon" was spelled out or abbreviated ("teaspoon"-alone: AOR = 5.3 [95% CI, 3.8-7.3]); "teaspoon" with mL: AOR = 4.7 [95% CI, 3.3-6.5]; "tsp" with mL: AOR = 3.3 [95% CI, 2.4-4.7]; P < .001). Similar findings were noted across health literacy and language groups. Use of teaspoon units ("teaspoon" or "tsp") on prescription labels is associated with increased likelihood of parent choice of nonstandard dosing tools. Future studies might be helpful to examine the real-world effect of eliminating teaspoon units from medication labels, and identify additional strategies to promote the safe use of pediatric liquid medications. Copyright © 2016

  13. Optimal strategy analysis based on robust predictive control for inventory system with random demand

    NASA Astrophysics Data System (ADS)

    Saputra, Aditya; Widowati, Sutrisno

    2017-12-01

    In this paper, the optimal strategy for a single product single supplier inventory system with random demand is analyzed by using robust predictive control with additive random parameter. We formulate the dynamical system of this system as a linear state space with additive random parameter. To determine and analyze the optimal strategy for the given inventory system, we use robust predictive control approach which gives the optimal strategy i.e. the optimal product volume that should be purchased from the supplier for each time period so that the expected cost is minimal. A numerical simulation is performed with some generated random inventory data. We simulate in MATLAB software where the inventory level must be controlled as close as possible to a set point decided by us. From the results, robust predictive control model provides the optimal strategy i.e. the optimal product volume that should be purchased and the inventory level was followed the given set point.

  14. Effects of Dehydroepiandrosterone Supplementation during Stressful Military Training: A Randomized, Controlled, Double-Blind Field Study

    DTIC Science & Technology

    2011-01-01

    required to attend this course, which includes a period of mock- captivity. After an initial phase of classroom-based didactic training (5 days), students ...Effects of dehydroepiandrosterone supplementation during stressful military training: A randomized, controlled, double- blind field study MARCUS K...during stress. In this randomized, controlled, double- blind field study, we examined the effects of a 12-day DHEA regimen on stress indices in

  15. 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

  16. Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study.

    PubMed

    Yinger, Olivia Swedberg

    2016-01-01

    Children undergoing routine immunizations frequently experience severe distress, which may be improved through music therapy as procedural support. The purpose of this study was to examine effects of live, cognitive-behavioral music therapy during immunizations on (a) the behaviors of children, their parents, and their nurses; and (b) parental perceptions. Participants were children between the ages of 4 and 6 years (N = 58) who underwent immunizations, their parents (N = 62), and the nurses who administered the procedure (N = 19). Parent/child dyads were randomly assigned to receive music therapy (n = 29) or standard care (n = 29) during their immunization. Afterward, each parent rated their child's level of pain and the distress their child experienced compared to previous medical experiences. All procedures were videotaped and later viewed by trained observers, who classified child, parent, and nurse behaviors using the categories of the Child-Adult Medical Procedure Interaction Scale-Revised (CAMPIS-R). Significant differences between the music therapy and control groups were found in rates of child coping and distress behaviors and parent distress-promoting behaviors. Parents of children who received music therapy reported that their child's level of distress was less than during previous medical experiences, whereas parents of children in the control group reported that their child's level of distress was greater. No significant differences between groups were found in parents' ratings of children's pain or in rates of nurse behavior. Live, cognitive-behavioral music therapy has potential benefits for young children and their parents during immunizations. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  17. Is bowel preparation before excretory urography necessary? A prospective, randomized, controlled trial.

    PubMed

    Guo, Hongfeng; Huang, Yong; Xi, Zhijun; Song, Yi; Guo, Yinglu; Na, Yanqun

    2006-02-01

    A prospective, randomized, single blind, controlled trial was performed to determine whether routine bowel preparations are necessary for satisfactory visualization of the urinary system during IVP and compare the side effects of several bowel preparation methods. A total of 200 patients between 17 and 70 years old at the outpatient department who were prescribed IVP were enrolled in this prospective study. Patients were divided into 4 groups and randomly received liquid supper, senna, magnesium sulfate solution and PEG-ELS as bowel preparation before IVP. Control and contrast images were assessed by a radiologist and a urologist blinded to the bowel preparation. IVP was given a visualization score, a fecal residue score, a bowel gas score and an overall quality score. Images were also divided into anatomical sections to assess visualization, and the effect of fecal residue and bowel gas. Questionnaires were prepared about the side effects of bowel preparation. For contrast images there was no significant difference in terms of visualization,, fecal residue, bowel gas and overall quality scores among the 4 groups. The same result was seen on the control image except for fecal residue scores, when the senna and PEG-ELS groups had a lower fecal residue score than the liquid supper group (p = 0.001). Interestingly when considering sectional images, the right renal region of the control image showed that the senna and PEG-ELS groups had better visualization scores with less bowel gas and fecal residue than the liquid supper only group. Patients in all 3 laxative bowel preparation groups except the liquid supper group reported side effects. There was no statistically significant difference among these 3 groups in the attitude toward ingesting laxatives again. Our results suggest that routine bowel preparation prior to IVP does not improve the visibility or overall quality of control or contrast images, while patients experience certain side effects due to the bowel

  18. 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.

  19. Esophageal submucosal dissection under steady pressure automatically controlled endoscopy (SPACE): a randomized preclinical trial.

    PubMed

    Nakajima, K; Moon, J H; Tsutsui, S; Miyazaki, Y; Yamasaki, M; Yamada, T; Kato, M; Yasuda, K; Sumiyama, K; Yahagi, N; Saida, Y; Kondo, H; Nishida, T; Mori, M; Doki, Y

    2012-12-01

    A new overtube system has been developed for steady pressure automatically controlled endoscopy (SPACE) in the gastrointestinal tract. The objectives of this study were to validate the feasibility and safety of SPACE in the esophagus, and to evaluate its potential advantages over conventional (manually insufflating) endoscopy in endoscopic submucosal dissection (ESD). This was a multicenter preclinical trial using acute porcine models (n = 20). In Experiment 1 (feasibility/safety study), SPACE was attempted in the esophagus with continuous monitoring of cardiopulmonary parameters and intraluminal pressures in the downstream bowel. Different insufflation pressures were tested to optimize the insufflation condition. Each session was video-recorded and scored by blinded reviewers. In Experiment 2 (randomized trial), esophageal ESD was attempted using either SPACE or conventional endoscopy, and results were compared. In Experiment 1, SPACE was performed safely without intraluminal pressure elevation in the downstream bowel. According to video review, SPACE provided more stable, reproducible, and rapid visualization than conventional endoscopy. The insufflation pressure was optimized at 14 mmHg for esophageal SPACE. In Experiment 2, ESD was completed in all animals. The ESD time was significantly shorter with SPACE compared with conventional endoscopy (1326 vs. 1616 seconds; P = 0.009). Responses to questionnaires showed that 94 % - 100 % of participants considered SPACE to provide improved exposure and more uniform tissue tension than conventional endoscopy. Other data were comparable. SPACE is feasible, safe, and potentially effective for complicated endoscopic procedures, such as ESD. SPACE improves and standardizes endoscopic exposure and tissue tension. A clinical study is required to further confirm its safety and clinical effectiveness.

  20. The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

    PubMed

    Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

    2011-10-01

    The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

  1. Vilazodone for cannabis dependence: A randomized, controlled pilot trial.

    PubMed

    McRae-Clark, Aimee L; Baker, Nathaniel L; Gray, Kevin M; Killeen, Therese; Hartwell, Karen J; Simonian, Susan J

    2016-01-01

    The purpose of this study was to evaluate the efficacy of vilazodone, a selective serotonin receptor inhibitor and partial 5-HT1A agonist, for treatment of cannabis dependence. Seventy-six cannabis-dependent adults were randomized to receive either up to 40 mg/day of vilazodone (n = 41) or placebo (n = 35) for 8 weeks combined with a brief motivational enhancement therapy intervention and contingency management to encourage study retention. Cannabis use outcomes were assessed via weekly urine cannabinoid tests; secondary outcomes included cannabis use self-report and cannabis craving. Participants in both groups reported reduced self-reported cannabis use over the course of the study; however, vilazodone provided no advantage over placebo in reducing cannabis use. Men had significantly lower creatinine-adjusted cannabinoid levels and a trend for increased negative urine cannabinoid tests than women. Vilazodone was not more efficacious than placebo in reducing cannabis use. Important gender differences were noted, with women having worse cannabis use outcomes than men. Further medication development efforts for cannabis use disorders are needed, and gender should be considered as an important variable in future trials. © American Academy of Addiction Psychiatry.

  2. Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial.

    PubMed

    Kalita, J; Bhoi, S K; Misra, U K

    2013-07-01

    This study compares efficacy and safety of divalproate extended release (DVA-ER) and amitriptyline (AMT) in migraine. Three hundred migraineurs having >4 attacks monthly were randomized into DVA-ER or AMT. The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale (VAS). Secondary end points were functional disability, rescue medication, and adverse events. The median age was 32 years, and 241 were women. 150 patients each received DVA-ER and AMT. At 3 months, 74.7% in DVA-ER and 62% patients in AMT group improved in headache frequency (P = 0.02) and at 6 months, 65.3% and 54%, respectively (P = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA-ER and 64% in AMT (P = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA-ER group. Divalproate extended release is more effective at 3 months than AMT; however, at 6 months, both are equally effective in migraine prophylaxis. © 2013 John Wiley & Sons A/S.

  3. Randomized Controlled Trial Comparing Daycare and Overnight Stay Laparoscopic Cholecystectomy.

    PubMed

    Salleh, A A M; Affirul, C A; Hairol, O; Zamri, Z; Azlanudin, A; Hilmi, M A; Razman, J

    2015-01-01

    This present study sought to review the feasibility and patients' satisfaction of laparoscopic cholecystectomy to be perform as daycare procedure. Sixty-two patients with symptomatic gallstones were recruited within a year. They were randomized into overnight stay and daycare groups. The outcomes and post-operative complications were analyzed. Fifty-eight patients were eligible for analysis and four patients were excluded because of conversion to open cholecystectomy. All patients in daycare group reported no fever but two patients in the overnight stay group complaint of post-operative fever (p=0.150). The mean pain score using Visual Analogue Score (VAS) in daycare group was 2.93 but in the overnight stay was recorded as 3.59 (p=0.98). Five patients had post-operative nausea and vomiting (PONV) in daycare group compared to 2 patients in the overnight stay group (p=0.227). Patient's satisfaction were higher in the daycare group (p=0.160). All patients in daycare group were back at work within a week but in overnight stay, 11 patients had to stay off work for more than one week (p=0.01). Daycare laparoscopic cholecystectomy is safe and feasible. The satisfaction of daycare surgery is higher than overnight stay group. Patients' selection is an important aspect of its success.

  4. A randomized controlled trial of Telephone Continuing Care

    PubMed Central

    Coleman-Cowger, Victoria H.; Titus, Janet C; Funk, Rodney R; Orndorff, Matthew G.

    2009-01-01

    Telephone continuing care (TCC) was compared to usual continuing care (UCC) on substance use and related problems among adults discharged from residential treatment. Participants were randomly assigned to receive either UCC or TCC. A tapered TCC protocol, initiated by paraprofessional staff and volunteers, was provided during the first three months following discharge. The TCC condition participants reported high satisfaction ratings with the procedure and were more than twice as likely to enter continuing care than UCC participants. At the three-month point, TCC patients reported significantly fewer past month substance problems than UCC patients. Among the subgroup of lower severity (LS) participants, the TCC-LS sample had both significantly more days abstinent and fewer past month substance problems at three months than the UCC-LS sample. The significant between-group differences in substance use outcomes were not maintained at the six-month follow-up. The high satisfaction ratings and early, favorable response among TCC patients suggest the procedure is promising. Further research with larger samples and over a longer period of time is necessary. PMID:19729266

  5. Does Playworks Work? Findings from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  6. Analysis of Random Drop for Gateway Congestion Control

    DTIC Science & Technology

    1989-11-01

    21 2.4 Network Topologies ........................................... 22 3 Network Congestion 26 3.1 Local Packet Clustering ...Strategy .................... 29 3.1.3 LPC Simulation kesults ....... ............................ 30 3.2 Lossless Global Packet Clustering ...33 3.3 Lossy Global Packet Clustering ....... ............................ 36 3.3.1 Gateway Congestion Control ...... ......................... 36

  7. Behavior Therapy for Pediatric Trichotillomania: A Randomized