Exploratory and Confirmatory Analysis of the Trauma Practices Questionnaire

ERIC Educational Resources Information Center

Craig, Carlton D.; Sprang, Ginny

2009-01-01

Objective: The present study provides psychometric data for the Trauma Practices Questionnaire (TPQ). Method: A nationally randomized sample of 2,400 surveys was sent to self-identified trauma treatment specialists, and 711 (29.6%) were returned. Results: An exploratory factor analysis (N = 319) conducted on a randomly split sample (RSS) revealed…

Identifying Items to Assess Methodological Quality in Physical Therapy Trials: A Factor Analysis

PubMed Central

Cummings, Greta G.; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

2014-01-01

Background Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. Objective The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). Design A methodological research design was used, and an EFA was performed. Methods Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Results Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Limitation Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. Conclusions To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items. PMID:24786942

Identifying items to assess methodological quality in physical therapy trials: a factor analysis.

PubMed

Armijo-Olivo, Susan; Cummings, Greta G; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

2014-09-01

Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). A methodological research design was used, and an EFA was performed. Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items. © 2014 American Physical Therapy Association.

Do federal and state audits increase compliance with a grant program to improve municipal infrastructure (AUDIT study): study protocol for a randomized controlled trial.

PubMed

De La O, Ana L; Martel García, Fernando

2014-09-03

Poor governance and accountability compromise young democracies' efforts to provide public services critical for human development, including water, sanitation, health, and education. Evidence shows that accountability agencies like superior audit institutions can reduce corruption and waste in federal grant programs financing service infrastructure. However, little is know about their effect on compliance with grant reporting and resource allocation requirements, or about the causal mechanisms. This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service infrastructure serving marginalized households. The AUDIT study is a block randomized, controlled, three-arm parallel group exploratory trial. A convenience sample of 5 municipalities in each of 17 states in Mexico (n=85) were block randomized to be audited by federal auditors (n=17), by state auditors (n=17), and a control condition outside the annual program of audits (n=51) in a 1:1:3 ratio. Replicable and verifiable randomization was performed using publicly available lottery numbers. Audited municipalities were included in the national program of audits and received standard audits on their use of federal public service infrastructure grants. Municipalities receiving moderate levels of grant transfers were recruited, as these were outside the auditing sampling frame--and hence audit program--or had negligible probabilities of ever being audited. The primary outcome measures capture compliance with the grant program and markers for the causal mechanisms, including deterrence and information effects. Secondary outcome measure include differences in audit reports across federal and state auditors, and measures like career concerns, political promotions, and political clientelism capturing synergistic effects with municipal accountability systems. The survey firm and research assistants assessing outcomes were blind to treatment status. This study will improve our understanding of local accountability systems for public service delivery in the 17 states under study, and may have downstream policy implications. The study design also demonstrates the use of verifiable and replicable randomization, and of sequentially partitioned hypotheses to reduce the Type I error rate in multiple hypothesis tests. Controlled-trials.com Identifier ISRCTN22381841: Date registered 02/11/2012.

The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial.

PubMed

Tyson, Anna F; Kendig, Claire E; Mabedi, Charles; Cairns, Bruce A; Charles, Anthony G

2015-03-01

Changes in pulmonary dynamics following laparotomy are well documented. Deep breathing exercises, with or without incentive spirometry, may help counteract postoperative decreased vital capacity; however, the evidence for the role of incentive spirometry in the prevention of postoperative atelectasis is inconclusive. Furthermore, data are scarce regarding the prevention of postoperative atelectasis in sub-Saharan Africa. To determine the effect of the use of incentive spirometry on pulmonary function following exploratory laparotomy as measured by forced vital capacity (FVC). This was a single-center, randomized clinical trial performed at Kamuzu Central Hospital, Lilongwe, Malawi. Study participants were adult patients who underwent exploratory laparotomy and were randomized into the intervention or control groups (standard of care) from February 1 to November 30, 2013. All patients received routine postoperative care, including instructions for deep breathing and early ambulation. We used bivariate analysis to compare outcomes between the intervention and control groups. Adult patients who underwent exploratory laparotomy participated in postoperative deep breathing exercises. Patients in the intervention group received incentive spirometers. We assessed pulmonary function using a peak flow meter to measure FVC in both groups of patients. Secondary outcomes, such as hospital length of stay and mortality, were obtained from the medical records. A total of 150 patients were randomized (75 in each arm). The median age in the intervention and control groups was 35 years (interquartile range, 28-53 years) and 33 years (interquartile range, 23-46 years), respectively. Men predominated in both groups, and most patients underwent emergency procedures (78.7% in the intervention group and 84.0% in the control group). Mean initial FVC did not differ significantly between the intervention and control groups (0.92 and 0.90 L, respectively; P=.82 [95% CI, 0.52-2.29]). Although patients in the intervention group tended to have higher final FVC measurements, the change between the first and last measured FVC was not statistically significant (0.29 and 0.25 L, respectively; P=.68 [95% CI, 0.65-1.95]). Likewise, hospital length of stay did not differ significantly between groups. Overall postoperative mortality was 6.0%, with a higher mortality rate in the control group compared with the intervention group (10.7% and 1.3%, respectively; P=.02 [95% CI, 0.01-0.92]). Education and provision of incentive spirometry for unmonitored patient use does not result in statistically significant improvement in pulmonary dynamics following laparotomy. We would not recommend the addition of incentive spirometry to the current standard of care in this resource-constrained environment. clinicaltrials.gov Identifier: NCT01789177.

Pulsatile dry cupping in patients with osteoarthritis of the knee - a randomized controlled exploratory trial.

PubMed

Teut, Michael; Kaiser, Stefan; Ortiz, Miriam; Roll, Stephanie; Binting, Sylvia; Willich, Stefan N; Brinkhaus, Benno

2012-10-12

Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA). In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome. 21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9). In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed. Clinicaltrials.gov Identifier: NCT01057043.

Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial

PubMed Central

2012-01-01

Introduction Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA). Methods In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome. Results 21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9). Conclusion In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed. Trial registration Clinicaltrials.gov Identifier: NCT01057043 PMID:23057611

Dose Response Effects of Lisdexamfetamine Dimesylate Treatment in Adults with ADHD: An Exploratory Study

ERIC Educational Resources Information Center

Faraone, Stephen V.; Spencer, Thomas J.; Kollins, Scott H.; Glatt, Stephen J.; Goodman, David

2012-01-01

Objective: To explore dose-response effects of lisdexamfetamine dimesylate (LDX) treatment for ADHD. Method: This was a 4-week, randomized, double-blinded, placebo-controlled, parallel-group, forced-dose titration study in adult participants, aged 18 to 55 years, meeting "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.)…

Reading Intervention Using Interactive Metronome in Children with Language and Reading Impairment: A Preliminary Investigation

ERIC Educational Resources Information Center

Ritter, Michaela; Colson, Karen A.; Park, Jungjun

2013-01-01

This exploratory study examined the effects of Interactive Metronome (IM) when integrated with a traditional language and reading intervention on reading achievement. Forty-nine school-age children with language and reading impairments were assigned randomly to either an experimental group who received the IM treatment or to a control group who…

Mediating Role of Parental Influence in Children's Response to Television Commercials: An Exploratory Study.

ERIC Educational Resources Information Center

Prasad, V. Kanti; And Others

This study investigated, in a laboratory experimental framework, the relative influences of television commercials and parental counter-commercial advocacy on children's consumption choice behavior. Sixty-four 8- to 10-year-old boys were randomly assigned to one of three treatment groups: (1) no counter commercial advocacy (control group), (2)…

Anxiety Outcomes after Physical Activity Interventions: Meta-Analysis Findings

PubMed Central

Conn, Vicki S.

2011-01-01

Background Although numerous primary studies have documented the mental health benefits of physical activity (PA), no previous quantitative synthesis has examined anxiety outcomes of interventions to increase PA. Objectives This meta-analysis integrates extant research about anxiety outcomes from interventions to increase PA among healthy adults. Method Extensive literature searching located published and unpublished PA intervention studies with anxiety outcomes. Eligible studies reported findings from interventions designed to increase PA delivered to healthy adults without anxiety disorders. Data were coded from primary studies. Random-effects meta-analytic procedures were completed. Exploratory moderator analyses using meta-analysis ANOVA and regression analogues were conducted to determine if report, methods, sample, or intervention characteristics were associated with differences in anxiety outcomes. Results Data were synthesized across 3,289 subjects from 19 eligible reports. The overall mean anxiety effect size (d-index) for two-group comparisons was 0.22 with significant heterogeneity (Q = 32.15). Exploratory moderator analyses found larger anxiety improvement effect sizes among studies that included larger samples, used random allocation of subjects to treatment and control conditions, targeted only PA behavior instead of multiple health behaviors, included supervised exercise (vs. home-based PA), used moderate or high-intensity instead of low-intensity PA, and suggested subjects exercise at a fitness facility (vs. home) following interventions. Discussion These findings document that some interventions can decrease anxiety symptoms among healthy adults. Exploratory moderator analyses suggest possible directions for future primary research to compare interventions in randomized trials to confirm causal relationships. PMID:20410849

A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.

PubMed

Rascol, Olivier; Zesiewicz, Theresa; Chaudhuri, K Ray; Asgharnejad, Mahnaz; Surmann, Erwin; Dohin, Elisabeth; Nilius, Sigrid; Bauer, Lars

2016-07-01

Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed. © 2015, The American College of Clinical Pharmacology.

Group music therapy for patients with persistent post-traumatic stress disorder--an exploratory randomized controlled trial with mixed methods evaluation.

PubMed

Carr, Catherine; d'Ardenne, Patricia; Sloboda, Ann; Scott, Carleen; Wang, Duolao; Priebe, Stefan

2012-06-01

Not all patients with post-traumatic stress disorder (PTSD) respond to cognitive behavioural therapy (CBT). Literature suggests group music therapy might be beneficial in treating PTSD. However, feasibility and effectiveness have not been assessed. The study objectives were to assess whether group music therapy was feasible for patients who did not respond to CBT, and whether it has an effect on PTSD symptoms and depression. The study employed mixed methods comprising of an exploratory randomized controlled trial, qualitative content analysis of therapy, and patient interviews. Patients with significant PTSD symptoms (n = 17) following completion of CBT were randomly assigned to treatment (n = 9) or control groups (n = 8). The treatment group received 10 weeks of group music therapy after which exit interviews were conducted. Control group patients were offered the intervention at the end of the study. Symptoms were assessed on the Impact of Events Scale-Revised and Beck Depression Inventory II at the beginning and end of treatment. Treatment-group patients experienced a significant reduction in severity of PTSD symptoms (-20.18; 95% confidence interval [CI]: [-31.23, -9.12]) and a marginally significant reduction in depression (-11.92; 95%CI: [-24.05, 0.21]) at 10 weeks from baseline compared to the control. Patients viewed music therapy as helpful and reported experiences concur with current literature. Group music therapy appears feasible and effective for PTSD patients who have not sufficiently responded to CBT. Limitations include the small sample size and lack of blinding. Further research should address these limitations, test sustainability, and identify specific factors that address symptoms in treatment. ©2011 The British Psychological Society.

Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial.

PubMed

McDermott, Mary M; Guralnik, Jack M; Criqui, Michael H; Ferrucci, Luigi; Liu, Kiang; Spring, Bonnie; Tian, Lu; Domanchuk, Kathryn; Kibbe, Melina; Zhao, Lihui; Lloyd Jones, Donald; Liao, Yihua; Gao, Ying; Rejeski, W Jack

2015-05-20

Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease (PAD). Among people with PAD, we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control. One hundred ninety-four PAD participants were randomized. During months 1 to 6, the intervention group met weekly with other PAD participants and a facilitator. Group support and self-regulatory skills were used to help participants adhere to walking exercise. Ninety-percent of exercise was conducted at or near home. The control group attended weekly lectures. During months 6 to 12, each group received telephone contact only. Primary outcomes have been reported. Here we compare changes in exploratory outcomes of mobility loss (the inability to climb a flight of stairs or walk one-quarter mile without assistance), walking velocity, and the Short Physical Performance Battery. Compared to controls, fewer participants randomized to the intervention experienced mobility loss at 6-month follow-up: 6.3% versus 26.5%, P=0.002, odds ratio=0.19 (95% CI=0.06 to 0.58) and at 12-month follow-up: 5.2% versus 18.5%, P=0.029, odds ratio=0.24 (95% CI=0.06 to 0.97). The intervention improved fast-paced 4-m walking velocity at 6-month follow-up (P=0.005) and the Short Physical Performance Battery at 12-month follow-up (P=0.027), compared to controls. In exploratory analyses, a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients. URL: http://clinicaltrials.gov. Unique identifier: NCT00693940. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Unsupervised Exercise and Mobility Loss in Peripheral Artery Disease: A Randomized Controlled Trial

PubMed Central

McDermott, Mary M; Guralnik, Jack M; Criqui, Michael H; Ferrucci, Luigi; Liu, Kiang; Spring, Bonnie; Tian, Lu; Domanchuk, Kathryn; Kibbe, Melina; Zhao, Lihui; Lloyd Jones, Donald; Liao, Yihua; Gao, Ying; Rejeski, W Jack

2015-01-01

Background Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease (PAD). Among people with PAD, we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control. Methods and Results One hundred ninety-four PAD participants were randomized. During months 1 to 6, the intervention group met weekly with other PAD participants and a facilitator. Group support and self-regulatory skills were used to help participants adhere to walking exercise. Ninety-percent of exercise was conducted at or near home. The control group attended weekly lectures. During months 6 to 12, each group received telephone contact only. Primary outcomes have been reported. Here we compare changes in exploratory outcomes of mobility loss (the inability to climb a flight of stairs or walk one-quarter mile without assistance), walking velocity, and the Short Physical Performance Battery. Compared to controls, fewer participants randomized to the intervention experienced mobility loss at 6-month follow-up: 6.3% versus 26.5%, P=0.002, odds ratio=0.19 (95% CI=0.06 to 0.58) and at 12-month follow-up: 5.2% versus 18.5%, P=0.029, odds ratio=0.24 (95% CI=0.06 to 0.97). The intervention improved fast-paced 4-m walking velocity at 6-month follow-up (P=0.005) and the Short Physical Performance Battery at 12-month follow-up (P=0.027), compared to controls. Conclusions In exploratory analyses, a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients. Clinical Trial Registration URL: http://clinicaltrials.gov. Unique identifier: NCT00693940. PMID:25994445

Physical activity and adolescents: an exploratory randomized controlled trial investigating the influence of affective and instrumental text messages.

PubMed

Sirriyeh, Reema; Lawton, Rebecca; Ward, Jane

2010-11-01

The present study attempts to develop and pilot the feasibility and efficacy of a novel intervention using affective messages as a strategy to increase physical activity (PA) levels in adolescents. Design An exploratory pilot randomized control trial was used to compare behaviour change over 2 weeks. A modified form of the International Physical Activity Questionnaire was used to assess PA behaviour. A total of 120 adolescents (16-19 years) from 4 sixth forms in West Yorkshire completed the field-based study. Participants were randomly assigned to one of three experimental conditions, or the control condition (N=28). Participants in experimental conditions received 1 short messaging service (SMS) text message per day over the 2 weeks, which included manipulations of either affective beliefs (enjoyable/unenjoyable; N=31), instrumental beliefs (beneficial/harmful; N=30), or a combination of these (N=31). Control participants received one SMS text message per week. Outcomes were measured at baseline and at the end of the 2 week intervention. PA levels increased by the equivalent of 31.5  minutes of moderate (four metabolic equivalent) activity per week during the study. Main effects of condition (p=.049), and current physical activity level (p=.002) were identified, along with a significant interaction between condition and current activity level (p=.006). However, when the sample was split at baseline into active and inactive participants, a main effect of condition remained for inactive participants only (p=.001). Post hoc analysis revealed that inactive participants who received messages targeting affective beliefs increased their activity levels significantly more than the instrumental (p=.012), combined (p=.002), and control groups (p=.018). Strategies based on affective associations may be more effective for increasing PA levels in inactive individuals.

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold

PubMed Central

2010-01-01

Background The common cold, the most prevalent contagious viral disease in humans still lacks a safe and effective antiviral treatment. Iota-Carrageenan is broadly active against respiratory viruses in-vitro and has an excellent safety profile. This study investigated the efficacy and safety of an Iota-Carrageenan nasal spray in patients with common cold symptoms. Methods In a randomized, double-blind, placebo-controlled exploratory trial, 35 human subjects suffering from early symptoms of common cold received Iota-Carrageenan (0.12%) in a saline solution three times daily for 4 days, compared to placebo. Results Administration of Iota-Carrageenan nasal spray reduced the symptoms of common cold (p = 0.046) and the viral load in nasal lavages (p = 0.009) in patients with early symptoms of common cold. Pro-inflammatory mediators FGF-2, Fractalkine, GRO, G-CSF, IL-8, IL-1α, IP-10, IL-10, and IFN-α2 were reduced in the Iota-Carrageenan group. Conclusions Iota-Carrageenan nasal spray appears to be a promising treatment for safe and effective treatment of early symptoms of common cold. Larger trials are indicated to confirm the results. PMID:20696083

Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold.

PubMed

Eccles, Ron; Meier, Christiane; Jawad, Martez; Weinmüllner, Regina; Grassauer, Andreas; Prieschl-Grassauer, Eva

2010-08-10

The common cold, the most prevalent contagious viral disease in humans still lacks a safe and effective antiviral treatment. Iota-Carrageenan is broadly active against respiratory viruses in-vitro and has an excellent safety profile. This study investigated the efficacy and safety of an Iota-Carrageenan nasal spray in patients with common cold symptoms. In a randomized, double-blind, placebo-controlled exploratory trial, 35 human subjects suffering from early symptoms of common cold received Iota-Carrageenan (0.12%) in a saline solution three times daily for 4 days, compared to placebo. Administration of Iota-Carrageenan nasal spray reduced the symptoms of common cold (p = 0.046) and the viral load in nasal lavages (p = 0.009) in patients with early symptoms of common cold. Pro-inflammatory mediators FGF-2, Fractalkine, GRO, G-CSF, IL-8, IL-1alpha, IP-10, IL-10, and IFN-alpha2 were reduced in the Iota-Carrageenan group. Iota-Carrageenan nasal spray appears to be a promising treatment for safe and effective treatment of early symptoms of common cold. Larger trials are indicated to confirm the results.

Improved Digit Span in Children after a 6-Week Intervention of Playing a Musical Instrument: An Exploratory Randomized Controlled Trial

PubMed Central

Guo, Xia; Ohsawa, Chie; Suzuki, Akiko; Sekiyama, Kaoru

2018-01-01

Previous studies have reported that music training not only improves children's musical skills, but also enhances their cognitive functions. However, there is a disagreement about what domain(s) might be affected. Moreover, effects of short-term (

Improved Digit Span in Children after a 6-Week Intervention of Playing a Musical Instrument: An Exploratory Randomized Controlled Trial.

PubMed

Guo, Xia; Ohsawa, Chie; Suzuki, Akiko; Sekiyama, Kaoru

2017-01-01

Previous studies have reported that music training not only improves children's musical skills, but also enhances their cognitive functions. However, there is a disagreement about what domain(s) might be affected. Moreover, effects of short-term (

Effect of a 9-wk. after-school multiskills club on fundamental movement skill proficiency in 8- to 9-yr.-old children: an exploratory trial.

PubMed

Foweather, Lawrence; McWhannell, Nicola; Henaghan, Jayne; Lees, Adrian; Stratton, Gareth; Batterham, Alan M

2008-06-01

This exploratory study examined the effects of a 9-wk. after-school multiskills club on fundamental movement skill proficiency in 8- to 9-yr.-old children. Two schools were randomly assigned to either a control (n = 15 children) or multiskill club (n = 19 children) condition. The multiskill club received 18 coaching sessions designed to improve fundamental movement skills. The control group followed normal routines. 7 skills were assessed using process-oriented measures with video analysis. Participation in the multiskill club yielded significant improvements in proficiency at posttest only in static balance, while potentially practically important improvements were observed in performance of the catch, throw, and kick skills. The after-school multiskill club offered a viable opportunity for movement skill acquisition, but any such programme would need to run for a longer duration to assess whether this type of activity could benefit all skills.

Clinical Responses to Atomoxetine in Attention-Deficit/Hyperactivity Disorder: The Integrated Data Exploratory Analysis (IDEA) Study

ERIC Educational Resources Information Center

Newcorn, Jeffrey H.; Sutton, Virginia K.; Weiss, Margaret D.; Sumner, Calvin R.

2009-01-01

Data from six randomized controlled trials in the U.S. reveal that 47 percent of patients aged six to 18 years showed a much improved clinical response to atomoxetine as a treatment for attention deficit hyperactivity disorder while 40 percent did not have a response. Augmenting or switching treatment in non-responders by week 4 is suggested.

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

A Family-Based Randomized Controlled Trial of Pain Intervention for Adolescents with Sickle Cell Disease

PubMed Central

Barakat, Lamia P.; Schwartz, Lisa A.; Salamon, Katherine S.; Radcliffe, Jerilynn

2010-01-01

The study had two aims--to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n = 27) or a disease education attention control intervention (DISEASE ED) (n = 26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (prior to randomization), post-intervention, and one-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. PMID:20686425

fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study.

PubMed

Zilverstand, Anna; Sorger, Bettina; Slaats-Willemse, Dorine; Kan, Cornelis C; Goebel, Rainer; Buitelaar, Jan K

2017-01-01

Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study's small sample size, potential clinical benefits need to be further investigated in future studies. ISRCTN12390961.

Are Substance Use Prevention Programs More Effective in Schools Making Adequate Yearly Progress? A Study of Project ALERT

ERIC Educational Resources Information Center

Clark, Heddy Kovach; Ringwalt, Chris L.; Shamblen, Stephen R.; Hanley, Sean M.; Flewelling, Robert L.

2011-01-01

This exploratory study sought to determine if a popular school-based drug prevention program might be effective in schools that are making adequate yearly progress (AYP). Thirty-four schools with grades 6 through 8 in 11 states were randomly assigned either to receive Project ALERT (n = 17) or to a control group (n = 17); of these, 10 intervention…

Randomized Phase III Placebo-Controlled Trial of Letrozole Plus Oral Temsirolimus As First-Line Endocrine Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

PubMed Central

Wolff, Antonio C.; Lazar, Ann A.; Bondarenko, Igor; Garin, August M.; Brincat, Stephen; Chow, Louis; Sun, Yan; Neskovic-Konstantinovic, Zora; Guimaraes, Rodrigo C.; Fumoleau, Pierre; Chan, Arlene; Hachemi, Soulef; Strahs, Andrew; Cincotta, Maria; Berkenblit, Anna; Krygowski, Mizue; Kang, Lih Lisa; Moore, Laurence; Hayes, Daniel F.

2013-01-01

Purpose Recent data showed improvement in progression-free survival (PFS) when adding everolimus to exemestane in patients with advanced breast cancer experiencing recurrence/progression after nonsteroidal aromatase inhibitor (AI) therapy. Here, we report clinical outcomes of combining the mammalian target of rapamycin (mTOR) inhibitor temsirolimus with letrozole in AI-naive patients. Patients and Methods This phase III randomized placebo-controlled study tested efficacy/safety of first-line oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) versus letrozole/placebo in 1,112 patients with AI-naive, hormone receptor–positive advanced disease. An independent data monitoring committee recommended study termination for futility at the second preplanned interim analysis (382 PFS events). Results Patients were balanced (median age, 63 years; 10% stage III, 40% had received adjuvant endocrine therapy). Those on letrozole/temsirolimus experienced more grade 3 to 4 events (37% v 24%). There was no overall improvement in primary end point PFS (median, 9 months; hazard ratio [HR], 0.90; 95% CI, 0.76 to 1.07; P = .25) nor in the 40% patient subset with prior adjuvant endocrine therapy. An exploratory analysis showed improved PFS favoring letrozole/temsirolimus in patients ≤ age 65 years (9.0 v 5.6 months; HR, 0.75; 95% CI, 0.60 to 0.93; P = .009), which was separately examined by an exploratory analysis of 5-month PFS using subpopulation treatment effect pattern plot methodology (P = .003). Conclusion Adding temsirolimus to letrozole did not improve PFS as first-line therapy in patients with AI-naive advanced breast cancer. Exploratory analyses of benefit in younger postmenopausal patients require external confirmation. PMID:23233719

The Microbiome in Posttraumatic Stress Disorder and Trauma-Exposed Controls: An Exploratory Study.

PubMed

Hemmings, Sian M J; Malan-Müller, Stefanie; van den Heuvel, Leigh L; Demmitt, Brittany A; Stanislawski, Maggie A; Smith, David G; Bohr, Adam D; Stamper, Christopher E; Hyde, Embriette R; Morton, James T; Marotz, Clarisse A; Siebler, Philip H; Braspenning, Maarten; Van Criekinge, Wim; Hoisington, Andrew J; Brenner, Lisa A; Postolache, Teodor T; McQueen, Matthew B; Krauter, Kenneth S; Knight, Rob; Seedat, Soraya; Lowry, Christopher A

2017-10-01

Inadequate immunoregulation and elevated inflammation may be risk factors for posttraumatic stress disorder (PTSD), and microbial inputs are important determinants of immunoregulation; however, the association between the gut microbiota and PTSD is unknown. This study investigated the gut microbiome in a South African sample of PTSD-affected individuals and trauma-exposed (TE) controls to identify potential differences in microbial diversity or microbial community structure. The Clinician-Administered PTSD Scale for DSM-5 was used to diagnose PTSD according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Microbial DNA was extracted from stool samples obtained from 18 individuals with PTSD and 12 TE control participants. Bacterial 16S ribosomal RNA gene V3/V4 amplicons were generated and sequenced. Microbial community structure, α-diversity, and β-diversity were analyzed; random forest analysis was used to identify associations between bacterial taxa and PTSD. There were no differences between PTSD and TE control groups in α- or β-diversity measures (e.g., α-diversity: Shannon index, t = 0.386, p = .70; β-diversity, on the basis of analysis of similarities: Bray-Curtis test statistic = -0.033, p = .70); however, random forest analysis highlighted three phyla as important to distinguish PTSD status: Actinobacteria, Lentisphaerae, and Verrucomicrobia. Decreased total abundance of these taxa was associated with higher Clinician-Administered PTSD Scale scores (r = -0.387, p = .035). In this exploratory study, measures of overall microbial diversity were similar among individuals with PTSD and TE controls; however, decreased total abundance of Actinobacteria, Lentisphaerae, and Verrucomicrobia was associated with PTSD status.

Rotigotine and specific non-motor symptoms of Parkinson's disease: post hoc analysis of RECOVER.

PubMed

Ray Chaudhuri, K; Martinez-Martin, Pablo; Antonini, Angelo; Brown, Richard G; Friedman, Joseph H; Onofrj, Marco; Surmann, Erwin; Ghys, Liesbet; Trenkwalder, Claudia

2013-07-01

Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy. Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature. Of 287 patients randomized, NMSS data were available for 267 patients (178 rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05). Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effectiveness of Disease-Specific Cognitive Behavioral Therapy on Anxiety, Depression, and Quality of Life in Youth With Inflammatory Bowel Disease: A Randomized Controlled Trial.

PubMed

Stapersma, Luuk; van den Brink, Gertrude; van der Ende, Jan; Szigethy, Eva M; Beukers, Ruud; Korpershoek, Thea A; Theuns-Valks, Sabine D M; Hillegers, Manon H J; Escher, Johanna C; Utens, Elisabeth M W J

2018-05-29

To evaluate the effectiveness of a disease-specific cognitive behavioral therapy (CBT) protocol on anxiety and depressive symptoms and health-related quality of life (HRQOL) in adolescents and young adults with inflammatory bowel disease (IBD). A parallel group randomized controlled trial was conducted in 6 centers of (pediatric) gastroenterology. Included were 70 patients and young adults (10-25 years) with IBD and subclinical anxiety and/or depressive symptoms. Patients were randomized into 2 groups, stratified by center: (a) standard medical care (care-as-usual [CAU]) plus disease-specific manualized CBT (Primary and Secondary Control Enhancement Training for Physical Illness; PASCET-PI), with 10 weekly sessions, 3 parent sessions, and 3 booster sessions (n = 37), or (b) CAU only (n = 33). Primary analysis concerned the reliable change in anxiety and depressive symptoms after 3 months (immediate posttreatment assessment). Exploratory analyses concerned (1) the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, and (2) the influence of age, gender, and disease type on the effect of the PASCET-PI. Overall, all participants improved significantly in their anxiety and depressive symptoms and HRQOL, regardless of group, age, gender, and disease type. Primary chi-square tests and exploratory linear mixed models showed no difference in outcomes between the PASCET-PI (n = 35) and the CAU group (n = 33). In youth with IBD and subclinical anxiety and/or depressive symptoms, preliminary results of immediate post-treatment assessment indicated that a disease-specific CBT added to standard medical care did not perform better than standard medical care in improving psychological symptoms or HRQOL. ClinicalTrials.gov: NCT02265588.

Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

PubMed

Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

2013-05-07

It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more effective than the TPSAT protocol, this may influence standards of care and best practices for patients with dysphagia involving impaired thin-liquid control as a result of stroke. Clinicaltrials.gov http://NCT01370083.

An Exploratory Analysis of Game Telemetry from a Pediatric mHealth Intervention.

PubMed

Padman, Rema; Gupta, Disha; Sri Prakash, Bhargav; Krishnan, Chelladurai; Panchatcharam, K

2017-01-01

Pediatric obesity is a growing epidemic, with unhealthy eating habits and poor physical activity being major contributors. While video and mobile games have been shown to have a positive impact on behavior change in children, the mechanisms underlying game play that impact outcomes of interest are poorly understood. This research aims to examine the impact of a novel mobile gaming app on the design of behavioral interventions by learning from the rich and unique game telemetry generated from a randomized controlled trial of the app use by school children. In this exploratory analysis, we extract a partial dataset to build and analyze chronological sequences of game plays to understand key patterns in the game mechanics that players utilize as they navigate the game, and possible implications of the results.

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

PubMed Central

Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

2014-01-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history. PMID:25506545

Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial.

PubMed

Yadavaia, James E; Hayes, Steven C; Vilardaga, Roger

2014-10-01

Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history.

fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study

PubMed Central

Slaats-Willemse, Dorine; Kan, Cornelis C.; Goebel, Rainer; Buitelaar, Jan K.

2017-01-01

Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study’s small sample size, potential clinical benefits need to be further investigated in future studies. Trial Registration: ISRCTN12390961 PMID:28125735

Factors impacting the efficacy of venlafaxine extended release 75–225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan

PubMed Central

Watanabe, Yoshinori; Asami, Yuko; Hirano, Yoko; Kuribayashi, Kazuhiko; Itamura, Rio; Imaeda, Takayuki

2018-01-01

Purpose To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75–225 mg/day dose in patients with major depressive disorder (MDD). Methods We performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression–17 items (HAM-D17) total score, Hamilton Rating Scale for Depression–6 items score, and Montgomery–Asberg Depression Rating Scale total score. The following factors were considered in the subgroup analyses: sex, age, HAM-D17 total score at baseline, duration of MDD, duration of current depressive episode, history of previous depressive episodes, history of previous medications for MDD, and CYP2D6 phenotype. For each subgroup, an analysis of covariance model was fitted and the adjusted mean of the treatment effect and corresponding 95% CI were computed. Due to the exploratory nature of the investigation, no statistical hypothesis testing was used. Results Venlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group. Conclusion These results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER. PMID:29844674

Factors impacting the efficacy of venlafaxine extended release 75-225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan.

PubMed

Watanabe, Yoshinori; Asami, Yuko; Hirano, Yoko; Kuribayashi, Kazuhiko; Itamura, Rio; Imaeda, Takayuki

2018-01-01

To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75-225 mg/day dose in patients with major depressive disorder (MDD). We performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression-17 items (HAM-D 17 ) total score, Hamilton Rating Scale for Depression-6 items score, and Montgomery-Asberg Depression Rating Scale total score. The following factors were considered in the subgroup analyses: sex, age, HAM-D 17 total score at baseline, duration of MDD, duration of current depressive episode, history of previous depressive episodes, history of previous medications for MDD, and CYP2D6 phenotype. For each subgroup, an analysis of covariance model was fitted and the adjusted mean of the treatment effect and corresponding 95% CI were computed. Due to the exploratory nature of the investigation, no statistical hypothesis testing was used. Venlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group. These results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER.

Simulation-based camera navigation training in laparoscopy-a randomized trial.

PubMed

Nilsson, Cecilia; Sorensen, Jette Led; Konge, Lars; Westen, Mikkel; Stadeager, Morten; Ottesen, Bent; Bjerrum, Flemming

2017-05-01

Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group). Participants were surgical novices without prior laparoscopic experience. The primary outcome was assessment of camera navigation skills during a laparoscopic cholecystectomy. The secondary outcome was technical skills after training, using a previously developed model for testing camera navigational skills. The exploratory outcome measured participants' motivation toward the task as an operating assistant. Thirty-six participants were randomized. No significant difference was found in the primary outcome between the three groups (p = 0.279). The secondary outcome showed no significant difference between the interventions groups, total time 167 s (95% CI, 118-217) and 194 s (95% CI, 152-236) for the camera group and the procedure group, respectively (p = 0.369). Both interventions groups were significantly faster than the control group, 307 s (95% CI, 202-412), p = 0.018 and p = 0.045, respectively. On the exploratory outcome, the control group for two dimensions, interest/enjoyment (p = 0.030) and perceived choice (p = 0.033), had a higher score. Simulation-based training improves the technical skills required for camera navigation, regardless of practicing camera navigation or the procedure itself. Transfer to the clinical setting could, however, not be demonstrated. The control group demonstrated higher interest/enjoyment and perceived choice than the camera group.

Cadmium and lead residue control in a hazard analysis and critical control point (HACCP) environment.

PubMed

Pagan-Rodríguez, Doritza; O'Keefe, Margaret; Deyrup, Cindy; Zervos, Penny; Walker, Harry; Thaler, Alice

2007-02-21

In 2003-2004, the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) conducted an exploratory assessment to determine the occurrence and levels of cadmium and lead in randomly collected samples of kidney, liver, and muscle tissues of mature chickens, boars/stags, dairy cows, and heifers. The data generated in the study were qualitatively compared to data that FSIS gathered in a 1985-1986 study in order to identify trends in the levels of cadmium and lead in meat and poultry products. The exploratory assessment was necessary to verify that Hazard Analysis and Critical Control Point plans and efforts to control exposure to these heavy metals are effective and result in products that meet U.S. export requirements. A comparison of data from the two FSIS studies suggests that the incidence and levels of cadmium and lead in different slaughter classes have remained stable since the first study was conducted in 1985-1986. This study was conducted to fulfill FSIS mandate to ensure that meat, poultry, and egg products entering commerce in the United States are free of adulterants, including elevated levels of environmental contaminants such as cadmium and lead.

Investigating Clinical Benefits of a Novel Sleep-Focused, Mind-Body Program on Gulf War Illness Symptoms: An Exploratory Randomized Controlled Trial

DTIC Science & Technology

2015-06-01

emotional and psychological dysregulated states that accompany GWI, including disturbed sleep. CAM therapies such as mind-body interventions have...are experiential exercises used to direct attention towards the senses (tune into the senses), and “mind-body mapping ” techniques, which are written...fulfilled can lead to a dysfunctional mind-body state, with negative health 7 consequences. Defusing Requirements through mind-body mapping

Knowledge, Attitudes and Behaviours. Concerning Education for Sustainable Development: Two Exploratory Studies

ERIC Educational Resources Information Center

Michalos, Alex C.; Creech, Heather; McDonald, Christina; Kahlke, P. Maurine Hatch

2011-01-01

Celebrating the UN Decade of Education for Sustainable Development (2005-2014), this paper presents results of two exploratory surveys taken in the province of Manitoba, Canada in January to March 2008. A random sample of 506 adults completed a mailed out questionnaire designed to measure respondents' knowledge, attitudes and behaviours concerning…

[Variables related to the emergence of differential patterns in work motivation].

PubMed

Arrieta, Carlos; Navarro, José; Vicente, Susana

2008-11-01

Several longitudinal studies have shown that motivation at work acts chaotically. In very few cases, it may be linear or random. However, the factors that might explain why these different patterns emerge have not been analysed to date. In this exploratory study, we interviewed 73 employees whose motivational patterns were previously known. The results revealed that chaotic patterns were associated with high levels of motivation, self-efficacy beliefs, and perceptions of instrumentality, and also with intrinsic personal goal orientation and a perception of high work control. Linear patterns were associated with extrinsic goals and a perception of work as difficult, and random patterns were linked to high flexibility at work.

Reduction in salivary α-amylase levels following a mind-body intervention in cancer survivors--an exploratory study.

PubMed

Lipschitz, David L; Kuhn, Renee; Kinney, Anita Y; Donaldson, Gary W; Nakamura, Yoshio

2013-09-01

The main aim of this exploratory study was to assess whether salivary α-amylase (sAA) and salivary cortisol levels would be positively modulated by sleep-focused mind-body interventions in female and male cancer survivors. We conducted a randomized controlled trial in which 57 cancer survivors with self-reported sleep disturbance received either a Sleep Hygiene Education (SHE; n=18) control, or one of two experimental mind-body interventions, namely, Mind-Body Bridging (MBB; n=19) or Mindfulness Meditation (MM; n=20). Interventions were three sessions each conducted once per week for three consecutive weeks. Saliva cortisol and sAA were measured at baseline and 1 week after the last session. Participants also completed a sleep scale at the same time points when saliva was collected for biomarker measurement. Our study revealed that at post-intervention assessment, mean sAA levels upon awakening ("Waking" sample) declined in MBB compared with that of SHE. Mean Waking cortisol levels did not differ among treatment groups but declined slightly in SHE. Self-reported sleep improved across the three interventions at Post-assessment, with largest improvements in the MBB intervention. In this exploratory study, sleep focused mind-body intervention (MBB) attenuated Waking sAA levels, suggesting positive influences of a mind-body intervention on sympathetic activity in cancer survivors with sleep disturbance. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial.

PubMed

Murgia, Mauro; Pili, Roberta; Corona, Federica; Sors, Fabrizio; Agostini, Tiziano A; Bernardis, Paolo; Casula, Carlo; Cossu, Giovanni; Guicciardi, Marco; Pau, Massimiliano

2018-01-01

The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of gait disturbances associated with Parkinson's disease (PD). Typically, the RAS consists of metronome or music-based sounds (artificial RAS), while ecological footstep sounds (ecological RAS) have never been used for rehabilitation programs. The aim of this study was to compare the effects of a rehabilitation program integrated either with ecological or with artificial RAS. An observer-blind, randomized controlled trial was conducted to investigate the effects of 5 weeks of supervised rehabilitation integrated with RAS. Thirty-eight individuals affected by PD were randomly assigned to one of the two conditions (ecological vs. artificial RAS); thirty-two of them (age 68.2 ± 10.5, Hoehn and Yahr 1.5-3) concluded all phases of the study. Spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. Thirty-two participants were analyzed. The results revealed that both groups improved in the majority of biomechanical and clinical measures, independently of the type of sound. Moreover, exploratory analyses for separate groups were conducted, revealing improvements on spatio-temporal parameters only in the ecological RAS group. Overall, our results suggest that ecological RAS is equally effective compared to artificial RAS. Future studies should further investigate the role of ecological RAS, on the basis of information revealed by our exploratory analyses. Theoretical, methodological, and practical issues concerning the implementation of ecological sounds in the rehabilitation of PD patients are discussed. www.ClinicalTrials.gov, identifier NCT03228888.

Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study.

PubMed

Skolnick, Brett E; Shenouda, Magdy; Khutoryansky, Naum M; Pusateri, Anthony E; Gabriel, Don; Carr, Marcus E

2011-10-01

Clopidogrel (Plavix®) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven®) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding. In this single-center, randomized, placebo-controlled, double-blind, dose-escalation, exploratory phase I trial, we assessed the safety and effects of rFVIIa in reversing clopidogrel-enhanced bleeding in an experimentally induced punch biopsy in healthy subjects. Efficacy assessments included the reversal of bleeding characteristics (bleed duration [BD], the primary end point and blood loss volume [BV] induced by punch biopsy, and thromboelastograph [TEG®] parameters) with rFVIIa or placebo after clopidogrel treatment. A significant number of subjects (56%) had limited response to clopidogrel (defined as ≤30% platelet aggregation inhibition) and were discontinued from study. The remaining subjects continued and had 4 biopsies. Of 40 subjects randomized, 37 were evaluated for efficacy. Clopidogrel treatment increased BD and BV compared with the baseline biopsy. Recombinant FVIIa (10 and 20 μg/kg) significantly mitigated the clopidogrel-induced effects on BV (P = 0.007 and P = 0.001, respectively). Early trial termination limited the evaluation of effects of higher rFVIIa doses. Subgroup analyses of subjects biopsied by the same physician demonstrated significant reduction of clopidogrel-induced BD with 20 μg/kg rFVIIa (P = 0.048). Ex vivo analysis of rFVIIa demonstrated clotting dynamics presented by parameters time to clot onset (TEG®-R) and clot angle (TEG®-A) (P < 0.005). In this clinical study, rFVIIa (10 and 20 μg/kg) reversed the effect of clopidogrel on blood loss.

Testing novel patient financial incentives to increase breast cancer screening.

PubMed

Merrick, Elizabeth Levy; Hodgkin, Dominic; Horgan, Constance M; Lorenz, Laura S; Panas, Lee; Ritter, Grant A; Kasuba, Paul; Poskanzer, Debra; Nefussy, Renee Altman

2015-11-01

To examine the effects of 3 types of low-cost financial incentives for patients, including a novel "person-centered" approach on breast cancer screening (mammogram) rates. Randomized controlled trial with 4 arms: 3 types of financial incentives ($15 gift card, entry into lottery for $250 gift card, and a person-centered incentive with choice of $15 gift card or lottery) and a control group. Sample included privately insured Tufts Health Plan members in Massachusetts who were women aged 42 to 69 years with no mammogram claim in ≥ 2.6 years. A sample of 4700 eligible members were randomized to 4 study arms. The control group received a standard reminder letter and the incentive groups received a reminder letter plus an incentive offer for obtaining a mammogram within the next 4 months. Bivariate tests and multivariate logistic regression were used to assess the incentives' impact on mammogram receipt. Data were analyzed for 4427 members (after exclusions such as undeliverable mail). The percent of members receiving a mammogram during the study was 11.7% (gift card), 12.1% (lottery), 13.4% (person-centered/choice), and 11.9% (controls). Differences were not statistically significant in bivariate or multivariate full-sample analyses. In exploratory subgroup analyses of members with a mammogram during the most recent year prior to the study-defined gap, person-centered incentives were associated with a higher likelihood of mammogram receipt. None of the low-cost incentives tested had a statistically significant effect on mammogram rates in the full sample. Exploratory findings for members who were more recently screened suggest that they may be more responsive to person-centered incentives.

An Exploratory Study of Universal Design for Teaching Chemistry to Students with and without Disabilities

ERIC Educational Resources Information Center

King-Sears, Margaret E.; Johnson, Todd M.; Berkeley, Sheri; Weiss, Margaret P.; Peters-Burton, Erin E.; Evmenova, Anya S.; Menditto, Anna; Hursh, Jennifer C.

2015-01-01

In this exploratory study, students in four co-taught high school chemistry classes were randomly assigned to a Universal Design for Learning (UDL) treatment or a comparison condition. Each co-teaching team taught one comparison and treatment class. UDL principles were operationalized for treatment: (a) a self-management strategy (using a…

Prior Knowledge Influence on Self-Explanation Effectiveness when Solving Problems: An Exploratory Study in Science Learning

ERIC Educational Resources Information Center

Ionas, Ioan Gelu; Cernusca, Dan; Collier, Harvest L.

2012-01-01

This exploratory study presents the outcomes of using self-explanation to improve learners' performance in solving basic chemistry problems. The results of the randomized experiment show the existence of a moderation effect between prior knowledge and the level of support self-explanation provides to learners, suggestive of a synergistic effect…

What works best for whom? An exploratory, subgroup analysis in a randomized, controlled trial on the effectiveness of a workplace intervention in low back pain patients on return to work.

PubMed

Steenstra, Ivan A; Knol, Dirk L; Bongers, Paulien M; Anema, Johannes R; van Mechelen, Willem; de Vet, Henrica C W

2009-05-20

Exploratory subgroup analysis in a randomized controlled trial (RCT). To detect possible moderators in the effectiveness of a workplace intervention in a population of workers with sick leave due to sub acute nonspecific low back pain. In a recently published RCT, a workplace intervention was effective on return to work, compared to usual care. Examining the heterogeneity of effect sizes within the population in this RCT (n = 196) can lead to information on the effectiveness of the intervention in subgroups of patients. A subgroup analysis was performed by adding interaction terms to the statistical model. Before analysis the following possible moderators for treatment were identified: age, gender, pain, functional status, heavy work, and sick leave in the previous 12 months. Cox regression analyses were performed and survival curves were plotted. The interaction (P = 0.02) between age (dichotomized at the median value) and the workplace intervention indicates a modifying effect. The workplace intervention is more effective for workers > or =44 years (HR, 95% CI = 2.5, [1.6, 4.1] vs. 1.2 [0.8, 1.8] for workers <44 years old). The interaction between sick leave in the previous 12 months and the workplace intervention is significant (P = 0.02). The intervention is more effective for workers with previous sick leave (HR, 95% CI = 2.8 [1.7, 4.9] vs. 1.3 [0.8, 2.0]). A modifying effect of gender, heavy work, and pain score and functional status on the effectiveness of this intervention was not found. The findings from these exploratory analyses should be tested in future RCTs. This workplace intervention seems very suitable for return to work of older workers and workers with previous sick leave. Gender, perceived heavy work, and baseline scores in pain and functional status should not be a basis for assignment to this intervention.

The reduction of intoxication and disorder in premises licensed to serve alcohol: an exploratory randomised controlled trial.

PubMed

Moore, Simon C; Brennan, Iain R; Murphy, Simon; Byrne, Ellie; Moore, Susan N; Shepherd, Jonathan P; Moore, Laurence

2010-10-14

Licensed premises offer a valuable point of intervention to reduce alcohol-related harm. To describe the research design for an exploratory trial examining the feasibility and acceptability of a premises-level intervention designed to reduce severe intoxication and related disorder. The study also aims to assess the feasibility of a potential future large scale effectiveness trial and provide information on key trial design parameters including inclusion criteria, premises recruitment methods, strategies to implement the intervention and trial design, outcome measures, data collection methods and intra-cluster correlations. A randomised controlled trial in licensed premises that had experienced at least one assault in the year preceding the intervention, documented in police or hospital Emergency Department (ED) records. Premises were recruited from four study areas by piloting four recruitment strategies of varying intensity. Thirty two licensed premises were grouped into matched pairs to reduce potential bias and randomly allocated to the control or intervention condition. The study included a nested process evaluation to provide information on intervention acceptability and implementation. Outcome measures included police-recorded violent incidents, assault-related attendances at each premises' local ED and patron Breath Alcohol Concentration assessed on exiting and entering study premises. The most successful recruitment method involved local police licensing officers and yielded a 100% success rate. Police-records of violence provided the most appropriate source of data about disorder at the premises level. The methodology of an exploratory trial is presented and despite challenges presented by the study environment it is argued an exploratory trial is warranted. Initial investigations in recruitment methods suggest that study premises should be recruited with the assistance of police officers. Police data were of sufficient quality to identify disorder and street surveys are a feasible method for measuring intoxication at the individual level. UKCRN 7090; ISRCTN: 80875696. Medical Research Council (G0701758) to Simon Moore, Simon Murphy, Laurence Moore and Jonathan Shepherd.

The reduction of intoxication and disorder in premises licensed to serve alcohol: An exploratory randomised controlled trial

PubMed Central

2010-01-01

Background Licensed premises offer a valuable point of intervention to reduce alcohol-related harm. Objective To describe the research design for an exploratory trial examining the feasibility and acceptability of a premises-level intervention designed to reduce severe intoxication and related disorder. The study also aims to assess the feasibility of a potential future large scale effectiveness trial and provide information on key trial design parameters including inclusion criteria, premises recruitment methods, strategies to implement the intervention and trial design, outcome measures, data collection methods and intra-cluster correlations. Design A randomised controlled trial in licensed premises that had experienced at least one assault in the year preceding the intervention, documented in police or hospital Emergency Department (ED) records. Premises were recruited from four study areas by piloting four recruitment strategies of varying intensity. Thirty two licensed premises were grouped into matched pairs to reduce potential bias and randomly allocated to the control or intervention condition. The study included a nested process evaluation to provide information on intervention acceptability and implementation. Outcome measures included police-recorded violent incidents, assault-related attendances at each premises' local ED and patron Breath Alcohol Concentration assessed on exiting and entering study premises. Results The most successful recruitment method involved local police licensing officers and yielded a 100% success rate. Police-records of violence provided the most appropriate source of data about disorder at the premises level. Conclusion The methodology of an exploratory trial is presented and despite challenges presented by the study environment it is argued an exploratory trial is warranted. Initial investigations in recruitment methods suggest that study premises should be recruited with the assistance of police officers. Police data were of sufficient quality to identify disorder and street surveys are a feasible method for measuring intoxication at the individual level. Trial registration UKCRN 7090; ISRCTN: 80875696 Funding Medical Research Council (G0701758) to Simon Moore, Simon Murphy, Laurence Moore and Jonathan Shepherd PMID:20946634

Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis.

PubMed

Davis, Lori L; Pilkinton, Patricia; Poddar, Swati; Blansett, Catherine; Toscano, Richard; Parker, Pamela E

2014-06-01

To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder (PTSD). A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized, controlled trial of Individual Placement and Support in Veterans with PTSD. When examining groups within each moderator, there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation (number needed to treat [NNT] = 1.5) and inadequate housing (NNT = 1.5) compared with the main finding of the pilot study (NNT = 2.07). Compared with the main finding of the pilot study, there was no greater advantage of IPS for those with adequate transportation (NNT = 2.4) or adequate housing (NNT = 2.4). Compared with the main finding in the pilot study, those without a family care burden had a greater benefit from IPS (NNT = 1.4) and those with family care burden had a reduced treatment effect (NNT = 3.3). These results are exploratory and are not intended to guide clinical decision-making, but rather offer a potentially useful strategy in the design of larger trials of IPS.

An exploratory trial of a health education programme to promote healthy lifestyles through social and emotional competence in young children: Study protocol.

PubMed

Bermejo-Martins, Elena; López-Dicastillo, Olga; Mujika, Agurtzane

2018-01-01

To implement and evaluate a health education programme based on the development of social and emotional competence in young children. Children's social and emotional skills play a key role in the adoption and maintenance of their lifestyles. Currently, a more comprehensive perspective dealing with these aspects is needed to promote healthy habits in children and develop effective health education programmes. An exploratory randomized controlled trial. A convenience sample of 30 children (5 and 6 years old) will be recruited from a public school in Spain, with 15 participants in the experimental group and 15 in the control group. Participants in the experimental group will receive the first unit of the programme, consisting of developing emotional knowledge skills around daily health habits (eating, hygiene, sleep and physical exercise) using different game-based dynamics and an emotional diary, while those in the control group will continue with their usual school routine. Outcome measures include emotional knowledge ability, basic social skills and children's health profile. The perceived impact of the intervention by parents, acceptability (by parents and children) and feasibility of the programme will be also assessed. Data will be collected at baseline, postintervention and at 7-month follow-up. This study offers an innovative intervention aimed at improving children's healthy lifestyles from a holistic perspective by addressing social and emotional competence as one of the most influential aspects of children's development. This exploratory trial is an essential step to explore crucial aspects of the full-scale clinical trial. © 2017 John Wiley & Sons Ltd.

Using Relevance Prompts: An Exploratory Study to Promote Eighth Graders' Comprehension and Retelling of Narrative Text

ERIC Educational Resources Information Center

Fogarty, Melissa S.; Davis, John L.; Anderson, Leah L.; Myint, Ahmarlay

2017-01-01

This exploratory study investigated the effects of modifying eighth grade students' purposes for reading through a prompt designed to increase engagement with the text. The current study was conducted using a randomized between-subjects design, with a relevance prompt as the between-subjects factor and reader proficiency as a covariate. A sample…

Data Science Programs in U.S. Higher Education: An Exploratory Content Analysis of Program Description, Curriculum Structure, and Course Focus

ERIC Educational Resources Information Center

Tang, Rong; Sae-Lim, Watinee

2016-01-01

In this study, an exploratory content analysis of 30 randomly selected Data Science (DS) programs from eight disciplines revealed significant gaps in current DS education in the United States. The analysis centers on linguistic patterns of program descriptions, curriculum requirements, and DS course focus as pertaining to key skills and domain…

A meta-analysis of anxiety symptom prevention with cognitive-behavioral interventions.

PubMed

Zalta, Alyson K

2011-06-01

This meta-analysis assessed efficacy of cognitive-behavioral interventions in preventing anxiety symptoms. A systematic review identified 15 independent pretest-posttest randomized or quasi-randomized efficacy trials for analysis. At posttest, intervention groups demonstrated significantly greater symptom reduction compared to control groups resulting in weighted mean effect sizes (Hedges' g) of 0.25 for general anxiety, 0.24 for disorder-specific symptoms, and 0.22 for depression after the removal of outliers. These effects appeared to diminish over 6- and 12-month follow-up. Exploratory moderator analyses indicated that individually administered media interventions were more effective than human-administered group interventions at preventing general anxiety and depression symptoms. Implications of current findings are discussed with attention to existing gaps in the literature.

Charting the expansion of strategic exploratory behavior during adolescence.

PubMed

Somerville, Leah H; Sasse, Stephanie F; Garrad, Megan C; Drysdale, Andrew T; Abi Akar, Nadine; Insel, Catherine; Wilson, Robert C

2017-02-01

Although models of exploratory decision making implicate a suite of strategies that guide the pursuit of information, the developmental emergence of these strategies remains poorly understood. This study takes an interdisciplinary perspective, merging computational decision making and developmental approaches to characterize age-related shifts in exploratory strategy from adolescence to young adulthood. Participants were 149 12-28-year-olds who completed a computational explore-exploit paradigm that manipulated reward value, information value, and decision horizon (i.e., the utility that information holds for future choices). Strategic directed exploration, defined as information seeking selective for long time horizons, emerged during adolescence and maintained its level through early adulthood. This age difference was partially driven by adolescents valuing immediate reward over new information. Strategic random exploration, defined as stochastic choice behavior selective for long time horizons, was invoked at comparable levels over the age range, and predicted individual differences in attitudes toward risk taking in daily life within the adolescent portion of the sample. Collectively, these findings reveal an expansion of the diversity of strategic exploration over development, implicate distinct mechanisms for directed and random exploratory strategies, and suggest novel mechanisms for adolescent-typical shifts in decision making. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Safety of Spectacles for Children's Vision: A Cluster-Randomized Controlled Trial.

PubMed

Ma, Xiaochen; Congdon, Nathan; Yi, Hongmei; Zhou, Zhongqiang; Pang, Xiaopeng; Meltzer, Mirjam E; Shi, Yaojiang; He, Mingguang; Liu, Yizhi; Rozelle, Scott

2015-11-01

To study safety of children's glasses in rural China, where fear that glasses harm vision is an important barrier for families and policy makers. Exploratory analysis from a cluster-randomized, investigator-masked, controlled trial. Among primary schools (n = 252) in western China, children were randomized by school to 1 of 3 interventions: free glasses provided in class, vouchers for free glasses at a local facility, or glasses prescriptions only (Control group). The main outcome of this analysis is uncorrected visual acuity after 8 months, adjusted for baseline acuity. Among 19 934 children randomly selected for screening, 5852 myopic (spherical equivalent refractive error ≤-0.5 diopters) eyes of 3001 children (14.7%, mean age 10.5 years) had VA ≤6/12 without glasses correctable to >6/12 with glasses, and were eligible. Among these, 1903 (32.5%), 1798 (30.7%), and 2151 (36.8%) were randomized to Control, Voucher, and Free Glasses, respectively. Intention-to-treat analyses were performed on all 1831 (96.2%), 1699 (94.5%), and 2007 (93.3%) eyes of children with follow-up in Control, Voucher, and Free Glasses groups. Final visual acuity for eyes of children in the treatment groups (Free Glasses and Voucher) was significantly better than for Control children, adjusting only for baseline visual acuity (difference of 0.023 logMAR units [0.23 vision chart lines, 95% CI: 0.03, 0.43]) or for other baseline factors as well (0.025 logMAR units [0.25 lines, 95% CI 0.04, 0.45]). We found no evidence that spectacles promote decline in uncorrected vision with aging among children. Copyright © 2015 Elsevier Inc. All rights reserved.

LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors.

PubMed

Davis, Jaimie N; Martinez, Lauren C; Spruijt-Metz, Donna; Gatto, Nicole M

2016-01-01

To evaluate the effect of an exploratory 12-week nutrition, cooking, and gardening trial (LA Sprouts) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden, eat, and cook FV; motivation to garden, eat, and cook FV; attitudes toward FV; nutrition and gardening knowledge; and home gardening habits. Randomized controlled trial. Four elementary schools. Three hundred four predominately Hispanic/Latino third- through fifth-grade students were randomized to either the LA Sprouts group (n = 167 students) or control group (n = 137 students). Twelve-week after-school nutrition, cooking, and gardening intervention. Determinants of dietary behavior as measured by questionnaire at baseline and postintervention. Analyses of covariance. After the 12-week program, compared with controls, LA Sprouts participants improved scores for identification of vegetables (+11% vs +5%; P = .001) and nutrition and gardening knowledge (+14.5% vs -5.0%; P = .003), and were more likely to garden at home (+7.5% vs -4.4%; P = .003). The LA Sprouts program positively affected a number of determinants of dietary behaviors that suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Social Worker Perceptions of the Portrayal of the Profession in the News and Entertainment Media: An Exploratory Study

ERIC Educational Resources Information Center

Zugazaga, Carole B.; Surette, Raymond B.; Mendez, Monica; Otto, Charles W.

2006-01-01

This exploratory study describes social workers' perceptions of the depiction of the social work profession found in the news and entertainment media. A random sample of 665 MSW social workers who were members of the Florida Chapter of the National Association of Social Workers were surveyed regarding how they felt the profession was depicted in…

A Fitbit and Facebook mHealth intervention for promoting physical activity among adolescent and young adult childhood cancer survivors: A pilot study.

PubMed

Mendoza, Jason A; Baker, K Scott; Moreno, Megan A; Whitlock, Kathryn; Abbey-Lambertz, Mark; Waite, Alan; Colburn, Trina; Chow, Eric J

2017-12-01

Physical activity (PA) may be important for preventing chronic diseases for adolescent and young adult (AYA) childhood cancer survivors. Randomized controlled trials (RCTs) of PA interventions for AYA survivors are sparse, but necessary to determine effective programs for increasing PA among this population. Thus, we conducted a pilot RCT, testing the feasibility of a mobile health (mHealth) intervention to promote PA among AYA survivors. We recruited 14- to 18-year-olds who were ≥1-year post cancer therapy from Seattle Children's Hospital. The 10-week intervention consisted of a wearable PA-tracking device (Fitbit Flex) and a peer-based virtual support group (Facebook group). Research staff helped set step goals and awarded badges weekly. Controls received usual care. Baseline assessments occurred before randomization and follow-up assessments occurred during weeks 8-10 of the intervention period. Feasibility criteria are defined below. Qualitative interviews assessed acceptability. Exploratory outcomes included PA, quality of life, and motivation for PA. All feasibility criteria were met: we recruited 60 survivors, intervention participants wore the Fitbit on the majority (71.5%) of intervention days, and ≥90% of all participants completed questionnaires. Qualitative data confirmed intervention acceptability. Exploratory analyses found no significant adjusted group differences for change in moderate-to-vigorous PA (4.4 vs. 5.0 min/day; P = 0.92) or sedentary time (-4.5 vs. 1.0 min/day; P = 0.73), comparing intervention subjects to controls. Some modest differences were found for select subscales of quality of life and motivation for PA. This mHealth PA intervention was feasible and acceptable to AYA childhood cancer survivors and warrants a fully powered RCT. © 2017 Wiley Periodicals, Inc.

A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease.

PubMed

Ostrowitzki, Susanne; Lasser, Robert A; Dorflinger, Ernest; Scheltens, Philip; Barkhof, Frederik; Nikolcheva, Tania; Ashford, Elizabeth; Retout, Sylvie; Hofmann, Carsten; Delmar, Paul; Klein, Gregory; Andjelkovic, Mirjana; Dubois, Bruno; Boada, Mercè; Blennow, Kaj; Santarelli, Luca; Fontoura, Paulo

2017-12-08

Gantenerumab is a fully human monoclonal antibody that binds aggregated amyloid-β (Aβ) and removes Aβ plaques by Fc receptor-mediated phagocytosis. In the SCarlet RoAD trial, we assessed the efficacy and safety of gantenerumab in prodromal Alzheimer's disease (AD). In this randomized, double-blind, placebo-controlled phase III study, we investigated gantenerumab over 2 years. Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection. The primary endpoint was the change from baseline to week 104 in Clinical Dementia Rating Sum of Boxes (CDR-SB) score. We evaluated treatment effects on cerebrospinal fluid biomarkers (all patients) and amyloid positron emission tomography (substudy). A futility analysis was performed once 50% of patients completed 2 years of treatment. Safety was assessed in patients who received at least one dose. Of the 3089 patients screened, 797 were randomized. The study was halted early for futility; dosing was discontinued; and the study was unblinded. No differences between groups in the primary (least squares mean [95% CI] CDR-SB change from baseline 1.60 [1.28, 1.91], 1.69 [1.37, 2.01], and 1.73 [1.42, 2.04] for placebo, gantenerumab 105 mg, and gantenerumab 225 mg, respectively) or secondary clinical endpoints were observed. The incidence of generally asymptomatic amyloid-related imaging abnormalities increased in a dose- and APOE ε4 genotype-dependent manner. Exploratory analyses suggested a dose-dependent drug effect on clinical and biomarker endpoints. The study was stopped early for futility, but dose-dependent effects observed in exploratory analyses on select clinical and biomarker endpoints suggest that higher dosing with gantenerumab may be necessary to achieve clinical efficacy. ClinicalTrials.gov, NCT01224106 . Registered on October 14, 2010.

META-ANALYSIS OF ACUTE EXERCISE EFFECTS ON STATE ANXIETY: AN UPDATE OF RANDOMIZED CONTROLLED TRIALS OVER THE PAST 25 YEARS.

PubMed

Ensari, Ipek; Greenlee, Tina A; Motl, Robert W; Petruzzello, Steven J

2015-08-01

One prominent and well-cited meta-analysis published nearly 25 years ago reported that an acute or single bout of exercise reduced state anxiety by approximately ¼ standard deviation. We conducted a meta-analysis of randomized controlled trials (RCTs) published after that meta-analysis for updating our understanding of the acute effects of exercise on state anxiety. We searched PubMed, EBSCOHost, Medline, PsycINFO, ERIC, and ScienceDirect for RCTs of acute exercise and state anxiety as an outcome. There were 36 RCTs that met inclusion criteria and yielded data for effect size (ES) generation (Cohen's d). An overall ES was calculated using a random effects model and expressed as Hedge's g. The weighted mean ES was small (Hedge's g = 0.16, standard error (SE) = 0.06), but statistically significant (P < 0.05), and indicated that a single bout of exercise resulted in an improvement in state anxiety compared with control. The overall ES was heterogeneous and post hoc, exploratory analyses using both random- and fixed-effects models identified several variables as moderators including sample age, sex and health status, baseline activity levels, exercise intensity, modality and control condition, randomization, overall study quality, and the anxiety measure (P < 0.05). The cumulative evidence from high quality studies indicates that acute bouts of exercise can yield a small reduction in state anxiety. The research is still plagued by floor effects associated with recruiting persons with normal or lower levels of state anxiety, and this should be overcome in subsequent trials. © 2015 Wiley Periodicals, Inc.

The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial.

PubMed

Alyousif, Zainab; Miller, Jennifer L; Sandoval, Mariana Y; MacPherson, Chad W; Nagulesapillai, Varuni; Dahl, Wendy J

2018-04-27

Constipation is a frequent problem in adults with Prader-Willi syndrome. Certain probiotics have been shown to improve transit and gastrointestinal symptoms of adults with functional constipation. The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp. lactis B94 (B. lactis B94) on stool frequency, stool form, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Adults with Prader-Willi syndrome (18-75 years old, n = 36) will be recruited and enrolled in a 20-week, randomized, double-blind, placebo-controlled, crossover study. Study subjects will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Subjects will complete daily records of stool frequency and stool form (a proxy of transit time). Dietary intake data also will be collected. Stools, one in each period, will be collected for exploratory microbiota analyses. To our knowledge, this is the first randomized controlled trial evaluating the effectiveness of B. lactis in adults with Prader-Willi syndrome. The results of this study will provide evidence of efficacy for future clinical trials in patient populations with constipation. ClinicalTrials.gov ( NCT03277157 ). Registered on 08 September 2017.

The enigma of site of action of migraine preventives: no effect of metoprolol on trigeminal pain processing in patients and healthy controls.

PubMed

Hebestreit, Julia M; May, Arne

2017-12-19

Beta-blockers are a first choice migraine preventive medication. So far it is unknown how they exert their therapeutic effect in migraine. To this end we examined the neural effect of metoprolol on trigeminal pain processing in 19 migraine patients and 26 healthy controls. All participants underwent functional magnetic resonance imaging (fMRI) during trigeminal pain twice: Healthy subjects took part in a placebo-controlled, randomized and double-blind study, receiving a single dose of metoprolol and placebo. Patients were examined with a baseline scan before starting the preventive medication and 3 months later whilst treated with metoprolol. Mean pain intensity ratings were not significantly altered under metoprolol. Functional imaging revealed no significant differences in nociceptive processing in both groups. Contrary to earlier findings from animal studies, we did not find an effect of metoprolol on the thalamus in either group. However, using a more liberal and exploratory threshold, hypothalamic activity was slightly increased under metoprolol in patients and migraineurs. No significant effect of metoprolol on trigeminal pain processing was observed, suggesting a peripheral effect of metoprolol. Exploratory analyses revealed slightly enhanced hypothalamic activity under metoprolol in both groups. Given the emerging role of the hypothalamus in migraine attack generation, these data need further examination.

Middle Level Practices in European International and Department of Defense Schools.

ERIC Educational Resources Information Center

Waggoner, V. Christine; McEwin, C. Kenneth

1993-01-01

Discusses results of a 1989-90 survey of 70 randomly selected international schools and 70 randomly selected Department of Defense Schools in Europe. Programs and practices surveyed included enrollments, grade organization, curriculum and instructional plans, core subjects, grouping patterns, exploratory courses, advisory programs, and scheduling.…

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial

PubMed Central

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60–77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals. PMID:28777749

Baseline Telomere Length and Effects of a Multidomain Lifestyle Intervention on Cognition: The FINGER Randomized Controlled Trial.

PubMed

Sindi, Shireen; Ngandu, Tiia; Hovatta, Iiris; Kåreholt, Ingemar; Antikainen, Riitta; Hänninen, Tuomo; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Paajanen, Teemu; Peltonen, Markku; Khalsa, Dharma Singh; Wolozin, Benjamin; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia; Solomon, Alina

2017-01-01

Leukocyte telomere length (LTL) is a biomarker of aging, and it is associated with lifestyle. It is currently unknown whether LTL is associated with the response to lifestyle interventions. The goal is to assess whether baseline LTL modified the cognitive benefits of a 2-year multidomain lifestyle intervention (exploratory analyses). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a 2-year randomized controlled trial including 1,260 people at risk of cognitive decline, aged 60-77 years identified from the general population. Participants were randomly assigned to the lifestyle intervention (diet, exercise, cognitive training, and vascular risk management) and control (general health advice) groups. Primary outcome was change in cognition (comprehensive neuropsychological test battery). Secondary outcomes were changes in cognitive domains: memory, executive functioning, and processing speed. 775 participants (392 control, 383 intervention) had baseline LTL (peripheral blood DNA). Mixed effects regression models with maximum likelihood estimation were used to analyze change in cognition as a function of randomization group, time, baseline LTL, and their interaction. Intervention and control groups did not significantly differ at baseline. Shorter LTL was related to less healthy baseline lifestyle. Intervention benefits on executive functioning were more pronounced among those with shorter baseline LTL (p-value for interaction was 0.010 adjusted for age and sex, and 0.007 additionally adjusted for baseline lifestyle factors). The FINGER intervention cognitive benefits were more pronounced with shorter baseline LTL, particularly for executive functioning, indicating that the multidomain lifestyle intervention was especially beneficial among higher-risk individuals.

Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial.

PubMed

Capozzi, Lauren C; McNeely, Margaret L; Lau, Harold Y; Reimer, Raylene A; Giese-Davis, Janine; Fung, Tak S; Culos-Reed, S Nicole

2016-04-15

Patients with head and neck cancer experience loss of weight and muscle mass, decreased functioning, malnutrition, depression, and declines in quality of life during and after treatment. The purpose of this exploratory randomized study was to determine the optimal timing for the initiation of a lifestyle and progressive resistance exercise training intervention (during or after radiation therapy), as determined by intervention adherence and by comparing between-group outcomes across 24 weeks. Sixty patients with head and neck cancer were randomized to engage in a 12-week lifestyle intervention and progressive resistance-training program either during radiation treatment or immediately after completion. The primary outcome of body composition--specifically, lean body mass, body mass index, and body fat--as well as secondary outcomes of fitness, quality of life, depression, and nutrition status were evaluated. The progressive resistance-training intervention carried out during treatment did not significantly influence the primary outcome of body composition, despite a significant increase in weekly physical activity reported by the intervention group. A small-to-medium intervention effect was noted for some secondary outcomes, including fitness, quality of life, and nutrition status. Regardless of whether patients received the immediate or delayed progressive resistance-training intervention, the analysis revealed a main effect of time on body composition, fitness, quality of life, depression, and nutritional scores. Although the intervention during treatment did not reduce the loss of lean body mass, delaying the exercise program until after treatment completion was associated with improved intervention adherence, a finding with important clinical implications. © 2016 American Cancer Society.

Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study.

PubMed

Kablinger, Anita S; Lindner, Marie A; Casso, Stephanie; Hefti, Franz; DeMuth, George; Fox, Barbara S; McNair, Lindsay A; McCarthy, Bruce G; Goeders, Nicholas E

2012-07-01

Although cocaine dependence affects an estimated 1.6 million people in the USA, there are currently no medications approved for the treatment of this disorder. Experiments performed in animal models have demonstrated that inhibitors of the stress response effectively reduce intravenous cocaine self-administration. This exploratory, double-blind, placebo-controlled study was designed to assess the safety and efficacy of combinations of the cortisol synthesis inhibitor metyrapone, and the benzodiazepine oxazepam, in 45 cocaine-dependent individuals. The subjects were randomized to a total daily dose of 500 mg metyrapone/20 mg oxazepam (low dose), a total daily dose of 1500 mg metyrapone/20 mg oxazepam (high dose), or placebo for 6 weeks of treatment. The outcome measures were a reduction in cocaine craving and associated cocaine use as determined by quantitative measurements of the cocaine metabolite benzoylecgonine (BE) in urine at all visits. Of the randomized subjects, 49% completed the study. The combination of metyrapone and oxazepam was well tolerated and tended to reduce cocaine craving and cocaine use, with significant reductions at several time points when controlling for baseline scores. These data suggest that further assessments of the ability of the metyrapone and oxazepam combination to support cocaine abstinence in cocaine-dependent subjects are warranted.

Effect of motivational interviewing on rates of early childhood caries: a randomized trial.

PubMed

Harrison, Rosamund; Benton, Tonya; Everson-Stewart, Siobhan; Weinstein, Phil

2007-01-01

The purposes of this randomized controlled trial were to: (1) test motivational interviewing (MI) to prevent early childhood caries; and (2) use Poisson regression for data analysis. A total of 240 South Asian children 6 to 18 months old were enrolled and randomly assigned to either the MI or control condition. Children had a dental exam, and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention. Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression. Hazard ratios were produced. Analyses included all participants whenever possible. Poisson regression supported a protective effect of MI (hazard ratio [HR]=0.54 (95%CI=035-0.84)-that is, the M/ group had about a 46% lower rate of dmfs at 2 years than did control children. Similar treatment effect estimates were obtained from models that included, as alternative outcomes, ds, dms, and dmfs, including "white spot lesions." Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had: (1) prechewed their food; (2) been raised in a rural environment; and (3) a higher family income (P<.05). A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries.

A preliminary investigation on the efficacy of N-acetyl cysteine for mania or hypomania.

PubMed

Magalhães, Pedro Vieira da Silva; Dean, Olivia M; Bush, Ashley I; Copolov, David L; Malhi, Gin S; Kohlmann, Kristy; Jeavons, Susan; Schapkaitz, Ian; Anderson-Hunt, Murray; Berk, Michael

2013-06-01

Oxidative imbalance has emerged as a treatment target in bipolar disorder. As very limited data are available on the clinical use of antioxidants for mania, we report here results from a post hoc and exploratory subgroup analysis of a randomized, placebo-controlled trial of N-acetyl cysteine (NAC). This was a placebo-controlled, randomized, clinical trial assessing the effect of NAC over 24 weeks in mania or hypomania. Symptomatic and functional outcomes were collected over the study period. Fifteen participants were available for this report; two participants in each group failed to complete all assessments. Within-group analyses pointed to an improvement in the NAC group on manic symptoms and worsening in the placebo group on depressive symptoms at endpoint. Although the sample size was small, these results indicated within-group efficacy for this glutathione precursor as compared to placebo. Future trials specifically designed to demonstrate the efficacy of NAC in mania are needed.

Do Brief Alcohol Interventions Reduce Tobacco Use among Adolescents and Young Adults? A Systematic Review and Meta-Analysis

PubMed Central

Hennessy, Emily A.; Tanner-Smith, Emily E.; Steinka-Fry, Katarzyna T.

2015-01-01

This meta-analysis synthesizes studies of brief interventions (BIs) that targeted alcohol consumption and reported both alcohol and tobacco outcomes. It examines whether BIs reduce alcohol and tobacco use for adolescents and young adults among interventions that (1) directly targeted tobacco and alcohol use, or (2) did not target tobacco use but measured it as a secondary outcome. Multiple databases and grey literature sources were searched (1980–2012) resulting in the identification of 18 randomized or controlled quasi-experimental studies (5949 participants). Analyses were conducted using random effects inverse-variance weighted three-level models. BIs were associated with a significant reduction in alcohol consumption relative to control groups (ḡ = 0.11, 95% CI [0.04, 0.17]) but not with a significant decrease in tobacco use (ḡ = 0.07, 95% CI [−0.01, 0.16]). Directly addressing tobacco was not a significant moderator affecting tobacco use outcomes. Post-hoc exploratory analysis revealed potential questions to address with future research. PMID:26130030

Teaching adolescents about changing bodies: Randomized controlled trial of an Internet puberty education and body dissatisfaction prevention program.

PubMed

Cousineau, Tara M; Franko, Debra L; Trant, Meredith; Rancourt, Diana; Ainscough, Jessica; Chaudhuri, Anamika; Brevard, Julie

2010-09-01

This study tested the efficacy of an Internet-based prevention program, Trouble on the Tightrope: In Search of Skateboard Sam, on pubertal knowledge, body esteem, and self-esteem. One hundred and ninety participants (mean age 11.6 years) were randomized to either an intervention or attention placebo control condition and were assessed at baseline, after three Internet-based sessions, and at 3-month follow-up. Although the primary hypotheses were not supported, exploratory moderator analyses indicated that the intervention was beneficial for select students. Specifically, pubertal status moderated the effects on weight-related body esteem and several domains of self-esteem, resulting in positive effects for participants in the intervention group who had begun puberty. Gender differences were found on self-esteem subscales, indicating more robust effects for girls than boys. Tailored Internet programs based on personal characteristics such as gender and pubertal status may be a fruitful area for future research with adolescents. Copyright © 2010 Elsevier Ltd. All rights reserved.

Comparison of Wiltse's paraspinal approach and open book laminectomy for thoracolumbar burst fractures with greenstick lamina fractures: a randomized controlled trial.

PubMed

Chen, Zhi-da; Wu, Jin; Yao, Xiao-Tao; Cai, Tao-Yi; Zeng, Wen-Rong; Lin, Bin

2018-03-02

Posterior short-segment pedicle screw fixation is used to treat thoracolumbar burst fractures. However, no randomized controlled studies have compared the efficacy of the two approaches--the Wiltse's paraspinal approach and open book laminectomy in the treatment of thoracolumbar burst fractures with greenstick lamina fractures. Patients with burst fractures of the thoracolumbar spine without neurological deficit were randomized to receive either the Wiltse's paraspinal approach (group A, 24 patients) or open book laminectomy (group B, 23 patients). Patients were followed postoperatively for average of 27.4 months. Clinical and radiographic data of the two approaches were collected and compared. Our results showed the anterior segmental height, kyphotic angle, visual analog scale (VAS) score, and Smiley-Webster Scale (SWS) score significantly improved postoperatively in both groups, indicating that both the Wiltse's paraspinal approach and open book laminectomy can effectively treat thoracolumbar burst fractures with greenstick lamina fractures. The Wiltse's paraspinal approach was found to have significantly shorter operating time, less blood loss, and shorter length of hospital stay compared to open book laminectomy. However, there were two (2/24) patients in group A that had neurological deficits postoperatively and required a second exploratory operation. Dural tears and/or cauda equina entrapment were subsequently found in four patients in group B and all two patients of neurological deficits in group A during operation. No screw loosening, plate breakage, or other internal fixation failures were found at final follow-up. The results demonstrated that either of the two surgical approaches can achieve satisfactory results in treating thoracolumbar burst fractures in patients with greenstick lamina fractures. However, if there is any clinical or radiographic suspicion of a dural tear and/or cauda equina entrapment pre-operation, patients should receive an open book laminectomy to avoid a second exploratory operation. More research is still needed to optimize clinical decision-making regarding surgical approach.

Quiet Ego, Self-Regulatory Skills, and Perceived Stress in College Students.

PubMed

Wayment, Heidi A; Cavolo, Keragan

2018-04-13

Examine the unique contributions of self-control and grit subscales (perseverance, interest consistency) as potential mediators of the relationship between quiet ego characteristics and less perceived stress in college students. Data from 1117 college students were collected between October, 2015 and May, 2016. The sample was split randomly into exploratory and confirmatory samples. Multiple mediator models were tested with PROCESS module (SPSS v. 24) in both samples. Hypotheses were largely confirmed with self-control fully mediating the link between quiet ego and perceived stress in both samples. Although many self-regulatory constructs may argue for their positive impact on college student outcomes, interventions that strengthen self-control, and not grit, may be most promising to reduce perceived stress. Further, interventions to strengthen quiet ego characteristics may be beneficial for strengthening self-control in college students.

An exploratory study of the effectiveness of group narrative therapy on the school behavior of girls with attention-deficit/hyperactivity symptoms.

PubMed

Looyeh, Majid Yoosefi; Kamali, Khosrow; Shafieian, Roya

2012-10-01

This study explored the effectiveness of group narrative therapy for improving the school behavior of a small sample of girls with attention-deficit/hyperactivity disorder (ADHD). Fourteen clinics referred 9- to 11-year-old girls with a clinical diagnosis of ADHD were randomly assigned to treatment and wait-list control groups. Posttreatment ratings by teachers showed that narrative therapy had a significant effect on reducing ADHD symptoms 1 week after completion of treatment and sustained after 30 days. Copyright © 2012 Elsevier Inc. All rights reserved.

The Effects of Tailoring Knowledge Acquisition on Colorectal Cancer Screening Self-Efficacy

PubMed Central

Jerant, Anthony; To, Patricia; Franks, Peter

2015-01-01

Interventions tailored to psychological factors such as personal and vicarious behavioral experiences can enhance behavioral self-efficacy, but are complex to develop and implement. Information seeking theory suggests tailoring acquisition of health knowledge (without concurrent psychological factor tailoring) could enhance self-efficacy, simplifying the design of tailored behavior change interventions. To begin to examine this issue, the authors conducted exploratory analyses of data from a randomized controlled trial, comparing the effects of an experimental colorectal cancer (CRC) screening intervention tailoring knowledge acquisition with the effects of a non-tailored control on CRC screening knowledge and self-efficacy in 1159 patients comprising three ethnicity/language strata (Hispanic/Spanish 23.4%, Hispanic/English 27.2%, non-Hispanic/English 49.3%) and five recruitment center strata. Adjusted for study strata, the mean post-intervention knowledge score was significantly higher in the experimental group versus control. Adjusted experimental intervention exposure (B = 0.22, 95% CI [0.14, 0.30]), pre-intervention knowledge (B = 0.11, 95% CI [0.05, 0.16]), and post-intervention knowledge (B = 0.03, 95% CI [0.01, 0.05]) were independently associated with subsequent CRC screening self-efficacy (p < .001 all associations). These exploratory findings suggest tailoring knowledge acquisition may enhance self-efficacy, with potential implications for tailored intervention design, but require confirmation in studies specifically designed to examine this issue. PMID:25928315

Testing the Feasibility of Developmental Asset Measures on College Students to Guide Health Promotion Efforts

ERIC Educational Resources Information Center

Zullig, Keith J.; Ward, Rose Marie; King, Keith A.; Patton, Jon M.; Murray, Karen A.

2009-01-01

The purpose of this investigation was to assess the reliability and validity of eight developmental asset measures among a stratified, random sample (N = 540) of college students to guide health promotion efforts. The sample was randomly split to produce exploratory and confirmatory samples for factor analysis using principal axis factoring and…

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

PubMed

Hu, Xiao-Yang; Chen, Ni-Ni; Chai, Qian-Yun; Yang, Guo-Yan; Trevelyan, Esmé; Lorenc, Ava; Liu, Jian-Ping; Robinson, Nicola

2015-10-26

Low back pain (LBP) is a common musculoskeletal condition often treated using integrative medicine (IM). Most reviews have focused on a single complementary and alternative medicine (CAM) therapy for LBP rather than evaluating wider integrative approaches. This exploratory systematic review aimed to identify randomized controlled trials (RCTs) and provide evidence on the effectiveness, cost effectiveness and adverse effects of integrative treatment for LBP. A literature search was conducted in 12 English and Chinese databases. RCTs evaluating an integrative treatment for musculoskeletal related LBP were included. Reporting, methodological quality and relevant clinical characteristics were assessed and appraised. Metaanalyses were performed for outcomes where trials were sufficiently homogenous. Fifty-six RCTs were identified evaluating integrative treatment for LBP. Although reporting and methodological qualities were poor, meta-analysis showed a favourable effect for integrative treatment over conventional and CAM treatment for back pain and function at 3 months or less follow-up. Two trials investigated costs, reporting £ 5332 per quality adjusted life years with 6 Alexander technique lessons plus exercise at 12 months follow-up; and an increased total costs of $244 when giving an additional up to 15 sessions of CAM package of care at 12 weeks. Sixteen trials mentioned safety; no severe adverse effects were reported. Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details (registration No. CRD42013003916).

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

PubMed

Wyatt, Gwen K; Sikorskii, Alla; Safikhani, Abolfazl; McVary, Kevin T; Herman, James

2016-06-01

Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

The mesencephalic trigeminal sensory nucleus is involved in the control of feeding and exploratory behavior in mice.

PubMed

Ishii, Toshiaki; Furuoka, Hidefumi; Itou, Takuya; Kitamura, Nobuo; Nishimura, Masakazu

2005-06-28

The mesencephalic trigeminal nucleus (Me5), which receives input from oral proprioceptors and projects to higher brain regions, is involved in mastication-induced modulation of satiation. To investigate how the Me5 is involved in the control of feeding and exploratory behavior, we examined the effect of bilateral electrolytic lesions of the Me5 on feeding and exploratory behavior in mice. Mouse feeding and exploratory behaviors were analyzed using a food-search-compulsion-apparatus (FSCA), which was designed to distinguish between the two behaviors under standard living conditions. To assess anxiety in mice in an unfamiliar environment, exploratory activity was analyzed in an automated hole-board apparatus. Mice with bilateral Me5 lesions had unique feeding and exploratory behavior profiles in the FSCA compared with sham-operated mice. Me5-lesioned mice spent more time in the food chamber during each trial in the FSCA, but the number of entries into the food chamber was decreased by 40% compared to sham-operated mice. Moreover, Me5 lesions markedly inhibited exploratory behavior, manifested as low-frequency exploration. In spite of the low-frequency exploration in the FSCA, Me5 lesions had no effect on various exploratory activities analyzed in the hole-board apparatus, i.e., total locomotor activity, frequency and duration of rearing and head-dipping, and latency to the first head-dipping. These results suggest that the Me5 is involved in the control of feeding and exploratory behavior through its ascending neuronal pathways in mice without modulating the emotional state.

Effectiveness of maternal counseling in reducing caries in Cree children.

PubMed

Harrison, R L; Veronneau, J; Leroux, B

2012-11-01

This cluster-randomized pragmatic (effectiveness) trial tested maternal counseling based on Motivational Interviewing (MI) as an approach to control caries in indigenous children. Nine Cree communities in Quebec, Canada were randomly allocated to test or control. MI-style counseling was delivered in test communities to mothers during pregnancy and at well-baby visits. Data on outcomes were collected when children were 30 months old. Two hundred seventy-two mothers were recruited from the 5 test and 4 control communities. Baseline characteristics were comparable but not equivalent for both groups. At trial's end, 241 children had follow-up. The primary analysis outcome was enamel caries with substance loss (d2); no statistically significant treatment effect was detected. Prevalence of treated and untreated caries at the d2 level was 76% in controls vs. 65% in test (p = 0.17). Exploratory analyses suggested a substantial preventive effect for untreated decay at or beyond the level of the dentin, d3 (prevalences: 60% controls vs. 35% test), and a particularly large treatment effect when mothers had 4 or more MI-style sessions. Overall, these results provide preliminary evidence that, for these young, indigenous children, an MI-style intervention has an impact on severity of caries (clinical trial registration ISRCTN41467632).

Effects of web-based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Tsuno, Kanami; Tsuchiya, Masao; Shimada, Kyoko; Namba, Katsuyuki; Shimazu, Akihito

2017-01-24

The purpose of this randomized, controlled trial was to examine the effects of a psychoeducational information website on improving work engagement among individual workers with low work engagement, where work engagement was measured as a secondary outcome. Participants were recruited from registered members of a web survey site in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Immediately after the baseline survey, the intervention group was invited to study a psychoeducational website called the "UTSMed," which provided general mental health literacy and cognitive behavioral skills. Work engagement was assessed by using the Utrecht Work Engagement Scale at baseline, 1-, and 4-month follow-ups for both intervention and control groups. An exploratory analysis was conducted for a subgroup with low (lower than the median scores) work engagement scores at baseline. A total of 1,236 workers completed the baseline survey. In the low work engagement subgroup, a total of 313 and 300 participants were allocated to an intervention and control group, respectively. In the high work engagement subgroup, 305 and 318 participants were allocated to an intervention and control group, respectively. The program showed a significant effect on work engagement (t = 1.98, P = 0.048) at the 4-month follow-up in the low work engagement subgroup, with a small effect size (d = 0.17). A web-based psychoeducation resource of mental health literacy and cognitive behavioral skills may be effective for improving work engagement among individual workers with low work engagement.

Early chronic lead exposure reduces exploratory activity in young C57BL/6J mice.

PubMed

Flores-Montoya, Mayra Gisel; Sobin, Christina

2015-07-01

Research has suggested that chronic low-level lead exposure diminishes neurocognitive function in children. Tests that are sensitive to behavioral effects at lowest levels of lead exposure are needed for the development of animal models. In this study we investigated the effects of chronic low-level lead exposure on exploratory activity (unbaited nose poke task), exploratory ambulation (open field task) and motor coordination (Rotarod task) in pre-adolescent mice. C57BL/6J pups were exposed to 0 ppm (controls), 30 ppm (low-dose) or 230 ppm (high-dose) lead acetate via dams' drinking water administered from birth to postnatal day 28, to achieve a range of blood lead levels (BLLs) from not detectable to 14.84 µg dl(-1) ). At postnatal day 28, mice completed behavioral testing and were killed (n = 61). BLLs were determined by inductively coupled plasma mass spectrometry. The effects of lead exposure on behavior were tested using generalized linear mixed model analyses with BLL, sex and the interaction as fixed effects, and litter as the random effect. BLL predicted decreased exploratory activity and no threshold of effect was apparent. As BLL increased, nose pokes decreased. The C57BL/6J mouse is a useful model for examining effects of early chronic low-level lead exposure on behavior. In the C57BL/6J mouse, the unbaited nose poke task is sensitive to the effects of early chronic low-level lead exposure. This is the first animal study to show behavioral effects in pre-adolescent lead-exposed mice with BLL below 5 µg dl(-1). Copyright © 2014 John Wiley & Sons, Ltd.

Early chronic lead exposure reduces exploratory activity in young C57BL/6J mice

PubMed Central

Flores-Montoya, Mayra Gisel; Sobin, Christina

2014-01-01

Research has suggested that chronic low-level lead exposure diminishes neurocognitive function in children. Tests that are sensitive to behavioral effects at lowest levels of lead exposure are needed for the development of animal models. In this study we investigated the effects of chronic low-level lead exposure on exploratory activity (unbaited nose poke task), exploratory ambulation (open field task) and motor coordination (Rotarod task) in pre-adolescent mice. C57BL/6J pups were exposed to 0 ppm (controls), 30 ppm (low-dose) or 230 ppm (high-dose) lead acetate via dams’ drinking water administered from birth to postnatal day 28, to achieve a range of blood lead levels (BLLs) from not detectable to 14.84 μg dl−1). At postnatal day 28, mice completed behavioral testing and were killed (n = 61). BLLs were determined by inductively coupled plasma mass spectrometry. The effects of lead exposure on behavior were tested using generalized linear mixed model analyses with BLL, sex and the interaction as fixed effects, and litter as the random effect. BLL predicted decreased exploratory activity and no threshold of effect was apparent. As BLL increased, nose pokes decreased. The C57BL/6J mouse is a useful model for examining effects of early chronic low-level lead exposure on behavior. In the C57BL/6J mouse, the unbaited nose poke task is sensitive to the effects of early chronic low-level lead exposure. This is the first animal study to show behavioral effects in pre-adolescent lead-exposed mice with BLL below 5 μg dl−1. PMID:25219894

Children, parents and pets exercising together (CPET): exploratory randomised controlled trial.

PubMed

Morrison, Ryan; Reilly, John J; Penpraze, Victoria; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; McNicol, Lindsay; Calvert, Michael; Yam, Philippa S

2013-11-27

Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds. Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. The acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial. ISRCTN85939423.

Children, parents and pets exercising together (CPET): exploratory randomised controlled trial

PubMed Central

2013-01-01

Background Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9–11 year olds. Methods Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Results Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. Conclusions The acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial. Trial registration ISRCTN85939423 PMID:24279294

Cognitive behavior therapy for comorbid migraine and/or tension-type headache and major depressive disorder: An exploratory randomized controlled trial.

PubMed

Martin, Paul R; Aiello, Rachele; Gilson, Kathryn; Meadows, Graham; Milgrom, Jeannette; Reece, John

2015-10-01

Numerous studies have demonstrated comorbidity between migraine and tension-type headache on the one hand, and depression on the other. Presence of depression is a negative prognostic indicator for behavioral treatment of headaches. Despite the recognised comorbidity, there is a limited research literature evaluating interventions designed for comorbid headaches and depression. Sixty six participants (49 female, 17 male) suffering from migraine and/or tension-type headache and major depressive disorder were randomly allocated to a Routine Primary Care control group or a Cognitive Behavior Therapy group that also received routine primary care. The treatment program involved 12 weekly 50-min sessions administered by clinical psychologists. Participants in the treatment group improved significantly more than participants in the control group from pre-to post-treatment on measures of headaches, depression, anxiety, and quality of life. Improvements achieved with treatment were maintained at four month follow-up. Comorbid anxiety disorders were not a predictor of response to treatment, and the only significant predictor was gender (men improved more than women). The new integrated treatment program appears promising and worthy of further investigation. Copyright © 2015 Elsevier Ltd. All rights reserved.

Positive Psychology Interventions for Patients With Heart Disease: A Preliminary Randomized Trial.

PubMed

Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R; Celano, Christopher M; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C

2016-01-01

Positive psychologic characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Participants were randomly assigned to receive 1 of 3 different 6-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychologic outcome measures postintervention (7wk) and at follow-up (15wk) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. When comparing outcomes between interventions and control participants (N = 55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β = 14.43, 95% CI: 8.66-20.2, p < 0.001), depression (β = -3.87, 95% CI: -7.72 to 0.02, p = 0.049), and hope (β = 7.12, 95% CI: 1.25-13.00, p =0.017), with moderate-large effect sizes. Efficacy of the 3 interventions was similar. Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Positive psychology interventions for patients with heart disease: a preliminary randomized trial

PubMed Central

Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R.; Celano, Christopher M.; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C.

2016-01-01

Objective Positive psychological characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Method Participants were randomly assigned to receive one of three different six-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychological outcome measures post-intervention (7 weeks) and at follow-up (15 weeks) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. Results When comparing outcomes between interventions and control participants (N=55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β=14.43, 95% confidence interval [CI]=8.66–20.2, p<.001), depression (β=−3.87, 95% CI=−7.72 to 0.02, p=.049), and hope (β=7.12, 95% CI=1.25–13.00, p=.017), with moderate-large effect sizes. Efficacy of the three interventions was similar. Conclusions Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. PMID:27137709

Rating the Relevance of QUORUM-Selected ASRS Incident Narratives to a "Controlled Flight into Terrain" Accident

NASA Technical Reports Server (NTRS)

McGreevy, Michael W.; Statler, Irving C.

1998-01-01

An exploratory study was conducted to identify commercial aviation incidents that are relevant to a "controlled flight into terrain" (CFIT) accident using a NASA-developed text processing method. The QUORUM method was used to rate 67820 incident narratives, virtually all of the narratives in the Aviation Safety Reporting System (ASRS) database, according to their relevance to two official reports on the crash of American Airlines Flight 965 near Cali, Colombia in December 1995. For comparison with QUORUM's ratings, three experienced ASRS analysts read the reports of the crash and independently rated the relevance of the 100 narratives that were most highly rated by QUORUM, as well as 100 narratives randomly selected from the database. Eighty-four of 100 QUORUM-selected narratives were rated as relevant to the Cali accident by one or more of the analysts. The relevant incidents involved a variety of factors, including, over-reliance on automation, confusion and changes during descent/approach, terrain avoidance, and operations in foreign airspace. In addition, the QUORUM collection of incidents was found to be significantly more relevant than the random collection.

Managing salinity in Upper Colorado River Basin streams: Selecting catchments for sediment control efforts using watershed characteristics and random forests models

USGS Publications Warehouse

Tillman, Fred; Anning, David W.; Heilman, Julian A.; Buto, Susan G.; Miller, Matthew P.

2018-01-01

Elevated concentrations of dissolved-solids (salinity) including calcium, sodium, sulfate, and chloride, among others, in the Colorado River cause substantial problems for its water users. Previous efforts to reduce dissolved solids in upper Colorado River basin (UCRB) streams often focused on reducing suspended-sediment transport to streams, but few studies have investigated the relationship between suspended sediment and salinity, or evaluated which watershed characteristics might be associated with this relationship. Are there catchment properties that may help in identifying areas where control of suspended sediment will also reduce salinity transport to streams? A random forests classification analysis was performed on topographic, climate, land cover, geology, rock chemistry, soil, and hydrologic information in 163 UCRB catchments. Two random forests models were developed in this study: one for exploring stream and catchment characteristics associated with stream sites where dissolved solids increase with increasing suspended-sediment concentration, and the other for predicting where these sites are located in unmonitored reaches. Results of variable importance from the exploratory random forests models indicate that no simple source, geochemical process, or transport mechanism can easily explain the relationship between dissolved solids and suspended sediment concentrations at UCRB monitoring sites. Among the most important watershed characteristics in both models were measures of soil hydraulic conductivity, soil erodibility, minimum catchment elevation, catchment area, and the silt component of soil in the catchment. Predictions at key locations in the basin were combined with observations from selected monitoring sites, and presented in map-form to give a complete understanding of where catchment sediment control practices would also benefit control of dissolved solids in streams.

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

PubMed

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

2016-08-01

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

A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities.

PubMed

Lewis, Vivian; Martina, Camille A; McDermott, Michael P; Trief, Paula M; Goodman, Steven R; Morse, Gene D; LaGuardia, Jennifer G; Sharp, Daryl; Ryan, Richard M

2016-07-01

To conduct a randomized controlled trial to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010 to 2013 into mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows, and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability.The primary analysis was a comparison of intervention effects on changes in protégés' satisfaction of their basic psychological needs (competence, autonomy, and relatedness) with their mentor. They completed a well-validated, online questionnaire every two months for one year. There was no significant effect at the end of one year of either mentor training or peer mentoring on protégés' psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés' overall psychological need satisfaction with their mentor at two months, the time point closest to completing mentor training. This randomized controlled trial showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 1).

PubMed

Sufi, Farzana; Hall, Claire; Mason, Stephen; Shaw, David; Kennedy, Liam; Gallob, John T

2016-04-01

To evaluate the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) compared with control toothpastes containing no known anti-sensitivity ingredients. This was the first of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. The experimental toothpaste contained 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties. Efficacy was evaluated against an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS, and two commercially available fluoride toothpastes as controls. After an initial lead-in period, subjects were randomized to one of the four study treatments and instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality-of-life measure for DH). A total of 134 subjects were randomized and completed the study. All treatments demonstrated statistically significant reductions in sensitivity from baseline at Week 4 and Week 8 for each clinical measure of sensitivity (all P ≤ 0.001). The 0% CSPS toothpaste demonstrated small but statistically significant reductions in Schiff sensitivity score compared with the other study toothpastes at Week 8 (all P< 0.05), whereas the experimental 5% CSPS toothpaste significantly improved the tactile threshold at Week 4 compared with the 0% CSPS toothpaste (P = 0.0467). The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Correlation analysis showed weak-to-moderate associations between the DHEQ outcomes and clinical endpoints. Study treatments were well tolerated. The treatment differences observed in this exploratory study were small and inconsistent between measures. The reasons for the inconsistencies are not clear but may be related to the properties of the abrasivity-matched 0% CSPS formulation, with the increased level of dental silica conferring an advantage in terms of reducing DH. The ability of dental silicas to occlude exposed dentin tubules and thereby reduce DH has been demonstrated in previous studies, and may warrant further clinical investigation.

Positive Imagery-Based Cognitive Bias Modification as a Web-Based Treatment Tool for Depressed Adults

PubMed Central

Blackwell, Simon E.; Browning, Michael; Mathews, Andrew; Pictet, Arnaud; Welch, James; Davies, Jim; Watson, Peter; Geddes, John R.

2015-01-01

Depression is a global health problem requiring treatment innovation. Targeting neglected cognitive aspects may provide a useful route. We tested a cognitive-training paradigm using positive mental imagery (imagery cognitive bias modification, imagery CBM), developed via experimental psychopathology studies, in a randomized controlled trial. Training was delivered via the Internet to 150 individuals with current major depression. Unexpectedly, there was no significant advantage for imagery CBM compared with a closely matched control for depression symptoms as a whole in the full sample. In exploratory analyses, compared with the control, imagery CBM significantly improved anhedonia over the intervention and improved depression symptoms as a whole for those participants with fewer than five episodes of depression and those who engaged to a threshold level of imagery. Results suggest avenues for improving imagery CBM to inform low-intensity treatment tools for depression. Anhedonia may be a useful treatment target for future work. PMID:25984421

SCIL-STROKE (Subcutaneous Interleukin-1 Receptor Antagonist in Ischemic Stroke): A Randomized Controlled Phase 2 Trial.

PubMed

Smith, Craig J; Hulme, Sharon; Vail, Andy; Heal, Calvin; Parry-Jones, Adrian R; Scarth, Sylvia; Hopkins, Karen; Hoadley, Margaret; Allan, Stuart M; Rothwell, Nancy J; Hopkins, Stephen J; Tyrrell, Pippa J

2018-05-01

The proinflammatory cytokine IL-1 (interleukin-1) has a deleterious role in cerebral ischemia, which is attenuated by IL-1 receptor antagonist (IL-1Ra). IL-1 induces peripheral inflammatory mediators, such as interleukin-6, which are associated with worse prognosis after ischemic stroke. We investigated whether subcutaneous IL-1Ra reduces the peripheral inflammatory response in acute ischemic stroke. SCIL-STROKE (Subcutaneous Interleukin-1 Receptor Antagonist in Ischemic Stroke) was a single-center, double-blind, randomized, placebo-controlled phase 2 trial of subcutaneous IL-1Ra (100 mg administered twice daily for 3 days) in patients presenting within 5 hours of ischemic stroke onset. Randomization was stratified for baseline National Institutes of Health Stroke Scale score and thrombolysis. Measurement of plasma interleukin-6 and other peripheral inflammatory markers was undertaken at 5 time points. The primary outcome was difference in concentration of log(interleukin-6) as area under the curve to day 3. Secondary outcomes included exploratory effect of IL-1Ra on 3-month outcome with the modified Rankin Scale. We recruited 80 patients (mean age, 72 years; median National Institutes of Health Stroke Scale, 12) of whom 73% received intravenous thrombolysis with alteplase. IL-1Ra significantly reduced plasma interleukin-6 ( P <0.001) and plasma C-reactive protein ( P <0.001). IL-1Ra was well tolerated with no safety concerns. Allocation to IL-1Ra was not associated with a favorable outcome on modified Rankin Scale: odds ratio (95% confidence interval)=0.67 (0.29-1.52), P =0.34. Exploratory mediation analysis suggested that IL-1Ra improved clinical outcome by reducing inflammation, but there was a statistically significant, alternative mechanism countering this benefit. IL-1Ra reduced plasma inflammatory markers which are known to be associated with worse clinical outcome in ischemic stroke. Subcutaneous IL-1Ra is safe and well tolerated. Further experimental studies are required to investigate efficacy and possible interactions of IL-1Ra with thrombolysis. URL: http://www.clinicaltrials.gov. Unique identifier: ISRCTN74236229. © 2018 American Heart Association, Inc.

Baseline Brain Activity Predicts Response to Neuromodulatory Pain Treatment

PubMed Central

Jensen, Mark P.; Sherlin, Leslie H.; Fregni, Felipe; Gianas, Ann; Howe, Jon D.; Hakimian, Shahin

2015-01-01

Objectives The objective of this study was to examine the associations between baseline electroencephalogram (EEG)-assessed brain oscillations and subsequent response to four neuromodulatory treatments. Based on available research, we hypothesized that baseline theta oscillations would prospectively predict response to hypnotic analgesia. Analyses involving other oscillations and the other treatments (meditation, neurofeedback, and both active and sham transcranial direct current stimulation) were viewed as exploratory, given the lack of previous research examining brain oscillations as predictors of response to these other treatments. Design Randomized controlled study of single sessions of four neuromodulatory pain treatments and a control procedure. Methods Thirty individuals with spinal cord injury and chronic pain had their EEG recorded before each session of four active treatments (hypnosis, meditation, EEG biofeedback, transcranial direct current stimulation) and a control procedure (sham transcranial direct stimulation). Results As hypothesized, more presession theta power was associated with greater response to hypnotic analgesia. In exploratory analyses, we found that less baseline alpha power predicted pain reduction with meditation. Conclusions The findings support the idea that different patients respond to different pain treatments and that between-person treatment response differences are related to brain states as measured by EEG. The results have implications for the possibility of enhancing pain treatment response by either 1) better patient/treatment matching or 2) influencing brain activity before treatment is initiated in order to prepare patients to respond. Research is needed to replicate and confirm the findings in additional samples of individuals with chronic pain. PMID:25287554

Effects of web-based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial

PubMed Central

Imamura, Kotaro; Kawakami, Norito; Tsuno, Kanami; Tsuchiya, Masao; Shimada, Kyoko; Namba, Katsuyuki; Shimazu, Akihito

2016-01-01

Objective: The purpose of this randomized, controlled trial was to examine the effects of a psychoeducational information website on improving work engagement among individual workers with low work engagement, where work engagement was measured as a secondary outcome. Methods: Participants were recruited from registered members of a web survey site in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Immediately after the baseline survey, the intervention group was invited to study a psychoeducational website called the "UTSMed," which provided general mental health literacy and cognitive behavioral skills. Work engagement was assessed by using the Utrecht Work Engagement Scale at baseline, 1-, and 4-month follow-ups for both intervention and control groups. An exploratory analysis was conducted for a subgroup with low (lower than the median scores) work engagement scores at baseline. Results: A total of 1,236 workers completed the baseline survey. In the low work engagement subgroup, a total of 313 and 300 participants were allocated to an intervention and control group, respectively. In the high work engagement subgroup, 305 and 318 participants were allocated to an intervention and control group, respectively. The program showed a significant effect on work engagement (t = 1.98, P = 0.048) at the 4-month follow-up in the low work engagement subgroup, with a small effect size (d = 0.17). Conclusion: A web-based psychoeducation resource of mental health literacy and cognitive behavioral skills may be effective for improving work engagement among individual workers with low work engagement. PMID:27885247

The effectiveness of an intervention to reduce alcohol-related violence in premises licensed for the sale and on-site consumption of alcohol: a randomized controlled trial.

PubMed

Moore, Simon C; Alam, M Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-11-01

Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

The effectiveness of an intervention to reduce alcohol‐related violence in premises licensed for the sale and on‐site consumption of alcohol: a randomized controlled trial

PubMed Central

Alam, M. Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-01-01

Abstract Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault‐related injury through poor operational practices that, if addressed, could reduce violence. We tested the real‐world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police‐recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow‐up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455‐day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention‐to‐treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20–1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow‐up visits). Conclusion An Environmental Health Practitioner‐led intervention in premises licensed for the sale and on‐site consumption of alcohol resulted in an increase in police recorded violence. PMID:28543914

Characterization of the rat exploratory behavior in the elevated plus-maze with Markov chains.

PubMed

Tejada, Julián; Bosco, Geraldine G; Morato, Silvio; Roque, Antonio C

2010-11-30

The elevated plus-maze is an animal model of anxiety used to study the effect of different drugs on the behavior of the animal. It consists of a plus-shaped maze with two open and two closed arms elevated 50cm from the floor. The standard measures used to characterize exploratory behavior in the elevated plus-maze are the time spent and the number of entries in the open arms. In this work, we use Markov chains to characterize the exploratory behavior of the rat in the elevated plus-maze under three different conditions: normal and under the effects of anxiogenic and anxiolytic drugs. The spatial structure of the elevated plus-maze is divided into squares, which are associated with states of a Markov chain. By counting the frequencies of transitions between states during 5-min sessions in the elevated plus-maze, we constructed stochastic matrices for the three conditions studied. The stochastic matrices show specific patterns, which correspond to the observed behaviors of the rat under the three different conditions. For the control group, the stochastic matrix shows a clear preference for places in the closed arms. This preference is enhanced for the anxiogenic group. For the anxiolytic group, the stochastic matrix shows a pattern similar to a random walk. Our results suggest that Markov chains can be used together with the standard measures to characterize the rat behavior in the elevated plus-maze. Copyright © 2010 Elsevier B.V. All rights reserved.

An exploratory mixed-methods crossover study comparing DVD- vs. Web-based patient decision support in three conditions: The importance of patient perspectives.

PubMed

Halley, Meghan C; Rendle, Katharine A S; Gillespie, Katherine A; Stanley, Katherine M; Frosch, Dominick L

2015-12-01

The last 15 years have witnessed considerable progress in the development of decision support interventions (DESIs). However, fundamental questions about design and format of delivery remain. An exploratory, randomized mixed-method crossover study was conducted to compare a DVD- and Web-based DESI. Randomized participants used either the Web or the DVD first, followed by the alternative format. Participants completed a questionnaire to assess decision-specific knowledge at baseline and a questionnaire and structured qualitative interview after viewing each format. Tracking software was used to capture Web utilization. Transcripts were analyzed using integrated inductive and deductive approaches. Quantitative data were analyzed using exploratory bivariate and multivariate analyses. Exploratory knowledge analyses suggest that both formats increased knowledge, with limited evidence that the DVD increased knowledge more than the Web. Format preference varied across participants: 44% preferred the Web, 32% preferred the DVD and 24% preferred 'both'. Patient discussions of preferences for DESI information structure and the importance of a patients' stage of a given decision suggest these characteristics may be important factors underlying variation in utilization, format preferences and knowledge outcomes. Our results suggest that both DESI formats effectively increase knowledge. Patients' perceptions of these two formats further suggest that there may be no single 'best' format for all patients. These results have important implications for understanding why different DESI formats might be preferable to and more effective for different patients. Further research is needed to explore the relationship between these factors and DESI utilization outcomes across diverse patient populations. © 2014 John Wiley & Sons Ltd.

Evaluation Study of the Exploratory Visit: An Innovative Outreach Activity of the ILGWU's Friendly Visiting Program

ERIC Educational Resources Information Center

Wright, Holly; And Others

1977-01-01

The exploratory visit to recent retirees, an outreach component of the International Ladies Garment Workers Union Friendly Visiting Program, was evaluated. A post-test only control group effect study revealed exploratory visits were effective in establishing a link between the program and the retiree. (Author)

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

PubMed

Foster, J D; Ewings, P; Falk, S; Cooper, E J; Roach, H; West, N P; Williams-Yesson, B A; Hanna, G B; Francis, N K

2016-10-01

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

Determining the Effects That the Order of Abstraction and Type of Reflection Have on Content Knowledge When Teaching Experientially: An Exploratory Experiment

ERIC Educational Resources Information Center

Baker, Marshall A.; Brown, Nicholas R.; Blackburn, J. Joey; Robinson, J. Shane

2014-01-01

The purpose of this experimental study was to determine the effects of order of abstraction and type of reflection on student knowledge acquisition. Students were assigned randomly to one of four treatment combinations in the completely randomized 2 x 2 design which included either abstraction prior to or directly after an experience, and either…

The Exercising Together Project: Design and recruitment for a randomized, controlled trial to determine the benefits of partnered strength training for couples coping with prostate cancer

PubMed Central

Winters-Stone, Kerri M.; Lyons, Karen S.; Nail, Lillian M.; Beer, Tomasz M.

2011-01-01

Prostate cancer can threaten quality of life for the patient and his spouse and the quality of his marital relationship. The purpose of our study is to evaluate the effects of “Exercising Together” – a partnered strength training program for married couples coping with prostate cancer – on the physical and emotional health of prostate cancer survivors (PCS) and their spouses and on marital quality. We are conducting a 6-month randomized controlled trial with two groups: 1) Exercising Together - a progressive, supervised strength training program and 2) a usual care control condition. The primary aims of this exploratory study are to: 1) Determine the effect of partnered strength training on physical and emotional health (muscle strength, physical function, body composition and self-report physical and mental health) in PCS, 2) Determine the effect of partnered strength training on physical and emotional health in spouses and 3) Explore the effect of partnered strength training on marital quality (incongruence, communication, relationship quality, intimacy) of the PCS and spouse. Target accrual has been met in this study with 64 couples enrolled and randomized to exercise (n=32) or usual care (n=32) groups. This study is the first to examine the feasibility of this exercise format in both the chronically ill patient and spouse and explore benefits at the individual and couple level. PMID:22101224

The Exercising Together project: design and recruitment for a randomized, controlled trial to determine the benefits of partnered strength training for couples coping with prostate cancer.

PubMed

Winters-Stone, Kerri M; Lyons, Karen S; Nail, Lillian M; Beer, Tomasz M

2012-03-01

Prostate cancer can threaten quality of life for the patient and his spouse and the quality of his marital relationship. The purpose of our study is to evaluate the effects of "Exercising Together" - a partnered strength training program for married couples coping with prostate cancer - on the physical and emotional health of prostate cancer survivors (PCS) and their spouses and on marital quality. We are conducting a 6-month randomized controlled trial with two groups: 1) Exercising Together - a progressive, supervised strength training program and 2) a usual care control condition. The primary aims of this exploratory study are to: 1) Determine the effect of partnered strength training on physical and emotional health (muscle strength, physical function, body composition and self-report physical and mental health) in PCS, 2) Determine the effect of partnered strength training on physical and emotional health in spouses and 3) Explore the effect of partnered strength training on marital quality (incongruence, communication, relationship quality, intimacy) of the PCS and spouse. Target accrual has been met in this study with 64 couples enrolled and randomized to exercise (n=32) or usual care (n=32) groups. This study is the first to examine the feasibility of this exercise format in both the chronically ill patient and spouse and explore benefits at the individual and couple level. Copyright © 2011 Elsevier Inc. All rights reserved.

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

2018-06-01

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.

An exploratory randomised controlled trial of a premises-level intervention to reduce alcohol-related harm including violence in the United Kingdom

PubMed Central

2012-01-01

Background To assess the feasibility of a randomised controlled trial of a licensed premises intervention to reduce severe intoxication and disorder; to establish effect sizes and identify appropriate approaches to the development and maintenance of a rigorous research design and intervention implementation. Methods An exploratory two-armed parallel randomised controlled trial with a nested process evaluation. An audit of risk factors and a tailored action plan for high risk premises, with three month follow up audit and feedback. Thirty-two premises that had experienced at least one assault in the year prior to the intervention were recruited, match paired and randomly allocated to control or intervention group. Police violence data and data from a street survey of study premises’ customers, including measures of breath alcohol concentration and surveyor rated customer intoxication, were used to assess effect sizes for a future definitive trial. A nested process evaluation explored implementation barriers and the fidelity of the intervention with key stakeholders and senior staff in intervention premises using semi-structured interviews. Results The process evaluation indicated implementation barriers and low fidelity, with a reluctance to implement the intervention and to submit to a formal risk audit. Power calculations suggest the intervention effect on violence and subjective intoxication would be raised to significance with a study size of 517 premises. Conclusions It is methodologically feasible to conduct randomised controlled trials where licensed premises are the unit of allocation. However, lack of enthusiasm in senior premises staff indicates the need for intervention enforcement, rather than voluntary agreements, and on-going strategies to promote sustainability. Trial registration UKCRN 7090; ISRCTN: 80875696 PMID:22676069

The effect of motivational interviewing on oral healthcare knowledge, attitudes and behaviour of parents and caregivers of preschool children: an exploratory cluster randomised controlled study.

PubMed

Naidu, Rahul; Nunn, June; Irwin, Jennifer D

2015-09-02

Motivational Interviewing (MI) has been used across primary healthcare and been shown to be effective in reducing the prevalence of early childhood caries (ECC) in preschool children. This study aimed to compare the effect of MI, in contrast to traditional dental health education (DHE), on oral health knowledge, attitudes, beliefs and behaviours among parents and caregivers of preschool children in Trinidad. The design of this exploratory study included a cluster randomised controlled trial and semi-structured focus groups. Six preschools (79 parents and caregivers) in Eastern Trinidad were randomly assigned to a test or control group (3 preschools in each group). Parents and caregivers in the test-group (n = 25) received a talk on dental health using an MI approach and the control-group (n = 54) received a talk using traditional DHE. Both groups received additional, written dental health information. The MI group also received two telephone call follow-ups as part of the MI protocol. Both groups were given questionnaires before the talks and four months later. Question items included oral health knowledge, beliefs, attitudes, brushing behaviour, oral health self-efficacy, oral health fatalism and a specific instrument to asses 'readiness for change', the Readiness Assessment of Parents Concerning Infant Dental Decay (RAPIDD). Participants in the test-group were also invited to take part in a focus group to share their views on the dental health talk. At four month follow-up, knowledge items on fluoride use, tooth brushing, dietary practice and dental attendance increased in both the test (DHE + MI) and control (DHE) groups ((p < 0.05, Chi Square test). In the test-group there were increases in mean child tooth brushing frequency and reduction in oral health fatalism (p < 0.05 t-test). Findings from a thematic analysis of the focus group suggested that the MI talk and telephone follow-up were well accepted and helpful in supporting parent and caregiver efforts to improve oral health practices for their preschool children. In this exploratory controlled study there was some evidence that using an MI approach when delivering oral health information had a positive effect on parent/ caregiver oral health knowledge, attitudes and behaviours compared to traditional DHE. There is need for further research involving the use of brief-counselling techniques in this Caribbean population.

Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer's disease: secondary analyses from a randomized, controlled trial.

PubMed

Kamphuis, P J G H; Verhey, F R J; Olde Rikkert, M G M; Twisk, J W R; Swinkels, S H N; Scheltens, P

2011-08-01

To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer's disease (AD). DESIGN/SETTING/PARTICIPANTS/INTERVENTION /MEASUREMENTS: These analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild AD (Mini-Mental State Examination score of 20-26) were randomized to receive either the active product or an iso-caloric control product. While primary outcomes included measures of cognition, the 23-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale was included as a secondary outcome. Both ADCS-ADL and BMI were assessed at baseline and Weeks 6, 12 and 24. Data were analyzed using a repeated-measures mixed model. Overall, data suggested an increased BMI in the active versus the control group at Week 24 (ITT: p = 0.07; PP: p = 0.03), but no treatment effect on ADCS-ADL was observed. However, baseline BMI was found to be a significant treatment effect modifier (ITT: p = 0.04; PP: p = 0.05), and an increase in ADCS-ADL was observed at Week 12 in patients with a 'low' baseline BMI (ITT: p = 0.02; PP: p = 0.04). These data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI.

The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

PubMed

Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

2013-02-01

To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

Antidepressants and testicular cancer: cause versus association.

PubMed

Andrade, Chittaranjan

2014-03-01

A data mining study that examined associations between 105 drugs and 55 cancer sites found significant associations between 2 selective serotonin reuptake inhibitors (fluoxetine and paroxetine) and testicular cancer. The study suggested several reasons why these associations merited further investigation. A later study tested specific relationships between 12 antidepressant drugs and testicular cancer and subtypes thereof; whereas significant relationships were again found, these disappeared after adjusting for confounding variables. These 2 studies are educative because they illustrate how false-positive results can easily arise in exploratory research and how confounding may be responsible for statistically significant relationships in study designs that are not randomized controlled trials. © Copyright 2014 Physicians Postgraduate Press, Inc.

Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis-a proof of principle and exploratory trial: is dose tapering practical in good responders?

PubMed

Ibrahim, Fowzia; Lorente-Cánovas, Beatriz; Doré, Caroline J; Bosworth, Ailsa; Ma, Margaret H; Galloway, James B; Cope, Andrew P; Pande, Ira; Walker, David; Scott, David L

2017-11-01

RA patients receiving TNF inhibitors (TNFi) usually maintain their initial doses. The aim of the Optimizing Treatment with Tumour Necrosis Factor Inhibitors in Rheumatoid Arthritis trial was to evaluate whether tapering TNFi doses causes loss of clinical response. We enrolled RA patients receiving etanercept or adalimumab and a DMARD with DAS28 under 3.2 for over 3 months. Initially (months 0-6) patients were randomized to control (constant TNFi) or two experimental groups (tapering TNFi by 33 or 66%). Subsequently (months 6-12) control subjects were randomized to taper TNFi by 33 or 66%. Disease flares (DAS28 increasing ⩾0.6 with at least one additional swollen joint) were the primary outcome. Two hundred and forty-four patients were screened, 103 randomized and 97 treated. In months 0-6 there were 8/50 (16%) flares in controls, 3/26 (12%) with 33% tapering and 6/21 (29%) with 66% tapering. Multivariate Cox analysis showed time to flare was unchanged with 33% tapering but was reduced with 66% tapering compared with controls (adjusted hazard ratio 2.81, 95% CI: 0.99, 7.94; P = 0.051). Analysing all tapered patients after controls were re-randomized (months 6-12) showed differences between groups: there were 6/48 (13%) flares with 33% tapering and 14/39 (36%) with 66% tapering. Multivariate Cox analysis showed 66% tapering reduced time to flare (adjusted hazard ratio 3.47, 95% CI: 1.26, 9.58; P = 0.016). Tapering TNFi by 33% has no impact on disease flares and appears practical in patients in sustained remission and low disease activity states. EudraCT, https://www.clinicaltrialsregister.eu, 2010-020738-24; ISRCTN registry, https://www.isrctn.com, 28955701. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis—a proof of principle and exploratory trial: is dose tapering practical in good responders?

PubMed Central

Lorente-Cánovas, Beatriz; Doré, Caroline J; Bosworth, Ailsa; Ma, Margaret H; Galloway, James B; Cope, Andrew P; Pande, Ira; Walker, David; Scott, David L

2017-01-01

Abstract Objectives RA patients receiving TNF inhibitors (TNFi) usually maintain their initial doses. The aim of the Optimizing Treatment with Tumour Necrosis Factor Inhibitors in Rheumatoid Arthritis trial was to evaluate whether tapering TNFi doses causes loss of clinical response. Methods We enrolled RA patients receiving etanercept or adalimumab and a DMARD with DAS28 under 3.2 for over 3 months. Initially (months 0–6) patients were randomized to control (constant TNFi) or two experimental groups (tapering TNFi by 33 or 66%). Subsequently (months 6–12) control subjects were randomized to taper TNFi by 33 or 66%. Disease flares (DAS28 increasing ⩾0.6 with at least one additional swollen joint) were the primary outcome. Results Two hundred and forty-four patients were screened, 103 randomized and 97 treated. In months 0–6 there were 8/50 (16%) flares in controls, 3/26 (12%) with 33% tapering and 6/21 (29%) with 66% tapering. Multivariate Cox analysis showed time to flare was unchanged with 33% tapering but was reduced with 66% tapering compared with controls (adjusted hazard ratio 2.81, 95% CI: 0.99, 7.94; P = 0.051). Analysing all tapered patients after controls were re-randomized (months 6–12) showed differences between groups: there were 6/48 (13%) flares with 33% tapering and 14/39 (36%) with 66% tapering. Multivariate Cox analysis showed 66% tapering reduced time to flare (adjusted hazard ratio 3.47, 95% CI: 1.26, 9.58; P = 0.016). Conclusion Tapering TNFi by 33% has no impact on disease flares and appears practical in patients in sustained remission and low disease activity states. Trail registration EudraCT, https://www.clinicaltrialsregister.eu, 2010-020738-24; ISRCTN registry, https://www.isrctn.com, 28955701 PMID:28968858

A Randomized Controlled Trial of the Effects of Online Pain Management Education on Primary Care Providers.

PubMed

Trudeau, Kimberlee J; Hildebrand, Cristina; Garg, Priyanka; Chiauzzi, Emil; Zacharoff, Kevin L

2017-04-01

To improve pain management practices, we developed an online interactive continuing education (CE) program for primary care providers (PCPs). This program follows the flow of clinical decision-making through simulated cases at critical pain treatment points along the pain treatment continuum. A randomized controlled trial was conducted to test the efficacy of this program. Participants were randomized to either the experimental condition or the control condition (online, text-based CE program). A total of 238 primary care providers were recruited through hospitals, professional newsletters, and pain conferences. Participants in both conditions reported significantly improved scores on knowledge (KNOW-PAIN 50), attitudes (CAOS), and pain practice behaviors (PPBS) scales over the four-month study. The experimental condition showed significantly greater change over time on the tamper-resistant formulations (TRFs) of opioids and dosing CAOS subscale compared with the control condition. Post hoc comparisons suggested that participants in the experimental condition were less likely to endorse use of opioid TRFs over time compared with the control condition. Exploratory analyses for potential moderators indicated a significant three-way interaction with time, condition, and discipline (i.e., physician vs other) for the impediments and concerns attitudes subscale and the early refill behaviors subscale. Post hoc comparisons indicated that physicians in the experimental condition exhibited the greatest change in attitudes and the nonphysicians exhibited the greatest change in reported behaviors in response to requests for early refills. Findings suggest online CE programs may positively impact PCPs' knowledge, attitudes, and pain practice behaviors but provide minimal evidence for the value of including interactivity. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Randomized controlled trial of peer-led recovery education using Building Recovery of Individual Dreams and Goals through Education and Support (BRIDGES).

PubMed

Cook, Judith A; Steigman, Pamela; Pickett, Sue; Diehl, Sita; Fox, Anthony; Shipley, Patricia; MacFarlane, Rachel; Grey, Dennis D; Burke-Miller, Jane K

2012-04-01

The purpose of this study was to test the efficacy of a peer-led, mental illness education intervention called Building Recovery of Individual Dreams and Goals through Education and Support (BRIDGES). Subjects were recruited from outpatient community mental health settings in eight Tennessee communities. Using a single-blind, randomized controlled trial design, 428 individuals with serious mental illness (SMI) were interviewed at baseline and assigned to BRIDGES or to a services as usual wait list control condition. Two-and-one-half hour classes were taught once a week for 8 weeks by peers who were certified BRIDGES instructors. Subjects were followed-up at immediate post-intervention and 6-months later. The primary outcome was self-perceived recovery, measured by the Recovery Assessment Scale (RAS). A secondary outcome was hopefulness as assessed by the State Hope Scale (SHS). An exploratory hypothesis examined the impact of depressive symptoms on both recovery outcomes. Eighty six percent of participants were followed up. On average, participants attended five sessions. Intent-to-treat analysis using mixed-effects random regression found that, compared to controls, intervention participants reported: 1) significantly greater improvement in total RAS scores as well as subscales measuring personal confidence and tolerable symptoms; and 2) significantly greater improvement in hopefulness as assessed by the agency subscale of the SHS. While study subjects with high levels of depressive symptoms had significantly poorer outcomes, outcomes were superior for BRIDGES participants regardless of depressive symptoms. Peer-led mental illness education improves participants' self-perceived recovery and hopefulness over time, even controlling for severity of depressive symptoms. Copyright © 2011 Elsevier B.V. All rights reserved.

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net HIV Clinic: The Connect4Care (C4C) Trial.

PubMed

Christopoulos, Katerina A; Riley, Elise D; Carrico, Adam W; Tulsky, Jacqueline; Moskowitz, Judith T; Dilworth, Samantha; Coffin, Lara S; Wilson, Leslie; Peretz, Jason Johnson; Hilton, Joan F

2018-02-21

Text messaging is a promising strategy to support HIV care engagement, but little is known about its efficacy in urban safety-net HIV clinic populations. We conducted a randomized controlled trial of a supportive and motivational text messaging intervention, Connect4Care (C4C), among viremic patients who had a history of poor retention or were new to clinic. Participants were randomized (stratified by new HIV diagnosis status) to receive one of the following for 12 months: 1) thrice-weekly intervention messages, plus texted primary care appointment reminders and a monthly text message requesting confirmation of study participation, or; 2) texted reminders and monthly messages alone. Viral load was assessed at 6 and 12 months. The primary outcome was virologic suppression (<200 copies/mL) at 12 months, estimated via repeated measures log-binomial regression, adjusted for new diagnosis status. The secondary outcome was retention in clinic care. Between August 2013-November 2015, 230 participants were randomized. Virologic suppression at 12 months was similar between intervention and control participants (48.8% vs. 45.8%), with negligible change from 6-month estimates, yielding RR 1.07 (95% CI: 0.82, 1.39). Suppression was higher in the newly diagnosed (78.3% vs. 45.3%). There were no intervention effects on the secondary outcome. Exploratory analyses suggested that patients with more responses to study text messages had better outcomes, regardless of arm. The C4C text messaging intervention did not significantly increase virologic suppression or retention in care. Response to text messages may be a useful way for providers to gauge risk for poor HIV outcomes. NCT01917994.

A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine.

PubMed

Saper, Joel R; Mathew, Ninan T; Loder, Elizabeth W; DeGryse, Ronald; VanDenburgh, Amanda M

2007-09-01

Several randomized, controlled studies have reported benefits of botulinum toxin type A (BoNTA; Allergan Inc., Irvine, CA, USA) over placebo in the treatment of migraine. Some studies reported significant benefits at dosages as low as 16 U, while other studies reported safety, tolerability, and efficacy at dosages up to 260 U. However, the optimal treatment paradigm and patient population have yet to be defined. To compare different injection sites and doses of BoNTA in the prevention of episodic migraine. This was a randomized, double-blind, placebo-controlled study of 232 patients with a history of four to eight moderate to severe migraines per month, with or without aura. Patients were randomized to placebo or one of four BoNTA groups that received injections into different muscle regions: frontal (10 U), temporal (6 U), glabellar (9 U), or all three areas (total dose 25 U). For 3 months following a single treatment, patients recorded migraine-related variables in a daily diary. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines (P > or = 0.411). In general, no statistically significant differences were observed for any efficacy variable. The overall rates of adverse events (any type) or treatment-related adverse events were similar among the groups. In this exploratory study of episodic migraine patients, low-dose injections of BoNTA into the frontal, temporal, and/or glabellar muscle regions were not more effective than placebo. BoNTA was safe and well tolerated. Future studies may examine higher BoNTA doses, flexible injection sites, multiple treatments, and disallow concomitant prophylactic medications.

Learning, memory and exploratory similarities in genetically identical cloned dogs.

PubMed

Shin, Chi Won; Kim, Geon A; Park, Won Jun; Park, Kwan Yong; Jeon, Jeong Min; Oh, Hyun Ju; Kim, Min Jung; Lee, Byeong Chun

2016-12-30

Somatic cell nuclear transfer allows generation of genetically identical animals using donor cells derived from animals with particular traits. To date, few studies have investigated whether or not these cloned dogs will show identical behavior patterns. To address this question, learning, memory and exploratory patterns were examined using six cloned dogs with identical nuclear genomes. The variance of total incorrect choice number in the Y-maze test among cloned dogs was significantly lower than that of the control dogs. There was also a significant decrease in variance in the level of exploratory activity in the open fields test compared to age-matched control dogs. These results indicate that cloned dogs show similar cognitive and exploratory patterns, suggesting that these behavioral phenotypes are related to the genotypes of the individuals.

LA Sprouts: A 12-week gardening, nutrition, and cooking randomized control trial improves determinants of dietary behaviors

PubMed Central

Davis, Jaimie N; Martinez, Lauren C.; Spruijt-Metz, Donna; Gatto, Nicole M.

2015-01-01

Objective To evaluate the effect of an exploratory 12-week nutrition, cooking and gardening RCT (“LA Sprouts”) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden/eat/cook FV; motivation to garden/eat/cook FV; attitudes towards FV; nutrition and gardening knowledge; and home gardening habits. Design and Participants Four elementary schools with 304 predominately Hispanic/Latino 3rd–5th grade students were randomized to either the LA Sprouts (n=167 students) or Control group (n=137 students). LA Sprouts participants received 12 weeks of weekly 90-minute culturally tailored gardening, nutrition, and cooking classes after school. Questionnaire data examining dietary determinants were obtained at baseline and post-intervention. Results After the 12-week program, LA Sprouts participants compared with controls improved scores for identification of vegetables (+11% vs. +5%; P=.001), nutrition and gardening knowledge (+14.5% vs. −5.0%; P =.003), and were more likely to garden at home (+7.5% vs. −4.4%; P=.003). Conclusions The LA Sprouts program positively impacted a number of determinants of dietary behaviors, which suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. PMID:26453367

Does hearing the patient perspective improve consultation skills in examinations? An exploratory randomized controlled trial in medical undergraduate education.

PubMed

Snow, Rosamund; Crocker, Joanna; Talbot, Katherine; Moore, Jane; Salisbury, Helen

2016-12-01

Medical education increasingly includes patient perspectives, but few studies look at the impact on students' proficiency in standard examinations. We explored students' exam performance after viewing video of patients' experiences. Eighty-eight medical students were randomized to one of two e-learning modules. The experimental group saw video clips of patients describing their colposcopy, while the control group viewed a clinician describing the procedure. Students then completed a Multiple Choice Questionnaire (MCQ) and were assessed by a blinded clinical examiner in an Objective Structured Clinical Examination (OSCE) with a blinded simulated patient (SP). The SP scored students using the Doctors' Interpersonal Skills Questionnaire (DISQ). Students rated the module's effect on their skills and confidence. Regression analyses were used to compare the effect of the two modules on these outcomes, adjusting for gender and graduate entry. The experimental group performed better in the OSCE than the control group (odds ratio 2.7 [95%CI 1.2-6.1]; p = 0.016). They also reported significantly more confidence in key areas, including comfort with patients' emotions (odds ratio 6.4 [95%CI 2.7-14.9]; p < 0.0005). There were no other significant differences. Teaching that included recorded elements of real patient experience significantly improved students' examination performance and confidence.

Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1.

PubMed

Elm, Jordan J

2012-10-01

Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double-blind, parallel-group, placebo-controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long-term Study-1 (LS-1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS-1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS-1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5-year follow-up visit against the background of dopaminergic therapy and best PD care. Copyright © 2012 Movement Disorder Society.

Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries.

PubMed

Gruber, Joann F; Hille, Darcy A; Liu, G Frank; Kaplan, Susan S; Nelson, Micki; Goveia, Michelle G; Mast, T Christopher

2017-01-01

Rotavirus is the leading cause of severe diarrhea worldwide in young children. Although rotavirus vaccine efficacy is high in developed countries, efficacy is lower in developing countries. Here, we investigated heterogeneity of rotavirus vaccine efficacy by infant characteristics in developing countries. An exploratory, post hoc analysis was conducted using randomized controlled trial data of the pentavalent rotavirus vaccine (RV5) conducted in Africa and Asia (NCT00362648). Infants received either 3 doses of vaccine/placebo and were followed for up to 2 years. Within subgroups, vaccine efficacies and 95% confidence intervals (CIs) against rotavirus gastroenteritis (RVGE) were estimated using Poisson regression. We assessed heterogeneity of efficacy by age at first dose, gender, breastfeeding status and nutrition status. African children receiving the first dose at <8 weeks had lower efficacy (23.7%; 95% CI: -8.2%-46.3%) than those vaccinated at ≥8 weeks (59.1%; 95% CI: 34.0%-74.6%). Marginally statistically significant differences were observed by age at first dose, gender and underweight status in Ghana and gender in Asian countries. Heterogeneity of efficacy was observed for age at first dose in African countries. This was an exploratory analysis; additional studies are needed to validate these results.

The effect of driven exercise on treatment outcomes for adolescents with anorexia and bulimia nervosa.

PubMed

Stiles-Shields, Colleen; DclinPsy, Bryony Bamford; Lock, James; Le Grange, Daniel

2015-05-01

This study investigated the prevalence of driven exercise (DE) and its role in treatment outcome for adolescents with bulimia nervosa (BN) and anorexia nervosa (AN). Participants were 201 adolescents with an eating disorder (ED) (80 with BN and 121 with AN) presenting for outpatient treatment at two specialist clinics. All adolescents participated in one of two randomized controlled trials. Descriptive statistics were conducted to evaluate the presence and frequency of baseline DE. Exploratory hierarchical regressions were used to evaluate the effect of baseline DE on treatment outcomes. About 66.3% of adolescents with BN and 23.1% of adolescents with AN presented with baseline DE. The presence of baseline DE predicted significantly worse outcomes for adolescents with AN in terms of ED symptom severity (ps < .004); however, baseline DE did not significantly predict any of the evaluated outcomes for adolescents with BN (ps < .05). The results of this secondary exploratory data suggest that DE is prevalent for adolescents with BN and AN. However, DE may be related to different constructs for adolescents with AN than those with BN, suggesting differences in treatment needs. © 2014 Wiley Periodicals, Inc.

Circle of Security–Parenting: A randomized controlled trial in Head Start

PubMed Central

CASSIDY, JUDE; BRETT, BONNIE E.; GROSS, JACQUELYN T.; STERN, JESSICA A.; MARTIN, DAVID R.; MOHR, JONATHAN J.; WOODHOUSE, SUSAN S.

2017-01-01

Although evidence shows that attachment insecurity and disorganization increase risk for the development of psychopathology (Fearon, Bakermans-Kranenburg, van IJzendoorn, Lapsley, & Roisman, 2010; Groh, Roisman, van IJzendoorn, Bakermans-Kranenburg, & Fearon, 2012), implementation challenges have precluded dissemination of attachment interventions on the broad scale at which they are needed. The Circle of Security–Parenting Intervention (COS-P; Cooper, Hoffman, & Powell, 2009), designed with broad implementation in mind, addresses this gap by training community service providers to use a manualized, video-based program to help caregivers provide a secure base and a safe haven for their children. The present study is a randomized controlled trial of COS-P in a low-income sample of Head Start enrolled children and their mothers. Mothers (N = 141; 75 intervention, 66 waitlist control) completed a baseline assessment and returned with their children after the 10-week intervention for the outcome assessment, which included the Strange Situation. Intent to treat analyses revealed a main effect for maternal response to child distress, with mothers assigned to COS-P reporting fewer unsupportive (but not more supportive) responses to distress than control group mothers, and a main effect for one dimension of child executive functioning (inhibitory control but not cognitive flexibility when maternal age and marital status were controlled), with intervention group children showing greater control. There were, however, no main effects of intervention for child attachment or behavior problems. Exploratory follow-up analyses suggested intervention effects were moderated by maternal attachment style or depressive symptoms, with moderated intervention effects emerging for child attachment security and disorganization, but not avoidance; for inhibitory control but not cognitive flexibility; and for child internalizing but not externalizing behavior problems. This initial randomized controlled trial of the efficacy of COS-P sets the stage for further exploration of “what works for whom” in attachment intervention. PMID:28401843

Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients.

PubMed

Pacheco, Larissa Sgaria; Garcia, Valter Duro; Prá, Ronivan Luis Dal; Cardoso, Bruna Doleys; Rodrigues, Mariana Ferras; Zanetti, Helen Kris; Meinerz, Gisele; Neumann, Jorge; Gnatta, Diego; Keitel, Elizete

2018-05-14

Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

Use of tactile feedback to control exploratory movements to characterize object compliance.

PubMed

Su, Zhe; Fishel, Jeremy A; Yamamoto, Tomonori; Loeb, Gerald E

2012-01-01

Humans have been shown to be good at using active touch to perceive subtle differences in compliance. They tend to use highly stereotypical exploratory strategies, such as applying normal force to a surface. We developed similar exploratory and perceptual algorithms for a mechatronic robotic system (Barrett arm/hand system) equipped with liquid-filled, biomimetic tactile sensors (BioTac(®) from SynTouch LLC). The distribution of force on the fingertip was measured by the electrical resistance of the conductive liquid trapped between the elastomeric skin and a cluster of four electrodes on the flat fingertip surface of the rigid core of the BioTac. These signals provided closed-loop control of exploratory movements, while the distribution of skin deformations, measured by more lateral electrodes and by the hydraulic pressure, were used to estimate material properties of objects. With this control algorithm, the robot plus tactile sensor was able to discriminate the relative compliance of various rubber samples.

Seeking to reduce nonbeneficial treatment in the ICU: an exploratory trial of proactive ethics intervention*.

PubMed

Andereck, William S; McGaughey, J Westly; Schneiderman, Lawrence J; Jonsen, Albert R

2014-04-01

To investigate whether the proactive intervention of a clinical ethicist in cases of prolonged lengths of stay in a critical care setting reduces nonbeneficial treatment while increasing perceived patient/surrogate and provider satisfaction and reducing associated costs. Nonbeneficial treatment is defined here as the use of life-sustaining treatments delivered to patients who had been in the ICU for 5 days and did not survive to discharge. Prospective randomized exploratory trial from October 2007 to February 2010 in the adult ICU of a large, urban, not-for-profit community hospital. Medical/surgical ICU of California Pacific Medical Center, a large tertiary not-for-profit hospital in San Francisco, CA. Three hundred eighty-four patients with ICU lengths of stay of five days or greater. Patients were randomized to either an intervention arm (Proactive Ethics Intervention) (n = 174) or control arm (n = 210). There were 56 patients in the intervention arm and 52 patients in the control arm who did not survive to discharge. Proactive ethics intervention involves a trained bioethicist in the care of all ICU patients with a length of stay greater than or equal to 5 days. The intervention used a nine step process model designed to look for manifest or latent ethics conflicts and address them. The primary outcome measures were days in the ICU; overall length of hospital stay; mortality; nonbeneficial treatments, for example, provision of nutritional support; surrogate and survivor satisfaction, and cost. The intervention and control arms showed no significant difference in mortality. Proactive Ethics Intervention, at the 95% CI, was not associated with reductions of overall length of stay (23 d for intervention and 21 d for control, p = 0.74), ICU days (11 in each arm, p = 0.91), life-sustaining treatments (days on ventilator: intervention, 14.6; control, 13.7; p = 0.74; days receiving artificial nutrition and hydration: intervention, 16.5; control, 15.9; p = 0.85), or cost ($167,350.00 for intervention and $164,670.00 for control, p =0.92) in patients who did not survive to discharge. Perceptions of quality of care by patients and providers showed no difference between intervention and control arms. Our study finds that Proactive Ethics Intervention, provided to all patients in a critical care setting for 5 days, and before an ethical conflict has been recognized, is ineffective in reducing overall length of hospital stay, ICU days, nonbeneficial treatments, or hospital costs. It is also not effective in increasing perceptions of quality of care by patients or providers.

Smoke your troubles away: exploring the effects of death cognitions on cannabis craving and consumption.

PubMed

Nagar, Maayan; Rabinovitz, Sharon

2015-01-01

Two studies informed by the terror management health model were conducted to examine the question of how death cognition affects cannabis craving and whether actual cannabis smoking alleviates death cognitions. The first study examined whether priming thoughts of death are associated with subjective cannabis craving among 42 frequent cannabis users randomly assigned to either a mortality salience or control task. When reminded of their death, participants craved cannabis, even though there was no change in their conscious negative mood. The second study examined the effect of cannabis smoking on death cognitions in an exploratory field setting. Fifty frequent cannabis users were randomly assigned to either mortality reminders or control task and completed death-related words accessibility measures before and after smoking cannabis. Results indicate that cannabis served as a buffer and prevented death-related thoughts from entering consciousness, thus acting as a defense mechanism against death anxiety. These findings indicate that death-related concerns may play a hitherto unsuspected role in cannabis craving and consumption. Also discussed are the implications of a terror management perspective in communication of negative health consequences of recreational cannabis smoking and in the use of cannabis for medical purposes among people with terminal illness.

Evidence that self-incentives increase fruit consumption: a randomized exploratory trial among high-risk romanian adolescents.

PubMed

Armitage, Christopher J

2014-04-01

High mortality rates associated with cancer and cardiovascular disease in Romania have been partly attributed to low fruit consumption. The aim of the present research was to test whether self-incentives delivered via implementation intentions could increase fruit consumption among 238 high-risk Romanian adolescents. Participants were randomly allocated to either: (1) a control condition (asked to plan to increase their fruit intake but given no further instruction), (2) a standard implementation intention condition (asked to form an implementation intention using standard open-ended instructions), or (3) a self-incentivizing implementation intention condition (asked to reward themselves at the end of the week if they had successfully consumed an extra portion of fruit each day). There were significant increases in fruit consumption in the self-incentivizing implementation intention condition, but not in the control condition or-contrary to predictions-in the standard implementation intention condition. The findings support the use of implementation intentions to deliver self-incentives and increase fruit consumption, and suggest that providing children with a structured prompt might enhance the effectiveness of implementation intention-based interventions compared with standard implementation intention instructions.

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS).

PubMed

Jang, Saeheon; Jung, Sungwon; Pae, Chiun; Kimberly, Blanchard Portland; Craig Nelson, J; Patkar, Ashwin A

2013-12-01

We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥ 14 and a CGI-S score of ≥ 3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e., lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD. © 2013 Published by Elsevier B.V.

Patients' Perceptions and Experiences of a mHealth Diabetes Self-management System.

PubMed

Georgsson, Mattias; Staggers, Nancy

2017-03-01

Chronic diseases, including diabetes, constitute a substantial disease burden around the world. Mobile self-management systems now play a significant and increasingly important role in patients' disease management. Yet, patients' perceptions of these systems after longer-term use are largely unexplored. A random sample of 10 diabetes patients was assessed immediately after they exited a larger, 6-month randomized controlled trial on the use of a mHealth system called Care4Life. This descriptive, exploratory study assessed patients' perceptions and experiences of mHealth using a questionnaire and semistructured interview whose development was guided by the Technology Acceptance Model. Results indicated that patients saw clear benefits in using the technology and had favorable behavioral disease outcomes after using Care4Life. Suggestions for improving the system were highly individual despite the apparent homogeneity of the patient group. The study begins to fill the gap about the longer-term use of mHealth systems in chronic disease management and reflects the significance of individual needs for mHealth systems.

Addition of topical pimecrolimus to once-daily mid-potent steroid confers no short-term therapeutic benefit in the treatment of severe atopic dermatitis; a randomized controlled trial.

PubMed

Spergel, J M; Boguniewicz, M; Paller, A S; Hebert, A A; Gallagher, P R; McCormick, C; Parneix-Spake, A; Hultsch, T

2007-08-01

Combination therapy with pimecrolimus cream 1%, a topical calcineurin inhibitor (TCI), and fluticasone propionate cream 0.05% (FP), a mid-potency topical corticosteroid, may have a synergistic effect for treatment of atopic dermatitis (AD) because their mechanism of action differs. To assess the efficacy of concomitant pimecrolimus twice daily/FP once daily vs. vehicle twice daily/FP once daily in patients with severe AD. An exploratory, 2-week, double-blind, randomized, within-patient study was conducted (n = 45). Two target areas of similar severity, size and location were assessed. Assessments included the modified Eczema Area and Severity Index (0-12 scale) (primary variable), localized investigator global assessment (0-4 scale) and Patients' Self-Assessment of Disease Severity (0-4 scale). Data for all variables were similar for the TCI/FP and vehicle/FP treatments. The efficacy observed for treatment of severe AD flares with this TCI/FP combination regimen was equivalent to that of vehicle/FP.

A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis.

PubMed

Kowdley, Kris V; Luketic, Velimir; Chapman, Roger; Hirschfield, Gideon M; Poupon, Raoul; Schramm, Christoph; Vincent, Catherine; Rust, Christian; Parés, Albert; Mason, Andrew; Marschall, Hanns-Ulrich; Shapiro, David; Adorini, Luciano; Sciacca, Cathi; Beecher-Jones, Tessa; Böhm, Olaf; Pencek, Richard; Jones, David

2018-05-01

Obeticholic acid (OCA), a potent farnesoid X receptor agonist, was studied as monotherapy in an international, randomized, double-blind, placebo-controlled phase 2 study in patients with primary biliary cholangitis who were then followed for up to 6 years. The goals of the study were to assess the benefit of OCA in the absence of ursodeoxycholic acid, which is relevant for patients who are intolerant of ursodeoxycholic acid and at higher risk of disease progression. Patients were randomized and dosed with placebo (n = 23), OCA 10 mg (n = 20), or OCA 50 mg (n = 16) given as monotherapy once daily for 3 months (1 randomized patient withdrew prior to dosing). The primary endpoint was the percent change in alkaline phosphatase from baseline to the end of the double-blind phase of the study. Secondary and exploratory endpoints included change from baseline to month 3/early termination in markers of cholestasis, hepatocellular injury, and farnesoid X receptor activation. Efficacy and safety continue to be monitored through an ongoing 6-year open-label extension (N = 28). Alkaline phosphatase was reduced in both OCA groups (median% [Q1, Q3], OCA 10 mg -53.9% [-62.5, -29.3], OCA 50 mg -37.2% [-54.8, -24.6]) compared to placebo (-0.8% [-6.4, 8.7]; P < 0.0001) at the end of the study, with similar reductions observed through 6 years of open-label extension treatment. OCA improved many secondary and exploratory endpoints (including γ-glutamyl transpeptidase, alanine aminotransferase, conjugated bilirubin, and immunoglobulin M). Pruritus was the most common adverse event; 15% (OCA 10 mg) and 38% (OCA 50 mg) discontinued due to pruritus. OCA monotherapy significantly improved alkaline phosphatase and other biochemical markers predictive of improved long-term clinical outcomes. Pruritus increased dose-dependently with OCA treatment. Biochemical improvements were observed through 6 years of open-label extension treatment. (Hepatology 2018;67:1890-1902). © 2017 The Authors. Hepatology published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases.

Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial.

PubMed

O'Donoghue, Michelle L; Glaser, Ruchira; Cavender, Matthew A; Aylward, Philip E; Bonaca, Marc P; Budaj, Andrzej; Davies, Richard Y; Dellborg, Mikael; Fox, Keith A A; Gutierrez, Jorge Antonio T; Hamm, Christian; Kiss, Robert G; Kovar, František; Kuder, Julia F; Im, Kyung Ah; Lepore, John J; Lopez-Sendon, Jose L; Ophuis, Ton Oude; Parkhomenko, Alexandr; Shannon, Jennifer B; Spinar, Jindrich; Tanguay, Jean-Francois; Ruda, Mikhail; Steg, P Gabriel; Theroux, Pierre; Wiviott, Stephen D; Laws, Ian; Sabatine, Marc S; Morrow, David A

2016-04-19

p38 Mitogen-activated protein kinase (MAPK)-stimulated inflammation is implicated in atherogenesis, plaque destabilization, and maladaptive processes in myocardial infarction (MI). Pilot data in a phase 2 trial in non-ST elevation MI indicated that the p38 MAPK inhibitor losmapimod attenuates inflammation and may improve outcomes. To evaluate the efficacy and safety of losmapimod on cardiovascular outcomes in patients hospitalized with an acute myocardial infarction. LATITUDE-TIMI 60, a randomized, placebo-controlled, double-blind, parallel-group trial conducted at 322 sites in 34 countries from June 3, 2014, until December 8, 2015. Part A consisted of a leading cohort (n = 3503) to provide an initial assessment of safety and exploratory efficacy before considering progression to part B (approximately 22,000 patients). Patients were considered potentially eligible for enrollment if they had been hospitalized with an acute MI and had at least 1 additional predictor of cardiovascular risk. Patients were randomized to either twice-daily losmapimod (7.5 mg; n = 1738) or matching placebo (n = 1765) on a background of guideline-recommended therapy. Patients were treated for 12 weeks and followed up for an additional 12 weeks. The primary end point was the composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization with the principal analysis specified at week 12. In part A, among the 3503 patients randomized (median age, 66 years; 1036 [29.6%] were women), 99.1% had complete ascertainment for the primary outcome. The primary end point occurred by 12 weeks in 123 patients treated with placebo (7.0%) and 139 patients treated with losmapimod (8.1%; hazard ratio, 1.16; 95% CI, 0.91-1.47; P = .24). The on-treatment rates of serious adverse events were 16.0% with losmapimod and 14.2% with placebo. Among patients with acute MI, use of losmapimod compared with placebo did not reduce the risk of major ischemic cardiovascular events. The results of this exploratory efficacy study did not justify proceeding to a larger efficacy trial in the existing patient population. clinicaltrials.gov Identifier: NCT02145468.

[Factor structure validity of the social capital scale used at baseline in the ELSA-Brasil study].

PubMed

Souto, Ester Paiva; Vasconcelos, Ana Glória Godoi; Chor, Dora; Reichenheim, Michael E; Griep, Rosane Härter

2016-07-21

This study aims to analyze the factor structure of the Brazilian version of the Resource Generator (RG) scale, using baseline data from the Brazilian Longitudinal Health Study in Adults (ELSA-Brasil). Cross-validation was performed in three random subsamples. Exploratory factor analysis using exploratory structural equation models was conducted in the first two subsamples to diagnose the factor structure, and confirmatory factor analysis was used in the third to corroborate the model defined by the exploratory analyses. Based on the 31 initial items, the model with the best fit included 25 items distributed across three dimensions. They all presented satisfactory convergent validity (values greater than 0.50 for the extracted variance) and precision (values greater than 0.70 for compound reliability). All factor correlations were below 0.85, indicating full discriminative factor validity. The RG scale presents acceptable psychometric properties and can be used in populations with similar characteristics.

Feasibility and acceptability of two incentive-based implementation strategies for mental health therapists implementing cognitive-behavioral therapy: a pilot study to inform a randomized controlled trial.

PubMed

Beidas, Rinad S; Becker-Haimes, Emily M; Adams, Danielle R; Skriner, Laura; Stewart, Rebecca E; Wolk, Courtney Benjamin; Buttenheim, Alison M; Williams, Nathaniel J; Inacker, Patricia; Richey, Elizabeth; Marcus, Steven C

2017-12-15

Informed by our prior work indicating that therapists do not feel recognized or rewarded for implementation of evidence-based practices, we tested the feasibility and acceptability of two incentive-based implementation strategies that seek to improve therapist adherence to cognitive-behavioral therapy for youth, an evidence-based practice. This study was conducted over 6 weeks in two community mental health agencies with therapists (n = 11) and leaders (n = 4). Therapists were randomized to receive either a financial or social incentive if they achieved a predetermined criterion on adherence to cognitive-behavioral therapy. In the first intervention period (block 1; 2 weeks), therapists received the reward they were initially randomized to if they achieved criterion. In the second intervention period (block 2; 2 weeks), therapists received both rewards if they achieved criterion. Therapists recorded 41 sessions across 15 unique clients over the project period. Primary outcomes included feasibility and acceptability. Feasibility was assessed quantitatively. Fifteen semi-structured interviews were conducted with therapists and leaders to assess acceptability. Difference in therapist adherence by condition was examined as an exploratory outcome. Adherence ratings were ascertained using an established and validated observational coding system of cognitive-behavioral therapy. Both implementation strategies were feasible and acceptable-however, modifications to study design for the larger trial will be necessary based on participant feedback. With respect to our exploratory analysis, we found a trend suggesting the financial reward may have had a more robust effect on therapist adherence than the social reward. Incentive-based implementation strategies can be feasibly administered in community mental health agencies with good acceptability, although iterative pilot work is essential. Larger, fully powered trials are needed to compare the effectiveness of implementation strategies to incentivize and enhance therapists' adherence to evidence-based practices such as cognitive-behavioral therapy.

The impact of a universal intervention targeting perfectionism in children: An exploratory controlled trial.

PubMed

Vekas, Eva J; Wade, Tracey D

2017-11-01

Perfectionism is considered to be an underlying mechanism of relevance to a broad array of indicators of psychological distress. The current research examined the impact of a three-session intervention targeting perfectionism in children on perfectionism, self-criticism, and well-being. The design of the current study can be considered quasi-experimental as the intervention and control classes were not randomly allocated but decided by convenience factors at the school level. Students (aged 10.08-12.79 years) were allocated to the intervention (N = 107, 41 boys) or control condition (N = 105, 33 boys), completing self-report assessments on perfectionism, self-criticism, and well-being at baseline, post-intervention, and 3-month follow-up. At post-intervention, children in the intervention group had significantly lower perfectionism than the control group (d = 0.35, 95% confidence intervals [CI]: 0.07-0.62) and at 3-month follow-up had significantly higher levels of well-being (d = 0.33, 95% CI: 0.06-0.60). As predicted by theory, decreases in perfectionism mediated the relationship between condition and improved well-being. This exploratory study provides evidence for the usefulness of a brief universal prevention programme targeting perfectionism. Future research should use more robust designs, explore longer-term effects, and the impact on a wider range of variables, including scholastic achievement. Clinical implications Perfectionism linked with negative outcomes in children can be decreased in a classroom setting. Decreasing perfectionism leads to improved well-being in children. Limitations More rigorous designs along with better assessment of perfectionism are required in further evaluations. The impact of perfectionism on scholastic achievement in children requires further investigation. © 2017 The British Psychological Society.

An exploratory cluster randomised trial of a university halls of residence based social norms marketing campaign to reduce alcohol consumption among 1st year students.

PubMed

Moore, Graham F; Williams, Annie; Moore, Laurence; Murphy, Simon

2013-04-18

This exploratory trial examines the feasibility of implementing a social norms marketing campaign to reduce student drinking in universities in Wales, and evaluating it using cluster randomised trial methodology. Fifty residence halls in 4 universities in Wales were randomly assigned to intervention or control arms. Web and paper surveys were distributed to students within these halls (n = 3800), assessing exposure/contamination, recall of and evaluative responses to intervention messages, perceived drinking norms and personal drinking behaviour. Measures included the Drinking Norms Rating Form, the Daily Drinking Questionnaire and AUDIT-C. A response rate of 15% (n = 554) was achieved, varying substantially between sites. Intervention posters were seen by 80% and 43% of students in intervention and control halls respectively, with most remaining materials seen by a minority in both groups. Intervention messages were rated as credible and relevant by little more than half of students, though fewer felt they would influence their behaviour, with lighter drinkers more likely to perceive messages as credible. No differences in perceived norms were observed between intervention and control groups. Students reporting having seen intervention materials reported lower descriptive and injunctive norms than those who did not. Attention is needed to enhancing exposure, credibility and perceived relevance of intervention messages, particularly among heavier drinkers, before definitive evaluation can be recommended. A definitive evaluation would need to consider how it would achieve sufficient response rates, whilst hall-level cluster randomisation appears subject to a significant degree of contamination. ISRCTN: ISRCTN48556384.

Effectiveness of a new dentifrice with baking soda and peroxide in removing extrinsic stain and whitening teeth.

PubMed

Ghassemi, A; Hooper, W; Vorwerk, L; Domke, T; DeSciscio, P; Nathoo, S

2012-01-01

The primary purpose of this randomized, controlled, six-week clinical trial was to determine the effectiveness and safety of a new whitening dentifrice in removing extrinsic tooth stain and whitening teeth. An additional two-week exploratory study was conducted to determine whether the whitening or stain-prevention activity of the dentifrice would persist following cessation of use. In the first study (Phase I), one-hundred and forty-six qualifying subjects were randomly assigned to either a sodium bicarbonate whitening dentifrice group (Arm & Hammer Advance White Extreme Whitening Baking Soda and Peroxide Toothpaste) or a silica-based negative control dentifrice group, and brushed twice daily with their assigned dentifrice for six weeks. Tooth shade on the labial surfaces of the eight incisors was assessed using a Vita Classic shade guide, and extrinsic tooth stain was scored using a Modified Lobene Stain Index (MLSI) at baseline, week 4, and week 6. In Phase II (after the week 6 examination), volunteers from the Arm & Hammer whitening dentifrice group were randomly assigned to continue using the whitening dentifrice or to use the negative control dentifrice twice daily for two weeks. The six-week shade and stain index scores served as the baseline for this exploratory phase and were rescored after two weeks. The whitening dentifrice group had statistically significant (p < 0.0001) mean shade score reductions of 1.82 and 2.57 from baseline to weeks 4 and 6, respectively. For the same periods, the negative control dentifrice group was virtually unchanged from baseline. For tooth stain, the MLSI total mean scores for the whitening dentifrice group showed statistically significant (p < 0.0001) decreases from baseline of 1.42 (41.6%) and 2.11 (61.6%) at weeks 4 and 6, respectively. In contrast, the negative control dentifrice group had a MLSI reduction of 0.07 at week 4 and a 0.06 increase at week 6. Between-group analyses using baseline-adjusted ANCOVA showed the whitening dentifrice to be statistically significantly more effective (p < 0.0001) than the negative control for shade and tooth stain reductions for all index comparisons. Compared to the six-week (baseline) scores, subjects who continued to use the whitening dentifrice for the additional two weeks experienced statistically significant (p < 0.0001) further mean reductions of 0.88 in shade score and 0.46 in MLSI score, while subjects who switched to the negative control dentifrice experienced smaller, statistically significant (p < 0.05) reductions of 0.34 in shade score and 0.13 in total MLSI score. The Arm & Hammer whitening dentifrice tested in this study is effective for removing extrinsic tooth stain and whitening teeth. While the results also suggest that this dentifrice may have stain-prevention activity that persists following cessation of product use, such activity would need to be confirmed with further studies.

Hypnosis for childbirth: a retrospective comparative analysis of outcomes in one obstetrician's practice.

PubMed

VandeVusse, Leona; Irland, Jacqueline; Healthcare, Wheaton Franciscan; Berner, Margaret A; Fuller, Shauna; Adams, Debra

2007-10-01

This exploratory, descriptive study, done retrospectively from perinatal medical records, compared childbirth outcomes in one obstetrician's caseload between 50 women who elected antepartal hypnosis preparation (usually a 5-class series) and 51 who did not. The groups were demographically similar. To achieve similar numbers to the hypnosis group, the control group was randomly selected from the women in the caseload who opted not to take hypnosis preparation, based on characteristics of parity and delivery mode. Prenatal hypnosis preparation resulted in significantly less use of sedatives, analgesia, and regional anesthesia during labor and in higher 1-minute neonatal Apgar scores. Other physiologic and outcome measures did not reveal statistical significance, although some trends were of clinical interest. Well-controlled studies are warranted for clinicians to offer hypnosis more frequently as a pain relief option for childbirth. Additional information provided includes pragmatic, clinical, and cost information about incorporating hypnosis into a physician's practice.

Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial.

PubMed

Rosso, Isabelle M; Killgore, William D S; Olson, Elizabeth A; Webb, Christian A; Fukunaga, Rena; Auerbach, Randy P; Gogel, Hannah; Buchholz, Jennifer L; Rauch, Scott L

2017-03-01

Prior research has shown that the Sadness Program, a technician-assisted Internet-based cognitive behavioral therapy (iCBT) intervention developed in Australia, is effective for treating major depressive disorder (MDD). The current study aimed to expand this work by adapting the protocol for an American population and testing the Sadness Program with an attention control group. In this parallel-group, randomized controlled trial, adult MDD participants (18-45 years) were randomized to a 10-week period of iCBT (n = 37) or monitored attention control (MAC; n = 40). Participants in the iCBT group completed six online therapy lessons, which included access to content summaries and homework assignments. During the 10-week trial, iCBT and MAC participants logged into the web-based system six times to complete self-report symptom scales, and a nonclinician technician contacted participants weekly to provide encouragement and support. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), and the secondary outcomes were the Patient Health Questionnaire-9 and Kessler-10. Intent-to-treat analyses revealed significantly greater reductions in depressive symptoms in iCBT compared with MAC participants, using both the self-report measures and the clinician-rated HRSD (d = -0.80). Importantly, iCBT participants also showed significantly higher rates of clinical response and remission. Exploratory analyses did not support illness severity as a moderator of treatment outcome. The Sadness Program led to significant reductions in depression and distress symptoms. With its potential to be delivered in a scalable, cost-efficient manner, iCBT is a promising strategy to enhance access to effective care. © 2016 Wiley Periodicals, Inc.

Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision.

PubMed

Nollett, Claire L; Bray, Nathan; Bunce, Catey; Casten, Robin J; Edwards, Rhiannon T; Hegel, Mark T; Janikoun, Sarah; Jumbe, Sandra E; Ryan, Barbara; Shearn, Julia; Smith, Daniel J; Stanford, Miles; Xing, Wen; Margrain, Tom H

2016-08-01

The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient's physician, with a waiting-list control group in people with sight loss and depressive symptoms. This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person's physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.'s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large.

Postural control and head stability during natural gaze behaviour in 6- to 12-year-old children.

PubMed

Schärli, A M; van de Langenberg, R; Murer, K; Müller, R M

2013-06-01

We investigated how the influence of natural exploratory gaze behaviour on postural control develops from childhood into adulthood. In a cross-sectional design, we compared four age groups: 6-, 9-, 12-year-olds and young adults. Two experimental trials were performed: quiet stance with a fixed gaze (fixed) and quiet stance with natural exploratory gaze behaviour (exploratory). The latter was elicited by having participants watch an animated short film on a large screen in front of them. 3D head rotations in space and centre of pressure (COP) excursions on the ground plane were measured. Across conditions, both head rotation and COP displacement decreased with increasing age. Head movement was greater in the exploratory condition in all age groups. In all children-but not in adults-COP displacement was markedly greater in the exploratory condition. Bivariate correlations across groups showed highly significant positive correlations between COP displacement in ML direction and head rotation in yaw, roll, and pitch in both conditions. The regularity of COP displacements did not show a clear developmental trend, which indicates that COP dynamics were qualitatively similar across age groups. Together, the results suggest that the contribution of head movement to eye-head saccades decreases with age and that head instability-in part resulting from such gaze-related head movements-is an important limiting factor in children's postural control. The lack of head stabilisation might particularly affect children in everyday activities in which both postural control and visual exploration are required.

The Counseling Competencies Scale: Validation and Refinement

ERIC Educational Resources Information Center

Lambie, Glenn W.; Mullen, Patrick R.; Swank, Jacqueline M.; Blount, Ashley

2018-01-01

Supervisors evaluated counselors-in-training at multiple points during their practicum experience using the Counseling Competencies Scale (CCS; N = 1,070). The CCS evaluations were randomly split to conduct exploratory factor analysis and confirmatory factor analysis, resulting in a 2-factor model (61.5% of the variance explained).

Television and Its News: A Discrepancy Examination.

ERIC Educational Resources Information Center

Melton, Gary Warren

This exploratory endeavor utilized a functional discrepancy model of mass communication research to examine the audience experience with television generally and its news in particular. Specifically, gratifications sought from television in general and gratifications perceived as being obtained from television news are analyzed for a random sample…

Hippocampal brain-network coordination during volitional exploratory behavior enhances learning

PubMed Central

Voss, Joel L.; Gonsalves, Brian D.; Federmeier, Kara D.; Tranel, Daniel; Cohen, Neal J.

2010-01-01

Exploratory behaviors during learning determine what is studied and when, helping to optimize subsequent memory performance. We manipulated how much control subjects had over the position of a moving window through which they studied objects and their locations, in order to elucidate the cognitive and neural determinants of exploratory behaviors. Our behavioral, neuropsychological, and neuroimaging data indicate volitional control benefits memory performance, and is linked to a brain network centered on the hippocampus. Increases in correlated activity between the hippocampus and other areas were associated with specific aspects of memory, suggesting that volitional control optimizes interactions among specialized neural systems via the hippocampus. Memory is therefore an active process intrinsically linked to behavior. Furthermore, brain structures typically seen as passive participants in memory encoding (e.g., the hippocampus) are actually part of an active network that controls behavior dynamically as it unfolds. PMID:21102449

Hippocampal brain-network coordination during volitional exploratory behavior enhances learning.

PubMed

Voss, Joel L; Gonsalves, Brian D; Federmeier, Kara D; Tranel, Daniel; Cohen, Neal J

2011-01-01

Exploratory behaviors during learning determine what is studied and when, helping to optimize subsequent memory performance. To elucidate the cognitive and neural determinants of exploratory behaviors, we manipulated the control that human subjects had over the position of a moving window through which they studied objects and their locations. Our behavioral, neuropsychological and neuroimaging data indicate that volitional control benefits memory performance and is linked to a brain network that is centered on the hippocampus. Increases in correlated activity between the hippocampus and other areas were associated with specific aspects of memory, which suggests that volitional control optimizes interactions among specialized neural systems through the hippocampus. Memory is therefore an active process that is intrinsically linked to behavior. Furthermore, brain structures that are typically seen as passive participants in memory encoding (for example, the hippocampus) are actually part of an active network that controls behavior dynamically as it unfolds.

Otolith Dysfunction Alters Exploratory Movement in Mice

PubMed Central

Blankenship, Philip A.; Cherep, Lucia A.; Donaldson, Tia N.; Brockman, Sarah N.; Trainer, Alexandria D.; Yoder, Ryan M.; Wallace, Douglas G.

2017-01-01

The organization of rodent exploratory behavior appears to depend on self-movement cue processing. As of yet, however, no studies have directly examined the vestibular system’s contribution to the organization of exploratory movement. The current study sequentially segmented open field behavior into progressions and stops in order to characterize differences in movement organization between control and otoconia-deficient tilted mice under conditions with and without access to visual cues. Under completely dark conditions, tilted mice exhibited similar distance traveled and stop times overall, but had significantly more circuitous progressions, larger changes in heading between progressions, and less stable clustering of home bases, relative to control mice. In light conditions, control and tilted mice were similar on all measures except for the change in heading between progressions. This pattern of results is consistent with otoconia-deficient tilted mice using visual cues to compensate for impaired self-movement cue processing. This work provides the first empirical evidence that signals from the otolithic organs mediate the organization of exploratory behavior, based on a novel assessment of spatial orientation. PMID:28235587

Surface shape affects the three-dimensional exploratory movements of nocturnal arboreal snakes.

PubMed

Jayne, Bruce C; Olberding, Jeffrey P; Athreya, Dilip; Riley, Michael A

2012-12-01

Movement and searching behaviors at diverse spatial scales are important for understanding how animals interact with their environment. Although the shapes of branches and the voids in arboreal habitats seem likely to affect searching behaviors, their influence is poorly understood. To gain insights into how both environmental structure and the attributes of an animal may affect movement and searching, we compared the three-dimensional exploratory movements of snakes in the dark on two simulated arboreal surfaces (disc and horizontal cylinder). Most of the exploratory movements of snakes in the dark were a small fraction of the distances they could reach while bridging gaps in the light. The snakes extended farther away from the edge of the supporting surface at the ends of the cylinder than from the sides of the cylinder or from any direction from the surface of the disc. The exploratory movements were not random, and the surface shape and three-dimensional directions had significant interactive effects on how the movements were structured in time. Thus, the physical capacity for reaching did not limit the area that was explored, but the shape of the supporting surface and the orientation relative to gravity did create biased searching patterns.

Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study

PubMed Central

2012-01-01

Background Treatment options for patients suffering from progressive forms of multiple sclerosis (MS) remain inadequate. Mast cells actively participate in the pathogenesis of MS, in part because they release large amounts of various mediators that sustain the inflammatory network. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. This exploratory study assessed the safety and clinical benefit of masitinib in the treatment of primary progressive MS (PPMS) or relapse-free secondary progressive MS (rfSPMS). Methods Multicenter, randomized, placebo-controlled, proof-of-concept trial. Masitinib was administered orally at 3 to 6 mg/kg/day for at least 12 months, with dose adjustment permitted in event of insufficient response with no toxicity. The primary response endpoint was the change relative to baseline in the multiple sclerosis functional composite score (MSFC). Clinical response was defined as an increase in MSFC score relative to baseline of > 100%. Results Thirty-five patients were randomized to receive masitinib (N = 27) or placebo (N = 8). Masitinib was relatively well tolerated with the most common adverse events being asthenia, rash, nausea, edema, and diarrhea. The overall frequency of adverse events was similar to the placebo group, however, a higher incidence of severe and serious events was associated with masitinib treatment. Masitinib appeared to have a positive effect on MS-related impairment for PPMS and rfSPMS patients, as evidenced by an improvement in MSFC scores relative to baseline, compared with a worsening MSFC score in patients receiving placebo; +103% ± 189 versus -60% ± 190 at month-12, respectively. This positive, albeit non-statistically significant response was observed as early as month-3 and sustained through to month-18, with similar trends seen in the PPMS and rfSPMS subpopulations. A total of 7/22 (32%) assessable masitinib patients reported clinical response following 12 months of treatment (according to the modified intent-to-treat population, observed cases) compared with none in the placebo group. The Expanded Disability Status Scale remained stable for both treatment groups. Conclusion These data suggest that masitinib is of therapeutic benefit to PPMS and rfSPMS patients and could therefore represent an innovative avenue of treatment for this disease. This exploratory trial provides evidence that may support a larger placebo-controlled investigation. PMID:22691628

Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design.

PubMed

Berg, Marie; Linden, Karolina; Adolfsson, Annsofie; Sparud Lundin, Carina; Ranerup, Agneta

2018-05-02

Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The randomization element in a randomized controlled trial design can become a barrier to achieving a critical mass of user interactions in Web-based interventions, especially when social support is included. For extended study periods, the technology used may need to be adapted in line with newly available technical options to avoid the risk of becoming outdated in the user realm, which in turn might jeopardize study validity in terms of randomized controlled trial designs. On the basis of lessons learned in this randomized controlled trial, we give recommendations to consider when designing and evaluating Web-based health interventions. ©Marie Berg, Karolina Linden, Annsofie Adolfsson, Carina Sparud Lundin, Agneta Ranerup. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.05.2018.

A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients.

PubMed

Stocchi, Fabrizio; Borgohain, Rupam; Onofrj, Marco; Schapira, Anthony H V; Bhatt, Mohit; Lucini, Valentina; Giuliani, Rodolfo; Anand, Ravi

2012-01-01

Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation. Copyright © 2011 Movement Disorder Society.

Cost-effectiveness of focal psychodynamic therapy and enhanced cognitive-behavioural therapy in out-patients with anorexia nervosa.

PubMed

Egger, N; Wild, B; Zipfel, S; Junne, F; Konnopka, A; Schmidt, U; de Zwaan, M; Herpertz, S; Zeeck, A; Löwe, B; von Wietersheim, J; Tagay, S; Burgmer, M; Dinkel, A; Herzog, W; König, H-H

2016-12-01

Anorexia nervosa (AN) is a serious illness leading to substantial morbidity and mortality. The treatment of AN very often is protracted; repeated hospitalizations and lost productivity generate substantial economic costs in the health care system. Therefore, this study aimed to determine the differential cost-effectiveness of out-patient focal psychodynamic psychotherapy (FPT), enhanced cognitive-behavioural therapy (CBT-E), and optimized treatment as usual (TAU-O) in the treatment of adult women with AN. The analysis was conducted alongside the randomized controlled Anorexia Nervosa Treatment of OutPatients (ANTOP) study. Cost-effectiveness was determined using direct costs per recovery at 22 months post-randomization (n = 156). Unadjusted incremental cost-effectiveness ratios (ICERs) were calculated. To derive cost-effectiveness acceptability curves (CEACs) adjusted net-benefit regressions were applied assuming different values for the maximum willingness to pay (WTP) per additional recovery. Cost-utility and assumptions underlying the base case were investigated in exploratory analyses. Costs of in-patient treatment and the percentage of patients who required in-patient treatment were considerably lower in both intervention groups. The unadjusted ICERs indicated FPT and CBT-E to be dominant compared with TAU-O. Moreover, FPT was dominant compared with CBT-E. CEACs showed that the probability for cost-effectiveness of FTP compared with TAU-O and CBT-E was ⩾95% if the WTP per recovery was ⩾€9825 and ⩾€24 550, respectively. Comparing CBT-E with TAU-O, the probability of being cost-effective remained <90% for all WTPs. The exploratory analyses showed similar but less pronounced trends. Depending on the WTP, FPT proved cost-effective in the treatment of adult AN.

Does Interpersonal Loss Preceding Panic Disorder Onset Moderate Response to Psychotherapy? An Exploratory Study

PubMed Central

Klass, Ellen Tobey; Milrod, Barbara L.; Leon, Andrew C.; Kay, Sarah J.; Schwalberg, Michael; Li, Chunshan; Markowitz, John C.

2013-01-01

Background Little research has addressed moderators of treatment outcome for anxiety disorders, and none has considered interpersonal loss as a predictor of outcome. Purpose To examine the effect of interpersonal loss events within the six weeks preceding panic disorder (PD) onset as a moderator of outcome in a randomized controlled trial of Panic-Focused Psychodynamic Therapy (PFPP) and Applied Relaxation Therapy (ART). Researchers hypothesized that such loss events would predict better outcome in PFPP but would not affect ART outcome. Method Forty-nine subjects with PD were randomly assigned to a 12-week course of PFPP or ART. Independent raters blinded to treatment condition and study hypotheses rated subjects on the Panic Disorder Severity Scale (PDSS) and Sheehan Disability Scale. Exploratory analyses assessed between-group effect size for PFPP and ART following standard moderator analytic procedures. Results Three-quarters of subjects reported a narrowly defined interpersonal loss (LOSS) in the 6 weeks preceding PD onset. Subjects had a mean duration of PD of 8.2 (9.5) years. PFPP was more efficacious than ART, but LOSS did not moderate PFPP outcome. An unexpected finding was that LOSS moderated ART outcome: subjects without LOSS showed no response to ART (PDSS change= 0.00 [2.90]), whereas LOSS had a pre/post effect size of 4.29 (5.60). Neither examination of various potential confounding variables nor sensitivity analyses of assumptions regarding attrition altered these findings. Conclusions Interpersonal loss events preceding onset of panic disorder were common. These losses moderated outcome in ART, a therapy that does not focus on such losses. Implications and need for future research are discussed. PMID:19026262

Efficacy of heparinoid moisturizer as a prophylactic agent for radiation dermatitis following radiotherapy after breast-conserving surgery: a randomized controlled trial.

PubMed

Sekiguchi, Kenji; Akahane, Keiko; Ogita, Mami; Haga, Chiori; Ito, Ryoko; Arai, Satoru; Ishida, Yasushi; Tsukada, Yoichiro; Kawamori, Jiro

2018-05-01

The application of heparinoid moisturizer for 2 weeks following whole-breast radiotherapy (WBRT) was previously reported to significantly increase skin water content (WC) and help improve skin dryness and desquamation. The prospective open-label, randomized trial included an exploratory arm to investigate the preventive efficacy of heparinoid moisturizer for acute radiation dermatitis (ARD). Between April 2011 and April 2013, patients receiving WBRT were assigned (1:2:2) to receive either: moisturizer for prophylaxis (group P), moisturizer starting 2 weeks after WBRT for treatment (group M), and no moisturizer (group C). This paper presents the results of comparison between the exploratory arm and no moisturizer group. Skin WC was measured prior to WBRT, on the last day of WBRT, and 2 weeks, 4 weeks and 3 months following WBRT. Signs and symptoms were also assessed. Comparing two groups, WC values were significantly higher in group P until 4 weeks following WBRT. At 2 weeks following WBRT, mean WC values in group P and C were 38.5 ± 6.1 arbitrary units (a.u.) and 30.2 ± 7.8 a.u., respectively (P < 0.001). In group C, dryness was more severe at 2 and 4 weeks following WBRT and desquamation more severe until 3 months following WBRT. However, the erythema score showed no difference between the two groups. Regarding symptoms, group C pain scores on the last day of WBRT were significantly higher than in group P (P < 0.030). The preventive application of heparinoid moisturizer has the potential of reducing skin desquamation and dryness in patients receiving WBRT.

Effects of a Value-Reappraisal Intervention on Statistics Students' Motivation and Performance

ERIC Educational Resources Information Center

Acee, Taylor W.; Weinstein, Claire Ellen

2010-01-01

The authors investigated the effects of an exploratory value-reappraisal intervention on students' motivation and performance in an undergraduate introductory statistics course. They sampled 82 students from 2 instructors' sections during both the fall and spring semesters. Students were randomly assigned within each section to either the…

Using Web-Based Practice to Enhance Mathematics Learning and Achievement

ERIC Educational Resources Information Center

Nguyen, Diem M.; Kulm, Gerald

2005-01-01

This article describes 1) the special features and accessibility of an innovative web-based practice instrument (WebMA) designed with randomized short-answer, matching and multiple choice items incorporated with automatically adapted feedback for middle school students; and 2) an exploratory study that compares the effects and contributions of…

The 15-Second Television Commercial: A Study of Executive Perception.

ERIC Educational Resources Information Center

Asahina, Roberta R.

An exploratory study examined the perceptions of creative directors and broadcast production managers in advertising agencies regarding the perceived effects of the 15-second commercial upon creative formats and production techniques. A sample of 600 randomly selected advertising executives and managers were surveyed using a 55-item mailed…

Staying on track: a cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion.

PubMed

Patel, Ashlesha; Stern, Lisa; Unger, Zoe; Debevec, Elie; Roston, Alicia; Hanover, Rita; Morfesis, Johanna

2014-05-01

To evaluate whether automated reminders increase on-time completion of the three-dose human papillomavirus (HPV) vaccine series. Ten reproductive health centers enrolled 365 women aged 19-26 to receive dose one of the HPV vaccine. Health centers were matched and randomized so that participants received either routine follow-up (control) or automated reminder messages for vaccine doses two and three (intervention). Intervention participants selected their preferred method of reminders - text, e-mail, phone, private Facebook message, or standard mail. We compared vaccine completion rates between groups over a period of 32 weeks. The reminder system did not increase completion rates, which overall were low at 17.2% in the intervention group and 18.9% in the control group (p=0.881). Exploratory analyses revealed that participants who completed the series on-time were more likely to be older (OR=1.15, 95% CI 1.01-1.31), report having completed a four-year college degree or more (age-adjusted OR=2.51, 95% CI 1.29-4.90), and report three or more lifetime sexual partners (age-adjusted OR=3.45, 95% CI 1.20-9.92). The study intervention did not increase HPV vaccine series completion. Despite great public health interest in HPV vaccine completion and reminder technologies, completion rates remain low. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effect of Lycopene Supplementation on Oxidative Stress: An Exploratory Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Jinyao; Song, Yang

2013-01-01

Abstract Lycopene is a potentially useful compound for preventing and treating cardiovascular diseases and cancers. Studies on the effects of lycopene on oxidative stress offer insights into its mechanism of action and provide evidence-based rationale for its supplementation. In this analysis, randomized controlled trials of the effects of oral lycopene supplementation on any valid outcomes of oxidative stress were identified and pooled through a search of international journal databases and reference lists of relevant publications. Two reviewers extracted data from each of the identified studies. Only studies of sufficient quality were included. Twelve parallel trials and one crossover trial were included in the systematic review, and six trials provided data for quantitative meta-analysis. Our results indicate that lycopene supplementation significantly decreases the DNA tail length, as determined using comet assays, with a mean difference (MD) of −6.27 [95% confidence interval (CI) −10.74, −1.90] (P=.006) between the lycopene intervention groups and the control groups. Lycopene supplementation does not significantly prolong the lag time of low-density lipoprotein (MD 3.76 [95% CI −2.48, 10.01]; P=.24). Lycopene possibly alleviates oxidative stress; however, biomarker research for oxidative stress needs be more consistent with the outcomes in lycopene intervention trials for disease prevention. PMID:23631493

A Randomized Controlled Trial of Family Finding: A Relative Search and Engagement Intervention for Youth Lingering in Foster Care.

PubMed

Vandivere, Sharon; Malm, Karin E; Allen, Tiffany J; Williams, Sarah Catherine; McKlindon, Amy

2017-12-01

Youth who have experienced foster care are at risk of negative outcomes in adulthood. The family finding model aims to promote more positive outcomes by finding and engaging relatives of children in foster care in order to provide options for legal and emotional permanency. The present study tested whether family finding, as implemented in North Carolina from 2008 through 2011, improved child welfare outcomes for youth at risk of emancipating foster care without permanency. A randomized controlled trial evaluation was carried out in nine counties in North Carolina. All children eligible for intervention services between 2008 and 2011 underwent random assignment. Effects were tested with an intent-to-treat design. Outcome data were obtained for all subjects from child welfare administrative data. Additional outcome data for a subset of older youth came from in-person interviews. Subjects included 568 children who were in foster care, were 10-17 years old (at time of referral), had no identified permanent placement resource, and had no plan for reunification. The confirmatory outcome was moves to more family-like placements, whether through a step-down in foster care placement or discharge from foster care to legal permanency. No impact on the confirmatory outcome was observed. Findings regarding exploratory impacts are also described; these must be interpreted with caution, given the large number of outcomes compared. The evaluation failed to find evidence that family finding improves the outcomes of older youth at risk of emancipation from foster care.

Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study.

PubMed

Baldwin, David S; Green, Mary; Montgomery, Stuart A

2014-11-01

'Recurrent brief depression' (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2-4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

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

Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl; Gils, Carla H. van; Kotte, Alexis N.T.J.

2012-06-01

Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondarymore » outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.« less

Exploratory Study of Basement Moisture During Operation of Active Soil Depressurization Radon Control Systems

EPA Pesticide Factsheets

As part of an exploratory study, three houses were monitored for moisture indicators, radon levels, building operations, and other environmental parameters while ASD systems were cycled on and off. December 6, 2007, Revised 3/10/08.

Caloric restriction in young rats disturbs hippocampal neurogenesis and spatial learning.

PubMed

Cardoso, Armando; Marrana, Francisco; Andrade, José P

2016-09-01

It is widely known that caloric restriction (CR) has benefits on several organic systems, including the central nervous system. However, the majority of the CR studies was performed in adult animals and the information about the consequences on young populations is limited. In this study, we analyzed the effects of young-onset CR, started at 4weeks of age, in the number of neuropeptide Y (NPY)-containing neurons and in neurogenesis of the hippocampal formation, using doublecortin (DCX) and Ki67 as markers. Knowing that CR treatment could interfere with exploratory activity, anxiety, learning and memory we have analyzed the performance of the rats in the open-field, elevated plus-maze and Morris water maze tests. Animals aged 4weeks were randomly assigned to control or CR groups. Controls were maintained in the ad libitum regimen during 2months. The adolescent CR rats were fed, during 2months, with 60% of the amount of food consumed by controls. We have found that young-onset CR treatment did not affect the total number of NPY-immunopositive neurons in dentate hilus, CA3 and CA1 hippocampal subfields and did not change the exploratory activity and anxiety levels. Interestingly, we have found that young-onset CR might affect spatial learning process since those animals showed worse performance during the acquisition phase of Morris water maze. Furthermore, young-onset CR induced alterations of neurogenesis in the dentate subgranular layer that seems to underlie the impairment of spatial learning. Our data suggest that adolescent animals are vulnerable to CR treatment and that this diet is not suitable to be applied in this age phase. Copyright © 2016 Elsevier Inc. All rights reserved.

The REM Sleep Behavior Disorder Screening Questionnaire: Validation Study of the Korean Version (RBDQ-KR).

PubMed

You, Sooyeoun; Moon, Hye-Jin; Do, So Young; Wing, Yun-Kwok; Sunwoo, Jun-Sang; Jung, Ki-Young; Cho, Yong Won

2017-12-15

REM sleep behavior disorder (RBD) is a parasomnia that is commonly associated with neurodegenerative disorders. We aimed to validate the Hong Kong version of the self-reported RBD questionnaire (RBDQ-HK) with the Korean version (RBDQ-KR) and to investigate its clinical usefulness. One-hundred five patients with RBD and 105 age- and sex-matched controls were enrolled. Thirty were randomly selected for a retest with the questionnaire after 2 to 4 weeks without any treatment. Receiver operating characteristic curve and exploratory factor analysis were used to evaluate the scale, which had a score ranging from 0 to 100. There was no difference in mean age and sex in patients with RBD and control subjects. Patients with RBD had a significantly higher total RBDQ-KR score than the control group ( P < .001). The RBDQ-KR demonstrated high sensitivity (93.3%), specificity (89.5%), positive predictive value (89.9%), and negative predictive value (93.1%). Cronbach α coefficient for internal consistency of the total score of the RBDQ-KR was 0.9, which shows high reliability. Exploratory factor analysis showed two components, dream-related and behavioral factors, consistent with the main clinical features of RBD. Based on the results, the best cutoff for the total score ranging from 0 to 100 was at 18/19 and for factor 2 ranging from 0 to 75 was at 11. This study showed RBDQ-KR is a valid and reliable questionnaire for RBD symptoms and severity in Korea. It serves as an effective tool to identify patients with RBD and to facilitate future clinical and research studies. © 2017 American Academy of Sleep Medicine

Intranasal oxytocin does not modulate jumping to conclusions in schizophrenia: Potential interactions with caudate volume and baseline social functioning.

PubMed

Caravaggio, Fernando; Gerretsen, Philip; Mar, Wanna; Chung, Jun Ku; Plitman, Eric; Nakajima, Shinichiro; Kim, Julia; Iwata, Yusuke; Patel, Raihaan; Chakravarty, M Mallar; Remington, Gary; Graff-Guerrero, Ariel; Menon, Mahesh

2017-07-01

Patients with schizophrenia (SCZ) tend to sample less information when making a decision, jumping to conclusions (JTC) without sufficient evidence. This "JTC bias" may be a trait marker of the disease and may not improve with antipsychotic treatment. We conducted a double-blind, placebo-controlled trial to test whether intranasal oxytocin could reduce JTC in stable, medicated patients with SCZ and healthy controls (HCs). We also explored whether striatal volume, clinical symptoms, and baseline social functioning (SF) was related to JTC performance. Forty-three male, medicated SCZ patients (Mean Age: 40.81±11.44) and sixteen HCs (Mean Age: 30.38±9.85) participated in a double-blind, placebo-controlled, cross-over study. Participants completed the Beads Task on two separate visits (minimum 20days apart). Participants were randomized to receive either intranasal oxytocin (50IU in solution) or intranasal placebo (saline). Twenty of the SCZ patients and all sixteen HCs also provided T1 MRIs (3-T). Patients with SCZ took fewer draws to decision (DTD) than HCs (t(57)=2.78, p=0.007). Oxytocin did not significantly change DTD in patients (t(42)=-1.11, p=0.27), nor in HCs (t(15)=-0.62, p=0.55). Exploratory analyses found ventral caudate volumes were negatively correlated with DTD (r(18)=-0.50, p=0.03) in patients. Moreover, oxytocin was more likely to improve JTC in patients with lower baseline SF. However, these exploratory findings did not survive correction for multiple comparisons. We replicate increased JTC in SCZ. However, acute intranasal oxytocin did not modify JTC. Future studies with larger samples should explore how brain morphology and SF are related to JTC performance in patients with SCZ. Copyright © 2017 Elsevier Ltd. All rights reserved.

An exploratory cluster randomised trial of a university halls of residence based social norms marketing campaign to reduce alcohol consumption among 1st year students

PubMed Central

2013-01-01

Aims This exploratory trial examines the feasibility of implementing a social norms marketing campaign to reduce student drinking in universities in Wales, and evaluating it using cluster randomised trial methodology. Methods Fifty residence halls in 4 universities in Wales were randomly assigned to intervention or control arms. Web and paper surveys were distributed to students within these halls (n = 3800), assessing exposure/contamination, recall of and evaluative responses to intervention messages, perceived drinking norms and personal drinking behaviour. Measures included the Drinking Norms Rating Form, the Daily Drinking Questionnaire and AUDIT-C. Results A response rate of 15% (n = 554) was achieved, varying substantially between sites. Intervention posters were seen by 80% and 43% of students in intervention and control halls respectively, with most remaining materials seen by a minority in both groups. Intervention messages were rated as credible and relevant by little more than half of students, though fewer felt they would influence their behaviour, with lighter drinkers more likely to perceive messages as credible. No differences in perceived norms were observed between intervention and control groups. Students reporting having seen intervention materials reported lower descriptive and injunctive norms than those who did not. Conclusions Attention is needed to enhancing exposure, credibility and perceived relevance of intervention messages, particularly among heavier drinkers, before definitive evaluation can be recommended. A definitive evaluation would need to consider how it would achieve sufficient response rates, whilst hall-level cluster randomisation appears subject to a significant degree of contamination. Trial registration ISRCTN: ISRCTN48556384 PMID:23594918

Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

PubMed

Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

2015-01-01

The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

A preliminary evaluation of synthetic cannabinoid use among adolescent cannabis users: Characteristics and treatment outcomes.

PubMed

Blevins, Claire E; Banes, Kelsey E; Stephens, Robert S; Walker, Denise D; Roffman, Roger A

2016-12-01

Little is known regarding the use of synthetic cannabinoids (SC), particularly use among adolescent substance users who may be at higher risk. The present exploratory study seeks to describe SC use and subjective effects among cannabis-using adolescents as well as compare the characteristics of cannabis users who do and do not use SC. Exploratory analyses evaluated cannabis treatment outcomes among SC users and non-users. Participants enrolled in a randomized, controlled intervention for cannabis-using high school students aged 14-19 (N=252) completed questionnaires regarding their use of SC and other substances. Those who used SC in the past 60days reported subjective effects of SC, consequences, and SC use disorder symptoms. Baseline characteristics, alcohol and other drug use, and treatment outcomes of SC users were compared to participants who never tried SC. Within this sample 29% had tried SC, and 6% used SC recently. Although most reported use at a relatively low rate, 43% of recent SC users reported SC use-disorder symptoms. Positive and negative subjective effects of SC were endorsed, with positive subjective effects reported more often. SC use was associated with more cannabis use, but not more alcohol or other (non-SC and non-cannabis) drug use. SC users did not differ from non-users on cannabis treatment outcomes. This exploratory study described SC use, and compared characteristics and treatment outcomes among SC users and non-users. Negative subjective effects of SC were reported as occurring less often, but SC use was associated with use disorder psychopathology. SC use was associated with more problematic cannabis use at baseline, but was not associated with use of other substances or differences in treatment outcome. Copyright © 2016 Elsevier Ltd. All rights reserved.

Estrogen for Alzheimer's disease in women: randomized, double-blind, placebo-controlled trial.

PubMed

Henderson, V W; Paganini-Hill, A; Miller, B L; Elble, R J; Reyes, P F; Shoupe, D; McCleary, C A; Klein, R A; Hake, A M; Farlow, M R

2000-01-25

AD, the most prevalent cause of dementia, affects twice as many women as men. Therapeutic options are limited, but results of prior studies support the hypothesis that estrogen treatment may improve symptoms of women with this disorder. Forty-two women with mild-to-moderate dementia due to AD were enrolled into a randomized, double-blind, placebo-controlled, parallel-group trial of unopposed conjugated equine estrogens (1.25 mg/day) for 16 weeks. Outcome data were available for 40 women at 4 weeks and 36 women at 16 weeks. At both 4 and 16 weeks, there were no significant differences or statistical trends between treatment groups on the primary outcome measure (the cognitive subscale of the Alzheimer's Disease Assessment Scale), clinician-rated global impression of change, or caregiver-rated functional status. Exploratory analyses of mood and specific aspects of cognitive performance also failed to demonstrate substantial group differences. Although conclusions are limited by small sample size and the possibility of a type II error, results suggest that short-term estrogen therapy does not improve symptoms of most women with AD. These findings do not address possible long-term effects of estrogen in AD, possible interactions between estrogen and other treatment modalities, or putative effects of estrogen in preventing or delaying onset of this disorder.

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

PubMed

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

2018-06-05

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

Single-case experimental design yielded an effect estimate corresponding to a randomized controlled trial.

PubMed

Shadish, William R; Rindskopf, David M; Boyajian, Jonathan G

2016-08-01

We reanalyzed data from a previous randomized crossover design that administered high or low doses of intravenous immunoglobulin (IgG) to 12 patients with hypogammaglobulinaemia over 12 time points, with crossover after time 6. The objective was to see if results corresponded when analyzed as a set of single-case experimental designs vs. as a usual randomized controlled trial (RCT). Two blinded statisticians independently analyzed results. One analyzed the RCT comparing mean outcomes of group A (high dose IgG) to group B (low dose IgG) at the usual trial end point (time 6 in this case). The other analyzed all 12 time points for the group B patients as six single-case experimental designs analyzed together in a Bayesian nonlinear framework. In the randomized trial, group A [M = 794.93; standard deviation (SD) = 90.48] had significantly higher serum IgG levels at time six than group B (M = 283.89; SD = 71.10) (t = 10.88; df = 10; P < 0.001), yielding a mean difference of MD = 511.05 [standard error (SE) = 46.98]. For the single-case experimental designs, the effect from an intrinsically nonlinear regression was also significant and comparable in size with overlapping confidence intervals: MD = 495.00, SE = 54.41, and t = 495.00/54.41 = 9.10. Subsequent exploratory analyses indicated that how trend was modeled made a difference to these conclusions. The results of single-case experimental designs accurately approximated results from an RCT, although more work is needed to understand the conditions under which this holds. Copyright © 2016 Elsevier Inc. All rights reserved.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

Individual differences and repeatability in vocal production: stress-induced calling exposes a songbird's personality.

PubMed

Guillette, Lauren M; Sturdy, Christopher B

2011-11-01

Recent research in songbirds has demonstrated that male singing behavior varies systematically with personality traits such as exploration and risk taking. Here we examine whether the production of bird calls, in addition to bird songs, is repeatable and related to exploratory behavior, using the black-capped chickadee (Poecile atricapillus) as a model. We assessed the exploratory behavior of individual birds in a novel environment task. We then recorded the vocalizations and accompanying motor behavior of both male and female chickadees, over the course of several days, in two different contexts: a control condition with no playback and a stressful condition where chick-a-dee mobbing calls were played to individual birds. We found that several vocalizations and behaviors were repeatable within both a control and a stressful context, and across contexts. While there was no relationship between vocal output and exploratory behavior in the control context, production of alarm and chick-a-dee calls in the stressful condition was positively associated with exploratory behavior. These findings are important because they show that bird calls, in addition to bird song, are an aspect of personality, in that calls are consistent both within and across contexts, and covary with other personality measures (exploration).

Individual differences and repeatability in vocal production: stress-induced calling exposes a songbird's personality

NASA Astrophysics Data System (ADS)

Guillette, Lauren M.; Sturdy, Christopher B.

2011-11-01

Recent research in songbirds has demonstrated that male singing behavior varies systematically with personality traits such as exploration and risk taking. Here we examine whether the production of bird calls, in addition to bird songs, is repeatable and related to exploratory behavior, using the black-capped chickadee ( Poecile atricapillus) as a model. We assessed the exploratory behavior of individual birds in a novel environment task. We then recorded the vocalizations and accompanying motor behavior of both male and female chickadees, over the course of several days, in two different contexts: a control condition with no playback and a stressful condition where chick-a-dee mobbing calls were played to individual birds. We found that several vocalizations and behaviors were repeatable within both a control and a stressful context, and across contexts. While there was no relationship between vocal output and exploratory behavior in the control context, production of alarm and chick-a-dee calls in the stressful condition was positively associated with exploratory behavior. These findings are important because they show that bird calls, in addition to bird song, are an aspect of personality, in that calls are consistent both within and across contexts, and covary with other personality measures (exploration).

Effects of Dog-Assisted Therapy on Communication and Basic Social Skills of Adults With Intellectual Disabilities: A Pilot Study.

PubMed

Scorzato, Ivano; Zaninotto, Leonardo; Romano, Michela; Menardi, Chiara; Cavedon, Lino; Pegoraro, Alessandra; Socche, Laura; Zanetti, Piera; Coppiello, Deborah

2017-06-01

Thirty-nine adults with severe to profound intellectual disability (ID) were randomly assigned to either an experimental group (n = 21) or a control group (n = 18). Assessment was blinded and included selected items from the International Classification of Functioning, Disability and Health (ICF), the Behavioral Assessment Battery (BAB), and the Learning Accomplishment Profile (LAP). The experimental group, who attended a dog-assisted treatment intervention over a 20-week period, showed significant improvements in several cognitive domains, including attention to movement (BAB-AM), visuomotor coordination (BAB-VM), exploratory play (BAB-EP), and motor imitation (BAB-CO-MI), as well as in some social skills, as measured by LAP items. Effects were specific to the intervention and independent of age or basic level of disability.

The medical food Souvenaid affects brain phospholipid metabolism in mild Alzheimer's disease: results from a randomized controlled trial.

PubMed

Rijpma, Anne; van der Graaf, Marinette; Lansbergen, Marieke M; Meulenbroek, Olga; Cetinyurek-Yavuz, Aysun; Sijben, John W; Heerschap, Arend; Olde Rikkert, Marcel G M

2017-07-26

Synaptic dysfunction contributes to cognitive impairment in Alzheimer's disease and may be countered by increased intake of nutrients that target brain phospholipid metabolism. In this study, we explored whether the medical food Souvenaid affects brain phospholipid metabolism in patients with Alzheimer's disease. Thirty-four drug-naive patients with mild Alzheimer's disease (Mini Mental State Examination score ≥20) were enrolled in this exploratory, double-blind, randomized controlled study. Before and after 4-week intervention with Souvenaid or an isocaloric control product, phosphorus and proton magnetic resonance spectroscopy (MRS) was performed to assess surrogate measures of phospholipid synthesis and breakdown (phosphomonoesters [PME] and phosphodiesters [PDEs]), neural integrity (N-acetyl aspartate), gliosis (myo-inositol), and choline metabolism (choline-containing compounds [tCho]). The main outcome parameters were PME and PDE signal intensities and the PME/PDE ratio. MRS data from 33 patients (60-86 years old; 42% males; Souvenaid arm n = 16; control arm n = 17) were analyzed. PME/PDE and tCho were higher after 4 weeks of Souvenaid compared with control (PME/PDE least squares [LS] mean difference [95% CI] 0.18 [0.06-0.30], p = 0.005; tCho LS mean difference [95% CI] 0.01 [0.00-0.02], p = 0.019). No significant differences were observed in the other MRS outcome parameters. MRS reveals that Souvenaid affects brain phospholipid metabolism in mild Alzheimer's disease, in line with findings in preclinical studies. Netherlands Trial Register, NTR3346 . Registered on 13 March 2012.

Exploratory Analysis of Supply Chains in the Defense Industrial Base

DTIC Science & Technology

2012-04-01

Instruments Industry Group 382: Laboratory Apparatus and Analytical, Optical, Measuring, and Controlling Instruments 3821 Laboratory Apparatus and Furniture ...I N S T I T U T E F O R D E F E N S E A N A LY S E S Exploratory Analysis of Supply Chains in the Defense Industrial Base James R. Dominy...contract DASW01-04-C-0003, AH-7-3315, “Exploratory Analysis of Supply Chains in the Defense Industrial Base,” for the Director, Industrial Policy. The

An Exploratory Survey of Teachers' Attitudes toward Sex-Stereotyping.

ERIC Educational Resources Information Center

Minix, Nancy A.; And Others

This survey examined the attitudes of teachers in southwestern Kentucky toward sex-stereotyping in the classroom. A random sample of 35 teachers of grades kindergarten through adult completed a written survey instrument that asked them to read statements regarding sex-stereotyping and to rate themselves regarding their own classroom practices.…

Investigating the Relationship between Coupon Collecting and Top-of-Mind Brand Awareness.

ERIC Educational Resources Information Center

Pokrywczynski, Jim

To determine if coupon collecting has any influence on product information processing like brand awareness, and to understand better the coupon collecting process, an exploratory study examined the relationship between coupon-collecting behavior and brand awareness for the coupons collected. Subjects, 152 randomly chosen respondents from a Midwest…

Preservice Teachers' Beliefs and Attitude about Teaching and Learning Mathematics through Music: An Intervention Study

ERIC Educational Resources Information Center

An, Song A.; Ma, Tingting; Capraro, Mary Margaret

2011-01-01

This article presents exploratory research investigating the integration of music and a mathematics lesson as an intervention to promote preservice teachers' attitude and confidence and to extend their beliefs toward teaching mathematics integrated with music. Thirty students were randomly selected from 64 preservice teachers in a southern…

Digital Print Concepts: Conceptualizing a Modern Framework for Measuring Emerging Knowledge

ERIC Educational Resources Information Center

Javorsky, Kristin H.

2014-01-01

This dissertation sought to produce and empirically test a theoretical model for the literacy construct of print concepts that would take into account the unique affordances of digital picture books for emergent readers. The author used an exploratory study of twenty randomly selected digital story applications to identify print conventions, text…

Serendipity in Teaching and Learning: The Importance of Critical Moments

ERIC Educational Resources Information Center

Giordano, Peter J.

2010-01-01

Can professors, through their casual, random remarks to students, alter lives and transform identities? The answer, based on two exploratory studies described in this article, appears to be yes. Drawing from constructive-developmental ideas of student maturation and from features of chaos theory as applied to the complex dynamic system of…

A Multidimensional Scaling Approach to Developmental Dimensions in Object Permanence and Tracking Stimuli.

ERIC Educational Resources Information Center

Townes-Rosenwein, Linda

This paper discusses a longitudinal, exploratory study of developmental dimensions related to object permanence theory and explains how multidimensional scaling techniques can be used to identify developmental dimensions. Eighty infants, randomly assigned to one of four experimental groups and one of four counterbalanced orders of stimuli, were…

College and Career Readiness Assessment: Validation of the Key Cognitive Strategies Framework

ERIC Educational Resources Information Center

Lombardi, Allison R.; Conley, David T.; Seburn, Mary A.; Downs, Andrew M.

2013-01-01

In this study, the authors examined the psychometric properties of the key cognitive strategies (KCS) within the CollegeCareerReady[TM] School Diagnostic, a self-report measure of critical thinking skills intended for high school students. Using a cross-validation approach, an exploratory factor analysis was conducted with a randomly selected…

An Exploratory Study of Software Cost Estimating at the Electronic Systems Division.

DTIC Science & Technology

1976-07-01

action’. to improve the software cost Sestimating proces., While thin research was limited to the M.nD onvironment, the same types of problema may exist...Methods in Social Science. Now York: Random House, 1969. 57. Smith, Ronald L. Structured Programming Series (Vol. XI) - Estimating Software Project

Development and Validation of Academic Dishonesty Scale (ADS): Presenting a Multidimensional Scale

ERIC Educational Resources Information Center

Bashir, Hilal; Bala, Ranjan

2018-01-01

The purpose of the study was to develop a scale measuring academic dishonesty of undergraduate students. The sample of the study constitutes nine hundred undergraduate students selected via random sampling technique. After receiving expert's opinions for the face and content validity of the scale, the exploratory factor analysis (EFA) and…

Validation of a Tool to Assess and Track Undergraduate Attitudes toward Those Living in Poverty

ERIC Educational Resources Information Center

Blair, Kevin D.; Brown, Marlo; Schoepflin, Todd; Taylor, David B.

2014-01-01

Purpose: This article describes the development and validation of the Undergraduate Perceptions of Poverty Tracking Survey (UPPTS). Method: Data were collected from 301 undergraduates at a small university in the Northeast and analyzed using exploratory factor analysis augmented by random qualitative validation. Results: The resulting survey…

Assessing Students' Metacognitive Awareness of Learning Strategies among Secondary School Students in Edo State, Nigeria

ERIC Educational Resources Information Center

Okoza, Jolly; Aluede, Oyaziwo; Owens-Sogolo, Osasere

2013-01-01

This study examined metacognitive awareness of learning strategies among Secondary School Students in Edo State, Nigeria. The study was an exploratory one, which utilized descriptive statistics. A total number of 1200 students drawn through multistage proportionate random sampling technique participated in the study. The study found that secondary…

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

PubMed

Hausmann, Leslie R M; Ibrahim, Said A; Kwoh, C Kent; Youk, Ada; Obrosky, D Scott; Weiner, Debra K; Vina, Ernest; Gallagher, Rollin M; Mauro, Genna T; Parks, Acacia

2018-01-01

Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis. Published by Elsevier Inc.

A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities

PubMed Central

Lewis, Vivian; Martina, Camille A.; McDermott, Michael P.; Trief, Paula; Goodman, Steven R.; Morse, Gene D.; LaGuardia, Jennifer G.; Sharp, Daryl; Ryan, Richard M.

2015-01-01

Purpose To conduct a randomized controlled trial (RCT) to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Method Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010–2013 into: mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability. The primary analysis was a comparison of intervention effects on changes in protégés’ satisfaction of their basic psychological needs (competence, autonomy and relatedness) with their mentor. They completed a well-validated, online questionnaire every 2 months for 1 year. Results There was no significant effect at the end of 1 year of either mentor training or peer mentoring on protégés’ psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés’ overall psychological need satisfaction with their mentor at 2 months, the time point closest to completing mentor training. Conclusions This RCT showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study. PMID:26717501

Computer-delivered indirect screening and brief intervention for drug use in the perinatal period: A randomized trial.

PubMed

Ondersma, Steven J; Svikis, Dace S; Thacker, Casey; Resnicow, Ken; Beatty, Jessica R; Janisse, James; Puder, Karoline

2018-04-01

Under-reporting of drug use in the perinatal period is well-documented, and significantly limits the reach of proactive intervention approaches. The Wayne Indirect Drug Use Screener (WIDUS) focuses on correlates of drug use rather than use itself. This trial tested a computer-delivered, brief intervention designed for use with indirect screen-positive cases, seeking to motivate reductions in drug use without presuming its presence. Randomized clinical trial with 500 WIDUS-positive postpartum women recruited between August 14, 2012 and November 19, 2014. Participants were randomly assigned to either a time control condition or a single-session, tailored, indirect brief intervention. The primary outcome was days of drug use over the 6-month follow-up period; secondary outcomes included urine and hair analyses results at 3- and 6-month follow-up. All outcomes were measured by blinded evaluators. Of the 500 participants (252 intervention and 248 control), 36.1% of participants acknowledged drug use in the 3 months prior to pregnancy, but 89% tested positive at the 6-month follow-up. Participants rated the intervention as easy to use (4.9/5) and helpful (4.4/5). Analyses revealed no between-group differences in drug use (52% in the intervention group, vs. 53% among controls; OR 1.03). Exploratory analyses also showed that intervention effects were not moderated by baseline severity, WIDUS score, or readiness to change. The present trial showed no evidence of efficacy for an indirect, single-session, computer-delivered, brief intervention designed as a complement to indirect screening. More direct approaches that still do not presume active drug use may be possible and appropriate. Copyright © 2018 Elsevier B.V. All rights reserved.

Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards

PubMed Central

Mercincavage, Melissa; Wileyto, E. Paul; Saddleson, Megan L.; Lochbuehler, Kirsten; Donny, Eric C.; Strasser, Andrew A.

2017-01-01

Aims To determine (1) if nicotine content affects study attrition – a potential behavioral measure of acceptability – in a trial that required compliance with three levels of reduced nicotine content (RNC) cigarettes, and (2) if attrition is associated with subjective and behavioral responses to RNC cigarettes. Design Secondary analysis of a 35-day, parallel design, open-label, randomized controlled trial. After a 5-day baseline period, participants were randomized to smoke for three, 10-day periods: their preferred brand (control group), or RNC cigarettes with three nicotine levels in a within-subject, stepdown (1 group: high-moderate-low) or non-stepdown (5 groups: high-low-moderate, low-moderate-high, low-high-moderate, moderate-low-high, moderate-high-low) fashion. Setting A single site in Philadelphia, Pennsylvania, USA. Participants 246 non-treatment-seeking daily smokers (M age = 39.52, CPD = 20.95, 68.3% White) were recruited from October 2007 to June 2013. Measurements The primary outcome was attrition. Key predictors were nicotine content transition and study period. Exploratory predictors were taste and strength subjective ratings, total puff volume, and carbon monoxide (CO) boost. Covariates included: age, gender, race, education, and nicotine dependence. Findings Overall attrition was 31.3% (n = 77): 24.1% of the control and 25.0% of the stepdown RNC cigarette groups dropped out vs. 44.6% of non-stepdown groups (p = 0.006). Compared with controls, attrition odds were 4.5 and 4.7 times greater among smokers transitioning from preferred and the highest RNC cigarettes to the lowest RNC cigarettes, respectively (p’s = .001 and .003). Providing more favorable initial taste ratings of study cigarettes decreased attrition odds by 2% (p = .012). Conclusions The majority of participants completed a 35-day trial of varying levels of reduced nicotine content cigarettes. Participant drop-out was greater for cigarettes with lower nicotine content and less in smokers reporting more favorable subjective ratings of the cigarettes. PMID:28107596

Exploratory factor analysis of signalment and conformational measurements in Thoroughbred horses with and without recurrent laryngeal neuropathy.

PubMed

McGivney, C L; Gough, K F; McGivney, B A; Farries, G; Hill, E W; Katz, L M

2018-06-23

Conflicting results have been reported for risk factors for recurrent laryngeal neuropathy (RLN) based on resting endoscopic evaluation and comparison of single conformation traits, with many traits correlated to one another. To simplify identification of signalment and conformation traits (i.e. variables) associated with RLN cases and controls diagnosed with exercising overground endoscopy (OGE) using exploratory factor analysis (EFA). Prospective cohort. Pearson's rank correlation was used to establish significance and association between variables collected from n = 188 Thoroughbreds from one stable by observers blinded to OGE results. Exploratory factor analysis was conducted on 9 variables for cases and controls; common elements between variables developed a factor, with variables grouped into 3 factors for cases and controls, respectively. Correlation (loading) between each variable and factor was calculated to rank relationships between variables and cases/controls, with factors retrospectively named based on their underlying correlations with variables. Numerous inter-correlations were present between variables. Most strongly correlated in cases were wither height with body weight (r = 0.70) and ventral neck length (r = 0.68) and in controls body weight with rostral neck circumference (r = 0.58). Wither height (r = 0.61) significantly loaded the top-ranked factor for cases ('height RLN '), explaining 25% of conformational variance. Ventral neck length (r = 0.69) and age (r = 0.57) significantly loaded the second-ranked factor for cases ('neck length RLN '), explaining 16% of conformational variance. Rostral neck circumference (r = 0.86) and body weight (r = 0.6) significantly loaded the top-ranked factor for controls ('body size CON '), explaining 19% of the variance. Wither height (r = 0.84) significantly loaded the second-ranked factor for controls ('height CON '), explaining 13% of the variance. Horses had not reached skeletal maturity. Exploratory factor analysis allowed weightings to be determined for each variable. Wither height was the predominant conformational feature associated with RLN. Exploratory factor analysis confirms aggregated conformational differences exist between RLN cases and controls, suitable for future evaluations. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

EXPLORATORY ANALYSIS OF THE EFFECTS OF PARTICULATE CHARACTERISTICS ON THE VARIATION IN PARTITIONING OF NONPOLAR ORGANIC CONTAMINANTS TO MARINE SEDIMENTS

EPA Science Inventory

The partitioning of nonpolar organic contaminants to marine sediments is considered to be controlled by the amount of organic carbon present. However, several studies propose that other characteristics of sediments may affect the partitioning of contaminants. For this exploratory...

An Exploratory Study of Responses to Low-Dose Lithium in African Americans and Hispanics

PubMed Central

Arnold, Jodi Gonzalez; Salcedo, Stephanie; Ketter, Terrence A.; Calabrese, Joseph R.; Rabideau, Dustin J.; Nierenberg, Andrew A.; Bazan, Melissa; Leon, Andrew C.; Friedman, Edward S.; Iosifescu, Dan; Sylvia, Louisa G.; Ostacher, Michael; Thase, Michael; Reilly-Harrington, Noreen A.; Bowden, Charles L.

2015-01-01

Objectives Few prospective studies examine the impact of ethnicity or race on outcomes with lithium for bipolar disorder. This exploratory study examines differences in lithium response and treatment outcomes in Hispanics, African Americans, and non-Hispanic Whites with bipolar disorder in the Lithium Treatment Moderate Dose Use Study (LiTMUS). Methods LiTMUS was a six-site randomized controlled trial of low-dose lithium added to optimized treatment (OPT; personalized, evidence-based pharmacotherapy) versus OPT alone in outpatients with bipolar disorder. Of 283 participants, 47 African Americans, 39 Hispanics, and 175 non-Hispanic whites were examined. We predicted minority groups would have more negative medication attitudes and higher attrition rates, but better clinical outcomes. Results African Americans in the lithium group improved more on depression and life functioning compared to whites over the 6 month study. African Americans in the OPT only group had marginal improvement on depression symptoms. For Hispanics, satisfaction with life did not significantly improve in the OPT only group, in contrast to whites and African Americans who improved over time on all measures. Attitudes toward medications did not differ across ethnic/racial groups. Conclusions African Americans show some greater improvements with lithium than non-Hispanic whites, and Hispanics showed more consistent improvements in the lithium group. The impact of low-dose lithium should be studied in a larger sample as there may be particular benefit for African Americans and Hispanics. Given that the control group (regardless of ethnicity/race) had significant improvements, optimized treatment may be beneficial for any ethnic group. PMID:25827507

The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial.

PubMed

Brenner, Amy; Shakur-Still, Haleema; Chaudhri, Rizwana; Fawole, Bukola; Arulkumaran, Sabaratnam; Roberts, Ian

2018-06-07

In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19-0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33-1.86). Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after excluding early hysterectomies. ISRCTN trial registration number ISRCTN76912190, 8 Dec 2008; ClinicalTrials.gov number NCT00872469, 30 March 2009; PACTR number PACTR201007000192283, 9 Feb 2010; EudraCT number 2008-008441-38, 8 Dec 2010 (retrospectively registered).

Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals.

PubMed

Salden, Bouke N; Troost, Freddy J; de Groot, Eric; Stevens, Yala R; Garcés-Rimón, Marta; Possemiers, Sam; Winkens, Bjorn; Masclee, Ad A

2016-12-01

Endothelial dysfunction (ED) is involved in the development of atherosclerosis. Hesperidin, a citrus flavonoid with antioxidant and other biological properties, potentially exerts beneficial effects on endothelial function (EF). We investigated the effect of hesperidin 2S supplementation on EF in overweight individuals. This was a randomized, double-blind, placebo-controlled study in which 68 individuals were randomly assigned to receive hesperidin 2S (450 mg/d) or a placebo for 6 wk. At baseline and after 6 wk of intervention, flow-mediated dilation (FMD), soluble vascular adhesion molecule-1 (sVCAM-1), soluble intracellular adhesion molecule-1 (sICAM-1), soluble P-selectin (sP-selectin), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were assessed. Acute, reversible ED was induced by intake of a high-fat meal (HFM). A second FMD scan was performed 2 h postprandially, and adhesion molecules were assessed 2 and 4 h postprandially. An additional exploratory analysis was performed in subjects with baseline FMD ≥3%. No significant change in fasting or postprandial FMD was observed after 6 wk of hesperidin intake compared with placebo intake. However, there was a trend for a reduction of sVCAM-1, sICAM-1, sP-selectin, SBP, and DBP after 6 wk of hesperidin treatment. In the FMD ≥3% group, hesperidin protected individuals from postprandial ED (P = 0.050) and significantly downregulated sVCAM-1 and sICAM-1 (all P ≤ 0.030). The results reported in the current article were not adjusted for multiplicity. Six weeks of consumption of hesperidin 2S did not improve basal or postprandial FMD in our total study population. There was a tendency toward a reduction of adhesion molecules and a decrease in SBP and DBP. Further exploratory analyses revealed that, in subjects with baseline FMD ≥3%, hesperidin 2S improved ED after an HFM and reduced adhesion molecules. These results indicate the cardiovascular health benefits of hesperidin 2S in overweight and obese individuals with a relatively healthy endothelium. This trial was registered at clinicaltrials.gov as NCT02228291. © 2016 American Society for Nutrition.

Enhancing decision-making and cognitive impulse control with transcranial direct current stimulation (tDCS) applied over the orbitofrontal cortex (OFC): A randomized and sham-controlled exploratory study.

PubMed

Ouellet, Julien; McGirr, Alexander; Van den Eynde, Frederique; Jollant, Fabrice; Lepage, Martin; Berlim, Marcelo T

2015-10-01

Decision-making and impulse control (both cognitive and motor) are complex interrelated processes which rely on a distributed neural network that includes multiple cortical and subcortical regions. Among them, the orbitofrontal cortex (OFC) seems to be particularly relevant as demonstrated by several neuropsychological and neuroimaging investigations. In the present study we assessed whether transcranial direct current stimulation (tDCS) applied bilaterally over the OFC is able to modulate decision-making and cognitive impulse control. More specifically, 45 healthy subjects were randomized to receive a single 30-min session of active or sham anodal tDCS (1.5 mA) applied over either the left or the right OFC (coupled with contralateral cathodal tDCS). They were also assessed pre- and post-tDCS with a battery of computerized tasks. Our results show that participants who received active anodal tDCS (irrespective of laterality), vs. those who received sham tDCS, displayed more advantageous decision-making (i.e., increased Iowa Gambling Task "net scores" [p = 0.04]), as well as improved cognitive impulse control (i.e., decreased "interference" in the Stroop Word-Colour Task [p = 0.007]). However, we did not observe tDCS-related effects on mood (assessed by visual analogue scales), attentional levels (assessed by the Continuous Performance Task) or motor impulse control (assessed by the Stop-Signal Task). Our study potentially serves as a key translational step towards the development of novel non-invasive neuromodulation-based therapeutic interventions directly targeting vulnerability factors for psychiatric conditions such as suicidal behaviour and addiction. Copyright © 2015 Elsevier Ltd. All rights reserved.

Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.

PubMed

Ley, Chit Moy; Ni, Qing; Liao, Xing; Gao, Huai-Lin; Robinson, Nicola

2016-10-01

To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes. This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.

An exploratory study of a number sense program to develop kindergarten students' number proficiency.

PubMed

Sood, Sheetal; Jitendra, Asha K

2013-01-01

This study examined the effectiveness of a number sense program on kindergarten students' number proficiency and responsiveness to treatment as a function of students' risk for mathematics difficulties. The program targeted development of relationships among numbers (e.g., spatial, more and less). A total of 101 kindergarten students (not at risk: 22 control and 36 experimental; at risk: 18 and 25) from five classrooms in a high-poverty elementary school participated in the study. Using a quasi-experimental design, classrooms were randomly assigned to either the intervention (number sense instruction, NSI) or control condition. Results indicated significant differences favoring the treatment students on all measures of number sense (e.g., spatial relationships, more and less relationships, benchmarks of five and ten, nonverbal calculations) at posttest and on a 3-week retention test. Furthermore, the effects were not mediated by at-risk status, suggesting that NSI may benefit a wide range of students. Implications in terms of preventing early mathematical learning difficulties are discussed.

Application of the Delphi technique in healthcare maintenance.

PubMed

Njuangang, Stanley; Liyanage, Champika; Akintoye, Akintola

2017-10-09

Purpose The purpose of this paper is to examine the research design, issues and considerations in the application of the Delphi technique to identify, refine and rate the critical success factors and performance measures in maintenance-associated infections. Design/methodology/approach In-depth literature review through the application of open and axial coding were applied to formulate the interview and research questions. These were used to conduct an exploratory case study of two healthcare maintenance managers, randomly selected from two National Health Service Foundation Trusts in England. The results of exploratory case study provided the rationale for the application of the Delphi technique in this research. The different processes in the application of the Delphi technique in healthcare research are examined thoroughly. Findings This research demonstrates the need to apply and integrate different research methods to enhance the validity of the Delphi technique. The rationale for the application of the Delphi technique in this research is because some healthcare maintenance managers lack knowledge about basic infection control (IC) principles to make hospitals safe for patient care. The result of first round of the Delphi exercise is a useful contribution in its own rights. It identified a number of salient issues and differences in the opinions of the Delphi participants, noticeably between healthcare maintenance managers and members of the infection control team. It also resulted in useful suggestions and comments to improve the quality and presentation of the second- and third-round Delphi instruments. Practical implications This research provides a research methodology that can be adopted by researchers investigating new and emerging issues in the healthcare sector. As this research demonstrates, the Delphi technique is relevant in soliciting expert knowledge and opinion to identify performance measures to control maintenance-associated infections in hospitals. The methodology provided here could be applied by other researchers elsewhere to probe, investigate and generate rich information about new and emerging healthcare research topics. Originality/value The authors demonstrate how different research methods can be integrated to enhance the validity of the Delphi technique. For example, the results of an exploratory case study provided the rationale for the application of the Delphi technique investigating the key performance measures in maintenance-associated infections. The different processes involved in the application of the Delphi technique are also carefully explored and discussed in depth.

Measuring Student Graduateness: Reliability and Construct Validity of the Graduate Skills and Attributes Scale

ERIC Educational Resources Information Center

Coetzee, Melinde

2014-01-01

This study reports the development and validation of the Graduate Skills and Attributes Scale which was initially administered to a random sample of 272 third-year-level and postgraduate-level, distance-learning higher education students. The data were analysed using exploratory factor analysis. In a second study, the scale was administered to a…

Nursing Home Quality, Cost, Staffing, and Staff Mix

ERIC Educational Resources Information Center

Rantz, Marilyn J.; Hicks, Lanis; Grando, Victoria; Petroski, Gregory F.; Madsen, Richard W.; Mehr, David R.; Conn, Vicki; Zwygart-Staffacher, Mary; Scott, Jill; Flesner, Marcia; Bostick, Jane; Porter, Rose; Maas, Meridean

2004-01-01

Purpose: The purpose of this study was to describe the processes of care, organizational attributes, cost of care, staffing level, and staff mix in a sample of Missouri homes with good, average, and poor resident outcomes. Design and Methods: A three-group exploratory study design was used, with 92 nursing homes randomly selected from all nursing…

The Interrelationships of Preadolescents' Student Characteristics Influencing Selection of Career Exploration Courses [And Abstract]. Industrial Arts Education Monograph No. 1.

ERIC Educational Resources Information Center

Meehan, Merrill L.

The study investigated the interaction of personal and environmental factors influencing seventh graders' selection of career exploration courses for increased exploration in the eighth grade. A stratified random sample (496 students) was drawn from the Pittsburgh Public School's Occupational, Vocational, and Technical Exploratory Program.…

A spatial stochastic programming model for timber and core area management under risk of fires

Treesearch

Yu Wei; Michael Bevers; Dung Nguyen; Erin Belval

2014-01-01

Previous stochastic models in harvest scheduling seldom address explicit spatial management concerns under the influence of natural disturbances. We employ multistage stochastic programming models to explore the challenges and advantages of building spatial optimization models that account for the influences of random stand-replacing fires. Our exploratory test models...

Vicarious Trauma: An Exploratory Study of the Impact of Providing Sexual Abuse Treatment on Clinicians' Trust and Intimacy

ERIC Educational Resources Information Center

VanDeusen, Karen M.; Way, Ineke

2006-01-01

This study examined vicarious trauma effects in male and female clinicians who treat sexual abuse survivors (n = 111) and sexual offenders (n = 272). The national survey was conducted using a random sample of clinical members of two professional organizations. Analyses tested the relationships between demographic variables, maltreatment history,…

An Exploration of Students' Motivation to Lead: An Analysis by Race, Gender, and Student Leadership Behaviors

ERIC Educational Resources Information Center

Rosch, David M.; Collier, Daniel; Thompson, Sara E.

2015-01-01

This exploratory study examined the motivation to lead of a random sample of 1,338 undergraduate students to determine the degree to which motivation to lead can predict leadership behaviors. Results suggested that students' internal self-identity as a leader positively predicted behavior, while their "social normative" motivation to…

Arts and the Quality of Life: An Exploratory Study

ERIC Educational Resources Information Center

Michalos, Alex C.

2005-01-01

The aim of this investigation was to measure the impact of the arts broadly construed on the quality of life. A randomly drawn household sample of 315 adult residents of Prince George, British Columbia served as the working data-set. Examining zero-order correlations, among other things, it was found that playing a musical instrument a number of…

The Interaction of Motivation and Therapist Adherence Predicts Outcome in Cognitive Behavioral Therapy for Panic Disorder: Preliminary Findings

ERIC Educational Resources Information Center

Huppert, Jonathan D.; Barlow, David H.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.

2006-01-01

This report is a post-hoc, exploratory examination of the relationships among patient motivation, therapist protocol adherence, and panic disorder outcome in patients treated with cognitive behavioral therapy within the context of a randomized clinical trial for the treatment of panic disorder (Barlow, Gorman, Shear, & Woods, 2000). Results…

An Exploratory Analysis of the Impact of Family Functioning on Treatment for Depression in Adolescents

ERIC Educational Resources Information Center

Feeny, Norah C.; Silva, Susan G.; Reinecke, Mark A.; McNulty, Steven; Findling, Robert L.; Rohde, Paul; Curry, John F.; Ginsburg, Golda S.; Kratochvil, Christopher J.; Pathak, Sanjeev M.; May, Diane E.; Kennard, Betsy D.; Simons, Anne D.; Wells, Karen C.; Robins, Michele; Rosenberg, David; March, John S.

2009-01-01

This article explores aspects of family environment and parent-child conflict that may predict or moderate response to acute treatments among depressed adolescents (N = 439) randomly assigned to fluoxetine, cognitive behavioral therapy, their combination, or placebo. Outcomes were Week 12 scores on measures of depression and global impairment. Of…

Teaching Effectiveness in Private Higher Education Institutions in Botswana: Analysis of Students' Perceptions

ERIC Educational Resources Information Center

Baliyan, Som Pal; Moorad, Fazlur Rehman

2018-01-01

This quantitative study analyzed the perceptions of students on teaching effectiveness in private higher education institutions in Botswana. An exploratory and descriptive survey research design was adopted in this study. A valid and reliable questionnaire was used to collect data through a survey of 560 stratified randomly sampled students in…

Factor Structure and Psychometric Properties of the Young Schema Questionnaire (Short Form) in Chinese Undergraduate Students

ERIC Educational Resources Information Center

Cui, Lixia; Lin, Wenwen; Oei, Tian P. S.

2011-01-01

This study investigated cross-cultural differences in the factor structure and psychometric properties of the Young Schema Questionnaire (short form; YSQ-SF). The participants were 712 Chinese undergraduate students. The total sample was randomly divided into two sub-samples. Exploratory Factor Analysis (EFA) was conducted on questionnaire results…

Content Analysis of Conceptually Based Physical Education in Southeastern United States Universities and Colleges

ERIC Educational Resources Information Center

Williams, Suzanne Ellen; Greene, Leon; Satinsky, Sonya; Neuberger, John

2016-01-01

Purpose: The purposes of this study were to explore PE in higher education through the offering of traditional activity- and skills-based physical education (ASPE) and conceptually-based physical education (CPE) courses, and to conduct an exploratory content analysis on the CPE available to students in randomized colleges and universities in the…

Evaluation of a Serious Self-Regulation Game Intervention for Overweight-Related Behaviors ("Balance It"): A Pilot Study.

PubMed

Spook, Jorinde; Paulussen, Theo; Kok, Gerjo; van Empelen, Pepijn

2016-09-26

Serious games have the potential to promote health behavior. Because overweight is still a major issue among secondary vocational education students in the Netherlands, this study piloted the effects of "Balance It," a serious self-regulation game intervention targeting students' overweight-related behaviors: dietary intake and physical activity (PA). We aimed to pilot the effects of Balance It on secondary vocational education students' dietary intake and PA. In total, 501 secondary vocational education students participated at baseline (intervention: n=250; control: n=251) in this pre-post cluster randomized trial. After 4 weeks, at immediate posttest, 231 students filled in the posttest questionnaire (intervention: n=105; control: n=126). The sample had a mean age of 17.28 (SD 1.26, range 15-21) years, 62.8% (145/231) were female, and 26.8% (62/231) had a non-Dutch background. Body mass index (BMI kg/m 2 ) ranged from 14.4 to 31.1 (mean 21.1, SD 3.3). The intervention and control groups were compared on the primary (behavioral) outcomes of dietary intake (fruit and vegetable consumption, snack consumption, and soft drink consumption) and PA (moderate and vigorous). Additionally, we explored (1) differences between the intervention and control groups in determinants of dietary intake and PA, including attitude, self-efficacy, intention, barrier identification, action planning, and action control, and (2) differences between active (intervention) users and the control group in dietary intake, PA, and associated determinants. After corrections for multiple testing, we did not find significant differences between the intervention group and control group in terms of dietary intake, PA, and determinants of dietary intake and PA. Exploratory research indicated that only 27.6% (29/105) of the intervention group reported actual intervention use (ie, active users). For exploratory reasons, we compared the active users (n=29) with the control group (n=124) and corrected for multiple testing. Results showed that active users' snack consumption decreased more strongly (active users: mean change=-0.20; control group: mean change=-0.08; beta=-0.36, P=.01, R 2 change=.05), and their use of active transport had a stronger increase (active users: mean change=0.92; control group=-0.12; beta=1.58, P=.02, R 2 change=.03) than the control group. Results also revealed significant differences in action planning (active users: mean change=0.42; control group: mean change=0.07; beta=0.91, P=.01, R 2 change=.04) and action control (active users: mean change=0.63; control group: mean change=-0.05; beta=1.25, P=.001, R 2 change=.08) in terms of unhealthy eating. The Balance It intervention did not show favorable effects on dietary intake and PA compared to the control condition. However, only a small number of people in the intervention condition actually used Balance It (27.6%). Exploratory analyses did suggest that, if used as planned, Balance It could contribute to changing dietary intake and PA behaviors, albeit it remains debatable whether this would be sufficient to prevent overweight.

Evaluation of a Serious Self-Regulation Game Intervention for Overweight-Related Behaviors (“Balance It”): A Pilot Study

PubMed Central

Paulussen, Theo; Kok, Gerjo; van Empelen, Pepijn

2016-01-01

Background Serious games have the potential to promote health behavior. Because overweight is still a major issue among secondary vocational education students in the Netherlands, this study piloted the effects of “Balance It,” a serious self-regulation game intervention targeting students’ overweight-related behaviors: dietary intake and physical activity (PA). Objective We aimed to pilot the effects of Balance It on secondary vocational education students’ dietary intake and PA. Methods In total, 501 secondary vocational education students participated at baseline (intervention: n=250; control: n=251) in this pre-post cluster randomized trial. After 4 weeks, at immediate posttest, 231 students filled in the posttest questionnaire (intervention: n=105; control: n=126). The sample had a mean age of 17.28 (SD 1.26, range 15-21) years, 62.8% (145/231) were female, and 26.8% (62/231) had a non-Dutch background. Body mass index (BMI kg/m2) ranged from 14.4 to 31.1 (mean 21.1, SD 3.3). The intervention and control groups were compared on the primary (behavioral) outcomes of dietary intake (fruit and vegetable consumption, snack consumption, and soft drink consumption) and PA (moderate and vigorous). Additionally, we explored (1) differences between the intervention and control groups in determinants of dietary intake and PA, including attitude, self-efficacy, intention, barrier identification, action planning, and action control, and (2) differences between active (intervention) users and the control group in dietary intake, PA, and associated determinants. Results After corrections for multiple testing, we did not find significant differences between the intervention group and control group in terms of dietary intake, PA, and determinants of dietary intake and PA. Exploratory research indicated that only 27.6% (29/105) of the intervention group reported actual intervention use (ie, active users). For exploratory reasons, we compared the active users (n=29) with the control group (n=124) and corrected for multiple testing. Results showed that active users’ snack consumption decreased more strongly (active users: mean change=–0.20; control group: mean change=–0.08; beta=–0.36, P=.01, R2 change=.05), and their use of active transport had a stronger increase (active users: mean change=0.92; control group=–0.12; beta=1.58, P=.02, R2 change=.03) than the control group. Results also revealed significant differences in action planning (active users: mean change=0.42; control group: mean change=0.07; beta=0.91, P=.01, R2 change=.04) and action control (active users: mean change=0.63; control group: mean change=–0.05; beta=1.25, P=.001, R2 change=.08) in terms of unhealthy eating. Conclusions The Balance It intervention did not show favorable effects on dietary intake and PA compared to the control condition. However, only a small number of people in the intervention condition actually used Balance It (27.6%). Exploratory analyses did suggest that, if used as planned, Balance It could contribute to changing dietary intake and PA behaviors, albeit it remains debatable whether this would be sufficient to prevent overweight. PMID:27670222

The mesencephalic trigeminal sensory nucleus is involved in acquisition of active exploratory behavior induced by changing from a diet of exclusively milk formula to food pellets in mice.

PubMed

Ishii, Toshiaki; Furuoka, Hidefumi; Kitamura, Nobuo; Muroi, Yoshikage; Nishimura, Masakazu

2006-09-21

Post-weaning mice fed exclusively milk display low-frequency exploratory behavior [Ishii, T., Itou, T., and Nishimura, M. (2005) Life Sci. 78, 174-179] compared to mice fed a food pellet diet. This low-frequency exploratory behavior switched to high-frequency exploration after a switch from exclusively milk formula to a food pellet diet. Acquisition of the high-frequency exploratory behavior was irreversible. Recently, we demonstrated that the mesencephalic trigeminal nucleus (Me5) is involved in the control of feeding and exploratory behavior in mice without modulating the emotional state [Ishii, T., Furuoka, H., Itou, T., Kitamura, N., and Nishimura, M. (2005) Brain Res. 1048, 80-86]. We therefore investigated whether the Me5 is involved in acquisition of high-frequency exploratory behavior induced by the switch in diet from an exclusively milk formula to food pellets. Mouse feeding and exploratory behaviors were analyzed using a food search compulsion apparatus, which was designed to distinguish between the two behaviors under standard living conditions. Immunohistochemical analysis of immediate early genes indicated that the Me5, which receives signals from oral proprioceptors, is transiently activated after the diet change. The change from low-frequency to high-frequency exploratory behavior was prevented in milk-fed mice by bilateral lesion of the Me5. These results suggest that the Me5 is activated by signals associated with mastication-induced proprioception and contributes to the acquisition of active exploratory behavior.

GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

PubMed

Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

2017-01-01

To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Oral ELND005 (scyllo-Inositol) in Young Adults with Down Syndrome without Dementia.

PubMed

Rafii, Michael S; Skotko, Brian G; McDonough, Mary Ellen; Pulsifer, Margaret; Evans, Casey; Doran, Eric; Muranevici, Gabriela; Kesslak, Patrick; Abushakra, Susan; Lott, Ira T

2017-01-01

ELND005 (scyllo-Inositol; cyclohexane-1,2,3,4,5,6-hexol) has been evaluated as a potential disease-modifying treatment for Alzheimer's disease (AD). Individuals with Down syndrome (DS) have an increased risk for developing AD dementia. To evaluate the safety and tolerability of ELND005 and to determine its pharmacokinetics (PK) and relationship between PK parameters, safety outcome measures, and exploratory efficacy outcome measures in young adults with DS without dementia. This was a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter Phase II study of the safety and pharmacokinetics of ELND005 administered orally for 4 weeks (ClinicalTrials.gov NCT01791725). Participants who met study eligibility criteria were randomly assigned in a 2 : 1:1 ratio to receive ELND005 at either 250 mg twice daily (BID) or 250 mg once daily (QD) or matching placebo for 4 weeks. There were no apparent treatment group-related trends on cognitive or behavioral measures and there were no SAEs and no deaths in the study. Overall, mean changes from baseline in clinical laboratory parameters, vital sign measurements, electrocardiogram results, and other physical findings were unremarkable. ELND005 accumulation averaged approximately 2-fold with QD dosing, and 3- to 4-fold with BID dosing. Overall, treatment of adults with DS with ELND005 at both doses was well tolerated, achieved measurable blood levels and demonstrated no safety findings. Further studies will be needed to test efficacy.

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Oral ELND005 (scyllo-Inositol) in Young Adults with Down Syndrome without Dementia

PubMed Central

Rafii, Michael S.; Skotko, Brian G.; McDonough, Mary Ellen; Pulsifer, Margaret; Evans, Casey; Doran, Eric; Muranevici, Gabriela; Kesslak, Patrick; Abushakra, Susan; Lott, Ira T.

2018-01-01

Background ELND005 (scyllo-Inositol; cyclohexane-1,2,3,4,5,6-hexol) has been evaluated as a potential disease-modifying treatment for Alzheimer’s disease (AD). Individuals with Down syndrome (DS) have an increased risk for developing AD dementia. Objective To evaluate the safety and tolerability of ELND005 and to determine its pharmacokinetics (PK) and relationship between PK parameters, safety outcome measures, and exploratory efficacy outcome measures in young adults with DS without dementia. Methods This was a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter Phase 2 study of the safety and pharmacokinetics of ELND005 administered orally for 4 weeks (ClinicalTrials.gov NCT01791725). Participants who met study eligibility criteria were randomly assigned in a 2:1:1 ratio to receive ELND005 at either 250 mg twice daily (BID) or 250 mg once daily (QD) or matching placebo for 4 weeks. Results There were no apparent treatment group-related trends on cognitive or behavioral measures and there were no SAEs and no deaths in the study. Overall, mean changes from baseline in clinical laboratory parameters, vital sign measurements, electrocardiogram (ECG) results, and other physical findings were unremarkable. ELND005 accumulation averaged approximately 2-fold with QD dosing, and 3- to 4-fold with BID dosing. Conclusion Overall, treatment of adults with DS with ELND005 at both doses was well tolerated, achieved measurable blood levels and demonstrated no safety findings. Further studies will be needed to test efficacy. PMID:28453471

Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.

PubMed

Spruill, Tanya M; Reynolds, Harmony R; Dickson, Victoria Vaughan; Shallcross, Amanda J; Visvanathan, Pallavi D; Park, Chorong; Kalinowski, Jolaade; Zhong, Hua; Berger, Jeffrey S; Hochman, Judith S; Fishman, Glenn I; Ogedegbe, Gbenga

2018-04-21

Elevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women including rumination (i.e., repetitive negative thinking) and low social support. This article describes the rationale and design of a multicenter randomized controlled trial to test the effects of telephone-delivered MBCT (MBCT-T) in women with MI. We plan to randomize 144 women reporting elevated perceived stress at least two months after MI to MBCT-T or enhanced usual care (EUC), which each involve eight weekly telephone sessions. Perceived stress and a set of patient-centered health outcomes and potential mediators will be assessed before and after the 8-week telephone programs and at 6-month follow-up. We will test the hypothesis that MBCT-T will be associated with greater 6-month improvements in perceived stress (primary outcome), disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality (secondary outcomes) compared with EUC. Changes in mindfulness, rumination and perceived social support will be evaluated as potential mediators in exploratory analyses. If found to be effective, this innovative, scalable intervention may be a promising secondary prevention strategy for women with MI experiencing elevated perceived stress. Copyright © 2018 Elsevier Inc. All rights reserved.

Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial.

PubMed

Palermo, Tonya M; Law, Emily F; Fales, Jessica; Bromberg, Maggie H; Jessen-Fiddick, Tricia; Tai, Gabrielle

2016-01-01

Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent's pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families.

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Effect of Daikenchuto (TJ-100) on gastrointestinal symptoms following laparoscopic colectomy in patients with colon cancer: study protocol for a randomized controlled trial.

PubMed

Hoshino, Nobuaki; Kawada, Kenji; Hida, Koya; Wada, Toshiaki; Takahashi, Ryo; Yoshitomi, Mami; Sakai, Yoshiharu

2017-11-21

Postoperative paralytic ileus can be a difficult complication for both surgeons and patients. Causes and treatments have been discussed for more than two centuries, but have not yet been fully resolved. Daikenchuto (TJ-100, DKT) is a traditional Japanese herbal medicine. Recently, some beneficial mechanisms of DKT to relieve paralytic ileus have been reported. DKT can suppress inflammation, increase intestinal blood flow, and accelerate bowel movements. Therefore, we have designed a randomized controlled trial to investigate the effects of DKT on postoperative gastrointestinal symptoms following laparoscopic colectomy in patients with left-sided colon cancer at a single institution. As primary endpoints, the following outcomes will be evaluated: (i) grade of abdominal pain determined using the numeric rating scale (NRS), (ii) grade of abdominal distention determined using the NRS, and (iii) quality of life determined using the Gastrointestinal Quality Life Index (GIQLI). As secondary endpoints, the following will be evaluated: (i) postoperative nutritional status (Onodera's Prognostic Nutritional Index (PNI) and the Controlling Nutritional Status score (CONUT score)), (ii) duration to initial flatus, (iii) duration to initial defecation, (iv) bowel gas volume, (v) character of stool (Bristol Stool Form Scale), (vi) defecation frequency per day, (vii) postoperative complications (Clavien-Dindo classification), (viii) length of postoperative hospital stay, and (ix) metabolites in the stool and blood. This trial is an open-label study, and needs to include 40 patients (20 patients per group) and is expected to span 2 years. To our knowledge, this is the first randomized controlled trial to investigate the effects of DKT on postoperative subjective outcomes (i.e., postoperative quality of life) following laparoscopic colectomy as primary endpoints. Exploratory metabolomics analysis of metabolites in stool and blood will be conducted in this trial, which previously has only been performed in a few human studies. The study aims to guide a future full-scale pragmatic randomized trial to assess the overall effectiveness of DKT to improve the postoperative quality of life following laparoscopic colectomy. UMIN-CTR (Japan), UMIN000023318 . Registered on 25 July 2016.

Cognitive outcomes of TMS treatment in bipolar depression: Safety data from a randomized controlled trial.

PubMed

Myczkowski, Martin L; Fernandes, Adriano; Moreno, Marina; Valiengo, Leandro; Lafer, Beny; Moreno, Ricardo A; Padberg, Frank; Gattaz, Wagner; Brunoni, Andre R

2018-08-01

Bipolar depression (BD) is a highly prevalent condition associated with marked cognitive deficits that persist even in the euthymic phase of the illness. Pharmacological treatments for BD might further aggravate cognitive impairment, highlighting the need of developing interventions that present cognitive safety. In this study, we evaluated the cognitive effects of H1-coil (deep) transcranial magnetic stimulation (TMS) in patients with treatment-resistant bipolar depression. Fourty-three patients were randomized to receive 20 sessions of active (55 trains, 18 Hz, 120% resting motor threshold intensity) or sham rTMS within a double-blind, sham-controlled trial. A battery of 20 neuropsychological assessments, grouped in 6 domains (attention and processing speed, working memory and executive function, inhibitory control, language, immediate verbal memory, and long-term verbal memory) was performed at baseline and after 4 and 8 weeks of trial onset. Depressive symptoms were assessed with the 17-item Hamilton Rating Scale for Depression. Cognitive improvement was shown for all cognitive domains. It occurred regardless of intervention group and depression improvement. For the language domain, greater improvement was observed in the sham group over time. No correlations between depression (at baseline or during treatment) and cognitive improvement were found. Absence of healthy control group. The results of this exploratory study provide evidence on the cognitive safety of H1-coil TMS for BD patients. Putative pro-cognitive effects of rTMS in BD were not observed and thus should be further investigated. Copyright © 2018 Elsevier B.V. All rights reserved.

An Exploratory Study of Problem Gambling on Casino versus Non-Casino Electronic Gaming Machines

ERIC Educational Resources Information Center

Clarke, Dave; Pulford, Justin; Bellringer, Maria; Abbott, Max; Hodgins, David C.

2012-01-01

Electronic gaming machines (EGMs) have been frequently associated with problem gambling. Little research has compared the relative contribution of casino EGMs versus non-casino EGMs on current problem gambling, after controlling for demographic factors and gambling behaviour. Our exploratory study obtained data from questionnaires administered to…

Academic and Personal Development through Group Work: An Exploratory Study

ERIC Educational Resources Information Center

Steen, Sam

2011-01-01

This exploratory study linked academic and personal development within a group counseling intervention. A pre-test post-test research design compared social skills, learning behaviors, and achievement with a convenience sample and control group of students from three elementary schools. For the treatment group, grade point average in Language Arts…

A Study of the Exploratory Behavior of Legally Blind and Sighted Preschoolers.

ERIC Educational Resources Information Center

Olson, Myrna R.

1983-01-01

Fifteen legally blind preschoolers and 15 sighted controls matched for age, sex, and socioeconomic status were observed with novel and non-novel toys. Analysis of the exploratory behavior revealed no significant differences between the interaction of each group with either toy except in patterns of sensory utilization. (CL)

Examining Metacognitive Processes in Exploratory Computer-Based Learning Environments Using Activity Log Analysis

ERIC Educational Resources Information Center

Chang, Yoo Kyung

2010-01-01

Metacognition is widely studied for its influence on the effectiveness of learning. With Exploratory Computer-Based Learning Environments (ECBLE), metacognition is found to be especially important because these environments require adaptive metacognitive control by the learners due to their open-ended structure that allows for multiple learning…

Uridine monophosphate, folic acid and vitamin B12 in patients with symptomatic peripheral entrapment neuropathies.

PubMed

Negrão, Luis; Nunes, Paula

2016-01-01

Carpal tunnel syndrome is the most common type of peripheral entrapment neuropathy. We performed an exploratory, open-label, multicenter, observational study of 48 patients with peripheral entrapment neuropathy. Patients received a daily capsule of uridine monophosphate, folic acid + vitamin B12 for 2 months and were evaluated using the Pain DETECT questionnaire. The global score for pain decreased from 17.3 ± 5.9 at baseline to 10.3 ± 6.1 at the final evaluation (p < 0.001). Concomitant analgesic and anti-inflammatory treatment was stopped or the dose reduced in 77.4% of patients. Uridine monophosphate + folic acid + vitamin B12 reduced total pain score, intensity and characterization of pain and associated symptoms. These results should be tested in a well-designed, adequately powered randomized controlled trial.

Risk of myocardial infarction and stroke in bipolar disorder: a systematic review and exploratory meta-analysis

PubMed Central

Prieto, M.L.; Cuéllar-Barboza, A.B.; Bobo, W.V.; Roger, V.L.; Bellivier, F.; Leboyer, M.; West, C.P.; Frye, M.A.

2016-01-01

Objective To review the evidence on and estimate the risk of myocardial infarction and stroke in bipolar disorder. Method A systematic search using MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and bibliographies (1946 – May, 2013) was conducted. Case-control and cohort studies of bipolar disorder patients age 15 or older with myocardial infarction or stroke as outcomes were included. Two independent reviewers extracted data and assessed quality. Estimates of effect were summarized using random-effects meta-analysis. Results Five cohort studies including 13 115 911 participants (27 092 bipolar) were included. Due to the use of registers, different statistical methods, and inconsistent adjustment for confounders, there was significant methodological heterogeneity among studies. The exploratory meta-analysis yielded no evidence for a significant increase in the risk of myocardial infarction: [relative risk (RR): 1.09, 95% CI 0.96–1.24, P = 0.20; I2 = 6%]. While there was evidence of significant study heterogeneity, the risk of stroke in bipolar disorder was significantly increased (RR 1.74, 95% CI 1.29–2.35; P = 0.0003; I2 = 83%). Conclusion There may be a differential risk of myocardial infarction and stroke in patients with bipolar disorder. Confidence in these pooled estimates was limited by the small number of studies, significant heterogeneity and dissimilar methodological features. PMID:24850482

Hypnosis in patients with perceived stress - a systematic review.

PubMed

Fisch, S; Brinkhaus, B; Teut, M

2017-06-19

Although hypnosis and hypnotherapy have become more popular in recent years, the evidence for hypnosis to influence perceived stress is unclear. In this systematic review we searched and evaluated randomized clinical studies investigating the effect of hypnosis on perceived stress reduction and coping. The Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Review of Effects, EMBASE, Medline, PsycINFO, PSYNDEX and PubMed were systematically screened from their inception until December 2015 for randomized controlled trials (RCTs) reporting about hypnosis or hypnotherapy for stress reduction in healthy participants. Risk of Bias was assessed according the Cochrane Collaboration recommendations. Nine RCTs with a total of 365 participants met the inclusion criteria and were included in this review. Most included participants were medical students, predominantly female (n = 211). Mean age of participants ranged in most studies between 20 and 25 years, in three studies the mean ages were between 30 and 42 years. Perceived stress was measured by a wide range of psychological questionnaires including Face Valid Stress Test, Stress Thermometer, and immunological data was collected. All nine included studies used explorative designs and showed a high risk of bias. Six out of nine studies reported significant positive effects of hypnosis for stress reduction in the main outcome parameter compared to control groups (3 active controls, 3 no therapy controls). Immunological outcomes were assessed in six studies, the results were inconclusive. Due to exploratory designs and high risk of bias, the effectiveness of hypnosis or hypnotherapy in stress reduction remains still unclear. More high quality clinical research is urgently needed.

Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study.

PubMed

Moljord, I E O; Lara-Cabrera, M L; Salvesen, Ø; Rise, M B; Bjørgen, D; Antonsen, D Ø; Olsø, T M; Evensen, G H; Gudde, C B; Linaker, O M; Steinsbekk, A; Eriksen, L

2017-06-01

To investigate the effect of having a contract for self-referral to inpatient treatment (SRIT) in patients with severe mental disorders. A randomized controlled trial with 53 adult patients; 26 participants received a SRIT contract, which they could use to refer themselves into a Community Mental Health Centre up to five days for each referral without contacting a doctor in advance. Outcomes were assessed after 12 months with the self-report questionnaires Patient Activation Measure (PAM-13), Recovery Assessment Scale (RAS), and the Behavior and Symptom Identification Scale (BASIS-32) and analyzed using linear mixed and regression models. There was no significant effect on PAM-13 (estimated mean difference (emd) -0.41, 95% CI (CI):-7.49-6.67), nor on the RAS (emd 0.02, CI:-0.27-0.31) or BASIS-32 (0.09, CI:-0.28-0.45). An exploratory post hoc analysis showed effect of SRIT in those with low PAM below ≤47 (p=0.049). There were no group differences after 12 months, but both groups maintained their baseline levels. SRIT contracts can be recommended as it supports the rights to self-determination, promote user participation in decision-making in own treatment without any indication of adverse effects. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

Oxytocin Effect on Collective Decision Making: A Randomized Placebo Controlled Study.

PubMed

Hertz, Uri; Kelly, Maria; Rutledge, Robb B; Winston, Joel; Wright, Nicholas; Dolan, Raymond J; Bahrami, Bahador

2016-01-01

Collective decision making often benefits both the individuals and the group in a variety of contexts. However, for the group to be successful, individuals should be able to strike a balance between their level of competence and their influence on the collective decisions. The hormone oxytocin has been shown to promote trust, conformism and attention to social cues. We wondered if this hormone may increase participants' (unwarranted) reliance on their partners' opinion, resulting in a reduction in collective benefit by disturbing the balance between influence and competence. To test this hypothesis we employed a randomized double-blind placebo-controlled design in which male dyads self-administered intranasal oxytocin or placebo and then performed a visual search task together. Compared to placebo, collective benefit did not decrease under oxytocin. Using an exploratory time dependent analysis, we observed increase in collective benefit over time under oxytocin. Moreover, trial-by-trial analysis showed that under oxytocin the more competent member of each dyad was less likely to change his mind during disagreements, while the less competent member showed a greater willingness to change his mind and conform to the opinion of his more reliable partner. This role-dependent effect may be mediated by enhanced monitoring of own and other's performance level under oxytocin. Such enhanced social learning could improve the balance between influence and competence and lead to efficient and beneficial collaboration.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

PubMed Central

Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

Factors associated with differential response to online cognitive behavioural therapy.

PubMed

Button, Katherine S; Wiles, Nicola J; Lewis, Glyn; Peters, Tim J; Kessler, David

2012-05-01

Patients differ in their response to treatments. There is obvious clinical utility in establishing patient characteristics that are associated with differential treatment responses (i.e., are effect modifiers or moderators of treatment response). Factors that moderate response to cognitive behavioural therapy (CBT) remain unclear. This study investigates whether factors prognostic of general depression outcome generally are also moderators of response to online CBT in a sample of depressed patients recruited through U.K. general practices. Secondary analysis of a randomised controlled trial, internet-based psychotherapy for depression. A total of 297 patients referred from 55 U.K. general practices and suffering from depression were randomly allocated to receive either online CBT or waiting list control. Treatment effect was measured by comparing depression score at 4 months between randomization groups. Treatment effect modification was assessed using regression analyses focusing on interactions between treatment effect and putative moderator variables. Pretreatment severity and marital status moderated treatment response. More severe patients, and patients who were separated, widowed, or divorced, benefited most from the intervention. Weak evidence suggested that treatment effectiveness diminished with increasing recent adverse life events. No evidence was found to suggest that educational attainment, age, and history of depression-moderated treatment response. Secondary analyses of trials comparing two or more treatments allow factors that may moderate treatment response to be distinguished from more general prognostic indicators, although caution is needed in interpreting such exploratory analyses.

The use of step aerobics and the stability ball to improve balance and quality of life in community-dwelling older adults - a randomized exploratory study.

PubMed

Dunsky, Ayelet; Yahalom, Tal; Arnon, Michal; Lidor, Ronnie

2017-07-01

To explore the use of step aerobics (SA) and the stability ball (SB) as tools for balance improvement in community-dwelling older adults. Forty-two women (age: 72.2±5.8 years) who attended a community day center volunteered to participate in the study. Following the first assessment session, 28 women were assigned randomly to one of two experimental groups (the use of either SA or SB). The other 14 participants, who were engaged in a ceramic class, served as the control group. The study design was based on four assessment sessions and eight weeks of intervention. Assessment included four balance tests: Timed Up and Go (TUG), One-Leg Stand, Functional Reach, and the Performance-Oriented Assessment of Mobility (POMA). Quality of life was assessed by the use of the Short Form-36 Health Survey questionnaire. The TUG and POMA intervention improved significantly (d=.83 and d=.95, respectively) following the SA. In addition, general health perception following both the SA and SB interventions improved significantly relative to the control condition (d=.62 and d=.22, respectively). The findings of this study may imply that trainers should consider the inclusion of SA and SB as components of physical activity programs for seniors, aimed at improving balance ability and quality of life. Copyright © 2017 Elsevier B.V. All rights reserved.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

PubMed

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-08-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

A propaganda index for reviewing problem framing in articles and manuscripts: an exploratory study.

PubMed

Gambrill, Eileen; Reiman, Amanda

2011-01-01

To determine the effectiveness of an index in increasing recognition of misleading problem framing in articles and manuscripts. A propaganda index consisting of 32 items was developed drawing on related literature. Seventeen subjects who review manuscripts for possible publication were requested to read five recent published reports of randomized controlled trials concerning social anxiety and to identify indicators of propaganda (defined as encouraging beliefs and actions with the least thought possible). They then re-read the same five articles using a propaganda index to note instances of propaganda. Convenience sample of individuals who review manuscripts for possible publication and sample of recent published reports of randomized controlled trials regarding social anxiety in five different journals by different authors, blinded by author and journal. Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety such as hiding well argued alternative views and vagueness. This occurred in 117 out of 160 opportunities over five research reports. A convenience sample of 17 academics spotted only 4.5 percent of propaganda indicators. This increased to 64 percent with use of the 32 item propaganda index. Use of a propaganda index increased recognition of related indicators. However many instances remained undetected. This propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA.

A Propaganda Index for Reviewing Problem Framing in Articles and Manuscripts: An Exploratory Study

PubMed Central

Gambrill, Eileen; Reiman, Amanda

2011-01-01

Objective To determine the effectiveness of an index in increasing recognition of misleading problem framing in articles and manuscripts. Design A propaganda index consisting of 32 items was developed drawing on related literature. Seventeen subjects who review manuscripts for possible publication were requested to read five recent published reports of randomized controlled trials concerning social anxiety and to identify indicators of propaganda (defined as encouraging beliefs and actions with the least thought possible). They then re-read the same five articles using a propaganda index to note instances of propaganda. Data source Convenience sample of individuals who review manuscripts for possible publication and sample of recent published reports of randomized controlled trials regarding social anxiety in five different journals by different authors, blinded by author and journal. Results Data showed that there was a high rate of propagandistic problem framing in reports of RCTs regarding social anxiety such as hiding well argued alternative views and vagueness. This occurred in 117 out of 160 opportunities over five research reports. A convenience sample of 17 academics spotted only 4.5 percent of propaganda indicators. This increased to 64 percent with use of the 32 item propaganda index. Use of a propaganda index increased recognition of related indicators. However many instances remained undetected. Conclusion This propaganda index warrants further exploration as a complement to reporting guidelines such as CONSORT and PRISMA. PMID:21647426

Revising and Updating the Plant Science Components of the Connecticut Vocational Agriculture Curriculum.

ERIC Educational Resources Information Center

Connecticut Univ., Storrs. Dept. of Educational Leadership.

This curriculum guide provides the plant science components of the vocational agriculture curriculum for Regional Vocational Agriculture Centers. The curriculum is divided into exploratory units for students in the 9th and 10th grades and specialized units for students in grades 11 and 12. The five exploratory units are: agricultural pest control;…

The Perception of Marriage and Family Therapists Regarding Their Return on Investment When Getting Their Doctorate

ERIC Educational Resources Information Center

Salgado, Margie A.

2013-01-01

This was a randomized, exploratory study utilizing mixed methods. The purpose for this research was to explore the perception of therapists regarding their return on investment towards their doctoral degree in the field of marriage and family therapy. The primary focus of this study was on the financial, the emotional and the relational…

Development and Initial Validation of a Measure of Academic Behaviors Associated with College and Career Readiness

ERIC Educational Resources Information Center

Lombardi, Allison; Seburn, Mary; Conley, David

2011-01-01

In this cross-validation study, the authors examined the psychometric properties of a measure of academic behaviors associated with college and career readiness intended for high school students. An exploratory factor analysis (EFA) was conducted with a randomly selected portion of the sample (n = 413) and resulted in four reliable factors:…

Adaptation of the ORTHO-15 test to Polish women and men.

PubMed

Brytek-Matera, Anna; Krupa, Magdalena; Poggiogalle, Eleonora; Donini, Lorenzo Maria

2014-03-01

There is a lack of Polish tools to measure behaviour related to orthorexia nervosa. The purpose of the present study was to validate the Polish version of the ORTHO-15 test. 341 women and 59 men (N = 400) were recruited, whose age ranged from 18 to 35 years. Mean age was 23.09 years (SD = 3.14) in women and 24.02 years (SD = 3.87) in men. The ORTHO-15 test and the EAT-26 test were used in the present study. Factor analysis (exploratory and confirmatory analysis) was used in the present study. Exploratory factor analysis performed on the initial 15 items from a random split half of the study group suggested a nine-item two-factor structure. Confirmatory factor analysis performed on the second randomly selected half of the study group supported this two-factor structure of the ORTHO-15 test. The Polish version of the ORTHO-15 test demonstrated an internal consistency (Cronbach's alpha) equal to 0.644. The Polish version of the ORTHO-15 test is a reliable and valuable instrument to assess obsessive attitudes related to healthy and proper nutrition in Polish female and male population.

Hippocampal asymmetry in exploratory behavior to vasoactive intestinal polypeptide.

PubMed

Ivanova, Margarita; Ternianov, Alexandar; Belcheva, Stiliana; Tashev, Roman; Negrev, Negrin; Belcheva, Iren

2008-06-01

The effects of vasoactive intestinal polypeptide (VIP) microinjected uni- or bilaterally into the CA1 hippocampal area of male Wistar rats at a dose of 10, 50 and 100 ng on exploratory behavior were examined. VIP microinjected bilaterally at a high dose (100 ng) significantly decreased the horizontal movements, while at low doses (10 and 50 ng) had no effect on the exploratory activity. Microinjections of VIP into the left hippocampal CA1 area at doses 50 and 100 ng suppressed the exploratory activity, while right-side VIP administration at a dose 100 ng significantly increased horizontal movements compared to the respective controls. Vertical activity was stimulated only by VIP administered into the right hippocampal CA1 area at the three doses used. Neither bilateral nor left injections of VIP induced changes in the vertical movements. The main finding was the presence of hippocampal asymmetry in exploratory behavior to unilateral microinjections of VIP depending on the dose and the microinjected hemisphere.

Ruxolitinib reduces JAK2 p.V617F allele burden in patients with polycythemia vera enrolled in the RESPONSE study.

PubMed

Vannucchi, Alessandro Maria; Verstovsek, Srdan; Guglielmelli, Paola; Griesshammer, Martin; Burn, Timothy C; Naim, Ahmad; Paranagama, Dilan; Marker, Mahtab; Gadbaw, Brian; Kiladjian, Jean-Jacques

2017-07-01

In patients with polycythemia vera (PV), an elevated JAK2 p.V617F allele burden is associated with indicators of more severe disease (e.g., leukocytosis, splenomegaly, and increased thrombosis risk); however, correlations between allele burden reductions and clinical benefit in patients with PV have not been extensively evaluated in a randomized trial. This exploratory analysis from the multicenter, open-label, phase 3 Randomized Study of Efficacy and Safety in Polycythemia Vera With JAK Inhibitor INCB018424 Versus Best Supportive Care trial evaluated the long-term effect of ruxolitinib treatment on JAK2 p.V617F allele burden in patients with PV. Evaluable JAK2 p.V617F-positive patients randomized to ruxolitinib (n = 107) or best available therapy (BAT) who crossed over to ruxolitinib at week 32 (n = 97) had consistent JAK2 p.V617F allele burden reductions throughout the study. At all time points measured (up to weeks 208 [ruxolitinib-randomized] and 176 [ruxolitinib crossover]), mean changes from baseline over time in JAK2 p.V617F allele burden ranged from -12.2 to -40.0% (ruxolitinib-randomized) and -6.3 to -17.8% (ruxolitinib crossover). Complete or partial molecular response was observed in 3 patients (ruxolitinib-randomized, n = 2; ruxolitinib crossover, n = 1) and 54 patients (ruxolitinib-randomized, n = 33; ruxolitinib crossover, n = 20; BAT, n = 1), respectively. Among patients treated with interferon as BAT (n = 13), the mean maximal reduction in allele burden from baseline was 25.6% after crossover to ruxolitinib versus 6.6% before crossover. Collectively, the data from this exploratory analysis suggest that ruxolitinib treatment for up to 4 years provides progressive reductions in JAK2 p.V617F allele burden in patients with PV who are resistant to or intolerant of hydroxyurea. The relationship between allele burden changes and clinical outcomes in patients with PV remains unclear.

Quality of life, activity impairment, and healthcare resource utilization associated with atrial fibrillation in the US National Health and Wellness Survey.

PubMed

Goren, Amir; Liu, Xianchen; Gupta, Shaloo; Simon, Teresa A; Phatak, Hemant

2013-01-01

This study builds upon current studies of atrial fibrillation (AF) and health outcomes by examining more comprehensively the humanistic burden of illness (quality of life, activity impairment, and healthcare resource utilization) among adult patients with AF, using a large, nationally representative sample and matched controls. Data were analyzed from the Internet-based 2009 US National Health and Wellness Survey. Outcomes were Mental and Physical Component Summary (MCS and PCS) and health utility scores from the SF-12, activity impairment, hospitalizations, and healthcare provider and emergency room (ER) visits. Patients with self-reported diagnosis of AF were matched randomly on age and gender with an equal number of respondents without AF. Generalized linear models examined outcomes as a function of AF vs. non-AF status, controlling for CHADS2 score, comorbidity counts, demographics, and clinical variables. Exploratory structural equation modeling assessed the above in an integrated model of humanistic burden. Mean age of AF patients (1,296 from a total sample of 75,000) was 64.9 years and 65.1% were male. Adjusting for covariates, compared with non-AF patients, AF patients had lower MCS, PCS, and utility scores, greater activity impairment (rate ratio = 1.26), more traditional provider visits (rate ratio = 1.43), and increased odds of ER visits (OR = 2.53) and hospitalizations (OR = 2.71). Exploratory structural equation modeling analyses revealed that persons with AF experienced a significantly higher overall humanistic burden. This study highlights and clarifies the substantial burden of AF and its implications for preparing efficacious AF management plans to address the imminent rise in prevalence.

Systematic review of prognosis and return to play after sport concussion: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

PubMed

Cancelliere, Carol; Hincapié, Cesar A; Keightley, Michelle; Godbolt, Alison K; Côté, Pierre; Kristman, Vicki L; Stålnacke, Britt-Marie; Carroll, Linda J; Hung, Ryan; Borg, Jörgen; Nygren-de Boussard, Catharina; Coronado, Victor G; Donovan, James; Cassidy, J David

2014-03-01

To synthesize the best available evidence on prognosis after sport concussion. MEDLINE and other databases were searched (2001-2012) with terms including "craniocerebral trauma" and "sports." Reference lists of eligible articles were also searched. Randomized controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 concussion cases. Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. Evidence was synthesized qualitatively according to modified SIGN criteria, and studies were categorized as exploratory or confirmatory based on the strength of their design and evidence. After 77,914 records were screened, 52 articles were eligible for this review, and 24 articles (representing 19 studies) with a low risk of bias were accepted. Our findings are based on exploratory studies of predominantly male football players at the high school, collegiate, and professional levels. Most athletes recover within days to a few weeks, and American and Australian professional football players return to play quickly after mild traumatic brain injury. Delayed recovery appears more likely in high school athletes, in those with a history of previous concussion, and in those with a higher number and duration of postconcussion symptoms. The evidence concerning sports concussion course and prognosis is very preliminary, and there is no evidence on the effect of return-to-play guidelines on prognosis. Our findings have implications for further research. Well-designed, confirmatory studies are urgently needed to understand the consequences of sport concussion, including recurrent concussion, across different athletic populations and sports. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Health Philosophy of Dietitians and Its Implications for Life Satisfaction: An Exploratory Study.

PubMed

Grace-Farfaglia, Patricia; Pickett-Bernard, Denise; White Gorman, Andrea; Dehpahlavan, Jaleh

2017-10-19

Studies of health providers suggest that satisfaction with life is related to their values and sense of purpose which is best achieved when their professional role is in harmony with personal philosophy. Cross-sectional surveys suggest that personal health beliefs and practices of health professionals influence their clinical counseling practices. However, little is known about the influence of health philosophy on the personal satisfaction with life for dietitians. This study recruited a randomly selected, cross-sectional sample to complete a self-administered online survey. An exploratory factor analysis of was conducted for 479 participants resulting in a two-factor solution, clinical (α = 0.914) and wellness (α = 0.894) perceptions of health. An index score for the following valid and reliable scales were calculated: satisfaction with life, health conception, and healthy lifestyle and personal control. Pearson correlation coefficients between scores were analyzed to determine the degree of relationship. Potential mediators were explored with multiple regression. The relationships between variables were tested with structural equation modeling using a multigroup comparison between genders. The male participants were removed from the overall model and were separately evaluated. Health philosophy that is oriented toward wellness, was positively and significantly associated with life satisfaction, r (462) = 0.103, p < 0.05. Participants with higher Healthy Lifestyle and Personal Control scores reported greater life satisfaction, r (462) = 0.27, p = 0.000. Healthy lifestyle alone predicted 8.8% of the variance in life satisfaction ( R ² = 0.088, df 1462, p = 0.005). SEM confirmed the model had goodness-of-fit (χ² = 2.63, p = 0.453). The satisfaction with life of dietitians is directly and positively influenced by a greater wellness orientation and personal healthy lifestyle practices. The effect of practice and lifestyle on life satisfaction appears to be greater for men.

Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty.

PubMed

Collins, J; Longhurst, G; Roschel, H; Gualano, B

2016-01-01

Studies assessing the effects co-supplementation with creatine and protein, along with resistance training, in older individuals with frailty are lacking. This is an exploratory trial from the Pro-Elderly study ("Protein Intake and Resistance Training in Aging") aimed at gathering knowledge on the feasibility, safety, and efficacy of co-supplementation with creatine and protein supplementation, combined with resistance training, in older individuals with frailty. A 14-week, double-blind, randomized, parallel-group, placebo controlled exploratory trial. The subjects were randomly assigned to whey protein and creatine co-supplementation (WHEY+CR) or whey protein supplementation (WHEY) group. All subjects undertook a supervised exercise training program and were assessed at baseline and after 14 weeks. Muscle function, body composition, blood parameters, and self-reported adverse events were assessed. No interaction effects (between-group differences) were observed for any dependent variables (p > 0.05 for all). However, there were main time-effects in handgrip (WHEY+CR = 26.65 ± 31.29; WHEY = 13.84 ± 14.93 Kg; p = 0.0005), timed-up-and-go (WHEY+CR = -11.20 ± 9.37; WHEY = -17.76 ± 21.74 sec; p = 0.006), and timed-stands test (WHEY+CR = 47.50 ± 35.54; WHEY = 46.87 ± 24.23 reps; p = 0.0001), suggesting that WHEY+CR and WHEY were similarly effective in improving muscle function. All of the subjects showed improvements in at least two of the three functional tests, regardless of their treatments. Body composition and blood parameters were not changed (p > 0.05). No severe adverse effects were observed. Co-supplementation with creatine and whey protein was well-tolerable and free of adverse events in older subjects with frailty undertaking resistance training. Creatine supplementation did not augment the adaptive effects of resistance training along with whey protein on body composition or muscle function in this population. Clinicaltrials.gov: NCT01890382.

Safety and tolerability of the γ-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease.

PubMed

Coric, Vladimir; van Dyck, Christopher H; Salloway, Stephen; Andreasen, Niels; Brody, Mark; Richter, Ralph W; Soininen, Hilkka; Thein, Stephen; Shiovitz, Thomas; Pilcher, Gary; Colby, Susan; Rollin, Linda; Dockens, Randy; Pachai, Chahin; Portelius, Erik; Andreasson, Ulf; Blennow, Kaj; Soares, Holly; Albright, Charles; Feldman, Howard H; Berman, Robert M

2012-11-01

To assess the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of the -secretase inhibitor avagacestat in patients with mild to moderate Alzheimer disease (AD). Randomized, double-blind, placebo-controlled,24-week phase 2 study. Global, multicenter trial. A total of 209 outpatients with mild to moderate AD were randomized into the double-blind treatment phase. The median age of the patients was 75 years,58.9% were APOE ε4 carriers, and baseline measures of disease severity were similar among groups. Avagacestat, 25, 50, 100, or 125 mg daily,or placebo administered orally daily. Safety and tolerability of avagacestat. Discontinuation rates for the 25-mg and 50-mg doses of avagacestat were comparable with placebo but were higher in the 100-mg and 125-mg dose groups.Trends for worsening cognition, as measured by change from baseline Alzheimer Disease Assessment Scale cognitive subscale score, were observed in the 100-mg and125-mg dose groups. Treatment-emergent serious adverse events were similar across placebo and treatment groups. The most common reason for discontinuation was adverse events, predominantly gastrointestinal anddermatologic. Other adverse events occurring more frequentlyin patients undergoing treatment included reversibleglycosuria (without associated serum glucose changes), nonmelanoma skin cancer, and asymptomaticmagnetic resonance imaging findings. Exploratory cerebrospinal fluid amyloid isoforms and tau biomarker analysis demonstrated dose-dependent but not statistically significant reductions in a small subset of patients. Avagacestat dosed at 25 and 50 mg daily was relatively well tolerated and had low discontinuation rates. The 100-mg and 125-mg dose arms were poorly tolerated with trends for cognitive worsening. Exploratory cerebrospinal fluid biomarker substudies provide preliminary support for -secretase target engagement,but additional studies are warranted to better characterize pharmacodynamic effects at the 25- and 50-mg doses.This study establishes an acceptable safety and tolerability dose range for future avagacestat studies in AD. clinicaltrials.gov Identifier: NCT00810147

Nitric oxide synthase inhibition with the antipterin VAS203 improves outcome in moderate and severe traumatic brain injury: a placebo-controlled randomized Phase IIa trial (NOSTRA).

PubMed

Stover, John F; Belli, Antonio; Boret, Henry; Bulters, Diederik; Sahuquillo, Juan; Schmutzhard, Erich; Zavala, Elisabeth; Ungerstedt, Urban; Schinzel, Reinhard; Tegtmeier, Frank

2014-10-01

Traumatic brain injury (TBI) is an important cause of death and disability. Safety and pharmacodynamics of 4-amino-tetrahydrobiopterin (VAS203), a nitric oxide (NO)-synthase inhibitor, were assessed in TBI in an exploratory Phase IIa study (NOSynthase Inhibition in TRAumatic brain injury=NOSTRA). The study included 32 patients with TBI in six European centers. In a first open Cohort, eight patients received three 12-h intravenous infusions of VAS203 followed by a 12-h infusion-free interval over 3 days (total dose 15 mg/kg). Patients in Cohorts 2 and 3 (24) were randomized 2:1 to receive either VAS203 or placebo as an infusion for 48 or 72 h, respectively (total dose 20 and 30 mg/kg). Effects of VAS203 on intracranial pressure (ICP), cerebral perfusion pressure (CPP), brain metabolism using microdialysis, and the therapy intensity level (TIL) were end points. In addition, exploratory analysis of the extended Glasgow Outcome Score (eGOS) after 6 months was performed. Metabolites of VAS203 were detected in cerebral microdialysates. No significant differences between treatment and placebo groups were observed for ICP, CPP, and brain metabolism. TIL on day 6 was significantly decreased (p<0.04) in the VAS203 treated patients. The eGOS after 6 months was significantly higher in treated patients compared with placebo (p<0.01). VAS203 was not associated with hepatic, hematologic, or cardiac toxic effects. At the highest dose administered, four of eight patients receiving VAS203 showed transitory acute kidney injury (stage 2-3). In conclusion, the significant improvement in clinical outcome indicates VAS203-mediated neuroprotection after TBI. At the highest dose, VAS203 is associated with a risk of acute kidney injury.

The effects of video game therapy on balance and attention in chronic ambulatory traumatic brain injury: an exploratory study.

PubMed

Straudi, Sofia; Severini, Giacomo; Sabbagh Charabati, Amira; Pavarelli, Claudia; Gamberini, Giulia; Scotti, Anna; Basaglia, Nino

2017-05-10

Patients with traumatic brain injury often have balance and attentive disorders. Video game therapy (VGT) has been proposed as a new intervention to improve mobility and attention through a reward-learning approach. In this pilot randomized, controlled trial, we tested the effects of VGT, compared with a balance platform therapy (BPT), on balance, mobility and selective attention in chronic traumatic brain injury patients. We enrolled chronic traumatic brain injury patients (n = 21) that randomly received VGT or BPT for 3 sessions per week for 6 weeks. The clinical outcome measures included: i) the Community Balance & Mobility Scale (CB&M); ii) the Unified Balance Scale (UBS); iii) the Timed Up and Go test (TUG); iv) static balance and v) selective visual attention evaluation (Go/Nogo task). Both groups improved in CB&M scores, but only the VGT group increased on the UBS and TUG with a between-group significance (p < 0.05). Selective attention improved significantly in the VGT group (p < 0.01). Video game therapy is an option for the management of chronic traumatic brain injury patients to ameliorate balance and attention deficits. NCT01883830 , April 5 2013.

Emergence of Exploratory, Technical and Tactical Behavior in Small-Sided Soccer Games when Manipulating the Number of Teammates and Opponents.

PubMed

Torrents, Carlota; Ric, Angel; Hristovski, Robert; Torres-Ronda, Lorena; Vicente, Emili; Sampaio, Jaime

2016-01-01

The effects that different constraints have on the exploratory behavior, measured by the variety and quantity of different responses within a game situation, is of the utmost importance for successful performance in team sports. The aim of this study was to determine how the number of teammates and opponents affects the exploratory behavior of both professional and amateur players in small-sided soccer games. Twenty-two professional (age 25.6 ± 4.9 years) and 22 amateur (age 23.1 ± 0.7 years) male soccer players played three small-sided game formats (4 vs. 3, 4 vs. 5, and 4 vs. 7). These trials were video-recorded and a systematic observation instrument was used to notate the actions, which were subsequently analyzed by means of a principal component analysis and the dynamic overlap order parameter (measure to identify the rate and breadth of exploratory behavior on different time scales). Results revealed that a higher the number of opponents required for more frequent ball controls. Moreover, with a higher number of teammates, there were more defensive actions focused on protecting the goal, with more players balancing. In relation to attack, an increase in the number of opponents produced a decrease in passing, driving and controlling actions, while an increase in the number of teammates led to more time being spent in attacking situations. A numerical advantage led to less exploratory behavior, an effect that was especially clear when playing within a team of seven players against four opponents. All teams showed strong effects of the number of teammates on the exploratory behavior when comparing 5 vs 7 or 3 vs 7 teammates. These results seem to be independent of the players' level.

Impairment of exploratory behavior and spatial memory in adolescent rats in lithium-pilocarpine model of temporal lobe epilepsy.

PubMed

Kalemenev, S V; Zubareva, O E; Frolova, E V; Sizov, V V; Lavrentyeva, V V; Lukomskaya, N Ya; Kim, K Kh; Zaitsev, A V; Magazanik, L G

2015-01-01

Cognitive impairment in six-week -old rats has been studied in the lithium-pilocarpine model of adolescent temporal lobe epilepsy in humans. The pilocarpine-treated rats (n =21) exhibited (a) a decreased exploratory activity in comparison with control rats (n = 20) in the open field (OP) test and (b) a slower extinction of exploratory behavior in repeated OP tests. The Morris Water Maze (MWM) test showed that the effect of training was less pronounced in the pilocarpine-treated rats, which demonstrated disruption of predominantly short-term memory. Therefore, our study has shown that lithium-pilocarpine seizures induce substantial changes in exploratory behavior and spatial memory in adolescent rats. OP and MWM tests can be used in the search of drugs reducing cognitive impairments associated with temporal lobe epilepsy.

MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study.

PubMed

Fox, Robert J; Cree, Bruce A C; De Sèze, Jerome; Gold, Ralf; Hartung, Hans-Peter; Jeffery, Douglas; Kappos, Ludwig; Kaufman, Michael; Montalbán, Xavier; Weinstock-Guttman, Bianca; Anderson, Britt; Natarajan, Amy; Ticho, Barry; Duda, Petra

2014-04-29

RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, to switch to placebo, or to receive alternative immunomodulatory therapy (other therapies: IM interferon β-1a [IM IFN-β-1a], glatiramer acetate [GA], or methylprednisolone [MP]). During the 24-week randomized treatment period, patients underwent clinical and MRI assessments every 4 weeks. Patients (n = 175) were randomized to natalizumab (n = 45), placebo (n = 42), or other therapies (n = 88: IM IFN-β-1a, n = 17; GA, n = 17; MP, n = 54). Of 167 patients evaluable for efficacy, 49 (29%) had MRI disease activity recurrence: 0/45 (0%) natalizumab, 19/41 (46%) placebo, 1/14 (7%) IM IFN-β-1a, 8/15 (53%) GA, and 21/52 (40%) MP. Relapse occurred in 4% of natalizumab patients and in 15%-29% of patients in the other treatment arms. MRI disease activity recurred starting at 12 weeks (n = 3 at week 12) while relapses were reported as early as 4-8 weeks (n = 2 in weeks 4-8) after the last natalizumab dose. Overall, 50/167 patients (30%), all in placebo or other-therapies groups, restarted natalizumab early because of disease activity. MRI and clinical disease activity recurred in some patients during natalizumab interruption, despite use of other therapies. This study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for 1 year, stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab.

Evaluation of a Modified Version of the Posttraumatic Growth Inventory-Short Form

DTIC Science & Technology

2017-04-20

psychological well-being at a single time point. Methods: The study population (N = 135,843) was randomly and equally split into exploratory and confirmatory...with social support and personal mastery. Conclusions: The modified PTGI-SF in this study captures psychological well-being in cross-sectional...Keywords: Psychological well-being, Posttraumatic Growth Inventory, Military, Psychometrics Background Posttraumatic growth refers to the positive

"At Risk of Harm"? An Exploratory Survey of School Counsellors in the UK, Their Perceptions of Confidentiality, Information Sharing and Risk Management

ERIC Educational Resources Information Center

Jenkins, Peter; Palmer, Joanne

2012-01-01

The primary objective of this study was to explore perceptions of UK school counsellors of confidentiality and information sharing in therapeutic work with children and young people, using qualitative methods. The research design employed a two-stage process, using questionnaires and follow-up interviews, with a small, non-random sample of school…

Can Youth with Autism Spectrum Disorder Use Virtual Reality Driving Simulation Training to Evaluate and Improve Driving Performance? An Exploratory Study

ERIC Educational Resources Information Center

Cox, Daniel J.; Brown, Timothy; Ross, Veerle; Moncrief, Matthew; Schmitt, Rose; Gaffney, Gary; Reeve, Ron

2017-01-01

Investigate how novice drivers with autism spectrum disorder (ASD) differ from experienced drivers and whether virtual reality driving simulation training (VRDST) improves ASD driving performance. 51 novice ASD drivers (mean age 17.96 years, 78% male) were randomized to routine training (RT) or one of three types of VRDST (8-12 sessions). All…

An Intervention for HPV Risk Reduction Based on the Theory of Planned Behavior: An Exploratory Study with College-Aged Women

ERIC Educational Resources Information Center

Sweeney, Jocelyn Brineman; McAnulty, Richard D.; Reeve, Charlie; Cann, Arnie

2015-01-01

The goal of the study was to examine the effectiveness of a group intervention in reducing risks of contracting human papillomavirus (HPV) among college-aged women. Using a randomized design, the study examined the effectiveness of an HPV educational group intervention guided by the Theory of Planned Behavior. The intervention was provided in a…

Continuing Lipman's and Sharp's Pioneering Work on Philosophy for Children: Using "Harry" to Foster Critical Thinking in Hong Kong Students

ERIC Educational Resources Information Center

Lam, Chi-Ming

2012-01-01

This article reports the results of the first systematic, though only exploratory, study that assesses the effectiveness of the Philosophy for Children (commonly known as P4C) programme in promoting children's critical thinking in Hong Kong. Forty-two Secondary 1 students volunteered for this study, from whom 28 students were randomly selected and…

Organizational Citizenship Behavior at Catholic Institutions of Higher Education: Effects of Organizational Commitment, Interpersonal- and System-Level Trust

ERIC Educational Resources Information Center

Ball, Justin Ashby

2013-01-01

The purpose of this study was to conduct an exploratory investigation of OCB, trust, and commitment among faculty and staff within Catholic IHEs. Faculty and staff from two Catholic IHEs were the focus of the study. Twenty-five schools were randomly selected from the 50 largest Catholic IHEs by undergraduate enrollment, identified from the 2012…

Development of Attitudes towards Mathematics Scale (ATMS) Using Nigerian Data - Factor Analysis as a Determinant of Attitude Subcategories

ERIC Educational Resources Information Center

Zakariya, Yusuf F.

2017-01-01

This study was aimed at the development of an instrument for measuring students' attitudes towards mathematics. A survey research design was adopted involving 510 students randomly selected. Exploratory factor analysis (EFA) was carried out to determine the number of factors to be retained in the ATMS. The adequacy of the sample was confirmed by…

A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents

PubMed Central

Gray, Kevin M.; Carpenter, Matthew J.; Baker, Nathaniel L.; DeSantis, Stacia M.; Kryway, Elisabeth; Hartwell, Karen J.; McRae-Clark, Aimee L.; Brady, Kathleen T.

2012-01-01

Objective Preclinical findings suggest that the over-the-counter supplement N-acetylcysteine, via glutamate modulation in the nucleus accumbens, holds promise as a pharmacotherapy targeting substance dependence. We sought to investigate N-acetylcysteine as a novel cannabis cessation treatment in adolescents, a vulnerable group for whom existing treatments have limited efficacy. Method In this 8-week double-blind randomized placebo-controlled trial, treatment-seeking cannabis-dependent adolescents (age 15-21, N = 116) received N-acetylcysteine (1200 mg) or placebo twice daily, each added to a contingency management intervention and brief (≤10 minute) weekly cessation counseling. The primary efficacy measure was the odds of negative weekly urine cannabinoid tests during treatment among participants receiving N-acetylcysteine versus placebo, via intent-to-treat analysis. The primary tolerability measure was frequency of adverse events, compared by treatment group. Results N-acetylcysteine was well tolerated with minimal adverse events. N-acetylcysteine participants had more than twice the odds, compared to placebo participants, of submitting negative urine cannabinoid tests during treatment (odds ratio = 2.4, [95% CI: 1.1-5.2], p = 0.029). Exploratory secondary abstinence outcomes numerically favored N-acetylcysteine, but were not statistically significant. Conclusions This is the first randomized trial of pharmacotherapy for cannabis dependence in any age group yielding a positive primary cessation outcome via intent-to-treat analysis. Findings support N-acetylcysteine as a pharmacotherapy to complement psychosocial treatment for cannabis dependence in adolescents. Further research is needed to replicate these findings and explore the efficacy of N-acetylcysteine across a variety of treatment contexts and outcomes. Trial Registration clinicaltrials.gov identifier: NCT 01005810 PMID:22706327

Randomized trial of parent training to prevent adolescent problem behaviors during the high school transition.

PubMed

Mason, W Alex; Fleming, Charles B; Gross, Thomas J; Thompson, Ronald W; Parra, Gilbert R; Haggerty, Kevin P; Snyder, James J

2016-12-01

This randomized controlled trial tested a widely used general parent training program, Common Sense Parenting (CSP), with low-income 8th graders and their families to support a positive transition to high school. The program was tested in its original 6-session format and in a modified format (CSP-Plus), which added 2 sessions that included adolescents. Over 2 annual cohorts, 321 families were enrolled and randomly assigned to either the CSP, CSP-Plus, or minimal-contact control condition. Pretest, posttest, 1-year follow-up, and 2-year follow-up survey data on parenting as well as youth school bonding, social skills, and problem behaviors were collected from parents and youth (94% retention). Extending prior examinations of posttest outcomes, intent-to-treat regression analyses tested for intervention effects at the 2 follow-up assessments, and growth curve analyses examined experimental condition differences in yearly change across time. Separate exploratory tests of moderation by youth gender, youth conduct problems, and family economic hardship also were conducted. Out of 52 regression models predicting 1- and 2-year follow-up outcomes, only 2 out of 104 possible intervention effects were statistically significant. No statistically significant intervention effects were found in the growth curve analyses. Tests of moderation also showed few statistically significant effects. Because CSP already is in widespread use, findings have direct implications for practice. Specifically, findings suggest that the program may not be efficacious with parents of adolescents in a selective prevention context and may reveal the limits of brief, general parent training for achieving outcomes with parents of adolescents. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Prevalence of binge and loss of control eating among children and adolescents with overweight and obesity: An exploratory meta-analysis.

PubMed

He, Jinbo; Cai, Zhihui; Fan, Xitao

2017-02-01

Due to the inconsistency of the research findings in the current literature, the prevalence of binge and loss of control (LOC) eating among children and adolescents with overweight and obesity remains unclear. By using the meta-analytic approach, this article aimed at exploring the prevalence of binge/LOC eating among children and adolescents with overweight and obesity, and at identifying potential moderators, which may have contributed to the heterogeneity of the existing research findings. Four electronic databases (PubMed, Web of Science, EBSCOhost, and ProQuest Dissertations & Theses Global) were searched. The search period covered the research literature up to April 2016. A random-effects meta-analysis model was used to estimate the overall prevalence. Weighted random-effects model ANOVAs and univariate random-effects meta-regression were applied for the analysis of categorical moderators and continuous moderators, respectively. Thirty-six studies were identified. The overall prevalence of binge/LOC eating was estimated to be 26.3% (95% CI: 23.1-29.7%), with 22.2% (95% CI: 18.6-26.3%) and 31.2% (95% CI: 26.1-36.9%) for binge eating and LOC eating, respectively. Treatment status, binge eating vs. LOC eating and assessment methods appeared to be associated with the inconsistencies of the prevalence rates across the studies. The findings of this meta-analysis indicated that binge/LOC eating was prevalent among more than one quarter of children and adolescents with overweight and obesity. Considering the close relationship between disordered eating behaviors and obesity, future research concerning overweight and obesity among children and adolescents needs to take binge/LOC eating into consideration. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:91-103). © 2016 Wiley Periodicals, Inc.

Open-label placebo treatment in chronic low back pain: a randomized controlled trial

PubMed Central

Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J.; Kirsch, Irving

2016-01-01

Abstract This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland–Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (−0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (−1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain. PMID:27755279

Open-label placebo treatment in chronic low back pain: a randomized controlled trial.

PubMed

Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J; Kirsch, Irving

2016-12-01

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (-1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial.

PubMed

Klausen, Susanne Hwiid; Andersen, Lars L; Søndergaard, Lars; Jakobsen, Janus Christian; Zoffmann, Vibeke; Dideriksen, Kasper; Kruse, Anne; Mikkelsen, Ulla Ramer; Wetterslev, Jørn

2016-10-15

To assess benefit and harms of adding an eHealth intervention to health education and individual counseling in adolescents with congenital heart disease. Randomized clinical trial. Denmark. A total of 158 adolescents aged 13-16years with no physical activity restrictions after repaired complex congenital heart disease. PReVaiL consisted of individually tailored eHealth encouragement physical activity for 52weeks. All patients received 45min of group-based health education and 15min of individual counseling involving patients' parents. The primary outcome was maximal oxygen uptake (VO2 peak) at 52weeks after randomization. The secondary outcome was physical activity. Exploratory outcomes were generic and disease-specific questionnaires. In the intervention group, 58 patients (72%) completed the final test, but of those, only 46 (57%) fulfilled the compliance criteria of using the eHealth application for at least 2 consecutive weeks. In the control group, 61 patients (79%) completed both exercise tests. Adjusted for baseline values, the difference between the intervention group and the control group in mean VO2 peak at 1year was -0.65ml·kg(-1)·min(-1) (95% CI -2.66 to 1.36). Between-group differences at 1year in physical activity, generic health-related quality of life, and disease-specific quality of life were not statistically significant. Adding a tailored eHealth intervention to health education and individual counseling did not affect outcomes among adolescents with congenital heart disease. Our results do not support the use of this eHealth intervention in adolescents with complex congenital heart disease. Clinical trials.gov identifier: NCT01189981. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Disrupted subject-specific gray matter network properties and cognitive dysfunction in type 1 diabetes patients with and without proliferative retinopathy.

PubMed

van Duinkerken, Eelco; Ijzerman, Richard G; Klein, Martin; Moll, Annette C; Snoek, Frank J; Scheltens, Philip; Pouwels, Petra J W; Barkhof, Frederik; Diamant, Michaela; Tijms, Betty M

2016-03-01

Type 1 diabetes mellitus (T1DM) patients, especially with concomitant microvascular disease, such as proliferative retinopathy, have an increased risk of cognitive deficits. Local cortical gray matter volume reductions only partially explain these cognitive dysfunctions, possibly because volume reductions do not take into account the complex connectivity structure of the brain. This study aimed to identify gray matter network alterations in relation to cognition in T1DM. We investigated if subject-specific structural gray matter network properties, constructed from T1-weighted MRI scans, were different between T1DM patients with (n = 51) and without (n = 53) proliferative retinopathy versus controls (n = 49), and were associated to cognitive decrements and fractional anisotropy, as measured by voxel-based TBSS. Global normalized and local (45 bilateral anatomical regions) clustering coefficient and path length were assessed. These network properties measure how the organization of connections in a network differs from that of randomly connected networks. Global gray matter network topology was more randomly organized in both T1DM patient groups versus controls, with the largest effects seen in patients with proliferative retinopathy. Lower local path length values were widely distributed throughout the brain. Lower local clustering was observed in the middle frontal, postcentral, and occipital areas. Complex network topology explained up to 20% of the variance of cognitive decrements, beyond other predictors. Exploratory analyses showed that lower fractional anisotropy was associated with a more random gray matter network organization. T1DM and proliferative retinopathy affect cortical network organization that may consequently contribute to clinically relevant changes in cognitive functioning in these patients. © 2015 Wiley Periodicals, Inc.

Effect of Active Music Therapy and Individualized Listening to Music on Dementia: A Multicenter Randomized Controlled Trial.

PubMed

Raglio, Alfredo; Bellandi, Daniele; Baiardi, Paola; Gianotti, Marta; Ubezio, Maria Chiara; Zanacchi, Elisa; Granieri, Enrico; Imbriani, Marcello; Stramba-Badiale, Marco

2015-08-01

To assess the effects of active music therapy (MT) and individualized listening to music (LtM) on behavioral and psychological symptoms of dementia (BPSDs) in persons with dementia (PWDs). Randomized controlled trial. Nine Italian institutions. Persons with moderate to severe dementia and BPSDs (N = 120) were randomized to one of three treatments. All groups received standard care (SC), and two groups attended 20 individualized MT or LtM sessions, twice a week, in addition to SC. The Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Cornell-Brown Scale for Quality of Life in Dementia (CBS-QoL) were administered before treatment, after treatment, and at follow-up to evaluate behavioral and psychological outcomes. A specific coding scheme (Music Therapy Check List-Dementia) was used to evaluate the MT process. Behavioral assessment did not show significant differences between groups. All groups showed a reduction over time in NPI global score (P ≤ .001), CSDD (P = .001), and CBS-QoL (P = .01). The NPI global score fell 28% in the MT group, 12% in the LtM group, and 21% in the SC group at the end of treatment. An exploratory post hoc analysis showed similar within-group improvements for the NPI Delusion, Anxiety, and Disinhibition subscales. In the MT group, communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment. The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs. Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Trial design and rationale for APOLLO, a Phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy.

PubMed

Adams, David; Suhr, Ole B; Dyck, Peter J; Litchy, William J; Leahy, Raina G; Chen, Jihong; Gollob, Jared; Coelho, Teresa

2017-09-11

Patisiran is an investigational RNA interference (RNAi) therapeutic in development for the treatment of hereditary ATTR (hATTR) amyloidosis, a progressive disease associated with significant disability, morbidity, and mortality. Here we describe the rationale and design of the Phase 3 APOLLO study, a randomized, double-blind, placebo-controlled, global study to evaluate the efficacy and safety of patisiran in patients with hATTR amyloidosis with polyneuropathy. Eligible patients are 18-85 years old with hATTR amyloidosis, investigator-estimated survival of ≥2 years, Neuropathy Impairment Score (NIS) of 5-130, and polyneuropathy disability score ≤IIIb. Patients are randomized 2:1 to receive either intravenous patisiran 0.3 mg/kg or placebo once every 3 weeks. The primary objective is to determine the efficacy of patisiran at 18 months based on the difference in the change in modified NIS+7 (a composite measure of motor strength, sensation, reflexes, nerve conduction, and autonomic function) between the patisiran and placebo groups. Secondary objectives are to evaluate the effect of patisiran on Norfolk-Diabetic Neuropathy quality of life questionnaire score, nutritional status (as evaluated by modified body mass index), motor function (as measured by NIS-weakness and timed 10-m walk test), and autonomic symptoms (as measured by the Composite Autonomic Symptom Score-31 questionnaire). Exploratory objectives include assessment of cardiac function and pathologic evaluation to assess nerve fiber innervation and amyloid burden. Safety of patisiran will be assessed throughout the study. APOLLO represents the largest randomized, Phase 3 study to date in patients with hATTR amyloidosis, with endpoints that capture the multisystemic nature of this disease. This trial is registered at clinicaltrials.gov ( NCT01960348 ); October 9, 2013.

Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial

PubMed Central

Palermo, Tonya M.; Law, Emily F.; Fales, Jessica; Bromberg, Maggie H.; Jessen-Fiddick, Tricia; Tai, Gabrielle

2016-01-01

Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = −1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = −2.66, P = 0.007) and protective behaviors (b = −0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent’s pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families. PMID:26335910

A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.

PubMed

Gray, Kevin M; Sonne, Susan C; McClure, Erin A; Ghitza, Udi E; Matthews, Abigail G; McRae-Clark, Aimee L; Carroll, Kathleen M; Potter, Jennifer S; Wiest, Katharina; Mooney, Larissa J; Hasson, Albert; Walsh, Sharon L; Lofwall, Michelle R; Babalonis, Shanna; Lindblad, Robert W; Sparenborg, Steven; Wahle, Aimee; King, Jacqueline S; Baker, Nathaniel L; Tomko, Rachel L; Haynes, Louise F; Vandrey, Ryan G; Levin, Frances R

2017-08-01

Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults. In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six National Drug Abuse Treatment Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200mg (n=153) or placebo (n=149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants. There was not statistically significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio=1.00, 95% confidence interval 0.63-1.59, p=0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; exploratory analysis within medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group. In contrast with prior findings in adolescents, there is no evidence that NAC 1200mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors. Copyright © 2017 Elsevier B.V. All rights reserved.

Antisense oligonucleotide therapy rescues disruptions in organization of exploratory movements associated with Usher syndrome type 1C in mice.

PubMed

Donaldson, Tia N; Jennings, Kelsey T; Cherep, Lucia A; McNeela, Adam M; Depreux, Frederic F; Jodelka, Francine M; Hastings, Michelle L; Wallace, Douglas G

2018-02-15

Usher syndrome, Type 1C (USH1C) is an autosomal recessive inherited disorder in which a mutation in the gene encoding harmonin is associated with multi-sensory deficits (i.e., auditory, vestibular, and visual). USH1C (Usher) mice, engineered with a human USH1C mutation, exhibit these multi-sensory deficits by circling behavior and lack of response to sound. Administration of an antisense oligonucleotide (ASO) therapeutic that corrects expression of the mutated USH1C gene, has been shown to increase harmonin levels, reduce circling behavior, and improve vestibular and auditory function. The current study evaluates the organization of exploratory movements to assess spatial organization in Usher mice and determine the efficacy of ASO therapy in attenuating any such deficits. Usher and heterozygous mice received the therapeutic ASO, ASO-29, or a control, non-specific ASO treatment at postnatal day five. Organization of exploratory movements was assessed under dark and light conditions at two and six-months of age. Disruptions in exploratory movement organization observed in control-treated Usher mice were consistent with impaired use of self-movement and environmental cues. In general, ASO-29 treatment rescued organization of exploratory movements at two and six-month testing points. These observations are consistent with ASO-29 rescuing processing of multiple sources of information and demonstrate the potential of ASO therapies to ameliorate topographical disorientation associated with other genetic disorders. Copyright © 2017 Elsevier B.V. All rights reserved.

Insight into dementia care management using social-behavioral theory and mixed methods.

PubMed

Connor, Karen; McNeese-Smith, Donna; van Servellen, Gwen; Chang, Betty; Lee, Martin; Cheng, Eric; Hajar, Abdulrahman; Vickrey, Barbara G

2009-01-01

For health organizations (private and public) to advance their care-management programs, to use resources effectively and efficiently, and to improve patient outcomes, it is germane to isolate and quantify care-management activities and to identify overarching domains. The aims of this study were to identify and report on an application of mixed methods of qualitative statistical techniques, based on a theoretical framework, and to construct variables for factor analysis and exploratory factor analytic steps for identifying domains of dementia care management. Care-management activity data were extracted from the care plans of 181 pairs of individuals (with dementia and their informal caregivers) who had participated in the intervention arm of a randomized controlled trial of a dementia care-management program. Activities were organized into types, using card-sorting methods, influenced by published theoretical constructs on self-efficacy and general strain theory. These activity types were mapped in the initial data set to construct variables for exploratory factor analysis. Principal components extraction with varimax and promax rotations was used to estimate the number of factors. Cronbach's alpha was calculated for the items in each factor to assess internal consistency reliability. The two-phase card-sorting technique yielded 45 activity types out of 450 unique activities. Exploratory factor analysis produced four care-management domains (factors): behavior management, clinical strategies and caregiver support, community agency, and safety. Internal consistency reliability (Cronbach's alpha) of items for each factor ranged from.63 for the factor "safety" to.89 for the factor "behavior management" (Factor 1). Applying a systematic method to a large set of care-management activities can identify a parsimonious number of higher order categories of variables and factors to guide the understanding of dementia care-management processes. Further application of this methodology in outcome analyses and to other data sets is necessary to test its practicality.

Mobile Phone Apps for Preventing Cancer Through Educational and Behavioral Interventions: State of the Art and Remaining Challenges.

PubMed

Coughlin, Steven; Thind, Herpreet; Liu, Benyuan; Champagne, Nicole; Jacobs, Molly; Massey, Rachael I

2016-05-30

Rapid developments in technology have encouraged the use of mobile phones in smoking cessation, promoting healthy diet, nutrition, and physical activity, sun safety, and cancer screening. Although many apps relating to the prevention of cancer and other chronic diseases are available from major mobile phone platforms, relatively few have been tested in research studies to determine their efficacy. In this paper, we discuss issues related to the development and testing of new apps for preventing cancer through smoking cessation, sun safety, and other healthy behaviors, including key methodologic issues and outstanding challenges. An exploratory literature review was conducted using bibliographic searches in PubMed and CINAHL with relevant search terms (eg, smartphones, smoking cessation, cancer prevention, cancer screening, and carcinogens) to identify papers published in English through October 2015. Only 4 randomized controlled trials of the use of mobile phone apps for smoking cessation and 2 trials of apps for sun safety were identified, indicating that it is premature to conduct a systematic search and meta-analysis of the published literature on this topic. Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the cancer prevention and control capabilities of mobile phone apps. In developing new and refined apps for cancer prevention and control, both health literacy and eHealth literacy should be taken into account. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as smoking cessation, cancer screening, and sun safety. Mobile phone apps are likely to be a useful and low-cost intervention for preventing cancer through behavioral changes.

A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

PubMed

Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

2017-07-01

We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.

PubMed

Williams, Grant R; Nyrop, Kirsten A; Deal, Allison M; Muss, Hyman B; Sanoff, Hanna K

2015-05-01

Colorectal cancer (CRC) diagnosis and treatment can have substantial detrimental impacts on health related quality of life (HRQOL) and physical function. This is especially true for older CRC patients and is of paramount concern in chemotherapy treatment decision making; yet, few studies to date have focused on understanding and managing fatigue in older CRC patients. We present the design of a study to evaluate the feasibility and impact of a home-based, self-directed physical activity intervention on fatigue in older CRC patients receiving adjuvant chemotherapy treatment. Secondary aims pertain to intervention impact on HRQOL, physical function, and self-efficacy for managing fatigue. Multi-site, randomized controlled trial of physical activity intervention compared to usual care in a sample of older adults undergoing adjuvant chemotherapy for CRC. Forty CRC patients will be recruited and study questionnaires/assessments will be performed at baseline, 3 months, and after completion of adjuvant chemotherapy. The primary outcome is a comparison of the change in fatigue from baseline to 3 months between Intervention and Control arms. We will also compare changes in engagement in physical activity, HRQOL, physical function, and self-efficacy. Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). If positive, findings from this pilot study would suggest the potential for improving the care of older persons with CRC undergoing adjuvant chemotherapy through a home-based physical activity intervention to manage fatigue, HRQOL, and physical function. NCT02191969. Copyright © 2015 Elsevier Inc. All rights reserved.

Learning and Developing Individual Exercise Skills (L.A.D.I.E.S.) for a Better Life: a physical activity intervention for black women

PubMed Central

Goldmon, Moses V.; Karanja, Njeri; Heil, Daniel P.; Gizlice, Ziya

2012-01-01

Physical activity (PA) is low among African American women despite awareness of its positive impact on health. Learning and Developing Individual Exercise Skills for a Better Life (L.A.D.I.E.S.) compares three strategies for increasing PA among African American women using a cluster randomized, controlled trial. Underactive adult women from 30 churches (n=15 participants/church) were recruited. Churches were randomized to a faith-based intervention, a non-faith based intervention, or an information only control group. Intervention groups will meet 25 times in group sessions with other women from their church over a 10-month period. Control group participants will receive standard educational material promoting PA. All participants will be followed for an additional 12 months to assess PA maintenance. Data will be collected at baseline, 10, and 22 months. The primary outcome is PA (steps/day, daily moderate-to-vigorous PA). We expect treatment effects indicating that assignment to either of the active interventions is associated with greater magnitude of change in PA compared to the control group. In exploratory analyses, we will test whether changes in the faith-based intervention group are greater than changes in the non-faith-based intervention group. L.A.D.I.E.S. focuses on a significant issue—increasing PA levels—in a segment of the population most in need of successful strategies for improving health. If successful, L.A.D.I.E.S. will advance the field by providing an approach that is successful for initiating and sustaining change in physical activity, which has been shown to be a primary risk factor for a variety of health outcomes, using churches as the point of delivery. PMID:22917598

Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial.

PubMed

Lewinson, Ryan T; Vallerand, Isabelle A; Collins, Kelsey H; Wiley, J Preston; Lun, Victor M Y; Patel, Chirag; Woodhouse, Linda J; Reimer, Raylene A; Worobets, Jay T; Herzog, Walter; Stefanyshyn, Darren J

2016-10-01

Wedged insoles are believed to be of clinical benefit to individuals with knee osteoarthritis by reducing the knee adduction moment (KAM) during gait. However, previous clinical trials have not specifically controlled for KAM reduction at baseline, thus it is unknown if reduced KAMs actually confer a clinical benefit. Forty-eight participants with medial knee osteoarthritis were randomly assigned to either a control group where no footwear intervention was given, or a wedged insole group where KAM reduction was confirmed at baseline. KAMs, Knee Injury and Osteoarthritis Outcome Score (KOOS) and Physical Activity Scale for the Elderly (PASE) scores were measured at baseline. KOOS and PASE surveys were re-administered at three months follow-up. The wedged insole group did not experience a statistically significant or clinically meaningful change in KOOS pain over three months (p=0.173). Furthermore, there was no association between change in KAM magnitude and change in KOOS pain over three months within the wedged insole group (R 2 =0.02, p=0.595). Improvement in KOOS pain for the wedged insole group was associated with worse baseline pain, and a change in PASE score over the three month study (R 2 =0.57, p=0.007). As an exploratory comparison, there was no significant difference in change in KOOS pain (p=0.49) between the insole and control group over three months. These results suggest that reduced KAMs do not appear to provide any clinical benefit compared to no intervention over a follow-up period of three months. ClinicalTrials.gov ID Number: NCT02067208. Copyright © 2016 Elsevier B.V. All rights reserved.

Mobile Phone Apps for Preventing Cancer Through Educational and Behavioral Interventions: State of the Art and Remaining Challenges

PubMed Central

Champagne, Nicole; Jacobs, Molly; Massey, Rachael I

2016-01-01

Background Rapid developments in technology have encouraged the use of mobile phones in smoking cessation, promoting healthy diet, nutrition, and physical activity, sun safety, and cancer screening. Although many apps relating to the prevention of cancer and other chronic diseases are available from major mobile phone platforms, relatively few have been tested in research studies to determine their efficacy. Objective In this paper, we discuss issues related to the development and testing of new apps for preventing cancer through smoking cessation, sun safety, and other healthy behaviors, including key methodologic issues and outstanding challenges. Methods An exploratory literature review was conducted using bibliographic searches in PubMed and CINAHL with relevant search terms (eg, smartphones, smoking cessation, cancer prevention, cancer screening, and carcinogens) to identify papers published in English through October 2015. Results Only 4 randomized controlled trials of the use of mobile phone apps for smoking cessation and 2 trials of apps for sun safety were identified, indicating that it is premature to conduct a systematic search and meta-analysis of the published literature on this topic. Conclusions Future studies should utilize randomized controlled trial research designs, larger sample sizes, and longer study periods to better establish the cancer prevention and control capabilities of mobile phone apps. In developing new and refined apps for cancer prevention and control, both health literacy and eHealth literacy should be taken into account. There is a need for culturally appropriate, tailored health messages to increase knowledge and awareness of health behaviors such as smoking cessation, cancer screening, and sun safety. Mobile phone apps are likely to be a useful and low-cost intervention for preventing cancer through behavioral changes. PMID:27242162

Listening to a patient: An exploratory experimental investigation into the effects of vocalization and therapist gender on interpreting clinical material.

PubMed

Dauphin, Barry; Halverson, Stacey; Pouliot, Sarah; Slowik, Linda

2018-01-01

Carefully listening to the patient is of paramount importance for psychoanalysis and psychoanalytic psychotherapy. The present study explored whether patient vocalization as well as the gender of the analyst play significant roles in clinical listening. Fifty-one psychoanalysts and psychoanalytic therapists were randomly assigned to listen to one of two dramatized psychoanalytic sessions. The content of the sessions was the same for both versions, but the sessions were dramatized differently. Some differences emerged between the versions, especially on ratings of reality testing, impulse control, pressured speech, patient was confusing, and awareness of imagery. Furthermore, differences emerged between male and female analysts in terms of ratings of intervention strategies and countertransference reactions to the patient material. Session version and gender affect different ratings. Implications of the findings are discussed as is the utility of using more ecologically valid material in conducting empirical research into clinical judgment.

Understanding Physical Activity Motivation and Behaviour Through Self-Determination and Servant Leadership Theories in a Feasibility Study.

PubMed

Gray, Samantha M; Wharf Higgins, Joan; Rhodes, Ryan E

2017-09-27

Despite its well-established benefits, physical activity (PA) engagement is low in the adult population; evidence suggests that this is especially a concern for women > 60 years. The purpose of this mixed methods study was to explore the feasibility of a six-week randomized control trial of Self-Determination Theory-based dance and walking programs for older women. Primary outcomes were feasibility measures: recruitment, retention, and satisfaction. Secondary outcomes included self-reported PA, behavioural regulations, and psychological needs. Thirty-five women completed the study (M = 62.8 ± 4.8 years), representing 39% recruitment and 95% retention rate. Both programs were highly attended. Exploratory effect sizes for secondary measures were promising. Emergent themes highlighted the importance of servant leadership concepts in the group setting for motivating PA. Our findings provide support for expanding this trial to a full-scale study.

Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards.

PubMed

Mercincavage, Melissa; Wileyto, E Paul; Saddleson, Megan L; Lochbuehler, Kirsten; Donny, Eric C; Strasser, Andrew A

2017-06-01

To determine (1) if nicotine content affects study attrition-a potential behavioral measure of acceptability-in a trial that required compliance with three levels of reduced nicotine content (RNC) cigarettes, and (2) if attrition is associated with subjective and behavioral responses to RNC cigarettes. Secondary analysis of a 35-day, parallel-design, open-label, randomized controlled trial. After a 5-day baseline period, participants were randomized to smoke for three 10-day periods: their preferred brand (control group) or RNC cigarettes with three nicotine levels in a within-subject stepdown (one group: high-moderate-low) or non-stepdown (five groups: high-low-moderate, low-moderate-high, low-high-moderate, moderate-low-high, moderate-high-low) fashion. A single site in Philadelphia, PA, USA. A total of 246 non-treatment-seeking daily smokers [mean age = 39.52, cigarettes per day (CPD) = 20.95, 68.3% white] were recruited from October 2007 to June 2013. The primary outcome was attrition. Key predictors were nicotine content transition and study period. Exploratory predictors were taste and strength subjective ratings, total puff volume and carbon monoxide (CO) boost. Covariates included: age, gender, race, education and nicotine dependence. Overall attrition was 31.3% (n = 77): 24.1% of the control and 25.0% of the stepdown RNC cigarette groups dropped out versus 44.6% of non-stepdown groups (P = 0.006). Compared with controls, attrition odds were 4.5 and 4.7 times greater among smokers transitioning from preferred and the highest RNC cigarettes to the lowest RNC cigarettes, respectively (P = 0.001 and 0.003). Providing more favorable initial taste ratings of study cigarettes decreased attrition odds by 2% (P = 0.012). The majority of participants completed a 35-day trial of varying levels of reduced nicotine content cigarettes. Participant dropout was greater for cigarettes with lower nicotine content and less in smokers reporting more favorable subjective ratings of the cigarettes. © 2017 Society for the Study of Addiction.

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial.

PubMed

Bartunek, Jozef; Terzic, Andre; Davison, Beth A; Filippatos, Gerasimos S; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L; Shochat, Michael K; Kasprzak, Jaroslaw D; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A; Teerlink, John R; Gersh, Bernard J; Povsic, Thomas J; Henry, Timothy D; Metra, Marco; Hajjar, Roger J; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-03-01

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370 mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Randomized Phase II, Double-Blind, Placebo-Controlled Study of Exemestane With or Without Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Treatment With a Nonsteroidal Aromatase Inhibitor

PubMed Central

Yardley, Denise A.; Ismail-Khan, Roohi R.; Melichar, Bohuslav; Lichinitser, Mikhail; Munster, Pamela N.; Klein, Pamela M.; Cruickshank, Scott; Miller, Kathy D.; Lee, Min J.; Trepel, Jane B

2013-01-01

Purpose Entinostat is an oral isoform selective histone deacetylase inhibitor that targets resistance to hormonal therapies in estrogen receptor–positive (ER+) breast cancer. This randomized, placebo-controlled, phase II study evaluated entinostat combined with the aromatase inhibitor exemestane versus exemestane alone. Patients and Methods Postmenopausal women with ER+ advanced breast cancer progressing on a nonsteroidal aromatase inhibitor were randomly assigned to exemestane 25 mg daily plus entinostat 5 mg once per week (EE) or exemestane plus placebo (EP). The primary end point was progression-free survival (PFS). Blood was collected in a subset of patients for evaluation of protein lysine acetylation as a biomarker of entinostat activity. Results One hundred thirty patients were randomly assigned (EE group, n = 64; EP group, n = 66). Based on intent-to-treat analysis, treatment with EE improved median PFS to 4.3 months versus 2.3 months with EP (hazard ratio [HR], 0.73; 95% CI, 0.50 to 1.07; one-sided P = .055; two-sided P = .11 [predefined significance level of .10, one-sided]). Median overall survival was an exploratory end point and improved to 28.1 months with EE versus 19.8 months with EP (HR, 0.59; 95% CI, 0.36 to 0.97; P = .036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities. Treatment discontinuation because of adverse events was higher in the EE group versus the EP group (11% v 2%). Protein lysine hyperacetylation in the EE biomarker subset was associated with prolonged PFS. Conclusion Entinostat added to exemestane is generally well tolerated and demonstrated activity in patients with ER+ advanced breast cancer in this signal-finding phase II study. Acetylation changes may provide an opportunity to maximize clinical benefit with entinostat. Plans for a confirmatory study are underway. PMID:23650416

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

PubMed Central

Bartunek, Jozef; Terzic, Andre; Davison, Beth A.; Filippatos, Gerasimos S.; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G.; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M.; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L.; Shochat, Michael K.; Kasprzak, Jaroslaw D.; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R.; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A.; Teerlink, John R.; Gersh, Bernard J.; Povsic, Thomas J.; Henry, Timothy D.; Metra, Marco; Hajjar, Roger J.; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

2017-01-01

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. PMID:28025189

Hypothesis testing in hydrology: Theory and practice

NASA Astrophysics Data System (ADS)

Kirchner, James; Pfister, Laurent

2017-04-01

Well-posed hypothesis tests have spurred major advances in hydrological theory. However, a random sample of recent research papers suggests that in hydrology, as in other fields, hypothesis formulation and testing rarely correspond to the idealized model of the scientific method. Practices such as "p-hacking" or "HARKing" (Hypothesizing After the Results are Known) are major obstacles to more rigorous hypothesis testing in hydrology, along with the well-known problem of confirmation bias - the tendency to value and trust confirmations more than refutations - among both researchers and reviewers. Hypothesis testing is not the only recipe for scientific progress, however: exploratory research, driven by innovations in measurement and observation, has also underlain many key advances. Further improvements in observation and measurement will be vital to both exploratory research and hypothesis testing, and thus to advancing the science of hydrology.

Supplementation of omega 3 fatty acids may improve hyperactivity, lethargy, and stereotypy in children with autism spectrum disorders: a meta-analysis of randomized controlled trials

PubMed Central

Cheng, Yu-Shian; Tseng, Ping-Tao; Chen, Yen-Wen; Stubbs, Brendon; Yang, Wei-Chieh; Chen, Tien-Yu; Wu, Ching-Kuan; Lin, Pao-Yen

2017-01-01

Aim Deficiency of omega 3 fatty acids may be linked to autism spectrum disorder (ASD). Evidence about the potential therapeutic effects of supplementation of omega 3 fatty acids is lacking in ASD patients. Methods We searched major electronic databases from inception to June 21, 2017, for randomized clinical trials, which compared treatment outcomes between supplementation of omega 3 fatty acids and placebo in patients with ASD. An exploratory random-effects meta-analysis of the included studies was undertaken. Results and conclusion Six trials were included (n=194). Meta-analysis showed that supplementation of omega 3 fatty acids improved hyperactivity (difference in means =−2.692, 95% confidence interval [CI] =−5.364 to −0.020, P=0.048, studies =4, n=109), lethargy (difference in means =−1.969, 95% CI =−3.566 to −0.372, P=0.016, studies =4, n=109), and stereotypy (difference in means =−1.071, 95% CI =−2.114 to −0.029, P=0.044, studies =4, n=109). No significant differences emerged between supplementation of omega 3 fatty acids and placebo in global assessment of functioning (n=169) or social responsiveness (n=97). Our preliminary meta-analysis suggests that supplementation of omega 3 fatty acids may improve hyperactivity, lethargy, and stereotypy in ASD patients. However, the number of studies was limited and the overall effects were small, precluding definitive conclusions. Future large-scale randomized clinical trials are needed to confirm or refute our findings. PMID:29042783

Adolescent chronic variable social stress influences exploratory behavior and nicotine responses in male, but not female, BALB/cJ mice.

PubMed

Caruso, M J; Reiss, D E; Caulfield, J I; Thomas, J L; Baker, A N; Cavigelli, S A; Kamens, H M

2018-04-01

Anxiety disorders and nicotine use are significant contributors to global morbidity and mortality as independent and comorbid diseases. Early-life stress, potentially via stress-induced hypothalamic-pituitary-adrenal axis (HPA) dysregulation, can exacerbate both. However, little is known about the factors that predispose individuals to the development of both anxiety disorders and nicotine use. Here, we examined the relationship between anxiety-like behaviors and nicotine responses following adolescent stress. Adolescent male and female BALB/cJ mice were exposed to either chronic variable social stress (CVSS) or control conditions. CVSS consisted of repeated cycles of social isolation and social reorganization. In adulthood, anxiety-like behavior and social avoidance were measured using the elevated plus-maze (EPM) and social approach-avoidance test, respectively. Nicotine responses were assessed with acute effects on body temperature, corticosterone production, locomotor activity, and voluntary oral nicotine consumption. Adolescent stress had sex-dependent effects on nicotine responses and exploratory behavior, but did not affect anxiety-like behavior or social avoidance in males or females. Adult CVSS males exhibited less exploratory behavior, as indicated by reduced exploratory locomotion in the EPM and social approach-avoidance test, compared to controls. Adolescent stress did not affect nicotine-induced hypothermia in either sex, but CVSS males exhibited augmented nicotine-induced locomotion during late adolescence and voluntarily consumed less nicotine during adulthood. Stress effects on male nicotine-induced locomotion were associated with individual differences in exploratory locomotion in the EPM and social approach-avoidance test. Relative to controls, adult CVSS males and females also exhibited reduced corticosterone levels at baseline and adult male CVSS mice exhibited increased corticosterone levels following an acute nicotine injection. Results suggest that the altered nicotine responses observed in CVSS males may be associated with HPA dysregulation. Taken together, adolescent social stress influences later-life nicotine responses and exploratory behavior. However, there is little evidence of an association between nicotine responses and prototypical anxiety-like behavior or social avoidance in BALB/cJ mice. Copyright © 2017 Elsevier Inc. All rights reserved.

Influence of Music Therapy on Coping Skills and Anger Management in Forensic Psychiatric Patients: An Exploratory Study.

PubMed

Hakvoort, Laurien; Bogaerts, Stefan; Thaut, Michael H; Spreen, Marinus

2015-07-01

The effect of music therapy on anger management and coping skills is an innovative subject in the field of forensic psychiatry. This study explores the following research question: Can music therapy treatment contribute to positive changes in coping skills, anger management, and dysfunctional behavior of forensic psychiatric patients? To investigate this question, first a literature review is offered on music therapy and anger management in forensic psychiatry. Then, an explorative study is presented. In the study, a pre- and post-test design was used with a random assignment of patients to either treatment or control condition. Fourteen participants' complete datasets were collected. All participants received "treatment as usual." Nine of the participants received a standardized, music therapy anger management program; the five controls received, unplanned, an aggression management program. Results suggested that anger management skills improved for all participants. The improvement of positive coping skills and diminishing of avoidance as a coping skill were measured to show greater changes in music therapy participants. When controlling for the exact number of treatment hours, the outcomes suggested that music therapy might accelerate the process of behavioral changes. © The Author(s) 2013.

Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 2).

PubMed

Sufi, Farzana; Hall, Claire; Mason, Stephen; Shaw, David; Milleman, Jeffery; Milleman, Kimberly

2016-04-01

To compare the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) with that of control toothpastes containing no known anti-sensitivity ingredients. This was the second of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to one of four study treatments: the experimental toothpaste containing 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties; an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS; or one of two commercially available fluoride toothpastes as controls. Subjects were instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality of life measure for DH). A total of 137 subjects were included in the efficacy analysis. The experimental 5% CSPS toothpaste demonstrated statistically significant reductions from baseline in sensitivity at Week 4 and Week 8 for each clinical measure (all P< 0.01). It also demonstrated significantly greater improvements in DH compared with the two control toothpastes for the majority of clinical measures at Week 4 (P ≤ 0.01) and for all clinical measures at Week 8 (all P < 0.01). The abrasivity-matched 0% CSPS toothpaste was associated with similar outcomes to the 5% CSPS toothpaste. The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Strong correlations with DHEQ outcomes were only observed for the subjects' sensitivity rating in response to evaporative (air) stimuli at Week 8. Study treatments were well tolerated.

Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial.

PubMed

Kötter, Thomas; Niebuhr, Frank

2016-01-01

The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students. We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item), anxiety and depression (measured by the hospital anxiety and depression scale), as well as medical school stress (measured by the perceived medical school stress instrument). In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis. We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on the development of perceived medical school stress. However, we could not differentiate between the effects of group coaching only and group coaching in combination with two sessions of individual coaching. The health of medical students deteriorated while preparing for an examination. Short-term resource-oriented coaching might be an effective means of reducing medical school stress in candidates preparing for an examination.

Effects of exercise with or without blueberries in the diet on cardio-metabolic risk factors: An exploratory pilot study in healthy subjects

PubMed Central

Nyberg, Sofia; Gerring, Edvard; Gjellan, Solveig; Vergara, Marta; Lindström, Torbjörn

2013-01-01

Background. The improvement of insulin sensitivity by exercise has been shown to be inhibited by supplementation of vitamins acting as antioxidants. Objective. To examine effects of exercise with or without blueberries, containing natural antioxidants, on cardio-metabolic risk factors. Methods. Fifteen healthy men and 17 women, 27.6 ± 6.5 years old, were recruited, and 26 completed a randomized cross-over trial with 4 weeks of exercise by running/jogging 5 km five times/week and 4 weeks of minimal physical activity. Participants were also randomized to consume 150 g of blueberries, or not, on exercise days. Laboratory variables were measured before and after a 5 km running-race at maximal speed at the beginning and end of each period, i.e. there were four maximal running-races and eight samplings in total for each participant. Results. Insulin and triglyceride levels were reduced while HDL-cholesterol increased by exercise compared with minimal physical activity. Participants randomized to consume blueberries showed an increase in fasting glucose levels compared with controls, during the exercise period (blueberries: from 5.12 ± 0.49 mmol/l to 5.32 ± 0.29 mmol/l; controls: from 5.24 ± 0.27 mmol/l to 5.17 ± 0.23 mmol/l, P = 0.04 for difference in change). Triglyceride levels fell in the control group (from 1.1 ± 0.49 mmol/l to 0.93 ± 0.31 mmol/l, P = 0.02), while HDL-cholesterol increased in the blueberry group (from 1.51 ± 0.29 mmol/l to 1.64 ± 0.33 mmol/l, P = 0.006). Conclusions. Ingestion of blueberries induced differential effects on cardio-metabolic risk factors, including increased levels of both fasting glucose and HDL-cholesterol. However, since it is possible that indirect effects on food intake were induced, other than consumption of blueberries, further studies are needed to confirm the findings. PMID:23977864

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial.

PubMed

Johannsen, M; O'Toole, M S; O'Connor, M; Jensen, A B; Zachariae, R

2017-02-01

Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain. A total of 129 women treated for breast cancer reporting persistent pain were randomized to MBCT or a wait-list control. The primary outcome of pain intensity (11-point numeric rating scale) was measured at baseline, post-intervention, three, and six months follow-up. Proposed clinical moderators included age, axillary lymph node dissection (ALND), radiotherapy, and endocrine treatment. Psychological moderators included psychological distress [the Hospital Anxiety and Depression Scale (HADS)], the adult attachment dimensions anxiety and avoidance [the Experiences in Close Relationships Short Form (the ECR-SF)], and alexithymia [the Toronto Alexithymia Scale (TAS-20)]. Multi-level models were used to test moderation effects over time, i.e. time × group × moderator. Only attachment avoidance (p = 0.03, d = 0.36) emerged as a statistically significant moderator. Higher levels of attachment avoidance predicted a larger effect of MBCT in reducing pain intensity compared with lower levels attachment avoidance. None of the remaining psychological or clinical moderators reached statistical significance. However, based on the effect size, radiotherapy (p = 0.075, d = 0.49) was indicated as a possible clinical moderator of the effect, with radiotherapy being associated with a smaller effect of MBCT on pain intensity over time compared with no radiotherapy. Attachment avoidance, and potentially radiotherapy, may be clinically relevant factors for identifying the patients who may benefit most from MBCT as a pain intervention. Due to the exploratory nature of the analyses, the results should be considered preliminary.

Effects of exercise with or without blueberries in the diet on cardio-metabolic risk factors: an exploratory pilot study in healthy subjects.

PubMed

Nyberg, Sofia; Gerring, Edvard; Gjellan, Solveig; Vergara, Marta; Lindström, Torbjörn; Nystrom, Fredrik H

2013-11-01

The improvement of insulin sensitivity by exercise has been shown to be inhibited by supplementation of vitamins acting as antioxidants. To examine effects of exercise with or without blueberries, containing natural antioxidants, on cardio-metabolic risk factors. Fifteen healthy men and 17 women, 27.6 ± 6.5 years old, were recruited, and 26 completed a randomized cross-over trial with 4 weeks of exercise by running/jogging 5 km five times/week and 4 weeks of minimal physical activity. Participants were also randomized to consume 150 g of blueberries, or not, on exercise days. Laboratory variables were measured before and after a 5 km running-race at maximal speed at the beginning and end of each period, i.e. there were four maximal running-races and eight samplings in total for each participant. Insulin and triglyceride levels were reduced while HDL-cholesterol increased by exercise compared with minimal physical activity. Participants randomized to consume blueberries showed an increase in fasting glucose levels compared with controls, during the exercise period (blueberries: from 5.12 ± 0.49 mmol/l to 5.32 ± 0.29 mmol/l; controls: from 5.24 ± 0.27 mmol/l to 5.17 ± 0.23 mmol/l, P = 0.04 for difference in change). Triglyceride levels fell in the control group (from 1.1 ± 0.49 mmol/l to 0.93 ± 0.31 mmol/l, P = 0.02), while HDL-cholesterol increased in the blueberry group (from 1.51 ± 0.29 mmol/l to 1.64 ± 0.33 mmol/l, P = 0.006). Ingestion of blueberries induced differential effects on cardio-metabolic risk factors, including increased levels of both fasting glucose and HDL-cholesterol. However, since it is possible that indirect effects on food intake were induced, other than consumption of blueberries, further studies are needed to confirm the findings.

Double-blind, Randomized, 8-week Placebo-controlled followed by a 16-week open label extension study, with the LPA1 receptor antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis.

PubMed

Allanore, Yannick; Distler, Oliver; Jagerschmidt, Alexandre; Illiano, Stephane; Ledein, Laetitia; Boitier, Eric; Agueusop, Inoncent; Denton, Christopher P; Khanna, Dinesh

2018-05-06

Preclinical studies suggest a role for lysophosphatidic acid (LPA) in the pathogenesis of systemic sclerosis (SSc). SAR100842, a potent selective oral antagonist of LPA1 receptor, was assessed for safety, biomarkers and clinical efficacy in patients with diffuse cutaneous SSc (dcSSc). An 8-week double-blind, randomized, placebo-controlled study followed by a 16-week open label extension with SAR100842 was performed in patients with early dcSSc and a baseline Rodnan skin score (mRSS) of at least 15. The primary endpoint was safety during the double-blind phase of the trial. Exploratory endpoints included the identification of a LPA-induced gene signature in patients 'skin. 17 of 32 subjects were randomized to placebo and 15 to SAR100842; 30 patients participated in the extension study. The most frequent adverse events reported for SAR100842 during the blinded phase were headache, diarrhea, nausea and fall and the safety profile was acceptable during the extension part. At Week 8, mean reduction in mRSS was numerically greater in the SAR100842 compared to placebo (mean change [SD]: -3.57 [4.18] versus -2.76 [4.85]; difference [95% CI]: -1.2 [-4.37 to 2.02], p=0.46). A greater reduction of LPA related genes was observed in skin of SAR100842 group at Week 8, indicating LPA 1 target engagement. SAR100842, a selective orally available LPA 1 receptor antagonist, was well tolerated in patients with dcSSc. MRSS improved during the study although not reaching significance, and additional gene signature analysis suggested target engagement. These results need to be confirmed in a larger controlled trial. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

PubMed

Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian

2016-03-01

Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial.

PubMed

Raz, Itamar; Ziegler, Anette G; Linn, Thomas; Schernthaner, Guntram; Bonnici, Francois; Distiller, Larry A; Giordano, Carla; Giorgino, Francesco; de Vries, Liat; Mauricio, Didac; Procházka, Vlastimil; Wainstein, Julio; Elias, Dana; Avron, Ann; Tamir, Merana; Eren, Rachel; Peled, Dana; Dagan, Shlomo; Cohen, Irun R; Pozzilli, Paolo

2014-01-01

To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients. DIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16-45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA1c ≤7% (≤53 mmol/mol). Partial remission (target HbA1c on insulin ≤0.5 units/kg/day) and hypoglycemic event rate were exploratory end points. DiaPep277 was safe and well tolerated. Significant preservation of C-peptide secretion was observed in the DiaPep277-treated group compared with the placebo (relative treatment effects of 23.4%, P = 0.037, and 29.2%, P = 0.011, in the modified intent-to-treat [mITT] and per-protocol [PP] populations, respectively). The mixed-meal stimulation failed to distinguish between the groups. There was a trend toward efficacy in fasting C-peptide levels, though not statistically significant. Significantly more DiaPep277-treated than placebo-treated patients maintained target HbA1c (mITT 56% versus 44%, P = 0.03; PP 60% versus 45%, P = 0.0082) and entered partial remission (mITT 38% versus 29%, P = 0.08; PP 42% versus 30%, P = 0.035). DiaPep277 treatment reduced the relative hypoglycemic event risk (mITT by 20%; PP by 28%). DiaPep277 safely contributes to preservation of β-cell function and to improved glycemic control in patients with type 1 diabetes.

Development and validation of measures to assess prevention and control of AMR in hospitals.

PubMed

Flanagan, Mindy; Ramanujam, Rangaraj; Sutherland, Jason; Vaughn, Thomas; Diekema, Daniel; Doebbeling, Bradley N

2007-06-01

The rapid spread of antimicrobial resistance (AMR) in the US hospitals poses serious quality and safety problems. Expert panels, identifying strategies for optimizing antibiotic use and preventing AMR spread, have recommended hospitals undertake efforts to implement specific evidence-based practices. To develop and validate a measurement scale for assessing hospitals' efforts to implement recommended AMR prevention and control measures. Surveys were mailed to infection control professionals in a national sample of 670 US hospitals stratified by geographic region, bedsize, teaching status, and VA affiliation. : Four hundred forty-eight infection control professionals participated (67% response rate). Survey items measured implementation of guideline recommendations, practices for AMR monitoring and feedback, AMR-related outcomes (methicillin-resistant Staphylococcus aureus prevalence and outbreaks [MRSA]), and organizational features. "Derivation" and "validation" samples were randomly selected. Exploratory factor analysis was performed to identify factors underlying AMR prevention and control efforts. Multiple methods were used for validation. We identified 4 empirically distinct factors in AMR prevention and control: (1) practices for antimicrobial prescription/use, (2) information/resources for AMR control, (3) practices for isolating infected patients, and (4) organizational support for infection control policies. The Prevention and Control of Antimicrobial Resistance scale was reliable and had content and construct validity. MRSA prevalence was significantly lower in hospitals with higher resource/information availability and broader organizational support. The Prevention and Control of Antimicrobial Resistance scale offers a simple yet discriminating assessment of AMR prevention and control efforts. Use should complement assessment methods based exclusively on AMR outcomes.

Effects of interpretive nutrition labels on consumer food purchases: the Starlight randomized controlled trial.

PubMed

Ni Mhurchu, Cliona; Volkova, Ekaterina; Jiang, Yannan; Eyles, Helen; Michie, Jo; Neal, Bruce; Blakely, Tony; Swinburn, Boyd; Rayner, Mike

2017-03-01

Background: Nutrition labeling is a prominent policy to promote healthy eating. Objective: We aimed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases. Design: In this parallel-group randomized controlled trial, we enrolled household shoppers across New Zealand who owned smartphones and were aged ≥18 y. Eligible participants were randomly assigned (1:1:1) to receive either traffic light labels (TLLs), Health Star Rating labels (HSRs), or a control [nutrition information panel (NIP)]. Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens. The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period, which was measured by using the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC). Results: Between October 2014 and November 2015, 1357 eligible shoppers were randomly assigned to TLL ( n = 459), HSR ( n = 443), or NIP ( n = 455) labels. Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was -0.20 (95% CI: -0.94, 0.54; P = 0.60). The corresponding difference for HSR compared with NIP was -0.60 (95% CI: -1.35, 0.15; P = 0.12). In an exploratory per-protocol analysis of participants who used the labeling intervention more often than average ( n = 423, 31%), those who were assigned to TLL and HSR had significantly better NPSC scores [TLL compared with NIP: -1.33 (95% CI: -2.63, -0.04; P = 0.04); HSR compared with NIP: -1.70 (95% CI: -2.97, -0.43; P = 0.01)]. Shoppers who were randomly assigned to HSR and TLL also found the labels significantly more useful and easy to understand than the NIP (all P values <0.001). Conclusions: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases. However, shoppers who used interpretive labels found them to be significantly more useful and easy to understand, and compared with frequent NIP users, frequent TLL and HSR users had significantly healthier food purchases. This trial was registered at the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366446&isReview=true) as ACTRN12614000644662. © 2017 American Society for Nutrition.

Chemoprevention of Nonmelanoma Skin Cancer With Celecoxib: A Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Viner, Jaye L.; Pentland, Alice P.; Cantrell, Wendy; Bailey, Howard; Kang, Sewon; Linden, Kenneth G.; Heffernan, Michael; Duvic, Madeleine; Richmond, Ellen; Elewski, Boni E.; Umar, Asad; Bell, Walter; Gordon, Gary B.

2010-01-01

Background Preclinical studies indicate that the enzyme cyclooxygenase 2 plays an important role in ultraviolet-induced skin cancers. We evaluated the efficacy and safety of celecoxib, a cyclooxygenase 2 inhibitor, as a chemopreventive agent for actinic keratoses, the premalignant precursor of nonmelanoma skin cancers, and for nonmelanoma skin cancers, including cutaneous squamous cell carcinomas (SCCs) and basal cell carcinomas (BCCs). Methods A double-blind placebo-controlled randomized trial involving 240 subjects aged 37–87 years with 10–40 actinic keratoses was conducted at eight US academic medical centers. Patients were randomly assigned to receive 200 mg of celecoxib or placebo administered orally twice daily for 9 months. Subjects were evaluated at 3, 6, 9 (ie, completion of treatment), and 11 months after randomization. The primary endpoint was the number of new actinic keratoses at the 9-month visit as a percentage of the number at the time of randomization. In an intent-to-treat analysis, the incidence of actinic keratoses was compared between the two groups using t tests. In exploratory analyses, we evaluated the number of nonmelanoma skin cancers combined and SCCs and BCCs separately per patient at 11 months after randomization using Poisson regression, after adjustment for patient characteristics and time on study. The numbers of adverse events in the two treatment arms were compared using χ2 or Fisher exact tests. All statistical tests were two-sided. Results There was no difference in the incidence of actinic keratoses between the two groups at 9 months after randomization. However, at 11 months after randomization, there were fewer nonmelanoma skin cancers in the celecoxib arm than in the placebo arm (mean cumulative tumor number per patient 0.14 vs 0.35; rate ratio [RR] = .43, 95% confidence interval [CI] = 0.24 to 0.75; P = .003). After adjusting for age, sex, Fitzpatrick skin type, history of actinic keratosis at randomization, nonmelanoma skin cancer history, and patient time on study, the number of nonmelanoma skin cancers was lower in the celecoxib arm than in the placebo arm (RR = 0.41, 95% CI = 0.23 to 0.72, P = .002) as were the numbers of BCCs (RR = 0.40, 95% CI = 0.18 to 0.93, P = .032) and SCCs (RR = 0.42, 95% CI = 0.19 to 0.93, P = .032). Serious and cardiovascular adverse events were similar in the two groups. Conclusions Celecoxib may be effective for prevention of SCCs and BCCs in individuals who have extensive actinic damage and are at high risk for development of nonmelanoma skin cancers. PMID:21115882

A High School-Based Evaluation of TakeCARE, a Video Bystander Program to Prevent Adolescent Relationship Violence.

PubMed

Sargent, Kelli S; Jouriles, Ernest N; Rosenfield, David; McDonald, Renee

2017-03-01

Although bystander programs to prevent relationship and sexual violence have been evaluated with college students, few evaluations have been conducted with high school students. This study evaluated the effectiveness of TakeCARE, a brief video bystander program designed to promote helpful bystander behavior in situations involving relationship violence among high school students. Students (N = 1295; 52.5% female; 72.3% Hispanic) reported their bystander behavior at a baseline assessment. Classrooms (N = 66) were randomized to view TakeCARE or to a control condition, and high school counselors administered the video in the classrooms assigned to view TakeCARE. Students again reported their bystander behavior at a follow-up assessment approximately 3 months afterward. Results indicate that students who viewed TakeCARE reported more helpful bystander behavior at the follow-up assessment than students in the control condition. Results of exploratory analyses of the likelihood of encountering and intervening upon specific situations calling for bystander behavior are also reported. TakeCARE is efficacious when implemented in an urban high school by high school counselors.

Interventions to Improve Medication Adherence in Hypertensive Patients: Systematic Review and Meta-analysis.

PubMed

Conn, Vicki S; Ruppar, Todd M; Chase, Jo-Ana D; Enriquez, Maithe; Cooper, Pamela S

2015-12-01

This systematic review applied meta-analytic procedures to synthesize medication adherence interventions that focus on adults with hypertension. Comprehensive searching located trials with medication adherence behavior outcomes. Study sample, design, intervention characteristics, and outcomes were coded. Random-effects models were used in calculating standardized mean difference effect sizes. Moderator analyses were conducted using meta-analytic analogues of ANOVA and regression to explore associations between effect sizes and sample, design, and intervention characteristics. Effect sizes were calculated for 112 eligible treatment-vs.-control group outcome comparisons of 34,272 subjects. The overall standardized mean difference effect size between treatment and control subjects was 0.300. Exploratory moderator analyses revealed interventions were most effective among female, older, and moderate- or high-income participants. The most promising intervention components were those linking adherence behavior with habits, giving adherence feedback to patients, self-monitoring of blood pressure, using pill boxes and other special packaging, and motivational interviewing. The most effective interventions employed multiple components and were delivered over many days. Future research should strive for minimizing risks of bias common in this literature, especially avoiding self-report adherence measures.

EFFECTS OF A PROFESSIONAL DEVELOPMENT PROGRAM ON BEHAVIORAL ENGAGEMENT OF STUDENTS IN MIDDLE AND HIGH SCHOOL

PubMed Central

GREGORY, ANNE; ALLEN, JOSEPH P.; MIKAMI, AMORI Y.; HAFEN, CHRISTOPHER A.; PIANTA, ROBERT C.

2017-01-01

Student behavioral engagement is a key condition supporting academic achievement, yet student disengagement in middle and high schools is all too common. The current study used a randomized controlled design to test the efficacy of the My Teaching Partner-Secondary program to increase behavioral engagement. The program offers teachers personalized coaching and systematic feedback on teachers’ interactions with students, based on systematic observation of videorecordings of teacher-student interactions in the classroom. The study found that intervention teachers had significantly higher increases, albeit to a modest degree, in student behavioral engagement in their classrooms after 1 year of involvement with the program compared to the teachers in the control group (explaining 4% of variance). In exploratory analyses, two dimensions of teachers’ interactions with students—their focus on analysis and problem solving during instruction and their use of diverse instructional learning formats—acted as mediators of increased student engagement. The findings offer implications for new directions in teacher professional development and for understanding the classroom as a setting for adolescent development. PMID:28232767

Association Between Early Low-Dose Hydrocortisone Therapy in Extremely Preterm Neonates and Neurodevelopmental Outcomes at 2 Years of Age.

PubMed

Baud, Olivier; Trousson, Clémence; Biran, Valérie; Leroy, Emilie; Mohamed, Damir; Alberti, Corinne

2017-04-04

Dexamethasone to prevent bronchopulmonary dysplasia in very preterm neonates was associated with adverse neurodevelopmental events. Early low-dose hydrocortisone treatment has been reported to improve survival without bronchopulmonary dysplasia but its safety with regard to neurodevelopment remains to be assessed. To assess whether early hydrocortisone therapy in extremely preterm infants is associated with neurodevelopmental impairment at 2 years of age. An exploratory secondary analysis of the PREMILOC (Early Low-Dose Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia in Extremely Preterm Infants) randomized clinical trial conducted between 2008 and 2014 in 21 French neonatal intensive care units. Randomization was stratified by gestational age groups. Neurodevelopmental assessments were completed from 2010 to 2016. After birth, patients were randomly assigned to receive placebo or hydrocortisone (0.5 mg/kg twice per day for 7 days, followed by 0.5 mg/kg per day for 3 days). The prespecified exploratory secondary outcome of neurodevelopmental impairment was based on a standardized neurological examination and the revised Brunet-Lézine scale (global developmental quotient score and subscores; mean norm, 100 [SD, 15]). The minimal clinically important difference on the global developmental quotient was 5 points. Of 1072 neonates screened, 523 were assigned to hydrocortisone (n = 256) or placebo (n = 267) and 406 survived to 2 years of age. A total of 379 patients (93%; 46% female) were evaluated (194 in the hydrocortisone group and 185 in the placebo group) at a median corrected age of 22 months (interquartile range, 21-23 months). The distribution of patients without neurodevelopmental impairment (73% in the hydrocortisone group vs 70% in the placebo group), with mild neurodevelopmental impairment (20% in the hydrocortisone group vs 18% in the placebo group), or with moderate to severe neurodevelopmental impairment (7% in the hydrocortisone group vs 11% in the placebo group) was not statistically significantly different between groups (P = .33). The mean global developmental quotient score was not statistically significantly different between groups (91.7 in the hydrocortisone group vs 91.4 in the placebo group; between-group difference, 0.3 [95% CI, -2.7 to 3.4]; P = .83). The incidence of cerebral palsy or other major neurological impairments was not significantly different between groups. In this exploratory analysis of secondary outcomes of a randomized clinical trial of extremely preterm infants, early low-dose hydrocortisone was not associated with a statistically significant difference in neurodevelopment at 2 years of age. Further randomized studies are needed to provide definitive assessment of the neurodevelopmental safety of hydrocortisone in extremely preterm infants. clinicaltrials.gov Identifier: NCT00623740.

The Use of Valeriana Officinalis (Valerian) in Improving Sleep in Patients Who Are Undergoing Treatment for Cancer: A Phase III Randomized, Placebo-Controlled, Double-Blind Study: NCCTG Trial, N01C51

PubMed Central

Barton, Debra L.; Atherton, Pamela J.; Bauer, Brent A.; Moore, Dennis F.; Mattar, Bassam I.; LaVasseur, Beth I.; Rowland, Kendrith M.; Zon, Robin T.; LeLindqwister, Nguyet A.; Nagargoje, Gauri G.; Morgenthaler, Timothy I.; Sloan, Jeff A.; Loprinzi, Charles L.

2011-01-01

Background Sleep disorders are a substantial problem for cancer survivors, with prevalence estimates ranging from 23 to 61%. Although numerous prescription hypnotics are available, few are approved for long-term use or have demonstrated benefit in this circumstance. Hypnotics may have unwanted side effects, are costly, and cancer survivors often wish to avoid prescription drugs. New options with limited side effects are needed. The purpose of this trial was to evaluate the efficacy of a valerian officinalis supplement for sleep in people with cancer who were undergoing cancer treatment. Methods Participants were randomized to receive 450 mg of valerian or placebo orally 1 hour before bedtime for 8 weeks. The primary endpoint was area under the curve (AUC) of the overall Pittsburgh Sleep Quality Index. Secondary outcomes included the Functional Outcomes of Sleep Questionnaire, the Brief Fatigue Inventory and the Profile of Mood States. Toxicity was evaluated with both self reported numeric analogue scale questions and the Common Criteria Terminology Criteria (CTCAE) version 3.0. Questionnaires were completed at baseline, 4, and 8 weeks. Results A total of 227 patients were randomized onto this study between 3/19/2004 and 3/9/2007, with 119 being evaluable for the primary endpoint. The AUC over the 8 weeks for valerian was 51.4 (SD = 16) while for placebo it was 49.7 (SD = 15) with a p-value of 0.6957. A supplemental, exploratory analysis revealed that several fatigue endpoints, as measured by the BFI and POMS, were significantly better for those taking valerian over placebo. Participants also reported less trouble with sleep and less drowsiness on valerian than placebo. There were no significant differences in toxicities as measured by self report or the CTCAE v3 except for mild alkaline phosphatase increases, which were slightly more common in the placebo group. Conclusions This study failed to provide data to support the hypothesis that valerian, 450 mg, at bedtime could improve sleep as measured by the PSQI. However, exploratory analyses revealed improvement in some secondary outcomes, such as fatigue. Further research with valerian exploring physiologic effects in oncology symptom management may be warranted. PMID:21399726

The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5).

PubMed

Barton, Debra L; Atherton, Pamela J; Bauer, Brent A; Moore, Dennis F; Mattar, Bassam I; Lavasseur, Beth I; Rowland, Kendrith M; Zon, Robin T; Lelindqwister, Nguyet A; Nagargoje, Gauri G; Morgenthaler, Timothy I; Sloan, Jeff A; Loprinzi, Charles L

2011-01-01

Sleep disorders are a substantial problem for cancer survivors, with prevalence estimates ranging from 23% to 61%. Although numerous prescription hypnotics are available, few are approved for long-term use or have demonstrated benefit in this circumstance. Hypnotics may have unwanted side effects and are costly, and cancer survivors often wish to avoid prescription drugs. New options with limited side effects are needed. The purpose of this trial was to evaluate the efficacy of a Valerian officinalis supplement for sleep in people with cancer who were undergoing cancer treatment. Participants were randomized to receive 450 mg of valerian-or placebo orally 1 hour before bedtime for 8 weeks. The primary end point was area under the curve (AUC) of the overall Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included the Functional Outcomes of Sleep Questionnaire, the Brief Fatigue Inventory (BFI), and the Profile of Mood States (POMS). Toxicity was evaluated with both self-reported numeric analogue scale questions and the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Questionnaires were completed at baseline and at 4 and 8 weeks. A total of 227 patients were randomized into this study between March 19, 2004, and March 9, 2007, with 119 being evaluable for the primary end point. The AUC over the 8 weeks for valerian was 51.4 (SD = 16), while that for placebo was 49.7 (SD = 15), with a P value of 0.6957. A supplemental, exploratory analysis revealed that several fatigue end points, as measured by the BFI and POMS, were significantly better for those taking valerian over placebo. Participants also reported less trouble with sleep and less drowsiness on valerian than placebo. There were no significant differences in toxicities as measured by self-report or the CTCAE except for mild alkaline phosphatase increases, which were slightly more common in the placebo group. This study failed to provide data to support the hypothesis that valerian, 450 mg, at bedtime could improve sleep as measured by the PSQI. However, exploratory analyses revealed improvement in some secondary outcomes, such as fatigue. Further research with valerian exploring physiologic effects in oncology symptom management may be warranted.

A process-based approach to characterizing the effect of acute alprazolam challenge on visual paired associate learning and memory in healthy older adults.

PubMed

Pietrzak, Robert H; Scott, James Cobb; Harel, Brian T; Lim, Yen Ying; Snyder, Peter J; Maruff, Paul

2012-11-01

Alprazolam is a benzodiazepine that, when administered acutely, results in impairments in several aspects of cognition, including attention, learning, and memory. However, the profile (i.e., component processes) that underlie alprazolam-related decrements in visual paired associate learning has not been fully explored. In this double-blind, placebo-controlled, randomized cross-over study of healthy older adults, we used a novel, "process-based" computerized measure of visual paired associate learning to examine the effect of a single, acute 1-mg dose of alprazolam on component processes of visual paired associate learning and memory. Acute alprazolam challenge was associated with a large magnitude reduction in visual paired associate learning and memory performance (d = 1.05). Process-based analyses revealed significant increases in distractor, exploratory, between-search, and within-search error types. Analyses of percentages of each error type suggested that, relative to placebo, alprazolam challenge resulted in a decrease in the percentage of exploratory errors and an increase in the percentage of distractor errors, both of which reflect memory processes. Results of this study suggest that acute alprazolam challenge decreases visual paired associate learning and memory performance by reducing the strength of the association between pattern and location, which may reflect a general breakdown in memory consolidation, with less evidence of reductions in executive processes (e.g., working memory) that facilitate visual paired associate learning and memory. Copyright © 2012 John Wiley & Sons, Ltd.

Risk of myocardial infarction and stroke in bipolar disorder: a systematic review and exploratory meta-analysis.

PubMed

Prieto, M L; Cuéllar-Barboza, A B; Bobo, W V; Roger, V L; Bellivier, F; Leboyer, M; West, C P; Frye, M A

2014-11-01

To review the evidence on and estimate the risk of myocardial infarction and stroke in bipolar disorder. A systematic search using MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and bibliographies (1946 - May, 2013) was conducted. Case-control and cohort studies of bipolar disorder patients age 15 or older with myocardial infarction or stroke as outcomes were included. Two independent reviewers extracted data and assessed quality. Estimates of effect were summarized using random-effects meta-analysis. Five cohort studies including 13 115 911 participants (27 092 bipolar) were included. Due to the use of registers, different statistical methods, and inconsistent adjustment for confounders, there was significant methodological heterogeneity among studies. The exploratory meta-analysis yielded no evidence for a significant increase in the risk of myocardial infarction: [relative risk (RR): 1.09, 95% CI 0.96-1.24, P = 0.20; I(2)  = 6%]. While there was evidence of significant study heterogeneity, the risk of stroke in bipolar disorder was significantly increased (RR 1.74, 95% CI 1.29-2.35; P = 0.0003; I(2)  = 83%). There may be a differential risk of myocardial infarction and stroke in patients with bipolar disorder. Confidence in these pooled estimates was limited by the small number of studies, significant heterogeneity and dissimilar methodological features. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Exploring longitudinal course and treatment-baseline severity interactions in secondary outcomes of smoking cessation treatment in individuals with attention-deficit hyperactivity disorder.

PubMed

Luo, Sean X; Wall, Melanie; Covey, Lirio; Hu, Mei-Chen; Scodes, Jennifer M; Levin, Frances R; Nunes, Edward V; Winhusen, Theresa

2018-01-25

A double blind, placebo-controlled randomized trial (NCT00253747) evaluating osmotic-release oral system methylphenidate (OROS-MPH) for smoking-cessation revealed a significant interaction effect in which participants with higher baseline ADHD severity had better abstinence outcomes with OROS-MPH while participants with lower baseline ADHD severity had worse outcomes. This current report examines secondary outcomes that might bear on the mechanism for this differential treatment effect. Longitudinal analyses were conducted to evaluate the effect of OROS-MPH on three secondary outcomes (ADHD symptom severity, nicotine craving, and withdrawal) in the total sample (N = 255, 56% Male), and in the high (N = 134) and low (N = 121) baseline ADHD severity groups. OROS-MPH significantly improved ADHD symptoms and nicotine withdrawal symptoms in the total sample, and exploratory analyses showed that in both higher and lower baseline severity groups, OROS-MPH statistically significantly improved these two outcomes. No effect on craving overall was detected, though exploratory analyses showed statistically significantly decreased craving in the high ADHD severity participants on OROS-MPH. No treatment by ADHD baseline severity interaction was detected for the outcomes. Methylphenidate improved secondary outcomes during smoking cessation independent of baseline ADHD severity, with no evident treatment-baseline severity interaction. Our results suggest divergent responses to smoking cessation treatment in the higher and lower severity groups cannot be explained by concordant divergence in craving, withdrawal and ADHD symptom severity, and alternative hypotheses may need to be identified.

Regional differences in advanced gastric cancer: exploratory analyses of the AVAGAST placebo arm.

PubMed

Sawaki, Akira; Yamada, Yasuhide; Yamaguchi, Kensei; Nishina, Tomohiro; Doi, Toshihiko; Satoh, Taroh; Chin, Keisho; Boku, Narikazu; Omuro, Yasushi; Komatsu, Yoshito; Hamamoto, Yasuo; Koizumi, Wasaburo; Saji, Shigehira; Shah, Manish A; Van Cutsem, Eric; Kang, Yoon-Koo; Iwasaki, Junko; Kuriki, Hiroshi; Ohtsuka, Wataru; Ohtsu, Atsushi

2018-05-01

AVAGAST was an international, randomized, placebo-controlled phase III study of chemotherapy with or without bevacizumab as first-line therapy for patients with advanced gastric cancer. We performed exploratory analyses to evaluate regional differences observed in the trial. Analyses were performed in the placebo plus chemotherapy arm (intention-to-treat population). Chemotherapy was cisplatin 80 mg/m 2 for six cycles plus capecitabine (1000 mg/m 2 orally bid days 1-14) or 5-fluorouracil (800 mg/m 2 /day continuous IV infusion days 1-5) every 3 weeks until disease progression or unacceptable toxicity. Overall, 387 patients were assigned to placebo plus chemotherapy (eastern Europe/South America, n = 118; USA/western Europe, n = 81; Korea/other Asia, n = 94; Japan, n = 94). At baseline, poor performance status, liver metastases, and larger tumors were most frequent in eastern Europe/South America and least frequent in Japan. Patients received subsequent chemotherapy after disease progression as follows: eastern Europe/South America (14%); USA/western Europe (37%); Korea/other Asia (61%); and Japan (77%). Hazard ratios for overall survival versus USA/western Europe were 1.47 (95% CI, 1.09-1.99) for eastern Europe/South America, 0.91 (95% CI, 0.67-1.25) for Korea/other Asia, and 0.87 (95% CI, 0.64-1.19) for Japan. Regional differences in the healthcare environment may have contributed to the differences in overall survival observed in the AVAGAST study.

Biomarkers and perfusion – training-induced changes after stroke (BAPTISe): protocol of an observational study accompanying a randomized controlled trial

PubMed Central

2013-01-01

Background Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke. Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation, the underlying mechanisms leading to improvement are poorly understood. Training-induced increase of cerebral perfusion is a possible mediating mechanism. Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke. Methods/design This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled PHYS-STROKE trial. In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4 weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4 weeks of relaxation sessions (5 times a week, for 50 minutes). A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and an additional blood draw before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion, vessel size imaging, and microvessel density (the Q factor) to estimate the degree of neovascularization in the brain. Blood tests will determine several parameters of immunity, inflammation, endothelial function, and lipometabolism. Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups. Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3 months assessed by functional scores, in particular walking speed and Barthel index (co-primary endpoints of PHYS-STROKE). Additionally, we will assess the association between functional outcomes and biomarkers including imaging results. For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions. Discussion This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion, pertinent blood biomarker levels, and functional outcome. The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke. Trial registration NCT01954797. PMID:24330706

Factor Structure of the Brief Symptom Inventory--18 in Adult Survivors of Childhood Cancer: Results from the Childhood Cancer Survivor Study

ERIC Educational Resources Information Center

Recklitis, Christopher J.; Parsons, Susan K.; Shih, Mei-Chiung; Mertens, Ann; Robison, Leslie L.; Zeltzer, Lonnie

2006-01-01

The factor structure of the Brief Symptom Inventory--18 (BSI-18; L. R. Derogatis, 2000) was investigated in a sample of adult survivors of childhood cancer enrolled in the Childhood Cancer Survivor Study (CCSS; N = 8,945). An exploratory factor analysis with a randomly chosen subsample supported a 3-factor structure closely corresponding to the 3…

Experimental investigation of a new device to control the asymmetric flowfield on forebodies at large angles of attack

NASA Technical Reports Server (NTRS)

Moskovitz, Cary A.; Hall, Robert M.; Dejarnette, F. R.

1990-01-01

An exploratory experimental investigation of a new device to control the asymmetric flowfield on forebodies at large angles of attack has been conducted. The device is a rotatable forebody tip, which varies in cross section from circular at its base to elliptic at its tip. The device itself extends over a small portion of the aircraft or missile forebody. The device provides two important improvements. First, it replaced the normally random behavior of the nose side force as a function of nose tip orientation with a predictable and generally sinusoidal distribution and, second, the device showed promise for use as part of a vehicle control system, to be deflected in a prescribed manner to provide additional directional control for the vehicle. The device was tested on a cone/cylinder model having a 10 deg semiapex angle and on a 3.0 caliber tangent ogive model, each with a base diameter of 3.5 in, for angles of attack from 30 to 60 deg. Data were taken from 3 circumferential rows of pressure taps on each model at a Reynolds number of 84,000 based on cylinder diameter and by a helium-bubble flow visualization technique at a Reynolds number of 24,000.

A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial.

PubMed

Hull, Mark A; Sandell, Anna C; Montgomery, Alan A; Logan, Richard F A; Clifford, Gayle M; Rees, Colin J; Loadman, Paul M; Whitham, Diane

2013-07-29

The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2×2 factorial 'efficacy' study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55-73 year-old patients, who have been identified as 'high risk' (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and 'advanced') per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as 'intermediate risk' for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients. Current Controlled Trials ISRCTN05926847.

Control order and visuomotor strategy development for joystick-steered underground shuttle cars.

PubMed

Cloete, Steven; Zupanc, Christine; Burgess-Limerick, Robin; Wallis, Guy

2014-09-01

In this simulator-based study, we aimed to quantify performance differences between joystick steering systems using first-order and second-order control, which are used in underground coal mining shuttle cars. In addition, we conducted an exploratory analysis of how users of the more difficult, second-order system changed their behavior over time. Evidence from the visuomotor control literature suggests that higher-order control devices are not intuitive, which could pose a significant risk to underground mine personnel, equipment, and infrastructure. Thirty-six naive participants were randomly assigned to first- and second-order conditions and completed three experimental trials comprising sequences of 90 degrees turns in a virtual underground mine environment, with velocity held constant at 9 km/h(-1). Performance measures were lateral deviation, steering angle variability, high-frequency steering content, joystick activity, and cumulative time in collision with the virtual mine wall. The second-order control group exhibited significantly poorer performance for all outcome measures. In addition, a series of correlation analyses revealed that changes in strategy were evident in the second-order group but not the first-order group. Results were consistent with previous literature indicating poorer performance with higher-order control devices and caution against the adoption of the second-order joystick system for underground shuttle cars. Low-cost, portable simulation platforms may provide an effective basis for operator training and recruitment.

The effect of a holistic self-management plan on asthma control.

PubMed

Grammatopoulou, Eirini; Skordilis, Emmanouil K; Haniotou, Aikaterini; John, Zarotis; Athanasopoulos, Spyros

2017-08-01

The holistic self-management plan includes lifelong actions that enable patients to cope with their disease. The present study was designed to evaluate the effect of a holistic self-management plan on asthma control. A 12-month controlled study was conducted. Adult patients with mild-to-moderate asthma (n = 24) who attended the emergency asthma department were randomized to two groups: One group followed four educational sessions and three personal home sessions (n = 12), while a second group received a short manual with asthma information (n = 12). The main measure was the asthma control test (ACT), while secondary outcomes were self-efficacy (general self-efficacy scale, GSE), end-tidal carbon dioxide (ETCO 2 ), respiratory rate (RR), breathing hold time (BHT), the Nijmegen Questionnaire (NQ), and spirometry (FEV 1 % predicted (forced expiratory volume in 1 second % predicted)) scores. The 2 × 4 ANOVA showed a significant interaction effect between intervention and time in ACT (p = 0.001), GSE (p < 0.001), ETCO 2 (p < 0.001), RR (p < 0.001), BHT (p < 0.001), NQ (p = 0.05), and FEV 1 % predicted (p < 0.001). Predictors of asthma control were self-efficacy and ETCO 2 . In conclusion, this exploratory study provided support for the effectiveness of holistic self-management in asthma control. Behavioral changes, as indicated by the development of self-efficacy and the reduction of hyperventilation, contributed to the effectiveness of the intervention.

24-hour glucose profiles on diets varying in protein content and glycemic index.

PubMed

van Baak, Marleen A

2014-08-04

Evidence is increasing that the postprandial state is an important factor contributing to the risk of chronic diseases. Not only mean glycemia, but also glycemic variability has been implicated in this effect. In this exploratory study, we measured 24-h glucose profiles in 25 overweight participants in a long-term diet intervention study (DIOGENES study on Diet, Obesity and Genes), which had been randomized to four different diet groups consuming diets varying in protein content and glycemic index. In addition, we compared 24-h glucose profiles in a more controlled fashion, where nine other subjects followed in random order the same four diets differing in carbohydrate content by 10 energy% and glycemic index by 20 units during three days. Meals were provided in the lab and had to be eaten at fixed times during the day. No differences in mean glucose concentration or glucose variability (SD) were found between diet groups in the DIOGENES study. In the more controlled lab study, mean 24-h glucose concentrations were also not different. Glucose variability (SD and CONGA1), however, was lower on the diet combining a lower carbohydrate content and GI compared to the diet combining a higher carbohydrate content and GI. These data suggest that diets with moderate differences in carbohydrate content and GI do not affect mean 24-h or daytime glucose concentrations, but may result in differences in the variability of the glucose level in healthy normal weight and overweight individuals.

Two distinct modes of forebrain circuit dynamics underlie temporal patterning in the vocalizations of young songbirds

PubMed Central

Aronov, Dmitriy; Veit, Lena; Goldberg, Jesse H.; Fee, Michale S.

2011-01-01

Accurate timing is a critical aspect of motor control, yet the temporal structure of many mature behaviors emerges during learning from highly variable exploratory actions. How does a developing brain acquire the precise control of timing in behavioral sequences? To investigate the development of timing, we analyzed the songs of young juvenile zebra finches. These highly variable vocalizations, akin to human babbling, gradually develop into temporally-stereotyped adult songs. We find that the durations of syllables and silences in juvenile singing are formed by a mixture of two distinct modes of timing – a random mode producing broadly-distributed durations early in development, and a stereotyped mode underlying the gradual emergence of stereotyped durations. Using lesions, inactivations, and localized brain cooling we investigated the roles of neural dynamics within two premotor cortical areas in the production of these temporal modes. We find that LMAN (lateral magnocellular nucleus of the nidopallium) is required specifically for the generation of the random mode of timing, and that mild cooling of LMAN causes an increase in the durations produced by this mode. On the contrary, HVC (used as a proper name) is required specifically for producing the stereotyped mode of timing, and its cooling causes a slowing of all stereotyped components. These results show that two neural pathways contribute to the timing of juvenile songs, and suggest an interesting organization in the forebrain, whereby different brain areas are specialized for the production of distinct forms of neural dynamics. PMID:22072687

Effects of a Cognitive Behavioral Therapy Intervention Trial to Improve Disease Outcomes in Children with Inflammatory Bowel Disease.

PubMed

Levy, Rona L; van Tilburg, Miranda A L; Langer, Shelby L; Romano, Joan M; Walker, Lynn S; Mancl, Lloyd A; Murphy, Tasha B; Claar, Robyn L; Feld, Shara I; Christie, Dennis L; Abdullah, Bisher; DuPen, Melissa M; Swanson, Kimberly S; Baker, Melissa D; Stoner, Susan A; Whitehead, William E

2016-09-01

Studies testing the efficacy of behavioral interventions to modify psychosocial sequelae of inflammatory bowel disease in children are limited. This report presents outcomes through a 6-month follow-up from a large randomized controlled trial testing the efficacy of a cognitive behavioral intervention for children with inflammatory bowel disease and their parents. One hundred eighty-five children aged 8 to 17 years with a diagnosis of Crohn's disease or ulcerative colitis and their parents were randomized to one of two 3-session conditions: (1) a social learning and cognitive behavioral therapy condition or (2) an education support condition designed to control for time and attention. There was a significant overall treatment effect for school absences due to Crohn's disease or ulcerative colitis (P < 0.05) at 6 months after treatment. There was also a significant overall effect after treatment for child-reported quality of life (P < 0.05), parent-reported increases in adaptive child coping (P < 0.001), and reductions in parents' maladaptive responses to children's symptoms (P < 0.05). Finally, exploratory analyses indicated that for children with a higher level of flares (2 or more) prebaseline, those in social learning and cognitive behavioral therapy condition experienced a greater reduction in flares after treatment. This trial suggests that a brief cognitive behavioral intervention for children with inflammatory bowel disease and their parents can result in improved child functioning and quality of life, and for some children may decrease disease activity.

Exploratory behavior in rats postnatally exposed to cocaine and housed in an enriched environment.

PubMed

Magalhães, Ana; Melo, Pedro; Alves, Cecília Juliana; Tavares, Maria Amélia; de Sousa, Liliana; Summavielle, Teresa

2008-10-01

Exposure to cocaine in early periods of postnatal life is usually associated with changes in development of neurotransmitter systems and structure of the central nervous system. Such changes are most likely correlated with behavioral alterations. Environmental enrichment conditions (EC) in early stages is a factor that affects structural and behavioral development. The purpose of this study is to examine the effects of EC on rats postnatally exposed to cocaine on exploratory behavior. Wistar rats were assigned to four groups-Group 1: pups exposed to cocaine hydrochloride (15 mg/kg body weight/day) s.c., in two daily doses, from postnatal day (PND) 1 to 28 and reared in EC; Group 2: pups exposed to cocaine as previously described and reared in a standard environmental conditions (SC); Group 3: pups saline-injected and reared in EC; and Group 4: pups saline-injected and reared in SC. On PND 21, 24, and 28, groups of four rats (to reduce anxiety) were placed for 10 minutes into an arena with several objects. The following exploratory behavioral categories were examined: object interaction, exploration, manipulation, approximation, and total time of object contact. Animals from Group 2 showed decreased object interaction and total contact on PND 21. Control offspring reared in EE showed decreases in exploratory behavior at all ages analyzed compared with the control SE group, while cocaine-exposed animals reared in EC showed decreased object interaction, object approximation, and total exploratory behavior. The results in this group suggest that EC improved information acquisition and memory processes in animals postnatally exposed to cocaine.

Clinical Implications From an Exploratory Study of Postural Management of Breech Presentation

PubMed Central

Founds, Sandra A.

2013-01-01

The results from an exploratory study of the effectiveness of maternal knee-chest posture for producing cephalic version of breech presentation are shown. Methods are briefly described and clinical implications are presented. Among 25 women, fewer who performed the maternal knee-chest postural intervention experienced fetal cephalic version than women in the control group who did nothing to influence breech presentation. Despite limitations of the underpowered findings, trends in the data may indicate that parity and gestational age were potentially relevant covariates of version. Postural management is not an evidence-based practice. This exploratory study indicates that maternal knee-chest posture may work opposite to the expected direction, but the small sample size precludes generalizations about efficacy of knee-chest postural management. At least one adequately powered trial that controls for parity and gestational age is needed to determine whether knee-chest postural management results in no effect, a small, or small to moderate clinically significant effect. PMID:16814225

Moderators of Effects of Internet-Delivered Exercise and Pain Coping Skills Training for People With Knee Osteoarthritis: Exploratory Analysis of the IMPACT Randomized Controlled Trial.

PubMed

Lawford, Belinda J; Hinman, Rana S; Kasza, Jessica; Nelligan, Rachel; Keefe, Francis; Rini, Christine; Bennell, Kim L

2018-05-09

Internet-delivered exercise, education, and pain coping skills training is effective for people with knee osteoarthritis, yet it is not clear whether this treatment is better suited to particular subgroups of patients. The aim was to explore demographic and clinical moderators of the effect of an internet-delivered intervention on changes in pain and physical function in people with knee osteoarthritis. Exploratory analysis of data from 148 people with knee osteoarthritis who participated in a randomized controlled trial comparing internet-delivered exercise, education, and pain coping skills training to internet-delivered education alone. Primary outcomes were changes in knee pain while walking (11-point Numerical Rating Scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index function subscale) at 3 and 9 months. Separate regression models were fit with moderator variables (age, gender, expectations of outcomes, self-efficacy [pain], education, employment status, pain catastrophizing, body mass index) and study group as covariates, including an interaction between the two. Participants in the intervention group who were currently employed had significantly greater reductions in pain at 3 months than similar participants in the control group (between-group difference: mean 2.38, 95% CI 1.52-3.23 Numerical Rating Scale units; interaction P=.02). Additionally, within the intervention group, pain at 3 months reduced by mean 0.53 (95% CI 0.28-0.78) Numerical Rating Scale units per unit increase in baseline self-efficacy for managing pain compared to mean 0.11 Numerical Rating Scale units (95% CI -0.13 to 0.35; interaction P=.02) for the control group. People who were employed and had higher self-efficacy at baseline were more likely to experience greater improvements in pain at 3 months after an internet-delivered exercise, education, and pain coping skills training program. There was no evidence of a difference in the effect across gender, educational level, expectation of treatment outcome, or across age, body mass index, or tendency to catastrophize pain. Findings support the effectiveness of internet-delivered care for a wide range of people with knee osteoarthritis, but future confirmatory research is needed. Australian New Zealand Clinical Trials Registry ACTRN12614000243617; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365812&isReview=true (Archived by WebCite at http://www.webcitation.org/6z466oTPs). ©Belinda J Lawford, Rana S Hinman, Jessica Kasza, Rachel Nelligan, Francis Keefe, Christine Rini, Kim L Bennell. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.05.2018.

Fimbria-Fornix Lesions Disrupt the Dead Reckoning (Homing) Component of Exploratory Behavior in Mice

PubMed Central

Gorny, Joanna H.; Gorny, Bogdan; Wallace, Douglas G.; Whishaw, Ian Q.

2002-01-01

Exploration is the primary way in which rodents gather information about their spatial surroundings. Thus, spatial theories propose that damage to the hippocampus, a structure thought to play a fundamental role in spatial behavior, should disrupt exploration. Exploration in rats is organized. The animals create home bases that are central to exploratory excursions and returns, and hippocampal formation damage alters the organization of exploration by disrupting returns. Mice do not appear to readily establish home bases in novel environments, thus, for this species, it is more difficult to establish the contribution of the hippocampus to exploration. The purpose of the present study was threefold: develop a task in which mice center their exploration from a home base, determine whether the exploratory behavior is organized, and evaluate the role of fimbria-fornix lesions on exploration. Mice were given a novel exploratory task in which their nesting material was placed on a large circular table. Video records of control and fimbria-fornix mice were made in both light and dark (infrared light) conditions. Exploration patterns (outward trips, stops, and homeward trips) were reconstructed from the video records. Control mice centered their activity on their bedding, from which they made circuitous outward trips marked by many stops, and periodic direct returns. The bedding-centered behavior and outward trips of the fimbria-fornix mice were similar to those of the control mice, but significantly fewer direct return trips occurred. The direct homeward trips observed under light and dark conditions were consistent with a dead-reckoning strategy, in which an animal computes its present position and homeward trajectory from self-movement cues generated on the outward trip. Because the fimbria-fornix lesions disrupted the homeward component of exploratory trips, we conclude that the fimbria-fornix may contribute to dead reckoning in mice. The results also show that the home-bedding methodology facilitates the establishment of a home base by mice, thus providing a useful methodology for studies with mice. PMID:12464698

Exploring the Factor Structure of Neurocognitive Measures in Older Individuals

PubMed Central

Santos, Nadine Correia; Costa, Patrício Soares; Amorim, Liliana; Moreira, Pedro Silva; Cunha, Pedro; Cotter, Jorge; Sousa, Nuno

2015-01-01

Here we focus on factor analysis from a best practices point of view, by investigating the factor structure of neuropsychological tests and using the results obtained to illustrate on choosing a reasonable solution. The sample (n=1051 individuals) was randomly divided into two groups: one for exploratory factor analysis (EFA) and principal component analysis (PCA), to investigate the number of factors underlying the neurocognitive variables; the second to test the “best fit” model via confirmatory factor analysis (CFA). For the exploratory step, three extraction (maximum likelihood, principal axis factoring and principal components) and two rotation (orthogonal and oblique) methods were used. The analysis methodology allowed exploring how different cognitive/psychological tests correlated/discriminated between dimensions, indicating that to capture latent structures in similar sample sizes and measures, with approximately normal data distribution, reflective models with oblimin rotation might prove the most adequate. PMID:25880732

Aligning internal organizational factors with a service excellence mission: an exploratory investigation in health care.

PubMed

Ford, Robert C; Sivo, Stephen A; Fottler, Myron D; Dickson, Duncan; Bradley, Kenneth; Johnson, Lee

2006-01-01

In today's competitive health care environment, service excellence is rapidly becoming a major differentiating advantage between health care providers. Too often, senior executives talk about their commitment to a mission statement that extols the virtues of providing world class service to their patients only to undermine those statements with what they do, write, and say. This article presents an exploratory investigation into a new application of an internal mission alignment instrument that seeks to assess the extent to which an organization's internal processes are aligned with its service mission. This instrument was sent to 250 randomly selected employees from all clinical departments of a large southeastern hospital to explore the underlying alignment factors. A factor analysis of the data revealed eight factors that predicted beneficial employee outcomes such as organizational commitment and satisfaction with the job and organization.

Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial.

PubMed

David, M; Akerman, L; Ziv, M; Kadurina, M; Gospodinov, D; Pavlotsky, F; Yankova, R; Kouzeva, V; Ramon, M; Silverman, M H; Fishman, P

2012-03-01

CF101 demonstrated a marked anti-inflammatory effect in Phase 2 studies conducted in patients with rheumatoid arthritis and dry eye syndrome. The aim of this study was to evaluate the safety and efficacy of CF101 for the treatment of patients with moderate to severe plaque-type psoriasis. This was a phase 2, multicentre, randomized, double-blind, dose-ranging, placebo-controlled study. Seventy five patients with moderate to severe plaque-type psoriasis were enrolled, randomized and treated with CF101 (1, 2, or 4 mg) or placebo administered orally twice daily for 12 weeks. Safety and change from base line of Psoriasis Area and Severity Index (PASI) score and physician's global assessment (PGA) score over 12 weeks. In the 2 mg CF101-treated group, a progressive improvement in the mean change from baseline in the PASI score vs. placebo throughout the study period was observed, with a statistically significant difference on weeks 8 and 12 (P = 0.047; P = 0.031, respectively). In this group, 35.3% of the patients achieved PASI ≥ 50 response, and 23.5% of the patients achieved a PGA score of 0 or 1. CF101 was safe and well tolerated. CF101 was well tolerated and demonstrated clear evidence of efficacy in patients with moderate to severe plaque psoriasis. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Do depressed newly diagnosed cancer patients differentially benefit from nurse navigation?

PubMed

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

2015-01-01

To examine whether the effects of a nurse navigator intervention for cancer vary with baseline depressive symptoms. Participants were enrolled in a randomized controlled trial of a nurse navigation intervention for patients newly diagnosed with lung, breast or colorectal cancer (N=251). This exploratory analysis used linear regression models to estimate the effect of a nurse navigator intervention on patient experience of care. Models estimated differential effects by including interactions between randomization group and baseline depressive symptoms. Baseline scores on the 9-item Patient Health Questionnaire (PHQ) were categorized into 3 groups: no depression (PHQ=0-4, N=138), mild symptoms of depression (PHQ=5-9, N=76) and moderate to severe symptoms (PHQ=10 or greater, N=34). Patient experience outcomes were measured by subscales of the Patient Assessment of Chronic Illness Care (PACIC) and subscales from an adaptation of the Picker Institute's patient experience survey at 4-month follow-up. With the exception of the PACIC subscale of delivery system/practice design, interaction terms between randomization group and PHQ-9 scores were not statistically significant. The intervention was broadly useful; we found that it was equally beneficial for both depressed patients and patients who were not significantly depressed in the first 4 months postdiagnosis. However, because of the small sample size, we cannot conclude with certainty that patients with depressive symptoms did not differentially benefit from the intervention. Copyright © 2015 Elsevier Inc. All rights reserved.

Autonomous Circuitry for Substrate Exploration in Freely Moving Drosophila Larvae

PubMed Central

Berni, Jimena; Pulver, Stefan R.; Griffith, Leslie C.; Bate, Michael

2014-01-01

Summary Background Many organisms, from bacteria to human hunter-gatherers, use specialized random walk strategies to explore their environment. Such behaviors are an efficient stratagem for sampling the environment and usually consist of an alternation between straight runs and turns that redirect these runs. Drosophila larvae execute an exploratory routine of this kind that consists of sequences of straight crawls, pauses, turns, and redirected crawls. Central pattern generating networks underlying rhythmic movements are distributed along the anteroposterior axis of the nervous system. The way in which the operation of these networks is incorporated into extended behavioral routines such as substrate exploration has not yet been explored. In particular, the part played by the brain in dictating the sequence of movements required is unknown. Results We report the use of a genetic method to block synaptic activity acutely in the brain and subesophageal ganglia (SOG) of larvae during active exploratory behavior. We show that the brain and SOG are not required for the normal performance of an exploratory routine. Alternation between crawls and turns is an intrinsic property of the abdominal and/or thoracic networks. The brain modifies this autonomous routine during goal-directed movements such as those of chemotaxis. Nonetheless, light avoidance behavior can be mediated in the absence of brain activity solely by the sensorimotor system of the abdomen and thorax. Conclusions The sequence of movements for substrate exploration is an autonomous capacity of the thoracic and abdominal nervous system. The brain modulates this exploratory routine in response to environmental cues. PMID:22940472

Sunlight exposure and cardiovascular risk factors in the REGARDS study: a cross-sectional split-sample analysis

PubMed Central

2014-01-01

Background Previous research has suggested that vitamin D and sunlight are related to cardiovascular outcomes, but associations between sunlight and risk factors have not been investigated. We examined whether increased sunlight exposure was related to improved cardiovascular risk factor status. Methods Residential histories merged with satellite, ground monitor, and model reanalysis data were used to determine previous-year sunlight radiation exposure for 17,773 black and white participants aged 45+ from the US. Exploratory and confirmatory analyses were performed by randomly dividing the sample into halves. Logistic regression models were used to examine relationships with cardiovascular risk factors. Results The lowest, compared to the highest quartile of insolation exposure was associated with lower high-density lipoprotein levels in adjusted exploratory (−2.7 mg/dL [95% confidence interval: −4.2, −1.2]) and confirmatory (−1.5 mg/dL [95% confidence interval: −3.0, −0.1]) models. The lowest, compared to the highest quartile of insolation exposure was associated with higher systolic blood pressure levels in unadjusted exploratory and confirmatory, as well as the adjusted exploratory model (2.3 mmHg [95% confidence interval: 0.8, 3.8]), but not the adjusted confirmatory model (1.6 mg/dL [95% confidence interval: −0.5, 3.7]). Conclusions The results of this study suggest that lower long-term sunlight exposure has an association with lower high-density lipoprotein levels. However, all associations were weak, thus it is not known if insolation may affect cardiovascular outcomes through these risk factors. PMID:24946776

Individual music therapy for agitation in dementia: an exploratory randomized controlled trial.

PubMed

Ridder, Hanne Mette O; Stige, Brynjulf; Qvale, Liv Gunnhild; Gold, Christian

2013-01-01

Agitation in nursing home residents with dementia leads to increase in psychotropic medication, decrease in quality of life, and to patient distress and caregiver burden. Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been methodologically insufficient. The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes, and to explore its effect on psychotropic medication and quality of life. In a crossover trial, 42 participants with dementia were randomized to a sequence of six weeks of individual music therapy and six weeks of standard care. Outcome measures included agitation, quality of life and medication. Agitation disruptiveness increased during standard care and decreased during music therapy. The difference at -6.77 (95% CI (confidence interval): -12.71, -0.83) was significant (p = 0.027), with a medium effect size (0.50). The prescription of psychotropic medication increased significantly more often during standard care than during music therapy (p = 0.02). This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia. The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample.

Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.

PubMed

Crook, Derrick W; Walker, A Sarah; Kean, Yin; Weiss, Karl; Cornely, Oliver A; Miller, Mark A; Esposito, Roberto; Louie, Thomas J; Stoesser, Nicole E; Young, Bernadette C; Angus, Brian J; Gorbach, Sherwood L; Peto, Timothy E A

2012-08-01

Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%-51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%-60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13-40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI.

Engaging foster parents in treatment: a randomized trial of supplementing trauma-focused cognitive behavioral therapy with evidence-based engagement strategies.

PubMed

Dorsey, Shannon; Pullmann, Michael D; Berliner, Lucy; Koschmann, Elizabeth; McKay, Mary; Deblinger, Esther

2014-09-01

The goal of this study was to examine the impact of supplementing Trauma-focused Cognitive Behavioral Therapy (TF-CBT; Cohen et al., 2006) with evidence-based engagement strategies on foster parent and foster youth engagement in treatment, given challenges engaging foster parents in treatment. A randomized controlled trial of TF-CBT standard delivery compared to TF-CBT plus evidence-based engagement strategies was conducted with 47 children and adolescents in foster care and one of their foster parents. Attendance, engagement, and clinical outcomes were assessed 1 month into treatment, end of treatment, and 3 months post-treatment. Youth and foster parents who received TF-CBT plus evidence-based engagement strategies were more likely to be retained in treatment through four sessions and were less likely to drop out of treatment prematurely. The engagement strategies did not appear to have an effect on the number of canceled or no-show sessions or on treatment satisfaction. Clinical outcomes did not differ by study condition, but exploratory analyses suggest that youth had significant improvements with treatment. Strategies that specifically target engagement may hold promise for increasing access to evidence-based treatments and for increasing likelihood of treatment completion. Copyright © 2014 Elsevier Ltd. All rights reserved.

Engaging Foster Parents in Treatment: A Randomized Trial of Supplementing Trauma-focused Cognitive Behavioral Therapy with Evidence-based Engagement Strategies

PubMed Central

Pullmann, Michael D.; Berliner, Lucy; Koschmann, Elizabeth; McKay, Mary; Deblinger, Esther

2014-01-01

The goal of this study was to examine the impact of supplementing Trauma-focused Cognitive Behavioral Therapy (TF-CBT; Cohen, Mannarino, & Deblinger, 2006) with evidence-based engagement strategies on foster parent and foster youth engagement in treatment, given challenges engaging foster parents in treatment. A randomized controlled trial of TF-CBT standard delivery compared to TF-CBT plus evidence-based engagement strategies was conducted with 47 children and adolescents in foster care and one of their foster parents. Attendence, engagement, and clinical outcomes were assessed 1 month into treatment, end of treatment, and 3 months post-treatment. Youth and foster parents who received TF-CBT plus evidence-based engagement strategies were more likely to be retained in treatment through four sessions and were less likely to drop out of treatment prematurely. The engagement strategies did not appear to have an effect on the number of cancelled or no-show sessions or on treatment satisfaction. Clinical outcomes did not differ by study condition, but exploratory analyses suggest that youth had significant improvements with treatment. Strategies that specifically target engagement may hold promise for increasing access to evidence-based practices and for increasing likelihood of treatment completion. PMID:24791605

Design of the NL-ENIGMA study: Exploring the effect of Souvenaid on cerebral glucose metabolism in early Alzheimer's disease.

PubMed

Scheltens, Nienke M E; Kuyper, Ingrid S; Boellaard, Ronald; Barkhof, Frederik; Teunissen, Charlotte E; Broersen, Laus M; Lansbergen, Marieke M; van der Flier, Wiesje M; van Berckel, Bart N M; Scheltens, Philip

2016-11-01

Alzheimer's disease is associated with early synaptic loss. Specific nutrients are known to be rate limiting for synapse formation. Studies have shown that administering specific nutrients may improve memory function, possibly by increasing synapse formation. This Dutch study explores the Effect of a specific Nutritional Intervention on cerebral Glucose Metabolism in early Alzheimer's disease (NL-ENIGMA, Dutch Trial Register NTR4718, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4718). The NL-ENIGMA study is designed to test whether the specific multinutrient combination Fortasyn Connect present in the medical food Souvenaid influences cerebral glucose metabolism as a marker for improved synapse function. This study is a double-blind, randomized controlled parallel-group single-center trial. Forty drug-naive patients with mild cognitive impairment or mild dementia with evidence of amyloid deposition are 1:1 randomized to receive either the multinutrient combination or placebo once daily. Main exploratory outcome parameters include absolute quantitative positron emission tomography with 18 F-fluorodeoxyglucose (including arterial sampling) and standard uptake value ratios normalized for the cerebellum or pons after 24 weeks. We expect the NL-ENIGMA study to provide further insight in the potential of this multinutrient combination to improve synapse function.

Efficacy of repetitive transcranial magnetic stimulation with quetiapine in treating bipolar II depression: a randomized, double-blinded, control study.

PubMed

Hu, Shao-Hua; Lai, Jian-Bo; Xu, Dong-Rong; Qi, Hong-Li; Peterson, Bradley S; Bao, Ai-Min; Hu, Chan-Chan; Huang, Man-Li; Chen, Jing-Kai; Wei, Ning; Hu, Jian-Bo; Li, Shu-Lan; Zhou, Wei-Hua; Xu, Wei-Juan; Xu, Yi

2016-07-27

The clinical and cognitive responses to repetitive transcranial magnetic stimulation (rTMS) in bipolar II depressed patients remain unclear. In this study, thirty-eight bipolar II depressed patients were randomly assigned into three groups: (i) left high-frequency (n = 12), (ii) right low-frequency (n = 13), (iii) sham stimulation (n = 13), and underwent four-week rTMS with quetiapine concomitantly. Clinical efficacy was evaluated at baseline and weekly intervals using the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive functioning was assessed before and after the study with the Wisconsin Card Sorting Test (WCST), Stroop Word-Color Interference Test (Stroop), and Trail Making Test (TMT). Thirty-five patients were included in the final analysis. Overall, the mean scores of both the HDRS-17 and the MADRS significantly decreased over the 4-week trial, which did not differ among the three groups. Exploratory analyses revealed no differences in factor scores of HDRS-17s, or in response or remission rates. Scores of WCST, Stroop, or TMT did not differ across the three groups. These findings indicated active rTMS combined with quetiapine was not superior to quetiapine monotherapy in improving depressive symptoms or cognitive performance in patients with bipolar II depression.

A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma.

PubMed

Harris, Jeffrey M; Maciuca, Romeo; Bradley, Mary S; Cabanski, Christopher R; Scheerens, Heleen; Lim, Jeremy; Cai, Fang; Kishnani, Mona; Liao, X Charlene; Samineni, Divya; Zhu, Rui; Cochran, Colette; Soong, Weily; Diaz, Joseph D; Perin, Patrick; Tsukayama, Miguel; Dimov, Dimo; Agache, Ioana; Kelsen, Steven G

2016-03-18

Quilizumab, a humanized IgG1 monoclonal antibody, targets the M1-prime segment of membrane-expressed IgE, leading to depletion of IgE-switched and memory B cells. In patients with mild asthma, quilizumab reduced serum IgE and attenuated the early and late asthmatic reaction following whole lung allergen challenge. This study evaluated the efficacy and safety of quilizumab in adults with allergic asthma, inadequately controlled despite high-dose inhaled corticosteroids (ICS) and a second controller. Five hundred seventy-eight patients were randomized to monthly or quarterly dosing regimens of subcutaneous quilizumab or placebo for 36 weeks, with a 48-week safety follow-up. Quilizumab was evaluated for effects on the rate of asthma exacerbations, lung function, patient symptoms, serum IgE, and pharmacokinetics. Exploratory analyses were conducted on biomarker subgroups (periostin, blood eosinophils, serum IgE, and exhaled nitric oxide). Quilizumab was well tolerated and reduced serum total and allergen-specific IgE by 30-40 %, but had no impact on asthma exacerbations, lung function, or patient-reported symptom measures. At Week 36, the 300 mg monthly quilizumab group showed a 19.6 % reduction (p = 0.38) in the asthma exacerbation rate relative to placebo, but this was neither statistically nor clinically significant. Biomarker subgroups did not reveal meaningful efficacy benefits following quilizumab treatment. Quilizumab had an acceptable safety profile and reduced serum IgE. However, targeting the IgE pathway via depletion of IgE-switched and memory B cells was not sufficient for a clinically meaningful benefit for adults with allergic asthma uncontrolled by standard therapy. ClinicalTrials.gov NCT01582503.

Double-blind, controlled, clinical trial planned in germany to investigate the efficacy of psychotherapy combined with triptorelin in adult male patients with severe pedophilic disorders: presentation of the study protocol.

PubMed

Briken, Peer; Berner, Wolfgang

2012-01-01

The treatment of paraphilias, especially of pedophilia, centers upon cognitive-behavioral psychotherapy and pharmacologic interventions. Two open, uncontrolled clinical studies using the synthetic LHRH-agonist triptorelin suggested that, combined with psychotherapy, antiandrogen treatment reduced deviant sexual fantasies, urges, and behaviors in paraphilic patients. There is a need for further research using controlled, randomized trials to examine the effectiveness of sexual offender treatment including psychotherapeutic and pharmacologic interventions. The aim of this pilot study is to evaluate the efficacy and tolerability of cognitive-behavioral psychotherapy together with intramuscular (IM) 3-monthly injections of triptorelin in adult men with severe pedophilia. In this multicenter, forensic psychiatric hospital-based, double-blind, controlled, parallel group phase IV trial conducted in Germany, convicted male sexual offenders aged ≥ 18 years with pedophilia, as defined by DSM-IV-TR criteria, will be randomized to receive study-specific psychotherapy together either with triptorelin or placebo for 12 months (total of 4 injections). This is a pilot study, therefore exploratory data analyses will be carried out of three different target parameters: 1. Changes in psychosexual characteristics using the Multiphasic Sex Inventory (scale: sexual abuse of children) 2. Changes in the risk of violent sexual behavior using the Sexual Violence Risk-20 total score 3. Changes in serum testosterone concentration Treatment effects will be assessed by comparing baseline values with those at the final examination (month 12). The absence of real-life stimulants to test for actual recidivism limits possible findings. The study will be conducted in agreement with the European GCP-guideline, all relevant legal requirements, and the legal framework for voluntary treatment of convicted sexual offenders in Germany.

Effect of maternal death reviews and training on maternal mortality among cesarean delivery: post-hoc analysis of a cluster-randomized controlled trial.

PubMed

Zongo, Augustin; Dumont, Alexandre; Fournier, Pierre; Traore, Mamadou; Kouanda, Séni; Sondo, Blaise

2015-02-01

To explore the differential effect of a multifaceted intervention on hospital-based maternal mortality between patients with cesarean and vaginal delivery in low-resource settings. We reanalyzed the data from a major cluster-randomized controlled trial, QUARITE (Quality of care, Risk management and technology in obstetrics). These subgroup analyses were not pre-specified and were treated as exploratory. The intervention consisted of an initial interactive workshop and quarterly educational clinically oriented and evidence-based outreach visits focused on maternal death reviews (MDR) and best practices implementation. The trial originally recruited 191,167 patients who delivered in each of the 46 participating hospitals in Mali and Senegal, between 2007 and 2011. The primary endpoint was hospital-based maternal mortality. Subgroup-specific Odds Ratios (ORs) of maternal mortality were computed and tested for differential intervention effect using generalized linear mixed model between two subgroups (cesarean: 40,975; and vaginal delivery: 150,192). The test for homogeneity of intervention effects on hospital-based maternal mortality among the two delivery mode subgroups was statistically significant (p-value: 0.0201). Compared to the control, the adjusted OR of maternal mortality was 0.71 (95% CI: 0.58-0.82, p=0.0034) among women with cesarean delivery. The intervention had no significant effect among women with vaginal delivery (adjusted OR 0.87, 95% CI 0.69-1.11, p=0.6213). This differential effect was particularly marked for district hospitals. Maternal deaths reviews and on-site training on emergency obstetric care may be more effective in reducing maternal mortality among high-risk women who need a cesarean section than among low-risk women with vaginal delivery. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2018-06-01

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

Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adolescent with Post-traumatic Stress Disorder: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Moreno-Alcázar, Ana; Treen, Devi; Valiente-Gómez, Alicia; Sio-Eroles, Albert; Pérez, Víctor; Amann, Benedikt L; Radua, Joaquim

2017-01-01

Background: Post-traumatic stress disorder (PTSD) can occur in both adults and children/adolescents. Untreated PTSD can lead to negative long-term mental health conditions such as depression, anxiety, low self-concept, disruptive behaviors, and/or substance use disorders. To prevent these adverse effects, treatment of PTSD is essential, especially in young population due to their greater vulnerability. The principal aim of this meta-analysis was to examine the efficacy of eye movement desensitization and reprocessing (EMDR) therapy for PTSD symptoms in children and adolescents. Secondary objectives were to assess whether EMDR therapy was effective to improve depressive or anxious comorbid symptoms. Methods: We conducted a thorough systematic search of studies published until January 2017, using PubMed, Medline, Scopus, and ScienceDirect as databases. All randomized controlled trials with an EMDR group condition compared to a control group, such as treatment as usual or another psychological treatment, were included. Meta-analysis was conducted with MetaNSUE to avoid biases related to missing information. Results: Eight studies ( n = 295) met our inclusion criteria. EMDR therapy was superior to waitlist/placebo conditions and showed comparable efficacy to cognitive behavior therapy (CBT) in reducing post-traumatic and anxiety symptoms. A similar but non-statistically significant trend was observed for depressive symptoms. Exploratory subgroup analyses showed that effects might be smaller in studies that included more males and in more recent studies. Conclusion: Despite the small number of publications, the obtained results suggest that EMDR therapy could be a promising psychotherapeutic approach for the treatment of PTSD and comorbid symptoms in young individuals. However, further research with larger samples is needed to confirm these preliminary results as well as to analyze differences in the efficacy of EMDR therapy versus CBT.

Oral administration of Lactobacillus paracasei NCC 2461 for the modulation of grass pollen allergic rhinitis: a randomized, placebo-controlled study during the pollen season.

PubMed

Nembrini, Chiara; Singh, Anurag; De Castro, Carlos Antonio; Mercenier, Annick; Nutten, Sophie

2015-01-01

The efficacy of Lactobacillus paracasei NCC 2461 in modulating allergic rhinitis was previously evaluated in two exploratory clinical studies. Oral administration with NCC 2461 reduced specific subjective symptoms following nasal provocation tests with controlled grass pollen allergen concentrations. Our aim was to confirm the anti-allergic effect of NCC 2461 in grass pollen allergic subjects exposed to natural doses of allergens during the pollen season. A double-blind, randomized, placebo-controlled, parallel study was conducted with 131 grass pollen allergic subjects from May to July 2012 in concomitance with the pollen season in Berlin. NCC 2461 or placebo was administered daily for an 8-week period to adult subjects with clinical history of allergic rhinitis to grass pollen, positive skin prick test and IgE to grass pollen. During the 8 weeks, symptoms and quality of life questionnaires were filled out, and plasma was collected for IgE analysis at screening and at the end of the intervention. All subjects were included within a 5-day interval, ensuring exposure to similar air pollen counts for each individual during the trial period. The results obtained show that symptoms increased with pollen loads, confirming a natural exposure to the allergen and presence of pollen-induced allergic rhinitis in the subjects. However, no significant differences were observed in allergic rhinitis symptoms scores, quality of life, or specific IgE levels between subjects receiving NCC 2461 as compared to placebo administration. In contrast to previous findings, oral administration of NCC 2461 did not show a beneficial effect on allergic rhinitis in a field trial. The influence of study design, allergen exposure and intervention window on the efficacy of NCC 2461 in modulating respiratory allergy should be further evaluated.

Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial.

PubMed

Losina, Elena; Collins, Jamie E; Wright, John; Daigle, Meghan E; Donnell-Fink, Laurel A; Strnad, Doris; Usiskin, Ilana M; Yang, Heidi Y; Lerner, Vladislav; Katz, Jeffrey N

2016-09-01

To establish the efficacy of motivational interviewing-based postoperative care navigation in improving functional status after total knee arthroplasty (TKA) and to identify subgroups likely to benefit from the intervention. We conducted a parallel randomized controlled trial in TKA recipients with 2 arms: postoperative care with frequent followup by a care navigator or usual care. The primary outcome was the difference between the arms in Western Ontario and McMaster Universities Osteoarthritis Index function score change, over 6 months postsurgery. We performed a preplanned subgroup analysis of differential efficacy by obesity and exploratory subgroup analyses on sex and pain catastrophizing. We enrolled 308 subjects undergoing TKA for osteoarthritis. Mean ± SD preoperative function score was 41 ± 17 (0-100 scale, where 100 = worst function). At 6 months, subjects in the navigation arm improved by mean ± SD 30 ± 16 points compared to 27 ± 18 points in the usual-care arm (P = 0.148). Participants with moderate to high levels of pain catastrophizing were unlikely to benefit from navigation compared to those with lower levels of pain catastrophizing (P = 0.013 for interaction). Subjects assigned to the navigation intervention did not demonstrate greater functional improvement compared to those in the control group. The negative overall result could be explained by the large effect on functional improvement of TKA itself compared to the smaller, additional benefit from care navigation, as well as by potential differential effects for subjects with moderate to high degrees of pain catastrophizing. Greater focus on developing programs for reducing pain catastrophizing could lead to better functional outcomes following TKA. © 2016, American College of Rheumatology.

The effectiveness of a serious game to enhance empathy for care workers for people with disabilities: A parallel randomized controlled trial.

PubMed

Sterkenburg, P S; Vacaru, V S

2018-04-04

Empathic care is fundamental in healthcare settings and is associated to several positive outcomes for care workers (i.e. burnout, compassion satisfaction) and patients (i.e. therapeutic alliance, trust, wellbeing). Yet, studies showed a decrease in empathy in care workers, which is argued to be a product of personal distress. Thus, interventions should aim at enhancing empathy in care workers working for vulnerable populations to ensure optimal client-carer relationships. The current study investigates the effectiveness of the serious game "The world of EMPA" in enhancing empathy in care workers for people with disabilities, and tests the effect of personal distress on empathy change post intervention. We conducted a superiority parallel randomized controlled trial (RCT) and tested 224 participants in two conditions: the experimental group (n = 111) played a serious game and the control group (n = 113) read a digital information package about disabilities. Participants were assessed on empathy and personal distress prior to and after the intervention. Main results showed that the serious game did not significantly enhance empathy in care workers, whereas reading a digital information package yield a significant decrease in empathy. Exploratory analysis showed that the serious game decreased significantly personal distress in care-workers. This study showed that while the serious game "The world of EMPA" did not enhance empathy, it resulted in a decrease in personal distress in care workers for people with disabilities. Further evidence should corroborate these findings to unveil the mechanisms of this intervention and the long-term effects on personal distress. Copyright © 2018 Elsevier Inc. All rights reserved.

Impact of Exposure to Electronic Cigarette Advertising on Susceptibility and Trial of Electronic Cigarettes and Cigarettes in US Young Adults: A Randomized Controlled Trial.

PubMed

Villanti, Andrea C; Rath, Jessica M; Williams, Valerie F; Pearson, Jennifer L; Richardson, Amanda; Abrams, David B; Niaura, Raymond S; Vallone, Donna M

2016-05-01

This study assessed the impact of brief exposure to four electronic cigarette (e-cigarette) print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes in US young adults. A randomized controlled trial was conducted in a national sample of young adults from an online panel survey in 2013. Participants were randomized to ad exposure or control. Curiosity, intentions, and perceptions regarding e-cigarettes were assessed post-exposure and e-cigarette and cigarette use at 6-month follow-up. Analyses were conducted in 2014. Approximately 6% of young adults who had never used an e-cigarette at baseline tried an e-cigarette at 6-month follow-up, half of whom were current cigarette smokers at baseline. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette (18.3% exposed vs. 11.3% unexposed, AOR = 1.63, 95% CI = 1.18, 2.26) among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up (3.6% exposed vs. 1.2% unexposed, AOR = 2.85; 95% CI = 1.07, 7.61) among never users of cigarettes and e-cigarettes. Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users, nor cigarette use among smokers over time. Curiosity mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users. Exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Future studies are needed to examine the net effect of curiosity and trial of e-cigarettes on longer-term patterns of tobacco use. This randomized trial provides the first evidence of the effect of e-cigarette advertising on a behavioral outcome in young adults. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up in a small number of never e-cigarette users and greater likelihood of e-cigarette trial at follow-up among never users of cigarettes and e-cigarettes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The development and exploratory analysis of the Back Pain Attitudes Questionnaire (Back-PAQ)

PubMed Central

Darlow, Ben; Perry, Meredith; Mathieson, Fiona; Stanley, James; Melloh, Markus; Marsh, Reginald; Baxter, G David; Dowell, Anthony

2014-01-01

Objectives To develop an instrument to assess attitudes and underlying beliefs about back pain, and subsequently investigate its internal consistency and underlying structures. Design The instrument was developed by a multidisciplinary team of clinicians and researchers based on analysis of qualitative interviews with people experiencing acute and chronic back pain. Exploratory analysis was conducted using data from a population-based cross-sectional survey. Setting Qualitative interviews with community-based participants and subsequent postal survey. Participants Instrument development informed by interviews with 12 participants with acute back pain and 11 participants with chronic back pain. Data for exploratory analysis collected from New Zealand residents and citizens aged 18 years and above. 1000 participants were randomly selected from the New Zealand Electoral Roll. 602 valid responses were received. Measures The 34-item Back Pain Attitudes Questionnaire (Back-PAQ) was developed. Internal consistency was evaluated by the Cronbach α coefficient. Exploratory analysis investigated the structure of the data using Principal Component Analysis. Results The 34-item long form of the scale had acceptable internal consistency (α=0.70; 95% CI 0.66 to 0.73). Exploratory analysis identified five two-item principal components which accounted for 74% of the variance in the reduced data set: ‘vulnerability of the back’; ‘relationship between back pain and injury’; ‘activity participation while experiencing back pain’; ‘prognosis of back pain’ and ‘psychological influences on recovery’. Internal consistency was acceptable for the reduced 10-item scale (α=0.61; 95% CI 0.56 to 0.66) and the identified components (α between 0.50 and 0.78). Conclusions The 34-item long form of the scale may be appropriate for use in future cross-sectional studies. The 10-item short form may be appropriate for use as a screening tool, or an outcome assessment instrument. Further testing of the 10-item Back-PAQ's construct validity, reliability, responsiveness to change and predictive ability needs to be conducted. PMID:24860003

MS disease activity in RESTORE

PubMed Central

Cree, Bruce A.C.; De Sèze, Jerome; Gold, Ralf; Hartung, Hans-Peter; Jeffery, Douglas; Kappos, Ludwig; Kaufman, Michael; Montalbán, Xavier; Weinstock-Guttman, Bianca; Anderson, Britt; Natarajan, Amy; Ticho, Barry; Duda, Petra

2014-01-01

Objective: RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Methods: Eligible patients were relapse-free through the prior year on natalizumab and had no gadolinium-enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, to switch to placebo, or to receive alternative immunomodulatory therapy (other therapies: IM interferon β-1a [IM IFN-β-1a], glatiramer acetate [GA], or methylprednisolone [MP]). During the 24-week randomized treatment period, patients underwent clinical and MRI assessments every 4 weeks. Results: Patients (n = 175) were randomized to natalizumab (n = 45), placebo (n = 42), or other therapies (n = 88: IM IFN-β-1a, n = 17; GA, n = 17; MP, n = 54). Of 167 patients evaluable for efficacy, 49 (29%) had MRI disease activity recurrence: 0/45 (0%) natalizumab, 19/41 (46%) placebo, 1/14 (7%) IM IFN-β-1a, 8/15 (53%) GA, and 21/52 (40%) MP. Relapse occurred in 4% of natalizumab patients and in 15%–29% of patients in the other treatment arms. MRI disease activity recurred starting at 12 weeks (n = 3 at week 12) while relapses were reported as early as 4–8 weeks (n = 2 in weeks 4–8) after the last natalizumab dose. Overall, 50/167 patients (30%), all in placebo or other-therapies groups, restarted natalizumab early because of disease activity. Conclusions: MRI and clinical disease activity recurred in some patients during natalizumab interruption, despite use of other therapies. Classification of evidence: This study provides Class II evidence that for patients with MS taking natalizumab who are relapse-free for 1 year, stopping natalizumab increases the risk of MS relapse or MRI disease activity as compared with continuing natalizumab. PMID:24682966

A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis.

PubMed

Stein Gold, Linda F; Spelman, Lynda; Spellman, Mary C; Hughes, Matilda H; Zane, Lee T

2015-12-01

Crisaborole is a novel, boron-based, small-molecule, topical phosphodiesterase-4 inhibitor in development for the treatment of patients with mild to moderate atopic dermatitis (AD). In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed. A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤ 2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1). These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.

Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

PubMed

Carlson, Linda E; Zelinski, Erin L; Speca, Michael; Balneaves, Lynda G; Jones, Jennifer M; Santa Mina, Daniel; Wayne, Peter M; Campbell, Tavis S; Giese-Davis, Janine; Faris, Peter; Zwicker, Jennifer; Patel, Kamala; Beattie, Tara L; Cole, Steve; Toivonen, Kirsti; Nation, Jill; Peng, Philip; Thong, Bruce; Wong, Raimond; Vohra, Sunita

2017-08-01

A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system. Copyright © 2017 Elsevier Inc. All rights reserved.

Teacher Reporting Attitudes Scale (TRAS): confirmatory and exploratory factor analyses with a Malaysian sample.

PubMed

Choo, Wan Yuen; Walsh, Kerryann; Chinna, Karuthan; Tey, Nai Peng

2013-01-01

The Teacher Reporting Attitude Scale (TRAS) is a newly developed tool to assess teachers' attitudes toward reporting child abuse and neglect. This article reports on an investigation of the factor structure and psychometric properties of the short form Malay version of the TRAS. A self-report cross-sectional survey was conducted with 667 teachers in 14 randomly selected schools in Selangor state, Malaysia. Analyses were conducted in a 3-stage process using both confirmatory (stages 1 and 3) and exploratory factor analyses (stage 2) to test, modify, and confirm the underlying factor structure of the TRAS in a non-Western teacher sample. Confirmatory factor analysis did not support a 3-factor model previously reported in the original TRAS study. Exploratory factor analysis revealed an 8-item, 4-factor structure. Further confirmatory factor analysis demonstrated appropriateness of the 4-factor structure. Reliability estimates for the four factors-commitment, value, concern, and confidence-were moderate. The modified short form TRAS (Malay version) has potential to be used as a simple tool for relatively quick assessment of teachers' attitudes toward reporting child abuse and neglect. Cross-cultural differences in attitudes toward reporting may exist and the transferability of newly developed instruments to other populations should be evaluated.

Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial.

PubMed

Lewandowski, Kathryn Eve; Sperry, Sarah H; Ongur, Dost; Cohen, Bruce M; Norris, Lesley A; Keshavan, Matcheri S

2016-03-12

Cognitive dysfunction is a major feature of bipolar disorder with psychosis and is strongly associated with functional outcomes. Computer-based cognitive remediation has shown promise in improving cognition in patients with schizophrenia. However, despite similar neurocognitive deficits between patients with schizophrenia and bipolar disorder, few studies have extended neuroscience-based cognitive remediation programs to this population. The Treatment to Enhance Cognition in Bipolar Disorder study is an investigator-initiated, parallel group, randomized, blinded clinical trial of an Internet-based cognitive remediation protocol for patients with bipolar disorder I with psychosis (n = 100). We also describe the development of our dose-matched active control paradigm. Both conditions involve 70 sessions of computer-based activities over 24 weeks. The control intervention was developed to mirror the treatment condition in dose and format but without the neuroplasticity-based task design and structure. All participants undergo neuropsychological and clinical assessment at baseline, after approximately 25 hours of study activities, post treatment, and after 6 months of no study contact to assess durability. Neuroimaging at baseline and post treatment are offered in an "opt-in" format. The primary outcomes are scores on the MATRICS battery; secondary and exploratory outcomes include measures of clinical symptoms, community functioning, and neuroimaging changes. Associations between change in cognitive measures and change in community functioning will be assessed. Baseline predictors of treatment response will be examined. The present study is the first we are aware of to implement an Internet-based cognitive remediation program in patients with bipolar disorder with psychosis and to develop a comparable web-based control paradigm. The mixed online and study-site format allows accessible treatment while providing weekly staff contact and bridging. Based on user-provided feedback, participant blinding is feasible. ClinicalTrials.gov NCT01470781 ; 11 July 2011.

A randomized study to evaluate the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, haemophilus influenzae b, and meningococcal serogroup C combination vaccine administered to infants at 2, 4 and 12 months of age.

PubMed

Thollot, Franck; Scheifele, David; Pankow-Culot, Heidemarie; Cheuvart, Brigitte; Leyssen, Maarten; Ulianov, Liliana; Miller, Jacqueline M

2014-12-01

The immunogenicity and safety of the investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine were compared with those of licensed control vaccines. In this open, phase II, randomized study (NCT01090453), 480 infants from Germany, France and Canada received the heptavalent vaccine (Hepta group) or hexavalent and monovalent MenC control vaccines (HexaMenC group) co-administered with a 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. Immunogenicity was measured 1 month after the second primary dose, and before and 1 month after the booster dose. Safety and reactogenicity were also evaluated. Non-inferiority of immune responses to MenC and Hib induced by 2-dose primary vaccination with the heptavalent vaccine versus control vaccines was demonstrated. In exploratory analyses, postprimary and postbooster functional antibody geometric mean titers against MenC tended to be lower (1119.5 vs. 3200.5; 2653.8 vs. 6028.4) and antibody geometric mean concentrations against Hib higher (1.594 vs. 0.671 μg/mL; 17.678 vs. 13.737 μg/mL) in the Hepta versus the HexaMenC group. The heptavalent and control vaccines were immunogenic to all other antigens, although immune responses to poliovirus were lower than expected in both groups. No differences in safety and reactogenicity profiles were detected between groups. The heptavalent vaccine induced non-inferior MenC and Hib responses compared with control vaccines. Both vaccination regimens, when administered at 2, 4 and 12 months of age, had comparable safety profiles and were immunogenic to all antigens, with lower-than-expected responses to poliomyelitis.

Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss

PubMed Central

Rock, Cheryl L.; Flatt, Shirley W.; Pakiz, Bilgé; Barkai, Hava-Shoshana; Heath, Dennis D.; Krumhar, Kim C.

2017-01-01

Objective Providing portion-controlled prepackaged foods in a behavioral counseling intervention may promote more weight and fat loss than a standard self-selected diet. Methods: The primary aim was to test whether providing portion-controlled prepackaged lunch and dinner entrées within a behavioral weight loss intervention promotes greater weight loss at 12 weeks in overweight/obese adults compared to self-selected foods. Other aims were to examine effects on biological factors, fitness, and meal satisfaction. One-half of those assigned to prepackaged entrées were provided items with a higher protein level (>25% energy) as an exploratory aim. Results Participants (N=183) had a baseline weight of 95.9 (15.6) kg (mean [SD]) and BMI of 33.2 (3.5) kg/m2. Weight data at 12 weeks were available for 180 subjects. Weight loss for regular entrée, higher protein entrée and control groups was 8.6 (3.9), 7.8 (5.1), and 6.0 (4.4)%, respectively (P<0.05, intervention vs. control). Intervention participants lost more body fat than controls (5.7 [3.4] vs. 4.4 [3.3] kg, P<0.05). Conclusions A meal plan incorporating portion-controlled prepackaged entrées promotes greater weight and fat loss than a standard self-selected diet, with comparable meal satisfaction. Initial weight loss predicts long-term weight loss so these results are relevant to likelihood of longer term success. PMID:27225596

Planning representation for automated exploratory data analysis

NASA Astrophysics Data System (ADS)

St. Amant, Robert; Cohen, Paul R.

1994-03-01

Igor is a knowledge-based system for exploratory statistical analysis of complex systems and environments. Igor has two related goals: to help automate the search for interesting patterns in data sets, and to help develop models that capture significant relationships in the data. We outline a language for Igor, based on techniques of opportunistic planning, which balances control and opportunism. We describe the application of Igor to the analysis of the behavior of Phoenix, an artificial intelligence planning system.

Lower urinary tract symptoms after subtotal versus total abdominal hysterectomy: exploratory analyses from a randomized clinical trial with a 14-year follow-up.

PubMed

Andersen, Lea Laird; Møller, Lars Mikael Alling; Gimbel, Helga

2015-12-01

Lower urinary tract symptoms (LUTS) are common after hysterectomy and increase after menopause. We aimed to compare subtotal with total abdominal hysterectomy regarding LUTS, including urinary incontinence (UI) subtypes, 14 years after hysterectomy. Main results from this randomized clinical trial have been published previously; the analyses covered in this paper are exploratory. We performed a long-term questionnaire follow-up of women in a randomized clinical trial (n = 319), from 1996 to 2000 comparing subtotal with total abdominal hysterectomy. Of the randomized women, ten had died and five had left Denmark; 304 women were contacted. For univariate analyses, a χ(2)-test was used, and for multivariate analyses, we used logistic regression. The questionnaire was answered by 197 (64.7 %) women (subtotal 97; total 100). More women had subjective stress UI (SUI) in the subtotal group (n = 60; 62.5 %) compared with the total group (n = 45; 45 %), with a relative risk (RR) of 1.39 [95 % confidence interval (CI) 1.06-1.81; P = 0.014]. No difference was seen between subtotal and total abdominal hysterectomy in other LUTS. Factors associated with UI were UI prior to hysterectomy, local estrogen treatment, and body mass index (BMI) > 25 kg/m(2). High BMI was primarily associated with mixed UI (MUI) and urgency symptoms. Predictors of bothersome LUTS were UI and incomplete bladder emptying. The difference in the frequency of subjectively assessed UI between subtotal and total abdominal hysterectomy (published previously) is caused by a difference in subjectively assessed SUI; UI prior to hysterectomy and high BMI are related to UI 14 years after hysterectomy. The trial is registered on clinicaltrials.gov under Nykoebing Falster County Hospital Record sj-268: Total versus subtotal hysterectomy: http://clinicaltrials.gov/ct2/show/NCT01880710?term=hysterectomy&rank=27.

Next-generation smart traffic signals : RHODES with Intellidrive, the self-taught traffic control system.

DOT National Transportation Integrated Search

2009-01-01

Can a self-calibrating signal control system lead to wider adoption of adaptive traffic control systems? The focus of Next Generation of Smart Traffic Signals, an Exploratory Advanced Research (EAR) Program project, is a system that-with lit...

Reward and uncertainty in exploration programs

NASA Technical Reports Server (NTRS)

Kaufman, G. M.; Bradley, P. G.

1971-01-01

A set of variables which are crucial to the economic outcome of petroleum exploration are discussed. These are treated as random variables; the values they assume indicate the number of successes that occur in a drilling program and determine, for a particular discovery, the unit production cost and net economic return if that reservoir is developed. In specifying the joint probability law for those variables, extreme and probably unrealistic assumptions are made. In particular, the different random variables are assumed to be independently distributed. Using postulated probability functions and specified parameters, values are generated for selected random variables, such as reservoir size. From this set of values the economic magnitudes of interest, net return and unit production cost are computed. This constitutes a single trial, and the procedure is repeated many times. The resulting histograms approximate the probability density functions of the variables which describe the economic outcomes of an exploratory drilling program.

AERIS : eco-driving application development and testing.

DOT National Transportation Integrated Search

2012-06-01

This exploratory study investigates the potential of developing an Eco-Driving application that utilizes an eco-cruise control (ECC) system within state-of-the-art car-following models. The research focuses on integrating predictive cruise control an...

Mesenchymal stem cells restore orientation and exploratory behavior of rats after brain injury.

PubMed

Sokolova, I B; Fedotova, O R; Tsikunov, S G; Polyntsev, D G

2011-05-01

We studied the effects of intravenous and intracerebral transplantation of MSC on restoration of orientation and exploratory behavior of Wistar-Kyoto rats after removal of the left motor cortex. Removal of the motor cortex led to a significant reduction of the number of behavioral acts in the open field test. Two weeks after removal of the motor cortex and intravenous transplantation, the animals were as inhibited as the controls, but during the next 10 weeks, the behavioral status of these rats remained unchanged, while controls exhibited further behavioral degradation. After injection of MSC into the brain, the behavior of rats with trauma did not change in comparison with intact rats over 10 weeks.

Early whole brain radiotherapy in primary CNS lymphoma: negative impact on quality of life in the randomized G-PCNSL-SG1 trial.

PubMed

Herrlinger, Ulrich; Schäfer, Niklas; Fimmers, Rolf; Griesinger, Frank; Rauch, Michael; Kirchen, Heinz; Roth, Patrick; Glas, Martin; Bamberg, Michael; Martus, Peter; Thiel, Eckhard; Korfel, Agnieszka; Weller, Michael

2017-09-01

In the randomized G-PCNSL-SG-1 trial, the addition of whole brain radiotherapy (45 Gy) to high-dose methotrexate (HD-MTX)-based chemotherapy (early WBRT arm) did not prolong overall survival (OS) as compared to HD-MTX-based chemotherapy alone (no early WBRT arm) in primary CNS lymphoma (PCNSL) patients. To determine whether WBRT might lead to quality of life (QoL)-relevant late neurotoxicity, this trial prospectively monitored QoL. QoL measurements were performed using the EORTC-QLQ-C30 and BN20 questionnaires and combined with repeated Mini Mental State Examinations (MMSE). Exploratory data analysis included the 318 patients in the per-protocol population. In year 2 after randomization, cognitive functioning and global health status were reduced in the early WBRT arm as compared to the no early WBRT arm (p = 0.004 and p = 0.022, respectively). Also, fatigue (p = 0.037), appetite loss (p = 0.006) and hair loss (p = 0.002) were more intense in the early WBRT arm. MMSE testing revealed lower values (p = 0.002) in the early WBRT arm. A mixed model analysis of longitudinal data additionally showed differences favoring the no early WBRT arm in 15 of 26 dimensions of QoL. The analysis of subjective QoL questionnaires and objective MMSE testing revealed that QoL and cognition were conserved in the arm without early WBRT. Thus, even though it was an exploratory analysis, the results of G-PCNSL-SG1 challenge the place of WBRT in the primary therapy of PCNSL.

MAP: an iterative experimental design methodology for the optimization of catalytic search space structure modeling.

PubMed

Baumes, Laurent A

2006-01-01

One of the main problems in high-throughput research for materials is still the design of experiments. At early stages of discovery programs, purely exploratory methodologies coupled with fast screening tools should be employed. This should lead to opportunities to find unexpected catalytic results and identify the "groups" of catalyst outputs, providing well-defined boundaries for future optimizations. However, very few new papers deal with strategies that guide exploratory studies. Mostly, traditional designs, homogeneous covering, or simple random samplings are exploited. Typical catalytic output distributions exhibit unbalanced datasets for which an efficient learning is hardly carried out, and interesting but rare classes are usually unrecognized. Here is suggested a new iterative algorithm for the characterization of the search space structure, working independently of learning processes. It enhances recognition rates by transferring catalysts to be screened from "performance-stable" space zones to "unsteady" ones which necessitate more experiments to be well-modeled. The evaluation of new algorithm attempts through benchmarks is compulsory due to the lack of past proofs about their efficiency. The method is detailed and thoroughly tested with mathematical functions exhibiting different levels of complexity. The strategy is not only empirically evaluated, the effect or efficiency of sampling on future Machine Learning performances is also quantified. The minimum sample size required by the algorithm for being statistically discriminated from simple random sampling is investigated.

Exploratory Clinical Trial to Evaluate the Efficacy of a Topical Traditional Chinese Herbal Medicine in Psoriasis Vulgaris

PubMed Central

Yan, Yuhe; Liu, Wali; Andres, Philippe; Pernin, Colette; Chantalat, Laurent; Briantais, Philippe; Lin, Albert; Feng, Lilian

2015-01-01

Objective. To evaluate the efficacy and safety of herbal ointment, Shi Du Ruan Gao, in patients with plaque-type psoriasis. Design. Single-center, randomized, investigator-blinded, parallel group, placebo-controlled study. Participants. One hundred outpatients with mild to moderate chronic plaque-type psoriasis were enrolled. Intervention. The patients applied either Shi Du Ruan Gao ointment or vehicle ointment topically to for 8 weeks. Main Outcome Measures. The outcomes were assessed using the following criteria: Total Severity Score (TSS, sum of erythema, scaling, and plaque elevation/induration, on a 0 to 4 scale), Investigator Global Assessment (IGA) evaluated on a 0 (Clear) to 4 (s to very severe) scale, and Global Subjects' Assessment of treatment response on a 7-point scale from −1 (worse) to 5 (Cleared). Results. Significant reductions in the Total Severity Score (P < 0.001) (mean score: 2.7 after Shi Du Ruan Gao treatment versus 5.1 in control subjects). Both Investigator Global Assessment (IGA) and Global Subjects' Assessment of treatment are better in the Shi Du Ruan Gao group than the control group (P < 0.001). Conclusion. Shi Du Ruan Gao ointment was a safe, and effective therapy for plaque-type psoriasis. PMID:25834623

A meta-analytic review of psychological treatments for tinnitus.

PubMed

Andersson, G; Lyttkens, L

1999-08-01

Meta-analysis is a technique of combining results from different trials in order to obtain estimates of effects across studies. Meta-analysis has, as yet, rarely been used in audiological research. The aim of this paper was to conduct a meta-analysis on psychological treatment of tinnitus. The outcomes of 18 studies, including a total of 24 samples and up to 700 subjects, were included and coded. Included were studies on cognitive/cognitive-behavioural treatment, relaxation, hypnosis, biofeedback, educational sessions and problem-solving. Effect sizes for perceived tinnitus loudness, annoyance, negative affect (e.g. depression) and sleep problems were calculated for randomized controlled studies, pre-post-treatment design studies and follow-up results. Results showed strong to moderate effects on tinnitus annoyance for controlled studies (d = 0.86), pre-post designs (d = 0.5) and at follow-up (d = 0.48). Results on tinnitus loudness were weaker and disappeared at follow-up. Lower effect sizes were also obtained for measures of negative affect and sleep problems. Exploratory analyses revealed that cognitive-behavioural treatments were more effective on ratings of annoyance in the controlled studies. It is concluded that psychological treatment for tinnitus is effective, but that aspects such as depression and sleep problems may need to be targeted in future studies.

Bayesian Phase II optimization for time-to-event data based on historical information.

PubMed

Bertsche, Anja; Fleischer, Frank; Beyersmann, Jan; Nehmiz, Gerhard

2017-01-01

After exploratory drug development, companies face the decision whether to initiate confirmatory trials based on limited efficacy information. This proof-of-concept decision is typically performed after a Phase II trial studying a novel treatment versus either placebo or an active comparator. The article aims to optimize the design of such a proof-of-concept trial with respect to decision making. We incorporate historical information and develop pre-specified decision criteria accounting for the uncertainty of the observed treatment effect. We optimize these criteria based on sensitivity and specificity, given the historical information. Specifically, time-to-event data are considered in a randomized 2-arm trial with additional prior information on the control treatment. The proof-of-concept criterion uses treatment effect size, rather than significance. Criteria are defined on the posterior distribution of the hazard ratio given the Phase II data and the historical control information. Event times are exponentially modeled within groups, allowing for group-specific conjugate prior-to-posterior calculation. While a non-informative prior is placed on the investigational treatment, the control prior is constructed via the meta-analytic-predictive approach. The design parameters including sample size and allocation ratio are then optimized, maximizing the probability of taking the right decision. The approach is illustrated with an example in lung cancer.

Whole-Body Vibration Training and Its Application to Age-Related Performance Decrements: An Exploratory Analysis.

PubMed

Hawkey, Adam; Griffiths, Katie; Babraj, John; Cobley, James N

2016-02-01

Middle age is associated with a pronounced decline in power and flexibility. Whilst whole-body vibration training (WBVT) improves performance in a range of populations, whether WBVT can improve muscle power and flexibility in a middle-aged population is not known. The present study aimed to determine the influence of 5 weeks progressive WBVT in middle-aged (45-55 years) and younger (20-30 years) recreationally active females. Participants in each age group were randomly allocated to an intervention (WBVT) or control group. The WBVT groups trained for 5 weeks on a vibration platform, while the control groups performed identical exercises, with no vibration. Prior to, and after, the 5-week study vertical countermovement jump (VCMJ) and range of motion (ROM) performance were measured. WBVT significantly (p = 0.001) improved VCMJ performance when compared to the control groups. This improvement was significantly (p = 0.001) greater in the middle-aged compared with the younger WBVT group. WBVT significantly (p = 0.001) improved ROM irrespective of age. Taken together, these results suggest that WBVT can off-set age related performance decrements, which has therapeutic implications for musculoskeletal aging. Therefore, WBVT could be undertaken to minimise age-related performance deterioration in middle-aged female populations.

Yoga May Mitigate Decreases in High School Grades

PubMed Central

Butzer, Bethany; van Over, Max; Noggle Taylor, Jessica J.; Khalsa, Sat Bir S.

2015-01-01

This study involves an exploratory examination of the effects of a 12-week school-based yoga intervention on changes in grade point average (GPA) in 9th and 10th grade students. Participants included 95 high school students who had registered for physical education (PE) in spring 2010. PE class sections were group randomized to receive either a yoga intervention or a PE-as-usual control condition. The yoga intervention took place during the entire third quarter and half of the fourth quarter of the school year, and quarterly GPA was collected via school records at the end of the school year. Results revealed a significant interaction between group and quarter suggesting that GPA differed between the yoga and control groups over time. Post hoc tests revealed that while both groups exhibited a general decline in GPA over the school year, the control group exhibited a significantly greater decline in GPA from quarter 1 to quarter 3 than the yoga group. Both groups showed equivalent declines in GPA in quarter 4 after the yoga intervention had ended. The results suggest that yoga may have a protective effect on academic performance by preventing declines in GPA; however these preventive effects may not persist once yoga practice is discontinued. PMID:26347787

Exploratory Factor Analysis of the Anxiety Control Questionnaire among Older Adults

ERIC Educational Resources Information Center

Gerolimatos, Lindsay A.; Gould, Christine E.; Edelstein, Barry A.

2012-01-01

Among young adults and clinical populations, perceived inability to control internal and external events is associated with anxiety. At present, it is unclear what role perceived anxiety control plays in anxiety among older adults. The Anxiety Control Questionnaire (ACQ) was developed to assess one's perceived ability to cope with anxiety-related…

Striatopallidal neurons control avoidance behavior in exploratory tasks.

PubMed

LeBlanc, Kimberly H; London, Tanisha D; Szczot, Ilona; Bocarsly, Miriam E; Friend, Danielle M; Nguyen, Katrina P; Mengesha, Marda M; Rubinstein, Marcelo; Alvarez, Veronica A; Kravitz, Alexxai V

2018-04-25

The dorsal striatum has been linked to decision-making under conflict, but the mechanism by which striatal neurons contribute to approach-avoidance conflicts remains unclear. We hypothesized that striatopallidal dopamine D2 receptor (D2R)-expressing neurons promote avoidance, and tested this hypothesis in two exploratory approach-avoidance conflict paradigms in mice: the elevated zero maze and open field. Genetic elimination of D2Rs on striatopallidal neurons (iMSNs), but not other neural populations, increased avoidance of the open areas in both tasks, in a manner that was dissociable from global changes in movement. Population calcium activity of dorsomedial iMSNs was disrupted in mice lacking D2Rs on iMSNs, suggesting that disrupted output of iMSNs contributes to heightened avoidance behavior. Consistently, artificial disruption of iMSN output with optogenetic stimulation heightened avoidance of open areas of these tasks, while inhibition of iMSN output reduced avoidance. We conclude that dorsomedial striatal iMSNs control approach-avoidance conflicts in exploratory tasks, and highlight this neural population as a potential target for reducing avoidance in anxiety disorders.

Preventing obesity at weaning: parental views about the EMPOWER programme.

PubMed

Barlow, J; Whitlock, S; Hanson, S; Davis, H; Hunt, C; Kirkpatrick, S; Rudolf, M

2010-11-01

Infant growth and lifestyle are now recognized as being critical determinants of later obesity. EMPOWER (Empowering Parents to Prevent Obesity at Weaning: Exploratory Research) was developed as an intervention for parents whose babies are at high risk. Delivered by specially trained health visitors, it is underpinned by the Family Partnership Model and uses a strengths-based, solution-focused way of working with families. Mothers of babies participating in the pilot of EMPOWER in Leeds were recruited to take part in a study to examine perceptions about the programme's acceptability and usefulness. Interviews were taped and transcribed, and thematic analysis undertaken. Families talked positively about the approach of the EMPOWER health visitor with her emphasis on listening, partnership working and shared problem-solving. Parents particularly valued the use of a non-judgemental approach, which they felt had helped them to discuss openly, sensitive issues such as weight and diet. They identified a number of important benefits ranging from increased knowledge about the most appropriate types and amount of food to feed their toddler, to more far-reaching changes within the family as a whole, including modifications to their own diet and lifestyle. Programmes of this nature were perceived as more valuable than the standard help that is currently available. The EMPOWER programme appears to be both acceptable and valued by targeted parents and a potentially effective means of supporting high-risk families to prevent their children from developing obesity. An exploratory randomized controlled trial is now underway to ascertain the feasibility of conducting a definitive phase 3 trial. © 2010 Blackwell Publishing Ltd.

Can people catastrophize barriers? An exploratory analysis of the association between pain catastrophizing and perceptions of environmental factors.

PubMed

Ravesloot, Craig; Berendts, Cathy; Schiwal, Alex

2017-01-01

Measurement of the environment is taking on increased importance for understanding variability in participation. Most measures of the environment use subjective ratings, yet little is known about how people appraise the environment. /Hypothesis: We conducted this post-hoc study to examine whether or not catastrophizing, an important variable for understanding how pain contributes to disability, may be related to ratings of the environment. We hypothesized higher pain catastrophizing scores would be associated with greater environmental barriers and fewer facilitators. Individuals with functional impairments (N = 525) were recruited from a population-based random sample of households in a small western city in the United States to complete a paper-based survey about their health and community living experiences. We conducted exploratory regression analyses to investigate associations with environmental factor ratings. We found substantial associations between pain catastrophizing and both environmental barriers and personal factor problems after controlling for demographics, participation assessed by community trips per week, health conditions, impairment and pain level. The models accounted for 28% of the variance in environmental factor ratings and 52% of the variability personal factor ratings. We also present odds ratios for the association between personal characteristics and the likelihood of endorsing EF and PF. A variety of individual characteristics are associated with ratings of both environmental and personal factors that impact participation. Among these, pain catastrophizing is a robust predictor of EF and PF ratings which suggests future research designed specifically to test this relationship may generate useful results for developing interventions to increase participation. Copyright © 2016 Elsevier Inc. All rights reserved.

Specialist health visitor-led weight management intervention in primary care: exploratory evaluation.

PubMed

Jackson, Cath; Coe, Anne; Cheater, Francine M; Wroe, Stephen

2007-04-01

This paper is a report of an exploratory study to evaluate the effectiveness and acceptability of a specialist health visitor-led weight management clinic in primary care. Tackling obesity is a global health priority. Whilst there is evidence to support a role for primary healthcare professionals in its management, provision in England varies widely. Using designated 'obesity specialists' is an approach warranting further investigation. In 2003-2004, patients with a body mass index of 30 or more received a specialist health visitor-led intervention based on the Jan Felgens 'I2E2' model. Clinical outcome data and self-reported dietary consumption data were collected at weeks 1, 13, 27 and 52. Quantitative and qualitative data on patient acceptability of the clinic were collected at week 26. Eighty-nine patients attended the clinic. Mean body weight and body mass index and systolic and diastolic blood pressure decreased over time by statistically significant amounts. There was a non-significant decrease in fasting blood sugar over time, but approximately one in 10 patients with undiagnosed diabetes were identified. No statistically significant change was evident for cholesterol levels. Mean self-reported weekly consumption of cakes, desserts and snacks decreased and that of fruit and vegetables increased, each by statistically significant amounts. Participants found the clinic highly acceptable and identified the specialist health visitor as fundamental to its success. A partnership approach to weight management through which patients are empowered to make sustainable lifestyle changes now needs to be tested in a multi-centre randomized controlled trial.

Schooling as Violence: An Exploratory Overview.

ERIC Educational Resources Information Center

Harber, Clive

2002-01-01

Compulsory mass schooling has its origins in social control, resulting in authoritarianism and violence against students in the form of punishment. Control, power, and authoritarianism are also linked to schools' role in fostering violent behavior among students. (Contains 44 references.) (SK)

Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches.

PubMed

Vanderploeg, Rodney D; Schwab, Karen; Walker, William C; Fraser, Jamie A; Sigford, Barbara J; Date, Elaine S; Scott, Steven G; Curtiss, Glenn; Salazar, Andres M; Warden, Deborah L

2008-12-01

To determine the relative efficacy of 2 different acute traumatic brain injury (TBI) rehabilitation approaches: cognitive didactic versus functional-experiential, and secondarily to determine relative efficacy for different patient subpopulations. Randomized, controlled, intent-to-treat trial comparing 2 alternative TBI treatment approaches. Four Veterans Administration acute inpatient TBI rehabilitation programs. Adult veterans or active duty military service members (N=360) with moderate to severe TBI. One and a half to 2.5 hours of protocol-specific cognitive-didactic versus functional-experiential rehabilitation therapy integrated into interdisciplinary acute Commission for Accreditation of Rehabilitation Facilities-accredited inpatient TBI rehabilitation programs with another 2 to 2.5 hours daily of occupational and physical therapy. Duration of protocol treatment varied from 20 to 60 days depending on the clinical needs and progress of each participant. The 2 primary outcome measures were functional independence in living and return to work and/or school assessed by independent evaluators at 1-year follow-up. Secondary outcome measures consisted of the FIM, Disability Rating Scale score, and items from the Present State Exam, Apathy Evaluation Scale, and Neurobehavioral Rating Scale. The cognitive-didactic and functional-experiential treatments did not result in overall group differences in the broad 1-year primary outcomes. However, analysis of secondary outcomes found differentially better immediate posttreatment cognitive function (mean+/-SD cognitive FIM) in participants randomized to cognitive-didactic treatment (27.3+/-6.2) than to functional treatment (25.6+/-6.0, t332=2.56, P=.01). Exploratory subgroup analyses found that younger participants in the cognitive arm had a higher rate of returning to work or school than younger patients in the functional arm, whereas participants older than 30 years and those with more years of education in the functional arm had higher rates of independent living status at 1 year posttreatment than similar patients in the cognitive arm. Results from this large multicenter randomized controlled trial comparing cognitive-didactic and functional-experiential approaches to brain injury rehabilitation indicated improved but similar long-term global functional outcome. Participants in the cognitive treatment arm achieved better short-term functional cognitive performance than patients in the functional treatment arm. The current increase in war-related brain injuries provides added urgency for rigorous study of rehabilitation treatments. (http://ClinicalTrials.gov ID# NCT00540020.).

An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

PubMed

Son, Mi Ju; Im, Hwi-Jin; Ku, Boncho; Lee, Jun-Hwan; Jung, So Young; Kim, Young-Eun; Lee, Sung Bae; Kim, Jun Young; Son, Chang-Gue

2018-01-01

Introduction: Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration ( p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels ( p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire ( p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" ( p = 0.02). Five participants experienced minor adverse events, but no adverse events were specific to the GJD administration period. Conclusions: This trial produced the first clinical evidence that GJD might have anti-fatigue properties, especially under sleep deprivation; however, the investigation of cortisol-mediated mechanisms requires further larger-scale studies in the future. World Health Organization International Clinical Trials Registry Platform KCT0001681 (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=KCT0001681).

Rotigotine in Hemodialysis-Associated Restless Legs Syndrome: A Randomized Controlled Trial.

PubMed

Dauvilliers, Yves; Benes, Heike; Partinen, Markku; Rauta, Virpi; Rifkin, Daniel; Dohin, Elisabeth; Goldammer, Nadine; Schollmayer, Erwin; Schröder, Hanna; Winkelman, John W

2016-09-01

Restless legs syndrome (RLS) has been associated with insomnia, decreased quality of life, and increased morbidity and mortality in end-stage renal disease. This randomized controlled trial investigated effects of rotigotine in patients with RLS and end-stage renal disease. Double-blind placebo-controlled study. Adults with moderate to severe RLS (International RLS Study Group Rating Scale [IRLS] ≥ 15) and Periodic Limb Movement Index (PLMI) ≥ 15 who were receiving thrice-weekly hemodialysis enrolled from sites in the United States and Europe. Following randomization and titration (≤21 + 3 days) to optimal-dose rotigotine (1-3mg/24 h) or placebo, patients entered a 2-week maintenance period. Polysomnography was performed at baseline and the end of maintenance. Primary efficacy outcome: reduction in PLMI, assessed by ratio of PLMI at end of maintenance to baseline. Secondary/other outcomes (P values exploratory) included mean changes from baseline in PLMI, IRLS, and Clinical Global Impression item 1 (CGI-1 [severity of illness]) score. 30 patients were randomly assigned (rotigotine, 20; placebo, 10); 25 (15; 10) completed the study with evaluable data. Mean (SD) PLMI ratio (end of maintenance to baseline) was 0.7±0.4 for rotigotine and 1.3±0.7 for placebo (analysis of covariance treatment ratio, 0.44; 95% CI, 0.22 to 0.88; P=0.02). Numerical improvements were observed with rotigotine versus placebo in IRLS and CGI-1 (least squares mean treatment differences of -6.08 [95% CI, -12.18 to 0.02; P=0.05] and -0.81 [95% CI, -1.94 to 0.33; P=0.2]). 10 of 15 rotigotine and 2 of 10 placebo patients were CGI-1 responders (≥50% improvement). Hemodialysis did not affect unconjugated rotigotine concentrations. The most common adverse events (≥2 patients) were nausea (rotigotine, 4 [20%]; placebo, 0); vomiting (3 [15%]; 0); diarrhea (1 [5%]; 2 [20%]); headache (2 [10%]; 0); dyspnea (2 [10%]; 0); and hypertension (2 [10%]; 0). Small sample size and short duration. Rotigotine improved periodic limb movements and RLS symptoms in the short term among ESRD patients requiring hemodialysis in a small-scale study. No dose adjustments are necessary for hemodialysis patients. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial.

PubMed

Larsson, S; Struglics, A; Lohmander, L S; Frobell, R

2017-09-01

Prospectively monitor how treatment of acutely ruptured anterior cruciate ligament (ACL) affects biomarkers of inflammation and proteolytic degradation over 5 years. We studied 119 subjects with acute ACL injury from the randomized controlled knee anterior cruciate ligament, non-surgical versus surgical treatment (KANON)-trial (Clinical trial ISRCTN 84752559) who had synovial fluid, serum and urine samples available from at least two out of six visits over 5 years after acute ACL rupture. All subjects followed a similar rehabilitation protocol where, according to randomization, 60 also had early ACL reconstruction and 59 had the option to undergo a delayed ACL reconstruction if needed. Interleukin (IL)-6, IL-8, IL-10, interferon-gamma (IFNγ), tumor necrosis factor (TNF), amino acids alanine, arginine, glycine, serine (ARGS)-aggrecan, C-terminal crosslinking telopeptide type II collagen (CTX-II) and N-terminal crosslinking telopeptide type I collagen (NTX-I) were quantified by enzyme-linked immunosorbent assays (ELISA). Subjects randomized to early ACL reconstruction had higher cytokine concentrations in index knee synovial fluid at 4 months (IL-6, IL-8, IL-10, TNF), 8 months (IL-6 and TNF) and at 5 years (IFNγ) compared to those randomized to optional delayed reconstruction. Those that underwent delayed ACL reconstruction within 5 years (30 subjects), had higher synovial fluid concentrations of IL-6 at 5 years compared to those treated with rehabilitation alone. No differences between groups were noted for ARGS-aggrecan in synovial fluid and serum or CTX-II and NTX-I in urine over 5 years, neither as randomized nor as treated. Surgical ACL reconstruction constitutes a second trauma to the acutely injured joint resulting in a prolonged elevation of already high synovial fluid levels of inflammatory cytokines. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Are SGLT2 inhibitors reasonable antihypertensive drugs and renoprotective?

PubMed

Lovshin, J A; Gilbert, R E

2015-06-01

By eliminating glucose in the urine, the sodium-glucose-linked cotransporter-2 (SGLT2) inhibitors act as osmotic diuretics to lower blood pressure in addition to reducing plasma glucose and assisting with weight loss. While not approved as antihypertensive agents, the ability of this new class of antihyperglycemic agents to lower blood pressure is not insubstantial, and while not used primarily for this indication, they may assist diabetic individuals in attaining currently recommended blood pressure targets. In addition to lowering systemic pressure, preclinical and exploratory human studies suggest that SGLT2 inhibitors may also lower intraglomerular pressure, potentially reducing the rate of GFR decline in patients with diabetic nephropathy. However, given the lack of clinically meaningful endpoint data, the use of SGLT2 inhibitors, primarily, as either antihypertensive or renoprotective agents would, at present, be premature. Fortunately, further insight will be garnered from large, randomized controlled trials that will assess the effects of various SGLT2 inhibitors on cardiovascular and renal outcomes.

Predictors of response to Systems Training for Emotional Predictability and Problem Solving (STEPPS) for borderline personality disorder: an exploratory study.

PubMed

Black, D W; Allen, J; St John, D; Pfohl, B; McCormick, B; Blum, N

2009-07-01

Few predictors of treatment outcome or early discontinuation have been identified in persons with borderline personality disorder (BPD). The aim of the study was to examine the relationship between baseline clinical variables and treatment response and early discontinuation in a randomized controlled trial of System Training for Emotional Predictability and Problem Solving, a new cognitive group treatment. Improvement was rated using the Zanarini Rating Scale for BPD, the Clinical Global Impression Scale, the Global Assessment Scale and the Beck Depression Inventory. Subjects were assessed during the 20 week trial and a 1-year follow-up. Higher baseline severity was associated with greater improvement in global functioning and BPD-related symptoms. Higher impulsivity was predictive of early discontinuation. Optimal improvement was associated with attending > or = 15 sessions. Subjects likely to improve have the more severe BPD symptoms at baseline, while high levels of impulsivity are associated with early discontinuation.

Complementary and Alternative Medicine for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

PubMed Central

2005-01-01

To discuss challenges concerning treatment for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and review complementary and alternative medical (CAM) therapies being evaluated for this condition, we performed a comprehensive search of articles published from 1990–2005 using the PubMed, Medline databases. Data from the articles were abstracted and pooled by subject. Keywords cross-searched with CP/CPPS included: complementary, alternative, integrative, therapies, interventions, nutrition, antioxidants, herbs, supplements, biofeedback and acupuncture. Listed articles with no abstracts were not included. Various CAM therapies for CP/CPPS exist including biofeedback, acupuncture, hyperthermia and electrostimulation. Additionally, a variety of in vitro and in vivo studies testing herbal and nutritional supplements were found. Saw palmetto, cernilton and quercetin were the most frequently tested supplements for CP/CPPS. Although many CAM therapies demonstrate positive preliminary observations as prospective treatments for CP/CPPS, further exploratory studies including more randomized, controlled trials are necessary for significant validation as treatment options for this complex disorder. PMID:16322807

Benchmarking to improve the quality of cystic fibrosis care.

PubMed

Schechter, Michael S

2012-11-01

Benchmarking involves the ascertainment of healthcare programs with most favorable outcomes as a means to identify and spread effective strategies for delivery of care. The recent interest in the development of patient registries for patients with cystic fibrosis (CF) has been fueled in part by an interest in using them to facilitate benchmarking. This review summarizes reports of how benchmarking has been operationalized in attempts to improve CF care. Although certain goals of benchmarking can be accomplished with an exclusive focus on registry data analysis, benchmarking programs in Germany and the United States have supplemented these data analyses with exploratory interactions and discussions to better understand successful approaches to care and encourage their spread throughout the care network. Benchmarking allows the discovery and facilitates the spread of effective approaches to care. It provides a pragmatic alternative to traditional research methods such as randomized controlled trials, providing insights into methods that optimize delivery of care and allowing judgments about the relative effectiveness of different therapeutic approaches.

A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

PubMed

Blanc-Bisson, C; Dechamps, A; Gouspillou, G; Dehail, P; Bourdel-Marchasson, I

2008-01-01

To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual care. acute care geriatric medicine ward. A total of 76 acutely ill patients, acutely bedridden or with reduced mobility but who were autonomous for mobility within the previous 3 months. Patients in palliative care or with limiting mobility pathology were excluded. Mean age was 85.4 (SD 6.6) years. At admission, at clinical stability and one month later: anthropometry, energy and protein intakes, hand grip strength, ADL scores, and baseline inflammatory parameters. An exploratory principal axis analysis was performed on the baseline characteristics and general linear models were used to explore the course of ADL and nutritional variables. A 4-factor solution was found explaining 71.7% of variance with a factor "nutrition", a factor "function" (18.8% of variance) for ADL, handgrip strength, bedridden state, energy and protein intakes, serum albumin and C-reactive protein concentrations; a factor "strength" and a fourth factor . During follow-up, dietary intakes, handgrip strength, and ADL scores improved but no changes occurred for anthropometric variables. Intervention was associated only with an increase in protein intake. Better improvement in ADL was found in intervention group when model was adjusted on "function" factor items. Physical intervention programs should be proposed according to nutritional intakes with the aim of preventing illness induced disability.

Brief Report: HIV Assisted Partner Services Among Those With and Without a History of Intimate Partner Violence in Kenya.

PubMed

Goyette, Marielle S; Mutiti, Peter M; Bukusi, David; Wamuti, Beatrice M; Otieno, Felix A; Cherutich, Peter; Golden, Matthew R; Spiegel, Hans; Richardson, Barbra A; Ngʼangʼa, Anne; Farquhar, Carey

2018-05-01

HIV assisted partner services (APS) are a notification and testing strategy for sex partners of HIV-infected index patients. This cluster-randomized controlled trial secondary data analysis investigated whether history of intimate partner violence (IPV) modified APS effectiveness and risk of relationship dissolution. Eighteen HIV testing and counseling sites in Kenya randomized to provide immediate APS (intervention) or APS delayed for 6 weeks (control). History of IPV was ascertained at study enrollment and defined as reporting ever experiencing physical or sexual IPV. Those reporting IPV in the month before enrollment were excluded. We tested whether history of IPV modified intervention effectiveness and risk of relationship dissolution using population-averaged Poisson and log-binomial generalized estimating equation models. Exploratory analyses investigated associations between history of IPV and events that occurred after HIV diagnosis using log-binomial generalized estimating equation models. The study enrolled 1119 index participants and 1286 partners. Among index participants, 81 (7%) had history of IPV. History of IPV did not modify APS effectiveness in testing, newly diagnosing, or linking partners to care. History of IPV did not modify the association between receiving immediate APS and relationship dissolution during the study. Among participants who had not experienced IPV in the last month but had experienced IPV in their lifetimes, our results suggest that APS is an effective and safe partner notification strategy in Kenya. As APS is scaled up in different contexts, these data support including those reporting past IPV and closely monitoring adverse events.

Predictors and moderators in the randomized trial of multifamily psychoeducational psychotherapy for childhood mood disorders.

PubMed

MacPherson, Heather A; Algorta, Guillermo Perez; Mendenhall, Amy N; Fields, Benjamin W; Fristad, Mary A

2014-01-01

This study investigated predictors and moderators of mood symptoms in the randomized controlled trial (RCT) of Multi-Family Psychoeducational Psychotherapy (MF-PEP) for childhood mood disorders. Based on predictors and moderators in RCTs of psychosocial interventions for adolescent mood disorders, we hypothesized that children's greater functional impairment would predict worse outcome, whereas children's stress/trauma history and parental expressed emotion and psychopathology would moderate outcome. Exploratory analyses examined other demographic, functioning, and diagnostic variables. Logistic regression and linear mixed effects modeling were used in this secondary analysis of the MF-PEP RCT of 165 children, ages 8 to 12, with mood disorders, a majority of whom were male (73%) and White, non-Hispanic (90%). Treatment nonresponse was significantly associated with higher baseline levels of global functioning (i.e., less impairment; Cohen's d = 0.51) and lower levels of stress/trauma history (d = 0.56) in children and Cluster B personality disorder symptoms in parents (d = 0.49). Regarding moderators, children with moderately impaired functioning who received MF-PEP had significantly decreased mood symptoms (t = 2.10, d = 0.33) compared with waitlist control. MF-PEP had the strongest effect on severely impaired children (t = 3.03, d = 0.47). Comprehensive assessment of demographic, youth, parent, and familial variables should precede intervention. Treatment of mood disorders in high-functioning youth without stress/trauma histories and with parents with elevated Cluster B symptoms may require extra therapeutic effort, whereas severely impaired children may benefit most from MF-PEP.

A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial.

PubMed

Cheville, Andrea L; Kollasch, Jenny; Vandenberg, Justin; Shen, Tiffany; Grothey, Axel; Gamble, Gail; Basford, Jeffrey R

2013-05-01

Exercise benefits patients with cancer, but studies of home-based approaches, particularly among those with Stage IV disease, remain small and exploratory. To conduct an adequately powered trial of a home-based exercise intervention that can be facilely integrated into established delivery and reimbursement structures. Sixty-six adults with Stage IV lung or colorectal cancer were randomized, in an eight-week trial, to usual care or incremental walking and home-based strength training. The exercising participants were instructed during a single physiotherapy visit and subsequently exercised four days or more per week; training and step-count goals were advanced during bimonthly telephone calls. The primary outcome measure was mobility assessed with the Ambulatory Post Acute Care Basic Mobility Short Form. Secondary outcomes included ratings of pain and sleep quality as well as the ability to perform daily activities (Ambulatory Post Acute Care Daily Activities Short Form), quality of life (Functional Assessment of Cancer Therapy-General), and fatigue (Functional Assessment of Cancer Therapy-Fatigue). Three participants dropped out and seven died (five in the intervention and two in the control group, P=0.28). At Week 8, the intervention group reported improved mobility (P=0.01), fatigue (P=0.02), and sleep quality (P=0.05) compared with the usual care group, but did not differ on the other measures. A home-based exercise program seems capable of improving the mobility, fatigue, and sleep quality of patients with Stage IV lung and colorectal cancer. Copyright © 2013. Published by Elsevier Inc.

Optimizing Implementation of Obesity Prevention Programs: A Qualitative Investigation Within a Large-Scale Randomized Controlled Trial.

PubMed

Kozica, Samantha L; Teede, Helena J; Harrison, Cheryce L; Klein, Ruth; Lombard, Catherine B

2016-01-01

The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs. © 2015 National Rural Health Association.

Differences between Supportive Music and Imagery and Music Listening during Outpatient Chemotherapy and Potential Moderators of Treatment Effects.

PubMed

Burns, Debra S; Meadows, Anthony N; Althouse, Sandra; Perkins, Susan M; Cripe, Larry D

2018-03-09

Supportive music and imagery and music listening interventions have been effective in decreasing distress and improving mood in cancer patients receiving chemotherapy, but it is unclear whether the two interventions differ in their treatment benefits. Furthermore, previous studies have not examined moderators to determine which subgroup(s) of patients may benefit most from each intervention. To examine the effects of supportive music and imagery compared with preferred music listening on responsiveness to music therapy, distress, anxiety and depression, and benefit finding. A secondary purpose was to explore sense of coherence and locus of control as potential moderators of intervention effectiveness. A single-session, two-group comparative effectiveness randomized trial in two cancer centers. Patients were randomized to supportive music and imagery or preferred music listening during outpatient chemotherapy treatment. Data were collected at baseline and immediately after the 45-minute session. ANCOVA models were used to determine main effects of intervention as well as pairing potential moderators with group assignment to explore differences in intervention effects by moderator. There were differential effects between the two interventions with the supportive music and imagery group scoring higher in responsiveness to music therapy and benefit finding. The music listening group scores indicated lower distress. The exploratory moderating analyses suggested Health Locus of Control-Internal and Sense of Coherence influenced intervention effectiveness. Music and imagery and preferred music listening experiences may serve different therapeutic purposes, access and activate different patient resources, and may be helpful at different stages of treatment.

Randomized control trial: Online parent program and waiting period for unmarried parents in Title IV-D court.

PubMed

Rudd, Brittany N; Holtzworth-Munroe, Amy; Reyome, Jason G; Applegate, Amy G; D'Onofrio, Brian M

2015-10-01

Despite a lack of research on parent education programs for unmarried parents, many judicial officers mandate participation. We recruited an understudied sample likely at high risk for negative outcomes-182 court cases involving unmarried parents on government assistance in which paternity was contested and then established via genetic testing ordered by the court. This 2 × 2 randomized controlled trial evaluated the impact on initial litigation outcomes of two factors: (a) participation in an online parent education program or not and (b) having a waiting period between the establishment of paternity and the court hearing concerning child-related issues or not. Using an intent-to-treat framework, we found that among cases not assigned to the program, there was no difference in the rate of full agreement on child-related issues (e.g., child support, custody, parenting time) when comparing cases assigned to a waiting period and cases not assigned to a waiting period. In contrast, for cases assigned to the program, cases also assigned a waiting period were less likely to reach a full agreement than cases that had their hearing on the same day. In addition, cases in the "program and waiting period" condition were less likely to return to court for their hearing than cases in the "no program and waiting period" condition. In exploratory analyses of the subsample of cases in which both parents were present at the court hearing, the pattern of results remained the same, although the findings were no longer statistically significant. (c) 2015 APA, all rights reserved).

Effect of Extra Virgin Olive Oil on Biomarkers of Inflammation in HIV-Infected Patients: A Randomized, Crossover, Controlled Clinical Trial

PubMed Central

Dokmanović, Sanja Kozić; Kolovrat, Krunoslava; Laškaj, Renata; Jukić, Vedrana; Vrkić, Nada; Begovac, Josip

2015-01-01

Background Premature atherosclerosis in HIV-infected patients is associated with chronic infection by itself and adverse effects of antiretroviral treatment (ART). Extra virgin olive oil (EVOO) has a beneficial effect on the cardiovascular system because of its anti-inflammatory properties. The objective of this study was to determine whether the consumption of EVOO improves inflammation and atherosclerosis biomarkers in HIV-infected patients receiving ART. Material/Methods This randomized, crossover, controlled trial included 39 HIV-positive male participants who consumed 50 mL of EVOO or refined olive oil (ROO) daily. Four participants dropped out of the study. Leukocyte count, erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein (hsCRP), interleukin-6, fibrinogen, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, malondialdehyde, glutathione-peroxidase, superoxide dismutase, oxidized LDL and von Willebrand factor were determined before the first and after each of the 2 intervention periods. Intervention and washout periods lasted for 20 and 14 days, respectively. Results In participants with >90% compliance (N=30), hsCRP concentrations were lower after EVOO intervention (geometric mean [GM], 1.70 mg/L; 95% confidence interval [CI], 1.15–2.52) compared to ROO administration (GM, 2.92 mg/L; 95% CI, 1.95–4.37) (p=0.035). In participants using lopinavir/ritonavir, ESR and hsCRP concentrations decreased 62% and 151%, respectively, after EVOO administration. In the whole study population (N=35) we found no difference in analyzed biomarkers after EVOO administration. Conclusions Our exploratory study suggests that EVOO consumption could lower hsCRP in patients on ART. PMID:26280823

A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer.

PubMed

Carducci, Michael A; Saad, Fred; Abrahamsson, Per-Anders; Dearnaley, David P; Schulman, Claude C; North, Scott A; Sleep, Darryl J; Isaacson, Jeffrey D; Nelson, Joel B

2007-11-01

The objective of this study was to evaluate the efficacy and safety of atrasentan (Xinlay), a selective endothelin-A receptor antagonist, in patients with metastatic hormone-refractory prostate cancer (HRPC). This multinational, double-blind, placebo-controlled trial enrolled 809 men with metastatic HRPC. Patients were randomized 1:1 to receive either atrasentan 10 mg per day or placebo. The primary endpoint was time to disease progression (TTP), which was determined according to radiographic and clinical measures. Analyses of overall survival and changes in biomarkers also were performed. Atrasentan did not reduce the risk of disease progression relative to placebo (hazards ratio, 0.89; 95% confidence interval, 0.76-1.04; P = .136). Most patients progressed radiographically at the first 12-week bone scan without concomitant clinical progression. In exploratory analyses, increases from baseline to final bone alkaline phosphatase (BAP) and prostate-specific antigen (PSA) levels were significantly lower with atrasentan treatment (P < .05 for each). The median time to BAP progression (>/=50% increase from nadir) was twice as long with atrasentan treatment (505 days vs 254 days; P < .01). The delay in time to PSA progression did not reach statistical significance. Atrasentan generally was tolerated well, and the most common adverse events associated with treatment were headache, rhinitis, and peripheral edema, reflecting the vasodilatory and fluid-retention properties of endothelin-A receptor antagonism. Atrasentan did not delay disease progression in men with metastatic HRPC despite evidence of biologic effects on PSA and BAP as markers of disease burden.

Health Philosophy of Dietitians and Its Implications for Life Satisfaction: An Exploratory Study

PubMed Central

Grace-Farfaglia, Patricia; Pickett-Bernard, Denise; White Gorman, Andrea; Dehpahlavan, Jaleh

2017-01-01

Studies of health providers suggest that satisfaction with life is related to their values and sense of purpose which is best achieved when their professional role is in harmony with personal philosophy. Cross-sectional surveys suggest that personal health beliefs and practices of health professionals influence their clinical counseling practices. However, little is known about the influence of health philosophy on the personal satisfaction with life for dietitians. This study recruited a randomly selected, cross-sectional sample to complete a self-administered online survey. An exploratory factor analysis of was conducted for 479 participants resulting in a two-factor solution, clinical (α = 0.914) and wellness (α = 0.894) perceptions of health. An index score for the following valid and reliable scales were calculated: satisfaction with life, health conception, and healthy lifestyle and personal control. Pearson correlation coefficients between scores were analyzed to determine the degree of relationship. Potential mediators were explored with multiple regression. The relationships between variables were tested with structural equation modeling using a multigroup comparison between genders. The male participants were removed from the overall model and were separately evaluated. Health philosophy that is oriented toward wellness, was positively and significantly associated with life satisfaction, r(462) = 0.103, p < 0.05. Participants with higher Healthy Lifestyle and Personal Control scores reported greater life satisfaction, r(462) = 0.27, p = 0.000. Healthy lifestyle alone predicted 8.8% of the variance in life satisfaction (R2 = 0.088, df 1462, p = 0.005). SEM confirmed the model had goodness-of-fit (χ2 = 2.63, p = 0.453). The satisfaction with life of dietitians is directly and positively influenced by a greater wellness orientation and personal healthy lifestyle practices. The effect of practice and lifestyle on life satisfaction appears to be greater for men. PMID:29048357

Configural frequency analysis as a method of determining patients' preferred decision-making roles in dialysis.

PubMed

Loeffert, Sabine; Ommen, Oliver; Kuch, Christine; Scheibler, Fueloep; Woehrmann, Andrej; Baldamus, Conrad; Pfaff, Holger

2010-09-11

Numerous studies examined factors in promoting a patient preference for active participation in treatment decision making with only modest success. The purpose of this study was to identify types of patients wishing to participate in treatment decisions as well as those wishing to play a completely active or passive role based on a Germany-wide survey of dialysis patients; using a prediction typal analysis method that defines types as configurations of categories belonging to different attributes and takes particularly higher order interactions between variables into account. After randomly splitting the original patient sample into two halves, an exploratory prediction configural frequency analysis (CFA) was performed on one-half of the sample (n = 1969) and the identified types were considered as hypotheses for an inferential prediction CFA for the second half (n = 1914). 144 possible prediction types were tested by using five predictor variables and control preferences as criterion. An α-adjustment (0.05) for multiple testing was performed by the Holm procedure. 21 possible prediction types were identified as hypotheses in the exploratory prediction CFA; four patient types were confirmed in the confirmatory prediction CFA: patients preferring a passive role show low information seeking preference, above average trust in their physician, perceive their physician's participatory decision-making (PDM)-style positive, have a lower educational level, and are 56-75 years old (Type 1; p < 0.001) or > 76 years old (Type 2; p < 0.001). Patients preferring an active role show high information seeking preference, a higher educational level, and are < 55 years old. They have either below average trust, perceive the PDM-style negative (Type 3; p < 0.001) or above average trust and perceive the PDM-style positive (Type 4; p < 0.001). The method prediction configural frequency analysis was newly introduced to the research field of patient participation and could demonstrate how a particular control preference role is determined by an association of five variables.

Exploring online communication about cigarette smoking among Twitter users who self-identify as having schizophrenia

PubMed Central

Hswen, Yulin; Naslund, John A.; Chandrashekar, Pooja; Siegel, Robert; Brownstein, John S.; Hawkins, Jared B.

2018-01-01

Novel approaches are needed to address elevated tobacco use among people with schizophrenia. This exploratory study examined the frequency, timing, and type of communication about tobacco-related content on Twitter among users who self-identify as having schizophrenia compared with users from the general population. Over a 200-day period from January to July 2016, Twitter users who self-identify as having a schizophrenia spectrum disorder (n = 203) and a randomly selected group of general population control users (n = 173) posted 1,544,122 tweets. Communication frequency did not differ between groups. Tweets containing tobacco-related keywords were extracted. Twitter users with schizophrenia posted significantly more tweets containing any tobacco-related terms (mean = 3.74; SD = 16.3) compared with control users (mean = 0.82; SD = 1.8). A significantly greater proportion of Twitter users with schizophrenia (45%; n = 92) posted tweets containing any tobacco terms compared with control users (30%; n = 52). Schizophrenia users showed significantly greater odds of tweeting about tobacco compared with control users (OR = 1.99; 95% CI 1.29–3.07). These findings suggest that online communication about tobacco may parallel real world trends of elevated tobacco use observed among people with schizophrenia. By showing that Twitter users who self-identify as having schizophrenia discuss tobacco-related content online, popular social media could inform smoking cessation efforts targeting this at-risk group. PMID:28841509

The Effects of Blood Flow Restricted Electrostimulation on Strength and Hypertrophy.

PubMed

Slysz, Joshua T; Burr, Jamie F

2018-05-22

The combined effect of neuromuscular electrical stimulation (NMES) and blood flow restriction (BFR) on muscle mass and strength has not been thoroughly investigated. To examine the effects of combined and independent BFR and a low-intensity NMES on skeletal muscle adaptation. Exploratory study. Laboratory. Twenty recreationally active subjects. Subjects had each leg randomly allocated to 1 of 4 possible intervention groups: (1) cyclic BFR alone, (2) NMES alone, (3) BFR + NMES, or (4) control. Each leg was stimulated in its respective intervention group for 32 minutes, 4 days per week for 6 weeks. Mean differences in size (in grams) and isometric strength (in kilograms), between week 0 and week 6, were calculated for each group. Leg strength increased 32 (19) kg in the BFR + NMES group, which differed from the 3 (11) kg change in the control group (P = .03). The isolated NMES and BFR groups revealed increases of 16 (28) kg and 18 (17) kg, respectively, but these did not statistically differ from the control, or one another. No alterations were statistically significant for leg size. Compared with a control that received no treatment, the novel combination of BFR and NMES led to increasing muscular strength of the knee extensors, but not muscle mass which had a large interindividual variability in response.

New Submerged-Robot Control Optical Fiber Cable With Small-Diameter, High-Strength Frp Covered Optical Fiber

NASA Astrophysics Data System (ADS)

Fuse, K.; Shirasaka, Y.; Yanagawa, H.

1984-10-01

Of natural resources on the earth, the utilization of the oceans has the oldest history, and the development of them has been delayed most. However, hot expectation is being placed on the development of the oceans. The element that obstructs the acceleration of such development is the sea itself. From a technical viewpoint, the means to explore the oceans have not been developed sufficiently, and equipment such as special large vehicles and ships has been bulky, requiring a very large sum of money to prepare them. These have been part of the reasons why the development of the oceans has been delayed. For this reason, a large number of exploratory systems will be studied as the ocean development becomes active in the near future. A single optical fiber cable has been considered as a cable for control of an ocean exploratory robot, which weighs approximately 30 to 40 kg at most in air requiring no power feeding to the drive section inside the vehicle and running by self on a built-in battery, as well as for data transfer. This cable is believed most suitable in terms of high speed mobility, transmission characteristics, and system cost. The mode (system) of pay off of the cable paid off by the ship loading such a cable becomes very important in the design of optical fiber cables for control of ocean exploratory robots. This paper introduces a new FRP covered optical fiber cable developed as an optical fiber cable for control of ocean exploratory robots with a small diameter and rotating motion. This cable is considered most suitable for the pay off-system which is simple and offers the highest space utility. The paper describes a basic study made prior to an actual performance test in the sea, as well as its design and characteristics.

Virtual Reality Exposure Training for Musicians: Its Effect on Performance Anxiety and Quality.

PubMed

Bissonnette, Josiane; Dubé, Francis; Provencher, Martin D; Moreno Sala, Maria T

2015-09-01

Music performance anxiety affects numerous musicians, with many of them reporting impairment of performance due to this problem. This exploratory study investigated the effects of virtual reality exposure training on students with music performance anxiety. Seventeen music students were randomly assigned to a control group (n=8) or a virtual training group (n=9). Participants were asked to play a musical piece by memory in two separate recitals within a 3-week interval. Anxiety was then measured with the Personal Report of Confidence as a Performer Scale and the S-Anxiety scale from the State-Trait Anxiety Inventory (STAI-Y). Between pre- and post-tests, the virtual training group took part in virtual reality exposure training consisting of six 1-hour long sessions of virtual exposure. The results indicate a significant decrease in performance anxiety for musicians in the treatment group for those with a high level of state anxiety, for those with a high level of trait anxiety, for women, and for musicians with high immersive tendencies. Finally, between the pre- and post-tests, we observed a significant increase in performance quality for the experimental group, but not for the control group.

Comparing the Effect of Thinking Maps Training Package Developed by the Thinking Maps Method on the Reading Performance of Dyslexic Students.

PubMed

Faramarzi, Salar; Moradi, Mohammadreza; Abedi, Ahmad

2018-06-01

The present study aimed to develop the thinking maps training package and compare its training effect with the thinking maps method on the reading performance of second and fifth grade of elementary school male dyslexic students. For this mixed method exploratory study, from among the above mentioned grades' students in Isfahan, 90 students who met the inclusion criteria were selected by multistage sampling and randomly assigned into six experimental and control groups. The data were collected by reading and dyslexia test and Wechsler Intelligence Scale for Children-fourth edition. The results of covariance analysis indicated a significant difference between the reading performance of the experimental (thinking maps training package and thinking maps method groups) and control groups ([Formula: see text]). Moreover, there were significant differences between the thinking maps training package group and thinking maps method group in some of the subtests ([Formula: see text]). It can be concluded that thinking maps training package and the thinking maps method exert a positive influence on the reading performance of dyslexic students; therefore, thinking maps can be used as an effective training and treatment method.

EMPOWER: An Intervention to Address Barriers to Pain Management in Hospice

PubMed Central

Cagle, John G.; Zimmerman, Sheryl; Cohen, Lauren W.; Porter, Laura S.; Hanson, Laura C.; Reed, David

2017-01-01

Context Concerns about pain medications are major barriers to pain management in hospice, but few studies have focused on systematic methods to address these concerns. Objective We conducted a pilot cluster randomized controlled trial with four hospices to test preliminary efficacy of the EMPOWER intervention which included: hospice staff education; staff screening of barriers to pain management at admission; and discussion about misunderstandings regarding pain management with family caregivers and patients. Methods 126 family caregivers (55 intervention; 71 control) were interviewed at two weeks post-admission. If patients survived three months post-admission, caregivers were re-interviewed. Results At two weeks, caregivers in the intervention group reported better knowledge about pain management (p=.001), fewer concerns about pain and pain medications (p=.008), and lower patient pain over the past week (p=.014); and trended toward improvement in most other areas under study. Exploratory analyses suggest EMPOWER had a greater effect for Black subjects (vs. Whites) on reducing concern about stigma. At three months, the intervention group trended better on most study outcomes. Conclusion EMPOWER is a promising model to reduce barriers to pain management in hospice. PMID:24880000

An Exploratory Study of Spirituality in HIV Infected Adolescents and their Families: FAmily CEntered Advance Care Planning and Medication Adherence

PubMed Central

Lyon, Maureen E.; Garvie, Patricia A.; Kao, Ellin; Briggs, Linda; He, Jianping; Malow, Robert; D’Angelo, Lawrence J.; McCarter, Robert

2010-01-01

Purpose To explore the impact of spirituality and religious beliefs on FAmily CEntered (FACE) Advance Care Planning and medication adherence in HIV+ adolescents and their surrogate decision-makers. Methods A sample of HIV+ adolescents (n=40) and their surrogates, age 21 or older, (n=40) was randomized to an active Healthy Living Control group or the FACE Advance Care Planning intervention, guided by transactional stress and coping theory. Adolescents’ spirituality was assessed at baseline and 3 months post-intervention, using the FACIT-SP-4-EX, as was the belief that HIV is a punishment from God. Results Control adolescents increased faith and meaning/purpose more so than FACE adolescents (p=0.02). At baseline more behaviorally (16%) vs. perinatally (8%) infected adolescents believed HIV was a punishment from God, but not at 3-months post-intervention. Adolescents endorsing HIV was a punishment scored lower on spirituality (p=.05) and adherence to HAART (p= .04). Surrogates were more spiritual than adolescents (p=<.0001). Conclusion Providing family support in a friendly, facilitated, environment enhanced adolescents’ spirituality. Facilitated family conversations had an especially positive effect on behaviorally infected adolescents’ medication adherence and spiritual beliefs. PMID:21575826

Review of recent non-hyperbaric oxygen interventions for mild traumatic brain injury.

PubMed

Wilson, Steffanie H; Roth, Michael; Lindblad, Anne S; Weaver, Lindell K

2016-01-01

Traumatic brain injury (TBI) affects 3.2 to 5.3 million persons in the United States (U.S.), and the impact in the U.S. military is proportionally higher. Consensus is lacking regarding an accepted outcome to measure the effectiveness of interventions to improve the symptoms associated with TBI, and no standard-of-care treatment exists for mild TBI (mTBI). A recent literature review evaluated hyperbaric oxygen therapy (HBO₂) interventions, and findings were mixed. We conducted a systematic review of non-HBO₂ mTBI interventional trials published in 2005-2015 in military and civilian populations. A total of 154 abstracts, seven randomized controlled trials (RCTs) and five pilot studies were reviewed. RCTs were evaluated using Consolidated Standards of Reporting Trials criteria. Results indicated that studies published within the period of review were small pilot studies for rehabilitation therapy and motion capture or virtual reality gaming interventions. Neuropsychological assessments were commonly specified outcomes, and most studies included a combination of symptom and neuropsychological assessments. Findings indicated a lack of large-scale, well-controlled trials to address the symptoms and sequelae of this condition, but results of small exploratory studies show evidence of potentially promising interventions. Copyright© Undersea and Hyperbaric Medical Society.

Cost-effectiveness analysis of lifestyle intervention in obese infertile women.

PubMed

van Oers, A M; Mutsaerts, M A Q; Burggraaff, J M; Kuchenbecker, W K H; Perquin, D A M; Koks, C A M; van Golde, R; Kaaijk, E M; Schierbeek, J M; Klijn, N F; van Kasteren, Y M; Land, J A; Mol, B W J; Hoek, A; Groen, H

2017-07-01

What is the cost-effectiveness of lifestyle intervention preceding infertility treatment in obese infertile women? Lifestyle intervention preceding infertility treatment as compared to prompt infertility treatment in obese infertile women is not a cost-effective strategy in terms of healthy live birth rate within 24 months after randomization, but is more likely to be cost-effective using a longer follow-up period and live birth rate as endpoint. In infertile couples, obesity decreases conception chances. We previously showed that lifestyle intervention prior to infertility treatment in obese infertile women did not increase the healthy singleton vaginal live birth rate at term, but increased natural conceptions, especially in anovulatory women. Cost-effectiveness analyses could provide relevant additional information to guide decisions regarding offering a lifestyle intervention to obese infertile women. The cost-effectiveness of lifestyle intervention preceding infertility treatment compared to prompt infertility treatment was evaluated based on data of a previous RCT, the LIFEstyle study. The primary outcome for effectiveness was the vaginal birth of a healthy singleton at term within 24 months after randomization (the healthy live birth rate). The economic evaluation was performed from a hospital perspective and included direct medical costs of the lifestyle intervention, infertility treatments, medication and pregnancy in the intervention and control group. In addition, we performed exploratory cost-effectiveness analyses of scenarios with additional effectiveness outcomes (overall live birth within 24 months and overall live birth conceived within 24 months) and of subgroups, i.e. of ovulatory and anovulatory women, women <36 years and ≥36 years of age and of completers of the lifestyle intervention. Bootstrap analyses were performed to assess the uncertainty surrounding cost-effectiveness. Infertile women with a BMI of ≥29 kg/m2 (no upper limit) were allocated to a 6-month lifestyle intervention programme preceding infertility treatment (intervention group, n = 290) or to prompt infertility treatment (control group, n = 287). After excluding women who withdrew informed consent or who were lost to follow-up we included 280 women in the intervention group and 284 women in the control group in the analysis. Total mean costs per woman in the intervention group within 24 months after randomization were €4324 (SD €4276) versus €5603 (SD €4632) in the control group (cost difference of -€1278, P < 0.05). Healthy live birth rates were 27 and 35% in the intervention group and the control group, respectively (effect difference of -8.1%, P < 0.05), resulting in an incremental cost-effectiveness ratio of €15 845 per additional percentage increase of the healthy live birth rate. Mean costs per healthy live birth event were €15 932 in the intervention group and €15 912 in the control group. Exploratory scenario analyses showed that after changing the effectiveness outcome to all live births conceived within 24 months, irrespective of delivery within or after 24 months, cost-effectiveness of the lifestyle intervention improved. Using this effectiveness outcome, the probability that lifestyle intervention preceding infertility treatment was cost-effective in anovulatory women was 40%, in completers of the lifestyle intervention 39%, and in women ≥36 years 29%. In contrast to the study protocol, we were not able to perform the analysis from a societal perspective. Besides the primary outcome of the LIFEstyle study, we performed exploratory analyses using outcomes observed at longer follow-up times and we evaluated subgroups of women; the trial was not powered on these additional outcomes or subgroup analyses. Cost-effectiveness of a lifestyle intervention is more likely for longer follow-up times, and with live births conceived within 24 months as the effectiveness outcome. This effect was most profound in anovulatory women, in completers of the lifestyle intervention and in women ≥36 years old. This result indicates that the follow-up period of lifestyle interventions in obese infertile women is important. The scenario analyses performed in this study suggest that offering and reimbursing lifestyle intervention programmes in certain patient categories may be cost-effective and it provides directions for future research in this field. The study was supported by a grant from ZonMw, the Dutch Organization for Health Research and Development (50-50110-96-518). The department of obstetrics and gynaecology of the UMCG received an unrestricted educational grant from Ferring pharmaceuticals BV, The Netherlands. B.W.J.M. is a consultant for ObsEva, Geneva. The LIFEstyle RCT was registered at the Dutch trial registry (NTR 1530). http://www.trialregister.nl/trialreg/admin/rctview.asp?TC = 1530. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Cryotherapy and Topical Minocycline as Adjunctive Measures to Control Pain After Third Molar Surgery: An Exploratory Study

PubMed Central

Gelesko, Savannah; Long, Leann; Faulk, Jan; Phillips, Ceib; Dicus, Carolyn; White, Raymond P.

2013-01-01

Purpose To assess the impact of cryotherapy or topical minocycline on patients’ perceptions of recovery from pain after third molar surgery in an exploratory comparative-effectiveness study. Patients and Methods Subjects aged at least 14 years who were having all 4 third molars removed were enrolled in 3 separate institutional review board–approved studies. Study groups included subjects treated with a passively applied cold wrap for 24 hours postoperatively, subjects treated with topical minocycline during surgery, and subjects enrolled in a nonconcurrent comparison group who had received neither topical minocycline nor directed cryotherapy. Third molar surgery was performed in all cases by trained surgeons using the same protocol. An exact Kruskal-Wallis test was used to compare the distributions of the worst and average pain scores and a Fisher exact test to compare verbal responses from Gracely pain scales among the 3 groups for postsurgical days (PSDs) 1 to 3. Results This study comprised 51 cryotherapy subjects (2005–2009), 63 minocycline subjects (2003–2004), and 92 comparison-group subjects (2002–2006) who were treated at academic centers and in community practices across the United States (N = 206). Demographic descriptors were similar among all groups. For PSDs 1 through 3 (unadjusted), the highest scores for worst pain (6–7 [out of 7] on Likert-type scale) were reported less frequently in each of the study groups than in subjects in the comparison group, although the numbers of subjects reporting the highest scores were few. The distribution of pain outcomes was significantly different among the 3 groups for worst pain and affective words on PSD 1 (P = .04 for both). However, the small number of subjects who reported the highest pain scores precluded adequate multivariate statistical analyses for all outcomes on PSD 1 to 3. Conclusions Data from this exploratory study suggest that adjunctive therapy to decrease postoperative pain—cryotherapy or topical minocycline—might be effective at moderating the patient’s highest pain levels after third molar surgery. The topic should be studied further in a multicenter, prospective, randomized trial. PMID:21802812

Ondansetron and sertraline may interact with 5-HTTLPR and DRD4 polymorphisms to reduce drinking in non-treatment seeking alcohol dependent women: exploratory findings

PubMed Central

Kenna, George A.; Zywiak, William H.; Swift, Robert M.; McGeary, John E.; Clifford, James S.; Shoaff, Jessica R.; Fricchione, Samuel; Brickley, Michael; Beaucage, Kayla; Haass-Koffler, Carolina L.; Leggio, Lorenzo

2014-01-01

The purpose of this exploratory study was to examine the interaction of 5-HTTLPR and DRD4 exon III polymorphisms with gender in non-treatment seeking alcohol dependent (AD) individuals while alternately taking ondansetron and sertraline. Evidence suggests that alcohol dependence may be influenced by a genetic interaction that may be gender specific with temporal changes making pharmacological treatment with serotonergic drugs complex. The main trial was a within-subject double-blind placebo-controlled human laboratory study with 77 non-treatment-seeking AD individuals randomized (55 completed, 49 complete data) to receive 200mg/day of sertraline or 0.5mg/day of ondansetron for 3-weeks followed by an alcohol self-administration experiment (ASAE), then placebo for three weeks followed by a second ASAE, then receive the alternate drug, in a counterbalanced order, for three weeks followed by a third ASAE. Results for men were not significant. Women with the LL 5-HTTLPR genotype receiving ondansetron and SS/SL 5-HTTLPR genotypes receiving sertraline (matched), drank significantly fewer drinks per drinking day (DDD) during the 7-days prior to the first and third ASAEs than women receiving the mismatched medication (i.e. sertraline to LL and ondansetron to SS/SL). In a three-way interaction, 5-HTTLPR alleles by DRD4 alleles by medications, women with the LL genotype who received ondansetron and had DRD4 ≥7 exon III repeats drank significantly fewer DDD as did SS/SL women who received sertraline but conversely had DRD4 <7-repeats in the 7-day period leading up to the first and third ASAEs. Consistent with these data was a significant reduction of milliliters consumed ad lib during these same ASAEs. These exploratory findings add possible support to gender and genetic differences among AD individuals in response to serotonergic pharmacotherapies. Future trials should be powerful enough to take into account that endophenotypes and a targeting of serotonergic interactions may be essential to successfully treat alcohol dependence. PMID:25212749

Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization: design and rationale for the Geriatric OUt of hospital Randomized MEal Trial in Heart Failure (GOURMET-HF).

PubMed

Wessler, Jeffrey D; Maurer, Mathew S; Hummel, Scott L

2015-03-01

Heart failure (HF) is a major public health problem affecting predominantly older adults. Nonadherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life (QOL) in older adults after hospitalization for ADHF. This is a 3-center, randomized, single-blind, controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization. Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (<50% vs ≥50%). Study subjects will receive either preprepared, home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until study completion. The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge. Safety evaluation will focus on hypotension, renal insufficiency, and hyperkalemia. Exploratory end points include echocardiography, noninvasive vascular testing, markers of oxidative stress, and salt taste sensitivity. This randomized controlled trial will test the efficacy, feasibility, and safety of 4weeks of DASH/SRD after ADHF hospitalization. By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF, we will address a critical evidence gap in the care of older patients with ADHF. If effective and safe, this intervention could be scaled to assess effects on readmission and healthcare costs in older adults after ADHF. Published by Elsevier Inc.

Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM)

PubMed Central

Adler, Ubiratan C.; Krüger, Stephanie; Teut, Michael; Lüdtke, Rainer; Schützler, Lena; Martins, Friederike; Willich, Stefan N.; Linde, Klaus; Witt, Claudia M.

2013-01-01

Background The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. Aims To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. Methods A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. Results A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI −1.2;5.2) for Q-potencies vs. placebo and −3.1 (−5.9;−0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. Conclusions Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Trial registration clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43 PMID:24086352

Phase II randomized trial of radiation therapy, cetuximab, and pemetrexed with or without bevacizumab in patients with locally advanced head and neck cancer.

PubMed

Argiris, A; Bauman, J E; Ohr, J; Gooding, W E; Heron, D E; Duvvuri, U; Kubicek, G J; Posluszny, D M; Vassilakopoulou, M; Kim, S; Grandis, J R; Johnson, J T; Gibson, M K; Clump, D A; Flaherty, J T; Chiosea, S I; Branstetter, B; Ferris, R L

2016-08-01

We previously reported the safety of concurrent cetuximab, an antibody against epidermal growth factor receptor (EGFR), pemetrexed, and radiation therapy (RT) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In this non-comparative phase II randomized trial, we evaluated this non-platinum combination with or without bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF). Patients with previously untreated stage III-IVB SCCHN were randomized to receive: conventionally fractionated radiation (70 Gy), concurrent cetuximab, and concurrent pemetrexed (arm A); or the identical regimen plus concurrent bevacizumab followed by bevacizumab maintenance for 24 weeks (arm B). The primary end point was 2-year progression-free survival (PFS), with each arm compared with historical control. Exploratory analyses included the relationship of established prognostic factors to PFS and quality of life (QoL). Seventy-eight patients were randomized: 66 oropharynx (42 HPV-positive, 15 HPV-negative, 9 unknown) and 12 larynx; 38 (49%) had heavy tobacco exposure. Two-year PFS was 79% [90% confidence interval (CI) 0.69-0.92; P < 0.0001] for arm A and 75% (90% CI 0.64-0.88; P < 0.0001) for arm B, both higher than historical control. No differences in PFS were observed for stage, tobacco history, HPV status, or type of center (community versus academic). A significantly increased rate of hemorrhage occurred in arm B. SCCHN-specific QoL declined acutely, with marked improvement but residual symptom burden 1 year post-treatment. RT with a concurrent non-platinum regimen of cetuximab and pemetrexed is feasible in academic and community settings, demonstrating expected toxicities and promising efficacy. Adding bevacizumab increased toxicity without apparent improvement in efficacy, countering the hypothesis that dual EGFR-VEGF targeting would overcome radiation resistance, and enhance clinical benefit. Further development of cetuximab, pemetrexed, and RT will require additional prospective study in defined, high-risk populations where treatment intensification is justified. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

The effect of neonatal N-methyl-D-aspartate receptor blockade on exploratory and anxiety-like behaviors in adult BALB/c and C57BL/6 mice.

PubMed

Akillioglu, Kubra; Binokay, Secil; Kocahan, Sayad

2012-07-15

N-methyl-D-aspartate (NMDA) receptors play an important role in brain maturation and developmental processes. In our study, we evaluated the effects of neonatal NMDA receptor blockade on exploratory locomotion and anxiety-like behaviors of adult BALB/c and C57BL/6 mice. In this study, NMDA receptor hypofunction was induced 7-10 days after birth using MK-801 in BALB/c and C57BL/6 mice (0.25mg/kg twice a day for 4 days via intraperitoneal injection). The open-field (OF) and elevated plus maze (EPM) tests were used to evaluate exploratory locomotion and anxiety-like behaviors. In the OF, BALB/c mice spent less time in the center of the field (p<0.05) and had less vertical locomotor activity (p<0.01) compared to C57BL/6 mice. In BALB/c mice, MK-801 caused a decrease in vertical and horizontal locomotor activity in the OF test, compared to the control group (p<0.05). In C57BL/6 mice, MK-801 treatment increased horizontal locomotor activity and decreased time spent in the center in the OF test (p<0.05). In the EPM, the number of open-arm entries, the percentage of open-arm time (p<0.01) and total arm entries (p<0.05) were lower in BALB/c mice compared to C57BL/6 mice. In BALB/c mice, MK-801 caused an increase in the percentage of open-arm time compared to the control group (p<0.05). In C57BL/6 mice, MK-801 caused a decrease in the percentage of open-arm time compared to the control group (p<0.05). MK-801 decreased exploratory and anxiety-like behaviors in BALB/c mice. In contrast, MK-801 increased exploratory and anxiety-like behaviors in C57BL/6 mice. In conclusion, hereditary factors may play an important role in neonatal NMDA receptor blockade-induced responses. Copyright © 2012 Elsevier B.V. All rights reserved.

Assessing Mongolian gerbil emotional behavior: effects of two shock intensities and response-independent shocks during an extended inhibitory-avoidance task.

PubMed

Hurtado-Parrado, Camilo; González-León, Camilo; Arias-Higuera, Mónica A; Cardona, Angelo; Medina, Lucia G; García-Muñoz, Laura; Sánchez, Christian; Cifuentes, Julián; Forigua, Juan Carlos; Ortiz, Andrea; Acevedo-Triana, Cesar A; Rico, Javier L

2017-01-01

Despite step-down inhibitory avoidance procedures that have been widely implemented in rats and mice to study learning and emotion phenomena, performance of other species in these tasks has received less attention. The case of the Mongolian gerbil is of relevance considering the discrepancies in the parameters of the step-down protocols implemented, especially the wide range of foot-shock intensities (i.e., 0.4-4.0 mA), and the lack of information on long-term performance, extinction effects, and behavioral patterning during these tasks. Experiment 1 aimed to (a) characterize gerbils' acquisition, extinction, and steady-state performance during a multisession (i.e., extended) step-down protocol adapted for implementation in a commercially-available behavioral package (Video Fear Conditioning System-MED Associates Fairfax, VT, USA), and (b) compare gerbils' performance in this task with two shock intensities - 0.5 vs. 1.0 mA-considered in the low-to-mid range. Results indicated that the 1.0 mA protocol produced more reliable and clear evidence of avoidance learning, extinction, and reacquisition in terms of increments in freezing and on-platform time as well as suppression of platform descent. Experiment 2 aimed to (a) assess whether an alternate protocol consisting of a random delivery of foot shocks could replicate the effects of Experiment 1 and (b) characterize gerbils' exploratory behavior during the step-down task (jumping, digging, rearing, and probing). Random shocks did not reproduce the effects observed with the first protocol. The data also indicated that a change from random to response-dependent shocks affects (a) the length of each visit to the platform, but not the frequency of platform descends or freezing time, and (b) the patterns of exploratory behavior, namely, suppression of digging and rearing, as well as increments in probing and jumping. Overall, the study demonstrated the feasibility of the extended step-down protocol for studying steady performance, extinction, and reacquisition of avoidance behavior in gerbils, which could be easily implemented in a commercially available system. The observation that 1.0 mA shocks produced a clear and consistent avoidance behavior suggests that implementation of higher intensities is unnecessary for reproducing aversive-conditioning effects in this species. The observed patterning of freezing, platform descents, and exploratory responses produced by the change from random to periodic shocks may relate to the active defensive system of the gerbil. Of special interest is the probing behavior, which could be interpreted as risk assessment and has not been reported in other rodent species exposed to step-down and similar tasks.

Assessing Mongolian gerbil emotional behavior: effects of two shock intensities and response-independent shocks during an extended inhibitory-avoidance task

PubMed Central

González-León, Camilo; Arias-Higuera, Mónica A.; Cardona, Angelo; Medina, Lucia G.; García-Muñoz, Laura; Sánchez, Christian; Cifuentes, Julián; Forigua, Juan Carlos; Ortiz, Andrea; Acevedo-Triana, Cesar A.; Rico, Javier L.

2017-01-01

Despite step-down inhibitory avoidance procedures that have been widely implemented in rats and mice to study learning and emotion phenomena, performance of other species in these tasks has received less attention. The case of the Mongolian gerbil is of relevance considering the discrepancies in the parameters of the step-down protocols implemented, especially the wide range of foot-shock intensities (i.e., 0.4–4.0 mA), and the lack of information on long-term performance, extinction effects, and behavioral patterning during these tasks. Experiment 1 aimed to (a) characterize gerbils’ acquisition, extinction, and steady-state performance during a multisession (i.e., extended) step-down protocol adapted for implementation in a commercially-available behavioral package (Video Fear Conditioning System—MED Associates Fairfax, VT, USA), and (b) compare gerbils’ performance in this task with two shock intensities – 0.5 vs. 1.0 mA—considered in the low-to-mid range. Results indicated that the 1.0 mA protocol produced more reliable and clear evidence of avoidance learning, extinction, and reacquisition in terms of increments in freezing and on-platform time as well as suppression of platform descent. Experiment 2 aimed to (a) assess whether an alternate protocol consisting of a random delivery of foot shocks could replicate the effects of Experiment 1 and (b) characterize gerbils’ exploratory behavior during the step-down task (jumping, digging, rearing, and probing). Random shocks did not reproduce the effects observed with the first protocol. The data also indicated that a change from random to response-dependent shocks affects (a) the length of each visit to the platform, but not the frequency of platform descends or freezing time, and (b) the patterns of exploratory behavior, namely, suppression of digging and rearing, as well as increments in probing and jumping. Overall, the study demonstrated the feasibility of the extended step-down protocol for studying steady performance, extinction, and reacquisition of avoidance behavior in gerbils, which could be easily implemented in a commercially available system. The observation that 1.0 mA shocks produced a clear and consistent avoidance behavior suggests that implementation of higher intensities is unnecessary for reproducing aversive-conditioning effects in this species. The observed patterning of freezing, platform descents, and exploratory responses produced by the change from random to periodic shocks may relate to the active defensive system of the gerbil. Of special interest is the probing behavior, which could be interpreted as risk assessment and has not been reported in other rodent species exposed to step-down and similar tasks. PMID:29152417

Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial.

PubMed

Curley, Martha A Q; Wypij, David; Watson, R Scott; Grant, Mary Jo C; Asaro, Lisa A; Cheifetz, Ira M; Dodson, Brenda L; Franck, Linda S; Gedeit, Rainer G; Angus, Derek C; Matthay, Michael A

2015-01-27

Protocolized sedation improves clinical outcomes in critically ill adults, but its effect in children is unknown. To determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care. Cluster randomized trial conducted in 31 US pediatric intensive care units (PICUs). A total of 2449 children (mean age, 4.7 years; range, 2 weeks to 17 years) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge. Intervention PICUs (17 sites; n = 1225 patients) used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning. Control PICUs (14 sites; n = 1224 patients) managed sedation per usual care. The primary outcome was duration of mechanical ventilation. Secondary outcomes included time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, neurological testing, PICU and hospital lengths of stay, in-hospital mortality, sedation-related adverse events, measures of sedative exposure (wakefulness, pain, and agitation), and occurrence of iatrogenic withdrawal. Duration of mechanical ventilation was not different between the 2 groups (intervention: median, 6.5 [IQR, 4.1-11.2] days; control: median, 6.5 [IQR, 3.7-12.1] days). Sedation-related adverse events including inadequate pain and sedation management, clinically significant iatrogenic withdrawal, and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups. Intervention patients experienced more postextubation stridor (7% vs 4%; P = .03) and fewer stage 2 or worse immobility-related pressure ulcers (<1% vs 2%; P = .001). In exploratory analyses, intervention patients had fewer days of opioid administration (median, 9 [IQR, 5-15] days vs 10 [IQR, 4-21] days; P = .01), were exposed to fewer sedative classes (median, 2 [IQR, 2-3] classes vs 3 [IQR, 2-4] classes; P < .001), and were more often awake and calm while intubated (median, 86% [IQR, 67%-100%] of days vs 75% [IQR, 50%-100%] of days; P = .004) than control patients, respectively; however, intervention patients had more days with any report of a pain score ≥ 4 (median, 50% [IQR, 27%-67%] of days vs 23% [IQR, 0%-46%] of days; P < .001) and any report of agitation (median, 60% [IQR, 33%-80%] vs 40% [IQR, 13%-67%]; P = .003), respectively. Among children undergoing mechanical ventilation for acute respiratory failure, the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation. Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness, pain, and agitation. clinicaltrials.gov Identifier: NCT00814099.

Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18month randomized trial.

PubMed

Donnelly, J E; Ptomey, L T; Goetz, J R; Sullivan, D K; Gibson, C A; Greene, J L; Lee, R H; Mayo, M S; Honas, J J; Washburn, R A

2016-11-01

Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18month trial to compare weight loss (6months) and maintenance (7-18months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery. Copyright © 2016. Published by Elsevier Inc.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Effects of the Opioid Receptor Antagonist Naltrexone on Smoking and Related Behaviors in Smokers Preparing to Quit: A Randomized Controlled Trial

PubMed Central

King, Andrea; Cao, Dingcai; Zhang, Lingjiao; Rueger, Sandra Yu

2013-01-01

Aims To determine if naltrexone affects smoking behaviours in smokers preparing to quit, and whether such pre-quit responses predict post-quit date outcomes. Design Double-blind, placebo-controlled, randomized study. Current study focused on smoking-related outcomes in the pre-quit phase, which was one week prior to the quit date, and these findings were linked with reductions in same outcomes demonstrated in the post-quit phase previously published for this RCT in mediation analyses. Setting Community sample of adult smokers desiring to quit in Chicago, Illinois USA. Participants Participants were 315 smokers randomized to naltrexone (n=161; mean age=42.6 years; 60% white) or placebo (n=154; mean age=41.3 years; 55% white). Measurements Difference from baseline in the number of cigarettes smoked during pre-quit phase interval was the primary outcome. Secondary pre-quit outcomes were assessed using Likert scales of subjective responses and consumption of cigarettes, alcohol, and food. Number of cigarettes smoked, alcoholic drinks consumed, and the Brief Questionnaire of Smoking Urges were assessed in the post-quit phase. Findings Relative to placebo, naltrexone decreased the number of cigarettes smoked (−4.21 vs. −2.93, p<.05), smoking urge (p=.02), and number of alcoholic drinks consumed (p=.04). Exploratory mediation analyses linking outcomes of the pre quit and post quit phases found that naltrexone’s effects on reducing smoking urge, cigarettes smoked and alcoholic drinks consumed in the pre-quit phase demonstrated full mediation of their respective effects during the post-quit phase. Conclusions Naltrexone taken in the week before a quit attempt appears to reduce cigarette consumption, urges to smoke and alcohol consumption relative to placebo. The size of the effect statistically mediates the size of similar effects after the quit date. PMID:23714324

A Randomized controlled trial of culturally-tailored dance and reducing screen time to prevent weight gain in low-Income African-American girls: Stanford GEMS

PubMed Central

Robinson, Thomas N.; Matheson, Donna M.; Kraemer, Helena C.; Wilson, Darrell M.; Obarzanek, Eva; Thompson, Nikko S.; Alhassan, Sofiya; Spencer, Tirzah R.; Haydel, K. Farish; Fujimoto, Michelle; Varady, Ann; Killen, Joel D.

2013-01-01

Objective To test a 2-year community- and family-based obesity prevention intervention for low-income African-American girls. Design Randomized controlled trial with follow-up measures scheduled at 6, 12, 18 and 24 months. Setting Low-income areas of Oakland, CA. Participants 261 8–10 year old African-American girls and their parents/caregivers. Interventions Families were randomized to two-year, culturally-tailored interventions: (1) after school Hip-Hop, African and Step dance classes and a home/family-based intervention to reduce screen media use or (2) information-based health education. Main Outcome Measure Body mass index (BMI) change. Results Changes in BMI did not differ between groups (adjusted mean difference [95% confidence interval] = 0.04 [−.18, .27] kg/m2 per year). Among secondary outcomes, fasting total cholesterol (−3.49 [−5.28, −1.70] mg/dL per year), LDL-cholesterol (−3.02 [−4.74, −1.31] mg/dL per year), incidence of hyperinsulinemia (Relative Risk 0.35 [0.13, 0.93]), and depressive symptoms (−0.21 [−0.42, −0.001] per year) fell more among girls in the dance and screen time reduction intervention. In exploratory moderator analysis, the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline (P=.02) and/or those whose parents/guardians were unmarried (P<.01). Conclusions A culturally-tailored after-school dance and screen time reduction intervention for low-income, preadolescent African-American girls did not significantly reduce BMI gain compared to health education, but produced potentially clinically important reductions in lipids, hyperinsulinemia, and depressive symptoms. There was also evidence for greater effectiveness in high-risk subgroups of girls. PMID:21041592

Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial.

PubMed

Salmoirago-Blotcher, Elena; DeCosta, Julie; Harris, Kristie; Breault, Christopher; Dunsiger, Shira; Santos, Claudia; Snyder, Peter

2018-05-01

Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. Forty participants with at least 2 risk factors for dementia will be randomized (2 × 2 factorial design) to either AT (3 sessions/week for 12 weeks), MT (1 session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia. Results from the study will be disseminated through peer-reviewed journals and conference presentations. REGISTRATION DETAILS:: http://www.clinicalstrials.gov identifier NCT03289546.

A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS.

PubMed

Robinson, Thomas N; Matheson, Donna M; Kraemer, Helena C; Wilson, Darrell M; Obarzanek, Eva; Thompson, Nikko S; Alhassan, Sofiya; Spencer, Tirzah R; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; Killen, Joel D

2010-11-01

To test a 2-year community- and family-based obesity prevention program for low-income African American girls: Stanford GEMS (Girls' health Enrichment Multi-site Studies). Randomized controlled trial with follow-up measures scheduled at 6, 12, 18, and 24 months. Low-income areas of Oakland, California. African American girls aged 8 to 10 years (N=261) and their parents or guardians. Families were randomized to one of two 2-year, culturally tailored interventions: (1) after-school hip-hop, African, and step dance classes and a home/family-based intervention to reduce screen media use or (2) information-based health education. Changes in body mass index (BMI). Changes in BMI did not differ between groups (adjusted mean difference [95% confidence interval] = 0.04 [-0.18 to 0.27] per year). Among secondary outcomes, fasting total cholesterol level (adjusted mean difference, -3.49 [95% confidence interval, -5.28 to -1.70] mg/dL per year), low-density lipoprotein cholesterol level (-3.02 [-4.74 to -1.31] mg/dL per year), incidence of hyperinsulinemia (relative risk, 0.35 [0.13 to 0.93]), and depressive symptoms (-0.21 [-0.42 to -0.001] per year) decreased more among girls in the dance and screen time reduction intervention. In exploratory moderator analysis, the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline (P = .02) and/or those whose parents or guardians were unmarried (P = .01). A culturally tailored after-school dance and screen time reduction intervention for low-income, preadolescent African American girls did not significantly reduce BMI gain compared with health education but did produce potentially clinically important reductions in lipid levels, hyperinsulinemia, and depressive symptoms. There was also evidence for greater effectiveness in high-risk subgroups of girls.

A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. Design The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2 × 2 factorial ‘efficacy’ study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55–73 year-old patients, who have been identified as ‘high risk’ (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and ‘advanced’) per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as ‘intermediate risk’ for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients. Trial Registration Current Controlled Trials ISRCTN05926847 PMID:23895505

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial

PubMed Central

Burzinski, Cindy A.; Cox, Jennifer; Kloke, John; Stegner, Aaron; Cook, Dane B.; Singles, Janice; Mirgain, Shilagh; Coe, Christopher L.; Bačkonja, Miroslav

2016-01-01

Objective. To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). Design. 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Setting. Outpatient. Subjects. Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. Methods. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Results. Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen’s d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. Conclusions. Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP. PMID:26968850

Community-based walking exercise for peripheral artery disease: An exploratory pilot study

PubMed Central

Mays, Ryan J; Hiatt, William R; Casserly, Ivan P; Rogers, R Kevin; Main, Deborah S; Kohrt, Wendy M; Ho, P Michael; Regensteiner, Judith G

2016-01-01

Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease (PAD), but few exercise programs in community settings have been effective. The aim of this study was to determine the efficacy of a community-based walking exercise program with training, monitoring, and coaching (TMC) components to improve exercise performance and patient-reported outcomes in PAD patients. This was a randomized, controlled trial including PAD patients who previously received peripheral endovascular therapy or presented with stable claudication. Patients randomized (n=25) to the intervention group received a comprehensive community-based walking exercise program with elements of TMC over 14 weeks. Patients in the control group did not receive treatment beyond standard advice to walk. The primary outcome in the intent-to-treat (ITT) analyses was peak walking time (PWT) on a graded treadmill. Secondary outcomes included claudication onset time (COT) and patient-reported outcomes assessed via the Walking Impairment Questionnaire (WIQ). Intervention group patients (n=10) did not significantly improve PWT when compared with the control group patients (n=10) (mean±standard error: +2.1±0.7 vs. 0.0±0.7 min, p=0.052). Changes in COT and WIQ scores were greater for intervention patients compared with control patients (COT: +1.6±0.8 vs. −0.6±0.7 min, p=0.045; WIQ: +18.3±4.2 vs. −4.6±4.2%, p=0.001). This pilot using a walking program with TMC and an ITT analyses did not improve the primary outcome in PAD patients. Other walking performance and patient self-reported outcomes were improved following exercise in community settings. Further study is needed to determine whether this intervention improves outcomes in a trial employing a larger sample size. PMID:25755148

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial.

PubMed

Zgierska, Aleksandra E; Burzinski, Cindy A; Cox, Jennifer; Kloke, John; Stegner, Aaron; Cook, Dane B; Singles, Janice; Mirgain, Shilagh; Coe, Christopher L; Bačkonja, Miroslav

2016-10-01

To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Outpatient. Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN Patients with Intermittent Claudication Injected with ALDH Bright Cells (PACE) Trial

PubMed Central

Perin, Emerson C.; Murphy, Michael P.; March, Keith L.; Bolli, Roberto; Loughran, John; Yang, Phillip C.; Leeper, Nicholas J.; Dalman, Ronald L.; Alexander, Jason; Henry, Timothy D.; Traverse, Jay H.; Pepine, Carl J.; Anderson, R. David; Berceli, Scott; Willerson, James T.; Muthupillai, Raja; Gahremanpour, Amir; Raveendran, Ganesh; Velasquez, Omaida; Hare, Joshua M.; Schulman, Ivonne Hernandez; Kasi, Vijaykumar S.; Hiatt, William R.; Ambale-Venkatesh, Bharath; Lima, João A.; Taylor, Doris A.; Resende, Micheline; Gee, Adrian P.; Durett, April G.; Bloom, Jeanette; Richman, Sara; G’Sell, Patricia; Williams, Shari; Khan, Fouzia; Ross, Elsie Gyang; Santoso, Michelle R.; Goldman, JoAnne; Leach, Dana; Handberg, Eileen; Cheong, Benjamin; Piece, Nichole; DiFede, Darcy; Bruhn-Ding, Barb; Caldwell, Emily; Bettencourt, Judy; Lai, Dejian; Piller, Linda; Simpson, Lara; Cohen, Michelle; Sayre, Shelly L.; Vojvodic, Rachel W.; Moyé, Lem; Ebert, Ray F.; Simari, Robert D.; Hirsch, Alan T.

2017-01-01

Background Atherosclerotic peripheral artery disease (PAD) affects 8–12% of Americans over 65 and is associated with a major decline in functional status, increased myocardial infarction and stroke rates, and increased risk of ischemic amputation. Current treatment strategies for claudication have limitations. PACE is an NHLBI-sponsored, randomized, double-blind, placebo-controlled phase 2, exploratory clinical trial designed to assess safety and efficacy of autologous bone marrow–derived aldehyde dehydrogenase bright (ALDHbr) cells in PAD patients and to explore associated claudication physiologic mechanisms. Methods All participants, randomized 1:1 to receive ALDHbr cells or placebo, underwent bone marrow aspiration and isolation of ALDHbr cells, followed by ten injections into the thigh and calf of the index leg. The co-primary endpoints were: change from baseline to six months in peak walking time (PWT), collateral count, peak hyperemic popliteal flow, and capillary perfusion measured by magnetic resonance imaging (MRI); as well as safety. Results A total of 82 patients with claudication and infra-inguinal PAD were randomized at nine sites, of which 78 had analyzable data (57 male, 21 female; mean age 66±9 years). The mean differences in the change over six months between study groups for PWT (mean ± standard error of the mean [SEM]) (0.9±0.8 minutes; 95% CI −0.6 to 2.5; p=0.238), collateral count (0.9±0.6 arteries; 95% CI −0.2 to 2.1; p=0.116), peak hyperemic popliteal flow (0.0±0.4 mL/sec; 95% CI −0.8 to 0.8; p=0.978), and capillary perfusion (−0.2±0.6%; 95% CI −1.3 to 0.9; p=0.752) were not significant. Additionally, there were no significant differences for the secondary endpoints, including quality of life measures. There were no adverse safety outcomes. Correlative relationships between MRI measures and PWT were not significant. A post-hoc exploratory analysis suggested that ALDHbr cell administration might be associated with an increase in the number of collateral arteries (1.5±0.7; 95% CI 0.1 to 2.9; p=0.047) in participants with completely occluded femoral arteries. Conclusions ALDHbr cell administration did not improve PWT or MR outcomes, and the changes in PWT were not associated with the anatomic or physiologic MRI endpoints. Future PAD cell therapy investigational trial design may be informed by new anatomic and perfusion insights. PMID:28209728

Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial

PubMed Central

Wang, Monica L; Waring, Molly E; Jake-Schoffman, Danielle E; Oleski, Jessica L; Michaels, Zachary; Goetz, Jared M; Lemon, Stephenie C; Ma, Yunsheng

2017-01-01

Background Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. Objective This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. Methods Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. Results The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. Conclusions Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. Trial Registration ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW) PMID:29229591

Attitudes of student nurses enrolled in e-learning course towards academic dishonesty: a descriptive-exploratory study.

PubMed

Tayaben, Jude L

2014-01-01

The author investigated attitudes of nursing students enrolled in e-Learning towards academic dishonesty. The descriptive-exploratory design was used in the conduct of the study. Respondents were randomly selected 36 junior and senior nursing students. It revealed that nursing students perceived as neutral (mean = 2.77, mean = 3.17) in taking responsibility for promoting academic integrity in e-learning. The paraphrasing a sentence from internet source without referencing it (38.89%) got the most form of cheating. Female and level four (4) nursing students revealed as the most cheaters. The reasons not to cheat, nursing students considered punishment, and education or learning (91.67%) got the highest in ranks, and simply wrong (75%) got the lowest rank. Hence, there is a need to look on how to maintain academic honesty among nursing students in and out of the university with respect to e-learning as a means of teaching-learning method.

Genetic dissection of a regionally differentiated network for exploratory behavior in Drosophila larvae.

PubMed

Berni, Jimena

2015-05-18

An efficient strategy to explore the environment for available resources involves the execution of random walks where straight line locomotion alternates with changes of direction. This strategy is highly conserved in the animal kingdom, from zooplankton to human hunter-gatherers. Drosophila larvae execute a routine of this kind, performing straight line crawling interrupted at intervals by pause turns that halt crawling and redirect the trajectory of movement. The execution of this routine depends solely on the activity of networks located in the thoracic and abdominal segments of the nervous system, while descending input from the brain serves to modify it in a context-dependent fashion. I used a genetic method to investigate the location and function of the circuitry required for the different elements of exploratory crawling. By using the Slit-Robo axon guidance pathway to target neuronal midline crossing defects selectively to particular regions of the thoracic and abdominal networks, it has been possible to define at least three functions required for the performance of the exploratory routine: (1) symmetrical outputs in thoracic and abdominal segments that generate the crawls; (2) asymmetrical output that is uniquely initiated in the thoracic segments and generates the turns; and (3) an intermittent interruption to crawling that determines the time-dependent transition between crawls and turns. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Genetic Dissection of a Regionally Differentiated Network for Exploratory Behavior in Drosophila Larvae

PubMed Central

Berni, Jimena

2015-01-01

Summary An efficient strategy to explore the environment for available resources involves the execution of random walks where straight line locomotion alternates with changes of direction. This strategy is highly conserved in the animal kingdom, from zooplankton to human hunter-gatherers [1–8]. Drosophila larvae execute a routine of this kind, performing straight line crawling interrupted at intervals by pause turns that halt crawling and redirect the trajectory of movement [9–11]. The execution of this routine depends solely on the activity of networks located in the thoracic and abdominal segments of the nervous system, while descending input from the brain serves to modify it in a context-dependent fashion [9]. I used a genetic method to investigate the location and function of the circuitry required for the different elements of exploratory crawling. By using the Slit-Robo axon guidance pathway to target neuronal midline crossing defects selectively to particular regions of the thoracic and abdominal networks, it has been possible to define at least three functions required for the performance of the exploratory routine: (1) symmetrical outputs in thoracic and abdominal segments that generate the crawls; (2) asymmetrical output that is uniquely initiated in the thoracic segments and generates the turns; and (3) an intermittent interruption to crawling that determines the time-dependent transition between crawls and turns. PMID:25959962

Validating the Farsi version of the Pregnancy Worries and Stress Questionnaire (PWSQ): An exploratory factor analysis.

PubMed

Navidpour, Fariba; Dolatian, Mahrokh; Shishehgar, Sara; Yaghmaei, Farideh; Majd, Hamid Alavi; Hashemi, Seyed Saeed

2016-10-01

Biological, environmental, inter- and intrapersonal changes during the antenatal period can result in anxiety and stress in pregnant women. It is pivotal to identify potential stressors and prevent their foetal and maternal consequences. The present study was conducted to validate and examine the factor structure of the Farsi version of the Pregnancy Worries and Stress Questionnaire (PWSQ). In 2015, 502 Iranian healthy pregnant women, referred to selected hospitals in Tehran for prenatal care at 8-39 weeks of pregnancy, were recruited through a randomized cluster sampling. The PWSQ was translated into Farsi, and its validity and reliability were examined using exploratory factor analysis by SPSS version 21. The content validity of items on the PWSQ was between 0.63-1. The content validity index for relevance, clarity and simplicity were 0.92, 0.98, and 0.98, respectively, with a mean of 0.94. The Kaiser-Meyer-Olkin measure of sampling adequacy was 0.863. Test-retest reliability showed high internal consistency (α=0.89; p<0.0001). The psychometric evaluation and exploratory factor analysis showed that the translated questionnaire is a valid and reliable tool to identify stress in Iranian pregnant women. Application of the questionnaire can facilitate the diagnosis of stress in pregnant women and assist health care providers in providing timely support and minimizing negative outcomes of stress and anxiety in pregnant women and their infants.

Exploratory activity and habituation of Drosophila in confined domains

NASA Astrophysics Data System (ADS)

Soibam, B.; Chen, L.; Roman, G. W.; Gunaratne, G. H.

2014-09-01

Animals use locomotion to find food, shelter, and escape routes as well as to locate predators, competitors, and mates. Thus, locomotion is related to many behavioral traits, and can be used to characterize these more complex facets of behavior. Exploratory behaviors are random and need to be assessed through stochastic analysis. By comparing ensembles of trajectories from Drosophila and a model animal, we identify a pair of principles that govern the stochastic motion of a specific species. The first depends on local cues and quantify directional persistence, i.e., the propensity of an animal to maintain direction; the second, its attraction to walls, is relevant for exploration in confined arenas. Statistical properties of exploratory activity in several types of arenas can be computed from these principles. A pair of spiral arenas are designed to demonstrate that centrophobicity, or fear of the center of an arena, is not a fundamental feature of exploration. xxxx We provide evidence to show that the decay in an animal's activity following its introduction into a novel arena is correlated to its familiarity with the arena. We define two measures, coverage and habituation, to quantify familiarity. It is found that the relationship between activity and coverage is independent of the arena size. Finally, we use an analysis of exploration of mutant species to infer that in Drosophila, habituation relies on visual cues.

Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1.

PubMed

Wills, Anne-Marie A; Pérez, Adriana; Wang, Jue; Su, Xiao; Morgan, John; Rajan, Suja S; Leehey, Maureen A; Pontone, Gregory M; Chou, Kelvin L; Umeh, Chizoba; Mari, Zoltan; Boyd, James

2016-03-01

Greater body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) is associated with improved survival among persons with Huntington disease or amyotrophic lateral sclerosis. Weight loss is common among persons with Parkinson disease (PD) and is associated with worse quality of life. To explore the association between change in BMI, Unified Parkinson's Disease Rating Scale (UPDRS) motor and total scores, and survival among persons with PD and to test whether there is a positive association between BMI at randomization and survival. Secondary analysis (from May 27, 2014, to October 13, 2015) of longitudinal data (3-6 years) from 1673 participants who started the National Institute of Neurological Disorders and Stroke Exploratory Trials in PD Long-term Study-1 (NET-PD LS-1). This was a double-blind randomized placebo-controlled clinical trial of creatine monohydrate (10 g/d) that was performed at 45 sites throughout the United States and Canada. Participants with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) PD were enrolled from March 2007 to May 2010 and followed up until September 2013. Change across time in motor UPDRS score, change across time in total UPDRS score, and time to death. Generalized linear mixed models were used to estimate the effect of BMI on the change in motor and total UPDRS scores after controlling for covariates. Survival was analyzed using Cox proportional hazards models of time to death. A participant's BMI was measured at randomization, and BMI trajectory groups were classified according to whether participants experienced weight loss ("decreasing BMI"), weight stability ("stable BMI"), or weight gain ("increasing BMI") during the study. Of the 1673 participants (mean [SD] age, 61.7 [9.6] years; 1074 [64.2%] were male), 158 (9.4%) experienced weight loss (decreasing BMI), whereas 233 (13.9%) experienced weight gain (increasing BMI). After adjusting for covariates, we found that the weight-loss group's mean (SE) motor UPDRS score increased by 1.48 (0.28) (P < .001) more points per visit than the weight-stable group's mean (SE) motor UPDRS score. The weight-gain group's mean (SE) motor UPDRS score decreased by -0.51 (0.24) (P = .03) points per visit, relative to the weight-stable group. While there was an unadjusted difference in survival between the 3 BMI trajectory groups (log-rank P < .001), this was not significant after adjusting for covariates. Change in BMI was inversely associated with change in motor and total UPDRS scores in the NET-PD LS-1. Change in BMI was not associated with survival; however, these results were limited by the low number of deaths in the NET-PD LS-1. clinicaltrials.gov Identifier: NCT00449865.

Random number generation in bilingual Balinese and German students: preliminary findings from an exploratory cross-cultural study.

PubMed

Strenge, Hans; Lesmana, Cokorda Bagus Jaya; Suryani, Luh Ketut

2009-08-01

Verbal random number generation is a procedurally simple task to assess executive function and appears ideally suited for the use under diverse settings in cross-cultural research. The objective of this study was to examine ethnic group differences between young adults in Bali (Indonesia) and Kiel (Germany): 50 bilingual healthy students, 30 Balinese and 20 Germans, attempted to generate a random sequence of the digits 1 to 9. In Balinese participants, randomization was done in Balinese (native language L1) and Indonesian (first foreign language L2), in German subjects in the German (L1) and English (L2) languages. 10 of 30 Balinese (33%), but no Germans, were unable to inhibit habitual counting in more than half of the responses. The Balinese produced significantly more nonrandom responses than the Germans with higher rates of counting and significantly less occurrence of the digits 2 and 3 in L1 compared with L2. Repetition and cycling behavior did not differ between the four languages. The findings highlight the importance of taking into account culture-bound psychosocial factors for Balinese individuals when administering and interpreting a random number generation test.

Empowered to Play: A Case Study Describing the Impact of Powered Mobility on the Exploratory Play of Disabled Children.

PubMed

Sonday, Amshuda; Gretschel, Pam

2016-03-01

Exploratory play is one of the most vital ways in which children learn about their environment and develop. It is well documented that limited mobility restricts a child's ability to engage in their environment through exploratory play. In this study, a qualitative, collective case study design explored the impact of powered mobility on the exploratory play of two children with physical disabilities. Data were collected from the children, their parents and their siblings through participant observation and in-depth, informal interviews. This paper focuses on two themes: Opportunity to Play revealed how powered mobility increased opportunities for the children to become more actively engaged in exploratory play with others across a wider array of contexts, and My Child was Transformed highlighted significant changes in the affect and motivation of each child, which seemed to be linked to their increased internal control over their play choices. The findings suggest that the provision of powered mobility is a key contributor promoting the participation of physically disabled children in exploratory play. Because of undergraduate curricular constraints, a limitation of this study was that data were only confined to 2 months; affecting the depth of data gained that prolonged engagement would have offered. The study recommends for occupational therapy practice that occupational therapists advocate for easier access to powered mobility through governmental and policy means. The study also recommends further research be conducted on the experiences of the caregivers on how these powered mobility devices have influenced their day-to-day occupations. Copyright © 2015 John Wiley & Sons, Ltd.

Controlling Behaviors in Middle School Youth's Dating Relationships: Reactions and Help-Seeking Behaviors

ERIC Educational Resources Information Center

Elias-Lambert, Nada; Black, Beverly M.; Chigbu, Kingsley U.

2014-01-01

This exploratory study examined middle school students' (N = 380) help-seeking behaviors and other reactions to controlling behaviors in their dating relationships. Over three-fourths of the participants perpetrated and were victimized by controlling behaviors in their dating relationships. Youth used emotional/verbal and dominance/isolation forms…

Information Leaks and Limitations of Role-Based Access Control Mechanisms: A Qualitative Exploratory Single Case Study

ERIC Educational Resources Information Center

Antony, Laljith

2016-01-01

Failing to prevent leaks of confidential and proprietary information to unauthorized users from software applications is a major challenge that companies face. Access control policies defined in software applications with access control mechanisms are unable to prevent information leaks from software applications to unauthorized users. Role-based…

Bilingualism and Enhanced Attention in Early Adulthood

ERIC Educational Resources Information Center

Stafford, Catherine A.

2011-01-01

This exploratory study investigated executive attention during nonverbal and verbal processing among adults with a range of bilingual experience. Previous research has found that bilingual children control their attention better than their monolingual peers and that superior attentional control in some processing contexts persists into adulthood…

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial)

PubMed Central

Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

2018-01-01

PURPOSE: To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. DESIGN: The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. SUBJECTS AND SETTING: The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. METHODS: Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. RESULTS: Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: −1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were “very satisfied” with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups. CONCLUSIONS: The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes. PMID:29300287

A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

PubMed

Colwell, Janice C; Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was noted in both groups. The use of a ceramide-infused barrier significantly decreased cost and increased satisfaction with patient-reported outcomes.

Exploratory Study of Web-Based Planning and Mobile Text Reminders in an Overweight Population

PubMed Central

Murray, Peter; Cobain, Mark; Chinapaw, Mai; van Mechelen, Willem; Hurling, Robert

2011-01-01

Background Forming specific health plans can help translate good intentions into action. Mobile text reminders can further enhance the effects of planning on behavior. Objective Our aim was to explore the combined impact of a Web-based, fully automated planning tool and mobile text reminders on intention to change saturated fat intake, self-reported saturated fat intake, and portion size changes over 4 weeks. Methods Of 1013 men and women recruited online, 858 were randomly allocated to 1 of 3 conditions: a planning tool (PT), combined planning tool and text reminders (PTT), and a control group. All outcome measures were assessed by online self-reports. Analysis of covariance was used to analyze the data. Results Participants allocated to the PT (meansat urated fat 3.6, meancopingplanning 3) and PTT (meansaturatedfat 3.5, meancopingplanning 3.1) reported a lower consumption of high-fat foods (F 2,571 = 4.74, P = .009) and higher levels of coping planning (F 2,571 = 7.22, P < .001) than the control group (meansat urated f at 3.9, meancopingplanning 2.8). Participants in the PTT condition also reported smaller portion sizes of high-fat foods (mean 2.8; F 2, 569 = 4.12, P = .0) than the control group (meanportions 3.1). The reduction in portion size was driven primarily by the male participants in the PTT (P = .003). We found no significant group differences in terms of percentage saturated fat intake, intentions, action planning, self-efficacy, or feedback on the intervention. Conclusions These findings support the use of Web-based tools and mobile technologies to change dietary behavior. The combination of a fully automated Web-based planning tool with mobile text reminders led to lower self-reported consumption of high-fat foods and greater reductions in portion sizes than in a control condition. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 61819220; http://www.controlled-trials.com/ISRCTN61819220 (Archived by WebCite at http://www.webcitation.org/63YiSy6R8) PMID:22182483

Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial.

PubMed

Malinvaud, D; Londero, A; Niarra, R; Peignard, Ph; Warusfel, O; Viaud-Delmon, I; Chatellier, G; Bonfils, P

2016-03-01

Subjective tinnitus (ST) is a frequent audiologic condition that still requires effective treatment. This study aimed at evaluating two therapeutic approaches: Virtual Reality (VR) immersion in auditory and visual 3D environments and Cognitive Behaviour Therapy (CBT). This open, randomized and therapeutic equivalence trial used bilateral testing of VR versus CBT. Adult patients displaying unilateral or predominantly unilateral ST, and fulfilling inclusion criteria were included after giving their written informed consent. We measured the different therapeutic effect by comparing the mean scores of validated questionnaires and visual analog scales, pre and post protocol. Equivalence was established if both strategies did not differ for more than a predetermined limit. We used univariate and multivariate analysis adjusted on baseline values to assess treatment efficacy. In addition of this trial, purely exploratory comparison to a waiting list group (WL) was provided. Between August, 2009 and November, 2011, 148 of 162 screened patients were enrolled (VR n = 61, CBT n = 58, WL n = 29). These groups did not differ at baseline for demographic data. Three month after the end of the treatment, we didn't find any difference between VR and CBT groups either for tinnitus severity (p = 0.99) or tinnitus handicap (p = 0.36). VR appears to be at least as effective as CBT in unilateral ST patients. Copyright © 2016 Elsevier B.V. All rights reserved.

Fidaxomicin Versus Vancomycin for Clostridium difficile Infection: Meta-analysis of Pivotal Randomized Controlled Trials

PubMed Central

Crook, Derrick W.; Walker, A. Sarah; Kean, Yin; Weiss, Karl; Cornely, Oliver A.; Miller, Mark A.; Esposito, Roberto; Louie, Thomas J.; Stoesser, Nicole E.; Young, Bernadette C.; Angus, Brian J.; Gorbach, Sherwood L.; Peto, Timothy E. A.

2012-01-01

Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%–51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%–60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13–40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI. PMID:22752871

Individual music therapy for agitation in dementia: an exploratory randomized controlled trial

PubMed Central

Stige, Brynjulf; Qvale, Liv Gunnhild; Gold, Christian

2013-01-01

Objectives: Agitation in nursing home residents with dementia leads to increase in psychotropic medication, decrease in quality of life, and to patient distress and caregiver burden. Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been methodologically insufficient. The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes, and to explore its effect on psychotropic medication and quality of life. Method: In a crossover trial, 42 participants with dementia were randomized to a sequence of six weeks of individual music therapy and six weeks of standard care. Outcome measures included agitation, quality of life and medication. Results: Agitation disruptiveness increased during standard care and decreased during music therapy. The difference at −6.77 (95% CI (confidence interval): −12.71, −0.83) was significant (p = 0.027), with a medium effect size (0.50). The prescription of psychotropic medication increased significantly more often during standard care than during music therapy (p = 0.02). Conclusion: This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia. The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample. PMID:23621805

The development and exploratory analysis of the Back Pain Attitudes Questionnaire (Back-PAQ).

PubMed

Darlow, Ben; Perry, Meredith; Mathieson, Fiona; Stanley, James; Melloh, Markus; Marsh, Reginald; Baxter, G David; Dowell, Anthony

2014-05-23

To develop an instrument to assess attitudes and underlying beliefs about back pain, and subsequently investigate its internal consistency and underlying structures. The instrument was developed by a multidisciplinary team of clinicians and researchers based on analysis of qualitative interviews with people experiencing acute and chronic back pain. Exploratory analysis was conducted using data from a population-based cross-sectional survey. Qualitative interviews with community-based participants and subsequent postal survey. Instrument development informed by interviews with 12 participants with acute back pain and 11 participants with chronic back pain. Data for exploratory analysis collected from New Zealand residents and citizens aged 18 years and above. 1000 participants were randomly selected from the New Zealand Electoral Roll. 602 valid responses were received. The 34-item Back Pain Attitudes Questionnaire (Back-PAQ) was developed. Internal consistency was evaluated by the Cronbach α coefficient. Exploratory analysis investigated the structure of the data using Principal Component Analysis. The 34-item long form of the scale had acceptable internal consistency (α=0.70; 95% CI 0.66 to 0.73). Exploratory analysis identified five two-item principal components which accounted for 74% of the variance in the reduced data set: 'vulnerability of the back'; 'relationship between back pain and injury'; 'activity participation while experiencing back pain'; 'prognosis of back pain' and 'psychological influences on recovery'. Internal consistency was acceptable for the reduced 10-item scale (α=0.61; 95% CI 0.56 to 0.66) and the identified components (α between 0.50 and 0.78). The 34-item long form of the scale may be appropriate for use in future cross-sectional studies. The 10-item short form may be appropriate for use as a screening tool, or an outcome assessment instrument. Further testing of the 10-item Back-PAQ's construct validity, reliability, responsiveness to change and predictive ability needs to be conducted. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Physical activity intensity and type 2 diabetes risk in overweight youth: a randomized trial.

PubMed

Hay, J; Wittmeier, K; MacIntosh, A; Wicklow, B; Duhamel, T; Sellers, E; Dean, H; Ready, E; Berard, L; Kriellaars, D; Shen, G X; Gardiner, P; McGavock, J

2016-04-01

The chronic effects of high-intensity endurance training on metabolic health outcomes in overweight adolescents remains poorly understood. To test the hypothesis that high-intensity endurance training (ET) is superior to moderate-intensity ET for improving risk factors for type 2 diabetes in overweight adolescents. In this randomized trial, 106 overweight and obese adolescents (15.2 years; 76% female; 62% Caucasian) were randomly assigned to high-intensity ET (70-85% of heart rate reserve, n=38), moderate-intensity ET (40-55% heart rate reserve; n=32) or control for 6 months (n=36). The primary and secondary outcome measures were insulin sensitivity assessed using a frequently sampled intravenous glucose tolerance test and hepatic triglyceride content with magnetic resonance spectroscopy. Exploratory outcomes were cardiorespiratory fitness, physical activity and MRI and dual x-ray absorptiometry-derived measures of adiposity. The study had 96% retention and attendance was 61±21% and 55±24% in the high- and moderate-intensity ET arms. Intention-to-treat analyses revealed that, at follow-up, insulin sensitivity was not different between high-intensity (-1.0 mU kg(-1) min(-1); 95% confidence interval (CI): -1.6, +1.4 mU kg(-1) min(-1)) and moderate-intensity (+0.26 mU kg(-1) min(-1); 95% CI: -1.3, +1.8 mU kg(-1) min(-1)) ET arms compared with controls (interaction, P=0.97). Similarly, hepatic triglyceride at follow-up was not different in high-intensity (-1.7% fat/water (F/W); 95% CI: -7.0, +3.6% F/W) and moderate-intensity (-0.40% FW; 95% CI: -6.0, +5.3% F/W) ET compared with controls. Both high intensity (+4.4 ml per kg-FFM (fat-free mass) per minute; 95% CI: 1.7, 7.1 ml kg-FFM(-1) min(-1)) and moderate intensity (+4.4 ml kg-FFM(-1) min(-1); 95% CI: 1.6, 7.3 ml kg-FFM(-1) min(-1)) increased cardiorespiratory fitness, relative to controls (interaction P<0.001). ET improves cardiorespiratory fitness among obese adolescents; however, owing to lack of compliance, the influence of exercise intensity on insulin sensitivity and hepatic triglycerides remains unclear.

A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

PubMed

Bloom, R D; Trofe-Clark, J; Wiland, A; Alloway, R R

2013-01-01

An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Impact of a mHealth intervention for peer health workers on AIDS care in rural Uganda: a mixed methods evaluation of a cluster-randomized trial.

PubMed

Chang, Larry W; Kagaayi, Joseph; Arem, Hannah; Nakigozi, Gertrude; Ssempijja, Victor; Serwadda, David; Quinn, Thomas C; Gray, Ronald H; Bollinger, Robert C; Reynolds, Steven J

2011-11-01

Mobile phone access in low and middle-income countries is rapidly expanding and offers an opportunity to leverage limited human resources for health. We conducted a mixed methods evaluation of a cluster-randomized trial exploratory substudy on the impact of a mHealth (mobile phone) support intervention used by community-based peer health workers (PHW) on AIDS care in rural Uganda. 29 PHWs at 10 clinics were randomized by clinic to receive the intervention or not. PHWs used phones to call and text higher level providers with patient-specific clinical information. 970 patients cared for by the PHWs were followed over a 26 month period. No significant differences were found in patients' risk of virologic failure. Qualitative analyses found improvements in patient care and logistics and broad support for the mHealth intervention among patients, clinic staff, and PHWs. Key challenges identified included variable patient phone access, privacy concerns, and phone maintenance.

Performance of air traffic control specialists (ATCS'S) on a laboratory radar monitoring task : an exploratory study of complacency and a comparison of ATCS and non-ATCS performance.

DOT National Transportation Integrated Search

1982-04-01

The role of the air traffic control specialist (ATCS) is proposed highly automated air traffic systems of the future is currently receiving considerable attention. At the present time, a prevalent conception of the controller's role in such systems i...

Youth Attitudes towards Tobacco Control Laws: The Influence of Smoking Status and Grade in School

ERIC Educational Resources Information Center

Williams, Terrinieka T.; Jason, Leonard A.; Pokorny, Steven B.

2008-01-01

This study examined adolescent attitudes towards tobacco control laws. An exploratory factor analysis, using surveys from over 9,000 students, identified the following three factors: (1) youth attitudes towards the efficacy of tobacco control laws, (2) youth attitudes towards tobacco possession laws and (3) youth attitudes towards tobacco sales…

Cystic fibrosis respiratory tract salt concentration: An Exploratory Cohort Study.

PubMed

Grandjean Lapierre, Simon; Phelippeau, Michael; Hakimi, Cyrine; Didier, Quentin; Reynaud-Gaubert, Martine; Dubus, Jean-Christophe; Drancourt, Michel

2017-11-01

In cystic fibrosis patients, electrolytic and osmolality imbalance secondary to cystic fibrosis transmembrane conductance regulator mutations may impact on mucoid secretion accumulation and secondary colonization by opportunistic pathogens such as nontuberculous mycobacteria.We performed a noninvasive exploratory prospective controlled clinical study comparing sputum salinity and acid-base characteristics of cystic fibrosis and noncystic fibrosis control patients. A total of 57 patients and 62 controls were included.Sputum salt concentrations were 10.5 g/L (95% CI: 7.7-13.3) in patients and 7.4 g/L (95% CI: 5.9-8.9) in aged-matched controls, a difference that was found to be statistically significant (P < .05). No difference in pH was observed between patients and controls.These differences in respiratory secretions salt concentrations could influence host-pathogen interactions in the context of cystic fibrosis respiratory infections. We propose to include respiratory secretion salt measurement as a routine analysis on cystic fibrosis patients' sputum submitted for bacterial culture. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration.

PubMed

McBrayer, Zofeyah L; Dimova, Jiva; Pisansky, Marc T; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C; O'Connor, Michael B

2015-01-01

To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors.

Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration

PubMed Central

McBrayer, Zofeyah L.; Dimova, Jiva; Pisansky, Marc T.; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C.; O’Connor, Michael B.

2015-01-01

To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors. PMID:26444546

Prenatal stress exposure alters postnatal behavioral expression under conditions of novelty challenge in rhesus monkey infants.

PubMed

Schneider, M L

1992-11-01

This prospective study investigated whether mild maternal stress during pregnancy could alter the behavioral and affective responses in rhesus monkey infants in a complex, novel environment. Twenty-four rhesus monkey infants were tested on three occasions at 6 months of age in a novel environment. Twelve infants were derived from mothers exposed to a daily 10-min mild stressor from Day 90 to Day 145 postconception, while 12 were derived from mothers undisturbed during pregnancy. Prenatally stressed infants demonstrated more disturbance behavior, and lower levels of gross motor/exploratory behavior. Moreover, half of the prenatally stressed infants showed an abnormal response, falling asleep, while none of the control infants displayed this behavior. Males exhibited more clinging to surrogates, while females spent more time in gross motor/exploratory behaviors, with prenatally stressed males tending to spend the least time in gross motor/exploratory activity.

Exploratory behavior in mice selectively bred for developmental differences in aggressive behavior.

PubMed

Hood, Kathryn E; Quigley, Karen S

2008-01-01

The development and expression of exploratory behavior was assessed in the Cairns lines of Institute for Cancer Research (ICR) mice that were selectively bred for differences in aggressive behavior, with a high-aggressive 900 line, low-aggressive 100 line, and control 500 line. Four paradigms were employed. Developmental changes were evident in the complex novel arena, with older males faster to contact a novel object, and ambulating more than young males. Within the control 500 line, older males showed longer latency to emerge from the home cage, and shorter latency to contact novel objects. In the 900 line, younger males showed this same pattern. R. B. Cairns proposed that line differences in aggressive behavior arise through alterations in developmental timing [Cairns et al. [1983] Life-span developmental psychology (Vol. 5). New York: Academic Press; Gariépy et al. [2001] Animal Behaviour 61: 933-947]. The early appearance of mature patterns of exploratory behavior in 900 line males supports this interpretation. The 900 line males also appear to be behaviorally inhibited in novel settings such as the light-dark box and the neohypophagia paradigm, compared to the 500 and 100 lines (Experiments 1, 2, and 4). Moreover, in the most complex apparatus, the novel arena, 900 line males were slowest to exit the home cage, and fastest to contact a novel object. The apparent contrast in these parameters of exploratory behavior is discussed in relation to T. C. Schneirla's [1965 Advances in the study of behavior (Vol. 1). New York: PN Academic] approach-withdrawal theory. (c) 2007 Wiley Periodicals, Inc.

Evolutionary and immediate effects of crude-oil pollution: depression of exploratory behaviour across populations of Trinidadian guppies.

PubMed

Jacquin, L; Dybwad, C; Rolshausen, G; Hendry, A P; Reader, S M

2017-01-01

Human-induced perturbations such as crude-oil pollution can pose serious threats to aquatic ecosystems. To understand these threats fully it is important to establish both the immediate and evolutionary effects of pollutants on behaviour and cognition. Addressing such questions requires comparative and experimental study of populations that have evolved under different levels of pollution. Here, we compared the exploratory, activity and social behaviour of four populations of Trinidadian guppies (Poecilia reticulata) raised in common garden conditions for up to three generations. Two of these populations originated from tributaries with a long history of human-induced chronic crude-oil pollution with polycyclic aromatic hydrocarbons due to oil exploitation in Trinidad, the two others originating from non-polluted control sites. Laboratory-raised guppies from the oil-polluted sites were less exploratory in an experimental maze than guppies from the non-polluted sites and in a similar manner for the two independent rivers. We then compared the plastic behavioural responses of the different populations after an acute short-term experimental exposure to crude oil and found a decrease in exploration (but not in activity or shoaling) in the oil-exposed fish compared to the control subjects over all four populations. Taken together, these results suggest that both an evolutionary history with oil and an acute exposure to oil depressed guppy exploratory behaviour. We discuss whether the behavioural divergence observed represents adaptation to human-induced pollutants, the implications for conservation and the possible knock-on effects for information discovery and population persistence in fish groups.

Measuring Practicing Clinicians' Information Literacy. An Exploratory Analysis in the Context of Panel Management.

PubMed

Dixon, Brian E; Barboza, Katherine; Jensen, Ashley E; Bennett, Katelyn J; Sherman, Scott E; Schwartz, Mark D

2017-02-15

As healthcare moves towards technology-driven population health management, clinicians must adopt complex digital platforms to access health information and document care. This study explored information literacy, a set of skills required to effectively navigate population health information systems, among primary care providers in one Veterans' Affairs (VA) medical center. Information literacy was assessed during an 8-month randomized trial that tested a population health (panel) management intervention. Providers were asked about their use and comfort with two VA digital tools for panel management at baseline, 16 weeks, and post-intervention. An 8-item scale (range 0-40) was used to measure information literacy (Cronbach's α=0.84). Scores between study arms and provider types were compared using paired t-tests and ANOVAs. Associations between self-reported digital tool use and information literacy were measured via Pearson's correlations. Providers showed moderate levels of information literacy (M= 27.4, SD 6.5). There were no significant differences in mean information literacy between physicians (M=26.4, SD 6.7) and nurses (M=30.5, SD 5.2, p=0.57 for difference), or between intervention (M=28.4, SD 6.5) and control groups (M=25.1, SD 6.2, p=0.12 for difference). Information literacy was correlated with higher rates of self-reported information system usage (r=0.547, p=0.001). Clinicians identified data access, accuracy, and interpretability as potential information literacy barriers. While exploratory in nature, cautioning generalizability, the study suggests that measuring and improving clinicians' information literacy may play a significant role in the implementation and use of digital information tools, as these tools are rapidly being deployed to enhance communication among care teams, improve health care outcomes, and reduce overall costs.

Sensitivity to scale of willingness-to-pay within the context of menorrhagia.

PubMed

Sanghera, Sabina; Frew, Emma; Gupta, Janesh Kumar; Kai, Joe; Roberts, Tracy Elizabeth

2017-04-01

Willingness-to-pay (WTP) provides a broad assessment of well-being, capturing benefits beyond health. However, the validity of the approach has been questioned and the evidence relating to the sensitivity of WTP to changes in health status is mixed. Using menorrhagia (heavy menstrual bleeding) as a case study, this exploratory study assesses the sensitivity to scale of WTP to change in health status as measured by a condition-specific measure, MMAS, which includes both health and non-health benefits. The relationship between EQ-5D and change in health status is also assessed. Baseline EQ-5D and MMAS values were collected from women taking part in a randomized controlled trial for pharmaceutical treatment of menorrhagia. Following treatment, these measures were administered along with a WTP exercise. The relationship between the measures was assessed using Spearman's correlation analysis, and the sensitivity to scale of WTP was measured by identifying differences in WTP alongside differences in MMAS and EQ5D values. Our exploratory findings indicated that WTP, and not EQ-5D, was significantly positively correlated with change in MMAS, providing some evidence for convergent validity. These findings suggest that WTP is capturing the non-health benefits within the MMAS measure. Mean WTP also increased with percentage improvements in MMAS, suggesting sensitivity to scale. When compared to quality of life measured using the condition-specific MMAS measure, the convergent validity and sensitivity to scale of WTP is indicated. The findings suggest that WTP is more sensitive to change in MMAS, than with EQ-5D. © 2016 The Authors Health Expectations Published by John Wiley & Sons Ltd.

Droxidopa in patients with neurogenic orthostatic hypotension associated with Parkinson's disease (NOH306A).

PubMed

Hauser, Robert A; Hewitt, L Arthur; Isaacson, Stuart

2014-01-01

Neurogenic orthostatic hypotension (nOH) is common in Parkinson's disease (PD), and represents a failure to generate norepinephrine responses appropriate for postural change. Droxidopa (L-threo-3,4-dihydroxyphenylserine) is an oral norepinephrine prodrug. Interim analyses of the initial patients enrolled in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of droxidopa for nOH in PD (ClinicalTrials.gov Identifier: NCT01176240). PD patients with documented nOH underwent ≤ 2 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment (100-600 mg t.i.d.). The primary efficacy measure was change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to Week 8. Key secondary variables included dizziness/lightheadedness score (OHQ item 1) and patient-reported falls. Among 24 droxidopa and 27 placebo recipients, mean OHQ composite-score change at Week 8 was -2.2 versus -2.1 (p = 0.98); in response to this pre-planned futility analysis, the study was temporarily stopped and all data from these patients were considered exploratory. At Week 1, mean dizziness/lightheadedness score change favored droxidopa by 1.5 units (p = 0.24), with subsequent numerical differences favoring droxidopa throughout the observation period, and at Week 1, mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg (p = 0.04). Compared with placebo, the droxidopa group exhibited an approximately 50% lower rate of reported falls (p = 0.16) and fall-related injuries (post-hoc analysis). This exploratory analysis of a small dataset failed to show benefit of droxidopa, as compared with placebo by the primary endpoint. Nonetheless, there were signals of potential benefit for nOH, including improvement in dizziness/lightheadedness and reduction in falls, meriting evaluation in further trials.

The Implementation Leadership Scale (ILS): development of a brief measure of unit level implementation leadership.

PubMed

Aarons, Gregory A; Ehrhart, Mark G; Farahnak, Lauren R

2014-04-14

In healthcare and allied healthcare settings, leadership that supports effective implementation of evidenced-based practices (EBPs) is a critical concern. However, there are no empirically validated measures to assess implementation leadership. This paper describes the development, factor structure, and initial reliability and convergent and discriminant validity of a very brief measure of implementation leadership: the Implementation Leadership Scale (ILS). Participants were 459 mental health clinicians working in 93 different outpatient mental health programs in Southern California, USA. Initial item development was supported as part of a two United States National Institutes of Health (NIH) studies focused on developing implementation leadership training and implementation measure development. Clinician work group/team-level data were randomly assigned to be utilized for an exploratory factor analysis (n = 229; k = 46 teams) or for a confirmatory factor analysis (n = 230; k = 47 teams). The confirmatory factor analysis controlled for the multilevel, nested data structure. Reliability and validity analyses were then conducted with the full sample. The exploratory factor analysis resulted in a 12-item scale with four subscales representing proactive leadership, knowledgeable leadership, supportive leadership, and perseverant leadership. Confirmatory factor analysis supported an a priori higher order factor structure with subscales contributing to a single higher order implementation leadership factor. The scale demonstrated excellent internal consistency reliability as well as convergent and discriminant validity. The ILS is a brief and efficient measure of unit level leadership for EBP implementation. The availability of the ILS will allow researchers to assess strategic leadership for implementation in order to advance understanding of leadership as a predictor of organizational context for implementation. The ILS also holds promise as a tool for leader and organizational development to improve EBP implementation.

Comparative Cost-effectiveness of Strategies to Prevent Postoperative Clinical Recurrence of Crohn's Disease

PubMed Central

Doherty, Glen A.; Miksad, Rebecca A.; Cheifetz, Adam S.; Moss, Alan C.

2012-01-01

Background A number of treatments have been shown to reduce the risk of postoperative recurrence of Crohn's disease (CD). The optimal strategy is unknown. The aim was to evaluate the comparative cost-effectiveness of postoperative strategies to prevent clinical recurrence of CD. Methods Three prophylactic strategies were compared to “no prophylaxis”; mesalamine, azathioprine (AZA) / 6-mercaptopurine (6-MP), and infliximab. The probability of clinical recurrence, endoscopic recurrence, and therapy discontinuation due to adverse drug reactions (ADRs) were extracted from randomized controlled trials (RCTs). Quality-of-life scores and treatment costs were derived from published data. The primary model evaluated quality-adjusted life years (QALYs) and cost-effectiveness at 1 year after surgery. Sensitivity analysis assessed the impact of a range of recurrence rates on cost-effectiveness. An exploratory analysis evaluated cost-effectiveness outcomes 5 years after surgery. Results A strategy of “no prophylaxis” was the least expensive one at 1 and 5 years after surgery. Compared to this approach, AZA/6-MP had the most favorable incremental cost-effectiveness ratio (ICER) ($299,188/QALY gained), and yielded the highest net health benefits of the medication strategies at 1 year. Sensitivity analysis determined that the ICER of AZA/6-MP was preferable to mesalamine up to a recurrence rate of 52%, but mesalamine dominated at higher rates. In the 5-year exploratory analysis, mesalamine had the most favorable ICER over 5 years ($244,177/QALY gained). Conclusions Compared to no prophylactic treatment, AZA/6-MP has the most favorable ICER in the prevention of clinical recurrence of postoperative CD up to 1 year. At 5 years, mesalamine had the most favorable ICER in this model. PMID:21905173

Perceived work ability, quality of life, and fatigue in patients with rheumatoid arthritis after a 6-month course of TNF inhibitors: prospective intervention study and partial economic evaluation.

PubMed

Hoving, J L; Bartelds, G M; Sluiter, J K; Sadiraj, K; Groot, I; Lems, W F; Dijkmans, B A C; Wijbrandts, C A; Tak, P P; Nurmohamed, M T; Voskuyl, A E; Frings-Dresen, M H W

2009-01-01

The objective of this exploratory study was to evaluate the effects and costs of a 6-month course of tumour necrosis factor (TNF) inhibitors on work ability, quality of life, and fatigue in patients with rheumatoid arthritis (RA). In this prospective single-arm intervention study 59 consecutive patients of working age with established RA were recruited from an outpatient clinic in Amsterdam, the Netherlands. All patients received fortnightly subcutaneous injections of 40 mg adalimumab. The three outcomes at baseline and 6 months were: perceived work ability [Work Ability Index (WAI)], quality of life [Rheumatoid Arthritis Quality of Life instrument (RAQoL)], and fatigue [Checklist Individual Strength (CIS), Need for Recovery (NFR) scale]. Cost data of the preceding 6 months were collected using a self-administered patient questionnaire at baseline and follow-up. At 6 months, all outcomes showed a statistically significant improvement in mean scores from baseline, ranging from 10.0% (WAI), to 11.7% (RAQoL), to 15% (NFR) (subgroup paid work, n = 26). The total mean costs showed a twofold increase in mean costs per week per patient [difference EUR 169, 95% confidence interval (CI) EUR 113-226]. In this short-term exploratory evaluation, a 6-month course of TNF inhibitors improved work ability and quality of life, and reduced fatigue in patients with established RA. These effects are associated with an increase in total healthcare costs, attributable to the costs of TNF inhibitors. Randomized controlled trials with a longer follow-up are needed to show a long-term effect on work disability and the potential cost-effectiveness of TNF inhibitors.

The implementation leadership scale (ILS): development of a brief measure of unit level implementation leadership

PubMed Central

2014-01-01

Background In healthcare and allied healthcare settings, leadership that supports effective implementation of evidenced-based practices (EBPs) is a critical concern. However, there are no empirically validated measures to assess implementation leadership. This paper describes the development, factor structure, and initial reliability and convergent and discriminant validity of a very brief measure of implementation leadership: the Implementation Leadership Scale (ILS). Methods Participants were 459 mental health clinicians working in 93 different outpatient mental health programs in Southern California, USA. Initial item development was supported as part of a two United States National Institutes of Health (NIH) studies focused on developing implementation leadership training and implementation measure development. Clinician work group/team-level data were randomly assigned to be utilized for an exploratory factor analysis (n = 229; k = 46 teams) or for a confirmatory factor analysis (n = 230; k = 47 teams). The confirmatory factor analysis controlled for the multilevel, nested data structure. Reliability and validity analyses were then conducted with the full sample. Results The exploratory factor analysis resulted in a 12-item scale with four subscales representing proactive leadership, knowledgeable leadership, supportive leadership, and perseverant leadership. Confirmatory factor analysis supported an a priori higher order factor structure with subscales contributing to a single higher order implementation leadership factor. The scale demonstrated excellent internal consistency reliability as well as convergent and discriminant validity. Conclusions The ILS is a brief and efficient measure of unit level leadership for EBP implementation. The availability of the ILS will allow researchers to assess strategic leadership for implementation in order to advance understanding of leadership as a predictor of organizational context for implementation. The ILS also holds promise as a tool for leader and organizational development to improve EBP implementation. PMID:24731295

Online Communication about Depression and Anxiety among Twitter Users with Schizophrenia: Preliminary Findings to Inform a Digital Phenotype Using Social Media.

PubMed

Hswen, Yulin; Naslund, John A; Brownstein, John S; Hawkins, Jared B

2018-01-12

Digital technologies hold promise for supporting the detection and management of schizophrenia. This exploratory study aimed to generate an initial understanding of whether patterns of communication about depression and anxiety on popular social media among individuals with schizophrenia are consistent with offline representations of the illness. From January to July 2016, posts on Twitter were collected from a sample of Twitter users who self-identify as having a schizophrenia spectrum disorder (n = 203) and a randomly selected sample of control users (n = 173). Frequency and timing of communication about depression and anxiety were compared between groups. In total, the groups posted n = 1,544,122 tweets and users had similar characteristics. Twitter users with schizophrenia showed significantly greater odds of tweeting about depression compared with control users (OR = 2.69; 95% CI 1.76-4.10), and significantly greater odds of tweeting about anxiety compared with control users (OR = 1.81; 95% CI 1.20-2.73). This study offers preliminary insights that Twitter users with schizophrenia may express elevated symptoms of depression and anxiety in their online posts, which is consistent with clinical characteristics of schizophrenia observed in offline settings. Social media platforms could further our understanding of schizophrenia by informing a digital phenotype and may afford new opportunities to support early illness detection.

RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke.

PubMed

England, Timothy J; Hedstrom, Amanda; O'Sullivan, Saoirse; Donnelly, Richard; Barrett, David A; Sarmad, Sarir; Sprigg, Nikola; Bath, Philip M

2017-05-01

Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may improve outcome after acute stroke. We performed a pilot blinded placebo-controlled trial in patients with acute ischemic stroke, randomized 1:1 to receive 4 cycles of RIC within 24 hours of ictus. The primary outcome was tolerability and feasibility. Secondary outcomes included safety, clinical efficacy (day 90), putative biomarkers (pre- and post-intervention, day 4), and exploratory hemodynamic measures. Twenty-six patients (13 RIC and 13 sham) were recruited 15.8 hours (SD 6.2) post-onset, age 76.2 years (SD 10.5), blood pressure 159/83 mm Hg (SD 25/11), and National Institutes of Health Stroke Scale (NIHSS) score 5 (interquartile range, 3.75-9.25). RIC was well tolerated with 49 out of 52 cycles completed in full. Three patients experienced vascular events in the sham group: 2 ischemic strokes and 2 myocardial infarcts versus none in the RIC group ( P =0.076, log-rank test). Compared with sham, there was a significant decrease in day 90 NIHSS score in the RIC group, median NIHSS score 1 (interquartile range, 0.5-5) versus 3 (interquartile range, 2-9.5; P =0.04); RIC augmented plasma HSP27 (heat shock protein 27; P <0.05, repeated 2-way ANOVA) and phosphorylated HSP27 ( P <0.001) but not plasma S100-β, matrix metalloproteinase-9, endocannabinoids, or arterial compliance. RIC after acute stroke is well tolerated and appears safe and feasible. RIC may improve neurological outcome, and protective mechanisms may be mediated through HSP27. A larger trial is warranted. URL: http://www.isrctn.com. Unique identifier: ISRCTN86672015. © 2017 American Heart Association, Inc.

Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial

PubMed Central

Buchbinder, Susan P.; Mehrotra, Devan V.; Duerr, Ann; Fitzgerald, Daniel W.; Mogg, Robin; Li, David; Gilbert, Peter B.; Lama, Javier R.; Marmor, Michael; Rio, Carlos del; McElrath, M. Juliana; Casimiro, Danilo R.; Gottesdiener, Keith M.; Chodakewitz, Jeffrey A.; Corey, Lawrence; Robertson, Michael N.

2009-01-01

Background Observational data and non-human primate challenge studies suggest that cell-mediated immune (CMI) responses may provide control of HIV replication. The Step Study is the first direct assessment of the efficacy of a CMI vaccine to protect against HIV infection or alter early plasma HIV levels in humans. Method HIV-seronegative participants (3000) were randomized (1:1) to receive 3 injections of MRKAd5 HIV-1 gag/pol/nef vaccine or placebo. Randomization was pre-stratified by gender, baseline adenovirus type 5 (Ad5) titer, and study site. Participants were tested ~every 6 months for HIV acquisition; early plasma HIV RNA was measured ~3 months post-HIV diagnosis. Findings The vaccine elicited IFN-γ ELISPOT responses in 75% of vaccinees. In a pre-specified interim analysis among participants with baseline Ad5 ≤200, 24 of 741 vaccinees became HIV infected, versus 21 of 762 placebo recipients. All but one infection occurred in men. The early geometric mean plasma HIV RNA was comparable in infected vaccine and placebo recipients. In exploratory multivariate analyses, HIV incidence was higher in vaccinees versus placebo recipients among Ad5 seropositive men (5.1% versus 2.2% per year, respectively) and uncircumcised men (5.2% versus 1.4% per year, respectively). HIV incidence was similar in vaccinees versus placebo recipients among Ad5 seronegative men and circumcised men. Interpretation This CMI vaccine did not prevent HIV infection or lower early viral level. Mechanisms for failure of the vaccine to protect and for the increased HIV infection rates in subgroups of vaccinees are being explored. Additional follow-up will determine if elevated HIV incidence in vaccinee subgroups persists. PMID:19012954

The Impact of Aerobic Exercise on Fronto-Parietal Network Connectivity and Its Relation to Mobility: An Exploratory Analysis of a 6-Month Randomized Controlled Trial.

PubMed

Hsu, Chun L; Best, John R; Wang, Shirley; Voss, Michelle W; Hsiung, Robin G Y; Munkacsy, Michelle; Cheung, Winnie; Handy, Todd C; Liu-Ambrose, Teresa

2017-01-01

Impaired mobility is a major concern for older adults and has significant consequences. While the widely accepted belief is that improved physical function underlies the effectiveness of targeted exercise training in improving mobility and reducing falls, recent evidence suggests cognitive and neural benefits gained through exercise may also play an important role in promoting mobility. However, the underlying neural mechanisms of this relationship are currently unclear. Thus, we hypothesize that 6 months of progressive aerobic exercise training would alter frontoparietal network (FPN) connectivity during a motor task among older adults with mild subcortical ischemic vascular cognitive impairment (SIVCI)-and exercise-induced changes in FPN connectivity would correlate with changes in mobility. We focused on the FPN as it is involved in top-down attentional control as well as motor planning and motor execution. Participants were randomized either to usual-care (CON), which included monthly educational materials about VCI and healthy diet; or thrice-weekly aerobic training (AT), which was walking outdoors with progressive intensity. Functional magnetic resonance imaging was acquired at baseline and trial completion, where the participants were instructed to perform bilateral finger tapping task. At trial completion, compared with AT, CON showed significantly increased FPN connectivity strength during right finger tapping ( p < 0.05). Across the participants, reduced FPN connectivity was associated with greater cardiovascular capacity ( p = 0.05). In the AT group, reduced FPN connectivity was significantly associated with improved mobility performance, as measured by the Timed-Up-and-Go test ( r = 0.67, p = 0.02). These results suggest progressive AT may improve mobility in older adults with SIVCI via maintaining intra-network connectivity of the FPN.

Using Self-affirmation to Increase the Effects of Emotive Health Warnings on Smoking: A Randomized Exploratory Trial.

PubMed

Memish, Kate E; Schüz, Natalie; Frandsen, Mai; Ferguson, Stuart G; Schüz, Benjamin

2017-10-01

Emotive health messages are widely used tools in tobacco control. However, under some circumstances, they can be less effective than desired by eliciting defensive responses in smokers. This study tests whether enhancing a currently used emotive graphic smoking health warning with a self-affirmation component reduces cigarette consumption and whether potential effects are stronger in heavier smokers, as suggested by previous research. Participants (n = 265) were randomly allocated to a self-affirmation (reflecting on personal values and positive traits using a questionnaire) or matched control condition before viewing an emotive graphic health message from a current Australian government public health campaign. The primary outcome (cigarettes per day [CPD]) was assessed both before and a week following the intervention. No main effect of self-affirmation on smoking, but as hypothesized, a significant interaction between baseline smoking and self-affirmation was found that showed that heavier smokers (>21 CPD) who self-affirmed significantly reduced CPD compared to nonaffirmed smokers. These findings support the use of self-affirmation to enhance smoking awareness campaigns in heavier smokers. This study shows that enhancing emotive graphic smoking health messages with self-affirmation (the act of reflecting on positive aspects of oneself) increases their effectiveness in heavier smokers. This suggests that self-affirmation might be a particularly useful tool for health promotion targeting heavier smokers. This study adds to previous research in that it is the first to test the add-on effects of self-affirmation to current graphic health messages on smoking rather than smoking-related cognitions. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Early botulinum toxin treatment for spastic pes equinovarus--a randomized double-blind placebo-controlled study.

PubMed

Fietzek, U M; Kossmehl, P; Schelosky, L; Ebersbach, G; Wissel, J

2014-08-01

Spastic pes equinovarus is a frequent pathological posture of the lower extremity. Botulinum toxin (BoNT/A) has been successfully applied to treat lower limb spasticity. However, the best time to initiate treatment remains unclear. A beneficial effect of an early treatment has been suggested in previous studies. A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle. Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score (mAS) of at least 1+ after stroke, traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment. A second, open injection was optional at week 12. Patients received unilateral or bilateral injections with 230 or 460 U onabotulinumtoxinA, respectively. The course of the mAS was explored during the open study phase. Patients who had received BoNT/A treatment had lower mAS compared with placebo at week 12 (P < 0.01). During the open label phase, patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment. Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week 24 (P < 0.01). The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first 3 months after the lesion. Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment. © 2014 The Author(s) European Journal of Neurology © 2014 EAN.

Serum levels of bupivacaine after pre-peritoneal bolus vs. epidural bolus injection for analgesia in abdominal surgery: A safety study within a randomized controlled trial.

PubMed

Mungroop, Timothy H; van Samkar, Ganapathy; Geerts, Bart F; van Dieren, Susan; Besselink, Marc G; Veelo, Denise P; Lirk, Philipp

2017-01-01

Continuous wound infiltration (CWI) has become increasingly popular in recent years as an alternative to epidural analgesia. As catheters are not placed until the end of surgery, more intraoperative opioid analgesics might be needed. We, therefore, added a single pre-peritoneal bolus of bupivacaine at the start of laparotomy, similar to the bolus given with epidural analgesia. This was a comparative study within a randomized controlled trial (NTR4948). Patients undergoing hepato-pancreato-biliary surgery received either a pre-peritoneal bolus of 30ml bupivacaine 0.25%, or an epidural bolus of 10ml bupivacaine 0.25% at the start of laparotomy. In a subgroup of patients, we sampled blood and determined bupivacaine serum levels 20, 40, 60 and 80 minutes after bolus injection. We assumed toxicity of bupivacaine to be >1000 ng/ml. A total of 20 patients participated in this sub-study. All plasma levels measured as well as the upper limit of the predicted 99% confidence intervals per time point were well below the toxicity limit. In a mixed linear-effect model both groups did not differ statistically significant (p = 0.131). The intra-operative use of opioids was higher with CWI as compared to epidural (86 (SD 73) μg sufentanil vs. 50 (SD 32). In this exploratory study, the pre-peritoneal bolus using bupivacaine resulted in serum bupivacaine concentrations well below the commonly accepted toxic threshold. With CWI more additional analgesics are needed intraoperatively as compared to epidural analgesia, although this is compensated by a reduction in use of vasopressors with CWI. Netherlands Trial Register NTR4948.

Serum levels of bupivacaine after pre-peritoneal bolus vs. epidural bolus injection for analgesia in abdominal surgery: A safety study within a randomized controlled trial

PubMed Central

Geerts, Bart F.; van Dieren, Susan; Besselink, Marc G.; Veelo, Denise P.; Lirk, Philipp

2017-01-01

Background Continuous wound infiltration (CWI) has become increasingly popular in recent years as an alternative to epidural analgesia. As catheters are not placed until the end of surgery, more intraoperative opioid analgesics might be needed. We, therefore, added a single pre-peritoneal bolus of bupivacaine at the start of laparotomy, similar to the bolus given with epidural analgesia. Methods This was a comparative study within a randomized controlled trial (NTR4948). Patients undergoing hepato-pancreato-biliary surgery received either a pre-peritoneal bolus of 30ml bupivacaine 0.25%, or an epidural bolus of 10ml bupivacaine 0.25% at the start of laparotomy. In a subgroup of patients, we sampled blood and determined bupivacaine serum levels 20, 40, 60 and 80 minutes after bolus injection. We assumed toxicity of bupivacaine to be >1000 ng/ml. Results A total of 20 patients participated in this sub-study. All plasma levels measured as well as the upper limit of the predicted 99% confidence intervals per time point were well below the toxicity limit. In a mixed linear-effect model both groups did not differ statistically significant (p = 0.131). The intra-operative use of opioids was higher with CWI as compared to epidural (86 (SD 73) μg sufentanil vs. 50 (SD 32). Conclusions In this exploratory study, the pre-peritoneal bolus using bupivacaine resulted in serum bupivacaine concentrations well below the commonly accepted toxic threshold. With CWI more additional analgesics are needed intraoperatively as compared to epidural analgesia, although this is compensated by a reduction in use of vasopressors with CWI. Trial registration Netherlands Trial Register NTR4948 PMID:28614364

Experimental variation of social stress in virtual reality - Feasibility and first results in patients with psychotic disorders.

PubMed

Hesse, Klaus; Schroeder, Philipp A; Scheeff, Jonathan; Klingberg, Stefan; Plewnia, Christian

2017-09-01

Social interaction might lead to increased stress levels in patients with psychotic disorders. Impaired social stress tolerance is critical for social functioning and closely linked with symptom relapse and hospitalization. We present an interactive office built-up in virtual reality (VR). Patients with psychotic disorders (PP, N = 26 including N = 5 dropouts) and matched healthy controls (HC, N = 20) were examined with a VR simulating an open-plan office. In a randomized, controlled cross-over design, participants were introduced to virtual co-workers (avatars) and requested to ask them for task assistance. Social feedback in each of the two sessions was either cooperative or rejective in randomized order. The office environment was tolerable for most PP and all HC, five PP and none of the HC dropped out for any reason. Drop-outs reported simulator sickness, influence on thoughts and symptom exacerbations. Statistical trends indicated heightened paranoid ideations for PP after social rejection. State measures of paranoid ideations showed high convergent validity with conventional measures of delusions. Of note, measures of presence were higher for PP than for HC. The exploratory design limits the robustness of the findings. Only statistical trends on paranoid ideation were found. The use of VR to assess the effects of social rejection is feasible and tolerable for most PP (87%). However, its implementation for PP is challenged by increased simulator sickness and an additional stress load for some patients. Further studies continuing on these first results that point towards an increased paranoid ideation evoked by negative social feedback and generally higher subjective presence are needed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents.

PubMed

McCormack, S E; McCarthy, M A; Harrington, S G; Farilla, L; Hrovat, M I; Systrom, D M; Thomas, B J; Torriani, M; McInnis, K; Grinspoon, S K; Fleischman, A

2014-08-01

Obesity is associated with poor fitness and adverse metabolic consequences in children. To investigate how exercise and lifestyle modification may improve fitness and insulin sensitivity in this population. Randomized controlled trial, 21 obese (body mass index ≥ 95% percentile) subjects, ages 10 to 17 years. Subjects were given standardized healthful lifestyle advice for 8 weeks. In addition, they were randomized to an in-home supervised exercise intervention (n = 10) or control group (n = 11). Fasting laboratory studies (insulin, glucose, lipid profile) and assessments of fitness, body composition, skeletal muscle oxidative phosphorylation and intramyocellular lipid content (IMCL), were performed at baseline and study completion. Subjects were 13.0 ± 1.9 (standard deviation) years old, 72% female and 44% non-white. Exercise improved fitness (P = 0.03) and power (P = 0.01), and increased IMCL (P = 0.02). HOMA-IR decreased among all subjects in response to lifestyle modification advice (P = 0.01), regardless of exercise training assignment. In univariate analysis in all subjects, change in cardiovascular fitness was associated with change in HOMA-IR. In exploratory analyses, increased IMCL was associated with greater resting energy expenditure (r = 0.78, P = 0.005) and a decrease in fasting respiratory quotient (r = -0.70, P = 0.02) (n = 11). Change in fitness was found to be related to change in insulin resistance in response to lifestyle modification and exercise in obese children. IMCL increased with exercise in these obese children, which may reflect greater muscle lipid oxidative capacity. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

Does Dapagliflozin Affect Energy Intake and Appetite? A Randomized, Controlled Exploratory Study in Healthy Subjects.

PubMed

Bertran, Elizabeth; Berlie, Helen D; Nixon, Aaron; Jaber, Linda

2018-05-03

The primary aims of this study were to assess the effects of dapagliflozin versus placebo on energy intake and appetite ratings in healthy individuals. This was a randomized, single-blind, placebo-controlled, 2-period crossover study. In each period, healthy individuals received either dapagliflozin or placebo for 2 weeks. On assessment days, participants were asked to consume a standard preload breakfast. Appetite ratings were measured with 100-mm visual analog scales immediately before and during the 4.25-hour period after breakfast. Energy intake was measured at an ad libitum lunch. Energy intake and appetite responses were assessed at the end of each 2-week treatment period by mixed-design analysis of variance. Eighteen individuals completed all assessments (44% female; mean age, 22.8 years; 44% Caucasian; mean BMI, 25.2 kg/m 2 ). There was no difference in energy intake on dapagliflozin compared to placebo (mean difference, -19.8 kcal; P = .516). Mean differences in prebreakfast desire for salty foods (11.3 mm, P = .094) and postbreakfast desire for sweet foods (8.1 mm, P = .054) trended higher with dapagliflozin relative to placebo. Our data do not support an effect of dapagliflozin on energy intake or appetite measures in young, healthy subjects. Although not statistically significant, the size of the mean differences in prebreakfast desire for salty foods and postbreakfast desire for sweet foods on dapagliflozin were larger than placebo and reflect the drug's natriuretic and glucuretic effects. These findings should be further evaluated in patients with type 2 diabetes. © 2018, The American College of Clinical Pharmacology.

Placement matching of alcohol-dependent patients based on a standardized intake assessment: rationale and design of a randomized controlled trial.

PubMed

Buchholz, Angela; Friedrichs, Anke; Berner, Michael; König, Hans-Helmut; Konnopka, Alexander; Kraus, Ludwig; Kriston, Levente; Küfner, Heinrich; Piontek, Daniela; Rist, Fred; Röhrig, Jeanette

2014-10-14

Despite considerable research on substance-abuse placement matching, evidence is still inconclusive. The aims of this exploratory trial are to evaluate (a) the effects of following matching guidelines on health-care costs and heavy drinking, and (b) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients. A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited. During the first week of treatment, all patients will be administered Measurements in the Addictions for Triage and Evaluation (MATE), European Quality of Life-Five Dimensions health status questionnaire (EQ-5D), and the Client Socio--Demographic and Service Receipt Inventory-European Version (CSSRI-EU). Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results, including clear recommendations for subsequent treatment. Patients of the control group will receive treatment as usual and, if requested, global feedback regarding their assessment results, but no recommendations for subsequent treatment. At discharge, treatment outcome and referral decisions will be recorded. Six months after discharge, patients will be administered MATE-Outcome, EQ-5D, and CSSRI-EU during a telephone interview. This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients. A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines, outcomes, and potential mediating variables. German Clinical Trials Register DRKS00005035. Registered 03 June 2013.

Pharmacodynamic correlations using fresh and cryopreserved tissue following use of vaginal rings containing dapivirine and/or maraviroc in a randomized, placebo controlled trial

PubMed Central

Dezzutti, Charlene S.; Richardson-Harman, Nicola; Rohan, Lisa C.; Marzinke, Mark A.; Hoesley, Craig J.; Panther, Lori; Johnson, Sherri; Nuttall, Jeremy P.; Nel, Annalene; Chen, Beatrice A.

2016-01-01

Abstract Background: The ex vivo challenge assay is a bio-indicator of drug efficacy and was utilized in this randomized, placebo controlled trial as one of the exploratory endpoints. Fresh and cryopreserved tissues were evaluated for human immunodeficiency virus (HIV) infection and pharmacokinetic (PK)/pharmacodynamic (PD) relationships. Methods: HIV-negative women used vaginal rings containing 25 mg dapivirine (DPV)/100 mg maraviroc (MVC) (n = 12), DPV only (n = 12), MVC only (n = 12), or placebo (n = 12) for 28 days. Blood plasma, cervicovaginal fluid (CVF), and cervical biopsies were collected for drug quantification and the ex vivo challenge assay; half (fresh) were exposed immediately to HIV while the other half were cryopreserved, thawed, then exposed to HIV. HIV replication was monitored by p24 enzyme-linked immunosorbent assay from culture supernatant. Data were log-transformed and analyzed by linear least squared regression, nonlinear Emax dose–response model and Satterthwaite t test. Results: HIV replication was greater in fresh compared to cryopreserved tissue (P = 0.04). DPV was detected in all compartments, while MVC was consistently detected only in CVF. Significant negative correlations between p24 and DPV levels were observed in fresh cervical tissue (P = 0.01) and CVF (P = 0.03), but not plasma. CVF MVC levels showed a significant negative correlation with p24 levels (P = 0.03); drug levels in plasma and tissue were not correlated with HIV suppression. p24 levels from cryopreserved tissue did not correlate to either drug from any compartment. Conclusion: Fresh tissue replicated HIV to greater levels and defined PK/PD relationships while cryopreserved tissue did not. The ex vivo challenge assay using fresh tissue could prioritize drugs being considered for HIV prevention. PMID:27428211