Effects of Functional Fascial Taping on pain and function in patients with non-specific low back pain: a pilot randomized controlled trial.

PubMed

Chen, Shu-Mei; Alexander, Ron; Lo, Sing Kai; Cook, Jill

2012-10-01

To compare the short-term and medium-term effect of Functional Fascial Taping to placebo taping on pain and function in people with non-specific low back pain. A pilot randomized controlled trial with a 2-week intervention, and 2-, 6- and 12-week follow-up. Individuals with non-specific low back pain recruited from local communities. Forty-three participants with non-specific low back pain for more than 6 weeks were randomized into either Functional Fascial Taping group (n = 21) or placebo group (n = 22). The intervention group was treated with Functional Fascial Taping while the control group was treated with placebo taping. Both groups received four treatments over 2 weeks. Worst and average pain and function were assessed at baseline, after the 2-week intervention, and at 6 and 12 weeks follow-up. The Functional Fascial Taping group demonstrated significantly greater reduction in worst pain compared to placebo group after the 2-week intervention (P = 0.02, effect size = 0.74; 95% confidence interval 0.11-1.34). A higher proportion of participants in Functional Fascial Taping group attained the minimal clinically important difference in worst pain (P = 0.007) and function (P = 0.007) than those in placebo group after the 2-week intervention. There were no significant differences in either group's disability rating or clinically important difference in average pain at any time. Functional Fascial Taping reduced worst pain in patients with non-acute non-specific low back pain during the treatment phase. No medium-term differences in pain or function were observed.

Benefits and Sustainability of a Learning Collaborative for Implementation of Treat to Target in Rheumatoid Arthritis: Results of the TRACTION Trial Phase II.

PubMed

Solomon, Daniel H; Lu, Bing; Yu, Zhi; Corrigan, Cassandra; Harrold, Leslie R; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N; Losina, Elena

2018-01-05

We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence. We recruited 11 rheumatology sites and randomized them to either receive the LC during Phase I or to a wait-list control group that received the LC intervention during Phase II. The outcome was change in TTT implementation score (0 to 100, 100 is best) from pre- to post-intervention. TTT implementation score is defined as a percent of components documented in visit notes. Analyses examined: 1) the extent that the Phase I intervention teams sustained improvement in TTT; and, 2) predictors of TTT improvement. The analysis included 636 RA patients. At baseline, mean TTT implementation score was 11% in Phase I intervention sites and 13% in Phase II sites. After the intervention, TTT implementation score improved to 57% in the Phase I intervention sites and to 58% in the Phase II sites. Intervention sites from Phase I sustained the improvement during the Phase II (52%). Predictors of greater TTT improvement included only having rheumatologist providers at the site, academic affiliation of the site, fewer providers per site, and the rheumatologist provider being a trainee. Improvement in TTT remained relatively stable over a post-intervention period. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

PubMed Central

2012-01-01

Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months (follow-up) on their own. Safety endpoints include adverse event reporting. Intention-to-treat analysis will be applied to all data. Discussion Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes. Trial registration NCT01378806. PMID:22463125

Does stage tailoring matter in brief alcohol interventions for job-seekers? A randomized controlled trial.

PubMed

Freyer-Adam, Jennis; Baumann, Sophie; Schnuerer, Inga; Haberecht, Katja; Bischof, Gallus; John, Ulrich; Gaertner, Beate

2014-11-01

To investigate whether or not a stage tailored intervention is more effective than a non-stage tailored intervention of the same intensity in reducing alcohol use among job-seekers with unhealthy alcohol use, and whether initial motivation to change is a moderator of efficacy. A three-group randomized controlled trial with 3-, 6- and 15-month follow-ups. Three job agencies in Germany. A total of 1243 job-seekers with unhealthy alcohol use were randomized to (i) stage tailored intervention based on the transtheoretical model of change (ST), (ii) non-stage tailored intervention based on the theory of planned behaviour (NST) and (iii) assessment only (controls). Participants received feedback letters and manuals at baseline and 3 months later. Piecewise latent growth models were calculated measuring change in 'alcohol use' from baseline to month 3 (active intervention phase) and from months 3 to 15 (post-intervention phase, primary outcome). Motivation to change was included as a 4-point continuous measure. All groups reduced alcohol use from months 0 to 3 (controls: mean = -0.866, NST: mean = -0.883, ST: mean = -0.718, Ps ≤ 0.001). Post-intervention (months 3-15), low-motivated individuals in the ST group showed a greater reduction than those in the control group (β = 0.135, P = 0.039, Cohen's d = 0.42) and in the NST group (β = 0.180, P = 0.009, Cohen's d = 0.55). In contrast, compared to the ST group (β = 0.030, P = 0.361), alcohol use decreased more strongly with higher initial motivation in the NST group (β = -0.118, P = 0.010). Among job-seekers with high levels of alcohol consumption, an intervention tailored to motivational 'stage of change' was more effective than a non-stage tailored intervention for reducing alcohol use 15 months after baseline assessment in participants with low initial motivation to change. © 2014 Society for the Study of Addiction.

A nurse-delivered advice intervention can reduce chronic non-steroidal anti-inflammatory drug use in general practice: a randomized controlled trial.

PubMed

Jones, A C; Coulson, L; Muir, K; Tolley, K; Lophatananon, A; Everitt, L; Pringle, M; Doherty, M

2002-01-01

To find out whether a nurse-delivered educational package can reduce chronic oral non-steroidal anti-inflammatory drug (NSAID) usage in general practice. A prospective randomized controlled trial with assessment of economic cost/benefits was carried out in five general practices in Nottinghamshire with computerized prescribing systems, representing a mix of rural/urban and fundholding/non-fundholding practices. Patients suffering from non-malignant, non-inflammatory musculoskeletal pain received repeat prescriptions for oral NSAIDs. Two hundred and twenty-two patients were randomized to a control group (simple advice regarding NSAID use) or an intervention group (asked to withdraw their NSAIDs and employ appropriate alternative drug and non-drug therapies). All advice was supported by patient literature and delivered by a nurse practitioner trained in musculoskeletal assessment. The primary outcome measure was change in NSAID use 6 months after the intervention. Secondary outcome measures were changes in health and quality of life (SF-36 and EQ-5D questionnaires) and drug, health service and patient costs. An extra 28% of patients in the intervention group either stopped taking oral NSAIDs or reduced dosage by > or =50% at 6 months compared with controls. There was no detrimental effect on health and well-being. Oral NSAID prescription costs were significantly lowered in the intervention group but not in the control group. A non-significant increase in total drug prescription costs occurred in both groups. Nurse-based intervention can reduce chronic NSAID usage and costs in primary care and would be cost-effective if maintained in the long term. This intervention package would be readily applicable in primary care.

The Role of Salivary Neuropeptides in Pediatrics: Potential Biomarkers for Integrated Therapies

PubMed Central

Gershan, Lynn A; Durham, Paul L; Skidmore, Jaci; Shimizu, Joshua; Cady, Ryan J; Sheng, Xiaoming; Maloney, Christopher G

2015-01-01

Introduction Objective measures of symptom response to integrated complementary approaches in pediatrics are evolving. The purpose of this study was to document the concentration range of salivary neuropeptides in healthy controls and in children with cancer, to explore correlations between serum and salivary measurements for Calcitonin Gene-Related Peptide (CGRP) and Vasoactive Intestinal Polypeptide (VIP), and to determine whether there is a change in these salivary neuropeptide levels in response to integrated mind-body therapies. Methods A non-randomized pragmatic study with three phases: Phase 1- Healthy Control Saliva-10 healthy controls provided saliva samples; Phase 2- Cancer Diagnosis Serum-Saliva- 16 mixed-type cancer patients provided blood and saliva samples; Phase 3- Acute Lymphocytic Leukemia (ALL) Saliva Intervention- 12 patients with ALL provided pre- and post-complementary intervention saliva samples. Interventions 20-minutes of structured touch or scripted relaxation breathing were administered to patients in Phase 3; Phase 1 and 2 patients did not receive this intervention. Outcome Measures cortisol, CGRP, VIP, State/Trait Anxiety Scale, visual analogue scale, vital signs. Results Salivary CGRP and VIP were similar for children in Phases 1 and 2. There was a correlation between serum and salivary VIP in the mixed cancer group, though not between serum and salivary CGRP. In Phase 3 children, following a complementary intervention, salivary CGRP, heart rate, and systolic blood pressure decreased. Discussion/Conclusions These data provide evidence of a decrease in sympathetic output after integrative/complementary therapy intervention in children with cancer. The study underscores the potential role of salivary neuropeptides as non-invasive biomarkers for integrated therapies in pediatrics. PMID:26388958

A 12-week interdisciplinary rehabilitation trial in patients with gliomas - a feasibility study.

PubMed

Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek; Jarden, Jens Ole

2018-06-01

This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (<20%), adherence (>80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

PubMed

Carmona-Terés, Victoria; Lumillo-Gutiérrez, Iris; Jodar-Fernández, Lina; Rodriguez-Blanco, Teresa; Moix-Queraltó, Joanna; Pujol-Ribera, Enriqueta; Mas, Xavier; Batlle-Gualda, Enrique; Gobbo-Montoya, Milena; Berenguera, Anna

2015-02-25

The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. will receive standard care. quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. ISRCTN57405925. Registred 20 June 2014.

The Role of Salivary Neuropeptides in Pediatrics: Potential Biomarkers for Integrated Therapies.

PubMed

Gershan, Lynn A; Durham, Paul L; Skidmore, Jaci; Shimizu, Joshua; Cady, Ryan J; Sheng, Xiaoming; Maloney, Christopher G

2015-08-01

Objective measures of symptom response to integrated complementary approaches in pediatrics are evolving. The purpose of this study was to document the concentration range of salivary neuropeptides in healthy controls and in children with cancer, to explore correlations between serum and salivary measurements for Calcitonin Gene-Related Peptide (CGRP) and Vasoactive Intestinal Polypeptide (VIP), and to determine whether there is a change in these salivary neuropeptide levels in response to integrated mind-body therapies. A non-randomized pragmatic study with three phases: Phase 1- Healthy Control Saliva-10 healthy controls provided saliva samples; Phase 2- Cancer Diagnosis Serum-Saliva- 16 mixed-type cancer patients provided blood and saliva samples; Phase 3- Acute Lymphocytic Leukemia (ALL) Saliva Intervention- 12 patients with ALL provided pre- and post-complementary intervention saliva samples. 20-minutes of structured touch or scripted relaxation breathing were administered to patients in Phase 3; Phase 1 and 2 patients did not receive this intervention. cortisol, CGRP, VIP, State/Trait Anxiety Scale, visual analogue scale, vital signs. Salivary CGRP and VIP were similar for children in Phases 1 and 2. There was a correlation between serum and salivary VIP in the mixed cancer group, though not between serum and salivary CGRP. In Phase 3 children, following a complementary intervention, salivary CGRP, heart rate, and systolic blood pressure decreased. These data provide evidence of a decrease in sympathetic output after integrative/complementary therapy intervention in children with cancer. The study underscores the potential role of salivary neuropeptides as non-invasive biomarkers for integrated therapies in pediatrics.

Effectiveness of a Novel Qigong Meditative Movement Practice for Impaired Health in Flight Attendants Exposed to Second-Hand Cigarette Smoke.

PubMed

Payne, Peter; Fiering, Steven; Leiter, James C; Zava, David T; Crane-Godreau, Mardi A

2017-01-01

This single-arm non-randomized pilot study explores an intervention to improve the health of flight attendants (FA) exposed to second-hand cigarette smoke prior to the smoking ban on commercial airlines. This group exhibits an unusual pattern of long-term pulmonary dysfunction. We report on Phase I of a two-phase clinical trial; the second Phase will be a randomized controlled trial testing digital delivery of the intervention. Subjects were recruited in the Northeastern US; testing and intervention were administered in 4 major cities. The intervention involved 12 h of training in Meditative Movement practices. Based on recent research on the effects of nicotine on fear learning, and the influence of the autonomic nervous system on immune function, our hypothesis was that this training would improve autonomic function and thus benefit a range of health measures. Primary outcomes were the 6-min walk test and blood levels of C-reactive protein. Pulmonary, cardiovascular, autonomic, and affective measures were also taken. Fourteen participants completed the training and post-testing. There was a 53% decrease in high sensitivity C-Reactive Protein ( p ≤ 0.05), a 7% reduction in systolic blood pressure ( p ≤ 0.05), a 13% increase in the 6-min walk test ( p ≤ 0.005), and significant positive changes in several other outcomes. These results tend to confirm the hypothesized benefits of MM training for this population, and indicate that autonomic function may be important in the etiology and treatment of their symptoms. No adverse effects were reported. This trial is registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02612389/), and is supported by a grant from the Flight Attendant Medical Research Institute (FAMRI).

Modification of Fear Memory by Pharmacological and Behavioural Interventions during Reconsolidation.

PubMed

Thome, Janine; Koppe, Georgia; Hauschild, Sophie; Liebke, Lisa; Schmahl, Christian; Lis, Stefanie; Bohus, Martin

2016-01-01

Dysfunctional fear responses play a central role in many mental disorders. New insights in learning and memory suggest that pharmacological and behavioural interventions during the reconsolidation of reactivated fear memories may increase the efficacy of therapeutic interventions. It has been proposed that interventions applied during reconsolidation may modify the original fear memory, and thus prevent the spontaneous recovery and reinstatement of the fear response. We investigated whether pharmacological (propranolol) and behavioural (reappraisal, multisensory stimulation) interventions reduce fear memory, and prevent reinstatement of fear in comparison to a placebo control group. Eighty healthy female subjects underwent a differential fear conditioning procedure with three stimuli (CS). Two of these (CS+) were paired with an electric shock on day 1. On day 2, 20 subjects were pseudo-randomly assigned to either the propranolol or placebo condition, or underwent one of the two behavioural interventions after one of the two CS+ was reactivated. On day 3, all subjects underwent an extinction phase, followed by a reinstatement test. Dependent variables were US expectancy ratings, fear-potentiated startle, and skin conductance response. Differential fear responses to the reactivated and non-reactivated CS+ were observed only in the propranolol condition. Here, the non-reactivated CS+ evoked stronger fear-potentiated startle-responses compared to the placebo group. None of the interventions prevented the return of the extinguished fear response after re-exposure to the unconditioned stimulus. Our data are in line with an increasing body of research stating that the occurrence of reconsolidation may be constrained by boundary conditions such as subtle differences in experimental manipulations and instructions. In conclusion, our findings do not support a beneficial effect in using reconsolidation processes to enhance effects of psychotherapeutic interventions. This implies that more research is required before therapeutic interventions may benefit from a combination with reconsolidation processes.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Improving comprehension in adolescents with severe receptive language impairments: a randomized control trial of intervention for coordinating conjunctions.

PubMed

Ebbels, Susan H; Marić, Nataša; Murphy, Aoife; Turner, Gail

2014-01-01

Little evidence exists for the effectiveness of therapy for children with receptive language difficulties, particularly those whose difficulties are severe and persistent. To establish the effectiveness of explicit speech and language therapy with visual support for secondary school-aged children with language impairments focusing on comprehension of coordinating conjunctions in a randomized control trial with an assessor blind to group status. Fourteen participants (aged 11;3-16;1) with severe RELI (mean standard scores: CELF4 ELS = 48, CELF4 RLS = 53 and TROG-2 = 57), but higher non-verbal (Matrices = 83) and visual perceptual skills (Test of Visual Perceptual Skills (TVPS) = 86) were randomly assigned to two groups: therapy versus waiting controls. In Phase 1, the therapy group received eight 30-min individual sessions of explicit teaching with visual support (Shape Coding) with their usual SLT. In Phase 2, the waiting controls received the same therapy. The participants' comprehension was tested pre-, post-Phase 1 and post-Phase 2 therapy on (1) a specific test of the targeted conjunctions, (2) the TROG-2 and (3) a test of passives. After Phase 1, the therapy group showed significantly more progress than the waiting controls on the targeted conjunctions (d = 1.6) and overall TROG-2 standard score (d = 1.4). The two groups did not differ on the passives test. After Phase 2, the waiting controls made similar progress to those in the original therapy group, who maintained their previous progress. Neither group showed progress on passives. When the two groups were combined, significant progress was found on the specific conjunctions (d = 1.3) and TROG-2 raw (d = 1.1) and standard scores (d = 0.9). Correlations showed no measures taken (including Matrices and TVPS) correlated significantly with progress on the targeted conjunctions or the TROG-2. Four hours of Shape Coding therapy led to significant gains on comprehension of coordinating conjunctions which were maintained after 4 months. Given the significant progress at a group level and the lack of reliable predictors of progress, this approach could be offered to other children with similar difficulties to the participants. However, the intervention was delivered one-to-one by speech and language therapists, thus the effectiveness of this therapy method with other methods of delivery remains to be evaluated. © 2013 Royal College of Speech and Language Therapists.

Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.

PubMed

Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana

2016-08-01

Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of an Online Video-Based Intervention to Increase HIV Testing in Men Who Have Sex with Men in Peru

PubMed Central

Blas, Magaly M.; Alva, Isaac E.; Carcamo, Cesar P.; Cabello, Robinson; Goodreau, Steven M.; Kimball, Ann M.; Kurth, Ann E.

2010-01-01

Background Although many men who have sex with men (MSM) in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing. Methods We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were ‘intention to get tested’ and ‘HIV testing at the clinic.’ Findings In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR): 2.77, 95% Confidence Interval (CI): 1.42–5.39). After a mean of 125.5 days of observation (range 42–209 days), 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001). In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74–3.20). At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40–2.85). Conclusion This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations. Trial registration Clinicaltrials.gov NCT00751192 PMID:20454667

Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru.

PubMed

Blas, Magaly M; Alva, Isaac E; Carcamo, Cesar P; Cabello, Robinson; Goodreau, Steven M; Kimball, Ann M; Kurth, Ann E

2010-05-03

Although many men who have sex with men (MSM) in Peru are unaware of their HIV status, they are frequent users of the Internet, and can be approached by that medium for promotion of HIV testing. We conducted an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through a gay website. The videos were customized for two audiences based on self-identification: either gay or non-gay men. The outcomes evaluated were 'intention to get tested' and 'HIV testing at the clinic.' In the non-gay identified group, 97 men were randomly assigned to the video-based intervention and 90 to the text-based intervention. Non-gay identified participants randomized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days (62.5% vs. 15.4%, Relative Risk (RR): 2.77, 95% Confidence Interval (CI): 1.42-5.39). After a mean of 125.5 days of observation (range 42-209 days), 11 participants randomized to the video and none of the participants randomized to text attended our clinic requesting HIV testing (p = 0.001). In the gay-identified group, 142 men were randomized to the video-based intervention and 130 to the text-based intervention. Gay-identified participants randomized to the video were more likely to report intentions of getting an HIV test within 30 days, although not significantly (50% vs. 21.6%, RR: 1.54, 95% CI: 0.74-3.20). At the end of follow up, 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing (Hazard Ratio: 1.07, 95% CI: 0.40-2.85). This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru. This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM populations. Clinicaltrials.gov NCT00751192.

Complementary and alternative therapies to relieve labor pain: A comparative study between music therapy and Hoku point ice massage.

PubMed

Dehcheshmeh, Faranak Safdari; Rafiei, Hossein

2015-11-01

Pain is a common experience for women during labor. In the present study, we compared the effect of two types of non-pharmacological pain relief methods "music therapy" and "Hoku point ice massage" on the severity of labor pain. This prospective, randomized, controlled trial was conducted in Shahrekord, Iran, from September 2013 to June 2014. We randomly assigned 90 primiparous women who expected a normal childbirth into three groups: group "A" received music therapy, group "B" received Hoku point ice massage, and group "C" received usual labor care. At the beginning of the active phase (4 cm cervical dilation) and before and after each intervention (at dilations 4, 6, and 8 cm), the intensities of labor pain were measured using Visual Analogue Scale (VAS). At the beginning of the active phase, the mean VAS scores were 5.58 ± 1.29, 5.42 ± 1.31, and 6.13 ± 1.37 in the women in groups "A," "B," and "C," respectively (P > 0.05). After the intervention, the mean pain scores were significantly lower at all of the time points in groups "A" and "B" than in group "C" women (P < 0.05). Although the pain scores showed a more decreasing trend after the intervention in group "A" than that in group "B," the difference between the two groups was not statistically significant (P > 0.05). Music therapy and Hoku point ice massage are easily available and inexpensive methods and have a similar effect in relieving labor pain. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: a randomized controlled trial.

PubMed

Zwikker, Hanneke E; van den Ende, Cornelia H; van Lankveld, Wim G; den Broeder, Alfons A; van den Hoogen, Frank H; van de Mosselaar, Birgit; van Dulmen, Sandra; van den Bemt, Bart J

2014-03-01

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA). Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up. 123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months' follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: -1.0 (95% CI: -2.0, -0.1)). This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time. Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Goals of patient care system change with video-based education increases rates of advance cardiopulmonary resuscitation decision-making and discussions in hospitalised rehabilitation patients.

PubMed

Johnson, Claire E; Chong, Jeffrey C; Wilkinson, Anne; Hayes, Barbara; Tait, Sonia; Waldron, Nicholas

2017-07-01

Advance cardiopulmonary resuscitation (CPR) discussions and decision-making are not routine clinical practice in the hospital setting. Frail older patients may be at risk of non-beneficial CPR. To assess the utility and safety of two interventions to increase CPR decision-making, documentation and communication for hospitalised older patients. A pre-post study tested two interventions: (i) standard ward-based education forums with CPR content; and (ii) a combined, two-pronged strategy with 'Goals of Patient Care' (GoPC) system change and a structured video-based workshop; against usual practice (i.e. no formal training). Participants were a random sample of patients in a hospital rehabilitation unit. The outcomes were the proportion of patients documented as: (i) not for resuscitation (NFR); and (ii) eligible for rapid response team (RRT) calls, and rates of documented discussions with the patient, family and carer. When compared with usual practice, patients were more likely to be documented as NFR following the two-pronged intervention (adjusted odds ratio (aOR): 6.4, 95% confidence interval (CI): 3.0; 13.6). Documentation of discussions with patients was also more likely (aOR: 3.3, 95% CI:1.8; 6.2). Characteristics of patients documented NFR were similar between the phases, but were more likely for RRT calls following Phase 3 (P 0.03). An increase in advance CPR decisions occurred following GoPC system change with education. This appears safe as NFR patients had the same level of frailty between phases but were more likely to be eligible for RRT review. Increased documentation of discussions suggests routine use of the GoPC form may improve communication with patients about their care. © 2017 Royal Australasian College of Physicians.

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease.

PubMed

Elsner, Bernhard; Kugler, Joachim; Pohl, Marcus; Mehrholz, Jan

2016-07-18

Idiopathic Parkinson's disease (IPD) is a neurodegenerative disorder, with the severity of the disability usually increasing with disease duration. IPD affects patients' health-related quality of life, disability, and impairment. Current rehabilitation approaches have limited effectiveness in improving outcomes in patients with IPD, but a possible adjunct to rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve these outcomes in IPD. To assess the effectiveness of tDCS in improving motor and non-motor symptoms in people with IPD. We searched the following databases (until February 2016): the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library ; 2016 , Issue 2), MEDLINE, EMBASE, CINAHL, AMED, Science Citation Index, the Physiotherapy Evidence Database (PEDro), Rehabdata, and Inspec. In an effort to identify further published, unpublished, and ongoing trials, we searched trial registers and reference lists, handsearched conference proceedings, and contacted authors and equipment manufacturers. We included only randomised controlled trials (RCTs) and randomised controlled cross-over trials that compared tDCS versus control in patients with IPD for improving health-related quality of life , disability, and impairment. Two review authors independently assessed trial quality (JM and MP) and extracted data (BE and JM). If necessary, we contacted study authors to ask for additional information. We collected information on dropouts and adverse events from the trial reports. We included six trials with a total of 137 participants. We found two studies with 45 participants examining the effects of tDCS compared to control (sham tDCS) on our primary outcome measure, impairment, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). There was very low quality evidence for no effect of tDCS on change in global UPDRS score ( mean difference (MD) -7.10 %, 95% confidence interval (CI -19.18 to 4.97; P = 0.25, I² = 21%, random-effects model). However, there was evidence of an effect on UPDRS part III motor subsection score at the end of the intervention phase (MD -14.43%, 95% CI -24.68 to -4.18; P = 0.006, I² = 2%, random-effects model; very low quality evidence). One study with 25 participants measured the reduction in off and on time with dyskinesia, but there was no evidence of an effect (MD 0.10 hours, 95% CI -0.14 to 0.34; P = 0.41, I² = 0%, random-effects model; and MD 0.00 hours, 95% CI -0.12 to 0.12; P = 1, I² = 0%, random- effects model, respectively; very low quality evidence).Two trials with a total of 41 participants measured gait speed using measures of timed gait at the end of the intervention phase, revealing no evidence of an effect ( standardised mean difference (SMD) 0.50, 95% CI -0.17 to 1.18; P = 0.14, I² = 11%, random-effects model; very low quality evidence). Another secondary outcome was health-related quality of life and we found one study with 25 participants reporting on the physical health and mental health aspects of health-related quality of life (MD 1.00 SF-12 score, 95% CI -5.20 to 7.20; I² = 0%, inverse variance method with random-effects model; very low quality evidence; and MD 1.60 SF-12 score, 95% CI -5.08 to 8.28; I² = 0%, inverse variance method with random-effects model; very low quality evidence, respectively). We found no study examining the effects of tDCS for improving activities of daily living. In two of six studies, dropouts , adverse events, or deaths occurring during the intervention phase were reported. There was insufficient evidence that dropouts , adverse effects, or deaths were higher with intervention (risk difference (RD) 0.04, 95% CI -0.05 to 0.12; P = 0.40, I² = 0%, random-effects model; very low quality evidence).We found one trial with a total of 16 participants examining the effects of tDCS plus movement therapy compared to control (sham tDCS) plus movement therapy on our secondary outcome, gait speed at the end of the intervention phase, revealing no evidence of an effect (MD 0.05 m/s, 95% CI -0.15 to 0.25; inverse variance method with random-effects model; very low quality evidence). We found no evidence of an effect regarding differences in dropouts and adverse effects between intervention and control groups (RD 0.00, 95% CI -0.21 to 0.21; Mantel-Haenszel method with random-effects model; very low quality evidence). There is insufficient evidence to determine the effects of tDCS for reducing off time ( when the symptoms are not controlled by the medication) and on time with dyskinesia ( time that symptoms are controlled but the person still experiences involuntary muscle movements ) , and for improving health- related quality of life, disability, and impairment in patients with IPD. Evidence of very low quality indicates no difference in dropouts and adverse events between tDCS and control groups.

Psychosocial intervention in at-risk adolescents: using event-related potentials to assess changes in decision making and feedback processing.

PubMed

Pincham, H L; Bryce, D; Fonagy, P; Fearon, R M Pasco

2018-05-25

Decision making and feedback processing are two important cognitive processes that are impacted by social context, particularly during adolescence. The current study examined whether a psychosocial intervention could improve psychological wellbeing in at-risk adolescent boys, thereby improving their decision making and feedback processing skills. Two groups of at-risk adolescents were compared: those who were relatively new to a psychosocial intervention, and those who had engaged over a longer time period. Electroencephalography was recorded while the young people participated in a modified version of the Taylor Aggression Paradigm. The late positive potential (LPP) was measured during the decision phase of the task (where participants selected punishments for their opponents). The feedback-related negativity (FRN) and P3 components were measured during the task's outcome phase (where participants received 'win' or 'lose' feedback). Adolescents who were new to the intervention (the minimal-intervention group) were harsher in their punishment selections than those who had been engaged in the program for much longer. The minimal-intervention group also showed an enhanced LPP during the decision phase of the task, which may be indicative of immature decision making in that group. Analysis of the FRN and P3 amplitudes revealed that the minimal-intervention group was physiologically hypo-sensitive to feedback, compared with the extended-intervention group. Overall, these findings suggest that long-term community-based psychosocial intervention programs are beneficial for at-risk adolescents, and that event-related potentials can be employed as biomarkers of therapeutic change. However, because participants were not randomly allocated to treatment groups, alternative explanations cannot be excluded until further randomized controlled trials are undertaken.

Two-component Structure in the Entanglement Spectrum of Highly Excited States

NASA Astrophysics Data System (ADS)

Yang, Zhi-Cheng; Chamon, Claudio; Hamma, Alioscia; Mucciolo, Eduardo

We study the entanglement spectrum of highly excited eigenstates of two known models which exhibit a many-body localization transition, namely the one-dimensional random-field Heisenberg model and the quantum random energy model. Our results indicate that the entanglement spectrum shows a ``two-component'' structure: a universal part that is associated to Random Matrix Theory, and a non-universal part that is model dependent. The non-universal part manifests the deviation of the highly excited eigenstate from a true random state even in the thermalized phase where the Eigenstate Thermalization Hypothesis holds. The fraction of the spectrum containing the universal part decreases continuously as one approaches the critical point and vanishes in the localized phase in the thermodynamic limit. We use the universal part fraction to construct a new order parameter for the many-body delocalized-to-localized transition. Two toy models based on Rokhsar-Kivelson type wavefunctions are constructed and their entanglement spectra are shown to exhibit the same structure.

Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial.

PubMed

Tola, Habteyes Hailu; Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

2016-01-01

Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM). A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence. At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18-0.53), p < 0.001)). Psychological counseling and educational interventions, which were guided by HBM, significantly decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy. Pan African Clinical Trials Registry PACTR201506001175423.

Changes in Brain Volume and Cognition in a Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders

PubMed Central

Mortimer, James A.; Ding, Ding; Borenstein, Amy R.; DeCarli, Charles; Guo, Qihao; Wu, Yougui; Zhao, Qianhua; Chu, Shugang

2013-01-01

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRIs were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks, and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models. Compared to the No Intervention group, significant increases in brain volume were seen in the Tai Chi and Social Intervention groups (p < 0.05). Improvements also were observed in several neuropsychological measures in the Tai Chi group, including the Mattis Dementia Rating Scale score (p = 0.004), the Trailmaking Test A (p = 0.002) and B (p = 0.0002), the Auditory Verbal Learning Test (p = 0.009), and verbal fluency for animals (p = 0.01). The Social Interaction group showed improvement on some, but fewer neuropsychological indices. No differences were observed between the Walking and No Intervention groups. The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise (Tai Chi). In addition, intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements. PMID:22451320

Changes in brain volume and cognition in a randomized trial of exercise and social interaction in a community-based sample of non-demented Chinese elders.

PubMed

Mortimer, James A; Ding, Ding; Borenstein, Amy R; DeCarli, Charles; Guo, Qihao; Wu, Yougui; Zhao, Qianhua; Chu, Shugang

2012-01-01

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRIs were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks, and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models. Compared to the No Intervention group, significant increases in brain volume were seen in the Tai Chi and Social Intervention groups (p < 0.05). Improvements also were observed in several neuropsychological measures in the Tai Chi group, including the Mattis Dementia Rating Scale score (p = 0.004), the Trailmaking Test A (p = 0.002) and B (p = 0.0002), the Auditory Verbal Learning Test (p = 0.009), and verbal fluency for animals (p = 0.01). The Social Interaction group showed improvement on some, but fewer neuropsychological indices. No differences were observed between the Walking and No Intervention groups. The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise (Tai Chi). In addition, intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements.

An Innovative Multiphased Strategy to Recruit Underserved Adults into a Randomized Trial of a Community-Based Diabetes Risk Reduction Program

ERIC Educational Resources Information Center

Santoyo-Olsson, Jasmine; Cabrera, Julissa; Freyre, Rachel; Grossman, Melanie; Alvarez, Natalie; Mathur, Deepika; Guerrero, Maria; Delgadillo, Adriana T.; Kanaya, Alka M.; Stewart, Anita L.

2011-01-01

Purpose: To conduct and evaluate a two-phased community-based approach to recruit lower socioeconomic status, minority, or Spanish-speaking adults at risk of developing diabetes to a randomized trial of a lifestyle intervention program delivered by a public health department. Design: Within geographic areas comprising our target population, 4…

Modification of Fear Memory by Pharmacological and Behavioural Interventions during Reconsolidation

PubMed Central

Thome, Janine; Koppe, Georgia; Hauschild, Sophie; Liebke, Lisa; Schmahl, Christian; Lis, Stefanie; Bohus, Martin

2016-01-01

Background Dysfunctional fear responses play a central role in many mental disorders. New insights in learning and memory suggest that pharmacological and behavioural interventions during the reconsolidation of reactivated fear memories may increase the efficacy of therapeutic interventions. It has been proposed that interventions applied during reconsolidation may modify the original fear memory, and thus prevent the spontaneous recovery and reinstatement of the fear response. Methods We investigated whether pharmacological (propranolol) and behavioural (reappraisal, multisensory stimulation) interventions reduce fear memory, and prevent reinstatement of fear in comparison to a placebo control group. Eighty healthy female subjects underwent a differential fear conditioning procedure with three stimuli (CS). Two of these (CS+) were paired with an electric shock on day 1. On day 2, 20 subjects were pseudo-randomly assigned to either the propranolol or placebo condition, or underwent one of the two behavioural interventions after one of the two CS+ was reactivated. On day 3, all subjects underwent an extinction phase, followed by a reinstatement test. Dependent variables were US expectancy ratings, fear-potentiated startle, and skin conductance response. Results Differential fear responses to the reactivated and non-reactivated CS+ were observed only in the propranolol condition. Here, the non-reactivated CS+ evoked stronger fear-potentiated startle-responses compared to the placebo group. None of the interventions prevented the return of the extinguished fear response after re-exposure to the unconditioned stimulus. Conclusions Our data are in line with an increasing body of research stating that the occurrence of reconsolidation may be constrained by boundary conditions such as subtle differences in experimental manipulations and instructions. In conclusion, our findings do not support a beneficial effect in using reconsolidation processes to enhance effects of psychotherapeutic interventions. This implies that more research is required before therapeutic interventions may benefit from a combination with reconsolidation processes. PMID:27537364

Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

PubMed

Berry, Diane C; Neal, Madeline; Hall, Emily G; Schwartz, Todd A; Verbiest, Sarah; Bonuck, Karen; Goodnight, William; Brody, Seth; Dorman, Karen F; Menard, Mary K; Stuebe, Alison M

2013-10-10

Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations. NCT01809431.

Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study

PubMed Central

2013-01-01

Background Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Methods/Design Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22–36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22–36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Discussion Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations. Trial registration NCT01809431 PMID:24112417

Translating the Diabetes Prevention Program Lifestyle Intervention for Weight Loss into Primary Care: A Randomized Trial

PubMed Central

Ma, Jun; Yank, Veronica; Xiao, Lan; Lavori, Philip W.; Wilson, Sandra R.; Rosas, Lisa G.; Stafford, Randall S.

2013-01-01

Background The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes among high risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care. Methods We evaluated two adapted DPP lifestyle interventions among overweight/obese adults who were recruited from one primary care clinic and had prediabetes and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n=79), (2) a self-directed DVD intervention (n=81), or (3) usual care (n=81). During a 3-month intensive intervention phase, the DPP-based behavioral weight loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely–through secure email within an electronic health record system and the American Heart Association Heart360 Web site for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) from baseline to 15 months. Results At baseline, participants had a mean (±SD) age of 52.9±10.6 years and mean BMI 32.0±5.4 kg/m2 with 47% female, 78% Non-Hispanic white, and 17% Asian/Pacific Islander. At month 15, the mean (±SE) change in BMI from baseline was −2.2±0.3 kg/m2 in the coach-led group (vs. −0.9±0.3 kg/m2 in the usual care group, P<0.001) and −1.6±0.3 kg/m2 in the self-directed group (P=0.02 vs. usual care). The percentages of participants who achieved the 7% DPP-based weight loss goal were 37.0% (P=0.003) and 35.9% (P=0.004) in the coach-led and self-directed groups, respectively, versus 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose. Conclusions Proven effective in a primary care setting, the two DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact. Trial Registration Clinicaltrials.gov identifier: NCT00842426 PMID:23229846

Predictors of Short- and Long-Term Attrition From the Parents as Agents of Change Randomized Controlled Trial for Managing Pediatric Obesity.

PubMed

Spence, Nicholas D; Newton, Amanda S; Keaschuk, Rachel A; Ambler, Kathryn A; Jetha, Mary M; Holt, Nicholas L; Rosychuk, Rhonda J; Spence, John C; Sharma, Arya M; Ball, Geoff D C

Attrition in pediatric weight management is a substantial problem. This study examined factors associated with short- and long-term attrition from a lifestyle and behavioral intervention for parents of children with overweight or obesity. Fifty-two families with children ages 6 to 12 years old and body mass index at or above the 85th percentile participated in a randomized controlled trial focused on parents, comparing parent-based cognitive behavioral therapy with parent-based psychoeducation for pediatric weight management. We examined program attrition using two clinical phases of the intervention: short-term and long-term attrition, modeled using the general linear model. Predictors included intervention type, child/parent weight status, sociodemographic factors, and health of the family system. Higher self-assessed health of the family system was associated with lower short-term attrition; higher percentage of intervention sessions attended by parents was associated with lower long-term attrition. Different variables were significant in our short- and long-term models. Attrition might best be conceptualized based on short- and long-term phases of clinical, parent-based interventions for pediatric weight management. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults' physical activity.

PubMed

Adams, Marc A; Hurley, Jane C; Todd, Michael; Bhuiyan, Nishat; Jarrett, Catherine L; Tucker, Wesley J; Hollingshead, Kevin E; Angadi, Siddhartha S

2017-03-29

Emerging interventions that rely on and harness variability in behavior to adapt to individual performance over time may outperform interventions that prescribe static goals (e.g., 10,000 steps/day). The purpose of this factorial trial was to compare adaptive vs. static goal setting and immediate vs. delayed, non-contingent financial rewards for increasing free-living physical activity (PA). A 4-month 2 × 2 factorial randomized controlled trial tested main effects for goal setting (adaptive vs. static goals) and rewards (immediate vs. delayed) and interactions between factors to increase steps/day as measured by a Fitbit Zip. Moderate-to-vigorous PA (MVPA) minutes/day was examined as a secondary outcome. Participants (N = 96) were mainly female (77%), aged 41 ± 9.5 years, and all were insufficiently active and overweight/obese (mean BMI = 34.1 ± 6.2). Participants across all groups increased by 2389 steps/day on average from baseline to intervention phase (p < .001). Participants receiving static goals showed a stronger increase in steps per day from baseline phase to intervention phase (2630 steps/day) than those receiving adaptive goals (2149 steps/day; difference = 482 steps/day, p = .095). Participants receiving immediate rewards showed stronger improvement (2762 step/day increase) from baseline to intervention phase than those receiving delayed rewards (2016 steps/day increase; difference = 746 steps/day, p = .009). However, the adaptive goals group showed a slower decrease in steps/day from the beginning of the intervention phase to the end of the intervention phase (i.e. less than half the rate) compared to the static goals group (-7.7 steps vs. -18.3 steps each day; difference = 10.7 steps/day, p < .001) resulting in better improvements for the adaptive goals group by study end. Rate of change over the intervention phase did not differ between reward groups. Significant goal phase x goal setting x reward interactions were observed. Adaptive goals outperformed static goals (i.e., 10,000 steps) over a 4-month period. Small immediate rewards outperformed larger, delayed rewards. Adaptive goals with either immediate or delayed rewards should be preferred for promoting PA. ClinicalTrials.gov ID: NCT02053259 registered prospectively on January 31, 2014.

Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial.

PubMed

Sofi, Francesco; Dinu, Monica; Pagliai, Giuditta; Cesari, Francesca; Marcucci, Rossella; Casini, Alessandro

2016-05-04

Nutrition is able to alter the cardiovascular health of the general population. However, the optimal dietary strategy for cardiovascular disease prevention is still far from being defined. Mediterranean and vegetarian diets are those reporting the greatest grade of evidence in the literature, but no experimental studies comparing these two dietary patterns are available. This is an open randomized crossover clinical trial including healthy subjects with a low-to-medium cardiovascular risk profile, characterized by being overweight and by the presence of at least an additional metabolic risk factor (abdominal obesity, high total cholesterol, high LDL cholesterol, high triglycerides, impaired glucose fasting levels) but free from medications. A total of 100 subjects will be included and randomly assigned to two groups: Mediterranean calorie-restricted diet (n = 50) and vegetarian calorie-restricted diet (n = 50). The intervention phases will last 3 months each, and at the end of intervention phase I the groups will be crossed over. The two diets will be isocaloric and of three different sizes (1400 - 1600 - 1800 kcal/day), according to specific energy requirements. Adherence to the dietary intervention will be established through questionnaires and 24-h dietary recall. Anthropometric measurements, body composition, blood samples and stool samples will be obtained from each participant at the beginning and at the end of each intervention phase. The primary outcome measure will be change in weight from baseline. The secondary outcome measures will be variations of anthropometric and bioelectrical impedance variables as well as traditional and innovative cardiovascular biomarkers. Despite all the data supporting the efficacy of Mediterranean and vegetarian diets on the prevention of cardiovascular diseases, no studies have directly compared these two dietary profiles. The trial will test whether there are statistically significant differences between these dietary profiles in reducing the cardiovascular risk burden for the general population. ClinicalTrials.gov NCT02641834.

Two spatial light modulator system for laboratory simulation of random beam propagation in random media.

PubMed

Wang, Fei; Toselli, Italo; Korotkova, Olga

2016-02-10

An optical system consisting of a laser source and two independent consecutive phase-only spatial light modulators (SLMs) is shown to accurately simulate a generated random beam (first SLM) after interaction with a stationary random medium (second SLM). To illustrate the range of possibilities, a recently introduced class of random optical frames is examined on propagation in free space and several weak turbulent channels with Kolmogorov and non-Kolmogorov statistics.

Randomized Controlled Trial of Nuevo Amanecer: A Peer-delivered Stress Management Intervention for Spanish-speaking Latinas with Breast Cancer

PubMed Central

Nápoles, Anna María; Santoyo-Olsson, Jasmine; Ortiz, Carmen; Gregorich, Steven; Lee, Howard E.; Duron, Ysabel; Graves, Kristi; Luce, Judith A.; McGuire, Peggy; Díaz-Méndez, Marynieves; Stewart, Anita L.

2014-01-01

Background Latinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population. Purpose We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings. Methods We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes. Results In phase 1, we established project infrastructure: academic and community Co-Principal Investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low-literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners. Lessons Learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment. Limitations These were resource-intensive processes to develop and implement the program that need to be compared to less intensive alternatives. Conclusions Engaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context. If the randomized trial demonstrates that the intervention is effective, it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer. PMID:24577971

Effects of behavioral stress reduction Transcendental Meditation intervention in Persons with HIV

PubMed Central

Chhatre, Sumedha; Metzger, David S.; Frank, Ian; Boyer, Jean; Thompson, Edward; Nidich, Sanford; Montaner, Luis J.; Jayadevappa, Ravishankar

2013-01-01

Stress is implicated in the pathogenesis and progression of HIV. The Transcendental Meditation is a behavioral stress reduction program that incorporates mind-body approach, and has demonstrated effectiveness in improving outcomes via stress reduction. We evaluated the feasibility of implementing Transcendental Meditation and its effects on outcomes in persons with HIV. In this community based single blinded Phase-I, randomized controlled trial, outcomes (psychological and physiological stress, immune activation, generic and HIV-specific health related quality of life, depression and quality of well-being) were assessed at baseline and at six months, and were compared using parametric and non-parametric tests. Twenty two persons with HIV were equally randomized to Transcendental Meditation intervention or healthy eating (HE) education control group. Retention was 100% in Transcendental Meditation group and 91% in healthy eating control group. The Transcendental Meditation group exhibited significant improvement in vitality. Significant between group differences were observed for generic and HIV-specific health related quality of life.. Small sample size may possibly limit the ability to observe significant differences in some outcomes. Transcendental Meditation stress reduction intervention in community dwelling adults with HIV is viable and can enhance health related quality of life. Further research with large sample and longer follow-up is needed to validate our results. PMID:23394825

Moms in motion: a group-mediated cognitive-behavioral physical activity intervention.

PubMed

Cramp, Anita G; Brawley, Lawrence R

2006-08-22

When examining the prevalence of physical inactivity by gender and age, women over the age of 25 are at an increased risk for sedentary behavior. Childbearing and motherhood have been explored as one possible explanation for this increased risk. Post natal exercise studies to date demonstrate promising physical and psychological outcomes, however few physical activity interventions have been theory-driven and tailored to post natal exercise initiates. The purpose of this study was to compare the effects of a group-mediated cognitive behavioral intervention based upon social-cognitive theory and group dynamics (GMCB) to a standard care postnatal exercise program (SE). A randomized, two-arm intervention design was used. Fifty-seven post natal women were randomized to one of two conditions: (1) a standard exercise treatment (SE) and (2) a standard exercise treatment plus group-mediated cognitive behavioral intervention (GMCB). Participants in both conditions participated in a four-week intensive phase where participants received standard exercise training. In addition, GMCB participants received self-regulatory behavioral skills training via six group-mediated counseling sessions. Following the intensive phase, participants engaged in a four-week home-based phase of self-structured exercise. Measures of physical activity, barrier efficacy, and proximal outcome expectations were administered and data were analyzed using ANCOVA procedures. ANCOVA of change scores for frequency, minutes, and volume of physical activity revealed significant treatment effects over the intensive and home-based phases (p's < 0.01). In addition, ANCOVA of change in mean barrier efficacy and proximal outcome expectations at the conclusion of the intensive phase demonstrated that GMCB participants increased their initial level of barrier efficacy and outcome expectations while SE participants decreased (p < 0.05). While both exercise programs resulted in improvements to exercise participation, the GMCB intervention produced greater improvement in overall physical activity, barrier efficacy and proximal outcome expectations.

Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

PubMed

Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

2014-01-01

Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

Postcards in Persia: A Twelve to Twenty-four Month Follow-up of a Randomized Controlled Trial for Hospital-Treated Deliberate Self-Poisoning.

PubMed

Hassanian-Moghaddam, Hossein; Sarjami, Saeedeh; Kolahi, Ali-Asghar; Lewin, Terry; Carter, Gregory

2017-01-02

This study reports the outcomes, during follow-up, of a low-cost postcard intervention in a Randomized Control Trial of hospital-treated self-poisoning (n = 2300). The intervention was 9 postcards over 12 months (plus usual treatment) versus usual treatment. Three binary endpoints at 12-24 months (n = 2001) were: any suicidal ideation, suicide attempt, or self-cutting. There was a significant reduction in any suicidal ideation (RRR 0.20 CI 95% 0.13-0.27), (NNT 8, 6-13), and any suicide attempt (RRR 0.31, 0.06-0.50), (NNT 35, 19-195), in this non-western population. However, there was no effect on self-cutting (RRR -0.01, -1.05-0.51). Sustained, brief contact by mail may reduce some forms of suicidal behavior in self-poisoning patients during the post intervention phase.

Timing luteal support in ART: a systematic review F & S 19112 revision non-highlighted

PubMed Central

Connell, Matthew T.; Szatkowski, Jennifer M.; Terry, Nancy; DeCherney, Alan H.; Propst, Anthony M.; Hill, Micah J.

2015-01-01

Objective To summarize the available published randomized controlled trial data regarding timing of progesterone supplementation during the luteal phase of patients undergoing ART. Design A systematic review. Setting Not applicable. Patient(s) Undergoing in vitro fertilization. Intervention(s) Different starting times of progesterone for luteal support. Main Outcome Measure(s) Clinical pregnancy and live birth. Results Five randomized controlled trials were identified that met inclusion criteria with a total of 872 patients. A planned meta-analysis was not performed due to a high degree of clinical heterogeneity in regards to the timing, dose, and route of progesterone. Two studies compared progesterone initiated before oocyte retrieval versus the day of oocyte retrieval and pregnancy rates were 5–12% higher when starting progesterone on the day of oocyte retrieval. One study compared starting progesterone on post retrieval day 6 versus day 3, reporting a 16% decrease in pregnancy in the day 6 group. Trials comparing progesterone start times on the day of oocyte retrieval versus two or three days post retrieval showed no significant differences in pregnancy. Conclusions There appears to be a window for progesterone start time between the evening of oocyte retrieval and day 3 after oocyte retrieval. While some studies have suggested a potential benefit in delaying vaginal progesterone start time to 2 days after oocyte retrieval, this review could not find randomized controlled trials to adequately assess this. Further randomized clinical trials are needed to better define progesterone start time for luteal support after ART. PMID:25638420

Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

PubMed Central

2010-01-01

Background Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137 PMID:20594308

A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel

PubMed Central

2014-01-01

Background Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students. This is especially evident with regard to the level of use of evidence-based interventions with school children. Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities. School-wide positive behavioral interventions and supports (SWPBIS) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments, such as group cognitive behavioral therapy. In this article, we describe our ongoing research on creating internal capacity for program implementation. We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program. Methods/Design The study follows six K – 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support. Participants are: approximately 48 leadership team members, 180 school staff and 3,900 students in Tier 1, and 12 counselors, and 306 child participants in Tier 2. Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders. The study has three phases, baseline/training, implementation, and sustainability. We will measure implementation outcomes, service outcomes, child outcomes, and cost. Discussion Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools. The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence-based interventions for some of the most common behavioral health problems in school children. Trial registration ClinicalTrials.gov identifier: NCT01941069 PMID:24428904

A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel.

PubMed

Eiraldi, Ricardo; McCurdy, Barry; Khanna, Muniya; Mautone, Jennifer; Jawad, Abbas F; Power, Thomas; Cidav, Zuleyha; Cacia, Jaclyn; Sugai, George

2014-01-15

Urban schools lag behind non-urban schools in attending to the behavioral health needs of their students. This is especially evident with regard to the level of use of evidence-based interventions with school children. Increased used of evidence-based interventions in urban schools would contribute to reducing mental health services disparities in low-income communities. School-wide positive behavioral interventions and supports (SWPBIS) is a service delivery framework that can be used to deliver universal preventive interventions and evidence-based behavioral health treatments, such as group cognitive behavioral therapy. In this article, we describe our ongoing research on creating internal capacity for program implementation. We also examine the cost-effectiveness and resulting school climate when two different levels of external support are provided to personnel as they implement a two-tier SWPBIS program. The study follows six K - 8 schools in the School District of Philadelphia randomly assigned to consultation support or consultation-plus-coaching support. Participants are: approximately 48 leadership team members, 180 school staff and 3,900 students in Tier 1, and 12 counselors, and 306 child participants in Tier 2. Children who meet inclusion criteria for Tier 2 will participate in group cognitive behavioral therapy for externalizing or anxiety disorders. The study has three phases, baseline/training, implementation, and sustainability. We will measure implementation outcomes, service outcomes, child outcomes, and cost. Findings from this study will provide evidence as to the appropriateness of school-wide prevention and treatment service delivery models for addressing services disparities in schools. The effectiveness and cost-effectiveness analyses of the two levels of training and consultation should help urban school districts and policymakers with the planning and deployment of cost-effective strategies for the implementation of evidence-based interventions for some of the most common behavioral health problems in school children. ClinicalTrials.gov identifier: NCT01941069.

Participation and diffusion effects of a peer-intervention for HIV prevention among adults in rural Malawi.

PubMed

Crittenden, Kathleen S; Kaponda, Chrissie P N; Jere, Diana L; McCreary, Linda L; Norr, Kathleen F

2015-05-01

This paper examines whether a peer group intervention that reduced self-reported risky behaviors for rural adults in Malawi also had impacts on non-participants in the same communities. We randomly assigned two districts to the intervention and control conditions, and conducted surveys at baseline and 18 months post-intervention using unmatched independent random samples of intervention and control communities in 2003-2006. The six-session peer group intervention was offered to same-gender groups by trained volunteers. In this analysis, we divided the post-intervention sample into three exposure groups: 243 participants and 170 non-participants from the intervention district (total n = 415) and 413 control individuals. Controlling for demographics and participation, there were significant favorable diffusion effects on five partially overlapping behavioral outcomes: partner communication, ever used condoms, unprotected sex, recent HIV test, and a community HIV prevention index. Non-participants in the intervention district had more favorable outcomes on these behaviors than survey respondents in the control district. One behavioral outcome, community HIV prevention, showed both participation and diffusion effects. Participating in the intervention had a significant effect on six psychosocial outcomes: HIV knowledge (two measures), hope, condom attitudes, and self-efficacy for community HIV prevention and for safer sex; there were no diffusion effects. This pattern of results suggests that the behavioral changes promoted in the intervention spread to others in the same community, most likely through direct contact between participants and non-participants. These findings support the idea that diffusion of HIV-related behavior changes can occur for peer group interventions in communities, adding to the body of research supporting diffusion of innovations theory as a robust approach to accelerating change. If diffusion occurs, peer group intervention may be more cost-effective than previously realized. Wider implementation of peer group interventions can help meet the global goal of reducing new HIV infections. Copyright © 2015 Elsevier Ltd. All rights reserved.

Participation and Diffusion Effects of a Peer-Intervention for HIV Prevention among Adults in Rural Malawi

PubMed Central

Crittenden, Kathleen S.; Kaponda, Chrissie P. N.; Jere, Diana L.; McCreary, Linda L.; Norr, Kathleen F.

2015-01-01

This paper examines whether a peer group intervention that reduced self-reported risky behaviors for rural adults in Malawi also had impacts on non-participants in the same communities. We randomly assigned two districts to the intervention and control conditions, and conducted surveys at baseline and 18 months post-intervention using unmatched independent random samples of intervention and control communities in 2003-2006. The six-session peer group intervention was offered to same-gender groups by trained volunteers. In this analysis, we divided the post-intervention sample into three exposure groups: 243 participants and 170 non-participants from the intervention district (total n=415) and 413 control individuals. Controlling for demographics and participation, there were significant favorable diffusion effects on five partially overlapping behavioral outcomes: partner communication, ever used condoms, unprotected sex, recent HIV test, and a community HIV prevention index. Non-participants in the intervention district had more favorable outcomes on these behaviors than survey respondents in the control district. One behavioral outcome, community HIV prevention, showed both participation and diffusion effects. Participating in the intervention had a significant effect on six psychosocial outcomes: HIV knowledge (two measures), hope, condom attitudes, and self-efficacy for community HIV prevention and for safer sex; there were no diffusion effects. This pattern of results suggests that the behavioral changes promoted in the intervention spread to others in the same community, most likely through direct contact between participants and non-participants. These findings support the idea that diffusion of HIV-related behavior changes can occur for peer group interventions in communities, adding to the body of research supporting diffusion of innovations theory as a robust approach to accelerating change. If diffusion occurs, peer group intervention may be more cost-effective than previously realized. Wider implementation of peer group interventions can help meet the global goal of reducing new HIV infections. PMID:25864150

Low back pain in healthy postmenopausal women and the effect of physical activity: A secondary analysis in a randomized trial

PubMed Central

Marini, Mirca; Bendinelli, Benedetta; Assedi, Melania; Occhini, Daniela; Castaldo, Maria; Fabiano, Jacopo; Petranelli, Marco; Migliolo, Mario; Monaci, Marco; Masala, Giovanna

2017-01-01

Epidemiological studies on the prevalence of musculoskeletal pain have consistently shown that this is a relevant health problem, with non-specific low back pain (LBP) being the most commonly reported in adult females. Conflicting data on the association between LBP symptoms and physical activity (PA) have been reported. Here, we investigated the prevalence of LBP and the effect of a 24-month non-specific PA intervention on changes in LBP prevalence in a series of Italian healthy postmenopausal women. We performed a secondary analysis in the frame of the DAMA trial, a factorial randomized intervention trial aimed to evaluate the ability of a 24-month intervention, based on moderate-intensity PA, and/or dietary modification, in reducing mammographic breast density in healthy postmenopausal women. The PA intervention included at least 1 hour/day of moderate PA and a more strenuous weekly activity, collective walks and theoretical group sessions. A self-administered pain questionnaire was administered at baseline and at the end of the intervention. The questionnaire was specifically structured to investigate the occurrence of musculoskeletal pain, the body localization, intensity and duration of the pain. Two hundred and ten women (102 randomized to PA intervention, 108 not receiving the PA intervention) filled out the questionnaires. At baseline LBP was present in 32.9% of the participants. Among women randomized to the PA intervention, LBP prevalence at follow up (21.6%) was lower than at baseline (33.3%) (p = 0.02), while in women who did not receive the PA intervention the LBP prevalence at baseline and follow up were 32.4% and 25.9%, respectively (p = 0.30). Overall, there was no significant between-group effect of PA intervention on LBP. Further studies are needed to understand the role of non-specific PA intervention, aimed to improve overall fitness, on LBP prevalence. PMID:28489877

Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study

PubMed Central

Spigoni, Valentina; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo C.; Dei Cas, Alessandra

2017-01-01

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m2) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (−30 ± 20 mg/dL; p = 0.012), LDL cholesterol (−31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (−14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention. PMID:28704936

Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study.

PubMed

Spigoni, Valentina; Aldigeri, Raffaella; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo C; Dei Cas, Alessandra

2017-07-12

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m²) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (-30 ± 20 mg/dL; p = 0.012), LDL cholesterol (-31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (-14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.

Procedural and Physical Interventions for Vaccine Injections: Systematic Review of Randomized Controlled Trials and Quasi-Randomized Controlled Trials.

PubMed

Taddio, Anna; Shah, Vibhuti; McMurtry, C Meghan; MacDonald, Noni E; Ipp, Moshe; Riddell, Rebecca Pillai; Noel, Melanie; Chambers, Christine T

2015-10-01

This systematic review evaluated the effectiveness of physical and procedural interventions for reducing pain and related outcomes during vaccination. Databases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Data were extracted according to procedure phase (preprocedure, acute, recovery, and combinations of these) and pooled using established methods. A total of 31 studies were included. Acute infant distress was diminished during intramuscular injection without aspiration (n=313): standardized mean difference (SMD) -0.82 (95% confidence interval [CI]: -1.18, -0.46). Injecting the most painful vaccine last during vaccinations reduced acute infant distress (n=196): SMD -0.69 (95% CI: -0.98, -0.4). Simultaneous injections reduced acute infant distress compared with sequential injections (n=172): SMD -0.56 (95% CI: -0.87, -0.25). There was no benefit of simultaneous injections in children. Less infant distress during the acute and recovery phases combined occurred with vastus lateralis (vs. deltoid) injections (n=185): SMD -0.70 (95% CI: -1.00, -0.41). Skin-to-skin contact in neonates (n=736) reduced acute distress: SMD -0.65 (95% CI: -1.05, -0.25). Holding infants reduced acute distress after removal of the data from 1 methodologically diverse study (n=107): SMD -1.25 (95% CI: -2.05, -0.46). Holding after vaccination (n=417) reduced infant distress during the acute and recovery phases combined: SMD -0.65 (95% CI: -1.08, -0.22). Self-reported fear was reduced for children positioned upright (n=107): SMD -0.39 (95% CI: -0.77, -0.01). Non-nutritive sucking (n=186) reduced acute distress in infants: SMD -1.88 (95% CI: -2.57, -1.18). Manual tactile stimulation did not reduce pain across the lifespan. An external vibrating device and cold reduced pain in children (n=145): SMD -1.23 (95% CI: -1.58, -0.87). There was no benefit of warming the vaccine in adults. Muscle tension was beneficial in selected indices of fainting in adolescents and adults. Interventions with evidence of benefit in select populations include: no aspiration, injecting most painful vaccine last, simultaneous injections, vastus lateralis injection, positioning interventions, non-nutritive sucking, external vibrating device with cold, and muscle tension.

Estimating disease prevalence from two-phase surveys with non-response at the second phase

PubMed Central

Gao, Sujuan; Hui, Siu L.; Hall, Kathleen S.; Hendrie, Hugh C.

2010-01-01

SUMMARY In this paper we compare several methods for estimating population disease prevalence from data collected by two-phase sampling when there is non-response at the second phase. The traditional weighting type estimator requires the missing completely at random assumption and may yield biased estimates if the assumption does not hold. We review two approaches and propose one new approach to adjust for non-response assuming that the non-response depends on a set of covariates collected at the first phase: an adjusted weighting type estimator using estimated response probability from a response model; a modelling type estimator using predicted disease probability from a disease model; and a regression type estimator combining the adjusted weighting type estimator and the modelling type estimator. These estimators are illustrated using data from an Alzheimer’s disease study in two populations. Simulation results are presented to investigate the performances of the proposed estimators under various situations. PMID:10931514

Sustaining self-regulatory efficacy and psychological outcome expectations for postnatal exercise: effects of a group-mediated cognitive behavioural intervention.

PubMed

Cramp, A G; Brawley, L R

2009-09-01

The objective of the current investigation was to examine if the effects of a group-mediated cognitive behavioural counselling plus exercise intervention were superior to the effects of a standard exercise care condition on postnatal mothers' self-regulatory efficacy (SRE), outcome expectations (OEs) and self-directed physical activity (PA). The design of the study consisted of two intervention conditions; group-mediated cognitive behavioural counselling plus exercise (GMCB) and standard exercise (SE). Each condition consisted of two phases; a 4-week supervised, centre-based intensive exercise training phase followed by a 4-week home-based phase. Participants were 57 postnatal women randomly assigned to conditions (SE: N=31; GMCB: N=26). Measures of SRE and OEs were assessed prior to and following the centre-based aspect of the intervention. Physical activity was measured following the intensive exercise training phase as well as the home-based phase. GMCB participants' SRE and OEs were sustained during the intervention whereas those of SE participants declined. GMCB participants also reported significantly greater time spent engaging in self-directed PA at the conclusion of the intensive and home-based phases. Mediation analysis revealed that SRE partially mediated the relationship between intervention condition and post home-based PA as confirmed by a significant sobel test. These findings suggest that a theory-based GMCB counselling plus exercise intervention is superior to the SE condition in sustaining SRE and OEs, and in promoting greater self-directed PA. SRE partially mediated the relationship between intervention condition and post home-based PA supporting the targeting of that variable for change as part of the intervention.

Using School-Level Interviews to Develop a Multisite PE Intervention Program

PubMed Central

Moe, Stacey G.; Pickrel, Julie; McKenzie, Thomas L.; Strikmiller, Patricia K.; Coombs, Derek; Murrie, Dale

2008-01-01

The Trial of Activity for Adolescent Girls (TAAG) is a randomized, multicenter field trial in middle schools that aims to reduce the decline of physical activity in adolescent girls. To inform the development of the TAAG intervention, two phases of formative research are conducted to gain information on school structure and environment and on the conduct of physical education classes. Principals and designated staff at 64 eligible middle schools were interviewed using the School Survey during Phase 1. The following year (Phase 2), physical education department heads of the 36 schools selected into TAAG were interviewed. Responses were examined to design a standardized, multicomponent physical activity intervention for six regions of the United States. This article describes the contribution of formative research to the development of the physical education intervention component and summarizes the alignment of current school policies and practices with national and state standards. PMID:16397159

Effectiveness of a two-phase cognitive rehabilitation intervention for severely impaired schizophrenia patients.

PubMed

Silverstein, Steven M; Hatashita-Wong, Michi; Solak, Beth Anne; Uhlhaas, Peter; Landa, Yulia; Wilkniss, Sandra M; Goicochea, Claudia; Carpiniello, Kelly; Schenkel, Lindsay S; Savitz, Adam; Smith, Thomas E

2005-06-01

Several small-N, uncontrolled reports have demonstrated that the behavioral technique of attention shaping has significantly increased attention span among severely ill schizophrenia patients. In this study, we evaluated the effectiveness of using an individually administered intervention for improving sustained attention, Attention Process Training (APT), followed by an attention-shaping procedure within the context of an ongoing skills training group. Patients were randomly assigned to receive either the APT and attention-shaping sequence (n = 18) or equivalent hours of treatment in the same intensive behavioral rehabilitation program (n = 13). Results indicated dramatic improvements in attentiveness in the cognitive rehabilitation condition compared with the control condition, which demonstrated essentially no change in attentiveness over the 12 weeks of treatment. The attention-shaping intervention appeared to account for the majority of the effect. In contrast to the observational data, performance on neuropsychological tests was unaffected by the cognitive interventions. This two-phase intervention demonstrated effectiveness in promoting attentive behavior among chronic schizophrenia patients with severe attentional impairment.

Emtonjeni—A Structural Intervention to Integrate Sexual and Reproductive Health into Public Sector HIV Care in Cape Town, South Africa: Results of a Phase II Study

PubMed Central

Mantell, J. E.; Cooper, D.; Exner, T. M.; Moodley, J.; Hoffman, S.; Myer, L.; Leu, C.-S.; Bai, D.; Kelvin, E. A.; Jennings, K.; Stein, Z. A.; Constant, D.; Zweigenthal, V.; Cishe, N.; Nywagi, N.

2016-01-01

Integration of sexual and reproductive health within HIV care services is a promising strategy for increasing access to family planning and STI services and reducing unwanted pregnancies, perinatal HIV transmission and maternal and infant mortality among people living with HIV and their partners. We conducted a Phase II randomized futility trial of a multi-level intervention to increase adherence to safer sex guidelines among those wishing to avoid pregnancy and adherence to safer conception guidelines among those seeking conception in newly-diagnosed HIV-positive persons in four public-sector HIV clinics in Cape Town. Clinics were pair-matched and the two clinics within each pair were randomized to either a three-session provider-delivered enhanced intervention (EI) (onsite contraceptive services and brief milieu intervention for staff) or standard-of-care (SOC) provider-delivered intervention. The futility analysis showed that we cannot rule out the possibility that the EI intervention has a 10 % point or greater success rate in improving adherence to safer sex/safer conception guidelines than does SOC (p = 0.573), indicating that the intervention holds merit, and a larger-scale confirmatory study showing whether the EI is superior to SOC has merit. PMID:27807792

Femtosecond two-photon photoassociation of hot magnesium atoms: A quantum dynamical study using thermal random phase wavefunctions

NASA Astrophysics Data System (ADS)

Amaran, Saieswari; Kosloff, Ronnie; Tomza, Michał; Skomorowski, Wojciech; Pawłowski, Filip; Moszynski, Robert; Rybak, Leonid; Levin, Liat; Amitay, Zohar; Berglund, J. Martin; Reich, Daniel M.; Koch, Christiane P.

2013-10-01

Two-photon photoassociation of hot magnesium atoms by femtosecond laser pulses, creating electronically excited magnesium dimer molecules, is studied from first principles, combining ab initio quantum chemistry and molecular quantum dynamics. This theoretical framework allows for rationalizing the generation of molecular rovibrational coherence from thermally hot atoms [L. Rybak, S. Amaran, L. Levin, M. Tomza, R. Moszynski, R. Kosloff, C. P. Koch, and Z. Amitay, Phys. Rev. Lett. 107, 273001 (2011)]. Random phase thermal wavefunctions are employed to model the thermal ensemble of hot colliding atoms. Comparing two different choices of basis functions, random phase wavefunctions built from eigenstates are found to have the fastest convergence for the photoassociation yield. The interaction of the colliding atoms with a femtosecond laser pulse is modeled non-perturbatively to account for strong-field effects.

Liquid crystal polymers: evidence of hairpin defects in nematic main chains, comparison with side chain polymers

NASA Astrophysics Data System (ADS)

Li, M. H.; Brûlet, A.; Keller, P.; Cotton, J. P.

1996-09-01

This article describes the conformation of two species of liquid crystalline polymers as revealed by small angle neutron scattering. The results obtained with side chain polymers are recalled. The procedure used to analyze the scattering data of main chains in the nematic phase is reported in this paper. It permits a demonstration of the existence of hairpins. Comparison of both polymer species shows that in the isotropic phase, the two polymers adopt a random coil conformation. In the nematic phase, the conformations are very different; the side chains behave as a melt of penetrable random coils whereas the main chains behave as a nematic phase of non penetrable cylinders.

A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE).

PubMed

Radwan, Noura; Phillips, Ryan; Ross, Ashley; Rowe, Steven P; Gorin, Michael A; Antonarakis, Emmanuel S; Deville, Curtiland; Greco, Stephen; Denmeade, Samuel; Paller, Channing; Song, Daniel Y; Diehn, Maximilian; Wang, Hao; Carducci, Michael; Pienta, Kenneth J; Pomper, Martin G; DeWeese, Theodore L; Dicker, Adam; Eisenberger, Mario; Tran, Phuoc T

2017-06-29

We describe a randomized, non-blinded Phase II interventional study to assess the safety and efficacy of stereotactic ablative radiotherapy (SABR) for hormone-sensitive oligometastatic prostate adenocarcinoma, and to describe the biology of the oligometastatic state using immunologic, cellular, molecular, and functional imaging correlates. 54 men with oligometastatic prostate adenocarcinoma will be accrued. The primary clinical endpoint will be progression at 6 months from randomization with the hypothesis that SABR to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints will include local control at 6 months post-SABR, toxicity and quality of life, and androgen deprivation therapy (ADT)-free survival (ADT-FS). Further fundamental analysis of the oligometastatic state with be achieved through correlation with investigational 18 F-DCFPyL PET/CT imaging and measurement of circulating tumor cells, circulating tumor DNA, and circulating T-cell receptor repertoires, facilitating an unprecedented opportunity to characterize, in isolation, the effects of SABR on the dynamics of and immunologic response to oligometastatic disease. Patients will be randomized 2:1 to SABR or observation with minimization to balance assignment by primary intervention, prior hormonal therapy, and PSA doubling time. Progression after 6 months will be compared using Fisher's exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival (PFS), ADT free survival (ADT-FS), time to locoregional progression (TTLP) and time to distant progression (TTDP) will be calculated based on an intention-to-treat. Local control will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Withdrawal from the study prior to 6 months will be counted as progression. Adverse events will be summarized by type and grade. Quality of life pre- and post- SABR will be measured by Brief Pain Inventory. The ORIOLE trial is the first randomized, non-blinded Phase II interventional study in the North America evaluating the safety and efficacy of SABR in oligometastatic hormone-sensitive prostate cancer. Leading-edge laboratory and imaging correlates will provide unique insight into the effects of SABR on the oligometastatic state. ClinicalTrials.gov Identifier: NCT02680587. URL of Registry: https://clinicaltrials.gov/show/NCT02680587 Date of Registration: 02/08/2016. Date of First Participant Enrollment: 05/23/2016.

Systematic review of stigma reducing interventions for African/Black diasporic women

PubMed Central

Loutfy, Mona; Tharao, Wangari; Logie, Carmen; Aden, Muna A; Chambers, Lori A; Wu, Wei; Abdelmaseh, Marym; Calzavara, Liviana

2015-01-01

Introduction Literature indicates that racism, sexism, homophobia and HIV-related stigma have adverse impacts on health, well-being, and quality of life among HIV-positive women of African descent (African/Black diaspora). However, limited evidence exists on the effectiveness of interventions aimed at reducing stigma tailored for these women. This study systematically reviewed randomized controlled trials (RCTs), non-randomized observational and quasi-experimental studies evaluating the effectiveness of interventions aimed at reducing stigma experienced by this population. Methods The Cochrane methodology was used to develop a search strategy in consultation with a librarian scientist. Databases searched included the Cochrane Library, Ovid EMBASE, PsycInfo, and 10 others. Two reviewers independently assessed the studies for potential relevance and conducted the Cochrane grading of RCTs to assess risk of bias and the Newcastle–Ottawa scale to assess the quality of non-randomized studies. Eligible papers were selected if they employed an intervention design with African/Black diasporic women living with HIV as the target population and had a primary outcome of stigma reduction. Results Of the five studies that met all of the eligibility criteria, four demonstrated the effectiveness of interventions in reducing HIV-related stigma. Only two of the five studies were designed specifically for HIV-positive African/Black diasporic women. Limitations included the absence of interventions addressing other forms of stigma and discrimination (e.g. gender discrimination, racism, heterosexism). Conclusions Our findings suggest that there are limited interventions designed to address multiple forms of stigma, including gender and racial discrimination, experienced by HIV-positive African/Black diasporic women. PMID:25862565

Systematic review of stigma reducing interventions for African/Black diasporic women.

PubMed

Loutfy, Mona; Tharao, Wangari; Logie, Carmen; Aden, Muna A; Chambers, Lori A; Wu, Wei; Abdelmaseh, Marym; Calzavara, Liviana

2015-01-01

Literature indicates that racism, sexism, homophobia and HIV-related stigma have adverse impacts on health, well-being, and quality of life among HIV-positive women of African descent (African/Black diaspora). However, limited evidence exists on the effectiveness of interventions aimed at reducing stigma tailored for these women. This study systematically reviewed randomized controlled trials (RCTs), non-randomized observational and quasi-experimental studies evaluating the effectiveness of interventions aimed at reducing stigma experienced by this population. The Cochrane methodology was used to develop a search strategy in consultation with a librarian scientist. Databases searched included the Cochrane Library, Ovid EMBASE, PsycInfo, and 10 others. Two reviewers independently assessed the studies for potential relevance and conducted the Cochrane grading of RCTs to assess risk of bias and the Newcastle-Ottawa scale to assess the quality of non-randomized studies. Eligible papers were selected if they employed an intervention design with African/Black diasporic women living with HIV as the target population and had a primary outcome of stigma reduction. Of the five studies that met all of the eligibility criteria, four demonstrated the effectiveness of interventions in reducing HIV-related stigma. Only two of the five studies were designed specifically for HIV-positive African/Black diasporic women. Limitations included the absence of interventions addressing other forms of stigma and discrimination (e.g. gender discrimination, racism, heterosexism). Our findings suggest that there are limited interventions designed to address multiple forms of stigma, including gender and racial discrimination, experienced by HIV-positive African/Black diasporic women.

Assessment and rehabilitation of central sensory impairments for balance in mTBI using auditory biofeedback: a randomized clinical trial.

PubMed

Fino, Peter C; Peterka, Robert J; Hullar, Timothy E; Murchison, Chad; Horak, Fay B; Chesnutt, James C; King, Laurie A

2017-02-23

Complaints of imbalance are common non-resolving signs in individuals with post-concussive syndrome. Yet, there is no consensus rehabilitation for non-resolving balance complaints following mild traumatic brain injury (mTBI). The heterogeneity of balance deficits and varied rates of recovery suggest varied etiologies and a need for interventions that address the underlying causes of poor balance function. Our central hypothesis is that most chronic balance deficits after mTBI result from impairments in central sensorimotor integration that may be helped by rehabilitation. Two studies are described to 1) characterize balance deficits in people with mTBI who have chronic, non-resolving balance deficits compared to healthy control subjects, and 2) determine the efficacy of an augmented vestibular rehabilitation program using auditory biofeedback to improve central sensorimotor integration, static and dynamic balance, and functional activity in patients with chronic mTBI. Two studies are described. Study 1 is a cross-sectional study to take place jointly at Oregon Health and Science University and the VA Portland Health Care System. The study participants will be individuals with non-resolving complaints of balance following mTBI and age- and gender-matched controls who meet all inclusion criteria. The primary outcome will be measures of central sensorimotor integration derived from a novel central sensorimotor integration test. Study 2 is a randomized controlled intervention to take place at Oregon Health & Science University. In this study, participants from Study 1 with mTBI and abnormal central sensorimotor integration will be randomized into two rehabilitation interventions. The interventions will be 6 weeks of vestibular rehabilitation 1) with or 2) without the use of an auditory biofeedback device. The primary outcome measure is the daily activity of the participants measured using an inertial sensor. The results of these two studies will improve our understanding of the nature of balance deficits in people with mTBI by providing quantitative metrics of central sensorimotor integration, balance, and vestibular and ocular motor function. Study 2 will examine the potential for augmented rehabilitation interventions to improve central sensorimotor integration. This trial is registered at clinicaltrials.gov ( NCT02748109 ).

Systematic review of physiotherapy interventions to improve gross motor capacity and performance in children and adolescents with an acquired brain injury.

PubMed

Baque, Emmah; Sakzewski, Leanne; Barber, Lee; Boyd, Roslyn N

2016-01-01

To systematically review the efficacy of physiotherapy interventions to improve gross motor capacity, performance and societal participation in children aged 5-17 years with an acquired brain injury (ABI). Randomized and non-randomized controlled trials, cohort, case series, case-control and case studies were included and classified according to grades of evidence. Methodological quality of studies was assessed using the Downs and Black (D&B) scale and quantitative data was analysed using effect sizes. Two home-based studies investigated functional strength training (one randomized controlled trial, n = 20, level 2b, D&B = 16/32 and one non-randomized self-control study, n = 19, level 4, D&B = 15/32). Four studies evaluated virtual reality including: one pilot study, n = 50, level 4, D&B = 22/32; one single-subject, non-concurrent, randomized multiple baseline study, n = 3, level 4, D&B = 15/32; one case series study, n = 2, level 4, D&B = 15/32; one case study, n = 1, level 4, D&B = 15/32. Effect sizes for the randomized controlled trial ranged between 0.30-1.29 for the Functional Reach and Timed Up and Go outcome measures. There is preliminary evidence to support the efficacy of physiotherapy interventions to improve gross motor outcomes in children with an ABI. Both functional strength training and virtual-reality based therapy are potential treatment options for clinicians to prescribe in either home or clinical settings.

Evaluating Personalized Feedback Intervention Framing with a Randomized Controlled Trial to Reduce Young Adult Alcohol-Related Sexual Risk Taking.

PubMed

Lewis, Melissa A; Rhew, Isaac C; Fairlie, Anne M; Swanson, Alex; Anderson, Judyth; Kaysen, Debra

2018-03-06

The purpose of this study was to evaluate personalized feedback intervention (PFI) framing with two web-delivered PFIs aimed to reduce young adult alcohol-related risky sexual behavior (RSB). Combined PFIs typically use an additive approach whereby independent components on drinking and components on RSB are presented without the discussion of the influence of alcohol on RSB. In contrast, an integrated PFI highlights the RSB-alcohol connection by presenting integrated alcohol and RSB components that focus on the role of intoxication as a barrier to risk reduction in sexual situations. In a randomized controlled trial, 402 (53.98% female) sexually active young adults aged 18-25 were randomly assigned to a combined PFI, an integrated PFI, or attention control. All assessment and intervention procedures were web-based. At the 1-month follow-up, those randomly assigned to the integrated condition had a lower likelihood of having any casual sex partners compared to those in the control group. At the 6-month follow-up, the combined condition had a lower likelihood of having any casual sex partners compared to those in the control group. When examining alcohol-related RSB, at the 1-month follow-up, both interventions showed a lower likelihood of any drinking prior to sex compared to the control group. When examining alcohol-related sexual consequences, results showed a reduction in the non-zero count of consequences in the integrated condition compared to the control at the 1-month follow-up. For typical drinks per week, those in the combined condition showed a greater reduction in the non-zero count of drinks than those in the control condition at the 1-month follow-up. While there were no significant differences between the two interventions, the current findings highlight the utility of two efficacious web-based alcohol and RSB interventions among a national sample of at-risk young adults.

A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer.

PubMed

Solheim, Tora S; Laird, Barry J A; Balstad, Trude Rakel; Stene, Guro B; Bye, Asta; Johns, Neil; Pettersen, Caroline H; Fallon, Marie; Fayers, Peter; Fearon, Kenneth; Kaasa, Stein

2017-10-01

Cancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritional supplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy. Patients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival. Three hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention-related Serious Adverse Events and survival was similar between the groups. A multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention. © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.

Long-term multiple risk factor interventions in Japanese elderly diabetic patients: the Japanese Elderly Diabetes Intervention Trial--study design, baseline characteristics and effects of intervention.

PubMed

Araki, Atsushi; Iimuro, Satoshi; Sakurai, Takashi; Umegaki, Hiroyuki; Iijima, Katsuya; Nakano, Hiroshi; Oba, Kenzo; Yokono, Koichi; Sone, Hirohito; Yamada, Nobuhiro; Ako, Junya; Kozaki, Koichi; Miura, Hisayuki; Kashiwagi, Atsunori; Kikkawa, Ryuichi; Yoshimura, Yukio; Nakano, Tadasumi; Ohashi, Yasuo; Ito, Hideki

2012-04-01

To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups. This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients. © 2012 Japan Geriatrics Society.

Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

PubMed

Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Keim, Kathryn; Appelhans, Bradley M; Avery, Elizabeth F; Tahsin, Bettina; Li, Hong; Shapera, Merle; Fogelfeld, Leon

2014-11-01

The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group. Copyright © 2014 Elsevier Inc. All rights reserved.

Results of a pilot test of a brief computer-assisted tailored HIV prevention intervention for use with a range of demographic and risk groups.

PubMed

Zule, William A; Bobashev, Georgiy V; Reif, Susan M; Poulton, Winona; Coomes, Curtis M; Wechsberg, Wendee M

2013-11-01

There is a need for brief HIV prevention interventions that can be disseminated and implemented widely. This article reports the results of a small randomized field experiment that compared the relative effects of a brief two-session counselor-delivered computer-tailored intervention and a control condition. The intervention is designed for use with African-American, non-Hispanic white and Hispanic males and females who may be at risk of HIV through unprotected sex, selling sex, male to male sex, injecting drug use or use of stimulants. Participants (n = 120) were recruited using a quota sampling approach and randomized using block randomization, which resulted in ten male and ten female participants of each racial/ethnic group (i.e. African-American, non-Hispanic white and Hispanic) being assigned to either the intervention or a control arm. In logistic regression analyses using a generalized estimating equations approach, at 3-month followup, participants in the intervention arm were more likely than participants in the control arm to report condom use at last sex (Odds ratio [OR] = 4.75; 95 % Confidence interval [CI] = 1.70-13.26; p = 0.003). The findings suggest that a brief tailored intervention may increase condom use. Larger studies with longer followups are needed to determine if these results can be replicated.

Quasi experimental designs in pharmacist intervention research.

PubMed

Krass, Ines

2016-06-01

Background In the field of pharmacist intervention research it is often difficult to conform to the rigorous requirements of the "true experimental" models, especially the requirement of randomization. When randomization is not feasible, a practice based researcher can choose from a range of "quasi-experimental designs" i.e., non-randomised and at time non controlled. Objective The aim of this article was to provide an overview of quasi-experimental designs, discuss their strengths and weaknesses and to investigate their application in pharmacist intervention research over the previous decade. Results In the literature quasi experimental studies may be classified into five broad categories: quasi-experimental design without control groups; quasi-experimental design that use control groups with no pre-test; quasi-experimental design that use control groups and pre-tests; interrupted time series and stepped wedge designs. Quasi-experimental study design has consistently featured in the evolution of pharmacist intervention research. The most commonly applied of all quasi experimental designs in the practice based research literature are the one group pre-post-test design and the non-equivalent control group design i.e., (untreated control group with dependent pre-tests and post-tests) and have been used to test the impact of pharmacist interventions in general medications management as well as in specific disease states. Conclusion Quasi experimental studies have a role to play as proof of concept, in the pilot phases of interventions when testing different intervention components, especially in complex interventions. They serve to develop an understanding of possible intervention effects: while in isolation they yield weak evidence of clinical efficacy, taken collectively, they help build a body of evidence in support of the value of pharmacist interventions across different practice settings and countries. However, when a traditional RCT is not feasible for logistical and/or ethical reasons researchers should endeavour to use the more robust of the quasi experimental designs.

[Effectiveness of non-pharmacological interventions in the quality of life of caregivers of Alzheimer].

PubMed

Amador-Marín, Bárbara; Guerra-Martín, María Dolores

Explore the effectiveness of non-pharmacological interventions to improve the quality of life of family caregivers of Alzheimer's patients. We conducted a systematic review, in pairs, in the following databases: PubMed, Scopus, CINAHL, PsycINFO, WOS, Cochrane Library, IME, Cuiden Plus and Dialnet. Inclusion criteria were: 1. Studies published between 2010-2015. 2. Language: English, Portuguese and Spanish. 3. Randomized controlled clinical trials. 4. Score greater than or equal to 3 on the Jadad scale. 13 studies were included. Four performed a psychosocial intervention with family caregivers, three psychotherapeutic, two psychoeducational, two multicomponent, one educational and another with mutual support groups. The tools to assess quality of life: three studies used the Health Status Questionnaire (HSQ), three EuroQol-5D (two only used the EVA), two health questionnaire SF-36, two WHOQOL-BREF, two Quality of Life SF-12 and one Perceived Quality of Life Scale (PQoL). Regarding the effectiveness of non-pharmacological interventions, five studies obtained favorable results in the quality of life after psychotherapeutic interventions and community-type multicomponent training. The diversity of non-pharmacological interventions used and contents, differences in the number of sessions and hours, and variability of valuation tools used to measure quality of life of family caregivers, leads us to reflect on the appropriateness to standardize criteria, for the sake to improve clinical practice. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures.

PubMed

Bhandari, Mohit; Tornetta, Paul; Ellis, Thomas; Audige, Laurent; Sprague, Sheila; Kuo, Jonathann C; Swiontkowski, Marc F

2004-01-01

There have been a number of non-randomized studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. However, there remains considerable debate about whether the results of non-randomized studies are consistent with the results of randomized, controlled trials. Given the economic burden of hip fractures, it remains essential to identify therapies to improve outcomes; however, whether data from non-randomized studies of an intervention should be used to guide patient care remains unclear. We aimed to determine whether the pooled results of mortality and revision surgery among non-randomized studies were similar to those of randomized trials in studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. We conducted a Medline search from 1969 to June 2002, identifying both randomized and non-randomized studies comparing internal fixation with arthroplasty in patients with femoral neck fractures. Additional strategies to identify relevant articles included Cochrane database, SCISEARCH, textbooks, annual meeting programs, and content experts. We abstracted information on mortality and revision rates in each study and compared the pooled results between non-randomized and randomized studies. In addition, we explored potential reasons for dissimilar results between the two study designs. We identified 140 citations that addressed the general topic of comparison of arthroplasty and internal fixation for hip fracture. Of these, 27 studies met the eligibility criteria, 13 of which were non-randomized studies and 14 of which were randomized trials. Mortality data was available in all 13 non-randomized studies ( n=3108 patients) and in 12 randomized studies ( n=1767 patients). Non-randomized studies overestimated the risk of mortality by 40% when compared with the results of randomized trials (relative risk 1.44 vs 1.04, respectively). Information on revision risk was available in 9 non-randomized studies ( n=2764 patients) and all 14 randomized studies ( n=1901 patients). Both estimates from non-randomized and randomized studies revealed a significant reduction in the risk of revision surgery with arthroplasty compared with internal fixation (relative risk 0.38 vs 0.23, respectively). The reduction in the risk of revision surgery with arthroplasty compared with internal fixation was 62% for non-randomized studies and 77% for randomized trials. Thus, non-randomized studies underestimated the relative benefit of arthroplasty by 19.5%. Non-randomized studies with point estimates of relative risk similar to the pooled estimate for randomized trials all controlled for patient age, gender, and fracture displacement in their comparisons of mortality. We were unable to identify reasons for differences in the revision rate results between the study designs. Similar to other reports in medical subspecialties, non-randomized studies provided results dissimilar to randomized trials of arthroplasty vs internal fixation for mortality and revision rates in patients with femoral neck fractures. Investigators should be aware of these discrepancies when evaluating the merits of alternative surgical interventions, especially when both randomized trials and non-randomized comparative studies are available.

The Effects of Intrapartum Supportive Care on Fear of Delivery and Labor Outcomes: A Single-Blind Randomized Controlled Trial.

PubMed

İsbir, Gözde Gökçe; Serçekuş, Pinar

2017-04-01

Supportive care during labor, the primary role of intrapartum nurses and midwives, provides comfort to prepartum women and helps facilitate a positive labor experience. It has been argued that supportive care during labor reduces fear and anxiety as well as the resultant side effects. However, evidence supporting this argument is insufficient. The aim of this study was to assess the effects of intrapartum supportive care on fear of delivery and on the key parameters of the labor process. This study used a single-blind randomized controlled trial approach. Randomized block assignment was used to assign 72 participants to either the intervention group (n = 36) or the control group (n = 36). Three women in the intervention group and six in the control group were later excluded from the study because they received emergency cesarean delivery. The intervention group received continuous supportive care, and the control group received routine hospital care. No significant differences were identified between the two groups at baseline. The intervention group reported less fear of delivery during the active and transient phases of labor, higher perceived support and control during delivery, lower pain scores during the transient phase of labor, and a shorter delivery period than the control group (p < .05). However, no significant difference in the use of oxytocin during delivery between the two groups was reported. The results of this evidence-based study suggest that continuous support during labor has clinically meaningful benefits for women and that all women should receive this support throughout their labor and delivery process.

Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

PubMed Central

2010-01-01

Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history). Conclusions The lessons learned from the design and conduct of this clinical trial provide guidelines for future couples based clinical trials in HIV/STD risk reduction and can be generalized to other couples based behavioral interventions. PMID:18724188

Impact of the introduction of a specialist critical care pharmacist on the level of pharmaceutical care provided to the critical care unit.

PubMed

Richter, Anja; Bates, Ian; Thacker, Meera; Jani, Yogini; O'Farrell, Bryan; Edwards, Caroline; Taylor, Helen; Shulman, Rob

2016-08-01

To evaluate the impact of a dedicated specialist critical care pharmacist service on patient care at a UK critical care unit (CCU). Pharmacist intervention data was collected in two phases. Phase 1 was with the provision of a non-specialist pharmacist chart review service and Phase 2 was after the introduction of a specialist dedicated pharmacy service. Two CCUs with established critical care pharmacist services were used as controls. The impact of pharmacist interventions on optimising drug therapy or preventing harm from medication errors was rated on a 4-point scale. There was an increase in the mean daily rate of pharmacist interventions after the introduction of the specialist critical care pharmacist (5.45 versus 2.69 per day, P < 0.0005). The critical care pharmacist intervened on more medication errors preventing potential harm and optimised more medications. There was no significant change to intervention rates at the control sites. Across all study sites the majority of pharmacist interventions were graded to have at least moderate impact on patient care. The introduction of a specialist critical care pharmacist resulted in an increased rate of pharmacist interventions compared to a non-specialist pharmacist service thus improving the quality of patient care. © 2016 The Authors. IJPP © 2016 Royal Pharmaceutical Society.

Model of chiral spin liquids with Abelian and non-Abelian topological phases

NASA Astrophysics Data System (ADS)

Chen, Jyong-Hao; Mudry, Christopher; Chamon, Claudio; Tsvelik, A. M.

2017-12-01

We present a two-dimensional lattice model for quantum spin-1/2 for which the low-energy limit is governed by four flavors of strongly interacting Majorana fermions. We study this low-energy effective theory using two alternative approaches. The first consists of a mean-field approximation. The second consists of a random phase approximation (RPA) for the single-particle Green's functions of the Majorana fermions built from their exact forms in a certain one-dimensional limit. The resulting phase diagram consists of two competing chiral phases, one with Abelian and the other with non-Abelian topological order, separated by a continuous phase transition. Remarkably, the Majorana fermions propagate in the two-dimensional bulk, as in the Kitaev model for a spin liquid on the honeycomb lattice. We identify the vison fields, which are mobile (they are static in the Kitaev model) domain walls propagating along only one of the two space directions.

Impact of a Behavioral Weight Loss Intervention on Comorbidities in Overweight and Obese Breast Cancer Survivors

PubMed Central

Sedjo, Rebecca L.; Flatt, Shirley W.; Byers, Tim; Colditz, Graham A.; Demark-Wahnefried, Wendy; Ganz, Patricia A.; Wolin, Kathleen Y.; Elias, Anthony; Krontiras, Helen; Liu, Jingxia; Naughton, Michael; Pakiz, Bilgé; Parker, Barbara A.; Wyatt, Holly; Rock, Cheryl L.

2017-01-01

Purpose Comorbid medical conditions are common among breast cancer survivors, contribute to poorer long-term survival and increased overall mortality, and may be ameliorated by weight loss. This secondary analysis evaluated the impact of a weight loss intervention on comorbid medical conditions immediately following an intervention (12-months) and one-year post-intervention (24-month) using data from the Exercise and Nutrition to Enhance Recovery and Good health for You (ENERGY) trial – a phase III trial which was aimed at and successfully promoted weight loss. Methods ENERGY randomized 692 overweight/obese women who had completed treatment for early stage breast cancer to either a one-year group-based behavioral intervention designed to achieve and maintain weight loss or to a less intensive control intervention. Minimal support was provided post-intervention. New medical conditions, medical conditions in which non-cancer medications were prescribed, hospitalizations, and emergency room visits were compared at baseline, year 1 and 2. Changes over time were analyzed using chi-squared tests, Kaplan-Meier and logistic regression analyses. Results At 12 months, women randomized to the intervention had fewer new medical conditions compared to the control group (19.6% vs. 32.2%, p<0.001); however, by 24 months, there was no longer a significant difference. No difference was observed in each of four conditions for which non-cancer medications were prescribed, hospital visits, or emergency visits at either 12 or 24 months. Conclusions These results support a short-term benefit of modest weight loss on the likelihood of comorbid conditions; however, recidivism and weight regain likely explain no benefit at one-year post-intervention follow-up. PMID:26945570

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

PubMed

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

2016-04-04

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

Investigating the effect of Eye Movement Desensitization and Reprocessing (EMDR) on postoperative pain intensity in adolescents undergoing surgery: a randomized controlled trial.

PubMed

Maroufi, Mohsen; Zamani, Shahla; Izadikhah, Zahra; Marofi, Maryam; O'Connor, Peter

2016-09-01

To investigate the efficacy of Eye Movement Desensitization and Reprocessing for postoperative pain management in adolescents. Eye Movement Desensitization and Reprocessing is an inexpensive, non-pharmacological intervention that has successfully been used to treat chronic pain. It holds promise in the treatment of acute, postsurgical pain based on its purported effects on the brain and nervous system. A randomized controlled trial was used. Fifty-six adolescent surgical patients aged between 12-18 years were allocated to gender-balanced Eye Movement Desensitization and Reprocessing (treatment) or non-Eye Movement Desensitization and Reprocessing (control) groups. Pain was measured using the Wong-Baker FACES(®) Pain Rating Scale (WBFS) before and after the intervention (or non-intervention for the control group). A Wilcoxon signed-rank test demonstrated that the Eye Movement Desensitization and Reprocessing group experienced a significant reduction in pain intensity after treatment intervention, whereas the control group did not. Additionally, a Mann-Whitney U-test showed that, while there was no significant difference between the two groups at time 1, there was a significant difference in pain intensity between the two groups at time 2, with the Eye Movement Desensitization and Reprocessing group experiencing lower levels of pain. These results suggest that Eye Movement Desensitization and Reprocessing may be an effective treatment modality for postoperative pain. © 2016 John Wiley & Sons Ltd.

Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

PubMed

Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

2008-01-01

African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre-adolescent African-American girls.

Predictors and moderators of outcomes of HIV/STD sex risk reduction interventions in substance abuse treatment programs: a pooled analysis of two randomized controlled trials.

PubMed

Crits-Christoph, Paul; Gallop, Robert; Sadicario, Jaclyn S; Markell, Hannah M; Calsyn, Donald A; Tang, Wan; He, Hua; Tu, Xin; Woody, George

2014-01-16

The objective of the current study was to examine predictors and moderators of response to two HIV sexual risk interventions of different content and duration for individuals in substance abuse treatment programs. Participants were recruited from community drug treatment programs participating in the National Institute on Drug Abuse Clinical Trials Network (CTN). Data were pooled from two parallel randomized controlled CTN studies (one with men and one with women) each examining the impact of a multi-session motivational and skills training program, in comparison to a single-session HIV education intervention, on the degree of reduction in unprotected sex from baseline to 3- and 6- month follow-ups. The findings were analyzed using a zero-inflated negative binomial (ZINB) model. Severity of drug use (p < .01), gender (p < .001), and age (p < .001) were significant main effect predictors of number of unprotected sexual occasions (USOs) at follow-up in the non-zero portion of the ZINB model (men, younger participants, and those with greater severity of drug/alcohol abuse have more USOs). Monogamous relationship status (p < .001) and race/ethnicity (p < .001) were significant predictors of having at least one USO vs. none (monogamous individuals and African Americans were more likely to have at least one USO). Significant moderators of intervention effectiveness included recent sex under the influence of drugs/alcohol (p < .01 in non-zero portion of model), duration of abuse of primary drug (p < .05 in non-zero portion of model), and Hispanic ethnicity (p < .01 in the zero portion, p < .05 in the non-zero portion of model). These predictor and moderator findings point to ways in which patients may be selected for the different HIV sexual risk reduction interventions and suggest potential avenues for further development of the interventions for increasing their effectiveness within certain subgroups.

Efficacy of a Sun Protection Workbook for Kidney Transplant Recipients: A Randomized Controlled Trial of a Culturally Sensitive Educational Intervention

PubMed Central

Robinson, June K.; Guevara, Yanina; Gaber, Rikki; Clayman, Marla L.; Kwasny, Mary J.; Friedewald, John J.; Gordon, Elisa J.

2014-01-01

A culturally sensitive educational intervention that encouraged sun protection behaviors among kidney transplant recipients was developed and the short-term efficacy was evaluated. Non-Hispanic White, Hispanic/Latino, and non-Hispanic Black patients, who received a transplant 2–24 months prior to the study, were randomized into two study groups: intervention versus standard of care. Electronic reminders tailored to the weather conditions were sent every two weeks by text message or email. Self-reported surveys and biologic measurements were obtained prior to the intervention and six weeks later. Among the 101 study participants, there was a statistically significant increase in knowledge, recognition of personal risk of developing skin cancer, willingness to change sun protection behavior, and self-reported performance of sun protection in participants receiving the intervention in comparison with those receiving standard of care (p <0.05). The pigment darkening of the sun–exposed forearm and sun damage of the forearm and sunburns/ skin irritation from the sun were significantly less in participants receiving the intervention (p <0.05). Providing sun protection education at the beginning of summer with reminders tailored to weather conditions helped KTRs adopt sun protection practices. This sun protection program for KTRs may be incorporated into the care provided by the nephrologist or transplant surgeon. PMID:25395386

Interventions to reduce accidents in childhood: a systematic review.

PubMed

Barcelos, Raquel S; Del-Ponte, Bianca; Santos, Iná S

2017-12-30

To review the literature on interventions planned to prevent the incidence of injuries in childhood. The PubMed, Web of Science, and Bireme databases were searched by two independent reviewers, employing the single terms accidents, accident, injuries, injury, clinical trial, intervention, educational intervention, and multiple interventions, and their combinations, present in the article title or abstract, with no limits except period of publication (2006-2016) and studies in human subjects. Initially, 11,097 titles were located. Fifteen articles were selected for the review. Eleven were randomized trials (four carried out at the children's households, five in pediatric healthcare services, and two at schools), and four were non-randomized trials carried out at the children's households. Four of the randomized trials were analyzed by intention-to-treat and a protective effect of the intervention was observed: decrease in the number of risk factors, decrease in the number of medical consultations due to injuries, decrease in the prevalence of risk behaviors, and increase of the parents' knowledge regarding injury prevention in childhood. Traumatic injuries in childhood are amenable to primary prevention through strategies that consider the child's age and level of development, as well as structural aspects of the environment. Copyright © 2017 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

The Effect of Different Dosing Schedules of Intravitreal Sirolimus, a Mammalian Target of Rapamycin (mTOR) Inhibitor, in the Treatment of Non-Infectious Uveitis (An American Ophthalmological Society Thesis).

PubMed

Nguyen, Quan Dong; Sadiq, Mohammad Ali; Soliman, Mohamed Kamel; Agarwal, Aniruddha; Do, Diana V; Sepah, Yasir J

2016-08-01

To determine if two different doses of intravitreal sirolimus, an mTOR inhibitor, can decrease inflammation and is safe in eyes with non-infectious posterior, intermediate, or panuveitis in the Sirolimus as a Therapeutic Approach UVEitis: Protocol-2 (SAVE-2) Study. SAVE-2 is a prospective randomized, phase II, open-label interventional clinical trial conducted at 4 clinical centers in the United States. Eligible subjects were randomized into one of two treatments. Group 1 received 440µg of intravitreal sirolimus in study eyes on days 0, 30, 60, 90, 120, and 150; group 2 received 880µg of intravitreal sirolimus on days 0, 60, and 120. Fellow eyes were also eligible to receive sirolimus (of opposite dose to that of study eye). Primary endpoint of the study was at month 6 (M6). 24 subjects have been randomized in SAVE-2 and are included in the analysis. Vitreous haze decreased by ≥2 steps in 63.6% and 50% of patients in groups 1 and 2, respectively at M6 (p=0.695). Mean change in best-corrected visual acuity for subjects was +3.66 and -2.91 ETDRS letters in group 1 and 2, respectively. Among subjects with macular edema at baseline (n=13), the mean change in foveal thickness was -89.42µm in group 1 and +81.5µm in group 2 at M6. Both low and high doses of intravitreal sirolimus were found to decrease vitreous haze in eyes with non-infectious uveitis. Low dose (440µg) sirolimus administered monthly may be more efficacious in reducing uveitic macular edema than high dose (880µg) administered every 2 months.

The Effect of Different Dosing Schedules of Intravitreal Sirolimus, a Mammalian Target of Rapamycin (mTOR) Inhibitor, in the Treatment of Non-Infectious Uveitis (An American Ophthalmological Society Thesis)

PubMed Central

Nguyen, Quan Dong; Sadiq, Mohammad Ali; Soliman, Mohamed Kamel; Agarwal, Aniruddha; Do, Diana V.; Sepah, Yasir J.

2016-01-01

Purpose: To determine if two different doses of intravitreal sirolimus, an mTOR inhibitor, can decrease inflammation and is safe in eyes with non-infectious posterior, intermediate, or panuveitis in the Sirolimus as a Therapeutic Approach UVEitis: Protocol-2 (SAVE-2) Study. Methods: SAVE-2 is a prospective randomized, phase II, open-label interventional clinical trial conducted at 4 clinical centers in the United States. Eligible subjects were randomized into one of two treatments. Group 1 received 440µg of intravitreal sirolimus in study eyes on days 0, 30, 60, 90, 120, and 150; group 2 received 880µg of intravitreal sirolimus on days 0, 60, and 120. Fellow eyes were also eligible to receive sirolimus (of opposite dose to that of study eye). Primary endpoint of the study was at month 6 (M6). Results: 24 subjects have been randomized in SAVE-2 and are included in the analysis. Vitreous haze decreased by ≥2 steps in 63.6% and 50% of patients in groups 1 and 2, respectively at M6 (p=0.695). Mean change in best-corrected visual acuity for subjects was +3.66 and −2.91 ETDRS letters in group 1 and 2, respectively. Among subjects with macular edema at baseline (n=13), the mean change in foveal thickness was −89.42µm in group 1 and +81.5µm in group 2 at M6. Conclusions: Both low and high doses of intravitreal sirolimus were found to decrease vitreous haze in eyes with non-infectious uveitis. Low dose (440µg) sirolimus administered monthly may be more efficacious in reducing uveitic macular edema than high dose (880µg) administered every 2 months. PMID:27630374

A systematic review of non-pharmacological interventions for primary Sjögren's syndrome.

PubMed

Hackett, Katie L; Deane, Katherine H O; Strassheim, Victoria; Deary, Vincent; Rapley, Tim; Newton, Julia L; Ng, Wan-Fai

2015-11-01

To evaluate the effects of non-pharmacological interventions for primary SS (pSS) on outcomes falling within the World Health Organization International Classification of Functioning Disability and Health domains. We searched the following databases from inception to September 2014: Cochrane Database of Systematic Reviews; Medline; Embase; PsychINFO; CINAHL; and clinical trials registers. We included randomized controlled trials of any non-pharmacological intervention. Two authors independently reviewed titles and abstracts against the inclusion/exclusion criteria and independently assessed trial quality and extracted data. A total of 1463 studies were identified, from which 17 full text articles were screened and 5 studies were included in the review; a total of 130 participants were randomized. The included studies investigated the effectiveness of an oral lubricating device for dry mouth, acupuncture for dry mouth, lacrimal punctum plugs for dry eyes and psychodynamic group therapy for coping with symptoms. Overall, the studies were of low quality and at high risk of bias. Although one study showed punctum plugs to improve dry eyes, the sample size was relatively small. Further high-quality studies to evaluate non-pharmacological interventions for PSS are needed. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease.

PubMed

van der Kolk, Nicolien M; Overeem, Sebastiaan; de Vries, Nienke M; Kessels, Roy P C; Donders, Rogier; Brouwer, Marc; Berg, Daniela; Post, Bart; Bloem, Bas R

2015-04-16

Parkinson's disease (PD) is a neurodegenerative disorder with a wide range of motor and non-motor symptoms. Despite optimal medical management, PD still results in a high disability rate and secondary complications and many patients lead a sedentary lifestyle, which in turn is also associated with a higher co-morbidity and mortality. Exercise has been explored as a strategy to reduce secondary complications and results suggests that it not only provides general health benefits, but may also provide symptomatic relief. If this holds true exercise would be a very attractive addition to the therapeutic arsenal in PD. The supportive evidence remains incomplete. Here, we describe the design of the Park-in-Shape study, which primarily aims to evaluate whether aerobic exercise affords clinically relevant improvements in motor symptoms in sedentary PD patients. A specific new element is the introduction of gaming to optimize compliance to the exercise intervention. The Park-in-Shape study is a randomized controlled, assessor- and patient-blinded single center study. Two parallel groups will include a total of 130 patients, receiving either aerobic exercise on a home trainer equipped with gaming elements ("exergaming"), or a non-aerobic intervention (stretching, flexibility and relaxation exercises). Both groups are supported by a specifically designed motivational app that uses gaming elements to stimulate patients to exercise and rewards them after having completed the exercise. Both interventions are delivered at home at least 3 times a week for 30-45 minutes during 6 months. Eligible patients are community-dwelling, sedentary patients diagnosed with mild-moderate PD. The primary outcome is the MDS-UPDRS motor score (tested in the off state) after 6 months. Secondary outcomes include various motor and non-motor symptoms, quality of life, physical fitness, and adherence. This Park-in-Shape study is anticipated to answer the question whether high intensity aerobic exercise combined with gaming elements ("exergaming") provides symptomatic relief in PD. Strong elements include the double-blinded randomized controlled trial design, the MDS-UPDRS as valid primary outcome, the large sample size and unique combination of home-based pure aerobic exercise combined with gaming elements and motivational aspects. Dutch trial register NTR4743.

A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy.

PubMed

Rammant, Elke; Decaestecker, Karel; Bultijnck, Renée; Sundahl, Nora; Ost, Piet; Pauwels, Nele S; Deforche, Benedicte; Pieters, Ronny; Fonteyne, Valérie

2018-05-01

Summarizing the evidence on the effects of pre- and postoperative exercise and psychosocial rehabilitation interventions on patient-reported outcomes (PROs) and physical fitness in bladder cancer patients undergoing radical cystectomy. The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science and the Physiotherapy Evidence Database were searched independently by two authors from inception until 10 November 2017. Cited references of the studies and citing references retrieved via Web of Science were also checked. Randomized controlled trials (RCTs) and non-randomized studies assessing effects of exercise and psychosocial interventions in bladder cancer patients undergoing radical cystectomy were eligible. Primary outcome measures were PROs and physical fitness. Risk of bias was assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Scale. Five RCTs (three exercise and two psychosocial studies) and one non-randomized psychosocial study comprising 317 bladder cancer patients were included. Timing of the intervention was preoperative ( n = 2), postoperative ( n = 2) or both pre- and postoperative ( n = 2). Positive effects of exercise were found for physical fitness ( n = 3), some health-related quality-of-life (HRQoL) domains ( n = 2), personal activities in daily living ( n = 1) and muscle strength ( n = 1). Psychosocial interventions showed positive effects on anxiety ( n = 1), fatigue ( n = 1), depression ( n = 1), HRQoL ( n = 1) and posttraumatic growth ( n = 1). Quality assessment showed most shortcomings with sample sizes and strong heterogeneity was observed between studies. The evidence relating to the effects of exercise in bladder cancer is very limited and is even less for psychosocial interventions.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

PubMed

Haugland, Bente Storm Mowatt; Raknes, Solfrid; Haaland, Aashild Tellefsen; Wergeland, Gro Janne; Bjaastad, Jon Fauskanger; Baste, Valborg; Himle, Joe; Rapee, Ron; Hoffart, Asle

2017-03-04

Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

The effect of moxibustion on alleviating menstrual pain in a population of young nursing students: A prospective randomized cross-over pilot study.

PubMed

Gao, Jing; Wang, Qi; Xian, Shaoxiang; Feng, Yue-mei; Cao, Wei-xin; Ye, Jing-yun; Zhang, Qing-qing; Zou, Cai-lian; Wu, Qing-guang; Liu, Si-jun

2015-12-01

To investigate the effect of moxibustion on alleviating menstrual pain and relieving the symptoms of dysmenorrhea in a cohort of young nursing students in China. A randomized double blind clinical trial of crossover design was used. In the two-phase study, a total of 56 nursing students with menstrual pain in Guangzhou University of Chinese Medicine in China was randomly allocated into two groups. In the first treatment phase, the participants in Group A (n=28) received moxibustion therapy from five days before the menstrual period to the onset through a specific heating box in which burning moxa stick was fixed, the participants in Group B (n=28) received the same heating box but with a paper-wrapped stick incense fixed inside (placebo therapy) during the same intervention period. The acupoints Guanyuan(CV4) and Shenque(CV8) were selected for treatment. After the first treatment phase for two menstrual cycles, the intervention was stopped for three menstrual cycles during a wash period. In the second treatment phase, the intervention of two groups were switched. Group A received the placebo therapy and Group B received moxibustion therapy. NRS, VRS, PRI, VAS and BRS-6 were evaluated at the baseline and after each treatment phase. There was no statistically significant difference in age, history of dysmenorrhea, length of menstrual cycle, age at menarche, duration of menstrual flow, PRI score, VAS score, BRS score and RSS score between Group A and Group B (p>0.05). After the first treatment phase, the score of BRS-6 has significant differences between two groups at the first menstrual cycle (p<0.05). At the second menstrual cycle, the score of VAS, BRS-6,sensory of PRI, affective dimension of PR and total score of PRI in Group A were much lower than Group B (p<0.05). NRS and VRS had significant differences between two groups with Wilcoxon Mann-Whitney test after the first treatment phase (p<0.05). The frequency rating of weakness, loss of appetite, diarrhea, and the total score had significant differences between two groups at the first menstrual cycle (p<0.05). And the frequency rating of weakness, backache, facial blemishes, loss of appetite, diarrhea, and the total score had significant differences between two groups at the second menstrual cycle (p<0.05). The severity rating of backaches, loss of appetite, sleeplessness, and the total score had significant differences between two groups after the second menstrual cycle (p<0.05). After three months' wash period, the score of VAS, BRS-6, sensory of PRI, affective of PR, total score of PRI and VRS had significant differences between two groups after the second treatment phase (p<0.01). And the frequency rating of leg aches, dizziness, nervousness and the total score had significant differences between two groups after the second treatment phase (p<0.05). And the severity rating of abdominal pain, weakness, leg aches, dizziness, nervousness and the total score had significant differences between two groups after the second treatment phase (p<0.05). The results suggested that moxibustion therapy with a heating box was effective for alleviating menstrual pain and symptoms of young female university students in China. The effect of moxibustion might not only due to heat stimulation, but also from the burning of moxa stick. Boxing moxibustion could be recommended as a nonpharmacological pain relief intervention for university students for its cost effectiveness, practical design and relative safety, and it is easy for the university students themselves to self-administer at home. Copyright © 2015 Elsevier Ltd. All rights reserved.

Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

PubMed

Allison, Jeroan J; Nguyen, Hoa L; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Phan, Ngoc T; Vu, Nguyen C; Kim, Minjin; Goldberg, Robert J

2016-01-14

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel community-based intervention. Results from the full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam and other developing countries. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02483780 (registration date June 22, 2015).

Effects of guar gum ingestion on postprandial blood pressure in older adults.

PubMed

Jang, A L; Hwang, S K; Kim, D U

2015-03-01

The aim of this study was to investigate the effects of guar gum on postprandial blood pressure in older people. A randomized, double-blind, placebo-controlled, cross-over design. Community senior centers in B city, South Korea. Twenty-two older female adults aged 67 to 88 with postprandial hypotension. The participants were randomly assigned to guar gum (semi-fluid food with 9 gram) or placebo intervention during the first treatment phase. After a washout period of 1 week, the two interventions were switched to the other in the second treatment phase. Blood pressure was measured during both phases before having a meal and every 15 minutes during 120 minutes after a meal with automated sphygmomanometer. Change in systolic blood pressure (SBP) over time was significantly different between guar gum and placebo groups (F=4.07, p=0.001). Compared with placebo group, guar gum group had significantly low prevalence of postprandial hypotension (PPH) (guar gum group=18.2% vs. placebo group=72.7%; χ² =13.20, p<0.001). It also had significant difference in change of diastolic blood pressure (DBP) over time between guar gum and placebo groups (F=2.49, p=0.027). This findings show that guar gum could be effective on postprandial drops in blood pressure in older female adults.

Development and content of a group-based intervention to improve medication adherence in non-adherent patients with rheumatoid arthritis.

PubMed

Zwikker, Hanneke; van den Bemt, Bart; van den Ende, Cornelia; van Lankveld, Wim; den Broeder, Alfons; van den Hoogen, Frank; van de Mosselaar, Birgit; van Dulmen, Sandra

2012-10-01

To describe the systematic development and content of a short intervention to improve medication adherence to disease-modifying anti-rheumatic drugs in non-adherent patients with rheumatoid arthritis (RA). The intervention mapping (IM) framework was used to develop the intervention. The following IM steps were conducted: (1) a needs assessment; (2) formulation of specific intervention objectives; (3) inventory of methods and techniques needed to design the intervention and (4) production and piloting of the intervention. The intervention (consisting of two group sessions led by a pharmacist, a homework assignment, and a follow-up call) aims to improve the balance between necessity and concern beliefs about medication, and to resolve practical barriers in medication taking. The central communication method used is motivational interviewing. By applying the IM framework, we were able to create a feasible, time-efficient and promising intervention to improve medication adherence in non-adherent RA patients. Intervention effects are currently being assessed in a randomized controlled trial. This paper could serve as a guideline for other health care professionals when developing similar interventions. If the RCT demonstrates sufficient effectiveness of this intervention in reducing medication non-adherence in RA patients, the intervention could be embedded in clinical practice. Crown Copyright © 2012. Published by Elsevier Ireland Ltd. All rights reserved.

Cross-cultural medical education: can patient-centered cultural competency training be effective in non-Western countries?

PubMed

Ho, Ming-Jung; Yao, Grace; Lee, Keng-Lin; Beach, Mary Catherine; Green, Alexander R

2008-01-01

No evidence addresses the effectiveness of patient-centered cultural competence training in non-Western settings. To examine whether a patient-centered cultural competency curriculum improves medical students' skills in eliciting the patients' perspective and exploring illness-related social factors. Fifty-seven medical students in Taiwan were randomly assigned to either the control (n = 27) or one of two intervention groups: basic (n = 15) and extensive (n = 15). Both intervention groups received two 2-hour patient-centered cultural competency workshops. In addition, the extensive intervention group received a 2-hour practice session. The control group received no training. At the end of the clerkship, all students were evaluated with an objective structured clinical examination (OSCE). Students in the extensive intervention group scored significantly higher than the basic intervention and control groups in eliciting the patient's perspective (F = 18.38, p < 0.001, eta(2) = 0.40). Scores of both intervention groups were significantly higher than the control group in the exploring social factors (F = 6.66, p = 0.003, eta(2) = 0.20). Patient-centered cultural competency training can produce improvement in medical students' cross-cultural communication skills in non-Western settings, especially when adequate practice is provided.

Model of chiral spin liquids with Abelian and non-Abelian topological phases

DOE PAGES

Chen, Jyong-Hao; Mudry, Christopher; Chamon, Claudio; ...

2017-12-15

In this article, we present a two-dimensional lattice model for quantum spin-1/2 for which the low-energy limit is governed by four flavors of strongly interacting Majorana fermions. We study this low-energy effective theory using two alternative approaches. The first consists of a mean-field approximation. The second consists of a random phase approximation (RPA) for the single-particle Green's functions of the Majorana fermions built from their exact forms in a certain one-dimensional limit. The resulting phase diagram consists of two competing chiral phases, one with Abelian and the other with non-Abelian topological order, separated by a continuous phase transition. Remarkably, themore » Majorana fermions propagate in the two-dimensional bulk, as in the Kitaev model for a spin liquid on the honeycomb lattice. We identify the vison fields, which are mobile (they are static in the Kitaev model) domain walls propagating along only one of the two space directions.« less

Model of chiral spin liquids with Abelian and non-Abelian topological phases

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

Chen, Jyong-Hao; Mudry, Christopher; Chamon, Claudio

In this article, we present a two-dimensional lattice model for quantum spin-1/2 for which the low-energy limit is governed by four flavors of strongly interacting Majorana fermions. We study this low-energy effective theory using two alternative approaches. The first consists of a mean-field approximation. The second consists of a random phase approximation (RPA) for the single-particle Green's functions of the Majorana fermions built from their exact forms in a certain one-dimensional limit. The resulting phase diagram consists of two competing chiral phases, one with Abelian and the other with non-Abelian topological order, separated by a continuous phase transition. Remarkably, themore » Majorana fermions propagate in the two-dimensional bulk, as in the Kitaev model for a spin liquid on the honeycomb lattice. We identify the vison fields, which are mobile (they are static in the Kitaev model) domain walls propagating along only one of the two space directions.« less

"What did you say?" Using review of tape-recorded interactions to increase social acknowledgments by trainees in a community-based vocational program.

PubMed

Grossi, T A; Kimball, J W; Heward, W L

1994-01-01

Dana and Rick, two adults with developmental disabilities enrolled in a restaurant training program, had poor prospects for long-term employment because of inappropriate social behavior. They often made no response, mumbled inaudibly, or made a negative remark when spoken to by their supervisors or other employees. Each trainee's Individual Vocational Plan (IVP) included goals of prompt and polite acknowledgement of coworker initiations. Previous efforts to improve Dana and Rick's acknowledging behavior had been unsuccessful. Throughout the study, each trainee's responses to 20 verbal initiations by coworkers (i.e., requests, questions, corrective feedback, praise, and social comments) were recorded during each of two observation periods per workshift. Throughout one of the observation periods during the intervention phases, the trainees carried in their work aprons a small, audio cassette recorder that recorded their interactions with coworkers. The primary intervention consisted of a preworkshift meeting in which the trainee and experimenter reviewed five randomly selected interactions recorded during the previous day's shift. The review included self-evaluation, praise, corrective feedback, and role-play. A multiple baseline across subjects design showed each trainee acknowledged a greater number of coworker initiations as a function of the intervention. Each trainee also acknowledged more coworker initiations during the second observation period when the tape recorder was never worn. In a subsequent intervention phase, Dana reviewed her tape-recorded interactions prior to randomly selected shifts. Rick's acknowledgments increased to a socially valid level when the review procedure was supplemented with graphic feedback. Both trainees continued to acknowledge their coworkers' initiations at levels equal to nondisabled restaurant employees when they no longer wore the tape recorder during a final phase and during follow-up observations 4 to 8 weeks later.

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

PubMed

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

2014-04-01

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

Promoting state health department evidence-based cancer and chronic disease prevention: a multi-phase dissemination study with a cluster randomized trial component

PubMed Central

2013-01-01

Background Cancer and other chronic diseases reduce quality and length of life and productivity, and represent a significant financial burden to society. Evidence-based public health approaches to prevent cancer and other chronic diseases have been identified in recent decades and have the potential for high impact. Yet, barriers to implement prevention approaches persist as a result of multiple factors including lack of organizational support, limited resources, competing emerging priorities and crises, and limited skill among the public health workforce. The purpose of this study is to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention. Methods/design This paper describes the methods for a multi-phase dissemination study with a cluster randomized trial component that will evaluate the dissemination of public health knowledge about evidence-based prevention of cancer and other chronic diseases. Phase one involves development of measures of practitioner views on and organizational supports for evidence-based public health and data collection using a national online survey involving state health department chronic disease practitioners. In phase two, a cluster randomized trial design will be conducted to test receptivity and usefulness of dissemination strategies directed toward state health department chronic disease practitioners to enhance capacity and organizational support for evidence-based chronic disease prevention. Twelve state health department chronic disease units will be randomly selected and assigned to intervention or control. State health department staff and the university-based study team will jointly identify, refine, and select dissemination strategies within intervention units. Intervention (dissemination) strategies may include multi-day in-person training workshops, electronic information exchange modalities, and remote technical assistance. Evaluation methods include pre-post surveys, structured qualitative phone interviews, and abstraction of state-level chronic disease prevention program plans and progress reports. Trial registration clinicaltrials.gov: NCT01978054. PMID:24330729

Online Module for Carrier Screening in Ashkenazi Jewish Individuals Compared with In-Person Genetics Education: A Randomized Controlled Trial.

PubMed

Fan, Chia Wei; Castonguay, Lysanne; Rummell, Sonja; Lévesque, Sébastien; Mitchell, John J; Sillon, Guillaume

2018-04-01

To increase accessibility to genetics services for low-urgency patients seeking Ashkenazi Jewish (AJ) carrier screening, we designed an interactive computer (IC) module that provides pre-test genetics education and allows genetics professionals to order the test without meeting the patients beforehand. We compared this module with in-person genetic counseling (GC) using a randomized trial. AJ individuals were randomized to undergo genetics education via the IC module (n = 26) or GC (n = 28). We compared post-interventional genetics knowledge, perceived genetic risk, and anxiety between the two groups, after accounting for pre-interventional scores, using ANCOVA. Wilcoxon Rank-Sum test was used to compare post-interventional satisfaction. Post-interventional genetics knowledge, risk perception, or anxiety were not significantly different between the two groups after accounting for baseline scores (p = 0.50-0.54), although the data are inconclusive regarding the module's non-inferiority at a 5% margin. Post-intervention satisfaction scores were generally higher in the GC group than the IC module group. Our IC module has the potential to improve access to clinical genetics services for patients and staff, but it is not suitable for all AJ patients and cannot completely replace the benefits of in-person consultations.

The use of virtual world-based cardiac rehabilitation to encourage healthy lifestyle choices among cardiac patients: intervention development and pilot study protocol.

PubMed

Brewer, LaPrincess C; Kaihoi, Brian; Zarling, Kathleen K; Squires, Ray W; Thomas, Randal; Kopecky, Stephen

2015-04-08

Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients, and racial/ethnic minorities have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints, and transportation. The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, and smoking) to a greater degree than conventional CR participants. In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet, and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability, and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following (1) at least 150 minutes of physical activity per week, (2) daily consumption of five or more fruits and vegetables, and (3) smoking cessation. Patients will be assessed at 3, 6, and 12 months. The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016. While research on the use of virtual world technology in health programs is in its infancy, it offers unique advantages over current Web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy.

Speech characteristics after articulation therapy in children with cleft palate and velopharyngeal dysfunction - A single case experimental design.

PubMed

Derakhshandeh, Fatemeh; Nikmaram, Mohammadreza; Hosseinabad, Hedieh Hashemi; Memarzadeh, Mehrdad; Taheri, Masoud; Omrani, Mohammadreza; Jalaie, Shohreh; Bijankhan, Mahmood; Sell, Debbie

2016-07-01

The aim of this study was to investigate the impact of an intensive 10-week course of articulation therapy on articulation errors in cleft lip and palate patients who have Velopharyngeal Insufficiency (VPI), non-oral and passive cleft speech characteristics. Five children with cleft palate (+/-cleft lip) with VPI and non-oral and passive cleft speech characteristics underwent 40 intensive articulation therapies over 10 weeks in a single case experimental design. The percentage of non-oral CSCs (NCSCs), passive CSCs (PCSCs), stimulable consonants (SC), correct consonants in word imitation (CCI), and correct consonants in picture naming (CCN) were captured at baseline, during intervention and in follow up phases. Visual analysis and two effect size indexes of Percentage of Nonoverlapping Data and Percentage of Improvement Rate Difference were analyzed. Articulation therapy resulted in visible decrease in NCSCs for all 5 participants across the intervention phases. Intervention was effective in changing percentage of passive CSCs in two different ways; it reduced the PCSCs in three cases and resulted in an increase in PCSCs in the other two cases. This was interpreted as intervention having changed the non-oral CSCs to consonants produced within the oral cavity but with passive characteristics affecting manner of production including weakness, nasalized plosives and nasal realizations of plosives and fricatives. Percent SC increased throughout the intervention period in all five patients. All participants demonstrated an increase in percentage of CCI and CCN suggesting an increase in the consonant inventory. Follow-up data showed that all the subjects were able to maintain their ability to articulate learned phonemes correctly even after a 4-week break from intervention. This single case experimental study supports the hypothesis that speech intervention in patients with VPI can result in an improvement in oral placements and passive CSCs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of two different behavioral modification techniques among 5-7-year-old children: A randomized controlled trial.

PubMed

Vishwakarma, Aruna Prashanth; Bondarde, Prashant Arjun; Patil, Sudha Bhimangouda; Dodamani, Arun Suresh; Vishwakarma, Prashanth Yachrappa; Mujawar, Shoeb A

2017-01-01

Dental fear is a common, essential, and inevitable emotion that appears as a response to the stressful situation, which raises children's anxiety level, resulting in reduced demand for pediatric dental care. (1) To compare and evaluate the effectiveness of customized tell-play-do (TPD) technique with live modeling for behavior management of children. (2) To compare the behavioral modification techniques in managing the children during their dental visits. Ninety-eight children aged 5-7 years were enrolled in the study and randomly allocated into two groups. Phase I: first visit. Group I - children were conditioned to receive various dental procedures using live modeling followed by oral prophylaxis. Group II - TPD technique was introduced with customized playing dental objects followed by oral prophylaxis. Phase II: second visit. After 7 days interval, all the study subjects were subjected to rotary restorative treatment. Heart rate, Facial Image Scale (FIS), and Venham-6-point index were used before intervention, after intervention, and during dental procedure to quantify the anxious behavior. All 98 children after intervention underwent oral prophylaxis on first visit and rotary restorative treatment on second visit. The average pulse rate, FIS, and Venham scale scores were significantly lower among children who received TPD intervention when compared to those who received live modeling intervention. Unpaired t-test at 5% level of significance was considered as statistical significance. TPD is effective in reducing children's fear and anxiety about dental treatment, children enjoy playing with customized dental object. Thus, to promote adaptive behavior, TPD could be an alternate behavioral modification technique during pediatric dentistry.

Effect of preemptive intra-articular morphine and ketamine on pain after arthroscopic rotator cuff repair: a prospective, double-blind, randomized controlled study.

PubMed

Khashan, M; Dolkart, O; Amar, E; Chechik, O; Sharfman, Z; Mozes, G; Maman, E; Weinbroum, A A

2016-02-01

Rotator cuff tear is a leading etiology of shoulder pain and disability. Surgical treatment is indicated in patients with persistent pain who fail a trial of non-surgical treatment. Pain reduction following rotator cuff repair, particularly within the first 24-48 h, is a major concern to both doctors and patients. This study aimed to compare the postoperative antinociceptive additive effects of pre-incisional intra-articular (IA) ketamine when combined with morphine with two times the dose of morphine or saline. In this prospective, randomized, double blind, controlled trial patients undergoing arthroscopic rotator cuff tear repair (ARCR) under general anesthesia were enrolled. Patients were randomly assigned to one of the three intervention groups. Twenty minutes prior to incision, morphine (20 mg/10 ml), ketamine (50 mg + morphine 10 mg/10 ml), or saline (0.9 % 10 ml) (n = 15/group), were administered to all patients. First 24 h postoperative analgesia consisted of intravenous patient controlled analgesia (IV-PCA) morphine and oral rescue paracetamol 1000 mg or oxycodone 5 mg. 24-h, 2-week and 3-month patient rated pain numeric rating scale (NRS) and analgesics consumption were documented. Patients' demographic and perioperative data were similar among all groups. The 24-h and the 2-week NRSs were significantly (p < 0.05) lower in both treatment groups compared to placebo, but were not significantly different between the two intervention groups. PCA-morphine and oral analgesics were consumed similarly among the groups throughout the study phases. Pre-incisional intra-articular morphine reduced pain in the first 2 weeks after arthroscopic rotator cuff repair. Further research is warranted to elucidate the optimal timing and dosing of IA ketamine and morphine for postoperative analgesic effects.

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.

Virtual reality bringing a new reality to postthoracotomy lung cancer patients via a home-based exercise intervention targeting fatigue while undergoing adjuvant treatment.

PubMed

Hoffman, Amy J; Brintnall, Ruth Ann; Brown, Jean K; von Eye, Alexander; Jones, Lee W; Alderink, Gordon; Ritz-Holland, Deborah; Enter, Mark; Patzelt, Lawrence H; VanOtteren, Glenn M

2014-01-01

Little is known about rehabilitation for postthoracotomy non-small cell lung cancer (NSCLC) patients. This research uses a perceived self-efficacy-enhancing light-intensity exercise intervention targeting a priority symptom, cancer-related fatigue (CRF), for postthoracotomy NSCLC patients. This article reports on phase II of a 2-phase study. Phase I focused on initiation and tolerance of exercise during the 6 weeks immediately after thoracotomy, whereas phase II addressed maintenance of exercise for an additional 10 weeks including participants initiating and completing chemotherapy and/or radiation therapy. The objective of this study was to investigate the feasibility, acceptability, and preliminary efficacy of an exercise intervention for postthoracotomy NSCLC patients to include those initiating and completing adjuvant therapy. A single-arm design composed of 7 participants postthoracotomy for NSCLC performed light-intensity exercises using an efficacy-enhancing virtual-reality approach using the Nintendo Wii Fit Plus. Despite most participants undergoing chemotherapy and/or radiation therapy, participants adhered to the intervention at a rate of 88% with no adverse events while giving the intervention high acceptability scores on conclusion. Likewise, participants' CRF scores improved from initiation through the conclusion of the intervention with perceived self-efficacy for walking at a light intensity continuously for 60 minutes, improving significantly upon conclusion over presurgery values. Postthoracotomy NSCLC patients maintained exercise for an additional 10 weeks while undergoing adjuvant therapy showing rehabilitation potential because the exercise intervention was feasible, safe, well tolerated, and highly acceptable showing positive changes in CRF self-management. A randomized controlled trial is needed to further investigate these relationships.

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder.

PubMed

McMain, Shelley F; Guimond, Tim; Barnhart, Ryan; Habinski, Liat; Streiner, David L

2017-02-01

Evidence-based therapies for borderline personality disorder (BPD) are lengthy and scarce. Data on brief interventions are limited, and their role in the treatment of BPD is unclear. Our aim was therefore to evaluate the clinical effectiveness of brief dialectical behaviour therapy (DBT) skills training as an adjunctive intervention for high suicide risk in patients with BPD. Eighty-four out-patients were randomized to 20 weeks of DBT skills (n = 42) or a waitlist (WL; n = 42). The primary outcome was frequency of suicidal or non-suicidal self-injurious (NSSI) episodes. Assessments were conducted at baseline 10, 20 and 32 weeks. DBT participants showed greater reductions than the WL participants on suicidal and NSSI behaviours between baseline and 32 weeks (P < 0.0001). DBT participants showed greater improvements than controls on measures of anger, distress tolerance and emotion regulation at 32 weeks. This abbreviated intervention is a viable option that may be a useful adjunctive intervention for the treatment of high-risk behaviour associated with the acute phase of BPD. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Nandrolone decanoate as anabolic therapy in chronic kidney disease: a randomized phase II dose-finding study.

PubMed

Macdonald, Jamie H; Marcora, Samuele M; Jibani, Mahdi M; Kumwenda, Mick J; Ahmed, Wasim; Lemmey, Andrew B

2007-01-01

In patients with chronic kidney disease (CKD) receiving adequate erythropoietin therapy, the ideal dose of nandrolone decanoate (ND) to enhance muscle mass is not known. In this phase II dose-finding study, 54 patients with CKD stage 5 were randomized to either low, medium or high doses of ND (50, 100 or 200 mg/week for 24 weeks, respectively, in males; doses halved in females), while 7 patients acted as non-randomized controls. The primary outcome measure was appendicular lean mass (ALM) by dual-energy X-ray absorptiometry. Fluid overload (hydration of the fat-free mass) and indicators of physical functioning were secondary measures. Harms were also recorded. Data were analysed using Quade's (1967) non-parametric analysis of covariance. ND increased ALM in a dose-responsive manner (change scores = 0.3 +/- 0.3 vs. 0.8 +/- 0.3 vs. 1.5 +/- 0.5 vs. 2.1 +/- 0.4 kg, control vs. low vs. medium vs. high dose groups, respectively, p < 0.001) with no increases in fluid overload but no consistent effect on physical functioning. The highest dose of ND (100 mg/week) was intolerable in females because of virilizing effects. If goals of future studies are to improve body composition, dosing of ND up to 200 mg/week in males and 50 mg/week in females should be investigated. However, to realize improvements in physical functioning, future phase III trials of ND may require additional interventions such as exercise training. Copyright 2007 S. Karger AG, Basel.

Effects of Bread with Nigella Sativa on Lipid Profiles, Apolipoproteins and Inflammatory Factor in Metabolic Syndrome Patients

PubMed Central

2016-01-01

Nigella sativa (N.sativa) has been used in traditional medicine and many studies have been performed in different communities in order to reveal the effects of it on medical disorders and chronic diseases. The aim of this study was to investigate the effects of bread with N. Sativa on lipid profiles, apolipoproteins, and inflammatory factors in metabolic syndrome (MetS) patients. A randomized, double-blind, cross-over and clinical trial was conducted in 51 MetS patients of both sexes with age group of 20-65 years old in Chaloos, north of Iran. Patients were randomly divided in two groups. In phase 1, intervention group (A, n = 27) received daily a bread with N. sativa and wheat bran and control group (B, n = 24) received the same bread without N. sativa for 2 months. After 2 weeks of wash out period, phase 2 was started with switch the intervention between two groups. Measuring of lipid profiles, apolipoproteins and inflammatory factor was performed for all patients before and after two phases. In this study, treatment, sequence and time effects of intervention were evaluated and revealed that consumption of bread with N. sativa has no significant treatment and time effects on triglyceride (TG), cholesterol (CHOL), low density lipoprotein (LDL), high density lipoprotein (HDL), apolipoprotein (APO)-A, APO-B and high-sensitivity C-reactive protein (p > 0.05). Sequence effect was significant on CHOL, LDL, APO-A, and APO-B (p < 0.05) but was not significant on other parameters (p > 0.05). Consumption of bread with N. sativa has no a significant effect on lipid profiles, apolipoproteins and inflammatory factor in MetS patients. PMID:27152298

Intervention for the bereaved: gender differences in the efficacy of two counselling programmes.

PubMed

Schut, H A; Stroebe, M S; van den Bout, J; de Keijser, J

1997-02-01

This article describes an investigation of emotion-focused versus problem-focused intervention for widowers (N = 23) and widowers (N = 23) who were suffering elevated levels of distress 11 months after their loss. They were randomly assigned to an intervention condition and improvement (on the General Health Questionnaire) was compared with non-intervention controls (N = 59). Two alternative hypotheses were considered: (1) men, since they focus less on their emotions, would benefit from problem-focused counselling, while women, focusing more on their emotions, would benefit from emotion-focused intervention; (2) each gender, having been comparatively unsuccessful in coping through these usual strategies, would benefit more from intervention directed towards the less familiar strategy. Results supported the second hypothesis: widowers benefited more from emotion-focused, widows from problem-focused interventions. Implications for supporting widows and widowers are discussed.

Participant recruitment and retention in a pilot program to prevent weight gain in low-income overweight and obese mothers.

PubMed

Chang, Mei-Wei; Brown, Roger; Nitzke, Susan

2009-11-21

Recruitment and retention are key functions for programs promoting nutrition and other lifestyle behavioral changes in low-income populations. This paper describes strategies for recruitment and retention and presents predictors of early (two-month post intervention) and late (eight-month post intervention) dropout (non retention) and overall retention among young, low-income overweight and obese mothers participating in a community-based randomized pilot trial called Mothers In Motion. Low-income overweight and obese African American and white mothers ages 18 to 34 were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children in southern Michigan. Participants (n = 129) were randomly assigned to an intervention (n = 64) or control (n = 65) group according to a stratification procedure to equalize representation in two racial groups (African American and white) and three body mass index categories (25.0-29.9 kg/m(2), 30.0-34.9 kg/m(2), and 35.0-39.9 kg/m(2)). The 10-week theory-based culturally sensitive intervention focused on healthy eating, physical activity, and stress management messages that were delivered via an interactive DVD and reinforced by five peer-support group teleconferences. Forward stepwise multiple logistic regression was performed to examine whether dietary fat, fruit and vegetable intake behaviors, physical activity, perceived stress, positive and negative affect, depression, and race predicted dropout as data were collected two-month and eight-month after the active intervention phase. Trained personnel were successful in recruiting subjects. Increased level of depression was a predictor of early dropout (odds ratio = 1.04; 95% CI = 1.00, 1.08; p = 0.03). Greater stress predicted late dropout (odds ratio = 0.20; 95% CI = 0.00, 0.37; p = 0.01). Dietary fat, fruit, and vegetable intake behaviors, physical activity, positive and negative affect, and race were not associated with either early or late dropout. Less negative affect was a marginal predictor of participant retention (odds ratio = 0.57; 95% CI = 0.31, 1.03; p = 0.06). Dropout rates in this study were higher for participants who reported higher levels of depression and stress. Current Controlled Trials NCT00944060.

Systematic Review of Interventions to Reduce Urinary Tract Infection in Nursing Home Residents

PubMed Central

Meddings, Jennifer; Saint, Sanjay; Krein, Sarah L.; Gaies, Elissa; Reichert, Heidi; Hickner, Andrew; McNamara, Sara; Mann, Jason D.; Mody, Lona

2017-01-01

BACKGROUND Urinary tract infections (UTIs) in nursing homes are common, costly, and morbid. PURPOSE Systematic literature review of strategies to reduce UTIs in nursing home residents DATA SOURCES Ovid MEDLINE, Cochrane Library, CINAHL, Web of Science and Embase through June 22, 2015. STUDY SELECTION Interventional studies with a comparison group reporting at least one outcome for: catheter-associated UTI (CAUTI), UTIs not identified as catheter-associated, bacteriuria, or urinary catheter use. DATA EXTRACTION Two authors abstracted study design, participant and intervention details, outcomes, and quality measures. DATA SYNTHESIS Of 5,794 records retrieved, 20 records describing 19 interventions were included: 8 randomized controlled trials, 10 pre-post non-randomized interventions, and 1 non-randomized intervention with concurrent controls. Quality (range 8-25, median 15) and outcome definitions varied greatly. Thirteen studies employed strategies to reduce catheter use or improve catheter care; nine studies employed general infection prevention strategies (e.g., improving hand hygiene, surveillance, contact precautions, reducing antibiotics). The nineteen studies reported 12 UTI outcomes, 9 CAUTI outcomes, 4 bacteriuria outcomes, and 5 catheter use outcomes. Five studies showed CAUTI reduction (1 significantly); nine studies showed UTI reduction (none significantly); 2 studies showed bacteriuria reduction (none significantly). Four studies showed reduced catheter use (1 significantly). LIMITATIONS Studies were often underpowered to assess statistical significance; none were pooled given variety of interventions and outcomes. CONCLUSIONS Several practices, often implemented in bundles, appear to reduce UTI or CAUTI in nursing home residents such as improving hand hygiene, reducing and improving catheter use, managing incontinence without catheters, and enhanced barrier precautions. PMID:28459908

Long-term effects of inhaled budesonide on screening-detected lung nodules

PubMed Central

Veronesi, G.; Lazzeroni, M.; Szabo, E.; Brown, P. H.; DeCensi, A.; Guerrieri-Gonzaga, A.; Bellomi, M.; Radice, D.; Grimaldi, M. C.; Spaggiari, L.; Bonanni, B.

2015-01-01

Background A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT. Patients and methods We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed. Results The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms. Conclusions Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications. Clinical trial number NCT01540552. PMID:25672894

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design.

PubMed

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-02-01

Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

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

PubMed

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

2011-01-01

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

An organic khorasan wheat-based replacement diet improves risk profile of patients with acute coronary syndrome: a randomized crossover trial.

PubMed

Whittaker, Anne; Sofi, Francesco; Luisi, Maria Luisa Eliana; Rafanelli, Elena; Fiorillo, Claudia; Becatti, Matteo; Abbate, Rosanna; Casini, Alessandro; Gensini, Gian Franco; Benedettelli, Stefano

2015-05-11

Khorasan wheat is an ancient grain with previously reported health benefits in clinically healthy subjects. The aim of this study was to examine whether a replacement diet, thereby substituting all other cereal grains, with products made with organic khorasan wheat could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors, in patients with Acute Coronary Syndromes (ACS) in comparison to a similar replacement diet using products made from organic modern wheat. A randomized double-blinded crossover trial with two intervention phases was conducted on 22 ACS patients (9 F; 13 M). The patients were assigned to consume products (bread, pasta, biscuits and crackers) made either from organic semi-whole khorasan wheat or organic semi-whole control wheat for eight weeks in a random order. On average, patients ingested 62.0 g dry weight (DW) day-1 khorasan or control semolina; and 140.5 g DW day-1 khorasan or control flour, respectively. An eight-week washout period was implemented between the respective interventions. Blood analyses were performed both at the beginning and end of each intervention phase; thereby permitting a comparison of both the khorasan and control intervention phases, respectively, on circulatory risk factors for the same patient. Consumption of products made with khorasan wheat resulted in a significant amelioration in total cholesterol (-6.8%), low-density lipoprotein cholesterol (LDL-C) (-8.1%) glucose (-8%) and insulin (-24.6%) from baseline levels, independently of age, sex, traditional risk factors, medication and diet quality. Moreover, there was a significant reduction in reactive oxygen species (ROS), lipoperoxidation of circulating monocytes and lymphocytes, as well as in the levels of Tumor Necrosis Factor-alpha. No significant differences from baseline in the same patients were observed after the conventional control wheat intervention phase. The present results suggest that a replacement diet with cereal products made from organic khorasan wheat provides additional protection in patients with ACS. Circulating cardiovascular risk factors, including lipid parameters, and markers of both oxidative stress and inflammatory status, were reduced, irrespective of the number and combination of medicinal therapies with proven efficacy in secondary prevention.

Contests versus Norms: Implications of Contest-Based and Norm-Based Intervention Techniques

PubMed Central

Bergquist, Magnus; Nilsson, Andreas; Hansla, André

2017-01-01

Interventions using either contests or norms can promote environmental behavioral change. Yet research on the implications of contest-based and norm-based interventions is lacking. Based on Goal-framing theory, we suggest that a contest-based intervention frames a gain goal promoting intensive but instrumental behavioral engagement. In contrast, the norm-based intervention was expected to frame a normative goal activating normative obligations for targeted and non-targeted behavior and motivation to engage in pro-environmental behaviors in the future. In two studies participants (n = 347) were randomly assigned to either a contest- or a norm-based intervention technique. Participants in the contest showed more intensive engagement in both studies. Participants in the norm-based intervention tended to report higher intentions for future energy conservation (Study 1) and higher personal norms for non-targeted pro-environmental behaviors (Study 2). These findings suggest that contest-based intervention technique frames a gain goal, while norm-based intervention frames a normative goal. PMID:29218026

Contests versus Norms: Implications of Contest-Based and Norm-Based Intervention Techniques.

PubMed

Bergquist, Magnus; Nilsson, Andreas; Hansla, André

2017-01-01

Interventions using either contests or norms can promote environmental behavioral change. Yet research on the implications of contest-based and norm-based interventions is lacking. Based on Goal-framing theory, we suggest that a contest-based intervention frames a gain goal promoting intensive but instrumental behavioral engagement. In contrast, the norm-based intervention was expected to frame a normative goal activating normative obligations for targeted and non-targeted behavior and motivation to engage in pro-environmental behaviors in the future. In two studies participants ( n = 347) were randomly assigned to either a contest- or a norm-based intervention technique. Participants in the contest showed more intensive engagement in both studies. Participants in the norm-based intervention tended to report higher intentions for future energy conservation (Study 1) and higher personal norms for non-targeted pro-environmental behaviors (Study 2). These findings suggest that contest-based intervention technique frames a gain goal, while norm-based intervention frames a normative goal.

HealthKick: a nutrition and physical activity intervention for primary schools in low-income settings

PubMed Central

2010-01-01

Background The burden of non-communicable diseases, including type 2 diabetes, is growing in South Africa. This country has a complex mix of over- and under-nutrition, especially in low-income communities, and concerning levels of physical inactivity in children and youth. This paper describes HealthKick, a school-based nutrition and physical activity intervention in primary schools in these settings aimed at reducing diabetes risk factors. Methods/Design This study includes schools within historically disadvantaged, low-income communities from an urban area close to the city of Cape Town and from two rural areas outside of Cape Town, South Africa. The three Educational Districts involved are Metropole North, Cape Winelands and the Overberg. The study has three phases: intervention mapping and formative assessment, intervention development, and outcome and process evaluation. Sixteen schools were purposively selected to participate in the study and randomly allocated as intervention (eight schools) and control (eight schools). The primary aims of HealthKick are to promote healthful eating habits and increase regular participation in health-enhancing physical activity in children, parents and teachers, to prevent overweight, and reduce risk of chronic diseases (particularly type 2 diabetes); as well as to promote the development of an environment within the school and community that facilitates the adoption of healthy lifestyles. The components of HealthKick are: action planning, toolkit (resource guide, a resource box and physical activity resource bin), and an Educators' Manual, which includes a curriculum component. Discussion This study continues to highlight the key role that educators play in implementing a school-based intervention, but that developing capacity within school staff and stakeholders is not a simple or easy task. In spite of the challenges experienced thus far, valuable findings are being produced from this study, especially from Phase 1. Materials developed could be disseminated to other schools in low-income settings both within and outside of South Africa. Owing to the novelty of the HealthKick intervention in low-income South African primary schools, the findings of the evaluation phase have the potential to impact on policy and practice within these settings. PMID:20604914

Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS) – a randomized controlled trial protocol for a stationary cycling intervention

PubMed Central

Fowler, Eileen G; Knutson, Loretta M; DeMuth, Sharon K; Sugi, Mia; Siebert, Kara; Simms, Victoria; Azen, Stanley P; Winstein, Carolee J

2007-01-01

Background In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP) due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. Methods/design The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS) levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling) or a control (no cycling) group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR) range (70 – 80% maximum HR). Thirty sessions will take place over a 10–12 week period. All children will be evaluated before (baseline) and after (follow-up) the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM); the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT). Discussion This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS); a Phase I randomized controlled trial evaluating the efficacy of a stationary cycling intervention for children with spastic diplegic cerebral palsy. PMID:17374171

Evaluating the Efficacy of Lay Health Advisors for Increasing Risk-appropriate Pap Test Screening: A randomized controlled trial among Ohio Appalachian women

PubMed Central

Paskett, Electra D.; McLaughlin, John M.; Lehman, Amy M.; Katz, Mira L.; Tatum, Cathy M.; Oliveri, Jill M.

2011-01-01

Background Cervical cancer is a significant health disparity among women in Ohio Appalachia. The goal of this study was to evaluate the efficacy of a lay health advisor (LHA) intervention for improving Pap testing rates, to reduce cervical cancer, among women in need of screening. Methods Women from 14 Ohio Appalachian clinics in need of a Pap test were randomized to receive either usual care or an LHA intervention over a ten-month period. The intervention consisted of two in-person visits with an LHA, two phone calls, and four post cards. Both self-report and medical record review (MRR) data (primary outcome) were analyzed. Results Of the 286 women, 145 and 141 were randomized to intervention and usual care arms, respectively. According to MRR, more women in the LHA arm had a Pap test by the end of the study compared to those randomized to usual care (51.1% vs. 42.0%; OR=1.44, 95%CI: 0.89, 2.33; p=0.135). Results of self-report were more pronounced (71.3% vs. 54.2%; OR=2.10, 95%CI: 1.22, 3.61; p=0.008). Conclusions An LHA intervention showed some improvement in the receipt of Pap tests among Ohio Appalachian women in need of screening. While biases inherent in using self-reports of screening are well known, this study also identified biases in using MRR data in clinics located in underserved areas. Impact LHA interventions show promise for improving screening behaviors among non-adherent women from underserved populations. PMID:21430302

Mediation of effects of a theory-based behavioral intervention on self-reported physical activity in South African men.

PubMed

Jemmott, John B; Stephens-Shields, Alisa; O'Leary, Ann; Jemmott, Loretta Sweet; Teitelman, Anne; Ngwane, Zolani; Mtose, Xoliswa

2015-03-01

Increasing physical activity is an important public-health goal worldwide, but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases. This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1181 men in Eastern Cape Province, South Africa. Twenty-two matched-pairs of neighborhoods were randomly selected. Within pairs, neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline, immediate-post, and 6- and 12-month post-intervention assessments. Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome, self-reported physical activity averaged over the 6- and 12-month post-intervention assessments, using a product-of-coefficients approach in a generalized-estimating-equations framework. Data were collected in 2007-2010. Attitude, subjective norm, self-efficacy, and intention were significant mediators of intervention-induced increases in self-reported physical activity. The descriptive norm, not affected by the intervention, was not a mediator, but predicted increased self-reported physical activity. The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men. Copyright © 2015 Elsevier Inc. All rights reserved.

Mediation of Effects of a Theory-Based Behavioral Intervention on Self-Reported Physical Activity in South African Men

PubMed Central

Jemmott, John B.; Stephens, Alisa; O’Leary, Ann; Jemmott, Loretta Sweet; Teitelman, Anne; Ngwane, Zolani; Mtose, Xoliswa

2015-01-01

Objective Increasing physical activity is an important public-health goal worldwide, but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases. This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1,181 men in Eastern Cape Province, South Africa. Method Twenty-two matched-pairs of neighborhoods were randomly selected. Within pairs, neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline, immediate-post, and 6- and 12-month post-intervention assessments. Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome, self-reported physical activity averaged over the 6- and 12-month post-intervention assessments, using a product-of-coefficients approach in a generalized-estimating-equations framework. Data were collected in 2007–2010. Results Attitude, subjective norm, self-efficacy, and intention were significant mediators of intervention-induced increases in self-reported physical activity. The descriptive norm, not affected by the intervention, was not a mediator, but predicted increased self-reported physical activity. Conclusion The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men. PMID:25565482

Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial.

PubMed

Cavalcanti, Alexandre B; Bozza, Fernando Augusto; Machado, Flavia R; Salluh, Jorge I F; Campagnucci, Valquiria Pelisser; Vendramim, Patricia; Guimaraes, Helio Penna; Normilio-Silva, Karina; Damiani, Lucas Petri; Romano, Edson; Carrara, Fernanda; Lubarino Diniz de Souza, Juliana; Silva, Aline Reis; Ramos, Grazielle Viana; Teixeira, Cassiano; Brandão da Silva, Nilton; Chang, Chung-Chou H; Angus, Derek C; Berwanger, Otavio

2016-04-12

The effectiveness of checklists, daily goal assessments, and clinician prompts as quality improvement interventions in intensive care units (ICUs) is uncertain. To determine whether a multifaceted quality improvement intervention reduces the mortality of critically ill adults. This study had 2 phases. Phase 1 was an observational study to assess baseline data on work climate, care processes, and clinical outcomes, conducted between August 2013 and March 2014 in 118 Brazilian ICUs. Phase 2 was a cluster randomized trial conducted between April and November 2014 with the same ICUs. The first 60 admissions of longer than 48 hours per ICU were enrolled in each phase. Intensive care units were randomized to a quality improvement intervention, including a daily checklist and goal setting during multidisciplinary rounds with follow-up clinician prompting for 11 care processes, or to routine care. In-hospital mortality truncated at 60 days (primary outcome) was analyzed using a random-effects logistic regression model, adjusted for patients' severity and the ICU's baseline standardized mortality ratio. Exploratory secondary outcomes included adherence to care processes, safety climate, and clinical events. A total of 6877 patients (mean age, 59.7 years; 3218 [46.8%] women) were enrolled in the baseline (observational) phase and 6761 (mean age, 59.6 years; 3098 [45.8%] women) in the randomized phase, with 3327 patients enrolled in ICUs (n = 59) assigned to the intervention group and 3434 patients in ICUs (n = 59) assigned to routine care. There was no significant difference in in-hospital mortality between the intervention group and the usual care group, with 1096 deaths (32.9%) and 1196 deaths (34.8%), respectively (odds ratio, 1.02; 95% CI, 0.82-1.26; P = .88). Among 20 prespecified secondary outcomes not adjusted for multiple comparisons, 6 were significantly improved in the intervention group (use of low tidal volumes, avoidance of heavy sedation, use of central venous catheters, use of urinary catheters, perception of team work, and perception of patient safety climate), whereas there were no significant differences between the intervention group and the control group for 14 outcomes (ICU mortality, central line-associated bloodstream infection, ventilator-associated pneumonia, urinary tract infection, mean ventilator-free days, mean ICU length of stay, mean hospital length of stay, bed elevation to ≥30°, venous thromboembolism prophylaxis, diet administration, job satisfaction, stress reduction, perception of management, and perception of working conditions). Among critically ill patients treated in ICUs in Brazil, implementation of a multifaceted quality improvement intervention with daily checklists, goal setting, and clinician prompting did not reduce in-hospital mortality. clinicaltrials.gov Identifier: NCT01785966.

The effects of a rhythm and music-based therapy program and therapeutic riding in late recovery phase following stroke: a study protocol for a three-armed randomized controlled trial

PubMed Central

2012-01-01

Background Stroke represents one of the most costly and long-term disabling conditions in adulthood worldwide and there is a need to determine the effectiveness of rehabilitation programs in the late phase after stroke. Limited scientific support exists for training incorporating rhythm and music as well as therapeutic riding and well-designed trials to determine the effectiveness of these treatment modalities are warranted. Methods/Design A single blinded three-armed randomized controlled trial is described with the aim to evaluate whether it is possible to improve the overall health status and functioning of individuals in the late phase of stroke (1-5 years after stroke) through a rhythm and music-based therapy program or therapeutic riding. About 120 individuals will be consecutively and randomly allocated to one of three groups: (T1) rhythm and music-based therapy program; (T2) therapeutic riding; or (T3) control group receiving the T1 training program a year later. Evaluation is conducted prior to and after the 12-week long intervention as well as three and six months later. The evaluation comprises a comprehensive functional and cognitive assessment (both qualitative and quantitative), and questionnaires. Based on the International classification of functioning, disability, and health (ICF), the outcome measures are classified into six comprehensive domains, with participation as the primary outcome measure assessed by the Stroke Impact Scale (SIS, version 2.0.). The secondary outcome measures are grouped within the following domains: body function, activity, environmental factors and personal factors. Life satisfaction and health related quality of life constitute an additional domain. Current status A total of 84 participants were randomised and have completed the intervention. Recruitment proceeds and follow-up is on-going, trial results are expected in early 2014. Discussion This study will ascertain whether any of the two intervention programs can improve overall health status and functioning in the late phase of stroke. A positive outcome would increase the scientific basis for the use of such interventions in the late phase after stroke. Trial registration Clinical Trials.gov Identifier: NCT01372059 PMID:23171380

The effects of a rhythm and music-based therapy program and therapeutic riding in late recovery phase following stroke: a study protocol for a three-armed randomized controlled trial.

PubMed

Bunketorp Käll, Lina; Lundgren-Nilsson, Åsa; Blomstrand, Christian; Pekna, Marcela; Pekny, Milos; Nilsson, Michael

2012-11-21

Stroke represents one of the most costly and long-term disabling conditions in adulthood worldwide and there is a need to determine the effectiveness of rehabilitation programs in the late phase after stroke. Limited scientific support exists for training incorporating rhythm and music as well as therapeutic riding and well-designed trials to determine the effectiveness of these treatment modalities are warranted. A single blinded three-armed randomized controlled trial is described with the aim to evaluate whether it is possible to improve the overall health status and functioning of individuals in the late phase of stroke (1-5 years after stroke) through a rhythm and music-based therapy program or therapeutic riding. About 120 individuals will be consecutively and randomly allocated to one of three groups: (T1) rhythm and music-based therapy program; (T2) therapeutic riding; or (T3) control group receiving the T1 training program a year later. Evaluation is conducted prior to and after the 12-week long intervention as well as three and six months later. The evaluation comprises a comprehensive functional and cognitive assessment (both qualitative and quantitative), and questionnaires. Based on the International classification of functioning, disability, and health (ICF), the outcome measures are classified into six comprehensive domains, with participation as the primary outcome measure assessed by the Stroke Impact Scale (SIS, version 2.0.). The secondary outcome measures are grouped within the following domains: body function, activity, environmental factors and personal factors. Life satisfaction and health related quality of life constitute an additional domain. A total of 84 participants were randomised and have completed the intervention. Recruitment proceeds and follow-up is on-going, trial results are expected in early 2014. This study will ascertain whether any of the two intervention programs can improve overall health status and functioning in the late phase of stroke. A positive outcome would increase the scientific basis for the use of such interventions in the late phase after stroke. Clinical Trials.gov Identifier: NCT01372059.

Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

PubMed Central

2011-01-01

Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous), Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs. Trial Registration ACTRN12611000164998 PMID:21718543

Does abdominal massage improve gastrointestinal functions of intensive care patients with an endotracheal tube?: A randomized clinical trial.

PubMed

Dehghan, Mahlagha; Fatehi Poor, Amanollah; Mehdipoor, Roghayeh; Ahmadinejad, Mehdi

2018-02-01

Gastrointestinal dysfunction is one of the most common problems among patients hospitalized in intensive care units. Currently, medicinal and non-medicinal methods are being used to prevent gastrointestinal problems. Among non-medicinal methods, abdominal massage is considered as a relatively acceptable method. The present study aims to examine the effect of abdominal massage on gastrointestinal functions of the intensive care patients with an endotracheal tube. In this clinical trial, 70 intensive care patients with an endotracheal tube were chosen by convenience sampling and allocated to an intervention or a control group randomly. In the intervention group, a 15-min abdominal massage was conducted twice a day for three days, while the control group received only routine cares. The abdominal circumference, gastric residual volume, times of defecation, and frequency of constipation were measured. Gastric residual volume decreased significantly in the intervention group and increased significantly in the control group; however, there was no significant difference between two groups (P = .15). There was a significant difference between two groups regarding abdominal circumference and it was decreased in the intervention group (P < .001). The defecation times significantly increased in the intervention group (P = .002). After the intervention, the prevalence of constipation was significantly decreased in the intervention group (P = .008). The results revealed that abdominal massage could improve gastrointestinal functions in enterally fed patients with an endotracheal tube. It is suggested to use abdominal massage as an adjunct therapy for improving gastrointestinal functions in intensive care patients. Copyright © 2018 Elsevier Ltd. All rights reserved.

Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial.

PubMed

Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Griffiths, Mark D

2017-02-01

The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first-generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. A RCT employing intent-to-treat analysis. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. Statement of contribution What is already known on this subject? Designing interventions to treat fibromyalgia syndrome (FMS) continues to be a challenge. There is growing interest into the applications of mindfulness-based interventions for treating FMS. Second-generation mindfulness-based interventions (SG-MBIs) are a key new direction in mindfulness research. What does this study add? Meditation awareness training - an SG-MBI - resulted in significant reductions in FMS symptomatology. SG-MBIs recognize the spiritual aspect of mindfulness and may have a role in the treatment of FMS. © 2016 The British Psychological Society.

Translating evidence-based interventions for implementation: Experiences from Project HEAL in African American churches.

PubMed

Holt, Cheryl L; Tagai, Erin K; Scheirer, Mary Ann; Santos, Sherie Lou Z; Bowie, Janice; Haider, Muhiuddin; Slade, Jimmie L; Wang, Min Qi; Whitehead, Tony

2014-05-31

Community-based approaches have been increasing in the effort to raise awareness and early detection for cancer and other chronic disease. However, many times, such interventions are tested in randomized trials, become evidence-based, and then fail to reach further use in the community. Project HEAL (Health through Early Awareness and Learning) is an implementation trial that aims to compare two strategies of implementing evidence-based cancer communication interventions in African American faith-based organizations. This article describes the community-engaged process of transforming three evidence-based cancer communication interventions into a coherent, branded strategy for training community health advisors with two delivery mechanisms. Peer community health advisors receive training through either a traditional classroom approach (with high technical assistance/support) or a web-based training portal (with low technical assistance/support). We describe the process, outline the intervention components, report on the pilot test, and conclude with lessons learned from each of these phases. Though the pilot phase showed feasibility, it resulted in modifications to data collection protocols and team and community member roles and expectations. Project HEAL offers a promising strategy to implement evidence-based interventions in community settings through the use of technology. There could be wider implications for chronic disease prevention and control.

Effects of exercise and horticultural intervention on the brain and mental health in older adults with depressive symptoms and memory problems: study protocol for a randomized controlled trial [UMIN000018547].

PubMed

Makizako, Hyuma; Tsutsumimoto, Kota; Doi, Takehiko; Hotta, Ryo; Nakakubo, Sho; Liu-Ambrose, Teresa; Shimada, Hiroyuki

2015-11-04

Depressive symptoms and memory problems are significant risk factors for dementia. Exercise can reduce depressive symptoms and improve cognitive function in older people. In addition, the benefits of horticultural activity on physical and mental well-being have been demonstrated in people with dementia. Although evidence of such non-pharmacological interventions is mounting, no studies have examined whether physical exercise and horticultural activity exert a positive impact on brain and mental health (e.g., depressive symptoms) in non-demented older adults at high risk of cognitive impairment and depression. Therefore, we propose a randomized controlled trial to assess the efficacy and efficiency of physical exercise and horticultural activity in improving brain and mental health in community-dwelling older adults with memory problems and depressive symptoms. The 20-week randomized controlled trial will include 90 community-dwelling adults aged 65 years or older with memory problems and depressive symptoms. Participants will be randomized to one of three experiments: exercise, horticultural activity, or educational control group, using a 1:1:1 allocation ratio. The combined exercise program and horticultural activity program will consist of 20 weekly 90-minute sessions. Participants in the exercise group will practice aerobic exercise, muscle strength training, postural balance retraining, and dual-task training. The horticultural activity program will include crop-related activities, such as field cultivation, growing, and harvesting. Participants in the educational control group will attend two 90-minute educational classes during the 6-month trial period. Depressive symptoms and memory performance will be measured by the Geriatric Depression Scale-15, and the Logical Memory subtests of the Wechsler Memory Scale-Revised will be used to measure depressive symptoms and memory performance as primary outcomes, at baseline (prior to randomization), immediately following intervention (6 months from baseline), and 6 months after intervention. Hippocampal volume will be measured at baseline and immediately after intervention, using magnetic resonance imaging. Secondary outcomes will comprise cognitive function, including language, attention/executive performance, and processing speed; brain-derived neurotrophic-factor serum levels; and health-related quality of life. This intervention study will determine the clinical importance and efficacy of physical exercise and horticultural activity as non-pharmacological interventions in community-dwelling older adults at high risk of poor brain and mental health. UMIN000018547 ; registered 7 August 2015.

The effects of the one-step replica symmetry breaking on the Sherrington-Kirkpatrick spin glass model in the presence of random field with a joint Gaussian probability density function for the exchange interactions and random fields

NASA Astrophysics Data System (ADS)

Hadjiagapiou, Ioannis A.; Velonakis, Ioannis N.

2018-07-01

The Sherrington-Kirkpatrick Ising spin glass model, in the presence of a random magnetic field, is investigated within the framework of the one-step replica symmetry breaking. The two random variables (exchange integral interaction Jij and random magnetic field hi) are drawn from a joint Gaussian probability density function characterized by a correlation coefficient ρ, assuming positive and negative values. The thermodynamic properties, the three different phase diagrams and system's parameters are computed with respect to the natural parameters of the joint Gaussian probability density function at non-zero and zero temperatures. The low temperature negative entropy controversy, a result of the replica symmetry approach, has been partly remedied in the current study, leading to a less negative result. In addition, the present system possesses two successive spin glass phase transitions with characteristic temperatures.

Effect of just-in-time simulation training on tracheal intubation procedure safety in the pediatric intensive care unit.

PubMed

Nishisaki, Akira; Donoghue, Aaron J; Colborn, Shawn; Watson, Christine; Meyer, Andrew; Brown, Calvin A; Helfaer, Mark A; Walls, Ron M; Nadkarni, Vinay M

2010-07-01

Tracheal intubation-associated events (TIAEs) are common (20%) and life threatening (4%) in pediatric intensive care units. Physician trainees are required to learn tracheal intubation during intensive care unit rotations. The authors hypothesized that "just-in-time" simulation-based intubation refresher training would improve resident participation, success, and decrease TIAEs. For 14 months, one of two on-call residents, nurses, and respiratory therapists received 20-min multidisciplinary simulation-based tracheal intubation training and 10-min resident skill refresher training at the beginning of their on-call period in addition to routine residency education. The rate of first attempt and overall success between refresher-trained and concurrent non-refresher-trained residents (controls) during the intervention phase was compared. The incidence of TIAEs between preintervention and intervention phase was also compared. Four hundred one consecutive primary orotracheal intubations were evaluated: 220 preintervention and 181 intervention. During intervention phase, neither first-attempt success nor overall success rate differed between refresher-trained residents versus concurrent non-refresher-trained residents: 20 of 40 (50%) versus 15 of 24 (62.5%), P = 0.44 and 23 of 40 (57.5%) versus 18 of 24 (75.0%), P = 0.19, respectively. The resident's first attempt and overall success rate did not differ between preintervention and intervention phases. The incidence of TIAE during preintervention and intervention phases was similar: 22.0% preintervention versus 19.9% intervention, P = 0.62, whereas resident participation increased from 20.9% preintervention to 35.4% intervention, P = 0.002. Resident participation continued to be associated with TIAE even after adjusting for the phase and difficult airway condition: odds ratio 2.22 (95% CI 1.28-3.87, P = 0.005). Brief just-in-time multidisciplinary simulation-based intubation refresher training did not improve the resident's first attempt or overall tracheal intubation success.

The Effect of Foot Reflexology on Anxiety, Pain, and Outcomes of the Labor in Primigravida Women.

PubMed

Moghimi-Hanjani, Soheila; Mehdizadeh-Tourzani, Zahra; Shoghi, Mahnaz

2015-08-01

Reflexology is a technique used widely as one of non-pharmacological pain management techniques. The present study aimed to review and determine the effect of foot reflexology on anxiety, pain and outcomes of the labor in primigravida women. This clinical trial study was conducted on 80 primigravida mothers who were divided randomly into an intervention group (Foot reflexology applied for 40 min, n=40) and control group (n=40). The pain intensity was scored immediately after the end of intervention and at 30,60 and 120 min after the intervention in both groups, based on McGill Questionnaire for Pain Rating Index (PRI). Spielberger State-Trait Anxiety Inventory (STAI) was completed before and after intervention in both groups. Duration of labor phases, the type of labor and Apgar scores of the infant at the first and fifth minute were recorded in both groups. Descriptive and inferential statistics methods (t-test and chi-square test) were applied in analyzing data. Application of reflexology technique decreased pain intensity (at 30, 60 and 120 min after intervention) and duration of labor as well as anxiety level significantly (P<0.001). Furthermore, a significant difference was observed between two groups in terms of the frequency distribution of the type of labor and Apgar score (P<0.001). Results of this study show that reflexology reduces labor pain intensity, duration of labor, anxiety, frequency distribution of natural delivery and increases Apgar scores. Using this non-invasive technique, obstetricians can achieve, to some extent, to one of the most important goals of midwifery as pain relief and reducing anxiety during labor and encourage the mothers to have a vaginal delivery.

A double-blind randomized discontinuation phase II study of sorafenib (BAY 43-9006) in previously treated non-small cell lung cancer patients: Eastern Cooperative Oncology Group study E2501

PubMed Central

Wakelee, Heather A.; Lee, Ju-Whei; Hanna, Nasser H.; Traynor, Anne M.; Carbone, David P.; Schiller, Joan H.

2012-01-01

Introduction Sorafenib is a raf kinase and angiogenesis inhibitor with activity in multiple cancers. This phase II study in heavily pretreated non-small cell lung cancer (NSCLC) patients (≥ two prior therapies) utilized a randomized discontinuation design. Methods Patients received 400 mg of sorafenib orally twice daily for two cycles (two months) (Step 1). Responding patients on Step 1 continued on sorafenib; progressing patients went off study, and patients with stable disease were randomized to placebo or sorafenib (Step 2), with crossover from placebo allowed upon progression. The primary endpoint of this study was the proportion of patients having stable or responding disease two months after randomization. Results : There were 299 patients evaluated for Step 1 with 81 eligible patients randomized on Step 2 who received sorafenib (n=50) or placebo (n=31). The two-month disease control rates following randomization were 54% and 23% for patients initially receiving sorafenib and placebo respectively, p=0.005. The hazard ratio for progression on Step 2 was 0.51 (95% CI 0.30, 0.87, p=0.014) favoring sorafenib. A trend in favor of overall survival with sorafenib was also observed (13.7 versus 9.0 months from time of randomization), HR 0.67 (95% CI 0.40-1.11), p=0.117. A dispensing error occurred which resulted in unblinding of some patients, but not before completion of the 8 week initial step 2 therapy. Toxicities were manageable and as expected. Conclusions : The results of this randomized discontinuation trial suggest that sorafenib has single agent activity in a heavily pretreated, enriched patient population with advanced NSCLC. These results support further investigation with sorafenib as a single agent in larger, randomized studies in NSCLC. PMID:22982658

Interictal to Ictal Phase Transition in a Small-World Network

NASA Astrophysics Data System (ADS)

Nemzer, Louis; Cravens, Gary; Worth, Robert

Real-time detection and prediction of seizures in patients with epilepsy is essential for rapid intervention. Here, we perform a full Hodgkin-Huxley calculation using n 50 in silico neurons configured in a small-world network topology to generate simulated EEG signals. The connectivity matrix, constructed using a Watts-Strogatz algorithm, admits randomized or deterministic entries. We find that situations corresponding to interictal (non-seizure) and ictal (seizure) states are separated by a phase transition that can be influenced by congenital channelopathies, anticonvulsant drugs, and connectome plasticity. The interictal phase exhibits scale-free phenomena, as characterized by a power law form of the spectral power density, while the ictal state suffers from pathological synchronization. We compare the results with intracranial EEG data and show how these findings may be used to detect or even predict seizure onset. Along with the balance of excitatory and inhibitory factors, the network topology plays a large role in determining the overall characteristics of brain activity. We have developed a new platform for testing the conditions that contribute to the phase transition between non-seizure and seizure states.

The talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction.

PubMed

Melchart, Dieter; Doerfler, Wolfgang; Eustachi, Axel; Wellenhofer-Li, Yanqing; Weidenhammer, Wolfgang

2015-01-01

Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome 'change of body weight after 12 months' is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors 'group', 'baseline value' and 'study centre'. Secondary outcomes will be analyzed exploratively. The monitoring of the study will implement different measures to enhance compliance, avoid attrition and ensure data quality. Based on a blended learning concept and using web-based e-health tools the program promises to achieve sustainable effects in weight reduction. German Clinical Trials Register Freiburg (DRKS): DRKS00006736 (date registered 20/09/2014).

Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial.

PubMed

Giguere, Anik M C; Lawani, Moulikatou Adouni; Fortier-Brochu, Émilie; Carmichael, Pierre-Hugues; Légaré, France; Kröger, Edeltraut; Witteman, Holly O; Voyer, Philippe; Caron, Danielle; Rodríguez, Charo

2018-06-25

The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare providers empower seniors and their caregivers in making health-related decisions. In two phases, we will: (1) design and tailor the intervention; and (2) implement and evaluate it. We will use theory and user-centered design to tailor an intervention comprising a distance professional training program on shared decision-making and five shared decision-making tools dealing with difficult decisions often faced by seniors with dementia and their caregivers. Each tool will be designed in two versions, one for clinicians and one for patients. We will recruit 49 clinicians and 27 senior/caregiver to participate in three cycles of design-evaluation-feedback of each intervention components. Besides think-aloud and interview approaches, users will also complete questionnaires based on the Theory of Planned Behavior to identify the factors most likely to influence their adoption of shared decision-making after exposure to the intervention. We will then modify the intervention by adding/enhancing behavior-change techniques targeting these factors. We will evaluate the effectiveness of this tailored intervention before/after implementation, in a two-armed, clustered randomized trial. We will enroll a convenience sample of six primary care clinics (unit of randomization) in the province of Quebec and recruit the clinicians who practice there (mostly family physicians, nurses, and social workers). These clinics will then be randomized to immediate exposure to the intervention or delayed exposure. Overall, we will recruit 180 seniors with dementia, their caregivers, and their healthcare providers. We will evaluate the impact of the intervention on patient involvement in the decision-making process, decisional comfort, patient and caregiver personal empowerment in relation to their own healthcare, patient quality of life, caregiver burden, and decisional regret. The intervention will empower patients and their caregivers in their healthcare, by fostering their participation as partners during the decision-making process and by ensuring they make informed decisions congruent with their values and priorities. ClinicalTrials.org, NCT02956694 . Registered on 31 October 2016.

Remediation of social communication impairments following traumatic brain injury using metacognitive strategy intervention: a pilot study.

PubMed

Finch, Emma; Cornwell, Petrea; Copley, Anna; Doig, Emmah; Fleming, Jennifer

2017-01-01

To perform a pilot study to evaluate whether a novel metacognitive, goal-based intervention improved and maintained the social communication skills of adults with traumatic brain injury (TBI). Eight community-dwelling participants with TBI completed three study phases: (1) baseline, (2) eight-week intervention targeting social communication impairments and (3) follow-up. Participants completed the Profile of Pragmatic Impairment in Communication (PPIC), LaTrobe Communication Questionnaire (LCQ) and Goal Attainment Scaling (GAS) at the commencement of baseline phase, pre- and post-intervention and completion of the follow-up phase. During the intervention programme phase, participants attended two 1-hour therapy sessions (one individual; one group) per week focusing on remediating impaired social communication skills using metacognitive strategy intervention and goal-based therapy. Variable changes in PPIC feature-summary scores were observed post-intervention. A non-significant improvement in LCQ scores was also observed. There was a significant increase in GAS goal T-scores following the intervention, with six of the eight participants achieving or exceeding their expected level of performance on all goals. A goal-driven, metacognitive approach to intervention may assist individuals with TBI to achieve their personal social communication goals, with benefits reported by participants and observable during conversations. Further research is required.

Comparing Intervention Strategies among Rural, Low SES, Young Adult Tobacco Users

ERIC Educational Resources Information Center

Zanis, David A.; Hollm, Ronald E.; Derr, Daniel; Ibrahim, Jennifer K.; Collins, Bradley N.; Coviello, Donna; Melochick, Jennifer Ryan

2011-01-01

Objective: To evaluate 3-month tobacco quit rates of young adult tobacco users randomized to 2 intervention conditions. Methods: Overall 192 non-treatment-seeking 18-to-24-year-old tobacco users received educational information and advice to quit smoking. Participants were then block randomized to 2 brief intervention conditions: (1) a telephone…

Checklists of Methodological Issues for Review Authors to Consider When Including Non-Randomized Studies in Systematic Reviews

ERIC Educational Resources Information Center

Wells, George A.; Shea, Beverley; Higgins, Julian P. T.; Sterne, Jonathan; Tugwell, Peter; Reeves, Barnaby C.

2013-01-01

Background: There is increasing interest from review authors about including non-randomized studies (NRS) in their systematic reviews of health care interventions. This series from the Ottawa Non-Randomized Studies Workshop consists of six papers identifying methodological issues when doing this. Aim: To format the guidance from the preceding…

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

PubMed Central

Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K

2007-01-01

Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups. Discussion The goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs. Trial registration NCT00243919. PMID:17996052

Integrating nutrition and early child-development interventions among infants and preschoolers in rural India.

PubMed

Fernandez-Rao, Sylvia; Hurley, Kristen M; Nair, Krishnapillai Madhavan; Balakrishna, Nagalla; Radhakrishna, Kankipati V; Ravinder, Punjal; Tilton, Nicholas; Harding, Kimberly B; Reinhart, Greg A; Black, Maureen M

2014-01-01

This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. The preschool phase is a cluster-randomized trial conducted in Anganwadi centers (AWCs), government-run preschools sponsored by the Integrated Child Development System of India. AWCs are randomized into MNP or placebo, with the MNP or placebo mixed into the children's food. The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries. © 2013 New York Academy of Sciences.

A randomized community trial of enhanced family planning outreach in Rakai, Uganda.

PubMed

Lutalo, Tom; Kigozi, Godfrey; Kimera, Edward; Serwadda, David; Wawer, Maria J; Zabin, Laurie Schwab; Gray, Ronald H

2010-03-01

A randomized community trial of a family planning outreach program was conducted in Rakai District, Uganda. Five communities received standard services; six intervention communities received additional family planning information, counseling, and contraceptive methods from government service providers and community-based volunteer agents using social marketing and other strategies. Condom use was promoted in all of the communities. The community-based family planning outreach program was implemented in two phases--1999-2000 (early) and 2001(late)--and its impact was evaluated by means of population surveys in 2002-03. At follow-up, hormonal contraceptive prevalence was 23 percent in the intervention communities, compared with 20 percent in the control communities. The differential was greater in the early-intervention communities than the late-intervention communities. Pregnancy rates at follow-up were 15 percent in the control and 13 percent in the intervention communities. No differentials in condom use were found between study arms. Family planning outreach via social marketing can significantly increase hormonal contraceptive use and decrease pregnancy rates, but the impact of this outreach program was modest.

A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

PubMed Central

Hegg, Roberto; Mattar, André; de Matos, João Nunes; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht; Cramer, Renato Peixoto; van-Eyll-Rocha, Sylvie

2016-01-01

OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®). PMID:27759847

Use of Mobile Phone Technology to Improve follow-up at a Community Mental Health Clinic: A Randomized Control Trial.

PubMed

Singh, Gaurav; Manjunatha, Narayana; Rao, Sabina; Shashidhara, H N; Moirangthem, Sydney; Madegowda, Rajendra K; Binukumar, B; Varghese, Mathew

2017-01-01

Mobile phone technology is being used worldwide to improve follow-ups in health care. Aim of the study is to evaluate whether the use of mobile technology will improve or not the follow-up of Indian patients from a community mental health center. Patients or caregivers having mobile phones and consenting for study were enrolled, and sociodemographic and clinical details of patients were taken. Participants were randomized into two groups (short message service [SMS] vs. non-SMS group). At first intervention level, a SMS was sent to SMS group (not in non-SMS group) 1 day before their appointment. At second-level intervention (voice call level), patients from both groups who missed their first appointment were given a voice call requesting them to come for follow-up, and the reasons for first missed appointments (MA) were also elicited. The effect of these two intervention levels (first SMS for SMS group and next voice calls for both groups) on follow-up was evaluated. A total of 214 patients were enrolled in the study. At first SMS intervention level of SMS group ( n = 106), 62.26% of participants reached appointment-on-time (RA), while in the non-SMS/as usual group ( n = 108), 45.37% of patients RA. The difference of these groups is statistically significant. At second-level intervention (voice call), 66 of 88 (another 15 were unable to contact) were came for follow-up consultation within 2 days of MA. Distance and diagnosis of alcohol dependence were significantly associated with MA. Social reasons were most common reasons for first MA. The use of mobile phone technology in an outpatient community psychiatric clinic improved follow-up significantly.

A randomized trial of enhanced HIV risk reduction and vaccine trial education interventions among HIV-negative, high-risk women who use non-injection drugs: The UNITY Study

PubMed Central

Koblin, Beryl A.; Bonner, Sebastian; Hoover, Donald R.; Xu, Guozhen; Lucy, Debbie; Fortin, Princess; Putnam, Sara; Latka, Mary H.

2014-01-01

Background Limited data are available on interventions to reduce sexual risk behaviors and increase knowledge of HIV vaccine trial concepts in high risk populations eligible to participate in HIV vaccine efficacy trials. Methods The UNITY Study was a two-arm randomized trial to determine the efficacy of enhanced HIV risk reduction and vaccine trial education interventions to reduce the occurrence of unprotected vaginal sex acts and increase HIV vaccine trial knowledge among 311 HIV-negative non-injection drug using women. The enhanced vaccine education intervention using pictures along with application vignettes and enhanced risk reduction counseling consisting of three one-on-one counseling sessions were compared to standard conditions. Follow-up visits at one week and one, six and twelve months after randomization included HIV testing and assessment of outcomes. Results During follow up, the percent of women reporting sexual risk behaviors declined significantly, but did not differ significantly by study arm. Knowledge of HIV vaccine trial concepts significantly increased but did not significantly differ by study arm. Concepts about HIV vaccine trials not adequately addressed by either condition included those related to testing a vaccine for both efficacy and safety, guarantees about participation in future vaccine trials, assurances of safety, medical care, and assumptions about any protective effect of a test vaccine. Conclusions Further research is needed to boost educational efforts and strengthen risk reduction counseling among high-risk non-injection drug using women. PMID:20190585

Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India.

PubMed

Dave, Paresh Vamanrao; Shah, Amar Niranjan; Nimavat, Pankaj B; Modi, Bhavesh B; Pujara, Kirit R; Patel, Pradip; Mehariya, Keshabhai; Rade, Kiran Vaman; Shekar, Soma; Sachdeva, Kuldeep S; Oeltmann, John E; Kumar, Ajay M V

2016-01-01

The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June-September 2012. We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child's DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%. Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively. DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success. Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229.

Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India

PubMed Central

Modi, Bhavesh B.; Pujara, Kirit R.; Patel, Pradip; Mehariya, Keshabhai; Rade, Kiran Vaman; Shekar, Soma; Sachdeva, Kuldeep S.; Oeltmann, John E.; Kumar, Ajay M. V.

2016-01-01

Background The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June–September 2012. Methods We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child’s DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%. Results Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively. Conclusion DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success. Trial Registration Clinical Trials Registry–India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229 PMID:26849442

A pragmatic randomized controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial.

PubMed

Daley, A J; Blamey, R V; Jolly, K; Roalfe, A K; Turner, K M; Coleman, S; McGuinness, M; Jones, I; Sharp, D J; MacArthur, C

2015-08-01

Postnatal depression affects about 10-15% of women in the year after giving birth. Many women and healthcare professionals would like an effective and accessible non-pharmacological treatment for postnatal depression. Women who fulfilled the International Classification of Diseases (ICD)-10 criteria for major depression in the first 6 months postnatally were randomized to receive usual care plus a facilitated exercise intervention or usual care only. The intervention involved two face-to-face consultations and two telephone support calls with a physical activity facilitator over 6 months to support participants to engage in regular exercise. The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at 6 months post-randomization. Secondary outcomes included EPDS score as a binary variable (recovered and improved) at 6 and 12 months post-randomization. A total of 146 women were potentially eligible and 94 were randomized. Of these, 34% reported thoughts of self-harming at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group [95% confidence interval (CI) -4.11 to 0.03, p = 0.05]. When also adjusting for pre-specified demographic variables the effect was larger and statistically significant (mean difference = -2.26, 95% CI -4.36 to -0.16, p = 0.03). Based on EPDS score a larger proportion of the intervention group was recovered (46.5% v. 23.8%, p = 0.03) compared with usual care at 6 months follow-up. This trial shows that an exercise intervention that involved encouragement to exercise and to seek out social support to exercise may be an effective treatment for women with postnatal depression, including those with thoughts of self-harming.

Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial.

PubMed

Fowler, Eileen G; Knutson, Loretta M; Demuth, Sharon K; Siebert, Kara L; Simms, Victoria D; Sugi, Mia H; Souza, Richard B; Karim, Roksana; Azen, Stanley P

2010-03-01

Effective interventions to improve and maintain strength (force-generating capacity) and endurance are needed for children with cerebral palsy (CP). This study was performed to examine the effects of a stationary cycling intervention on muscle strength, locomotor endurance, preferred walking speed, and gross motor function in children with spastic diplegic CP. This was a phase I randomized controlled trial with single blinding. The interventions were performed in community-based outpatient physical therapy clinics. Outcome assessments were performed in university laboratories. Sixty-two ambulatory children aged 7 to 18 years with spastic diplegic CP and Gross Motor Function Classification System levels I to III participated in this study. Participants were randomly assigned to cycling or control (no-intervention) groups. Thirty intervention sessions occurred over 12 weeks. Primary outcomes were peak knee extensor and flexor moments, the 600-Yard Walk-Run Test, the Thirty-Second Walk Test, and the Gross Motor Function Measure sections D and E (GMFM-66). Significant baseline-postintervention improvements were found for the 600-Yard Walk-Run Test, the GMFM-66, peak knee extensor moments at 120 degrees /s, and peak knee flexor moments at 30 degrees /s for the cycling group. Improved peak knee flexor moments at 120 degrees/s were found for the control group only, although not all participants could complete this speed of testing. Significant differences between the cycling and control groups based on change scores were not found for any outcomes. Limitations Heterogeneity of the patient population and intrasubject variability were limitations of the study. Significant improvements in locomotor endurance, gross motor function, and some measures of strength were found for the cycling group but not the control group, providing preliminary support for this intervention. As statistical differences were not found in baseline-postintervention change scores between the 2 groups; the results did not demonstrate that stationary cycling was more effective than no intervention. The results of this phase I study provide guidance for future research.

Randomized trial of a question prompt list to increase patient active participation during interactions with black patients and their oncologists.

PubMed

Eggly, Susan; Hamel, Lauren M; Foster, Tanina S; Albrecht, Terrance L; Chapman, Robert; Harper, Felicity W K; Thompson, Hayley; Griggs, Jennifer J; Gonzalez, Richard; Berry-Bobovski, Lisa; Tkatch, Rifky; Simon, Michael; Shields, Anthony; Gadgeel, Shirish; Loutfi, Randa; Ali, Haythem; Wollner, Ira; Penner, Louis A

2017-05-01

Communication during racially-discordant interactions is often of poor quality and may contribute to racial treatment disparities. We evaluated an intervention designed to increase patient active participation and other communication-related outcomes during interactions between Black patients and non-Black oncologists. Participants were 18 non-Black medical oncologists and 114 Black patients at two cancer hospitals in Detroit, Michigan, USA. Before a clinic visit to discuss treatment, patients were randomly assigned to usual care or to one of two question prompt list (QPL) formats: booklet (QPL-Only), or booklet and communication coach (QPL-plus-Coach). Patient-oncologist interactions were video recorded. Patients reported perceptions of the intervention, oncologist communication, role in treatment decisions, and trust in the oncologist. Observers assessed interaction length, patient active participation, and oncologist communication. The intervention was viewed positively and did not increase interaction length. The QPL-only format increased patient active participation; the QPL-plus-Coach format decreased patient perceptions of oncologist communication. No other significant effects were found. This QPL booklet is acceptable and increases patient active participation in racially-discordant oncology interactions. Future research should investigate whether adding physician-focused interventions might improve other outcomes. This QPL booklet is acceptable and can improve patient active participation in racially-discordant oncology interactions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Linking smokers to a quitline: randomized controlled effectiveness trial of a support person intervention that targets non-smokers

PubMed Central

Patten, Christi A.; Boyle, Raymond; Tinkelman, David; Brockman, Tabetha A.; Lukowski, Amy; Decker, Paul A.; D’Silva, Joanne; Lichtenstein, Edward; Zhu, Shu-Hong

2017-01-01

Abstract Evidence-based treatments (e.g. quitlines) are greatly underutilized by smokers limiting their public health impact. A three-session phone intervention for nonsmoking family members and friends (i.e. support persons) was successful for increasing smoker quitline enrollment. To enhance the intervention’s potential translatability, in this study, we delivered treatment for the non-smoker within ongoing quitline services and compared the efficacy of the three-call intervention to a streamlined version (one call). A total of 704 adult non-smokers (85% female, 95% White) wanting to help a smoker quit and recruited statewide in Minnesota participated in this randomized controlled trial with parallel groups. Non-smokers received mailed written materials and were randomly assigned to a control condition (no additional treatment, n = 235), or to a one- (n = 233) or three-call (n = 236) intervention delivered by quitline coaches. The main outcome was smoker quitline enrollment through 7-month follow-up. Smoker quitline enrollment was similar for those linked to non-smokers in the one- and three-call interventions (14.6% [34/233] and 14.8% [35/236]), and higher than for smokers linked to control participants (6.4% [15/235]), P = 0.006. Just one quitline coaching call delivered to non-smokers increased treatment enrollment among smokers. The reach of quitlines could be enhanced by targeting the social support network of smokers. PMID:28854569

Randomized controlled study of early medication change for non-improvers to antidepressant therapy in major depression--The EMC trial.

PubMed

Tadić, André; Wachtlin, Daniel; Berger, Mathias; Braus, Dieter F; van Calker, Dietrich; Dahmen, Norbert; Dreimüller, Nadine; Engel, Alice; Gorbulev, Stanislav; Helmreich, Isabella; Kaiser, Anne-Katrin; Kronfeld, Kai; Schlicht, Konrad F; Tüscher, Oliver; Wagner, Stefanie; Hiemke, Christoph; Lieb, Klaus

2016-04-01

Patients with Major Depressive Disorder (MDD) and no improvement after two weeks of antidepressant pharmacotherapy have a high risk of treatment failure. The aim of the study was to determine whether an early medication change (EMC) strategy is superior to a guideline-based treatment in MDD patients without improvement after two weeks of antidepressant pharmacotherapy. Eight-hundred-and-eighty-nine patients with MDD were enrolled, 879 patients received the SSRI escitalopram. Of those, 192 patients had no improvement, defined as a reduction of < 20% on the Hamilton Depression Rating Scale (HAMD-17) after 14 days of treatment, and were randomly assigned to open treatment with the EMC strategy (n = 97; venlafaxine XR for study days 15-56; in case of sustained non-improvement on day 28, lithium augmentation for days 29-56) or TAU (n = 95; escitalopram continuation; non-responders on day 28 were switched to venlafaxine XR for four weeks, i.e. days 29-56). The primary outcome was remission (HAMD-17 ≤ 7) after 8 weeks of treatment as assessed by blinded raters. Remission rates were 24% for EMC and 16% for TAU, which was not significantly different (p = 0.2056). Sensitivity analyses for the primary and secondary effectiveness endpoints consistently showed favorable results for patients randomized to EMC. The results confirm data from post-hoc analyses of clinical trials showing that early non-improvement identifies patients who likely need alternate interventions. However, the herein used two-step switch/augmentation strategy for this risk group was not more effective than the control intervention. Alternate strategies and other design aspects are discussed in order to support researchers addressing the same research question. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial.

PubMed

Díaz-Gete, Laura; Puigdomènech, Elisa; Briones, Elena Mercedes; Fàbregas-Escurriola, Mireia; Fernandez, Soraya; Del Val, Jose Luis; Ballvé, Jose Luis; Casajuana, Marc; Sánchez-Fondevila, Jessica; Clemente, Lourdes; Castaño, Carmen; Martín-Cantera, Carlos

2013-04-18

Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Randomized Controlled Multicentric Trial. 1060 smokers aged between 18-70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Clinical Trials.gov Identifier: NCT01494246.

C-A1-01: Changes in Physical Activity and Nutrition in a Behavioral Intervention Pilot Study - Passport to Brain Wellness

PubMed Central

Hanson, Leah R; Martinson, Brian C; Sherwood, Nancy E; Crain, A Lauren; Hayes, Marcia G; O’Connor, Patrick J; Matthews, Rachel B; Cooner, Jacob M

2010-01-01

Background/Aims: Increasing concerns about cognitive decline and dementia in the aging populations of most westernized countries suggests the need for interventions that can preserve cognitive function, are cost-effective, and feasibly implemented on a large scale. Empirical evidence is accumulating that points to the potential beneficial effects of cardiovascular fitness, healthy diet, social integration and participation in cognitively stimulating activities in the maintenance of cognitive function. We have developed and pilot tested “Passport,” a multi-component, cognitive-behavioral, phone and mail based intervention to promote such lifestyle changes in older adults. Methods: Cognitively intact (TICS ≥ 31), sedentary (<90 min physical activity[PA] per week) adults aged 61–80 years were recruited from among HealthPartners’ members. Baseline assessments included cognitive function, biomarkers, lifestyle factors, and physical traits. In the first phase, 21 participants were recruited and all assigned (non-randomized) to receive a course book, pedometer, tool kit and 7 bi-weekly phone coaching calls. In the second phase, 42 participants were recruited and randomized to either the Guided Intervention (n=22) or a Self-Directed (n=20) group, who received the study materials but no coaching. We completed 6 month follow-up measures with 58 (92%) subjects, and report here on their PA and nutritional outcomes. Results: The 63 enrolled subjects were female (60%), 70 years old, highly educated (73% college or more), predominantly retired (81%), non-Hispanic White (71%;) and married (65%). On average, they were overweight, BMI M=29.8, normotensive, systolic BP M=122.8, and normocholesterolemic, total serum cholesterol M=189.3. Mixed-model analyses indicated a time*treatment group effect on objectively monitored MVPA (p<.05), with a significant increase in the guided group (7.3 to 16.5mins/day, p<.05). We observed a significant effect of time on saturated fat intake (p<.05), with a significant pre-post reduction among Guided participants (26.1 to 23.4 grams, p<.05). Similar patterns of effects were observed for intake of fruits, vegetables and dietary fiber. Finally, we observed a time effect on intake of fish high in omega-3 fatty acids, driven by an increase in the non-randomized group (p<.05). Conclusions: Passport shows promise for improving aspects of lifestyle behaviors hypothesized to be important for the primary prevention of cognitive decline in older adults.

Defining, Designing, Implementing, and Evaluating Phase 4 HIV Prevention Effectiveness Trials for Vulnerable Populations

PubMed Central

Kelly, Jeffrey A.; Spielberg, Freya; McAuliffe, Timothy L.

2008-01-01

Summary The efficacy of behavioral HIV prevention interventions has been convincingly demonstrated in a large number of randomized controlled phase 3 research outcome trials. Little research attention has been directed toward studying the effectiveness of the same interventions when delivered by providers to their own clients or community members, however. This article argues for the need to conduct phase 4 effectiveness trials of HIV prevention interventions that have been found efficacious in the research arena. Such trials can provide important information concerning the impact of interventions when applied in heterogeneous “real-world” circumstances. This article raises design issues and methodologic questions that need to be addressed in the conduct of phase 4 trials of behavioral interventions. These issues include the selection and training of service providers engaged in such trials, maintenance of fidelity to intervention protocol in provider-delivered interventions, determination of intervention core elements versus aspects that require tailoring, selection of relevant phase 4 study outcomes, interpretation of findings indicative of field effectiveness, sustainability, and other aspects of phase 4 trial design. PMID:18301131

The Parkin'Play study: protocol of a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease.

PubMed

van de Weijer, Sjors C F; Duits, Annelien A; Bloem, Bastiaan R; Kessels, Roy P; Jansen, Jacobus F A; Köhler, Sebastian; Tissingh, Gerrit; Kuijf, Mark L

2016-11-03

In Parkinson's disease (PD), cognitive impairment is an important non-motor symptom heralding the development of dementia. Effective treatments to slow down the rate of cognitive decline in PD patients with mild cognitive impairment are lacking. Here, we describe the design of the Parkin'Play study, which assesses the effects of a cognitive health game intervention on cognition in PD. This study is a multicentre, phase-II, open-randomized clinical trial that aims to recruit 222 PD patients with mild cognitive impairment. Eligible patients have PD, Hoehn & Yahr stages I-III, are aged between 40 and 75 years, and have cognitive impairment but no dementia. The intervention group (n = 111) will be trained using a web-based health game targeting multiple cognitive domains. The control group (n = 111) will be placed on a waiting list. In order to increase compliance the health game adapts to the subjects' performance, is enjoyable, and can be played at home. From each group, 20 patients will undergo fMRI to test for potential functional brain changes underlying treatment. The primary outcome after 12 weeks of training is cognitive function, as assessed by a standard neuropsychological assessment battery and an online cognitive assessment. The neuropsychological assessment battery covers the following domains: executive function, memory, visual perception, visuoconstruction and language. A compound score for overall cognitive function will be calculated as the mean score of all test Z-scores based on the distribution of scores for both groups taken together. Secondary outcomes at follow-up visits up to 24 weeks include various motor and non-motor symptoms, compliance, and biological endpoints (fMRI). This study aims at evaluating whether a cognitive intervention among PD patients leads to an increased cognitive performance on targeted domains. Strengths of this study are a unique web-based health game intervention, the large sample size, a control group without intervention and innovations designed to increase compliance. NTR5637 on 7-jan-2016.

Effects of a mobility monitoring system on the cost of care in relation to reimbursement at Swiss nursing homes: learnings from a randomized controlled trial.

PubMed

Stark, Mario; Tietz, Rigo; Gattinger, Heidrun; Hantikainen, Virpi; Ott, Stefan

2017-12-01

Nursing homes in Switzerland are under pressure to efficiently coordinate staff activities to cover their personnel costs under the care financing system. In this study, the use of a mobility monitoring system accompanied with case conferences was investigated in order to improve sleep quality and estimate the cost benefit of this intervention. In an open two-phase randomized controlled trial at three nursing homes, residents with cognitive impairment were randomly assigned to an intervention group and a control group. In the intervention group, a 10-week period of intensive use of the monitoring system and case conferences led by an advanced nurse practitioner (Phase I) was followed by 3 months of reduced use of the monitoring system and case conferences led by an internal registered nurse (Phase II). In the control group, the monitoring system was only used for data acquisition. Nurses reported the activities with a specifically developed tool. Based on the recorded activities, the cost of care was calculated. The correlating reimbursement per patient was calculated from the care levels in the Swiss reimbursement system. Data from 44 residents was included in the analysis with a linear mixed model. Although analysis revealed no statistically significant effects, results indicate that the use of a monitoring system can guide nurses in organizing their tasks to increase effectiveness. Information systems such as the mobility monitor can help to identify single outliers that do not correspond with the overall situation. In the health care system, problematic individual cases can account for a disproportionally high cost levels. It was shown that information systems can have a significant economic impact in the long run. The study is registered at the German Clinical Trials Register under the Nr. DRKS00006829 .

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

PubMed

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

PubMed Central

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

2014-01-01

Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to: (a) determining pressure ulcer incidence/severity, (b) randomization imbalance, and (c) inadvertent potential control group contamination. Limitations We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. Conclusions Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence as well as the ability to implement needed mid-course corrections. PMID:24577972

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

A randomized pilot study of a community-based weight loss intervention for African-American women: Rationale and study design of Doing Me! Sisters Standing Together for a Healthy Mind and Body.

PubMed

Springfield, Sparkle; Buscemi, Joanna; Fitzgibbon, Marian L; Stolley, Melinda R; Zenk, Shannon N; Schiffer, Linda; Sampson, Jameika; Jones, Quiana; Murdock, Tanine; Davis, Iona; Holland, Loys; Watkins, April; Odoms-Young, Angela

2015-07-01

Despite the high prevalence of obesity among African-American women and modest success in behavioral weight loss interventions, the development and testing of weight management interventions using a community-based participatory research (CBPR) approach have been limited. Doing Me!: Sisters Standing Together for Healthy Mind and Body (Doing Me!) is an intervention adapted from an evidence-based behavioral obesity intervention using a CBPR approach. The purpose of Doing Me! is to test the feasibility and acceptability of this adapted intervention and determine its efficacy in achieving improvements in anthropometrics, diet, and physical activity. Sixty African-American women, from a low-income, urban community, aged 30-65 years will be randomized to one of two arms: 16-week Doing Me! (n = 30) or waitlist control (n = 30). Doing Me! employs CBPR methodology to involve community stakeholders and members during the planning, development, implementation, and evaluation phases of the intervention. There will be thirty-two 90-minute sessions incorporating 45 min of instruction on diet, physical activity, and/or weight management plus 45 min of physical activity. Data will be collected at baseline and post-intervention (16 weeks). Doing Me! is one of the first CBPR studies to examine the feasibility/acceptability of an adapted evidence-based behavioral weight loss intervention designed for obese African-American women. CBPR may be an effective strategy for implementing a weight management intervention among this high-risk population. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-10-19

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

Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

PubMed

Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

2016-01-30

This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. Copyright © 2016. Published by Elsevier Ireland Ltd.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

PubMed Central

Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

2017-01-01

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

Rationale of the BREAst cancer e-healTH [BREATH] multicentre randomised controlled trial: An Internet-based self-management intervention to foster adjustment after curative breast cancer by decreasing distress and increasing empowerment

PubMed Central

2012-01-01

Background After completion of curative breast cancer treatment, patients go through a transition from patient to survivor. During this re-entry phase, patients are faced with a broad range of re-entry topics, concerning physical and emotional recovery, returning to work and fear of recurrence. Standard and easy-accessible care to facilitate this transition is lacking. In order to facilitate adjustment for all breast cancer patients after primary treatment, the BREATH intervention is aimed at 1) decreasing psychological distress, and 2) increasing empowerment, defined as patients’ intra- and interpersonal strengths. Methods/design The non-guided Internet-based self-management intervention is based on cognitive behavioural therapy techniques and covers four phases of recovery after breast cancer (Looking back; Emotional processing; Strengthening; Looking ahead). Each phase of the fully automated intervention has a fixed structure that targets consecutively psychoeducation, problems in everyday life, social environment, and empowerment. Working ingredients include Information (25 scripts), Assignment (48 tasks), Assessment (10 tests) and Video (39 clips extracted from recorded interviews). A non-blinded, multicentre randomised controlled, parallel-group, superiority trial will be conducted to evaluate the effectiveness of the BREATH intervention. In six hospitals in the Netherlands, a consecutive sample of 170 will be recruited of women who completed primary curative treatment for breast cancer within 4 months. Participants will be randomly allocated to receive either usual care or usual care plus access to the online BREATH intervention (1:1). Changes in self-report questionnaires from baseline to 4 (post-intervention), 6 and 10 months will be measured. Discussion The BREATH intervention provides a psychological self-management approach to the disease management of breast cancer survivors. Innovative is the use of patients’ own strengths as an explicit intervention target, which is hypothesized to serve as a buffer to prevent psychological distress in long-term survivorship. In case of proven (cost) effectiveness, the BREATH intervention can serve as a low-cost and easy-accessible intervention to facilitate emotional, physical and social recovery of all breast cancer survivors. Trial registration This study is registered at the Netherlands Trial Register (NTR2935) PMID:22958799

The process of developing and implementing a telephone-based peer support program for postpartum depression: evidence from two randomized controlled trials

PubMed Central

2014-01-01

Background A randomized controlled trial evaluated the effect of telephone-based peer support on preventing postpartum depression (PPD) among high-risk mothers. The results indicated that support provided by peer volunteers may be an effective preventative strategy. The purpose of this paper is to outline the process of developing, implementing, maintaining, and evaluating the peer support program that we used in this PPD prevention trial. Methods The peer support program had been used successfully in a pilot trial and a previous breastfeeding peer support trial. Based on our experience and lessons learned, we developed a 4-phase, 12-step approach so that the peer support model could be copied and used by different health providers in various settings. We will use the PPD prevention trial to demonstrate the suggested steps. Results The trial aim to prevent the onset of PPD was established. Peer volunteers who previously experienced and recovered from self-reported PPD were recruited and attended a four-hour training session. Volunteers were screened and those identified as appropriate to provide support to postpartum mothers were selected. Women who scored more than 9 on the Edinburgh Postnatal Depression Scale within the first two weeks after childbirth were recruited to participate in the trial and proactive, individualized, telephone-based peer support (mother-to-mother) was provided to those randomized to the intervention group. Peer volunteers maintained the intervention, supported other volunteers, and evaluated the telephone-based support program. Possible negative effects of the intervention were assessed. An in-depth assessment of maternal perspectives of the program at 12 weeks postpartum was performed. Conclusions The 4-phase, 12-step approach delineated in this paper provides clear and concise guidelines for health professionals to follow in creating and implementing community-based, peer-support interventions with the potential to prevent PPD. Trial registration Current Controlled Trials ISRCTN68337727. PMID:24742217

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

Effect of Nutrients, Dietary Supplements and Vitamins on Cognition: a Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Forbes, Scott C.; Holroyd-Leduc, Jayna M.; Poulin, Marc J.; Hogan, David B.

2015-01-01

Background Observational studies have suggested that various nutrients, dietary supplements, and vitamins may delay the onset of age-associated cognitive decline and dementia. We systematically reviewed recent randomized controlled trials investigating the effect of nutritional interventions on cognitive performance in older non-demented adults. Methods We searched MEDLINE, CINAHL, Embase, and the Cochrane Library for articles published between 2003 and 2013. We included randomized trials of ≥ 3 months’ duration that examined the cognitive effects of a nutritional intervention in non-demented adults > 40 years of age. Meta-analyses were done when sufficient trials were available. Results Twenty-four trials met inclusion criteria (six omega-3 fatty acids, seven B vitamins, three vitamin E, eight other interventions). In the meta-analyses, omega-3 fatty acids showed no significant effect on Mini-Mental State Examination (MMSE) scores (four trials, mean difference 0.06, 95% CI −0.08 – 0.19) or digit span forward (three trials, mean difference −0.02, 95% CI −0.30 – 0.25), while B vitamins showed no significant effect on MMSE scores (three trials, mean difference 0.02, 95% CI −0.22 – 0.25). None of the vitamin E studies reported significant effects on cognitive outcomes. Among the other nutritional interventions, statistically significant differences between the intervention and control groups on at least one cognitive domain were found in single studies of green tea extract, Concord grape juice, chromium picolinate, beta-carotene, two different combinations of multiple vitamins, and a dietary approach developed for the control of hypertension. Conclusions Omega-3 fatty acids, B vitamins, and vitamin E supplementation did not affect cognition in non-demented middle-aged and older adults. Other nutritional interventions require further evaluation before their use can be advocated for the prevention of age-associated cognitive decline and dementia. PMID:26740832

Emergence of superconductivity and magnetic ordering tuned by Fe-vacancy in alkali-metal Fe chalcogenides RbxFe2-ySe2

NASA Astrophysics Data System (ADS)

Kobayashi, Yoshiaki; Kototani, Shouhei; Itoh, Masayuki; Sato, Masatoshi

2014-12-01

Samples of RbxFe2-ySe2 exhibiting superconductivity [superconducting (SC) samples] undergo a phase-separation into two phases, a Fe-vacancy ordered phase with antiferromagnetic (AFM) transition at TN1~500 K (AFM1 phase) and a phase with little Fe- vacancy and SC transition at Tc~30 K (SC phase). The samples of RbxFe2-ySe2 exhibiting no SC behaviour (non-SC samples) are phase-separated into three phases, the AFM1 phase, another AFM phase with TN2 ~150 K (AFM2 phase), and a paramagnetic phase with no SC transitions (paramagnetic non-SC phase). In this paper, we present the experimental results of magnetic susceptibility, electrical resistivity, and NMR measurements on single crystals of RbxFe2-ySe2 to reveal physical properties of these co-existing phases in the SC and non-SC samples. The 87Rb and 77Se NMR spectra show that the Fe vacancy concentration is very small in the Fe planes of the SC phase, whereas the AFM2 and paramagnetic non-SC phases in non-SC samples have larger amount of Fe vacancies. The randomness induced by the Fe vacancy in the non-SC samples makes the AFM2 and paramagnetic non-SC phases insulating/semiconducting and magnetically active, resulting in the absence of the superconductivity in RbxFe2-ySe2.

Psychological adjustment and levels of self esteem in children with visual-motor integration difficulties influences the results of a randomized intervention trial.

PubMed

Lahav, Orit; Apter, Alan; Ratzon, Navah Z

2013-01-01

This study evaluates how much the effects of intervention programs are influenced by pre-existing psychological adjustment and self-esteem levels in kindergarten and first grade children with poor visual-motor integration skills, from low socioeconomic backgrounds. One hundred and sixteen mainstream kindergarten and first-grade children, from low socioeconomic backgrounds, scoring below the 25th percentile on a measure of visual-motor integration (VMI) were recruited and randomly divided into two parallel intervention groups. One intervention group received directive visual-motor intervention (DVMI), while the second intervention group received a non-directive supportive intervention (NDSI). Tests were administered to evaluate visual-motor integration skills outcome. Children with higher baseline measures of psychological adjustment and self-esteem responded better in NDSI while children with lower baseline performance on psychological adjustment and self-esteem responded better in DVMI. This study suggests that children from low socioeconomic backgrounds with low VMI performance scores will benefit more from intervention programs if clinicians choose the type of intervention according to baseline psychological adjustment and self-esteem measures. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effects of treadmill training with load addition on non-paretic lower limb on gait parameters after stroke: A randomized controlled clinical trial.

PubMed

Ribeiro, Tatiana S; Silva, Emília M G S; Silva, Isaíra A P; Costa, Mayara F P; Cavalcanti, Fabrícia A C; Lindquist, Ana R

2017-05-01

The addition of load on the non-paretic lower limb for the purpose of restraining this limb and stimulating the use of the paretic limb has been suggested to improve hemiparetic gait. However, the results are conflicting and only short-term effects have been observed. This study aims to investigate the effects of adding load on non-paretic lower limb during treadmill gait training as a multisession intervention on kinematic gait parameters after stroke. With this aim, 38 subacute stroke patients (mean time since stroke: 4.5 months) were randomly divided into two groups: treadmill training with load (equivalent to 5% of body weight) on the non-paretic ankle (experimental group) and treadmill training without load (control group). Both groups performed treadmill training during 30min per day, for two consecutive weeks (nine sessions). Spatiotemporal and angular gait parameters were assessed by a motion system analysis at baseline, post-training (at the end of 9days of interventions) and follow-up (40days after the end of interventions). Several post-training effects were demonstrated: patients walked faster and with longer paretic and non-paretic steps compared to baseline, and maintained these gains at follow-up. In addition, patients exhibited greater hip and knee joint excursion in both limbs at post-training, while maintaining most of these benefits at follow-up. All these improvements were observed in both groups. Although the proposal gait training program has provided better gait parameters for these subacute stroke patients, our data indicate that load addition used as a restraint may not provide additional benefits to gait training. Copyright © 2017 Elsevier B.V. All rights reserved.

The long-term effects of a primary care physical activity intervention on mental health in low-active, community-dwelling older adults.

PubMed

Patel, Asmita; Keogh, Justin W L; Kolt, Gregory S; Schofield, Grant M

2013-01-01

To examine the effect that physical activity delivered via two different versions of the Green Prescription (a primary care physical activity scripting program) had on depressive symptomatology and general mental health functioning over a 12-month period in non-depressed, low-active, community-dwelling older adults. Two hundred and twenty-five participants from the Healthy Steps study took part in the present study. Healthy Steps participants were randomized to receive either the standard time-based or a modified pedometer-based Green Prescription. Depression, mental health functioning and physical activity were measured at baseline, post-intervention (3 months post-baseline) and at the 9-month follow-up period. At post-intervention, a positive association was found between increases in leisure-time physical activity and total walking physical activity and a decrease in depressive symptomatology (within the non-depressed range of the GDS-15) and an increase in perceived mental health functioning, regardless of intervention allocation. These improvements were also evident at the follow-up period for participants in both intervention allocation groups. Our findings suggest that the standard time-based Green Prescription and a modified pedometer-based Green Prescription are both effective in maintaining and improving mental health in non-depressed, previously low-active older adults.

A randomized controlled trial with bright light and melatonin for delayed sleep phase disorder: effects on subjective and objective sleep.

PubMed

Saxvig, Ingvild West; Wilhelmsen-Langeland, Ane; Pallesen, Ståle; Vedaa, Oystein; Nordhus, Inger Hilde; Bjorvatn, Bjørn

2014-02-01

Delayed sleep phase disorder (DSPD) is assumed to be common amongst adolescents, with potentially severe consequences in terms of school attendance and daytime functioning. The most common treatment approaches for DSPD are based on the administration of bright light and/or exogenous melatonin with or without adjunct behavioural instructions. Much is generally known about the chronobiological effects of light and melatonin. However, placebo-controlled treatment studies for DSPD are scarce, in particular in adolescents and young adults, and no standardized guidelines exist regarding treatment. The aim of the present study was, therefore, to investigate the short- and long-term effects on sleep of a DSPD treatment protocol involving administration of timed bright light and melatonin alongside gradual advancement of rise time in adolescents and young adults with DSPD in a randomized controlled trial and an open label follow-up study. A total of 40 adolescents and young adults (age range 16-25 years) diagnosed with DSPD were recruited to participate in the study. The participants were randomized to receive treatment for two weeks in one of four treatment conditions: dim light and placebo capsules, bright light and placebo capsules, dim light and melatonin capsules or bright light and melatonin capsules. In a follow-up study, participants were re-randomized to either receive treatment with the combination of bright light and melatonin or no treatment in an open label trial for approximately three months. Light and capsules were administered alongside gradual advancement of rise times. The main end points were sleep as assessed by sleep diaries and actigraphy recordings and circadian phase as assessed by salivary dim light melatonin onset (DLMO). During the two-week intervention, the timing of sleep and DLMO was advanced in all treatment conditions as seen by about 1 h advance of bed time, 2 h advance of rise time and 2 h advance of DLMO in all four groups. Sleep duration was reduced with approximately 1 h. At three-month follow-up, only the treatment group had maintained an advanced sleep phase. Sleep duration had returned to baseline levels in both groups. In conclusion, gradual advancement of rise time produced a phase advance during the two-week intervention, irrespective of treatment condition. Termination of treatment caused relapse into delayed sleep times, whereas long-term treatment with bright light and melatonin (three months) allowed maintenance of the advanced sleep phase.

EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

PubMed

Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

2017-02-01

Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.

PubMed

Hirai, Kei; Ishikawa, Yoshiki; Fukuyoshi, Jun; Yonekura, Akio; Harada, Kazuhiro; Shibuya, Daisuke; Yamamoto, Seiichiro; Mizota, Yuri; Hamashima, Chisato; Saito, Hiroshi

2016-05-24

The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program. After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder. There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control. A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent population. UMIN Clinical Trials Registry UMIN000004384 . Date of Registration: March 2011.

Treatment of sentence comprehension and production in aphasia: is there cross-modal generalisation?

PubMed

Adelt, Anne; Hanne, Sandra; Stadie, Nicole

2016-09-09

Exploring generalisation following treatment of language deficits in aphasia can provide insights into the functional relation of the cognitive processing systems involved. In the present study, we first review treatment outcomes of interventions targeting sentence processing deficits and, second report a treatment study examining the occurrence of practice effects and generalisation in sentence comprehension and production. In order to explore the potential linkage between processing systems involved in comprehending and producing sentences, we investigated whether improvements generalise within (i.e., uni-modal generalisation in comprehension or in production) and/or across modalities (i.e., cross-modal generalisation from comprehension to production or vice versa). Two individuals with aphasia displaying co-occurring deficits in sentence comprehension and production were trained on complex, non-canonical sentences in both modalities. Two evidence-based treatment protocols were applied in a crossover intervention study with sequence of treatment phases being randomly allocated. Both participants benefited significantly from treatment, leading to uni-modal generalisation in both comprehension and production. However, cross-modal generalisation did not occur. The magnitude of uni-modal generalisation in sentence production was related to participants' sentence comprehension performance prior to treatment. These findings support the assumption of modality-specific sub-systems for sentence comprehension and production, being linked uni-directionally from comprehension to production.

The PEDALS Stationary Cycling Intervention and Health-Related Quality of Life in Children with Cerebral Palsy: A Randomized Controlled Trial

ERIC Educational Resources Information Center

DeMuth, Sharon K.; Knutson, Loretta M.; Fowler, Eileen G.

2012-01-01

Aim: The aim of this study was to assess health-related quality of life (HRQOL) following a stationary cycling intervention in children with cerebral palsy (CP). Method: This was a phase I multisite randomized controlled trial with single blinding. HRQOL was evaluated using the Pediatric Quality of Life Inventory SF15 (PedsQL; children) and…

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Methods/design Randomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18–70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. Discussion The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Trial Registration Clinical Trials.gov Identifier: NCT01494246. PMID:23597262

Extra virgin olive oil phenols and markers of oxidation in Greek smokers: a randomized cross-over study.

PubMed

Moschandreas, J; Vissers, M N; Wiseman, S; van Putte, K P; Kafatos, A

2002-10-01

To examine the effect of a low phenol olive oil and high phenol olive oil on markers of oxidation and plasma susceptibility to oxidation in normolipaemic smokers. Randomized single-blind cross-over trial with two intervention periods. The Medical School and University Hospital of the University of Crete, Heraklion, Crete, Greece. Twenty-five healthy males and females completed the study. Each intervention was of three weeks duration and intervention periods were separated by a two week washout. Seventy grams of extra virgin olive oil was supplied to each subject per day in the intervention periods. The olive oils supplied differed in their phenol content by 18.6 mg/day. Two fasting venous blood samples were taken at the end of each intervention period. The markers of antioxidant capacity measured in fasting plasma samples (total plasma resistance to oxidation, concentrations of protein carbonyl as a marker of protein oxidation, malondialdehyde and lipid hydroperoxides as markers of lipid oxidation and the ferric reducing ability of plasma) did not differ significantly between the low and high phenol olive oil diets. No effect of olive oil phenols on markers of oxidation in smokers was detected. It may be that the natural concentrations of phenols in olive oil are too low to produce an effect in the post-absorptive phase. Possible reasons for period effects and interactions between diet and administration period need attention to aid further cross-over trials of this kind. Unilever Research Vlaardingen, The Netherlands.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock

PubMed Central

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-01-01

Abstract Introduction: Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. Methods and analysis: It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect. PMID:29419665

Evaluation of physical activity interventions in children via the reach, efficacy/effectiveness, adoption, implementation, and maintenance (RE-AIM) framework: A systematic review of randomized and non-randomized trials.

PubMed

McGoey, Tara; Root, Zach; Bruner, Mark W; Law, Barbi

2016-01-01

Existing reviews of physical activity (PA) interventions designed to increase PA behavior exclusively in children (ages 5 to 11years) focus primarily on the efficacy (e.g., internal validity) of the interventions without addressing the applicability of the results in terms of generalizability and translatability (e.g., external validity). This review used the RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, Maintenance) framework to measure the degree to which randomized and non-randomized PA interventions in children report on internal and external validity factors. A systematic search for controlled interventions conducted within the past 12years identified 78 studies that met the inclusion criteria. Based on the RE-AIM criteria, most of the studies focused on elements of internal validity (e.g., sample size, intervention location and efficacy/effectiveness) with minimal reporting of external validity indicators (e.g., representativeness of participants, start-up costs, protocol fidelity and sustainability). Results of this RE-AIM review emphasize the need for future PA interventions in children to report on real-world challenges and limitations, and to highlight considerations for translating evidence-based results into health promotion practice. Copyright © 2015 Elsevier Inc. All rights reserved.

The Shared Decision Making Frontier: a Feasibility and Usability Study for Managing Non-Critical Chronic Illness by Combining Behavioural & Decision Theory with Online Technology.

PubMed

Russell, Amina; Van Woensel, William; Abidi, Samina Raza

2015-01-01

The objective of this study is to determine if shared decisions for managing non-critical chronic illness, made through an online biomedical technology intervention, us feasible and usable. The technology intervention incorporates behavioural and decision theories to increase patient engagement, and ultimately long term adherence to health behaviour change. We devised the iheart web intervention as a "proof of concept" in five phases. The implementation incorporates the Vaadin web application framework, Drools, EclipseLink and a MySQL database. Two-thirds of the study participants favoured the technology intervention, based on Likert-scale questions from a post-study questionnaire. Qualitative analysis of think aloud feedback, video screen captures and open-ended questions from the post-study questionnaire uncovered six main areas or themes for improvement. We conclude that online shared decisions for managing a non-critical chronic illness are feasible and usable through the iheart web intervention.

Martensitic phase transformations in the nanostructured surface layers induced by mechanical attrition treatment

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

Ni Zhichun; Wang Xiaowei; Wu Erdong

2005-12-01

Conversion electron Moessbauer spectroscopy (CEMS) and x-ray diffraction (XRD) analysis have been used to investigate the relationship between characteristics of phase transformation and the treatment time in surface nanocrystallized 316L stainless steel induced by surface mechanical attrition treatment (SMAT). A similar trend of development of the martensitic phase upon the treatment time has been observed from both CEMS and XRD measurements. However, in the CEMS measurement, two types of martensite phase with different magnetic hyperfine fields are revealed. Based on a random distribution of the non-iron coordinating atoms, a three-element theoretical model is developed to illustrate the difference of twomore » types of martensite phase. The calculated results indicate the segregation of the non-iron atoms associated with SMAT treatment.« less

Early functional outcome of two different orthotic concepts in ankle sprains: a randomized controlled trial.

PubMed

Best, Raymond; Böhle, Caroline; Schiffer, Thorsten; Petersen, Wolf; Ellermann, Andree; Brueggemann, Gert Peter; Liebau, Christian

2015-07-01

Purpose of the study was the evaluation of the early functional outcome of patients with an acute ankle sprain treated either with a semirigid, variable, phase-adapted modular ankle orthosis or an invariable orthotic reference device. Forty-seven patients with acute ankle sprain grade II or more were included. In addition, 77 healthy controls as a reference were investigated. The injured subjects were treated with one of the two devices by random for 6 weeks. Ankle scores (FAOS, AOFAS) were taken at baseline after injury, 1 and 3 months after injury. Functional performance tests (balance platform, zig zag run, shuttle run, vertical drop jump) were performed at 1 and 3 months after injury. No significant score differences could be found between the two intervention groups except for achieving a preinjury activity level after 3 months only in the modular orthosis group. Postural functional performances (balance test) also showed no significant differences whereas the results of the agility tests revealed small but significant better results in the modular orthosis group in comparison to the invariable orthosis group. Cohen's effect sizes were high. Differences between the two intervention groups were marginal and very small but significant and--regarding Cohen's effect sizes--effective. Especially relating to functional performance, this might be a careful indication that a more effective strategy for promoting a protected, rapid recovery to physical activity after ankle sprains might be achieved by applying a phase-adapted ankle orthosis. Especially in athletic patients, phase-adapted orthosis should be further investigated and considered to ensure fully protected ligament healing as well as to regain early functional recovery.

What's in a name? The challenge of describing interventions in systematic reviews: analysis of a random sample of reviews of non-pharmacological stroke interventions

PubMed Central

Hoffmann, Tammy C; Walker, Marion F; Langhorne, Peter; Eames, Sally; Thomas, Emma; Glasziou, Paul

2015-01-01

Objective To assess, in a sample of systematic reviews of non-pharmacological interventions, the completeness of intervention reporting, identify the most frequently missing elements, and assess review authors’ use of and beliefs about providing intervention information. Design Analysis of a random sample of systematic reviews of non-pharmacological stroke interventions; online survey of review authors. Data sources and study selection The Cochrane Library and PubMed were searched for potentially eligible systematic reviews and a random sample of these assessed for eligibility until 60 (30 Cochrane, 30 non-Cochrane) eligible reviews were identified. Data collection In each review, the completeness of the intervention description in each eligible trial (n=568) was assessed by 2 independent raters using the Template for Intervention Description and Replication (TIDieR) checklist. All review authors (n=46) were invited to complete a survey. Results Most reviews were missing intervention information for the majority of items. The most incompletely described items were: modifications, fidelity, materials, procedure and tailoring (missing from all interventions in 97%, 90%, 88%, 83% and 83% of reviews, respectively). Items that scored better, but were still incomplete for the majority of reviews, were: ‘when and how much’ (in 31% of reviews, adequate for all trials; in 57% of reviews, adequate for some trials); intervention mode (in 22% of reviews, adequate for all trials; in 38%, adequate for some trials); and location (in 19% of reviews, adequate for all trials). Of the 33 (71%) authors who responded, 58% reported having further intervention information but not including it, and 70% tried to obtain information. Conclusions Most focus on intervention reporting has been directed at trials. Poor intervention reporting in stroke systematic reviews is prevalent, compounded by poor trial reporting. Without adequate intervention descriptions, the conduct, usability and interpretation of reviews are restricted and therefore, require action by trialists, systematic reviewers, peer reviewers and editors. PMID:26576811

Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

PubMed

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-04-01

Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

Randomized controlled trials in children’s heart surgery in the 21st century: a systematic review

PubMed Central

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-01-01

Abstract OBJECTIVES Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. METHODS We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. RESULTS We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). CONCLUSIONS The recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice. PMID:29186478

Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial.

PubMed

Melchart, Dieter; Löw, Peter; Wühr, Erich; Kehl, Victoria; Weidenhammer, Wolfgang

2017-01-01

Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year. A total of 166 subjects with a body mass index of 28-35 kg/m 2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline. With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference ( P <0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

PubMed

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

Time-varying SMART design and data analysis methods for evaluating adaptive intervention effects.

PubMed

Dai, Tianjiao; Shete, Sanjay

2016-08-30

In a standard two-stage SMART design, the intermediate response to the first-stage intervention is measured at a fixed time point for all participants. Subsequently, responders and non-responders are re-randomized and the final outcome of interest is measured at the end of the study. To reduce the side effects and costs associated with first-stage interventions in a SMART design, we proposed a novel time-varying SMART design in which individuals are re-randomized to the second-stage interventions as soon as a pre-fixed intermediate response is observed. With this strategy, the duration of the first-stage intervention will vary. We developed a time-varying mixed effects model and a joint model that allows for modeling the outcomes of interest (intermediate and final) and the random durations of the first-stage interventions simultaneously. The joint model borrows strength from the survival sub-model in which the duration of the first-stage intervention (i.e., time to response to the first-stage intervention) is modeled. We performed a simulation study to evaluate the statistical properties of these models. Our simulation results showed that the two modeling approaches were both able to provide good estimations of the means of the final outcomes of all the embedded interventions in a SMART. However, the joint modeling approach was more accurate for estimating the coefficients of first-stage interventions and time of the intervention. We conclude that the joint modeling approach provides more accurate parameter estimates and a higher estimated coverage probability than the single time-varying mixed effects model, and we recommend the joint model for analyzing data generated from time-varying SMART designs. In addition, we showed that the proposed time-varying SMART design is cost-efficient and equally effective in selecting the optimal embedded adaptive intervention as the standard SMART design.

Cardiovascular risk factors in multi-ethnic middle school students: the HEALTHY primary prevention trial.

PubMed

Willi, S M; Hirst, K; Jago, R; Buse, J; Kaufman, F; El Ghormli, L; Bassin, S; Elliot, D; Hale, D E

2012-06-01

The objective of this study was to examine the effects of an integrated, multi-component, school-based intervention programme on cardiovascular disease (CVD) risk factors among a multi-ethnic cohort of middle school students. HEALTHY was a cluster randomized, controlled, primary prevention trial. Middle school was the unit of randomization and intervention. Half of the schools were assigned to an intervention programme consisting of changes in the total school food environment and physical education classes, enhanced by educational outreach and behaviour change activities and promoted by a social marketing campaign consisting of reinforcing messages and images. Outcome data reported (anthropometrics, blood pressure and fasting lipid levels) were collected on a cohort of students enrolled at the start of 6th grade (∼11-12 years old) and followed to end of 8th grade (∼13-14 years old). Forty-two middle schools were enrolled at seven field centres; 4363 students provided both informed consent and CVD data at baseline and end of study. The sample was 52.7% female, 54.5% Hispanic, 17.6% non-Hispanic Black, 19.4% non-Hispanic White and 8.5% other racial/ethnic combinations, and 49.6% were categorized as overweight or obese (body mass index ≥ 85th percentile) at baseline. A significant intervention effect was detected in the prevalence of hypertension in non-Hispanic Black and White males. The intervention produced no significant changes in lipid levels. The prevalence of some CVD risk factors is high in minority middle school youth, particularly males. A multi-component, school-based programme achieved only modest reductions in these risk factors; however, promising findings occurred in non-Hispanic Black and White males with hypertension. © 2012 The Authors. Pediatric Obesity © 2012 International Association for the Study of Obesity.

Condensation with two constraints and disorder

NASA Astrophysics Data System (ADS)

Barré, J.; Mangeolle, L.

2018-04-01

We consider a set of positive random variables obeying two additive constraints, a linear and a quadratic one; these constraints mimic the conservation laws of a dynamical system. In the simplest setting, without disorder, it is known that such a system may undergo a ‘condensation’ transition, whereby one random variable becomes much larger than the others; this transition has been related to the spontaneous appearance of non linear localized excitations in certain nonlinear chains, called breathers. Motivated by the study of breathers in a disordered discrete nonlinear Schrödinger equation, we study different instances of this problem in presence of a quenched disorder. Unless the disorder is too strong, the phase diagram looks like the one without disorder, with a transition separating a fluid phase, where all variables have the same order of magnitude, and a condensed phase, where one variable is much larger than the others. We then show that the condensed phase exhibits various degrees of ‘intermediate symmetry breaking’: the site hosting the condensate is chosen neither uniformly at random, nor is it fixed by the disorder realization. Throughout the article, our heuristic arguments are complemented with direct Monte Carlo simulations.

Meditation and blood pressure: a meta-analysis of randomized clinical trials.

PubMed

Shi, Lu; Zhang, Donglan; Wang, Liang; Zhuang, Junyang; Cook, Rebecca; Chen, Liwei

2017-04-01

We meta-analyzed the effect of meditation on blood pressure (BP), including both transcendental meditation and non-transcendental meditation interventions. We identified randomized controlled trials (RCTs) that examined the BP responses to meditation interventions through a systematic literature search of the PubMed, ABI/INFORM, MEDLINE, EMBASE, PsycINFO, and CINAHL databases (from January 1980 to October 2015). We meta-analyzed the change in SBP and DBP, stratified by type of meditation (transcendental meditation vs. non-transcendental meditation intervention) and by type of BP measurement [ambulatory BP monitoring (ABPM) vs. non-ABPM measurement]. Nineteen studies met the eligibility criteria. Among the studies using the ABPM measurement, the pooled SBP effect estimate was -2.49 mmHg [95% confidence interval (CI): -7.51, 2.53] for transcendental meditation intervention (statistically insignificant) and -3.77 mmHg (95% CI: -5.33, -2.21) for non-transcendental meditation interventions, whereas the pooled DBP effect estimate was -4.26 mmHg (95% CI: -6.21, -2.31) for transcendental meditation interventions and -2.18 mmHg (95% CI: -4.28, -0.09) for non-transcendental meditation interventions. Among the studies using the non-ABPM measurement, the pooled SBP effect estimate from transcendental meditation interventions was -5.57 mmHg (95% CI: -7.41, -3.73) and was -5.09 mmHg with non-transcendental meditation intervention (95% CI: -6.34, -3.85), whereas the pooled effect size in DBP change for transcendental meditation interventions was -2.86 mmHg (95% CI: -4.27, -1.44) and was -2.57 mmHg (95% CI: -3.36, -1.79) for non-transcendental meditation interventions. Non-transcendental meditation may serve as a promising alternative approach for lowering both SBP and DBP. More ABPM-measured transcendental meditation interventions might be needed to examine the benefit of transcendental meditation intervention on SBP reduction.

Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors.

PubMed

Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

2013-02-01

This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER), as compared to a matched-contact control intervention targeting physical activity (MoveMore). Both 5-week interventions included two interactive group sessions and three support telephone calls. Executing a patient-centered developmental process, the primary aim of this paper was to evaluate patient feedback on intervention content and structure. The secondary aim was to understand the potential reach (i.e., proportion enrolled, representativeness) and effectiveness (i.e. health behaviors, theorized mediating variables, quality of life) of SipSmartER. Twenty-five participants were randomized to SipSmartER (n=14) or MoveMore (n=11). Participants' intervention feedback was positive, ranging from 4.2-5.0 on a 5-point scale. Qualitative assessments reavealed several opportunties to improve clarity of learning materials, enhance instructions and communication, and refine research protocols. Although SSB consumption decreased more among the SipSmartER participants (-256.9 ± 622.6 kcals), there were no significant group differences when compared to control participants (-199.7 ± 404.6 kcals). Across both groups, there were significant improvements for SSB attitudes, SSB behavioral intentions, and two media literacy constructs. The value of using a patient-centered approach in the developmental phases of this intervention was apparent, and pilot findings suggest decreased SSB may be achieved through targeted health literacy and TPB strategies. Future efforts are needed to examine the potential public health impact of a large-scale trial to address health literacy and reduce SSB.

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers.

PubMed

Liu, Yu-Hsiang; Chang, Mei-Yueh; Chen, Chung-Hey

2010-04-01

The purpose of the study was to investigate the effects of music on pain reaction and anxiety during labour. Music therapy has been used on clinical medicine. Only few scientific studies validate the value on labour women. Randomised controlled trial. Sixty primiparas expected to have a normal spontaneous delivery were randomly assigned to either the experimental group (n = 30) or the control group (n = 30). The experimental group received routine care and music therapy, whereas the control group received routine care only. A self-report visual analogue scale for pain and a nurse-rated present behavioural intensity were used to measure labour pain. Anxiety was measured with a visual analogue scale for anxiety and finger temperature. Pain and anxiety between groups were compared during the latent phase (2-4 cm cervical dilation) and active phase (5-7 cm) separately. Our results revealed that compared with the control group, the experimental group had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labour. However, no significant differences were found between the two groups on all outcome measures during the active phase. This study provides evidence for the use of music as an empirically based intervention of women for labour pain and anxiety during the latent phase of labour. The findings support that music listening is an acceptable and non-medical coping strategy for labouring women. Especially, apply in reducing the pain and anxiety for women who are at the early phase of labour.

A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS study

PubMed Central

Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupomé, Gerardo; Ritenbaugh, Cheryl

2012-01-01

Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches. PMID:23001689

Nurse Home Visits Improve Maternal-Infant Interaction and Decrease Severity of Postpartum Depression

PubMed Central

Horowitz, June Andrews; Murphy, Christine A.; Gregory, Katherine; Wojcik, Joanne; Pulcini, Joyce; Solon, Lori

2013-01-01

Objective To test the efficacy of the relationship-focused behavioral coaching intervention Communicating and Relating Effectively (CARE) in increasing maternal-infant relational effectiveness between depressed mothers and their infants during the first nine months postpartum. Design Randomized clinical trial (RCT) with three phases. Methods In this three-phase study, women were screened for postpartum depression (PPD) in Phase I at 6 weeks postpartum. In Phase II, women were randomly assigned to treatment or control conditions and maternal-infant interaction was video-recorded at four intervals postpartum: 6 weeks, 3 months, 6 months, and 9 months. Phase III involved focus group and individual interviews with study participants. Setting Phase I mothers were recruited from obstetric units of two major medical centers. Phase II involved the RCT, a series of nurse-led home visits beginning at 6 weeks and ending at 9 months postpartum. Phase III focus groups were conducted at the university and personal interviews were conducted by telephone or in participants’ homes. Participants Postpartum mother-infant dyads (134) representative of southeastern New England, United States participated in the RCT. One hundred and twenty-five mother-infant dyads were fully retained in the 9-month protocol. Results Treatment and control groups had significant increases in quality of mother-infant interaction and decreases in depression severity. Qualitative findings indicated presence of the nurse, empathic listening, focused attention and self-reflection during data collection, directions for video-recorded interaction, and assistance with referrals likely contributed to improvements for both groups. Conclusions Efficacy of the CARE intervention was only partially supported. Nurse attention given to the control group and the data collection process likely confounded results and constituted an unintentional treatment. Results suggest that nurse-led home visits had a positive effect on outcomes for all participants. PMID:23682696

Embedded academic writing support for nursing students with English as a second language.

PubMed

Salamonson, Yenna; Koch, Jane; Weaver, Roslyn; Everett, Bronwyn; Jackson, Debra

2010-02-01

This paper reports a study which evaluated a brief, embedded academic support workshop as a strategy for improving academic writing skills in first-year nursing students with low-to-medium English language proficiency. Nursing students who speak English as a second language have lower academic success compared with their native English-speaking counterparts. The development of academic writing skills is known to be most effective when embedded into discipline-specific curricula. Using a randomized controlled design, in 2008 106 students pre-enrolled in an introductory bioscience subject were randomized to receive either the intervention, a 4-day embedded academic learning support workshop facilitated by two bioscience (content) nursing academics and a writing and editing professional, or to act as the control group. The primary focus of the workshop was to support students to work through a mock assignment by providing progressive feedback and written suggestions on how to improve their answers. Of the 59 students randomized to the intervention, only 28 attended the workshop. Bioscience assignment results were analysed for those who attended (attendees), those randomized to the intervention but who did not attend (non-attendees), and the control group. Using anova, the results indicated that attendees achieved statistically significantly higher mean scores (70.8, sd: 6.1) compared to both control group (58.4, sd: 3.4, P = 0.002) and non-attendees (48.5, sd: 5.5, P = 0.001). A brief, intensive, embedded academic support workshop was effective in improving the academic writing ability of nursing students with low-to-medium English language proficiency, although reaching all students who are likely to benefit from this intervention remains a challenge.

Systematic review of interventions for children with Fetal Alcohol Spectrum Disorders

PubMed Central

Peadon, Elizabeth; Rhys-Jones, Biarta; Bower, Carol; Elliott, Elizabeth J

2009-01-01

Background Children with Fetal Alcohol Spectrum Disorders (FASD) may have significant neurobehavioural problems persisting into adulthood. Early diagnosis may decrease the risk of adverse life outcomes. However, little is known about effective interventions for children with FASD. Our aim is to conduct a systematic review of the literature to identify and evaluate the evidence for pharmacological and non-pharmacological interventions for children with FASD. Methods We did an electronic search of the Cochrane Library, MEDLINE, EMBASE, PsychINFO, CINAHL and ERIC for clinical studies (Randomized controlled trials (RCT), quasi RCT, controlled trials and pre- and post-intervention studies) which evaluated pharmacological, behavioural, speech therapy, occupational therapy, physiotherapy, psychosocial and educational interventions and early intervention programs. Participants were aged under 18 years with a diagnosis of a FASD. Selection of studies for inclusion and assessment of study quality was undertaken independently by two reviewers. Meta-analysis was not possible due to diversity in the interventions and outcome measures. Results Twelve studies met the inclusion criteria. Methodological weaknesses were common, including small sample sizes; inadequate study design and short term follow up. Pharmacological interventions, evaluated in two studies (both RCT) showed some benefit from stimulant medications. Educational and learning strategies (three RCT) were evaluated in seven studies. There was some evidence to suggest that virtual reality training, cognitive control therapy, language and literacy therapy, mathematics intervention and rehearsal training for memory may be beneficial strategies. Three studies evaluating social communication and behavioural strategies (two RCT) suggested that social skills training may improve social skills and behaviour at home and Attention Process Training may improve attention. Conclusion There is limited good quality evidence for specific interventions for managing FASD, however seven randomized controlled trials that address specific functional deficits of children with FASD are underway or recently completed. PMID:19463198

Comparison of Two Theory-Based, Fully Automated Telephone Interventions Designed to Maintain Dietary Change in Healthy Adults: Study Protocol of a Three-Arm Randomized Controlled Trial

PubMed Central

Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

2014-01-01

Background Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. Objective The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. Methods The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. Results Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). Conclusions This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. Trial Registration Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs). PMID:25387065

Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients.

PubMed

Russell, Cynthia; Conn, Vicki; Ashbaugh, Catherine; Madsen, Richard; Wakefield, Mark; Webb, Andrew; Coffey, Deanna; Peace, Leanne

2011-01-01

Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients, yet there is a paucity of studies testing interventions in this area. Using a randomized controlled trial design, 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring. Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management. The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person's life routines, important people, and possible solutions to enhance medication taking. The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring. The mean medication adherence score for the continuous self-improvement intervention group (n = 8) was statistically significantly higher than the attention control group's (n = 5) mean medication adherence score (p = 0.03). The continuous self-improvement intervention effect size (Cohen's d) was large at 1.4. Participants' perceptions of the intervention were highly favorable. The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients. A fully-powered study with a diverse sample is needed to confirm these preliminary findings. © 2010 John Wiley & Sons A/S.

Effectiveness of a school-community linked program on physical activity levels and health-related quality of life for adolescent girls

PubMed Central

2014-01-01

Background This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life (HRQoL; the primary outcome), physical activity (PA), and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings. Method The study was a cluster-randomized controlled trial. Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria; one of each pair was randomly assigned to the intervention or control condition. Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year (2011). Female students in grades 7–9 in intervention schools participated in two 6-session PA units – a sport unit (football or tennis) and a recreational unit (leisure centre-based). These were incorporated into physical education (PE) curriculum and linked to PA opportunities for participation outside school. Students were surveyed at baseline and endpoint, self-reporting impact on primary and secondary outcome measures (HRQoL, PA) and PA mediators (e.g. self-efficacy). Linear mixed models for two-group (intervention, control) and three-group (completers, non-completers, control) analyses were conducted with baseline value, age and BMI as covariates, group as a fixed effect and school as random cluster effect. Results Participants completing baseline and endpoint measures included: 358 intervention (baseline response rate 33.7%, retention rate 61.3%) and 256 control (14.1% and 84.0%). Adjustment for age and BMI made no substantive difference to outcomes, and there were no cluster effects. For HRQoL, after adjustment for baseline scores, the intervention group showed significantly higher scores on all three PedsQL scores (physical functioning: M ± SE = 83.9 ± 0.7, p = .005; psychosocial: 79.9 ± 0.8, p = .001; total score: 81.3 ± 0.7, p = .001) than the control group (80.9 ± 0.8; 76.1 ± 0.9 and 77.8 ± 0.8). The three-group analysis found intervention non-completers had significantly higher PedsQL scores (84.0 ± 0.8, p = .021; 80.4 ± 0.9, p = .003; 81.7 ± 0.8, p = .002;) than controls (80.9 ± 0.8, 76.1 ± 0.9 and 77.8 ± 0.8). There were no significant differences for any PA measure. Intervention completers had significantly higher scores than non-completers and controls for some mediator variables (e.g. self-efficacy, behavioural control). Conclusion Positive outcomes were achieved from a modest school-community linked intervention. The school component contributed to maintaining HRQoL; students who completed the community component derived a range of intra-personal and inter-personal benefits. Trial registration ACTRN12614000446662. April 30th 2014. PMID:24966134

Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease.

PubMed

Schapira, A H V; Stocchi, F; Borgohain, R; Onofrj, M; Bhatt, M; Lorenzana, P; Lucini, V; Giuliani, R; Anand, R

2013-02-01

Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist (DA) therapy for early Parkinson's disease (PD). Study 017 was a 12-month, randomized, double-blind, placebo-controlled pre-planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; post hoc analyses were performed on each separate dose group. Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log-rank test; P = 0.3342). In post hoc analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and a delay in median time to intervention of 9 days (P < 0.05; 240- to 540-day analysis). The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. Post hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

[Evidence Based Public Health: resources on effectiveness of community interventions].

PubMed

Morales Asencio, José Miguel; Gonzalo Jiménez, Elena; Martín Santos, Francisco Javier; Morilla Herrera, Juan Carlos

2008-01-01

The evaluation of interventions in Public Health is a key element through the process of developing health policies, but it is not free of controversy. For doing this purpose it is essential the use of research outcomes, although there are sticking points related to the traditional approach of Evidence Based Medicine, dominated by the randomized clinical trial as the gold standard. Not always it is possible to develop randomized and controlled studies in Public Health (sometimes due to ethical limitations, or because of the technical impossibility for performing the trial or because conceptual incompatibility) and the interventions are mostly multifaceted, therefore, the interpretation of the results is a complex task. In other hand, the usual criteria for research appraisal underestimates systematically the observational studies which, frequently, are the indicated in Public Health scenarios. Nevertheless, a great advance has been implemented with the generation of strategies as TREND (Transparent Reporting of Evaluations with Non randomized Designs), as well as other instruments like STROBE (STrenghtening the Reporting of OBservational studies in Epidemiology) or MOOSE (Meta-analysis Of Observational Studies in Epidemiology). But regardless of the existence of more or less consolidated critical appraisal tools, we all need a solvent and rigorous way of knowing the outcomes of Public Health interventions. This would make more dynamic the review, design or planning phases, and it would contribute to facilitate the decision-making process when a well grounded knowledge be available. In this paper all the methodological process about searching evidence in Public Health interventions is reviewed, as well as the main sources providing this information, in order to facilitate this task to the Public health professionals.

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.

PubMed

Boudreaux, Edwin D; Miller, Ivan; Goldstein, Amy B; Sullivan, Ashley F; Allen, Michael H; Manton, Anne P; Arias, Sarah A; Camargo, Carlos A

2013-09-01

Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes. This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment. While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

PubMed Central

Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

2008-01-01

Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520 PMID:18793398

Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

PubMed Central

Indahl, Aage; Andersen, Lars L.; Burton, Kim; Hertzum-Larsen, Rasmus

2017-01-01

Background Low back pain (LBP) is common in the population and multifactorial in nature, often involving negative consequences. Reassuring information to improve coping is recommended for reducing the negative consequences of LBP. Adding a simple non-threatening explanation for the pain (temporary muscular dysfunction) has been successful at altering beliefs and behavior when delivered with other intervention elements. This study investigates the isolated effect of this specific information on future occupational behavior outcomes when delivered to the workforce. Design A cluster-randomized controlled trial. Methods Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non-threatening explanation for LBP—the ‘functional-disturbance’-model. Data collections took place monthly over a 1-year period using text message tracking (SMS). Primary outcomes were self-reported days of cutting down usual activities and work participation. Secondary outcomes were self-reported back beliefs, work ability, number of healthcare visits, bothersomeness, restricted activity, use of pain medication, and sadness/depression. Results There was no between-group difference in the development of LBP during follow-up. Cumulative logistic regression analyses showed no between-group difference on days of cutting down activities, but increased odds for more days of work participation in the intervention group (OR = 1.83 95% CI: 1.08–3.12). Furthermore, the intervention group was more likely to report: higher work ability, reduced visits to healthcare professionals, lower bothersomeness, lower levels of sadness/depression, and positive back beliefs. Conclusion Reassuring information involving a simple non-threatening explanation for LBP significantly increased the odds for days of work participation and higher work ability among workers who went on to experience LBP during the 12-month follow-up. Our results confirm the potential for public-health education for LBP, and add to the discussion of simple versus multidisciplinary interventions. PMID:28346472

Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

PubMed

Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

2014-05-20

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective. This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates, barriers to participation, logistics of scheduling group-based interventions, acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations. This information is of value to researchers and funders in the design and commissioning of future research. Current Controlled Trials ISRCTN52305381.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

PubMed

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. ISRCTN61538090 Registered 20 April 2015.

Evaluating Non-Randomized Educational Interventions: A Graphical Discussion

ERIC Educational Resources Information Center

Theobald, Roddy; Richardson, Thomas

2014-01-01

A central goal of the education literature is to demonstrate that specific educational interventions--instructional interventions at the student or classroom level, structural interventions at the school level, or funding interventions at the school district level, for example--have a "treatment effect" on student achievement. This paper…

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial.

PubMed

Kriss, Jennifer L; Frew, Paula M; Cortes, Marielysse; Malik, Fauzia A; Chamberlain, Allison T; Seib, Katherine; Flowers, Lisa; Ault, Kevin A; Howards, Penelope P; Orenstein, Walter A; Omer, Saad B

2017-03-13

Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups. We conducted a prospective randomized controlled trial to pilot test two interventions - an affective messaging video and a cognitive messaging iBook - among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy. Among the enrolled women (n=106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26-6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66-4.09). From baseline to follow-up, women's reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman's physician. Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings. clinicaltrials.gov Identifier: NCT01740310. Copyright © 2017 Elsevier Ltd. All rights reserved.

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

Ayurvedic interventions for osteoarthritis: a systematic review and meta-analysis.

PubMed

Kessler, Christian S; Pinders, Lea; Michalsen, Andreas; Cramer, Holger

2015-02-01

Ayurveda is one of the fastest growing systems within complementary and alternative medicine. However, the evidence for its effectiveness is unsatisfactory. The aim of this work was to review and meta-analyze the effectiveness and safety of different Ayurvedic interventions in patients with osteoarthritis (OA). 138 electronic databases were searched through August 2013. Randomized controlled trials, randomized crossover studies, cluster-randomized trials, and non-randomized controlled clinical trials were eligible. Adults with pre-diagnosed OA were included as participants. Interventions were included as Ayurvedic if they were explicitly labeled as such. Main outcome measures were pain, physical function, and global improvement. Risk of bias was assessed using the Cochrane risk of bias tool. 19 randomized and 14 non-randomized controlled trials on 12 different drugs and 3 non-pharmaceutical interventions with a total of 2,952 patients were included. For the compound preparation, Rumalaya, large and apparently unbiased effects beyond placebo were found for pain (standardized mean difference [SMD] -3.73; 95 % confidence interval [CI] -4.97, -2.50; P < 0.01) and global improvement (risk ratio 12.20; 95 % CI 5.83, 25.54; P < 0.01). There is also some evidence that effects of the herbal compound preparation Shunti-Guduchi are comparable to those of glucosamine for pain (SMD 0.08; 95 % CI -0.20, 0.36; P = 0.56) and function (SMD 0.15; 95 % CI -0.12, 0.36; P = 0.41). Based on single trials, positive effects were found for the compound preparations RA-11, Reosto, and Siriraj Wattana. For Boswellia serrata, Lepidium Sativum, a Boswellia serrata containing multicomponent formulation and the compounds Nirgundi Taila, Panchatikta Ghrita Guggulu, and Rhumayog, and for non-pharmacological interventions like Ayurvedic massage, steam therapy, and enema, no evidence for significant effects against potential methodological bias was found. No severe adverse events were observed in all trials. The drugs Rumalaya and Shunti-Guduchi seem to be safe and effective drugs for treatment of OA-patients, based on these data. However, several limitations relate to clinical research on Ayurveda. Well-planned, well-conducted and well-published trials are warranted to improve the evidence for Ayurvedic interventions.

Quenched bond randomness: Superfluidity in porous media and the strong violation of universality

NASA Astrophysics Data System (ADS)

Falicov, Alexis; Berker, A. Nihat

1997-04-01

The effects of quenched bond randomness are most readily studied with superfluidity immersed in a porous medium. A lattice model for3He-4He mixtures and incomplete4He fillings in aerogel yields the signature effect of bond randomness, namely the conversion of symmetry-breaking first-order phase transitions into second-order phase transitions, the λ-line reaching zero temperature, and the elimination of non-symmetry-breaking first-order phase transitions. The model recognizes the importance of the connected nature of aerogel randomness and thereby yields superfluidity at very low4He concentrations, a phase separation entirely within the superfluid phase, and the order-parameter contrast between mixtures and incomplete fillings, all in agreement with experiments. The special properties of the helium mixture/aerogel system are distinctly linked to the aerogel properties of connectivity, randomness, and tenuousness, via the additional study of a regularized “jungle-gym” aerogel. Renormalization-group calculations indicate that a strong violation of the empirical universality principle of critical phenomena occurs under quenched bond randomness. It is argued that helium/aerogel critical properties reflect this violation and further experiments are suggested. Renormalization-group analysis also shows that, adjoiningly to the strong universality violation (which hinges on the occurrence or non-occurrence of asymptotic strong coupling—strong randomness under rescaling), there is a new “hyperuniversality” at phase transitions with asymptotic strong coupling—strong randomness behavior, for example assigning the same critical exponents to random- bond tricriticality and random- field criticality.

Reducing inappropriate non-steroidal anti-inflammatory prescription in primary care patients with chronic kidney disease.

PubMed

Keohane, David M; Dennehy, Thomas; Keohane, Kenneth P; Shanahan, Eamonn

2017-08-14

Purpose The purpose of this paper is to reduce inappropriate non-steroidal anti-inflammatory prescribing in primary care patients with chronic kidney disease (CKD). Once diagnosed, CKD management involves delaying progression to end stage renal failure and preventing complications. It is well established that non-steroidal anti-inflammatories have a negative effect on kidney function and consequently, all nephrology consensus groups suggest avoiding this drug class in CKD. Design/methodology/approach The sampling criteria included all practice patients with a known CKD risk factor. This group was refined to include those with an estimated glomerular filtration rate (eGFR)<60 ml/min per 1.73m2 (stage 3 CKD or greater). Phase one analysed how many prescriptions had occurred in this group over the preceding three months. The intervention involved creating an automated alert on at risk patient records if non-steroidal anti-inflammatories were prescribed and discussing the rationale with practice staff. The re-audit phase occurred three months' post intervention. Findings The study revealed 728/7,500 (9.7 per cent) patients at risk from CKD and 158 (2.1 per cent) who were subsequently found to have an eGFR<60 ml/min, indicating=stage 3 CKD. In phase one, 10.2 per cent of at risk patients had received a non-steroidal anti-inflammatory prescription in the preceding three months. Additionally, 6.2 per cent had received non-steroidal anti-inflammatories on repeat prescription. Phase two post intervention revealed a significant 75 per cent reduction in the total non-steroidal anti-inflammatories prescribed and a 90 per cent reduction in repeat non-steroidal anti-inflammatory prescriptions in those with CKD. Originality/value The study significantly reduced non-steroidal anti-inflammatory prescription in those with CKD in primary care settings. It also created a CKD register within the practice and an enduring medication alert system for individuals that risk nephrotoxic non-steroidal anti-inflammatory prescription. It established a safe, reliable and efficient process for reducing morbidity and mortality, improving quality of life and limiting the CKD associated health burden.

IMITS: Information and Clinical Technologies for the Advancement of Healthcare

DTIC Science & Technology

2008-12-01

a model to evaluate the efficacy of Platelet Gel Therapy on non-healing diabetic foot wounds... the safety and efficacy of Platelet Gel Therapy on non-healing diabetic lower extremity wounds. The implementation of the study protocol, “ A Randomized...prototype for select MTFs. One of the initial steps within Phase Two will be for the DWA project team to provide a project review at SGR

Random scalar fields and hyperuniformity

NASA Astrophysics Data System (ADS)

Ma, Zheng; Torquato, Salvatore

2017-06-01

Disordered many-particle hyperuniform systems are exotic amorphous states of matter that lie between crystals and liquids. Hyperuniform systems have attracted recent attention because they are endowed with novel transport and optical properties. Recently, the hyperuniformity concept has been generalized to characterize two-phase media, scalar fields, and random vector fields. In this paper, we devise methods to explicitly construct hyperuniform scalar fields. Specifically, we analyze spatial patterns generated from Gaussian random fields, which have been used to model the microwave background radiation and heterogeneous materials, the Cahn-Hilliard equation for spinodal decomposition, and Swift-Hohenberg equations that have been used to model emergent pattern formation, including Rayleigh-Bénard convection. We show that the Gaussian random scalar fields can be constructed to be hyperuniform. We also numerically study the time evolution of spinodal decomposition patterns and demonstrate that they are hyperuniform in the scaling regime. Moreover, we find that labyrinth-like patterns generated by the Swift-Hohenberg equation are effectively hyperuniform. We show that thresholding (level-cutting) a hyperuniform Gaussian random field to produce a two-phase random medium tends to destroy the hyperuniformity of the progenitor scalar field. We then propose guidelines to achieve effectively hyperuniform two-phase media derived from thresholded non-Gaussian fields. Our investigation paves the way for new research directions to characterize the large-structure spatial patterns that arise in physics, chemistry, biology, and ecology. Moreover, our theoretical results are expected to guide experimentalists to synthesize new classes of hyperuniform materials with novel physical properties via coarsening processes and using state-of-the-art techniques, such as stereolithography and 3D printing.

Effectiveness of short message services reminder on childhood immunization programme in Kadoma, Zimbabwe - a randomized controlled trial, 2013.

PubMed

Bangure, Donewell; Chirundu, Daniel; Gombe, Notion; Marufu, Tawanda; Mandozana, Gibson; Tshimanga, Mufuta; Takundwa, Lucia

2015-02-12

Globally, non-attendance for immunization appointments remains a challenge to healthcare providers. A review of the 2011 immunization coverage for Kadoma City, Zimbabwe was 74% for Oral Polio Vaccine (OPV), Pneumococcal and Pentavalent antigens. The immunization coverage was less than 90%, which is the target for Kadoma City. Adoption of short message services (SMS) reminders has been shown to enhance attendance in some medical settings. The study was conducted to determine the effectiveness of SMS reminders on immunization programme for Kadoma City. A randomized controlled trial was conducted at Kadoma City clinics in Zimbabwe. Women who delivered and were residents of Kadoma City were recruited into the study. In the intervention group, SMS reminders were sent at 6, 10 and 14 weeks in addition to routine health education. In the non-intervention no SMS reminders were used, however routine health education was offered. Data were collected using interviewer administered questionnaire. Data were analyzed using Epi Info 7™, where frequencies, means, risk ratios and risk differences were generated. A total of 304 participants were recruited, 152 for the intervention group and 152 for the non-intervention group. The immunization coverage at 6 weeks was 97% in the intervention group and 82% in the non-intervention group (p < 0.001). At 14 weeks immunization coverage was 95% for intervention and 75% for non-intervention group (p < 0.001). Those who did not delay receiving immunization at 14 weeks was 82% for the intervention and 8% for non-intervention group. Median delay for intervention was 0 days (Q1 = 0; Q3 = 0) and 10 days (Q1 = 6; Q3 = 17) for non-intervention group. The risk difference (RD) for those who received SMS reminders than those in the non intervention group was 16.3% (95% CI: 12.5-28.0) at 14 weeks. Immunization coverage in the intervention group was significantly higher than in non-intervention group. Overall increase in immunization coverage can be attributed to use of SMS. ISRCTN70918594 . Registration Date: 28 August 2014.

Does providing written dietary advice improve the ingestion of non-allergic nuts in children with existing nut allergies? - A randomized controlled trial.

PubMed

Norman, M; South, C; Quinn, P; Chan, D; Palmer, S; Netting, M; Gold, M

2016-05-01

Allergy to one or more nuts is common in children and often complete nut avoidance is advised. More recently, introduction of non-allergic nuts into the diet is advised by some allergists. This study aims to determine whether the provision of additional written dietary advice increases the ingestion of non-allergic nuts by children with nut allergy. Secondary aims include determining which factors facilitate or prevent successful inclusion of non-allergic nuts in the diet, and how inclusion influences quality of life, sensitization and the rate of nut reactions. This is a randomized, double-blinded, controlled trial of children with nut allergy who were asked to ingest one or more non-allergic nuts. Participants were 75 children aged 2-16 years (Intervention=36, Control=39), recruited in Adelaide, Australia. Randomized participants were supplied with the intervention (recipe booklet and monthly reminder text messages) or provided standard verbal dietary advice. After 6 months participants were assessed by a blinded investigator with regard to nut ingestion, quality of life, sensitization and nut reactions. The intervention did not increase the ingestion of non-allergic nuts. A negative hospital challenge was a predictor of successful introduction. Parental report of child concern about a reaction was the greatest barrier. Ingestion of non-allergic nuts did not improve quality of life or change nut sensitization. Few nut reactions occurred during the study. Ingestion of non-allergic nuts by children with nut allergy was not improved by additional dietary intervention. Selective introduction of non-allergic nuts is difficult to achieve when the child is anxious about introduction and challenges cannot be done in a medically supervised setting. This dietary intervention did not improve non-allergic nut ingestion by nut allergic children. Hospital challenge increased introduction rates, whilst parentally reported child concern about a reaction reduced success. Non-allergic nut ingestion did not change quality of life or sensitization. © 2016 John Wiley & Sons Ltd.

Sexual risk reduction among non-injection drug users: report of a randomized controlled trial.

PubMed

Castor, Delivette; Pilowsky, Daniel J; Hadden, Bernadette; Fuller, Crystal; Ompad, Danielle C; de Leon, Cora L; Neils, Greg; Hoepner, Lori; Andrews, Howard F; Latkin, Carl; Hoover, Donald R

2010-01-01

We conducted a randomized controlled trial of a sexual risk-reduction intervention targeting non-injection drug users (NIDUs) and members of their drug-use/sexual networks (N=270). The intervention was based primarily on the social-influencing approach, and was delivered in four sessions. Sexual risk behaviors were examined at baseline, and 3, 6, 9, and 12 months after the completion of the intervention using the vaginal equivalent episodes (VEE), a weighted sexual risk behavior index. VEE scores decreased in both the active and control conditions in the first six months post-intervention and continued to decline in the control group. However, in the active condition, VEE scores increased after the nine-month assessment and approached baseline levels by the 12-month assessment. There was no evidence of significant differences in high-risk sexual behaviors between the intervention and control conditions. Future studies are needed to improve behavioral interventions in this population.

Tailored telephone counseling increases colorectal cancer screening.

PubMed

Rawl, Susan M; Christy, Shannon M; Monahan, Patrick O; Ding, Yan; Krier, Connie; Champion, Victoria L; Rex, Douglas

2015-08-01

To compare the efficacy of two interventions to promote colorectal cancer screening participation and forward stage movement of colorectal cancer screening adoption among first-degree relatives of individuals diagnosed with adenomatous polyps. One hundred fifty-eight first-degree relatives of individuals diagnosed with adenomatous polyps were randomly assigned to receive one of two interventions to promote colorectal cancer screening. Participants received either a tailored telephone counseling plus brochures intervention or a non-tailored print brochures intervention. Data were collected at baseline and 3 months post-baseline. Group differences and the effect of the interventions on adherence and stage movement for colorectal cancer screening were examined using t-tests, chi-square tests, and logistic regression. Individuals in the tailored telephone counseling plus brochures group were significantly more likely to complete colorectal cancer screening and to move forward on stage of change for fecal occult blood test, any colorectal cancer test stage and stage of the risk-appropriate test compared with individuals in the non-tailored brochure group at 3 months post-baseline. A tailored telephone counseling plus brochures intervention successfully promoted forward stage movement and colorectal cancer screening adherence among first-degree relatives of individuals diagnosed with adenomatous polyps. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Comparing Weight Loss-Maintenance Outcomes of a Worksite-Based Lifestyle Program Delivered via DVD and Face-to-Face: A Randomized Trial.

PubMed

Ing, Claire Townsend; Miyamoto, Robin E S; Fang, Rui; Antonio, Mapuana; Paloma, Diane; Braun, Kathryn L; Kaholokula, Joseph Keawe'aimoku

2018-03-01

Native Hawaiians and other Pacific Islanders have high rates of overweight and obesity compared with other ethnic groups in Hawai'i. Effective weight loss and weight loss-maintenance programs are needed to address obesity and obesity-related health inequities for this group. Compare the effectiveness of a 9-month, worksite-based, weight loss-maintenance intervention delivered via DVD versus face-to-face in continued weight reduction and weight loss maintenance beyond the initial weight loss phase. We tested DVD versus face-to-face delivery of the PILI@Work Program's 9-month, weight loss-maintenance phase in Native Hawaiian-serving organizations. After completing the 3-month weight loss phase, participants ( n = 217) were randomized to receive the weight loss-maintenance phase delivered via trained peer facilitators or DVDs. Participant assessments at randomization and postintervention included weight, height, blood pressure, physical functioning, exercise frequency, and fat intake. Eighty-three face-to-face participants were retained at 12 months (74.1%) compared with 73 DVD participants (69.5%). There was no significant difference between groups in weight loss or weight loss maintenance. The number of lessons attended in Phase 1 of the intervention (β = 0.358, p = .022) and baseline systolic blood pressure (β = -0.038, p = .048) predicted percent weight loss at 12 months. Weight loss maintenance was similar across groups. This suggests that low-cost delivery methods for worksite-based interventions targeting at-risk populations can help address obesity and obesity-related disparities. Additionally, attendance during the weight loss phase and lower baseline systolic blood pressure predicted greater percent weight loss during the weight loss-maintenance phase, suggesting that early engagement and initial physical functioning improve long-term weight loss outcomes.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.

PubMed

Choi, Yoon Jin; Lee, Dong Ho; Choi, Myung Gyu; Lee, Sung Joon; Kim, Sung Kook; Song, Geun Am; Rhee, Poong Lyul; Jung, Hwoon Yong; Kang, Dae Hwan; Lee, Yong Chan; Lee, Si Hyung; Choi, Suck Chei; Shim, Ki Nam; Seol, Sang Yong; Moon, Jeong Seop; Shin, Yong Woon; Kim, Hyun Soo; Lee, Soo Teik; Cho, Jin Woong; Choi, Eun Kwang; Lee, Oh Young; Jang, Jin Seok

2017-11-01

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670). © 2017 The Korean Academy of Medical Sciences.

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A.

PubMed

Welzel, Grit; Boch, Angela; Sperk, Elena; Hofmann, Frank; Kraus-Tiefenbacher, Uta; Gerhardt, Axel; Suetterlin, Marc; Wenz, Frederik

2013-01-07

Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

A Randomized Controlled Trial of a Mobile Medical App for Kidney Transplant Recipients: Effect on Use of Sun Protection.

PubMed

Robinson, June K; Friedewald, John J; Desai, Amishi; Gordon, Elisa J

2016-01-01

Perception of skin cancer risk, belief that sun protection prevents skin cancer, and having sun protection choices enhance sun protection behaviors by kidney transplant recipients, who are at greater risk of developing skin cancer than the general population. A randomized controlled trial used stratified recruitment of non-Hispanic White, non-Hispanic Black, and Hispanic/Latino kidney transplant recipients, who received a transplant 2-24 months prior to the study. The same culturally sensitive SunProtect™ program was delivered to all recipients with tablet personal computers in two urban ambulatory offices. Text messages reminders were provided at two week intervals. Self-reported surveys and skin pigmentation measured prior to the intervention and six weeks later were analyzed. Among 552 eligible participants, 170 participated (62 non-Hispanic Whites, 60Blacks, and 48 Hispanics). Among participants receiving the intervention with skin that burns after sun exposure and becomes tan or becomes irritated and gets darker, there was a statistically significant increase in self-reported knowledge, recognition of personal skin cancer risk, confidence in sun protection preventing skin cancer, and sun protection behaviors in participants compared to those receiving usual education (p<0.05). At the six week follow-up, participants in the intervention group with skin that burns or becomes irritated, had significantly less darkening of the sun-exposed forearm than control participants (p<0.05). Providing sun protection education with SunProtect™ in the springwith reminders during the summer facilitated adoption of sun protection behaviors among kidney transplant recipients with skin that burns or becomes irritated.

What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews.

PubMed

Makady, Amr; de Boer, Anthonius; Hillege, Hans; Klungel, Olaf; Goettsch, Wim

Despite increasing recognition of the value of real-world data (RWD), consensus on the definition of RWD is lacking. To review definitions publicly available for RWD to shed light on similarities and differences between them. A literature review and stakeholder interviews were used to compile data from eight groups of stakeholders. Data from documents and interviews were subjected to coding analysis. Definitions identified were classified into four categories: 1) data collected in a non-randomized controlled trial setting, 2) data collected in a non-interventional/non-controlled setting, 3) data collected in a non-experimental setting, and 4) others (i.e., data that do not fit into the other three categories). The frequency of definitions identified per category was recorded. Fifty-three documents and 20 interviews were assessed. Thirty-eight definitions were identified: 20 out of 38 definitions (53%) were category 1 definitions, 9 (24%) were category 2 definitions, 5 (13%) were category 3 definitions, and 4 (11%) were category 4 definitions. Differences were identified between, and within, definition categories. For example, opinions differed on the aspects of intervention with which non-interventional/non-controlled settings should abide. No definitions were provided in two interviews or identified in 33 documents. Most of the definitions defined RWD as data collected in a non-randomized controlled trial setting. A considerable number of definitions, however, diverged from this concept. Moreover, a significant number of authors and stakeholders did not have an official, institutional definition for RWD. Persisting variability in stakeholder definitions of RWD may lead to disparities among different stakeholders when discussing RWD use in decision making. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Evaluation of an educational "toolbox" for improving nursing staff competence and psychosocial work environment in elderly care: results of a prospective, non-randomized controlled intervention.

PubMed

Arnetz, J E; Hasson, H

2007-07-01

Lack of professional development opportunities among nursing staff is a major concern in elderly care and has been associated with work dissatisfaction and staff turnover. There is a lack of prospective, controlled studies evaluating the effects of educational interventions on nursing competence and work satisfaction. The aim of this study was to evaluate the possible effects of an educational "toolbox" intervention on nursing staff ratings of their competence, psychosocial work environment and overall work satisfaction. The study was a prospective, non-randomized, controlled intervention. Nursing staff in two municipal elderly care organizations in western Sweden. In an initial questionnaire survey, nursing staff in the intervention municipality described several areas in which they felt a need for competence development. Measurement instruments and educational materials for improving staff knowledge and work practices were then collated by researchers and managers in a "toolbox." Nursing staff ratings of their competence and work were measured pre and post-intervention by questionnaire. Staff ratings in the intervention municipality were compared to staff ratings in the reference municipality, where no toolbox was introduced. Nursing staff ratings of their competence and psychosocial work environment, including overall work satisfaction, improved significantly over time in the intervention municipality, compared to the reference group. Both competence and work environment ratings were largely unchanged among reference municipality staff. Multivariate analysis revealed a significant interaction effect between municipalities over time for nursing staff ratings of participation, leadership, performance feedback and skills' development. Staff ratings for these four scales improved significantly in the intervention municipality as compared to the reference municipality. Compared to a reference municipality, nursing staff ratings of their competence and the psychosocial work environment improved in the municipality where the toolbox was introduced.

Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care.

PubMed

Baer, Heather J; Wee, Christina C; DeVito, Katerina; Orav, E John; Frolkis, Joseph P; Williams, Deborah H; Wright, Adam; Bates, David W

2015-08-01

Primary care providers often fail to identify patients who are overweight or obese or discuss weight management with them. Electronic health record-based tools may help providers with the assessment and management of overweight and obesity. We describe the design of a trial to examine the effectiveness of electronic health record-based tools for the assessment and management of overweight and obesity among adult primary care patients, as well as the challenges we encountered. We developed several new features within the electronic health record used by primary care practices affiliated with Brigham and Women's Hospital in Boston, MA. These features included (1) reminders to measure height and weight, (2) an alert asking providers to add overweight or obesity to the problem list, (3) reminders with tailored management recommendations, and (4) a Weight Management screen. We then conducted a pragmatic, cluster-randomized controlled trial in 12 primary care practices. We randomized 23 clinical teams ("clinics") within the practices to the intervention group (n = 11) or the control group (n = 12). The new features were activated only for clinics in the intervention group. The intervention was implemented in two phases: the height and weight reminders went live on 15 December 2011 (Phase 1), and all of the other features went live on 11 June 2012 (Phase 2). Study enrollment went from December 2011 through December 2012, and follow-up ended in December 2013. The primary outcomes were 6-month and 12-month weight change among adult patients with body mass index ≥25 who had a visit at one of the primary care clinics during Phase 2. Secondary outcome measures included the proportion of patients with a recorded body mass index in the electronic health record, the proportion of patients with body mass index ≥25 who had a diagnosis of overweight or obesity on the electronic health record problem list, and the proportion of patients with body mass index ≥25 who had a follow-up appointment about their weight or were prescribed weight loss medication. We encountered challenges in our development of an intervention within the existing structure of an electronic health record. For example, although we decided to randomize clinics within primary care practices, this decision may have introduced contamination and led to some imbalance of patient characteristics between the intervention and control practices. Using the electronic health record as the primary data source reduced the cost of the study, but not all desired data were recorded for every participant. Despite the challenges, this study should provide valuable information about the effectiveness of electronic health record-based tools for addressing overweight and obesity in primary care. © The Author(s) 2015.

Efficacy and safety of aripiprazole once-monthly in Asian patients with schizophrenia: a multicenter, randomized, double-blind, non-inferiority study versus oral aripiprazole.

PubMed

Ishigooka, Jun; Nakamura, Jun; Fujii, Yasuo; Iwata, Nakao; Kishimoto, Toshifumi; Iyo, Masaomi; Uchimura, Naohisa; Nishimura, Ryoji; Shimizu, Naoaki

2015-02-01

This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia. The study consisted of a screening phase and three phases: an oral conversion phase (≤12weeks), an oral stabilization phase (≤12weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400mg) or oral aripiprazole (6-24mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26. A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0% (AOM) and 94.7% (oral aripiprazole) and the difference was 0.3% (95% CI: -3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of -3.9% which is well above the pre-defined non-inferiority limit (-15%). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6% and 92.5% in both groups. Discontinuation rates due to all reasons were 25.9% (AOM) and 33.5% (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole. Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole. JapicCTI-101175. Copyright © 2014 Elsevier B.V. All rights reserved.

Surveying vendors of street-vended food: a new methodology applied in two Guatemalan cities.

PubMed Central

Mahon, B. E.; Sobel, J.; Townes, J. M.; Mendoza, C.; Gudiel Lemus, M.; Cano, F.; Tauxe, R. V.

1999-01-01

Lack of reliable data about street vendors, who are difficult to survey, has hampered efforts to improve the safety of street-vended food. A two-phase method for sampling vendors, surveying first in areas of concentrated vending activity identified by local authorities and second in randomly selected areas, was developed and implemented in two Guatemalan cities where street-vended food had been implicated in cholera transmission. In a 4-day survey in Escuintla, 59 vendors (42 from phase 1, 17 from phase 2) were interviewed. They demonstrated good knowledge of food safety and cholera but unsafe practices, implying that more effective, practical training was needed. In a 6-day survey in Guatemala City, 78 vendors (77 from phase 1, 1 from phase 2) were interviewed. Sixty-eight (87 %) vendors stored water, usually in wide-mouthed vessels prone to contamination; this led to a field test of a new system for safe water storage. Useful information for public health planning and intervention can be gathered rapidly with this new method for surveying street vendors. PMID:10459643

Long-term effects of inhaled budesonide on screening-detected lung nodules.

PubMed

Veronesi, G; Lazzeroni, M; Szabo, E; Brown, P H; DeCensi, A; Guerrieri-Gonzaga, A; Bellomi, M; Radice, D; Grimaldi, M C; Spaggiari, L; Bonanni, B

2015-05-01

A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT. We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed. The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms. Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications. NCT01540552. © The Author 2015. 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.

Effect of peer-based low back pain information and reassurance at the workplace on sick leave: a cluster randomized trial.

PubMed

Odeen, Magnus; Ihlebæk, Camilla; Indahl, Aage; Wormgoor, Marjon E A; Lie, Stein A; Eriksen, Hege R

2013-06-01

To evaluate whether information and reassurance about low back pain (LBP) given to employees at the workplace could reduce sick leave. A Cluster randomized controlled trial with 135 work units of about 3,500 public sector employees in two Norwegian municipalities, randomized into two intervention groups; Education and peer support (EPS) (n = 45 units), education and "peer support and access to an outpatient clinic" (EPSOC) (n = 48 units), and a control group (n = 42 units). Both interventions consisted of educational meetings based on a "non-injury model" and a "peer adviser" appointed by colleagues. Employees in the EPSOC group had access to an outpatient clinic for medical examination and further education. The control group received no intervention. The main outcome was sick leave based on municipal records. Secondary outcomes were self-reported pain, pain related fear of movement, coping, and beliefs about LBP from survey data of 1,746 employees (response rate about 50 %). EPS reduced sick leave by 7 % and EPSOC reduced sick leave by 4 % during the intervention year, while sick leave in the control group was increased by 7 % during the same period. Overall, Rate Ratios (RR) were statistically significant for EPSOC (RR = .84 (C.I = 0.71-.99) but not EPS (RR = .92 (C.I = 0.78-1.09)) in a mixed Poisson regression analysis. Faulty beliefs about LBP were reduced in both intervention groups. Educational meetings, combined with peer support and access to an outpatient clinic, were effective in reducing sick leave in public sector employees.

A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients.

PubMed

Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Sánchez-Labraca, Nuria; Quesada-Rubio, José Manuel; Granero-Molina, José; Moreno-Lorenzo, Carmen

2011-01-01

Fibromyalgia is a prevalent musculoskeletal disorder associated with widespread mechanical tenderness, fatigue, non-refreshing sleep, depressed mood and pervasive dysfunction of the autonomic nervous system: tachycardia, postural intolerance, Raynaud's phenomenon and diarrhoea. To determine the effects of craniosacral therapy on sensitive tender points and heart rate variability in patients with fibromyalgia. A randomized controlled trial. Ninety-two patients with fibromyalgia were randomly assigned to an intervention group or placebo group. Patients received treatments for 20 weeks. The intervention group underwent a craniosacral therapy protocol and the placebo group received sham treatment with disconnected magnetotherapy equipment. Pain intensity levels were determined by evaluating tender points, and heart rate variability was recorded by 24-hour Holter monitoring. After 20 weeks of treatment, the intervention group showed significant reduction in pain at 13 of the 18 tender points (P < 0.05). Significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement versus baseline values were observed in the intervention group but not in the placebo group. At two months and one year post therapy, the intervention group showed significant differences versus baseline in tender points at left occiput, left-side lower cervical, left epicondyle and left greater trochanter and significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement. Craniosacral therapy improved medium-term pain symptoms in patients with fibromyalgia.

Exploring the use of positive psychology interventions in brain injury survivors with challenging behaviour.

PubMed

Andrewes, H E; Walker, V; O'Neill, B

2014-01-01

To investigate the feasibility and effectiveness of conducting two positive psychology interventions to improve mood and self-concept with survivors of traumatic brain injury (TBI), within a neuro-rehabilitation hospital. Ten patients with brain injury were randomly allocated to an intervention and control group. The efficacy of the first intervention, 'three positive things in life' was measured via Seligman's Authentic Happiness Index (AHI), at base-line, directly following the intervention and at the end of the 12-week group programme. The second intervention, the 'Value in Action (VIA) signature strengths intervention' was measured by the Head Injury Semantic Differential Scale (HISDS) at baseline and at the end of the group. Compared to baseline and control group scores, the AHI index showed an increase in the intervention group's happiness following the intervention and at the end of the 12-week programme, albeit the latter increase was non-significant. The HISDS showed non-significant improvement in self-concept and reduction in polarization of the self in the present, future and past in the second intervention. Anecdotal evidence revealed a clear improved mood following the interventions. This study shows promising results for the effectiveness of Positive Psychology interventions and methods to improve feasibility when applying this treatment within a hospital setting.

Can sickness absence be reduced by stress reduction programs: on the effectiveness of two approaches.

PubMed

van Rhenen, Willem; Blonk, Roland W B; Schaufeli, Wilmar B; van Dijk, Frank J H

2007-05-01

The aim of the study was to evaluate the effectiveness of two brief preventive stress reduction programs--a cognitive focused program and a combined intervention of physical exercise and relaxation--on sickness absence in stressed and non-stressed employees working in various jobs in a telecom company. The study was designed as an a priori randomized trial and the follow-up period for sickness absence was 1 year. Sickness absence data of 242 employees were analyzed with respect to spells of sickness (frequency, incidence rate), days (length, duration) and time between intervention and first subsequent absent spell. For stressed employees this study suggests that the illness burden represented by absenteeism is not affected by the interventions. There is no substantial difference in effectiveness between the cognitive and physical interventions. However, in comparison with the physical intervention the cognitive intervention decreases the period between the intervention and the first recurrence of a sick leave period with 144 days (marginal significant). The illness burden represented by absenteeism is effected in detail but not substantially by the interventions.

Systematic review of behaviour change techniques to promote participation in physical activity among people with dementia.

PubMed

Nyman, Samuel R; Adamczewska, Natalia; Howlett, Neil

2018-02-01

The objective of this study was to systematically review the evidence for the potential promise of behaviour change techniques (BCTs) to increase physical activity among people with dementia (PWD). PsychINFO, MEDLINE, CINAHL, and the Cochrane Central Register of Controlled Trials databases were searched 01/01/2000-01/12/2016. Randomized controlled/quasi-randomized trials were included if they recruited people diagnosed/suspected to have dementia, used at least one BCT in the intervention arm, and had at least one follow-up measure of physical activity/adherence. Studies were appraised using the Cochrane Collaboration Risk of Bias Tool, and BCTs were coded using Michie et al., 2013, Annals of Behavioral Medicine, 46, 81. taxonomy. Intervention findings were narratively synthesized as either 'very promising', 'quite promising', or 'non-promising', and BCTs were judged as having potential promise if they featured in at least twice as many very/quite promising than non-promising interventions (as per Gardner et al., 2016, Health Psychology Review, 10, 89). Nineteen articles from nine trials reported physical activity findings on behavioural outcomes (two very promising, one quite promising, and two non-promising) or intervention adherence (one quite promising and four non-promising). Thirteen BCTs were used across the interventions. While no BCT had potential promise to increase intervention adherence, three BCTs had potential promise for improving physical activity behaviour outcomes: goal setting (behaviour), social support (unspecified), and using a credible source. Three BCTs have potential promise for use in future interventions to increase physical activity among PWD. Statement of contribution What is already known on this subject? While physical activity is a key lifestyle factor to enhance and maintain health and wellbeing amongst the general population, adults rarely participate in sufficient levels to obtain these benefits. Systematic reviews suggest that specific behaviour change techniques can increase physical activity, although one review suggested that self-regulatory techniques may be counterproductive when promoting physical activity among older people. Until now, no systematic review has been conducted to assess which behaviour change techniques may be associated with greater participation in physical activity among people with dementia. What does this study add? Interventions showed mixed promise for increasing physical activity and little effect on participant adherence. Goal setting (behaviour), social support (unspecified), and using a credible source are promising approaches. No technique showed promise for increasing adherence to physical activity interventions among people with dementia. © 2017 The British Psychological Society.

Testing the Intervention Effect in Single-Case Experiments: A Monte Carlo Simulation Study

ERIC Educational Resources Information Center

Heyvaert, Mieke; Moeyaert, Mariola; Verkempynck, Paul; Van den Noortgate, Wim; Vervloet, Marlies; Ugille, Maaike; Onghena, Patrick

2017-01-01

This article reports on a Monte Carlo simulation study, evaluating two approaches for testing the intervention effect in replicated randomized AB designs: two-level hierarchical linear modeling (HLM) and using the additive method to combine randomization test "p" values (RTcombiP). Four factors were manipulated: mean intervention effect,…

A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes.

PubMed

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. ClinicalTrials.gov NCT01426451.

A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

PubMed Central

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. Trial Registration ClinicalTrials.gov NCT01426451 PMID:25127251

A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.

PubMed

Li, Rhea; Donnella, Hayley; Knouse, Phillip; Raber, Margaret; Crawford, Karla; Swartz, Maria C; Wu, Jimin; Liu, Diane; Chandra, Joya

2017-02-01

Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management. © 2016 Wiley Periodicals, Inc.

The effect of massage therapy on the quality of sleep in breast cancer patients.

PubMed

Kashani, Fahimeh; Kashani, Parisa

2014-03-01

Annually, about 6000 new cases are diagnosed with breast cancer in Iran. In Iran, more women are affected with breast cancer than a decade earlier in comparison with other countries, and 70% of them are diagnosed at an advanced phase. Insomnia is the most common disorder following breast cancer, and interference in sleep quality and rest causes changes in physiological functions and reduces the body's daily performance. The objective of this study was to determine the effect of massage therapy on the quality of sleep in patients with breast cancer. This clinical trial was conducted for about 1 month in a referral chemotherapy clinic of a teaching hospital in Isfahan, Iran. The participants consisted of 57 women with breast cancer who were selected by simple random sampling. They were randomly assigned to two groups of control and experimental. The control group was treated only by usual medical therapy, whereas the case group was treated by combined medical-massage therapy. Data collection tools were the validated Pittsburgh Sleep Quality Index and a demographic questionnaire. Data were analyzed by SPSS using descriptive statistics, Chi-square test, paired t-test, and Student's t-test. The results showed significant differences in the mean scores of quality of sleep before and after the intervention in the case group, while no significant differences were observed in the mean scores of quality of sleep before and after the intervention in the control group. In addition, no significant differences were observed in the mean scores of quality of sleep before the intervention between case and control groups. However, significant differences were observed in the mean scores of quality of sleep after the intervention between case and control groups. According to the results of this study, learning and applying massage techniques by medical staff causes health promotion and improves the quality of sleep in cancer patients. Furthermore, massage therapy is suggested as a non-pharmacologic method to improve sleep quality in these patients.

A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Siqueira, Milena Ruas; da Rosa, Luciana de Toledo Bernardes; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2015-04-12

Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as 'a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment. The primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization. Despite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced cancer may benefit from a psychosocial and educational strategy that adequately prepares them for initial PC appointments after an early referral to PC. We anticipate that benefits of psychological intervention shall be synergistic to secondary emotional benefits from the early integration of PC. This trial was registered on 6 May 2014 with ClinicalTrials.gov (identifier: NCT02133274).

Quenched bond randomness: Superfluidity in porous media and the strong violation of universality

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

Falicov, A.; Berker, A.N.

1997-04-01

The effects of quenched bond randomness are most readily studied with superfluidity immersed in a porous medium. A lattice model for {sup 3}He-{sup 4}He mixtures and incomplete {sup 4}He fillings in aerogel yields the signature effect of bond randomness, namely the conversion of symmetry-breaking first-order phase transitions into second-order phase transitions, the A-line reaching zero temperature, and the elimination of non-symmetry-breaking first-order phase transitions. The model recognizes the importance of the connected nature of aerogel randomness and thereby yields superfluidity at very low {sup 4}He concentrations, a phase separation entirely within the superfluid phase, and the order-parameter contrast between mixturesmore » and incomplete fillings, all in agreement with experiments. The special properties of the helium mixture/aerogel system are distinctly linked to the aerogel properties of connectivity, randomness, and tenuousness, via the additional study of a regularized {open_quote}jungle-gym{close_quotes} aerogel. Renormalization-group calculations indicate that a strong violation of the empirical universality principle of critical phenomena occurs under quenched bond randomness. It is argued that helium/aerogel critical properties reflect this violation and further experiments are suggested. Renormalization-group analysis also shows that, adjoiningly to the strong universality violation (which hinges on the occurrence or non-occurrence of asymptotic strong coupling-strong randomness under resealing), there is a new {open_quotes}hyperuniversality{close_quotes} at phase transitions with asymptotic strong coupling-strong randomness behavior, for example assigning the same critical exponents to random-bond tricriticality and random-field criticality.« less

Boson expansions based on the random phase approximation representation

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

Pedrocchi, V.G.; Tamura, T.

1984-04-01

A new boson expansion theory based on the random phase approximation is presented. The boson expansions are derived here directly in the random phase approximation representation with the help of a technique that combines the use of the Usui operator with that of a new bosonization procedure, called the term-by-term bosonization method. The present boson expansion theory is constructed by retaining a single collective quadrupole random phase approximation component, a truncation that allows for a perturbative treatment of the whole problem. Both Hermitian, as well as non-Hermitian boson expansions, valid for even nuclei, are obtained.

[Effects of an educational and participatory community intervention on malaria control in Buenaventura, Colombia].

PubMed

Alvarado, Beatriz Eugenia; Alzate, Alberto; Mateus, Julio Cesar; Carvajal, Rocío

2006-09-01

A four-component, non randomized, primary-care based intervention for malaria control was implemented in Buenaventura, Colombia. To evaluate the effect of the applied intervention on knowledge about malaria, attention of febrile events and frequency of malaria occurrence in three communities of Buenaventura. A post-intervention evaluation with a non-equivalent control group was performed. Two non-intervened groups (those residing more and less than six months, respectively, in the area) and one intervened group were identified. We interviewed 661 women household heads. Contact was defined as having been exposed to at least one of the four intervention components. Fourteen percent of the respondents had contact with the intervention. The attention of a febrile episode was better in those who had contact with the intervention than in the nonintervened ones who had resided in the area for more than six months. Those without contact and with less than six months stay in the area reported lower use of bed-nets (OR:0.46; 95% CI:0.23-0.93) and less fumigation practices (OR:0.38; 95% CI:0.19-0.75). The analysis of the malaria case trend showed a reduction in the proportion of cases contributed by the intervened communities, from 25% to 17%, six years after the intervention. An educational strategy is effective to enhance knowledge and modify the practices of the urban population of Buenaventura with respect to malaria.

Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial

PubMed Central

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F.

2016-01-01

Background Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. Purpose To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. Methods The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Results Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked lowest. Intervention health facilities that were assessed by female community groups (Coef. = 0.2720, p = 0.0118) and informal groups with organized leadership structures like Artisans (Coef. = 0.2268, p = 0.0368) associated positively with higher intrinsic motivation levels of staff. Conclusion Community-based approach to health worker motivation is a potential complementary strategy that needs policy deliberation to explore its prospects. Albeit financial incentives remain critical sources of staff motivation, innovative non-financial approaches like SCE should complement the latter. PMID:27439012

Assessing the Impact of Community Engagement Interventions on Health Worker Motivation and Experiences with Clients in Primary Health Facilities in Ghana: A Randomized Cluster Trial.

PubMed

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Rinke de Wit, Tobias F

2016-01-01

Health worker density per 1000 population in Ghana is one of the lowest in the world estimated to be 2.3, below the global average of 9.3. Low health worker motivation induced by poor working conditions partly explain this challenge. Albeit the wage bill for public sector health workers is about 90% of domestic government expenditure on health in countries such as Ghana, staff motivation and performance output remain a challenge, suggesting the need to complement financial incentives with non-financial incentives through a community-based approach. In this study, a systematic community engagement (SCE) intervention was implemented to engage community groups in healthcare quality assessment to promote mutual collaboration between clients and healthcare providers, and enhance health worker motivation levels. SCE involves structured use of existing community groups and associations to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements made and rewards given to best performing facilities for closing quality care gaps. To evaluate the effect of SCE interventions on health worker motivation and experiences with clients. The study is a cluster randomized trial involving health workers in private (n = 38) and public (n = 26) primary healthcare facilities in two administrative regions in Ghana. Out of 324 clinical and non-clinical staff randomly interviewed at baseline, 234 (72%) were successfully followed at end-line and interviewed on workplace motivation factors and personal experiences with clients. Propensity score matching and difference-in-difference estimations were used to estimate treatment effect of the interventions on staff motivation. Intrinsic (non-financial) work incentives including cordiality with clients and perceived career prospects appeared to be prime sources of motivation for health staff interviewed in intervention health facilities while financial incentives were ranked lowest. Intervention health facilities that were assessed by female community groups (Coef. = 0.2720, p = 0.0118) and informal groups with organized leadership structures like Artisans (Coef. = 0.2268, p = 0.0368) associated positively with higher intrinsic motivation levels of staff. Community-based approach to health worker motivation is a potential complementary strategy that needs policy deliberation to explore its prospects. Albeit financial incentives remain critical sources of staff motivation, innovative non-financial approaches like SCE should complement the latter.

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial.

PubMed

Imam, Bita; Miller, William C; Finlayson, Heather C; Eng, Janice J; Payne, Michael Wc; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-12-22

The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed "Wii.n.Walk", an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants' homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks' duration. The primary outcome measure will be the "Two-Minute Walk Test" to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP).

Effectiveness of web-based versus folder support interventions for young informal carers of persons with mental illness: a randomized controlled trial.

PubMed

Ali, Lilas; Krevers, Barbro; Sjöström, Nils; Skärsäter, Ingela

2014-03-01

Compare the impact of two interventions, a web-based support and a folder support, for young persons who care for people who suffer from mental illness. This study was a randomized control trial, following the CONSORT statements, which compared the impact of two interventions. Primary outcome variable was stress, and secondary outcome variables were caring situation, general self-efficacy, well-being, health, and quality of life of young informal carers (N=241). Data were collected in June 2010 to April 2011, with self-assessment questionnaires, comparing the two interventions and also to detect changes. The stress levels were high in both groups at baseline, but decreased in the folder group. The folder group had improvement in their caring situation (also different from the web group), general self-efficacy, well-being, and quality of life. The web group showed increase in well-being. Young informal carers who take on the responsibility for people close to them; suffer consequences on their own health. They live in a life-situation characterized by high stress and low well-being. This signals a need for support. The non-significant differences show that each intervention can be effective, and that it depends upon the individual's preferences. This highlights the importance of adopting person-centered approach, in which young persons can themselves choose support strategy. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The effects of a multi-component higher-functioning autism anti-stigma program on adolescent boys.

PubMed

Staniland, Jessica J; Byrne, Mitchell K

2013-12-01

A six-session higher-functioning autism anti-stigma program incorporating descriptive, explanatory and directive information was delivered to adolescent boys and the impact upon knowledge, attitudes and behavioural intentions towards peers with autism was evaluated. Participants were seventh-, eighth- and ninth-grade students (N = 395) from regular classes in a mainstream school. Two-eighth-grade classes were randomly allocated to the intervention condition and all remaining students were either allocated to the no-intervention peer or no-intervention non-peer condition. The anti-stigma program improved the knowledge and attitudes, but not the behavioural intentions of participants towards their peers with autism. Knowledge and attitudinal changes were maintained at follow-up. There were no spill-over effects of the program to non-targeted students. These results provide some preliminary evidence for the effectiveness of multi-session anti-stigma programs incorporating combined information for adolescent students in inclusive educational environments.

Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England

PubMed Central

2013-01-01

Background Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Methods/design Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. Design: parallel group patient-level pragmatic randomized controlled trial. Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders. Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice. Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice. Sample size: 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate. Discussion At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken. Trial registration Current controlled trials: ISRCTN23560818 Clinical Trials US (clinicaltrials.gov): NCT01635361 PMID:24289059

Trauma-Informed Mindfulness-Based Stress Reduction for Female Survivors of Interpersonal Violence: Results From a Stage I RCT.

PubMed

Kelly, Amber; Garland, Eric L

2016-04-01

This pilot randomized controlled trial evaluated a novel trauma-informed model of mindfulness-based stress reduction (TI-MBSR) as a phase I trauma intervention for female survivors of interpersonal violence (IPV). A community-based sample of women (mean age = 41.5, standard deviation = 14.6) with a history of IPV was randomly assigned to an 8-week TI-MBSR intervention (n = 23) or a waitlist control group (n = 22). Symptoms of posttraumatic stress disorder (PTSD) and depression as well as anxious and avoidant attachment were assessed pre- and postintervention. Relative to the control group, participation in TI-MBSR was associated with statistically and clinically significant decreases in PTSD and depressive symptoms and significant reductions in anxious attachment. Retention in the intervention was high, with most participants completing at least 5 of the 8 sessions for the intervention. Minutes of mindfulness practice per week significantly predicted reductions in PTSD symptoms. TI-MBSR appears to be a promising and feasible phase I intervention for female survivors of interpersonal trauma. © 2016 Wiley Periodicals, Inc.

mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion.

PubMed

Martin, Seth S; Feldman, David I; Blumenthal, Roger S; Jones, Steven R; Post, Wendy S; McKibben, Rebeccah A; Michos, Erin D; Ndumele, Chiadi E; Ratchford, Elizabeth V; Coresh, Josef; Blaha, Michael J

2015-11-09

We hypothesized that a fully automated mobile health (mHealth) intervention with tracking and texting components would increase physical activity. mActive enrolled smartphone users aged 18 to 69 years at an ambulatory cardiology center in Baltimore, Maryland. We used sequential randomization to evaluate the intervention's 2 core components. After establishing baseline activity during a blinded run-in (week 1), in phase I (weeks 2 to 3), we randomized 2:1 to unblinded versus blinded tracking. Unblinding allowed continuous access to activity data through a smartphone interface. In phase II (weeks 4 to 5), we randomized unblinded participants 1:1 to smart texts versus no texts. Smart texts provided smartphone-delivered coaching 3 times/day aimed at individual encouragement and fostering feedback loops by a fully automated, physician-written, theory-based algorithm using real-time activity data and 16 personal factors with a 10 000 steps/day goal. Forty-eight outpatients (46% women, 21% nonwhite) enrolled with a mean±SD age of 58±8 years, body mass index of 31±6 kg/m(2), and baseline activity of 9670±4350 steps/day. Daily activity data capture was 97.4%. The phase I change in activity was nonsignificantly higher in unblinded participants versus blinded controls by 1024 daily steps (95% confidence interval [CI], -580 to 2628; P=0.21). In phase II, participants receiving texts increased their daily steps over those not receiving texts by 2534 (95% CI, 1318 to 3750; P<0.001) and over blinded controls by 3376 (95% CI, 1951 to 4801; P<0.001). An automated tracking-texting intervention increased physical activity with, but not without, the texting component. These results support new mHealth tracking technologies as facilitators in need of behavior change drivers. URL: http://ClinicalTrials.gov/. Unique identifier: NCT01917812. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Cost-effectiveness of strategies to market and train primary health care physicians in brief intervention techniques for hazardous alcohol use.

PubMed

Gomel, M K; Wutzke, S E; Hardcastle, D M; Lapsley, H; Reznik, R B

1998-07-01

The cost-effectiveness of strategies to market and train primary care physicians in brief intervention for hazardous alcohol consumption was examined. Physicians were randomly assigned to one of three marketing strategies designed to promote the "uptake" of a brief intervention package for hazardous and harmful alcohol consumption. The strategies were direct mail, tele-marketing, or academic detailing. One hundred and twenty-seven of those physicians who requested the package during the marketing phase (phase 1) and who also agreed to participate in the training and support phase of the project (phase 2) were matched into one of three training and support conditions: training and no support, training and minimal support, training and maximal support. An additional 34 physicians were randomly selected and assigned to a control condition. The ultimate aim of training and support was to maximise physician screening and counselling rates. Tele-marketing was found to be more cost-effective than academic detailing and direct mail in promoting the uptake of the package. For the training and support phase costs and effects increased with the level of support, hence the issue to be considered is whether the additional cost incurred in moving from one strategy to another is warranted given the increase in the level of outcome.

Focus is key: Panic-focused interpretations are associated with symptomatic improvement in panic-focused psychodynamic psychotherapy.

PubMed

Keefe, John R; Solomonov, Nili; Derubeis, Robert J; Phillips, Alexander C; Busch, Fredric N; Barber, Jacques P; Chambless, Dianne L; Milrod, Barbara L

2018-04-18

This study examines whether, in panic-focused psychodynamic psychotherapy (PFPP), interpretations of conflicts that underlie anxiety (panic-focused or PF-interpretations) are specifically associated with subsequent panic disorder (PD) symptom improvement, over and above the provision of non-symptom-focused interpretations. Technique use in Sessions 2 and 10 of a 24-session PFPP protocol was assessed for the 65 patients with complete outcome data randomized to PFPP in a two-site trial of psychotherapies for PD. Sessions were rated in 15-min segments for therapists' use of PF-interpretations, non-PF-interpretations, and PF-clarifications. Robust regressions were conducted to examine the relationship between these interventions and symptom change subsequent to the sampled session. Interpersonal problems were examined as a moderator of the relationship of PF-interpretations to symptom change. At Session 10, but not at Session 2, patients who received a higher degree of PF-interpretations experienced greater subsequent improvement in panic symptoms. Non-PF-interpretations were not predictive. Patients with more interpersonal distress benefitted particularly from the use of PF-interpretations at Session 10. By the middle phase of PFPP, panic-focused interpretations may drive subsequent improvements in panic symptoms, especially among patients with higher interpersonal distress. Interpretations of conflict absent a panic focus may not be especially helpful.

SU-E-T-56: A Novel Approach to Computing Expected Value and Variance of Point Dose From Non-Gated Radiotherapy Delivery

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

Zhou, S; Zhu, X; Zhang, M

Purpose: Randomness in patient internal organ motion phase at the beginning of non-gated radiotherapy delivery may introduce uncertainty to dose received by the patient. Concerns of this dose deviation from the planned one has motivated many researchers to study this phenomenon although unified theoretical framework for computing it is still missing. This study was conducted to develop such framework for analyzing the effect. Methods: Two reasonable assumptions were made: a) patient internal organ motion is stationary and periodic; b) no special arrangement is made to start a non -gated radiotherapy delivery at any specific phase of patient internal organ motion.more » A statistical ensemble was formed consisting of patient’s non-gated radiotherapy deliveries at all equally possible initial organ motion phases. To characterize the patient received dose, statistical ensemble average method is employed to derive formulae for two variables: expected value and variance of dose received by a patient internal point from a non-gated radiotherapy delivery. Fourier Series was utilized to facilitate our analysis. Results: According to our formulae, the two variables can be computed from non-gated radiotherapy generated dose rate time sequences at the point’s corresponding locations on fixed phase 3D CT images sampled evenly in time over one patient internal organ motion period. The expected value of point dose is simply the average of the doses to the point’s corresponding locations on the fixed phase CT images. The variance can be determined by time integration in terms of Fourier Series coefficients of the dose rate time sequences on the same fixed phase 3D CT images. Conclusion: Given a non-gated radiotherapy delivery plan and patient’s 4D CT study, our novel approach can predict the expected value and variance of patient radiation dose. We expect it to play a significant role in determining both quality and robustness of patient non-gated radiotherapy plan.« less

Thinking, Fast and Slow? Some Field Experiments to Reduce Crime and Dropout in Chicago. NBER Working Paper 21178

ERIC Educational Resources Information Center

Heller, Sara B.; Shah, Anuj K.; Guryan, Jonathan; Ludwig, Jens; Mullainathan, Sendhil; Pollack, Harold A.

2015-01-01

We present the results of three large-scale randomized controlled trials (RCTs) carried out in Chicago, testing interventions to reduce crime and dropout by changing the decision-making of economically disadvantaged youth. We study a program called Becoming a Man (BAM), developed by the non-profit Youth Guidance, in two RCTs implemented in 2009-10…

Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

PubMed

Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

2016-03-15

Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

The clinical examination of non-word repetition tasks in identifying Persian-speaking children with primary language impairment.

PubMed

Kazemi, Yalda; Saeednia, Soodeh

2017-02-01

This study aimed to examine the diagnostic accuracy of a non-word repetition (NWR) test in identifying Persian-speaking preschool children with specific/primary language impairment (PLI). Children with PLI show consistently poorer performance in non-word repetition tasks than their typically developing language (TDL) counterparts. It is assumed that the ability to repeat non-words triggers language skills and that the absence of this ability may be responsible for language impairment in PLI children. Twenty preschool children with PLI participated in this study and were compared with 31 peers whose language skills were developing typically. The TDL children were randomly selected from daycare centers, and the children with PLI were referred by qualified speech-language pathologists from speech therapy clinics. A Persian NWR test was administered and scored using two levels of scoring: item-level scoring and syllable-level scoring. Data were analyzed in two phases. The first phase aimed to determine any differences between the two groups of children in terms of NWR ability. The second phase examined the diagnostic measures of the test. The results of first phase documented that both scoring methods for the NWR test significantly differentiated between children with PLI and their normal peers. The second phase indicated that both scoring methods for the NWR test have good sensitivity and specificity in differentiating Persian-speaking children with PLI from their normal peers. Non-word repetition can be a reliable clinical marker of PLI in Persian-speaking preschool children. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The effects of PECS teaching to Phase III on the communicative interactions between children with autism and their teachers.

PubMed

Carr, Deborah; Felce, Janet

2007-04-01

The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h classroom observations recorded communications between the children and their teachers. These occurred: 6 weeks before teaching; during the week immediately prior to teaching; during the week immediately following teaching. For the control group, two 2-h observations were separated by a 5-week interval without PECS teaching. Communicative initiations and dyadic interactions increased significantly between the children and teachers in the PECS group but not for the control group.

A protocol for a systematic review of the effectiveness of interventions to reduce exposure to lead through consumer products and drinking water

PubMed Central

2014-01-01

Background The toxic heavy metal lead continues to be a leading environmental risk factor, with the number of attributable deaths having doubled between 1990 and 2010. Although major sources of lead exposure, in particular lead in petrol, have been significantly reduced in recent decades, lead is still used in a wide range of processes and objects, with developing countries disproportionally affected. The objective of this systematic review is to assess the effectiveness of regulatory, environmental and educational interventions for reducing blood lead levels and associated health outcomes in children, pregnant women and the general population. Methods/design The databases MEDLINE, Embase and the Global Health Library (GHL) will be searched using a sensitive search strategy. Studies in English, German, French, Spanish, Italian or Afrikaans will be screened according to predefined inclusion and exclusion criteria. We will consider randomized and non-randomized studies accepted by the Cochrane Effective Practice and Organization of Care (EPOC) Group, as well as additional non-randomized studies. Screening of titles and abstracts will be performed by one author. Full texts of potentially relevant studies will be independently assessed for eligibility by two authors. A single author will extract data, with a second reviewer checking the extraction form. Risk of bias will be assessed by two researchers using the Graphical Appraisal Tool for Epidemiological studies, as modified by the Centre for Public Health at the UK National Institute for Health and Care Excellence. Any inconsistencies in the assessment of eligibility, data extraction or quality appraisal will be resolved through discussion. Where two or more studies report the primary outcome blood lead levels within the same population group, intervention category and source of lead exposure, data will be pooled using random effects meta-analysis. In parallel, harvest plots as a graphical method of evidence synthesis will be used to present findings for blood lead levels and secondary outcomes. Discussion This systematic review will fill an important evidence gap with respect to the effectiveness of interventions to reduce lead in consumer products and drinking water in the context of new WHO guidelines for the prevention and management of lead poisoning. It will also contribute to setting a future research agenda. PMID:24731516

Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs.

PubMed

Wyman, Peter A; Henry, David; Knoblauch, Shannon; Brown, C Hendricks

2015-10-01

The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for non-random selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in two Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed.

Acute effects of whole body vibration on balance in persons with and without chronic ankle instability.

PubMed

Rendos, Nicole K; Jun, Hyung-Pil; Pickett, Nancy M; Lew Feirman, Karen; Harriell, Kysha; Lee, Sae Yong; Signorile, Joseph F

2017-01-01

Chronic ankle instability (CAI) is a common condition following ankle injury that is associated with compromised balance. Whole body vibration training (WBVT) programmes are linked with improved balance and function in athletic and non-athletic populations and may improve balance in CAI. Twelve healthy and seven CAI participants completed two randomly assigned interventions. Two Power Plate® platforms were attached back to back using a Theraband®. Participants stood on the active plate and inactive plate for WBVT and sham interventions, respectively. Each intervention included vibration of the active plate. Centre of pressure (COP) and the star excursion balance test (SEBT) were measured before and at 3, 15 and 30 min following the interventions. Significant improvements were found in the anterior direction of the SEBT following both interventions in CAI and varying patterns of improvement were observed for COP measurements in all participants. Therefore, WBVT does not appear to acutely improve balance in CAI.

A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Lerner, Matthew D.; Mikami, Amori Y.

2012-01-01

This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PubMed Central

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles. PMID:29216190

Stage-Based Healthy Lifestyles Program for Non-College Young Adults

ERIC Educational Resources Information Center

Walsh, Jennifer; Kattelmann, Kendra; White, Adrienne

2017-01-01

Purpose: The purpose of this paper is to test the feasibility of implementing a healthy lifestyles intervention to maintain or achieve healthy weight for low-income young adults in vocational education. Design/methodology/approach: Non-randomized, quasi-experimental feasibility test of a ten-week intervention with follow-up assessment designed…

Impact of a Six-Month Empowerment-Based Exercise Intervention Programme in Non-Physically Active Adolescent Swedish Girls

ERIC Educational Resources Information Center

Lindgren, Eva-Carin; Baigi, Amir; Apitzsch, Erwin; Bergh, Hakan

2011-01-01

Objective: This study evaluated changes in self-efficacy in non-physically active adolescent girls (13-19 years old) who participated in a six-month, empowerment-based exercise intervention programme (EIP). Design: The study used a pre- and post-test randomized group design and included one pre- and one post-test (at six months) and non-physically…

Next-Step Strategies for Panic Disorder Refractory to Initial Pharmacotherapy

PubMed Central

Simon, NM; Otto, MW; Worthington, JJ; Hoge, EA; Thompson, EH; LeBeau, RT; Moshier, SJ; Zalta, AK; Pollack, MH

2010-01-01

Background More data is needed to guide next step interventions for panic disorder refractory to initial intervention. Method This 24-week randomized clinical trial (RCT) consisted of three phases. Phase 1 is a 6-week lead-in with open-label sertraline flexibly dosed to 100mg (or escitalopram equivalent) to prospectively define treatment refractoriness (lack of remission). Phase 2 is a six-week double blind RCT of (1) increased dose serotonin selective reuptake inhibitor (SSRI) versus (2) continued SSRI plus placebo. Phase 3 is a 12-week RCT of added cognitive-behavioral therapy (CBT) compared to “medication-optimization” (MO) with SSRI plus clonazepam. Primary endpoints were remission and change in Panic Disorder Severity Scale (PDSS) score in the intent to treat sample in each phase. Results In Phase 1, 20.5% (8/39) achieved remission, and only baseline severity predicted endpoint PDSS (β (SE)= 1.04(0.15), t=6.76, p<0.000). In Phase 2, increasing the SSRI dose did not result in greater improvement or remission rates (placebo 15% [n=2] vs. increased dose 9%[n=1]: FET p=n.s.). In Phase 3, remission was minimal (MO = 11%; CBT =10%), with a lack of group difference in PDSS reduction (t(df)=0.51(17), p>0.60) consistent with a small effect size (d=0.24). Conclusion Although power was limited and larger studies are needed, we failed to find evidence for greater benefit of increased SSRI dose versus continuation of current dose for panic disorder symptomatic after 6 weeks at moderate dose. Further, augmentation with CBT or medication optimization with clonazepam augmentation in non-remitted panic after 12 weeks of an SSRI did not differ, suggesting both are reasonable next-step options. However, low overall remission rates in this comorbid refractory population suggest better predictors of response to specific treatments over time and additional interventions are needed. PMID:19814948

The impact of a workplace catering initiative on dietary intakes of salt and other nutrients: a pilot study.

PubMed

Geaney, F; Harrington, J; Fitzgerald, Ap; Perry, Ij

2011-08-01

Owing to modern lifestyles, individuals are dependent on out-of-home eating. The catering sector can have a pivotal role in influencing our food choices. The objective of the present study was to examine the impact of a structured catering initiative on food choices in a public sector workplace setting. A cross-sectional comparison study in two hospitals, one of which had implemented a catering initiative designed to provide nutritious food while reducing sugar, fat and salt intakes. Two public sector hospitals in Cork, Ireland. A total of 100 random participants aged 18-64 years (fifty intervention, fifty non-intervention) who consumed at least one main meal in the hospital staff canteen daily. Each respondent was asked to complete one anonymous 24 h dietary recall and questionnaire. Food and nutrient analysis was conducted using WISP (Weighed Intake Software Program). Reported mean intakes of total sugars (P < 0·001), total fat (P < 0·000), saturated fat (P < 0·000) and salt (P < 0·046) were significantly lower in the intervention hospital when adjusted for age and gender. In the intervention hospital, 72 % of respondents, compared with 42 % in the non-intervention hospital, complied with the recommended under-3 daily servings of food high in fat and sugar (P < 0·005). In the intervention hospital, 43 % of respondents exceeded the recommended salt intake of 4-6 g/d, compared with 57 % in the non-intervention hospital. Structured catering initiatives in the workplace are a potentially important option in the promotion of healthy food choices. Targeted public health programmes and health policy changes are needed to motivate caterers in the public sector and other industries to develop interventions that promote a healthy diet.

Contact resistance change memory using N-doped Cr2Ge2Te6 phase-change material showing non-bulk resistance change

NASA Astrophysics Data System (ADS)

Shuang, Y.; Sutou, Y.; Hatayama, S.; Shindo, S.; Song, Y. H.; Ando, D.; Koike, J.

2018-04-01

Phase-change random access memory (PCRAM) is enabled by a large resistance contrast between amorphous and crystalline phases upon reversible switching between the two states. Thus, great efforts have been devoted to identifying potential phase-change materials (PCMs) with large electrical contrast to realize a more accurate reading operation. In contrast, although the truly dominant resistance in a scaled PCRAM cell is contact resistance, less attention has been paid toward the investigation of the contact property between PCMs and electrode metals. This study aims to propose a non-bulk-resistance-dominant PCRAM whose resistance is modulated only by contact. The contact-resistance-dominated PCM exploited here is N-doped Cr2Ge2Te6 (NCrGT), which exhibits almost no electrical resistivity difference between the two phases but exhibits a typical switching behavior involving a three-order-of-magnitude SET/RESET resistance ratio owing to its large contact resistance contrast. The conduction mechanism was discussed on the basis of current-voltage characteristics of the interface between the NCrGT and the W electrode.

Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

PubMed Central

2013-01-01

Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. Methods/design The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group. The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups. Discussion Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients. Trial registration The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06. PMID:23945051

Combined Cognitive and Parent Training Interventions for Adolescents with ADHD and Their Mothers: A Randomized Controlled Trial

PubMed Central

Steeger, Christine M.; Gondoli, Dawn M.; Gibson, Bradley S.; Morrissey, Rebecca A.

2015-01-01

Objective This study examined the individual and combined effects of two non-pharmacological treatments for Attention-Deficit/Hyperactivity Disorder (ADHD): Cogmed working memory training (CWMT) for adolescents, and behavioral parent training (BPT) for mothers. Method Ninety-one adolescents (ages 11–15) and their mothers were randomized to one of four CWMT and BPT treatment and active control (placebo) group combinations of 5-week interventions. At pre- and post-test, mothers and teachers completed rating forms, and adolescents completed neuropsychological measures of working memory (WM). Results Individual intervention effects showed that treatment CWMT significantly improved WM spans, whereas there were no significant differences for treatment or control BPT on reports of parenting-related outcomes. Combined treatment effects indicated an overall pattern of greatest improvements for the control CWMT/treatment BPT group, as compared to the other three groups, on adolescent WM deficit, behavioral regulation problems, and global executive deficit. Most significant effects for outcomes were main effects of improvements over time. Conclusions: Combination CWMT and BPT did not result in increased treatment gains. However, potential effects of combined treatment may have been masked by greater perceived benefits arising from lack of struggle in the non-adaptive, CWMT active control condition. Future combined intervention research should focus on specific, theoretically-driven WM deficits among individuals with ADHD, include possible adaptations to the standard CWMT program, examine effectiveness of cognitive treatments combined with contextual interventions, and utilize appropriate control groups to fully understand the unique and combined effects of interventions. PMID:25731907

Non-pharmaceutical public health interventions for pandemic influenza: an evaluation of the evidence base.

PubMed

Aledort, Julia E; Lurie, Nicole; Wasserman, Jeffrey; Bozzette, Samuel A

2007-08-15

In an influenza pandemic, the benefit of vaccines and antiviral medications will be constrained by limitations on supplies and effectiveness. Non-pharmaceutical public health interventions will therefore be vital in curtailing disease spread. However, the most comprehensive assessments of the literature to date recognize the generally poor quality of evidence on which to base non-pharmaceutical pandemic planning decisions. In light of the need to prepare for a possible pandemic despite concerns about the poor quality of the literature, combining available evidence with expert opinion about the relative merits of non-pharmaceutical interventions for pandemic influenza may lead to a more informed and widely accepted set of recommendations. We evaluated the evidence base for non-pharmaceutical public health interventions. Then, based on the collective evidence, we identified a set of recommendations for and against interventions that are specific to both the setting in which an intervention may be used and the pandemic phase, and which can be used by policymakers to prepare for a pandemic until scientific evidence can definitively respond to planners' needs. Building on reviews of past pandemics and recent historical inquiries, we evaluated the relative merits of non-pharmaceutical interventions by combining available evidence from the literature with qualitative and quantitative expert opinion. Specifically, we reviewed the recent scientific literature regarding the prevention of human-to-human transmission of pandemic influenza, convened a meeting of experts from multiple disciplines, and elicited expert recommendation about the use of non-pharmaceutical public health interventions in a variety of settings (healthcare facilities; community-based institutions; private households) and pandemic phases (no pandemic; no US pandemic; early localized US pandemic; advanced US pandemic). The literature contained a dearth of evidence on the efficacy or effectiveness of most non-pharmaceutical interventions for influenza. In an effort to inform decision-making in the absence of strong scientific evidence, the experts ultimately endorsed hand hygiene and respiratory etiquette, surveillance and case reporting, and rapid viral diagnosis in all settings and during all pandemic phases. They also encouraged patient and provider use of masks and other personal protective equipment as well as voluntary self-isolation of patients during all pandemic phases. Other non-pharmaceutical interventions including mask-use and other personal protective equipment for the general public, school and workplace closures early in an epidemic, and mandatory travel restrictions were rejected as likely to be ineffective, infeasible, or unacceptable to the public. The demand for scientific evidence on non-pharmaceutical public health interventions for influenza is pervasive, and present policy recommendations must rely heavily on expert judgment. In the absence of a definitive science base, our assessment of the evidence identified areas for further investigation as well as non-pharmaceutical public health interventions that experts believe are likely to be beneficial, feasible and widely acceptable in an influenza pandemic.

'TXT2BFiT' a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial.

PubMed

Hebden, Lana; Balestracci, Kate; McGeechan, Kevin; Denney-Wilson, Elizabeth; Harris, Mark; Bauman, Adrian; Allman-Farinelli, Margaret

2013-03-18

Despite international efforts to arrest increasing rates of overweight and obesity, many population strategies have neglected young adults as a target group. Young adults are at high risk for unhealthy weight gain which tends to persist throughout adulthood with associated chronic disease health risks. TXT2BFiT is a nine month two-arm parallel-group randomized controlled trial aimed at improving weight management and weight-related dietary and physical activity behaviors among young adults. Participants are recruited via general practice (primary medical care) clinics in Sydney, New South Wales, Australia. All participants receive a mailed resource outlining national physical activity and dietary guidelines and access to the study website. Additional resources accessible to the intervention arm via the study website include Smartphone mobile applications, printable handouts, an interactive healthy weight tracker chart, and a community blog. The study consists of two phases: (1) Intensive phase (weeks 1 to 12): the control arm receives four short message service (SMS) text messages; the intervention arm receives eight SMS messages/week tailored to their baseline stage-of-change, one Email/week, and personalized coaching calls during weeks 0, 2, 5, 8, and 11; and (2) Maintenance phase (weeks 14 to 36): the intervention arm receives one SMS message/month, one Email/month and booster coaching calls during months 5 and 8. A sample of N = 354 (177 per arm) is required to detect differences in primary outcomes: body weight (kg) and body mass index (kg/m2), and secondary outcomes: physical activity, sitting time, intake of specific foods, beverages and nutrients, stage-of-change, self-efficacy and participant well-being, at three and nine months. Program reach, costs, implementation and participant engagement will also be assessed. This mobile phone based program addresses an important gap in obesity prevention efforts to date. The method of intervention delivery is via platforms that are highly accessible and appropriate for this population group. If effective, further translational research will be required to assess how this program might operate in the broader community. Australian New Zealand Clinical Trials Registry ACTRN12612000924853.

Small Changes and Lasting Effects (SCALE) Trial: The Formation of a Weight Loss Behavioral Intervention Using EVOLVE

PubMed Central

Phillips-Caesar, Erica G.; Winston, Ginger; Peterson, Janey C.; Wansink, Brian; Devine, Carol M.; Kanna, Balavanketsh; Michelin, Walid; Wethington, Elaine; Wells, Martin; Hollenberg, James; Charlson, Mary E.

2015-01-01

Background Obesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss. Methods Using a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant’s values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months. Results Over 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis. Conclusion The present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone. PMID:25633208

Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study.

PubMed

Barnestein-Fonseca, Pilar; Leiva-Fernández, José; Vidal-España, Francisca; García-Ruiz, Antonio; Prados-Torres, Daniel; Leiva-Fernández, Francisca

2011-02-14

Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment. The therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is extremely poor according to most studies. The research about COPD adherence has mainly focussed on quantifying its effect, and few studies have researched factors that affect non-adherence. Our study will evaluate the effectiveness of a multifactor intervention to improve the therapeutic adherence of COPD patients. A randomized controlled clinical trial with 140 COPD diagnosed patients selected by a non-probabilistic method of sampling. Subjects will be randomly allocated into two groups, using the block randomization technique. Every patient in each group will be visited four times during the year of the study. Motivational aspects related to adherence (beliefs and behaviour): group and individual interviews; cognitive aspects: information about illness; skills: inhaled technique training. Reinforcement of the cognitive-emotional aspects and inhaled technique training will be carried out in all visits of the intervention group. Adherence to a prescribed treatment involves a behavioural change. Cognitive, emotional and motivational aspects influence this change and so we consider the best intervention procedure to improve adherence would be a cognitive and emotional strategy which could be applied in daily clinical practice. Our hypothesis is that the application of a multifactor intervention (COPD information, dose reminders and reinforcing audiovisual material, motivational aspects and inhalation technique training) to COPD patients taking inhaled treatment will give a 25% increase in the number of patients showing therapeutic adherence in this group compared to the control group.We will evaluate the effectiveness of this multifactor intervention on patient adherence to inhaled drugs considering that it will be right and feasible to the clinical practice context. Current Controlled Trials ISRCTN18841601.

Stable and efficient retrospective 4D-MRI using non-uniformly distributed quasi-random numbers

NASA Astrophysics Data System (ADS)

Breuer, Kathrin; Meyer, Cord B.; Breuer, Felix A.; Richter, Anne; Exner, Florian; Weng, Andreas M.; Ströhle, Serge; Polat, Bülent; Jakob, Peter M.; Sauer, Otto A.; Flentje, Michael; Weick, Stefan

2018-04-01

The purpose of this work is the development of a robust and reliable three-dimensional (3D) Cartesian imaging technique for fast and flexible retrospective 4D abdominal MRI during free breathing. To this end, a non-uniform quasi random (NU-QR) reordering of the phase encoding (k y –k z ) lines was incorporated into 3D Cartesian acquisition. The proposed sampling scheme allocates more phase encoding points near the k-space origin while reducing the sampling density in the outer part of the k-space. Respiratory self-gating in combination with SPIRiT-reconstruction is used for the reconstruction of abdominal data sets in different respiratory phases (4D-MRI). Six volunteers and three patients were examined at 1.5 T during free breathing. Additionally, data sets with conventional two-dimensional (2D) linear and 2D quasi random phase encoding order were acquired for the volunteers for comparison. A quantitative evaluation of image quality versus scan times (from 70 s to 626 s) for the given sampling schemes was obtained by calculating the normalized mutual information (NMI) for all volunteers. Motion estimation was accomplished by calculating the maximum derivative of a signal intensity profile of a transition (e.g. tumor or diaphragm). The 2D non-uniform quasi-random distribution of phase encoding lines in Cartesian 3D MRI yields more efficient undersampling patterns for parallel imaging compared to conventional uniform quasi-random and linear sampling. Median NMI values of NU-QR sampling are the highest for all scan times. Therefore, within the same scan time 4D imaging could be performed with improved image quality. The proposed method allows for the reconstruction of motion artifact reduced 4D data sets with isotropic spatial resolution of 2.1  ×  2.1  ×  2.1 mm3 in a short scan time, e.g. 10 respiratory phases in only 3 min. Cranio-caudal tumor displacements between 23 and 46 mm could be observed. NU-QR sampling enables for stable 4D-MRI with high temporal and spatial resolution within short scan time for visualization of organ or tumor motion during free breathing. Further studies, e.g. the application of the method for radiotherapy planning are needed to investigate the clinical applicability and diagnostic value of the approach.

Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study.

PubMed

Avis, Jillian Ls; Cave, Andrew L; Donaldson, Stephanie; Ellendt, Carol; Holt, Nicholas L; Jelinski, Susan; Martz, Patricia; Maximova, Katerina; Padwal, Raj; Wild, T Cameron; Ball, Geoff Dc

2015-03-25

Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents' motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents' concern for, and motivation to, support children's healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children-boys and girls, 5 to 17 years old-will be recruited from a primary care pediatric clinic while they await their children's clinical appointment. Parents will be randomly assigned to one of five groups-four intervention groups and one control group-as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children's dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children's healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or "nudge" individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr).

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults

PubMed Central

Fitzpatrick, Stephanie L.; Coughlin, Janelle W.; Appel, Lawrence J.; Tyson, Crystal; Stevens, Victor J.; Jerome, Gerald J.; Dalcin, Arlene; Brantley, Phillip J.; Hill-Briggs, Felicia

2016-01-01

Background Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. Purpose The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. Method Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n=501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n=1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. Results In PREMIER, three distinct latent classes emerged: responders (45.9 %), non-responders (23.6 %), and early adherers (30.5 %). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16 %), non-responders (40 %), early adherers (2 %), and fruit/veggie only responders (41 %). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. Conclusion Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes. PMID:25331853

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.

PubMed

Fitzpatrick, Stephanie L; Coughlin, Janelle W; Appel, Lawrence J; Tyson, Crystal; Stevens, Victor J; Jerome, Gerald J; Dalcin, Arlene; Brantley, Phillip J; Hill-Briggs, Felicia

2015-08-01

Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Computer-supported indirect-form lifestyle-modification support program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP) for people with a family history of type 2 diabetes in a medical checkup setting: a randomized controlled trial.

PubMed

Tokunaga-Nakawatase, Yuri; Nishigaki, Masakazu; Taru, Chiemi; Miyawaki, Ikuko; Nishida, Junko; Kosaka, Shiho; Sanada, Hiromi; Kazuma, Keiko

2014-10-01

To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP), as a clinically feasible strategy for primary prevention, on diet and physical activity habits in adults with a family history of type 2 diabetes. This was a two-arm, randomized controlled trial: (1) lifestyle intervention (LI) group (n=70); (2) control (n=71). Healthy adults aged 30-60 years with a history of type 2 diabetes among their first-degree relatives were recruited. LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail. Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline, compared to control (-118.31 and -24.79 kcal/day, respectively, p=0.0099, Cohen's d=0.22), though the difference disappeared 1 year after from baseline. No difference was found in physical activity energy expenditure. A computer-based, non-face-to-face lifestyle intervention was effective on dietary habits, only during the intervention period. Further examination of the long-term effects of such intervention and physical activity is required. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Cognitive bias modification and CBT as early interventions for adolescent social and test anxiety: Two-year follow-up of a randomized controlled trial.

PubMed

de Hullu, Eva; Sportel, B Esther; Nauta, Maaike H; de Jong, Peter J

2017-06-01

This two-year follow-up study evaluated the long-term outcomes of two early interventions that aimed at reducing social and test anxiety in young adolescents at risk for developing social anxiety disorder. In this RCT, moderately socially anxious adolescents (N=240, mean age 13.6 years) were randomly assigned to a 10-week internet-based multifaceted cognitive bias modification training (CBM), a 10-week school-based cognitive behavioral group training (CBT), or a no-intervention control condition. Using multiple imputation, this study examined the changes in primary and secondary outcome measures from pretest to follow-up in a repeated measures design. Primary outcome: Self-reported social and test anxiety generally decreased from pre-test to two-year follow-up, regardless of treatment condition. The percentage of adolescents who developed a social anxiety disorder was very low (6%) and similar across conditions. Secondary outcome: There were beneficial changes in self-esteem, self-reported prosocial behaviors, and fear of negative evaluation, but none of these were related to treatment condition. Automatic social-threat associations did not significantly change. The CBM intervention was effective in changing interpretative bias as indexed by the Recognition Task but this long-term effect did not transfer to the Adolescent Interpretation and Belief Questionnaire. There was a substantial (50%) though seemingly non-selective attrition at follow-up. This RCT does not support the longer-term efficacy of school-based CBT or CBM as an early intervention for social and test anxiety. Rather, it emphasizes the positive 'natural' course of highly socially anxious adolescents over two years. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

Randomized controlled trial of exercise interventions to improve sleep quality and daytime sleepiness in individuals with multiple sclerosis: A pilot study.

PubMed

Siengsukon, Catherine F; Aldughmi, Mayis; Kahya, Melike; Bruce, Jared; Lynch, Sharon; Ness Norouzinia, Abigail; Glusman, Morgan; Billinger, Sandra

2016-01-01

Nearly 70% of individuals with multiple sclerosis (MS) experience sleep disturbances. Increasing physical activity in people with MS has been shown to produce a moderate improvement in sleep quality, and exercise has been shown to improve sleep quality in non-neurologically impaired adults. The purpose of this pilot randomized controlled trial study was to examine the effect of two exercise interventions on sleep quality and daytime sleepiness in individuals with MS. Twenty-eight individuals with relapsing-remitting or secondary progressive MS were randomized into one of two 12-week exercise interventions: a supervised, moderate-intensity aerobic exercise (AE) program or an unsupervised, low-intensity walking and stretching (WS) program. Only individuals who were ≥ 70% compliant with the programs were included in analysis ( n  = 12 AE; n  = 10 WS). Both groups demonstrated a moderate improvement in sleep quality, although only the improvement by the WS group was statistically significant. Only the AE group demonstrated a significant improvement in daytime sleepiness. Change in sleep quality and daytime sleepiness was not correlated with disease severity or with change in cardiovascular fitness, depression, or fatigue. The mechanisms for improvement in sleep quality and daytime sleepiness need further investigation, but may be due to introduction of zeitgebers to improve circadian rhythm.

The impact of two workplace-based health risk appraisal interventions on employee lifestyle parameters, mental health and work ability: results of a randomized controlled trial.

PubMed

Addley, K; Boyd, S; Kerr, R; McQuillan, P; Houdmont, J; McCrory, M

2014-04-01

Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental health and work ability in a UK context. A total of 180 employees were randomized into one of three groups: Group A (HRA augmented with health promotion and education activities), Group B (HRA only) and Group C (control, no intervention). After 12 months, changes in mean scoring in 10 lifestyle, mental health and work ability indices were compared, Groups A and B demonstrated non-significant improvements in 70% and 80%, respectively, compared with controls (40%). Odds ratios revealed that, compared with the control group, Group A was 29.2 (95% CI: 9.22-92.27) times more likely to report a perceived change in lifestyle behaviour; Group B 4.4 times (95% CI: 1.65-11.44). In conclusion, participation in the HRA was associated with a higher likelihood of perceived lifestyle behaviour change which was further increased in the augmented HRA group, thereby providing preliminary evidence that HRA and augmented HRA in particular may help UK employees make positive healthy lifestyle changes.

Adolescents’ impressions of antismoking media literacy education: qualitative results from a randomized controlled trial

PubMed Central

Primack, Brian A.; Fine, Danielle; Yang, Christopher K.; Wickett, Dustin; Zickmund, Susan

2009-01-01

Although media literacy represents an innovative venue for school-based antismoking programming, studies have not systematically compared student impressions of these and traditional programs. This study utilized data from a randomized trial comparing these two types of programs. After each program, students responded to three open-ended questions related to their assigned curriculum. Two coders, blinded to student assignments, independently coded these data. Coders had strong inter-rater agreement (kappa = 0.77). Our primary measures were spontaneously noted overall assessment, enjoyment/interest and the likelihood of changing smoking behavior. Of the 531 participants, 255 (48.0%) were randomized to the intervention (media literacy) group. Intervention participants had more net positive responses [rate ratio (RR) = 1.27, 95% confidence interval (CI) = 1.05, 1.54], more responses rating the program as compelling (RR = 1.63, 95% CI = 1.16, 2.29) and fewer responses rating the program as non-compelling (RR = 0.62, 95% CI = 0.39, 0.97). However, the intervention group was not more likely to suggest that the curriculum was likely to change behavior positively (RR = 0.57, 95% CI = 0.30, 1.06). Findings suggest that although media literacy provides a compelling format for the delivery of antitobacco programming, integration of components of traditional programming may help media literacy programs achieve maximal efficacy. PMID:19052155

A randomized-controlled trial focusing on socio-economic status for promoting vegetable intake among adults using a web-based nutrition intervention programme: study protocol.

PubMed

Nakamura, Saki; Inayama, Takayo; Arao, Takashi

2017-01-13

Web-based nutritional education programmes appear to be comparable to those delivered face-to-face. However, no existing web-based nutrition education or similar programme has yet been evaluated with consideration of socio-economic status. The objective of a nutritional education programme of promoting vegetable intake designed a randomized controlled trial (RCT) is to evaluate the results of intervention and to determine how socio-economic status influences the programme effects. Participants will be randomly sampled individuals (aged 30-59) stratified according national population statistics for sex, age, and household income. Participants were consented to survey participation (n = 1500), and will be randomly divided into intervention and control groups. The intervention period is 5 weeks with one step of diet-related education per week. The main outcome of the programme is dietary behaviour as eating vegetable (350 g per day, five small bowl). To encourage behavioural changes, the programme contents are prepared using behavioural theories and techniques tailored to the assumed group stages of behavioural change. In the first step, we employ the health belief model to encourage a shift from the pre-contemplative to the contemplative phase; in the second and third steps, social cognitive theory is used to encourage transition to the preparatory phase; in the fourth step, social cognitive theory and strengthening social support are used to promote progression to the execution phase; finally, in the fifth step, strengthening social capital and social support are used to promote the shift to the maintenance phase. The baseline, post intervention and follow-up survey was assessed using a self-administered questionnaire. For process evaluation, we use five items relating to programme participation and satisfaction. A follow-up survey of participants will be carried out 3 months after intervention completion. The fact that this study is an RCT with an established control group is a strong advantage. Information and communications technology is not limited by time or place. If we could show this web-based nutrition education programmes has a positive effect, it may be an appropriate tool for reaching individuals in lower socio-economic state. Current Controlled Trials UMIN-ICDR UMIN 000019376 (Registered October 16, 2015).

[Effect of Music Intervention on Maternal Anxiety and Fetal Heart Rate Pattern During Non-Stress Test].

PubMed

Oh, Myung Ok; Kim, Young Jeoum; Baek, Cho Hee; Kim, Ju Hee; Park, No Mi; Yu, Mi Jeong; Song, Han Sol

2016-06-01

The purpose of this cross-over experimental study was to examine effects of music intervention on maternal anxiety, fetal heart rate pattern and testing time during non-stress tests (NST) for antenatal fetal assessment. Sixty pregnant women within 28 to 40 gestational weeks were randomly assigned to either the experimental group (n=30) or control group (n=30). Music intervention was provided to pregnant women in the experimental group during NST. Degree of maternal anxiety and fetal heart rate pattern were our primary outcomes. State-trait anxiety inventory, blood pressure, pulse rate, and changes in peripheral skin temperature were assessed to determine the degree of maternal anxiety. Baseline fetal heart rate, frequency of acceleration in fetal heart rate, fetal movement test and testing time for reactive NST were assessed to measure the fetal heart rate pattern. The experimental group showed significantly lower scores in state anxiety than the control group. There were no significant differences in systolic blood pressure and pulse rate between the two groups. Baseline fetal heart rate was significantly lower in the experimental group than in the control group. Frequency of acceleration in fetal heart rate was significantly increased in the experimental group compared to the control group. There were no significant differences in fetal movement and testing time for reactive NST between the two groups. Present results suggest that music intervention could be an effective nursing intervention for alel viating anxiety during non-stress test.

Effects of Sex Education and Kegel Exercises on the Sexual Function of Postmenopausal Women: A Randomized Clinical Trial.

PubMed

Nazarpour, Soheila; Simbar, Masoumeh; Ramezani Tehrani, Fahimeh; Alavi Majd, Hamid

2017-07-01

The sex lives of women are strongly affected by menopause. Non-pharmacologic approaches to improving the sexual function of postmenopausal women might prove effective. To compare two methods of intervention (formal sex education and Kegel exercises) with routine postmenopausal care services in a randomized clinical trial. A randomized clinical trial was conducted of 145 postmenopausal women residing in Chalus and Noshahr, Iran. Their sexual function statuses were assessed using the Female Sexual Function Index (FSFI) questionnaire. After obtaining written informed consents, they were randomly assigned to one of three groups: (i) formal sex education, (ii) Kegel exercises, or (iii) routine postmenopausal care. After 12 weeks, all participants completed the FSFI again. Analysis of covariance was used to compare the participants' sexual function before and after the interventions, and multiple linear regression analysis was used to determine the predictive factors for variation in FSFI scores in the postintervention stage. Sexual function was assessed using the FSFI. There were no statistically significant differences in demographic and socioeconomic characteristics and FSFI total scores among the three study groups at the outset of the study. After 12 weeks, the scores of arousal in the formal sex education and Kegel groups were significantly higher compared with the control group (3.38 and 3.15 vs 2.77, respectively). The scores of orgasm and satisfaction in the Kegel group were significantly higher compared with the control group (4.43 and 4.88 vs 3.95 and 4.39, respectively). Formal sex education and Kegel exercises were used as two non-pharmacologic approaches to improve the sexual function of women after menopause. The main strength of this study was its design: a well-organized randomized trial using precise eligibility criteria with a small sample loss. The second strength was the methods of intervention used, namely non-pharmacologic approaches that are simple, easily accessible, and fairly inexpensive. The main limitation of the study was our inability to objectively assess the participants' commitment to exercise and the sexual function of their partners. Sex education programs and Kegel exercises could cause improvements in some domains of sexual function-specifically arousal, orgasm, and satisfaction-in postmenopausal women. Nazarpour S, Simbar M, Tehrani FR, Majd HA. Effects of Sex Education and Kegel Exercises on the Sexual Function of Postmenopausal Women: A Randomized Clinical Trial. J Sex Med 2017;14:959-967. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

The effect of four-phase teaching method on midwifery students’ emotional intelligence in managing the childbirth

PubMed Central

Mohamadirizi, Soheila; Fahami, Fariba; Bahadoran, Parvin; Ehsanpour, Soheila

2015-01-01

Background: An active teaching method has been used widely in medical education. The aim of this study was to determine the effectiveness of the four-phase teaching method on midwifery students’ emotional intelligence (EQ) in managing the childbirth. Materials and Methods: This was an experimental study that performed in 2013 in Isfahan University of Medical Sciences. Thirty midwifery students were involved in this study and selected through a random sampling method. The EQ questionnaire (43Q) was completed by both the groups, before and after the education. The collected data were analyzed using SPSS 14, the independent t-test, and the paired t-test. The statistically significant level was considered to be <0.05. Results: The findings of the independent t-test did not show any significant difference between EQ scores of the experimental and the control group before the intervention, whereas a statistically significant difference was observed after the intervention between the scores of two groups (P = 0.009). The paired t-test showed a statistically significant difference in EQ scores in the two groups after the intervention in the four-phase and the control group, respectively, as P = 0.005 and P = 0.018. Furthermore, the rate of self-efficiency has increased in the experimental group and control group as 66% and 13% (P = 0.024), respectively. Conclusion: The four-phase teaching method can increase the EQ levels of midwifery students. Therefore, the conduction of this educational model is recommended as an effective learning method. PMID:26097861

A systematic review and meta-analysis: Effectiveness of internet empowerment-based self-management interventions on adults with metabolic diseases.

PubMed

Kuo, Chia-Chi; Su, Yu-Jen; Lin, Chiu-Chu

2018-03-25

To synthesize the effects of Internet empowerment-based self-management interventions on adults with metabolic diseases. Metabolic diseases are prevalent and burden healthcare systems; they have become a major health problem worldwide. The effects of IESMIs on lifestyle changes have been shown to improve adults' physiological and psychological conditions. However, we found no systematic review evaluating these effects. Systematic review and meta-analysis of randomized and non-randomized controlled trials, conducted according to the Cochrane handbook. A literature search was conducted using the Airiti Library, Association for Computing Machinery, CINAHL, Cochrane Library, Embase, ProQuest, PubMed/MEDLINE and Index of the Taiwan Periodical Literature System databases (earliest-June 2016). Two reviewers used the Cochrane Collaboration bias assessment tool to assess the methodological quality of included studies. Extracted data were entered and analysed using RevMan 5.3.5 software. Inverse variance was used to estimate effect sizes. Weighted and standardized mean differences with 95% confidence intervals were calculated using a random effects model. Subgroup and sensitivity analyses were performed. Twenty-one randomized controlled trials were reviewed. Meta-analysis showed that the intervention significantly improved adults' exercise habits, glycated haemoglobin (HbA1c) levels, body weight, empowerment levels and quality of life. The intervention significantly improve the health status of adults with metabolic diseases, in particular their exercise habits, HbA1c levels, body weight, empowerment and quality of life. The intervention provides more convenient and faster access to healthcare for busy individuals with time constraints. These results suggest that healthcare professionals could develop accessible and friendly interactive online interfaces for patients to expand the use of these interventions in the clinical setting. © 2018 John Wiley & Sons Ltd.

Universal quantum computation with temporal-mode bilayer square lattices

NASA Astrophysics Data System (ADS)

Alexander, Rafael N.; Yokoyama, Shota; Furusawa, Akira; Menicucci, Nicolas C.

2018-03-01

We propose an experimental design for universal continuous-variable quantum computation that incorporates recent innovations in linear-optics-based continuous-variable cluster state generation and cubic-phase gate teleportation. The first ingredient is a protocol for generating the bilayer-square-lattice cluster state (a universal resource state) with temporal modes of light. With this state, measurement-based implementation of Gaussian unitary gates requires only homodyne detection. Second, we describe a measurement device that implements an adaptive cubic-phase gate, up to a random phase-space displacement. It requires a two-step sequence of homodyne measurements and consumes a (non-Gaussian) cubic-phase state.

The effect of two lottery-style incentives on response rates to postal questionnaires in a prospective cohort study in preschool children at high risk of asthma: a randomized trial.

PubMed

van der Mark, Lonneke B; van Wonderen, Karina E; Mohrs, Jacob; Bindels, Patrick Je; Puhan, Milo A; Ter Riet, Gerben

2012-12-18

In research with long-term follow-up and repeated measurements, quick and complete response to questionnaires helps ensure a study's validity, precision and efficiency. Evidence on the effect of non-monetary incentives on response rates in observational longitudinal research is scarce. To study the impact of two strategies to enhance completeness and efficiency in observational cohort studies with follow-up durations of around 2 years. METHOD AND INTERVENTION: In a factorial design, 771 children between 2 and 5 years old and their parents participating in a prospective cohort study were randomized to three intervention groups and a control group. Three types of lotteries were run: (i) daytrip tickets for the whole family to a popular amusement park if they returned all postal questionnaires, (ii) €12.50-worth gift vouchers for sending back the questionnaire on time after each questionnaire round and (iii) a combination of (i) and (ii). Primary outcome was the proportion of participants who returned all questionnaires without any reminder. Secondary outcomes were '100% returned with or without reminder', 'probability of 100% non-response', 'probability of withdrawal', 'proportion of returned questionnaires' and 'overall number of reminders sent'. After testing for interaction between the two lottery interventions, the two trials were analysed separately. We calculated risk differences (RD) and numbers needed to "treat" and their 95% confidence intervals. Daytrip nor voucher intervention had an effect on the proportion of participants who returned all questionnaires (RD -0.01; 95% CI-0.07 - 0.06) and (RD 0.02; 95% CI-0.50 - 0.08), respectively. No effects were found on the secondary outcomes. Our findings do not support the idea that lottery-style incentives lead to more complete response to postal questionnaires in observational cohort studies with repeated data collection and follow-up durations of around 2 years.

Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

PubMed

Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

2018-03-01

Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

[Non pharmacological treatment for Alzheimer's disease: comparison between musical and non-musical interventions].

PubMed

Narme, Pauline; Tonini, Audrey; Khatir, Fatiha; Schiaratura, Loris; Clément, Sylvain; Samson, Séverine

2012-06-01

On account of the limited effectiveness of pharmacological treatments in Alzheimer's disease (AD), there is a growing interest on nonpharmacological treatments, including musical intervention. Despite the large number of studies showing the multiple benefits of music on behavioral, emotional and cognitive disorders of patients with AD, only a few of them used a rigorous method. Finally, the specificity of musical as compared to non-musical and pleasant interventions has rarely been addressed. To investigate this issue, two randomized controlled trials were conducted contrasting the effects of musical to painting (Study 1) or cooking (Study 2) interventions on emotional state of 33 patients with AD. The patients' emotional state was assessed by analyzing professional caregivers' judgments of the patient's mood, then facial expressions and valence of the discourse from short-filmed interviews. In the first study (n=22), each intervention lasted 3 weeks (two sessions per week) and the patients' emotional state was assessed before, during and after intervention periods. After the interventions, the results showed that facial expression, discourse content and mood assessment improved (more positive than negative expressions) as compared to pre-intervention assessment. However, musical intervention was more effective and had longer effects as compared with painting. In the second study (n=11), we further examined long lasting effects of music as compared to cooking by adding evaluation of the patients' emotional state 2 and 4 weeks after the last intervention. Again, music was more effective to improve the emotional state. Music had positive effects that remained significant up to 4 weeks after the intervention, while cooking only produced short-term effect on mood. In both studies, benefits were significant in more than 80% of patients. Taken together, these findings show that music intervention has specific effects on patients' emotional well being, offering promising methods to improve the quality of life of patients with AD.

Evaluation of a Peer-Led Hypertension Intervention for Veterans: Impact on Peer Leaders

ERIC Educational Resources Information Center

Mosack, Katie E.; Patterson, Leslie; Brouwer, Amanda M.; Wendorf, Angela R.; Ertl, Kristyn; Eastwood, Dan; Morzinski, Jeffrey; Fletcher, Kathlyn; Whittle, Jeff

2013-01-01

Volunteer peer leaders (PLs) benefit from their involvement in health interventions but we know little about how they compare with other non-PL volunteers or with the intervention recipients themselves. We randomized 58 veterans' service organizations' posts (e.g. VFW) to peer- versus professionally led self-management support interventions. Our…

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

PubMed

Pastor, María-Ángeles; López-Roig, Sofía; Lledó, Ana; Peñacoba, Cecilia; Velasco, Lilian; Schweiger-Gallo, Inge; Cigarán, Margarita; Ecija, Carmen; Limón, Ramón; Sanz, Yolanda

2014-04-11

Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. ISRCTN68584893.

A Randomized Controlled Trial of Two Syntactic Treatment Procedures with Cantonese-Speaking, School-Age Children with Language Disorders

ERIC Educational Resources Information Center

To, Carol K. S.; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y. H

2015-01-01

Purpose: In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Method: Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment…

Details and acceptability of a nutrition intervention programme designed to improve the contents of children's packed lunches.

PubMed

Cleghorn, Christine L; Evans, Charlotte El; Kitchen, Meaghan S; Cade, Janet E

2010-08-01

To describe the 'Smart Lunch Box' intervention and provide details on feedback from the participants on the acceptability and usability of the intervention materials. A cluster randomised controlled trial, randomised by school. English schools were stratified on percentage free-school-meals eligibility and attainment at Key Stage 2. A 'Smart Lunch Box' with supporting materials and activities on healthy eating was delivered to parents and children via schools in the intervention group. Feedback forms containing information on a total of fifteen intervention items were filled out by the parents and/or children participating in the intervention and were collected after each of the three phases of the intervention. Eighty-nine primary schools in England, Scotland, Wales and Northern Ireland, randomly selected; forty-four schools in the intervention arm. A total of 1294 children, aged 9-10 years, took part in the trial. Of the 604 children in the intervention arm, 343 provided feedback after at least one of the three phases. A median of twelve items out of a total of fifteen were used by responders. The two intervention items most likely to be used were the individual food boxes and the cooler bags. Whether a participant liked an item significantly affected whether they used it for all items except the cooler bag, fruity face and individual food boxes. Practical intervention items aimed at parents are likely to be used in the longer term and therefore may be appropriate for use in an intervention strategy to improve packed lunches.

The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial.

PubMed

Cruz-Díaz, David; Romeu, Marta; Velasco-González, Carmen; Martínez-Amat, Antonio; Hita-Contreras, Fidel

2018-04-01

To assess the effectiveness of 12 weeks of Pilates practice on disability, pain and kinesiophobia in patients with chronic non-specific low back pain. This is a randomized controlled trial. This study was conducted in the university laboratory. A total of 64 participants with chronic non-specific low back pain were included. Participants were randomly allocated to intervention group consisted in Pilates intervention during 12 weeks ( n = 32) or control group who received no treatment ( n = 32). Disability, pain and kinesiophobia were assessed by Roland Morris Disability Questionnaire, visual analogue scale and Tampa Scale of Kinesiophobia, respectively. Measurements were performed at baseline, at 6 and 12 weeks after study completion. There were significant differences between groups with observed improvement in Pilates intervention group in all variables after treatment ( P < 0.001). Major changes on disability and kinesiophobia were observed at six weeks of intervention with no significant difference after 12 weeks ( P < 0.001). Mean changes of the intervention group compared with the control group were 4.00 (0.45) on the Roland Morris Disability Questionnaire and 5.50 (0.67) in the Tampa Scale of Kinesiophobia. Pain showed better results at six weeks with a slightly but statistically significant improvement at 12 weeks with Visual Analogue Scale scores of 2.40 (0.26) ( P < 0.001). Pilates intervention in patients with chronic non-specific low back pain is effective in the management of disability, pain and kinesiophobia.

The effect of training in reduced energy density eating and food self-monitoring accuracy on weight loss maintenance.

PubMed

Lowe, Michael R; Tappe, Karyn A; Annunziato, Rachel A; Riddell, Lynnette J; Coletta, Maria C; Crerand, Canice E; Didie, Elizabeth R; Ochner, Christopher N; McKinney, Shortie

2008-09-01

Failure to maintain weight losses in lifestyle change programs continues to be a major problem and warrants investigation of innovative approaches to weight control. The goal of this study was to compare two novel group interventions, both aimed at improving weight loss maintenance, with a control group. A total of 103 women lost weight on a meal replacement-supplemented diet and were then randomized to one of three conditions for the 14-week maintenance phase: cognitive-behavioral treatment (CBT); CBT with an enhanced food monitoring accuracy (EFMA) program; or these two interventions plus a reduced energy density eating (REDE) program. Assessments were conducted periodically through an 18-month postintervention. Outcome measures included weight and self-reported dietary intake. Data were analyzed using completers only as well as baseline-carried-forward imputation. Participants lost an average of 7.6 +/- 2.6 kg during the weight loss phase and 1.8 +/- 2.3 kg during the maintenance phase. Results do not suggest that the EFMA intervention was successful in improving food monitoring accuracy. The REDE group decreased the energy density (ED) of their diets more so than the other two groups. However, neither the REDE nor the EFMA condition showed any advantage in weight loss maintenance. All groups regained weight between 6- and 18-month follow-ups. Although no incremental weight maintenance benefit was observed in the EFMA or EFMA + REDE groups, the improvement in the ED of the REDE group's diet, if shown to be sustainable in future studies, could have weight maintenance benefits.

A Web-Based Psychoeducational Intervention Program for Depression and Anxiety in an Adult Community in Selangor, Malaysia: Protocol of a Randomized Controlled Trial.

PubMed

Kader Maideen, Siti Fatimah; Mohd-Sidik, Sherina; Rampal, Lekhraj; Mukhtar, Firdaus; Ibrahim, Normala; Phang, Cheng-Kar; Tan, Kit-Aun; Ahmad, Rozali

2016-06-21

Mental disorders are a major public health problem and are debilitating in many nations throughout the world. Many individuals either do not or are not able to access treatment. The Internet can be a medium to convey to the community accessible evidenced-based interventions to reduce these burdens. The objective of this study is to investigate the effectiveness of 4 weeks of a Web-based psychoeducational intervention program for depressive and anxiety symptoms in the community of Selangor, Malaysia. A two-arm randomized controlled trial of a single-blind study will be conducted to meet the objective of this study. We aim to recruit 84 participants each for the intervention and control groups. The recruitment will be from participants who participated in the first phase of this research. The primary outcomes of this study are depressive and anxiety scores, which will be assessed using the Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7, respectively. The secondary outcome includes mental health literacy of the participants, which will be assessed using the self-developed and adapted Mental Health Literacy Questionnaire. The psychoeducational intervention program consists of four sessions, which will be accessed each week. The depressive and anxiety symptoms will be compared between participants who participated in the psychoeducational program compared with the control group. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at follow-ups at week 5 and week 12, respectively. The psychoeducational intervention program consists of four sessions, which will be accessed at each week. The depressive and anxiety symptoms will be compared between the intervention and control groups using a series of mixed ANOVAs. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at two follow-ups at week 5 and week 12, respectively. To our knowledge, this study will be the first randomized controlled trial of a Web-based psychoeducational intervention program for depression and anxiety in an adult community in Malaysia. The results from this study will determine the effectiveness of a psychoeducational intervention program in the management of depression and anxiety among adults in the community. If proven to be effective, the intervention can serve as a new modality to manage and reduce the burden of these disorders in the community. International Standard Randomized Controlled Trial Number (ISRCTN): 39656144; http://www.isrctn.com/ISRCTN39656144 (Archived by WebCite at http://www.webcitation.org/6hSVhV71K).

Serological Markers of Sand Fly Exposure to Evaluate Insecticidal Nets against Visceral Leishmaniasis in India and Nepal: A Cluster-Randomized Trial

PubMed Central

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-01-01

Background Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. Methods As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. Results A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83–0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80–1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. Conclusions This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions. PMID:21931871

Serological markers of sand fly exposure to evaluate insecticidal nets against visceral leishmaniasis in India and Nepal: a cluster-randomized trial.

PubMed

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-09-01

Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83-0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80-1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial

PubMed Central

PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK

2017-01-01

ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494

Efficient identification and referral of low-income women at high risk for hereditary breast cancer: a practice-based approach.

PubMed

Joseph, G; Kaplan, C; Luce, J; Lee, R; Stewart, S; Guerra, C; Pasick, R

2012-01-01

Identification of low-income women with the rare but serious risk of hereditary cancer and their referral to appropriate services presents an important public health challenge. We report the results of formative research to reach thousands of women for efficient identification of those at high risk and expedient access to free genetic services. External validity is maximized by emphasizing intervention fit with the two end-user organizations who must connect to make this possible. This study phase informed the design of a subsequent randomized controlled trial. We conducted a randomized controlled pilot study (n = 38) to compare two intervention models for feasibility and impact. The main outcome was receipt of genetic counseling during a two-month intervention period. Model 1 was based on the usual outcall protocol of an academic hospital genetic risk program, and Model 2 drew on the screening and referral procedures of a statewide toll-free phone line through which large numbers of high-risk women can be identified. In Model 1, the risk program proactively calls patients to schedule genetic counseling; for Model 2, women are notified of their eligibility for counseling and make the call themselves. We also developed and pretested a family history screener for administration by phone to identify women appropriate for genetic counseling. There was no statistically significant difference in receipt of genetic counseling between women randomized to Model 1 (3/18) compared with Model 2 (3/20) during the intervention period. However, when unresponsive women in Model 2 were called after 2 months, 7 more obtained counseling; 4 women from Model 1 were also counseled after the intervention. Thus, the intervention model that closely aligned with the risk program's outcall to high-risk women was found to be feasible and brought more low-income women to free genetic counseling. Our screener was easy to administer by phone and appeared to identify high-risk callers effectively. The model and screener are now in use in the main trial to test the effectiveness of this screening and referral intervention. A validation analysis of the screener is also underway. Identification of intervention strategies and tools, and their systematic comparison for impact and efficiency in the context where they will ultimately be used are critical elements of practice-based research. Copyright © 2012 S. Karger AG, Basel.

Liquid-vapor phase equilibria and the thermodynamic properties of 2-methylpropanol- n-alkyl propanoate solutions

NASA Astrophysics Data System (ADS)

Suntsov, Yu. K.; Goryunov, V. A.; Chuikov, A. M.; Meshcheryakov, A. V.

2016-08-01

The boiling points of solutions of five binary systems are measured via ebulliometry in the pressure range of 2.05-103.3 kPa. Equilibrium vapor phase compositions, the values of the excess Gibbs energies, enthalpies, and entropies of solution of these systems are calculated. Patterns in the changes of phase equilibria and thermodynamic properties of solutions are established, depending on the compositions and temperatures of the systems. Liquid-vapor equilibria in the systems are described using the equations of Wilson and the NRTL (Non-Random Two-Liquid Model).

Does a diet low in FODMAPs reduce symptoms associated with functional gastrointestinal disorders? A comprehensive systematic review and meta-analysis.

PubMed

Marsh, Abigail; Eslick, Enid M; Eslick, Guy D

2016-04-01

Functional gastrointestinal symptoms such as abdominal pain, bloating, distension, constipation, diarrhea and flatulence have been noted in patients with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). The diversity of symptoms has meant that finding an effective treatment has been challenging with most treatments alleviating only the primary symptom. A novel treatment option for IBS and IBD currently generating much excitement is the low fermentable, oligo-, di-, mono-saccharides and polyol (FODMAP) diet. The aim of this meta-analysis was to determine the evidence of the efficacy of such a diet in the treatment of functional gastrointestinal symptoms. Electronic databases were searched through to March 2015 to identify relevant studies. Pooled odds ratios (ORs) and 95 % confidence intervals were calculated for the effect of a low FODMAP diet on the reduction in IBS [Symptoms Severity Score (SSS)] score and increase in IBS quality of life (QOL) score for both randomized clinical trials (RCTs) and non-randomized interventions using a random-effects model. Six RCTs and 16 non-randomized interventions were included in the analysis. There was a significant decrease in IBS SSS scores for those individuals on a low FODMAP diet in both the RCTs (OR 0.44, 95 % CI 0.25-0.76; I (2) = 35.52, p = 0.00) and non-randomized interventions (OR 0.03, 95 % CI 0.01-0.2; I (2) = 69.1, p = 0.02). In addition, there was a significant improvement in the IBS-QOL score for RCTs (OR 1.84, 95 % CI 1.12-3.03; I (2) = 0.00, p = 0.39) and for non-randomized interventions (OR 3.18, 95 % CI 1.60-6.31; I (2) = 0.00, p = 0.89). Further, following a low FODMAP diet was found to significantly reduce symptom severity for abdominal pain (OR 1.81, 95 % CI 1.13-2.88; I (2) = 0.00, p = 0.56), bloating (OR 1.75, 95 % CI 1.07-2.87; I (2) = 0.00, p = 0.45) and overall symptoms (OR 1.81, 95 % CI 1.11-2.95; I (2) = 0.00, p = 0.4) in the RCTs. In the non-randomized interventions similar findings were observed. The present meta-analysis supports the efficacy of a low FODMAP diet in the treatment of functional gastrointestinal symptoms. Further research should ensure studies include dietary adherence, and more studies looking at greater number of patients and long-term adherence to a low FODMAP diet need to be conducted.

Telemonitoring of home exercise cycle training in patients with COPD

PubMed Central

Franke, Karl-Josef; Domanski, Ulrike; Schroeder, Maik; Jansen, Volker; Artmann, Frank; Weber, Uwe; Ettler, Rainer; Nilius, Georg

2016-01-01

Background Regular physical activity is associated with reduced mortality in patients with chronic obstructive pulmonary disease (COPD). Interventions to reduce time spent in sedentary behavior could improve outcomes. The primary purpose was to investigate the impact of telemonitoring with supportive phone calls on daily exercise times with newly established home exercise bicycle training. The secondary aim was to examine the potential improvement in health-related quality of life and physical activity compared to baseline. Methods This prospective crossover-randomized study was performed over 6 months in stable COPD patients. The intervention phase (domiciliary training with supporting telephone calls) and the control phase (training without phone calls) were randomly assigned to the first or the last 3 months. In the intervention phase, patients were called once a week if they did not achieve a real-time monitored daily cycle time of 20 minutes. Secondary aims were evaluated at baseline and after 3 and 6 months. Health-related quality of life was measured by the COPD Assessment Test (CAT), physical activity by the Godin Leisure Time Exercise Questionnaire (GLTEQ). Results Of the 53 included patients, 44 patients completed the study (forced expiratory volume in 1 second 47.5%±15.8% predicted). In the intervention phase, daily exercise time was significantly higher compared to the control phase (24.2±9.4 versus 19.6±10.3 minutes). Compared to baseline (17.6±6.1), the CAT-score improved in the intervention phase to 15.3±7.6 and in the control phase to 15.7±7.3 units. The GLTEQ-score increased from 12.2±12.1 points to 36.3±16.3 and 33.7±17.3. Conclusion Telemonitoring is a simple method to enhance home exercise training and physical activity, improving health-related quality of life. PMID:27956829

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

PubMed

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

2014-06-01

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

Effects of the SAFE Children preventive intervention on developmental trajectories of attention-deficit/hyperactivity disorder symptoms.

PubMed

Fowler, Patrick J; Henry, David B; Schoeny, Michael; Gorman-Smith, Deborah; Tolan, Patrick H

2014-11-01

This study examined whether a family-based preventive intervention for inner-city children entering the first grade could alter the developmental course of attention-deficit/hyperactivity disorder (ADHD) symptoms. Participants were 424 families randomly selected and randomly assigned to a control condition (n = 192) or Schools and Families Educating Children (SAFE) Children (n = 232). SAFE Children combined family-focused prevention with academic tutoring to address multiple developmental-ecological needs. A booster intervention provided in the 4th grade to randomly assigned children in the initial intervention (n =101) evaluated the potential of increasing preventive effects. Follow-up occurred over 5 years with parents and teachers reporting on attention problems. Growth mixture models identified multiple developmental trajectories of ADHD symptoms. The initial phase of intervention placed children on more positive developmental trajectories for impulsivity and hyperactivity, demonstrating the potential for ADHD prevention in at-risk youth, but the SAFE Children booster had no additional effect on trajectory or change in ADHD indicators.

Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

PubMed

Befort, Christie A; Klemp, Jennifer R; Fabian, Carol; Perri, Michael G; Sullivan, Debra K; Schmitz, Kathryn H; Diaz, Francisco J; Shireman, Theresa

2014-03-01

Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. Copyright © 2014 Elsevier Inc. All rights reserved.

Evidence for intermittency and a truncated power law from highly resolved aphid movement data.

PubMed

Mashanova, Alla; Oliver, Tom H; Jansen, Vincent A A

2010-01-06

Power laws are increasingly used to describe animal movement. Despite this, the use of power laws has been criticized on both empirical and theoretical grounds, and alternative models based on extensions of conventional random walk theory (Brownian motion) have been suggested. In this paper, we analyse a large volume of data of aphid walking behaviour (65,068 data points), which provides a highly resolved dataset to investigate the pattern of movement. We show that aphid movement is intermittent--with alternations of a slow movement with frequent change of direction and a fast, relatively directed movement--and that the fast movement consists of two phases--a strongly directed phase that gradually changes into an uncorrelated random walk. By measuring the mean-squared displacement and the duration of non-stop movement episodes we found that both spatial and temporal aspects of aphid movement are best described using a truncated power law approach. We suggest that the observed spatial pattern arises from the duration of non-stop movement phases rather than from correlations in turning angles. We discuss the implications of these findings for interpreting movement data, such as distinguishing between movement and non-movement, and the effect of the range of data used in the analysis on the conclusions.

Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.

PubMed

Paramasivan, S; Rogers, C A; Welbourn, R; Byrne, J P; Salter, N; Mahon, D; Noble, H; Kelly, J; Mazza, G; Whybrow, P; Andrews, R C; Wilson, C; Blazeby, J M; Donovan, J L

2017-11-01

Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

The Utility of a Brief Web-Based Prevention Intervention as a Universal Approach for Risky Alcohol Use in College Students: Evidence of Moderation by Family History.

PubMed

Neale, Zoe E; Salvatore, Jessica E; Cooke, Megan E; Savage, Jeanne E; Aliev, Fazil; Donovan, Kristen K; Hancock, Linda C; Dick, Danielle M

2018-01-01

Background: Alcohol use on college campuses is prevalent and contributes to problems that affect the health, emotional wellbeing, and academic success of college students. Risk factors, such as family history of alcohol problems, predict future alcohol problems, but less is known about their potential impact on intervention effectiveness. The purpose of this study was to examine the effect of an intervention implemented in a non-randomized sample of drinking and non-drinking college freshmen. Methods: Freshmen college students recruited for the intervention study ( n = 153) completed a web-adaptation of the Brief Alcohol Screening and Intervention for College Students (BASICS) at the start of spring semester. We compared their 30-days post-intervention alcohol initiation, number of drinking days (DAYS), drinks per occasion (DRINKS), maximum drinks in 24 h (MAX24) and alcohol use disorder symptoms (AUDsx) to 151 comparison participants retrospectively matched on demographics and baseline alcohol use behaviors. We also tested baseline DRINKS, DAYS, AUDsx, MAX24, and parental family history (PFH) of alcohol problems as moderators of the effect of the intervention. Results: At follow-up, intervention participants had lower rates of AUDsx than comparison participants, especially among baseline drinkers. Among participants drinking 3+ days/month at baseline, intervention participants showed fewer DAYS at follow-up than the comparison group participants. BASICS was also associated with a decreased likelihood of initiation among baseline non-drinkers. PFH significantly interacted with treatment group, with positive PFH intervention participants reporting significantly fewer AUDsx at follow-up compared to positive PFH comparison participants. We found no evidence for an effect of the intervention on DRINKS or MAX24 in our analyses. Conclusions: Results suggest some indication that novel groups, such as non-drinkers, regular drinkers, and PFH positive students may experience benefits from BASICS. Although conclusions were limited by lack of randomization and short follow-up period, PFH positive and low to moderate drinking groups represent viable targets for future randomized studies.

Effects of rye bread enriched with green tea extract on weight maintenance and the characteristics of metabolic syndrome following weight loss: a pilot study.

PubMed

Bajerska, Joanna; Mildner-Szkudlarz, Sylwia; Walkowiak, Jarosław

2015-06-01

We examined whether the incorporation of green tea extract enriched rye bread (GTRB) into the diet can improve weight loss (WL) maintenance and control of abnormalities linked to metabolic syndrome (MS). A total of 55 obese men and women (mean age: 53.0±7.0 years, body mass index: 35.0±5.5 kg m(-2)) were recruited. The study had a single-blind randomized study design and consisted of an 8-week WL phase with low-energy calorie diet, followed by a 12-week weight maintenance (WM) phase. During the WM phase, the subjects were randomized into two groups, receiving either the control rye bread (control group) or the GTRB (intervention group). The ingestion of 280 and 360 g GTRB provided daily totals of 123.2 and 158.4 mg caffeine, and 188.3 and 242.1 mg of epigallocatechin gallate, for women and men, respectively. After the WL phase, subjects lost 7.3±3.1 kg of their baseline body weight. GTRB intake did not significantly influence the maintenance of WL, high-density lipoprotein-cholesterol, triglycerides, and glucose concentrations. Although, it resulted in significant differences (mean difference [95% confidence interval]) between the treatment groups in the maintenance of waist circumference (-1.22 cm [-2.4, -0.02; P=.04]), the results were not clinically meaningful. Nevertheless, the ingestion of GTRB led to the maintenance of lower blood pressure (BP), also the proportion of subjects fulfilling the criteria of MS after the WM phase was lower in the intervention group than in the control group. Although GTRB consumption did not improve significantly the WL maintenance, it resulted in a better control of BP.

The mental health of UK Gulf war veterans: phase 2 of a two phase cohort study.

PubMed

Ismail, Khalida; Kent, Kate; Brugha, Traolach; Hotopf, Matthew; Hull, Lisa; Seed, Paul; Palmer, Ian; Reid, Steve; Unwin, Catherine; David, Anthony S; Wessely, Simon

2002-09-14

To examine the prevalence of psychiatric disorders in veterans of the Gulf war with or without unexplained physical disability (a proxy measure of ill health) and in similarly disabled veterans who had not been deployed to the Gulf war (non-Gulf veterans). Two phase cohort study. Current and ex-service UK military personnel. Phase 1 consisted of three randomly selected samples of Gulf veterans, veterans of the 1992-7 Bosnia peacekeeping mission, and UK military personnel not deployed to the Gulf war (Era veterans) who had completed a postal health questionnaire. Phase 2 consisted of randomly selected subsamples from phase 1 of Gulf veterans who reported physical disability (n=111) or who did not report disability (n=98) and of Bosnia (n=54) and Era (n=79) veterans who reported physical disability. Psychiatric disorders assessed by the schedule for clinical assessment in neuropsychiatry and classified by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Only 24% (n=27) of the disabled Gulf veterans had a formal psychiatric disorder (depression, anxiety, or alcohol related disorder). The prevalence of psychiatric disorders in non-disabled Gulf veterans was 12%. Disability and psychiatric disorders were weakly associated in the Gulf group when confounding was adjusted for (adjusted odds ratio 2.4, 99% confidence interval 0.8 to 7.2, P=0.04). The prevalence of psychiatric disorders was similar in disabled non-Gulf veterans and disabled Gulf veterans ( 19% v 24%; 1.3, 0.5 to 3.4). All groups had rates for post-traumatic stress disorder of between 1% and 3%. Most disabled Gulf veterans do not have a formal psychiatric disorder. Post-traumatic stress disorder is not higher in Gulf veterans than in other veterans. Psychiatric disorders do not fully explain self reported ill health in Gulf veterans; alternative explanations for persistent ill health in Gulf veterans are needed.

Role of random electric fields in relaxors

PubMed Central

Phelan, Daniel; Stock, Christopher; Rodriguez-Rivera, Jose A.; Chi, Songxue; Leão, Juscelino; Long, Xifa; Xie, Yujuan; Bokov, Alexei A.; Ye, Zuo-Guang; Ganesh, Panchapakesan; Gehring, Peter M.

2014-01-01

PbZr1–xTixO3 (PZT) and Pb(Mg1/3Nb2/3)1–xTixO3 (PMN-xPT) are complex lead-oxide perovskites that display exceptional piezoelectric properties for pseudorhombohedral compositions near a tetragonal phase boundary. In PZT these compositions are ferroelectrics, but in PMN-xPT they are relaxors because the dielectric permittivity is frequency dependent and exhibits non-Arrhenius behavior. We show that the nanoscale structure unique to PMN-xPT and other lead-oxide perovskite relaxors is absent in PZT and correlates with a greater than 100% enhancement of the longitudinal piezoelectric coefficient in PMN-xPT relative to that in PZT. By comparing dielectric, structural, lattice dynamical, and piezoelectric measurements on PZT and PMN-xPT, two nearly identical compounds that represent weak and strong random electric field limits, we show that quenched (static) random fields establish the relaxor phase and identify the order parameter. PMID:24449912

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

PubMed

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

2017-05-01

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

Acceptance of a pre-visit intervention to engage teens in pediatric asthma visits.

PubMed

Sleath, Betsy; Carpenter, Delesha M; Davis, Scott A; Watson, Claire Hayes; Lee, Charles; Loughlin, Ceila E; Garcia, Nacire; Etheridge, Dana; Rivera-Duchesne, Laura; Reuland, Daniel S; Batey, Karolyne; Duchesne, Cristina; Tudor, Gail

2017-11-01

The objectives of this study were to: (a) describe teen feedback on an asthma question prompt list/video intervention designed to motivate teens to be more engaged during visits and (b) examine teen demographics associated with teen acceptance of the intervention. Two hundred and fifty-nine teens ages 11 to 17 with persistent asthma were enrolled into a randomized, controlled trial and assigned to either a standard care or an intervention group where they watched an educational video with their parents and received a prompt list to complete before visits. Teens were interviewed after visits. Of the 185 teens randomized to the intervention group: 93% said teens should complete the prompt lists before visits; 95% recommended teens should watch the video before visits; teens with moderate/severe persistent asthma were significantly more likely to find the prompt list useful; non-White teens were significantly more likely to find the prompt list and video more useful. Teens exposed to the question prompt list/video had very positive feedback about the intervention. Providers/practices should consider having teens complete question prompt lists during pre-visit wait time for use during visits and watch the video with their parents before visits. Copyright © 2017 Elsevier B.V. All rights reserved.

Quantum Fisher information of the GHZ state due to classical phase noise lasers under non-Markovian environment

NASA Astrophysics Data System (ADS)

Chen, Yu; Zou, Jian; Yang, Zi-Yi; Li, Longwu; Li, Hai; Shao, Bin

2016-08-01

The dynamics of N-qubit GHZ state quantum Fisher information (QFI) under phase noise lasers (PNLs) driving is investigated in terms of non-Markovian master equation. We first investigate the non-Markovian dynamics of the QFI of N-qubit GHZ state and show that when the ratio of the PNL rate and the system-environment coupling strength is very small, the oscillations of the QFIs decay slower which corresponds to the non-Markovian region; yet when it becomes large, the QFIs monotonously decay which corresponds to the Markovian region. When the atom number N increases, QFIs in both regions decay faster. We further find that the QFI flow disappears suddenly followed by a sudden birth depending on the ratio of the PNL rate and the system-environment coupling strength and the atom number N, which unveil a fundamental connection between the non-Markovian behaviors and the parameters of system-environment couplings. We discuss two optimal positive operator-valued measures (POVMs) for two different strategies of our model and find the condition of the optimal measurement. At last, we consider the QFI of two atoms with qubit-qubit interaction under random telegraph noises (RTNs).

Evaluation of a simplified modified Atkins diet for use by parents with low levels of literacy in children with refractory epilepsy: A randomized controlled trial.

PubMed

Sharma, Suvasini; Goel, Shaiphali; Jain, Puneet; Agarwala, Anuja; Aneja, Satinder

2016-11-01

This study was planned to develop and evaluate a simple, easy-to-understand variation of the modified Atkins diet, for use by parents with low levels of literacy in children with refractory epilepsy. This study was conducted in two phases. In the first phase, a simplified version of the modified Atkins diet was developed. In the second phase this was evaluated in children aged 2-14 years who had daily seizures despite the appropriate use of at least two anticonvulsant drugs, in an open-label randomized-controlled-trial. Children were randomized to receive either the simplified modified Atkins diet or no dietary intervention for a period of 3 months with the ongoing anticonvulsant medications being continued unchanged in both the groups. Reduction in seizure frequency was the primary outcome-measure. Data was analyzed using intention to treat approach. Adverse effects were also studied. (Clinical trial identifier NCT0189989). Forty-one children were randomly assigned to the diet-group, and 40 were assigned to the control-group. Two patients discontinued the diet during the study period. The proportion of children with>50% seizure reduction was significantly higher in the diet group as compared to the control group (56.1% vs 7.5%, p<0.0001). The proportion of children with 90% seizure reduction was also higher in the diet group (19.5% vs 2%, p=0.09). Six children in the diet group were seizure free at 3 months compared with two in the control group (p=0.26). At 3 months, 6 children had constipation and 5 had weight loss. A simplified version of the modified Atkins diet was developed for use by parents with low levels literacy. This diet was found to be feasible, efficacious and well tolerated in children with refractory epilepsy. Copyright © 2016 Elsevier B.V. All rights reserved.

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

PubMed

Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-12-01

The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves. © The Author(s) 2015.

Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis.

PubMed

Benham, J L; Yamamoto, J M; Friedenreich, C M; Rabi, D M; Sigal, R J

2018-06-12

Preliminary evidence suggests exercise in polycystic ovary syndrome (PCOS) may improve reproductive and cardiometabolic parameters. Our primary aim was to determine the impact of exercise training on reproductive health in women with PCOS. Our secondary aim was to determine the effect of exercise training on cardiometabolic indices. A systematic review of published literature was conducted using MEDLINE and EMBASE based on a pre-published protocol (PROSPERO CRD42017065324). The search was not limited by year. Randomized controlled trials, non-randomized controlled trials and uncontrolled trials that evaluated an exercise intervention in women with PCOS and reported reproductive outcomes were included. Reproductive outcomes were analysed semi-quantitatively and a meta-analysis was conducted for reported cardiometabolic outcomes. Of 517 screened abstracts, 14 studies involving 617 women with PCOS were included: seven randomized controlled trials, one non-randomized controlled trial and six uncontrolled trials. There were insufficient published data to describe the effect of exercise interventions on ovulation quantitatively, but semi-quantitative analysis suggested that exercise interventions may improve menstrual regularity, pregnancy and ovulation rates. Our meta-analysis found that exercise improved lipid profiles and decreased waist circumference, systolic blood pressure and fasting insulin. The impact of exercise interventions on reproductive function remains unclear. However, our meta-analysis suggests that exercise interventions may improve cardiometabolic profiles in women with PCOS. © 2018 World Obesity Federation.

Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol.

PubMed

Yan, Jin; Zhang, Aidi; Zhou, Liang; Huang, Zhulin; Zhang, Pan; Yang, Guoli

2017-04-24

Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM). Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app) aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs), personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers' development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject's participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis. This will be the first study of its kind in China to develop an app and implement app-based HIV prevention intervention among MSM. It is of great potential to determine whether app-based intervention is a cost-effective way to decrease HIV infection among MSM and explore intervention mechanism with an accurate method. Chinese Clinical Trial Register ( ChiCTR-IOR-15006724 ). Registered 10 July 2015.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

Computational studies of thermal and quantum phase transitions approached through non-equilibrium quenching

NASA Astrophysics Data System (ADS)

Liu, Cheng-Wei

Phase transitions and their associated critical phenomena are of fundamental importance and play a crucial role in the development of statistical physics for both classical and quantum systems. Phase transitions embody diverse aspects of physics and also have numerous applications outside physics, e.g., in chemistry, biology, and combinatorial optimization problems in computer science. Many problems can be reduced to a system consisting of a large number of interacting agents, which under some circumstances (e.g., changes of external parameters) exhibit collective behavior; this type of scenario also underlies phase transitions. The theoretical understanding of equilibrium phase transitions was put on a solid footing with the establishment of the renormalization group. In contrast, non-equilibrium phase transition are relatively less understood and currently a very active research topic. One important milestone here is the Kibble-Zurek (KZ) mechanism, which provides a useful framework for describing a system with a transition point approached through a non-equilibrium quench process. I developed two efficient Monte Carlo techniques for studying phase transitions, one is for classical phase transition and the other is for quantum phase transitions, both are under the framework of KZ scaling. For classical phase transition, I develop a non-equilibrium quench (NEQ) simulation that can completely avoid the critical slowing down problem. For quantum phase transitions, I develop a new algorithm, named quasi-adiabatic quantum Monte Carlo (QAQMC) algorithm for studying quantum quenches. I demonstrate the utility of QAQMC quantum Ising model and obtain high-precision results at the transition point, in particular showing generalized dynamic scaling in the quantum system. To further extend the methods, I study more complex systems such as spin-glasses and random graphs. The techniques allow us to investigate the problems efficiently. From the classical perspective, using the NEQ approach I verify the universality class of the 3D Ising spin-glasses. I also investigate the random 3-regular graphs in terms of both classical and quantum phase transitions. I demonstrate that under this simulation scheme, one can extract information associated with the classical and quantum spin-glass transitions without any knowledge prior to the simulation.

Translating basic behavioral and social science research to clinical application: the EVOLVE mixed methods approach.

PubMed

Peterson, Janey C; Czajkowski, Susan; Charlson, Mary E; Link, Alissa R; Wells, Martin T; Isen, Alice M; Mancuso, Carol A; Allegrante, John P; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B

2013-04-01

To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease populations. We employed a sequential mixed methods model (EVOLVE) to design and test the PA/SA intervention in order to increase physical activity in people with coronary artery disease (post-percutaneous coronary intervention [PCI]) or asthma (ASM) and to improve medication adherence in African Americans with hypertension (HTN). In an initial qualitative phase, we explored participant values and beliefs. We next pilot tested and refined the intervention and then conducted 3 randomized controlled trials with parallel study design. Participants were randomized to combined PA/SA versus an informational control and were followed bimonthly for 12 months, assessing for health behaviors and interval medical events. Over 4.5 years, we enrolled 1,056 participants. Changes were sequentially made to the intervention during the qualitative and pilot phases. The 3 randomized controlled trials enrolled 242 participants who had undergone PCI, 258 with ASM, and 256 with HTN (n = 756). Overall, 45.1% of PA/SA participants versus 33.6% of informational control participants achieved successful behavior change (p = .001). In multivariate analysis, PA/SA intervention remained a significant predictor of achieving behavior change (p < .002, odds ratio = 1.66), 95% CI [1.22, 2.27], controlling for baseline negative affect, comorbidity, gender, race/ethnicity, medical events, smoking, and age. The EVOLVE method is a means by which basic behavioral science research can be translated into efficacious interventions for chronic disease populations.

Applying STOPP Guidelines in Primary Care Through Electronic Medical Record Decision Support: Randomized Control Trial Highlighting the Importance of Data Quality.

PubMed

Price, Morgan; Davies, Iryna; Rusk, Raymond; Lesperance, Mary; Weber, Jens

2017-06-15

Potentially Inappropriate Prescriptions (PIPs) are a common cause of morbidity, particularly in the elderly. We sought to understand how the Screening Tool of Older People's Prescriptions (STOPP) prescribing criteria, implemented in a routinely used primary care Electronic Medical Record (EMR), could impact PIP rates in community (non-academic) primary care practices. We conducted a mixed-method, pragmatic, cluster, randomized control trial in research naïve primary care practices. Phase 1: In the randomized controlled trial, 40 fully automated STOPP rules were implemented as EMR alerts during a 16-week intervention period. The control group did not receive the 40 STOPP rules (but received other alerts). Participants were recruited through the OSCAR EMR user group mailing list and in person at user group meetings. Results were assessed by querying EMR data PIPs. EMR data quality probes were included. Phase 2: physicians were invited to participate in 1-hour semi-structured interviews to discuss the results. In the EMR, 40 STOPP rules were successfully implemented. Phase 1: A total of 28 physicians from 8 practices were recruited (16 in intervention and 12 in control groups). The calculated PIP rate was 2.6% (138/5308) (control) and 4.11% (768/18,668) (intervention) at baseline. No change in PIPs was observed through the intervention (P=.80). Data quality probes generally showed low use of problem list and medication list. Phase 2: A total of 5 physicians participated. All the participants felt that they were aware of the alerts but commented on workflow and presentation challenges. The calculated PIP rate was markedly less than the expected rate found in literature (2.6% and 4.0% vs 20% in literature). Data quality probes highlighted issues related to completeness of data in areas of the EMR used for PIP reporting and by the decision support such as problem and medication lists. Users also highlighted areas for better integration of STOPP guidelines with prescribing workflows. Many of the STOPP criteria can be implemented in EMRs using simple logic. However, data quality in EMRs continues to be a challenge and was a limiting step in the effectiveness of the decision support in this study. This is important as decision makers continue to fund implementation and adoption of EMRs with the expectation of the use of advanced tools (such as decision support) without ongoing review of data quality and improvement. Clinicaltrials.gov NCT02130895; https://clinicaltrials.gov/ct2/show/NCT02130895 (Archived by WebCite at http://www.webcitation.org/6qyFigSYT). ©Morgan Price, Iryna Davies, Raymond Rusk, Mary Lesperance, Jens Weber. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 15.06.2017.

Recruitment and baseline characteristics of the Community of Voices choir study to promote the health and well-being of diverse older adults.

PubMed

Johnson, Julene K; Gregorich, Steven E; Acree, Michael; Nápoles, Anna M; Flatt, Jason D; Pounds, Dana; Pabst, Alexandria; Stewart, Anita L

2017-12-01

To describe the recruitment and baseline results of the Community of Voices study that aims to examine the effect of a community choir intervention on the health and well-being of older adults from diverse racial/ethnic and socioeconomic backgrounds. Using community-based participatory research methods, we recruited adults age 60 and over from 12 Administration on Aging-supported senior centers in San Francisco into a 2-arm cluster-randomized controlled trial of the community choir intervention. Multiple outreach methods were used. We tracked outreach, screening, and recruitment metrics and collected demographics and baseline outcomes via community-based, interviewer-administered surveys and performance measures of cognition, physical function, and psychosocial variables. The study contacted 819 individuals, screened 636, and enrolled 390 diverse older adults over a 42-month, phased recruitment period. The mean age was 71.2 (SD = 7.3), and the majority were women. Two-thirds of the sample are non-white, and 20% of participants reported having financial hardship. Outreach and recruitment methods used in the Community of Voices trial facilitated enrollment of a large proportion of minority and lower-SES older adults in the final sample. Similar recruitment approaches could serve as a model for recruiting diverse racial/ethnic and socioeconomic older adults into research.

Interventions to manage dual practice among health workers.

PubMed

Kiwanuka, Suzanne N; Rutebemberwa, Elizeus; Nalwadda, Christine; Okui, Olico; Ssengooba, Freddie; Kinengyere, Alison A; Pariyo, George W

2011-07-06

Dual practice, whereby health workers hold two or more jobs, is a common phenomenon globally. In resource constrained low- and middle-income countries dual practice poses an ongoing threat to the efficiency, quality and equity of health services, especially in the public sector. Identifying effective interventions to manage dual practice is important. To assess the effects of regulations implemented to manage dual practice. Databases searched included: The Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 4, part of The Cochrane Library. www.thecochranelibrary.com, including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (searched 26 May 2011); MEDLINE In-Process & Other Non-Indexed Citations May 24, 2011 (searched 26 May 2011); MEDLINE, Ovid (1948 to May week 2 2011) (searched 26 May 2011); EMBASE, Ovid (1980 to 2011 week 20) (searched 26 May 2011); Science Citation Index and Social Sciences Citation Index, ISI Web of Science (1975 to present) (searched 04 December 2009); LILACS (searched January 2010); and AIM (December 2009) (searched 18 December 2009). Randomized controlled trials, non-randomized controlled trials, controlled before-and-after studies and interrupted-time-series studies. Dual practice was defined as holding more than one job. Studies for inclusion were those focusing on interventions to manage dual practice among health professionals employed in the public health sector. Two review authors independently applied the criteria for inclusion and exclusion of studies when scanning the identified titles and abstracts. The same two review authors independently screened full reports of selected citations. At each stage, results were compared and discrepancies settled through discussion. No studies were found which were eligible for inclusion in this review. There is a need to rigorously evaluate the effects of interventions implemented to manage dual practice among health workers. However, there is still much that is unknown about dual practice itself. The designing of studies to evaluate the effects of interventions to manage dual practice could benefit from prior studies to assess the various manifestations of dual practice, their prevalence and their likely impacts on health services delivery. These findings would then inform the design of studies to evaluate interventions to manage dual practice.

Measuring Outcomes of Digital Technology-Assisted Nursing Postpartum: A Randomized Controlled Trial.

PubMed

Mccarter, Deborah E; Demidenko, Eugene; Hegel, Mark T

2018-05-17

To determine if delivering electronic messages from nurses during the first six months postpartum is feasible, acceptable and effective in improving mood and decreasing parenting stress. Competing demands during the postpartum hospitalization make focused time for nurses to provide education and support difficult. Unmet needs following discharge may increase the incidence of postpartum depression. Untreated depression negatively affects families, especially for vulnerable women with limited access to health care. This is a longitudinal cohort study in three phases. Feasibility and acceptability were assessed during Phases 1 & 2. Phase 3 is a randomized controlled trial (RCT) with three conditions. This protocol was approved by the Institutional Review Board of the maternity hospital on 12 May 2015 and reviewed annually. Women are enrolled during the maternity hospitalization, after which randomization occurs. The control group receives usual care. Intervention I participants receive a standardized electronic message four times/week for six months postpartum. Intervention II participants receive the messages and the option to request a call from a nurse. Electronic surveys at 3 weeks, 3 months and 6 months postpartum measure depressive symptoms using the Edinburgh Postnatal Depression Scale and parenting stress using the Parenting Stress Index-Short form. Patient satisfaction, nursing time and expertise required are also measured. Phase 1 and 2 have demonstrated the intervention is feasible and acceptable to women. Phase 3 enrollment is completed, and the last follow-up surveys were emailed to participants in February 2018. Results will help inform efforts to continue nursing care after hospital discharge. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

Supportive monitoring and disease management through the internet: an internet-delivered intervention strategy for recurrent depression.

PubMed

Kordy, Hans; Backenstrass, Matthias; Hüsing, Johannes; Wolf, Markus; Aulich, Kai; Bürgy, Martin; Puschner, Bernd; Rummel-Kluge, Christine; Vedder, Helmut

2013-11-01

Major depression is a highly prevalent, disabling disorder associated with loss of quality of life and large economic burden for the society. Depressive disorders often follow a chronic or recurrent course. The risk of relapses increases with each additional episode. The internet-deliverable intervention strategy SUMMIT (SUpportive Monitoring and Disease Management over the InTernet) for patients with recurrent depression has been developed with the main objectives to prolong symptom-free phases and to shorten symptom-loaden phases. This paper describes the study design of a six-sites, three-arm, randomized clinical trial intended to evaluate the efficacy of this novel strategy compared to treatment as usual (TAU). Two hundred thirty six patients who had been treated for their (at least) third depressive episode in one of the six participating psychiatric centers were randomized into one of three groups: 1) TAU plus a twelve-month SUMMIT program participation with personal support or 2) TAU plus a twelve-month SUMMIT program participation without personal support, or 3) TAU alone. Primary outcome of this study is defined as the number of "well weeks" over 24months after index treatment assessed by blind evaluators based on the Longitudinal Interval Follow-Up Evaluation. If efficacious, the low monetary and nonmonetary expenditures of this automated, yet individualized intervention may open new avenues for providing an acceptable, convenient, and affordable long-term disease management strategy to people with a chronic mental condition such as recurrent depression. © 2013.

ST-segment resolution with bivalirudin versus heparin and routine glycoprotein IIb/IIIa inhibitors started in the ambulance in ST-segment elevation myocardial infarction patients transported for primary percutaneous coronary intervention: The EUROMAX ST-segment resolution substudy.

PubMed

Van't Hof, Arnoud; Giannini, Francesco; Ten Berg, Jurrien; Tolsma, Rudolf; Clemmensen, Peter; Bernstein, Debra; Coste, Pierre; Goldstein, Patrick; Zeymer, Uwe; Hamm, Christian; Deliargyris, Efthymios; Steg, Philippe G

2017-08-01

Myocardial reperfusion after primary percutaneous coronary intervention (PCI) can be assessed by the extent of post-procedural ST-segment resolution. The European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trial compared pre-hospital bivalirudin and pre-hospital heparin or enoxaparin with or without GPIIb/IIIa inhibitors (GPIs) in primary PCI. This nested substudy was performed in centres routinely using pre-hospital GPI in order to compare the impact of randomized treatments on ST-resolution after primary PCI. Residual cumulative ST-segment deviation on the single one hour post-procedure electrocardiogram (ECG) was assessed by an independent core laboratory and was the primary endpoint. It was calculated that 762 evaluable patients were needed to show non-inferiority (85% power, alpha 2.5%) between randomized treatments. A total of 871 participated with electrocardiographic data available in 824 patients (95%). Residual ST-segment deviation one hour after PCI was 3.8±4.9 mm versus 3.9±5.2 mm for bivalirudin and heparin+GPI, respectively ( p=0.0019 for non-inferiority). Overall, there were no differences between randomized treatments in any measures of ST-segment resolution either before or after the index procedure. Pre-hospital treatment with bivalirudin is non-inferior to pre-hospital heparin + GPI with regard to residual ST-segment deviation or ST-segment resolution, reflecting comparable myocardial reperfusion with the two strategies.

The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

PubMed

Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D; Steiner, Enikö; Joura, Elmar; Senn, Beate

2017-07-01

To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Finding the minimal intervention needed for sustained mammography adherence.

PubMed

Gierisch, Jennifer M; DeFrank, Jessica T; Bowling, J Michael; Rimer, Barbara K; Matuszewski, Jeanine M; Farrell, David; Skinner, Celette Sugg

2010-10-01

Regular adherence to mammography screening saves lives, yet few women receive regular mammograms. RCT. Participants were recruited through a state employee health plan. All were women aged 40-75 years and had recent mammograms prior to enrollment (n=3547). Data were collected from 2004 to 2009. Trial tested efficacy of a two-step adaptively-designed intervention to increase mammography adherence over 4 years. The first intervention step consisted of three reminder types: enhanced usual care reminders (EUCR); enhanced letter reminders (ELR); both delivered by mail, and automated telephone reminders (ATR). After delivery of reminders, women who became off-schedule in any of the 4 years received a second step of supplemental interventions. Three supplemental intervention arms contained priming letters and telephone counseling: barriers only (BarriCall); barriers plus positive consequences of getting mammograms (BarriConCall+); and barriers plus negative consequences of not getting mammograms (BarriConCall-). Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines (analyses conducted in 2009). All reminders performed equally well in reducing number of days of non-adherence. Women randomized to receive supplemental interventions had significantly fewer days of non-adherence compared to women who received EUCR (p=0.0003). BarrConCall+ and BarrConCall- conditions did not significantly differ in days non-adherent compared to women in the barriers-only condition (BarriCon). The minimal intervention needed for sustained mammography use is a combination of a reminder followed by a priming letter and barrier-specific telephone counseling for women who become off-schedule. Additional costs associated with supplemental interventions should be considered by organizations deciding which interventions to use. NCT01148875. Copyright © 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Benefits of Early Childhood Interventions across the World: (Under) Investing in the Very Young

ERIC Educational Resources Information Center

Nores, Milagros; Barnett, W. Steven

2010-01-01

This paper reviews the international (non-U.S.) evidence on the benefits of early childhood interventions. A total of 38 contrasts of 30 interventions in 23 countries were analyzed. It focuses on studies applying a quasi-experimental or random assignment. Studies were coded according to: the type of intervention (cash transfer, nutritional,…

Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial.

PubMed

Amini, E; Rafiei, P; Zarei, K; Gohari, M; Hamidi, M

2013-01-01

Music is considered a subset of developmental supportive care. It may act as a suitable auditory stimulant in preterm infants. Also, it may reduce stress responses in autonomic, motor and state systems. To assess and compare the influence of lullaby and classical music on physiologic parameters. This is a randomized clinical trial with cross-over design. A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days. Each infant was exposed to three phases: lullaby music, classical music, and no music (control) for two days each. The sequence of these phases was assigned randomly to each subject. Babies were continuously monitored for heart rate, respiratory rate, and oxygen saturation and changes between phases were analyzed. Lullaby reduced heart rate (p < 0.001) and respiratory rate (p = 0.004). These effects extended in the period after the exposure (p < .001 and p = 0.001, respectively). Classical music reduced heart rate (p = 0.018). The effects of classical music disappeared once the music stopped. Oxygen saturation did not change during intervention. Music can affect vital signs of preterm infants; this effect can possibly be related to the reduction of stress during hospitalization. The implications of these findings on clinical and developmental outcomes need further study.

Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial.

PubMed

Gong, Jie; Chen, Xinguang; Li, Sijian

2015-01-01

To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. Community-based and patient-centered self-care for behavioral intervention in urban settings of China. A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72 mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H2 for use in community settings for prevention. ISRCTN Register ISRCTN12608966.

Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.

PubMed

Bus, S A; van Deursen, R W; Armstrong, D G; Lewis, J E A; Caravaggi, C F; Cavanagh, P R

2016-01-01

Footwear and offloading techniques are commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. The goal of this systematic review is to assess the medical scientific literature on this topic to better inform clinical practice about effective treatment. We searched the medical scientific literature indexed in PubMed, EMBASE, CINAHL, and the Cochrane database for original research studies published since 1 May 2006 related to four groups of interventions: (1) casting; (2) footwear; (3) surgical offloading; and (4) other offloading interventions. Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were assessed for methodological quality, and extracted key data was presented in evidence and risk of bias tables. Uncontrolled studies were assessed and summarized on a narrative basis. Outcomes are presented and discussed in conjunction with data from our previous systematic review covering the literature from before 1 May 2006. We included two systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias show the efficacy of therapeutic footwear that demonstrates to relief plantar pressure and is worn by the patient, in the prevention of plantar foot ulcer recurrence. Two meta-analyses show non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers. Due to the limited number of controlled studies, clear evidence on the efficacy of surgical offloading and felted foam is not yet available. Interestingly, surgical offloading seems more effective in preventing than in healing ulcers. A number of controlled and uncontrolled studies show that plantar pressure can be reduced by several conservative and surgical approaches. Sufficient evidence of good quality supports the use of non-removable offloading to heal plantar neuropathic forefoot ulcers and therapeutic footwear with demonstrated pressure relief that is worn by the patient to prevent plantar foot ulcer recurrence. The evidence base to support the use of other offloading interventions is still limited and of variable quality. The evidence for the use of interventions to prevent a first foot ulcer or heal ischemic, infected, non-plantar, or proximal foot ulcers is practically non-existent. High-quality controlled studies are needed in these areas. Copyright © 2015 John Wiley & Sons, Ltd.

Psychosocial interventions for disruptive behaviour problems in children in low- and middle-income countries: a systematic review and meta-analysis.

PubMed

Burkey, Matthew D; Hosein, Megan; Morton, Isabella; Purgato, Marianna; Adi, Ahmad; Kurzrok, Mark; Kohrt, Brandon A; Tol, Wietse A

2018-04-06

Most of the evidence for psychosocial interventions for disruptive behaviour problems comes from Western, high-income countries. The transferability of this evidence to culturally diverse, low-resource settings with few mental health specialists is unknown. We conducted a systematic review with random-effects meta-analysis of randomized controlled trials examining the effects of psychosocial interventions on reducing behaviour problems among children (under 18) living in low- and middle-income countries (LMIC). Twenty-six randomized controlled trials (representing 28 psychosocial interventions), evaluating 4,441 subjects, met selection criteria. Fifteen (54%) prevention interventions targeted general or at-risk populations, whereas 13 (46%) treatment interventions targeted children selected for elevated behaviour problems. Most interventions were delivered in group settings (96%) and half (50%) were administered by non-specialist providers. The overall effect (standardized mean difference, SMD) of prevention studies was -0.25 (95% confidence interval (CI): -0.41 to -0.09; I 2 : 78%) and of treatment studies was -0.56 (95% CI: -0.51 to -0.24; I 2 : 74%). Subgroup analyses demonstrated effectiveness for child-focused (SMD: -0.35; 95% CI: -0.57 to -0.14) and behavioural parenting interventions (SMD: -0.43; 95% CI: -0.66 to -0.20), and that interventions were effective across age ranges. Our meta-analysis supports the use of psychosocial interventions as a feasible and effective way to reduce disruptive behaviour problems among children in LMIC. Our study provides strong evidence for child-focused and behavioural parenting interventions, interventions across age ranges and interventions delivered in groups. Additional research is needed on training and supervision of non-specialists and on implementation of effective interventions in LMIC settings. © 2018 Association for Child and Adolescent Mental Health.

Comparative Effectiveness of Three Occupational Therapy Sleep Interventions: A Randomized Controlled Study.

PubMed

Gutman, Sharon A; Gregory, Kristin A; Sadlier-Brown, Megan M; Schlissel, Marcy A; Schubert, Allison M; Westover, Lee Ann; Miller, Richard C

2017-01-01

Although sleep intervention is within the domain of occupational therapy, few studies exist supporting practice. Effectiveness of three sleep interventions was compared: Dreampad Pillow®, iRest® meditation, and sleep hygiene. Twenty-nine participants were randomly assigned to the Dreampad Pillow® ( n = 10), iRest® meditation ( n = 9), and sleep hygiene ( n = 10) groups. In Phase 1, all participants used a 7-day sleep hygiene regimen to reduce poor sleep habits. In Phase 2 (14 days), 10 participants used the Dreampad Pillow® and sleep hygiene, nine used the iRest meditation and sleep hygiene, and 10 continued sleep hygiene only. At intervention-end, the iRest meditation group experienced statistically greater time asleep than both the Dreampad Pillow® ( p < .006, d = 1.87) and sleep hygiene groups ( p < .03, d = 1.80). The Dreampad Pillow® group experienced statistically fewer nighttime awakenings than the iRest® meditation ( p < .04, d = -1.53) and sleep hygiene ( p < .004, d = -1.43) groups. No differences were found between groups in perceived sleep quality, length of time needed to fall asleep, and fatigue level next day. This study provides support for sleep interventions within occupational therapy's domain.

Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial.

PubMed

Mahendran, Rathi; Rawtaer, Iris; Fam, Johnson; Wong, Jonathan; Kumar, Alan Prem; Gandhi, Mihir; Jing, Kenny Xu; Feng, Lei; Kua, Ee Heok

2017-07-12

Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment. This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders. This will be the first study to compare the effectiveness of art therapy and music reminiscence activity in a randomized controlled trial. We expect that the trial will provide useful evidence for developing psychosocial interventions for the elderly with mild cognitive impairment. The study was registered on 7 July 2016 at Clinical Trials.gov, a service of the US National Institute of Health ( NCT02854085 ), retrospectively.

Probing the statistics of transport in the Hénon Map

NASA Astrophysics Data System (ADS)

Alus, O.; Fishman, S.; Meiss, J. D.

2016-09-01

The phase space of an area-preserving map typically contains infinitely many elliptic islands embedded in a chaotic sea. Orbits near the boundary of a chaotic region have been observed to stick for long times, strongly influencing their transport properties. The boundary is composed of invariant "boundary circles." We briefly report recent results of the distribution of rotation numbers of boundary circles for the Hénon quadratic map and show that the probability of occurrence of small integer entries of their continued fraction expansions is larger than would be expected for a number chosen at random. However, large integer entries occur with probabilities distributed proportionally to the random case. The probability distributions of ratios of fluxes through island chains is reported as well. These island chains are neighbours in the sense of the Meiss-Ott Markov-tree model. Two distinct universality families are found. The distributions of the ratio between the flux and orbital period are also presented. All of these results have implications for models of transport in mixed phase space.

Some Aspects of the Investigation of Random Vibration Influence on Ride Comfort

NASA Astrophysics Data System (ADS)

DEMIĆ, M.; LUKIĆ, J.; MILIĆ, Ž.

2002-05-01

Contemporary vehicles must satisfy high ride comfort criteria. This paper attempts to develop criteria for ride comfort improvement. The highest loading levels have been found to be in the vertical direction and the lowest in lateral direction in passenger cars and trucks. These results have formed the basis for further laboratory and field investigations. An investigation of the human body behaviour under random vibrations is reported in this paper. The research included two phases; biodynamic research and ride comfort investigation. A group of 30 subjects was tested. The influence of broadband random vibrations on the human body was examined through the seat-to-head transmissibility function (STHT). Initially, vertical and fore and aft vibrations were considered. Multi-directional vibration was also investigated. In the biodynamic research, subjects were exposed to 0·55, 1·75 and 2·25 m/s2 r.m.s. vibration levels in the 0·5- 40 Hz frequency domain. The influence of sitting position on human body behaviour under two axial vibrations was also examined. Data analysis showed that the human body behaviour under two-directional random vibrations could not be approximated by superposition of one-directional random vibrations. Non-linearity of the seated human body in the vertical and fore and aft directions was observed. Seat-backrest angle also influenced STHT. In the second phase of experimental research, a new method for the assessment of the influence of narrowband random vibration on the human body was formulated and tested. It included determination of equivalent comfort curves in the vertical and fore and aft directions under one- and two-directional narrowband random vibrations. Equivalent comfort curves for durations of 2·5, 4 and 8 h were determined.

Effects of a capacitive-resistive electric transfer therapy on physiological and biomechanical parameters in recreational runners: A randomized controlled crossover trial.

PubMed

Duñabeitia, Iratxe; Arrieta, Haritz; Torres-Unda, Jon; Gil, Javier; Santos-Concejero, Jordan; Gil, Susana M; Irazusta, Jon; Bidaurrazaga-Letona, Iraia

2018-05-26

This study compared the effects of a capacitive-resistive electric transfer therapy (Tecar) and passive rest on physiological and biomechanical parameters in recreational runners when performed shortly after an exhausting training session. Randomized controlled crossover trial. University biomechanical research laboratory. Fourteen trained male runners MAIN OUTCOME MEASURES: Physiological (running economy, oxygen uptake, respiratory exchange ratio, ventilation, heart rate, blood lactate concentration) and biomechanical (step length; stride angle, height, frequency, and contact time; swing time; contact phase; support phase; push-off phase) parameters were measured during two incremental treadmill running tests performed two days apart after an exhaustive training session. When running at 14 km/h and 16 km/h, the Tecar treatment group presented greater increases in stride length (p < 0.001), angle (p < 0.05) and height (p < 0.001) between the first and second tests than the control group and, accordingly, greater decreases in stride frequency (p < 0.05). Physiological parameters were similar between groups. The present study suggests that a Tecar therapy intervention enhances biomechanical parameters in recreational runners after an exhaustive training session more than passive rest, generating a more efficient running pattern without affecting selected physiological parameters. Copyright © 2018 Elsevier Ltd. All rights reserved.

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

PubMed

Cook, Andrea J; Delong, Elizabeth; Murray, David M; Vollmer, William M; Heagerty, Patrick J

2016-10-01

Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols. © The Author(s) 2016.

Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial.

PubMed

Yancy, William S; Shaw, Pamela A; Wesby, Lisa; Hilbert, Victoria; Yang, Lin; Zhu, Jingsan; Troxel, Andrea; Huffman, David; Foster, Gary D; Wojtanowski, Alexis C; Volpp, Kevin G

2018-05-25

Financial incentives can improve initial weight loss; we examined whether financial incentives can improve weight loss maintenance. Participants aged 30-80 years who lost at least 5 kg during the first 4-6 months in a nationally available commercial weight loss program were recruited via the internet into a three-arm randomized trial of two types of financial incentives versus active control during months 1-6 (Phase I) followed by passive monitoring during months 7-12 (Phase II). Interventions were daily self-weighing and text messaging feedback alone (control) or combined with a lottery-based incentive or a direct incentive. The primary outcome was weight change 6 months after initial weight loss. Secondary outcomes included weight change 12 months after initial weight loss (6 months after cessation of maintenance intervention), and self-reported physical activity and eating behaviors. Of 191 participants randomized, the mean age was 49.0 (SD = 10.5) years and weight loss prior to randomization was 11.4 (4.7) kg; 92% were women and 89% were White. Mean weight changes during the next 6 months (Phase I) were: lottery -3.0 (5.8) kg; direct -2.8 (5.8) kg; and control -1.4 (5.8) kg (all pairwise comparisons p > 0.1). Weight changes through the end of 12 months post-weight loss (Phase II) were: lottery -1.8 (10.5) kg; direct -0.7 (10.7) kg; and control -0.3 (9.4) kg (all pairwise comparisons p > 0.1). The percentages of participants who maintained their weight loss (defined as gaining ≤1.36 kg) were: lottery 79%, direct 76%, and control 67% at 6 months and lottery 66%, direct 62%, and control 59% at 12 months (all pairwise comparisons p > 0.1). At 6 and 12 months after initial weight loss, changes in self-reported physical activity or eating behaviors did not differ across arms. Compared with the active control of daily texting based on daily home weighing, lottery-based and direct monetary incentives provided no additional benefit for weight loss maintenance.

Coaching Non-technical Skills Improves Surgical Residents' Performance in a Simulated Operating Room.

PubMed

Yule, Steven; Parker, Sarah Henrickson; Wilkinson, Jill; McKinley, Aileen; MacDonald, Jamie; Neill, Adrian; McAdam, Tim

2015-01-01

To investigate the effect of coaching on non-technical skills and performance during laparoscopic cholecystectomy in a simulated operating room (OR). Non-technical skills (situation awareness, decision making, teamwork, and leadership) underpin technical ability and are critical to the success of operations and the safety of patients in the OR. The rate of developing assessment tools in this area has outpaced development of workable interventions to improve non-technical skills in surgical training and beyond. A randomized trial was conducted with senior surgical residents (n = 16). Participants were randomized to receive either non-technical skills coaching (intervention) or to self-reflect (control) after each of 5 simulated operations. Coaching was based on the Non-Technical Skills For Surgeons (NOTSS) behavior observation system. Surgeon-coaches trained in this method coached participants in the intervention group for 10 minutes after each simulation. Primary outcome measure was non-technical skills, assessed from video by a surgeon using the NOTSS system. Secondary outcomes were time to call for help during bleeding, operative time, and path length of laparoscopic instruments. Non-technical skills improved in the intervention group from scenario 1 to scenario 5 compared with those in the control group (p = 0.04). The intervention group was faster to call for help when faced with unstoppable bleeding in the final scenario (no. 5; p = 0.03). Coaching improved residents' non-technical skills in the simulated OR compared with those in the control group. Important next steps are to implement non-technical skills coaching in the real OR and assess effect on clinically important process measures and patient outcomes. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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

ERIC Educational Resources Information Center

Delaney, Katherine K.; Neuman, Susan B.

2016-01-01

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

Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial.

PubMed

Levin, Mindy F; Baniña, Melanie C; Frenkel-Toledo, Silvi; Berman, Sigal; Soroker, Nachum; Solomon, John M; Liebermann, Dario G

2018-01-04

Recovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved ("active control zone") after identification of a "spasticity zone". Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function. This single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task. This study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries. ClinicalTrials.gov, ID: NCT02725853 . Initially registered on 12 January 2016.

Effectiveness of a diode laser in addition to non-surgical periodontal therapy: study of intervention.

PubMed

Crispino, Antonio; Figliuzzi, Michele Mario; Iovane, Claudio; Del Giudice, Teresa; Lomanno, Simona; Pacifico, Delfina; Fortunato, Leonzio; Del Giudice, Roberto

2015-01-01

Chronic periodontitis affects 47% of adult population over the age of 30. The first phase of periodontal treatment is always represented by scaling and root planning (SRP), that is a causal, non-surgical therapy that recognizes as primary aims the control of bacterial infection and the reduction of periodontal plaque-associated inflammation. Yet, another innovative causal therapy is represented by the irradiation of periodontal pockets with laser. To evaluate the effect of a 940-nm diode laser as an adjunct to SRP in patients affected by periodontitis. Sixty-eight adult patients with moderate-to-severe periodontitis were sequentially enrolled and undergone to periodontal examination (V1) in order to detect gingival index (GI), plaque index (PI) and probing depth (PD). The patients were randomly divided into two groups: the first (n=34) received SRP treatment alone, the control group (n=34) received SRP and 940-nm diode laser therapy. Data were analyzed by Student's t-test, with two tails; for all clinical parameters, both groups reported statistically significant differences compared to basal values (p<0.0001). Both procedures were effective in improving GI, PI and PD, but the use of diode laser was associated with more evident results. Considered the better clinical outcomes, diode laser can be routinely associated with SRP in the treatment of periodontal pockets of patients with moderate-to-severe periodontitis.

Pathfinding to an optimal strategy of revascularization in primary coronary intervention in patients with multivessel disease: a network meta-analysis of randomized trials.

PubMed

Komócsi, András; Kehl, Dániel; d'Ascenso, Fabrizio; DiNicolantonio, James; Vorobcsuk, András

2017-03-01

In ST-segment elevation myocardial infarction (STEMI), current guidelines discourage treatment of the non-culprit lesions at the time of the primary intervention. Latest trials have challenged this strategy suggesting benefit of early complete revascularization. We performed a Bayesian multiple treatment network meta-analysis of randomized clinical trials (RCTs) in STEMI on culprit-only intervention (CO) versus different timing multivessel revascularization, including immediate (IM), same hospitalization (SH) or later staged (ST). Outcome parameters were pooled with a random-effects model. For multiple-treatment meta-analysis, a Bayesian Markov chain Monte Carlo method was used. Eight RCTs involving 2077 patients were identified. ST and IM revascularization was associated with a decrease in major adverse cardiac events (MACEs) compared to culprit-only approach (risk ratio [RR]: 0.43 credible interval [CrI]: 0.22-0.77 and RR: 0.36 CrI: 0.24-0.54, respectively). IM was superior to SH (RR: 0.49 CrI: 0.29-0.80). With regards to myocardial infarction IM was superior to SH (RR: 0.18 CrI: 0.02-0.99). The posterior probability of being the best choice of treatment regarding the frequency of MACEs was 71.2% for IM, 28.5% for ST, 0.3% for SH and 0.05% for culprit-only approach. Results from RCTs indicate that immediate or staged revascularization of non-culprit lesions reduces major adverse events in patients after primary percutaneous coronary intervention. Differences in MACEs suggest superiority of the immediate or staged intervention; however, further randomized trials are needed to determine the optimal timing of revascularization of the non-culprit lesions.

Neurodevelopmental delay among children under the age of three years at immunization clinics in Lagos State, Nigeria - Preliminary report.

PubMed

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Ogun, Oluwayemi C; Eaton, Julian

2016-04-29

Late diagnosis and interventions characterize childhood neurodevelopmental disorders in Sub-Saharan Africa. This has negatively impacted on the prognosis of the children with neurodevelopmental disorders. This study examined the prevalence and pattern of neurodevelopmental delays among children under the age of 3 years attending immunization clinics in Lagos State, Nigeria and also affords opportunity of early follow-up and interventions, which had been documented to improve prognosis. The study involved two stage assessments; which consisted of first phase screening of the children for neurodevelopmental delays in immunization clinics at primary healthcare centers Lagos State, Nigeria and second phase which consists of definitive clinical evaluation and follow-up interventions for children screened positive for neurodevelopmental delays. Twenty seven (0.9%) of a total of 3,011 children under the age of 3 years were screened positive for neurodevelopmental delays and subsequently undergoing clinical evaluation and follow-up interventions. Preliminary working diagnoses among these children include cerebral palsy, autism spectrum disorder trait, nutritional deficiency, Down syndrome and Non-specific neurodevelopmental delay with co-morbid seizure disorder accounting for 33.3%, 14.8%, 18.5%, 7.4% and 25.9% respectively. This is a preliminary report that would be followed up with information on medium and long term intervention phase.

The effects of listening to preferred music on pain intensity after open heart surgery

PubMed Central

Jafari, Hedayat; Zeydi, Amir Emami; Khani, Soghra; Esmaeili, Ravanbakhsh; Soleimani, Aria

2012-01-01

Background: Pain is a common phenomenon after surgery. Cardiac surgeries are no exception and patients generally experience acute pain after these surgeries. Inadequate pain management after cardiac surgery predisposes patients to many complications. Therefore, the aim of this study was to determine the effects of listening to preferred music on pain intensity after open heart surgery. Materials and Methods: This study was a randomized clinical trial (RCT) conducted in open heart intensive care unit (ICU) of a university hospital in Sari, Iran. A total of 60 patients who were scheduled to undergo open heart surgery were randomly allocated in two groups. Patients in the intervention group (n = 30) listened to their preferred music by headphones for 30 minutes, whereas those in the control group (n = 30) did not listen to music. Using a Numerical Rating Scale (NRS), pain intensity was measured among the patients before the intervention, and immediately, 30 minutes and one hour after the intervention. Data was analyzed by Chi-square test, student's t-test and repeated measures analysis of variance (ANOVA). Findings: Mean pain intensity in the intervention group before, immediately after, 30 minutes and one hour after the intervention were 5.8, 3.1, 2.5 and 2.4, respectively. Corresponding numbers in the control group were 4.7, 4.7, 4.8 and 4.9, respectively. Repeated measures ANOVA showed music to significantly reduce pain intensity (p = 0.0001) Conclusions: Music can be effective as a non-pharmacological, inexpensive, non-invasive and side effect free method for pain management after open heart surgery. PMID:23493927

Effects of Supplementation of the Synbiotic Ecologic® 825/FOS P6 on Intestinal Barrier Function in Healthy Humans: A Randomized Controlled Trial

PubMed Central

Wilms, E.; Gerritsen, J.; Smidt, H.; Besseling-van der Vaart, I.; Rijkers, G. T.; Garcia Fuentes, A. R.; Masclee, A. A. M.; Troost, F. J.

2016-01-01

Background and Aims Probiotics, prebiotics and synbiotics have been suggested as dietary strategies to improve intestinal barrier function. This study aimed to assess the effect of two weeks synbiotic supplementation on intestinal permeability under basal and stressed conditions. Secondary aims were the assessment of two weeks synbiotic supplementation on systemic immune function and gastrointestinal symptoms including defecation pattern. Design Twenty healthy adults completed a double-blind, controlled, randomized, parallel design study. Intervention Groups either received synbiotic (1.5 × 1010 CFU Ecologic® 825 + 10 g fructo-oligosaccharides (FOS P6) per day) or control supplements for two weeks. Outcomes Intestinal segment specific permeability was assessed non-invasively by oral administration of multiple sugar probes and, subsequently, assessing the excretion of these probes in urine. This test was conducted at baseline and at the end of intervention, in the absence and in the presence of an indomethacin challenge. Indomethacin was applied to induce a compromised gut state. Plasma zonulin, cytokines and chemokines were measured at baseline and at the end of intervention. Gastrointestinal symptoms and stool frequency were recorded at baseline and daily during intervention. Results Significantly more male subjects were in the synbiotic group compared to the control group (P = 0.025). Indomethacin significantly increased urinary lactulose/rhamnose ratio versus without indomethacin, both in the control group (P = 0.005) and in the synbiotic group (P = 0.017). Urinary sugar recoveries and ratios, plasma levels of zonulin, cytokines and chemokines, and gastrointestinal symptom scores were not significantly different after control or synbiotic intervention. Stool frequency within the synbiotic group was significantly increased during synbiotic intervention compared to baseline (P = 0.039) and higher compared to control intervention (P = 0.045). Conclusion Two weeks Ecologic® 825/FOS P6 supplementation increased stool frequency, but did not affect intestinal permeability neither under basal nor under indomethacin-induced stressed conditions, immune function or gastrointestinal symptoms in healthy adults. PMID:27936169

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Does a pre-intervention functional assessment increase intervention effectiveness? A meta-analysis of within-subject interrupted time-series studies.

PubMed

Hurl, Kylee; Wightman, Jade; Haynes, Stephen N; Virues-Ortega, Javier

2016-07-01

This study examined the relative effectiveness of interventions based on a pre-intervention functional behavioral assessment (FBA), compared to interventions not based on a pre-intervention FBA. We examined 19 studies that included a direct comparison between the effects of FBA- and non-FBA-based interventions with the same participants. A random effects meta-analysis of effect sizes indicated that FBA-based interventions were associated with large reductions in problem behaviors when using non-FBA-based interventions as a reference intervention (Effect size=0.85, 95% CI [0.42, 1.27], p<0.001). In addition, non-FBA based interventions had no effect on problem behavior when compared to no intervention (0.06, 95% CI [-0.21, 0.33], p=0.664). Interestingly, both FBA-based and non-FBA-based interventions had significant effects on appropriate behavior relative to no intervention, albeit the overall effect size was much larger for FBA-based interventions (FBA-based: 1.27, 95% CI [0.89, 1.66], p<0.001 vs. non-FBA-based: 0.35, 95% CI [0.14, 0.56], p=0.001). In spite of the evidence in favor of FBA-based interventions, the limited number of comparative studies with high methodological standards underlines the need for further comparisons of FBA-based versus non-FBA-based interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Depression in older adults deteriorates quality of life and increases morbidity, mortality, and medical expenses. Medicine and social policy should work together to decrease this burden. Existing prevention studies are often based on time-consuming psychotherapies, which therefore are not feasible for a wide application at the community level. Postcard interventions have been shown to be effective for patients after hospitalization for major depression, drug overdose, or self-harm. This paper describes the protocol of a pragmatic, randomized controlled trial designed to examine the efficacy of a postcard intervention for depression among community-dwelling individuals aged 65 years or older. Methods/Design This is a pragmatic, non-blinded, parallel comparison, randomized controlled trial using Zelen’s design in a community setting. Participants will include community-dwelling older adults (aged 65 years or older) with limited social support (indicated by eating meals alone) and with symptoms of depression (scoring 4 or higher on the 15-item Geriatric Depression Scale (GDS)). The intervention will consist of sending postcards with handwritten messages and seasonal reports from a historical city to participants once a month for eight consecutive months. Self-addressed, stamped envelopes will be enclosed to facilitate non-obligatory replies. Primary outcomes will be changes in the GDS scores that are administered to all elderly inhabitants of the community every year as part of annual health checks. Secondary outcomes include quality of life as measured by a visual analogue scale, and self-rated basic and advanced activities of daily living. We will also examine the subjective sense of effectiveness of the intervention, recollection of the number of intervention mailings received, and the number of mailed replies as the index of the acceptability of the postcard intervention. The time × group interaction for two consecutive years will be analyzed using a generalized linear mixed model. To detect an effect size of 0.5 at alpha error of 0.05 and statistical power of 0.80, 63 participants per group are required. Based on an estimated consent and dropout rate of 70%, a total of 180 subjects will be recruited. Trial registration UMIN000010529 PMID:23837527

A health insurance company-initiated practice support intervention for optimizing acid-suppressing drug prescriptions in primary care.

PubMed

Smeets, Hugo M; Hoes, Arno W; Zuithoff, Nicolaas P A; van Dijk, Paul C M; van der Lee, Arnold P M; de Wit, Niek J

2011-08-01

A health insurance-initiated programme to improve cost-effectiveness of acid-suppressing drugs (ASDs). To evaluate the effect of two different interventions of general practitioner support in reducing drug prescription. A sequential cluster randomized controlled trial with 90 participating general practitioners in a telephone support (TS) group or practice visit (PV) group. TS group received support in phase-1 (first 6 months), but served as control group in phase-2 (6-12 months period). PV group received no intervention in phase-1, serving as the control group for the TS group, but received support in phase-2. Prescription data were extracted from Agis Health Insurance Database. Outcomes were the proportion of responders to drug reduction and the number of defined daily dose (DDD). Differences in users and DDD were analysed using multilevel regression analysis. At baseline, 3424 patients used ASD chronically (211 DDDs, on average). The difference between TS and control groups among responders was 3.2% [95% confidence interval (CI): 0.8; 5.6] and relative risk was 1.26 (95% CI: 1.06; 1.51). The difference between PV and control groups was not relevant (0.4%, 95% CI: -1.99; 2.79 and relative risk: 1.01, 95% CI: 0.82; 1.20). The difference in DDD per patient was -3.0 (95% CI: -8.9; 2.9) and -5.82 (95% CI: -12.4; 0.73), respectively. This health insurance company-initiated intervention had a moderate effect on ASD prescription. In contrast to TS, PVs did not seem to reduce ASD prescription rates.

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

PubMed

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

Soy Food Intake and Biomarkers of Breast Cancer Risk: Possible Difference in Asian Women?

PubMed Central

Maskarinec, Gertraud; Ju, Dan; Morimoto, Yukiko; Franke, Adrian A.; Stanczyk, Frank Z.

2017-01-01

Soy foods may protect against breast cancer in Asian but not in Western populations. We examined if the levels of various markers of breast cancer risk and inflammation, as well as the effects of soy food consumption on these markers, differ between Asian and non-Asian premenopausal women in two soy intervention trials. One study randomized 220 women to a 2-year intervention and the other one randomized 96 women in a cross-over design to examine the effects of consumption of 2 daily soy servings on nipple aspirate fluid (NAF) volume, estrogens in serum, NAF, and urine, insulin-like growth factor-1 (IGF-1), IGF binding protein 3, and inflammatory markers in serum, and mammographic densities. Mixed linear models were applied to assess ethnic differences in biomarkers and response to the soy diet. Serum C-reactive protein, serum leptin, NAF volume, and NAF estrone-sulfate were lower, while urinary isoflavones were higher in Asian than in non-Asian women. A significant interaction (pinteraction=0.05) between ethnicity and soy diet was observed for IGF-1 but not for other biomarkers. The current findings suggest possible ethnic differences in levels of biomarkers for breast cancer risk but little evidence that Asian women respond differently to soy foods than non-Asian women. PMID:27918846

An independent randomized clinical trial of multisystemic therapy with non-court-referred adolescents with serious conduct problems.

PubMed

Weiss, Bahr; Han, Susan; Harris, Vicki; Catron, Thomas; Ngo, Victoria K; Caron, Annalise; Gallop, Robert; Guth, Carol

2013-12-01

Adolescent conduct problems exact serious social as well as personal costs, and effective treatments are essential. One of the most widely disseminated and effective programs for the treatment of serious conduct problems in adolescents is Multisystemic Therapy (MST). However, most evaluations of MST have involved the developers of MST. The purpose of the present study was to conduct an independent evaluation of MST, with non-court-referred adolescents with conduct problems. Participants were 164 adolescents ages 11-18 years who were recruited from self-contained behavior intervention classrooms in public schools. Adolescents and their families were randomly assigned to receive MST or services as usual. Outcome measures assessed conduct problems, school functioning, and court records of criminal behavior. Participants were followed for 18 months after baseline using parent, adolescent, and teacher reports; arrest data were collected for 2.5 years postbaseline. Two of 4 primary outcome measures focused on externalizing problems showed significant treatment effects favoring MST. Several secondary and intervention targets pertaining to family functioning and parent psychopathology showed positive effects of MST, and no negative effects were identified. Results provide some further support for the effectiveness of MST, although smaller effect sizes than previous studies also suggest the complexity of successful dissemination, particularly to non-court-referred populations.

Soy Food Intake and Biomarkers of Breast Cancer Risk: Possible Difference in Asian Women?

PubMed

Maskarinec, Gertraud; Ju, Dan; Morimoto, Yukiko; Franke, Adrian A; Stanczyk, Frank Z

2017-01-01

Soy foods may protect against breast cancer in Asian but not in Western populations. We examined if the levels of various markers of breast cancer risk and inflammation, as well as the effects of soy food consumption on these markers, differ between Asian and non-Asian premenopausal women in two soy intervention trials. One study randomized 220 women to a 2-yr intervention and the other one randomized 96 women in a crossover design to examine the effects of consumption of 2 daily soy servings on nipple aspirate fluid (NAF) volume; estrogens in serum, NAF, and urine; insulin-like growth factor-1 (IGF-1), IGF-binding protein 3, and inflammatory markers in serum; and mammographic densities. Mixed linear models were applied to assess ethnic differences in biomarkers and response to the soy diet. Serum C-reactive protein, serum leptin, NAF volume, and NAF estrone sulfate were lower, while urinary isoflavones were higher in Asian than in non-Asian women. A significant interaction (p interaction = 0.05) between ethnicity and soy diet was observed for IGF-1 but not for other biomarkers. The current findings suggest possible ethnic differences in levels of biomarkers for breast cancer risk but little evidence that Asian women respond differently to soy foods than non-Asian women.

Effect of educational program on quality of life of patients with heart failure: a randomized clinical trial.

PubMed

Lakdizaji, Sima; Hassankhni, Hadi; Mohajjel Agdam, Alireza; Khajegodary, Mohammad; Salehi, Rezvanieh

2013-03-01

Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of a continuous training program on quality of life of patients with heart failure. This randomized clinical trial study was conducted during May to August 2011. Forty four participants with heart failure referred to Shahid Madani's polyclinics of Tabriz were selected through convenient sampling method and were randomly allocated to two groups. The intervention group (n = 22) received ongoing training including one-to-one teaching, counseling sessions and phone calls over 3 months. The control group (n = 22) received routine care program. Data on quality of life was collected using the Minnesota Living with Heart Failure Questionnaire at baseline as well as three months later. The statistical tests showed significant differences in the physical, emotional dimensions and total quality of life in intervention group. But in control group, no significant differences were obtained. There was not any significant association in demographic characteristics and quality of life. Ongoing training programs can be effective in improving quality of life of patients with heart failure. Hence applying ongoing educational program as a non-pharmacological intervention can help to improve the quality of life of these patients.

The effects of asking a fertility intention question in primary care settings: a systematic review protocol.

PubMed

Henning, Paul A; Burgess, Carolyne K; Jones, Heidi E; Norman, Wendy V

2017-01-19

Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care. A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention. Types of studies will include randomized controlled trials, non-randomized trials, and observation studies. Participants will include patients of reproductive age presenting to primary health care settings. Interventions will include any assessment of fertility intention and follow-up care compared with a control group or no intervention. Outcomes will include quantitative data with rates for contraceptive uptake, and any pregnancy related outcome. Databases (Ovid MEDLINE; Pubmed; CINAHL; EMBASE; CDR/DARE databases; Web of Science; ISRCTN registry; Clinicaltrials.gov; Cochrane Library) will be searched from the year 2000 to current. Screening of identified articles and data extraction will be conducted in duplicate by two independent reviewers. Methodological quality will be assessed using the Jadad scale. Methodological quality of observational and non-randomized trials will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus or by consulting a third author. Meta-analyses will be performed if appropriate. Determining the effect of including questions of pregnancy intention into primary care can provide evidence for the development of clinical practice guidelines and inform primary care providers if this simple and low-cost intervention should be routinely employed. This review will also identify any gaps in the current literature on this topic and provide direction for future research in this area of study. Systematic Review Registration: PROSPERO CRD42015019726.

Pain management in the neonatal piglet during routine management procedures. Part 1: a systematic review of randomized and non-randomized intervention studies.

PubMed

Dzikamunhenga, R S; Anthony, R; Coetzee, J; Gould, S; Johnson, A; Karriker, L; McKean, J; Millman, S T; Niekamp, S R; O'Connor, A M

2014-06-01

Routine procedures carried out on piglets (i.e. castration, tail docking, teeth clipping, and ear notching) are considered painful. Unfortunately the efficacy of current pain mitigation modalities is poorly understood. The aim of this systematic review was to synthesize the existing primary scientific literature regarding the effectiveness of pain management interventions used for routine procedures on piglets. The review question was, 'In piglets under twenty-eight days old, undergoing castration, tail docking, teeth clipping, and/or methods of identification that involve cutting of the ear tissue, what is the effect of pain mitigation compared with no pain mitigation on behavioral and non-behavioral outcomes that indicate procedural pain and post-procedural pain?' A review protocol was designed a priori. Data sources used were Agricola (EBSCO), CAB Abstracts (Thomson Reuters), PubMed, Web of Science (Thomson Reuters), BIOSIS Previews (Thomson Reuters), and ProQuest Dissertations & Theses Full Text. No restrictions on year of publication or language were placed on the search. Eligible studies assessed an intervention designed to mitigate the pain of the procedures of interest and included a comparison group that did not receive an intervention. Eligible non-English studies were translated using a translation service. Two reviewers independently screened titles and abstracts for relevance using pre-defined questions. Data were extracted from relevant articles onto pre-defined forms. From the 2203 retrieved citations forty publications, containing 52 studies met the eligibility criteria. In 40 studies, piglets underwent castration only. In seven studies, piglets underwent tail docking only. In one study, piglets underwent teeth clipping only, and in one study piglets underwent ear notching only. Three studies used multiple procedures. Thirty-two trial arms assessed general anesthesia protocols, 30 trial arms assessed local anesthetic protocols, and 28 trial arms assessed non-steroidal anti-inflammatory drugs (NSAIDs) protocols. Forty-one trial arms were controls where piglets received either placebo or no treatment. Forty-five outcomes were extracted from the studies, however only the results from studies that assessed cortisol (six studies), β-endorphins (one study), vocalisations (nine studies), and pain-related behaviors (nine studies) are reported. Other outcomes were reported in only one or two studies. Confident decision making will likely be difficult based on this body of work because lack of comprehensive reporting precludes calculation of the magnitude of pain mitigation for most outcomes.

Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance Trial

PubMed Central

Champagne, Catherine M.; Broyles, Stephanie T; Moran, Laura D.; Cash, Katherine C.; Levy, Erma J.; Lin, Pao-Hwa; Batch, Bryan C.; Lien, Lillian F.; Funk, Kristine L.; Dalcin, Arlene; Loria, Catherine; Myers, Valerie H.

2011-01-01

Background Dietary components effective in weight maintenance efforts have not been adequately identified. Objective To determine impact of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance (WLM) clinical trial. Design WLM was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months. Participants/setting The multicenter trial was conducted from 2003–2007. This substudy included 828 successful weight loss participants. Methods Dietary Measures The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber and fruit/vegetable and dairy servings were utilized as predictor variables. Data collection The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points; randomization (beginning of Phase II), 12 and 30 months. Intervention The main intervention focused on long term maintenance of weight loss using the Dietary Approaches to Hypertension (DASH) diet. This substudy examined whether changes to specific dietary variables were associated with weight loss and maintenance. Statistical analyses performed Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates. Results Participants who substituted protein for fat lost, on average, 0.33 kg per 6-months during Phase I (p<0.0001) and 0.07 kg per 6-months during Phase II (p<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6-months (p<0.0001) and 0.04 kg per 6-months (p=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (−0.17 kg per 6-months per 1-serving increase, p=0.0002), but not in Phase I. Dietary fiber revealed no significant findings. Conclusion Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance. PMID:22117658

Non-Markovianity Measure Based on Brukner-Zeilinger Invariant Information for Unital Quantum Dynamical Maps

NASA Astrophysics Data System (ADS)

He, Zhi; Zhu, Lie-Qiang; Li, Li

2017-03-01

A non-Markovianity measure based on Brukner-Zeilinger invariant information to characterize non-Markovian effect of open systems undergoing unital dynamical maps is proposed. The method takes advantage of non-increasing property of the Brukner-Zeilinger invariant information under completely positive and trace-preserving unital maps. The simplicity of computing the Brukner-Zeilinger invariant information is the advantage of the proposed measure because of mainly depending on the purity of quantum state. The measure effectively captures the characteristics of non-Markovianity of unital dynamical maps. As some concrete application, we consider two typical non-Markovian noise channels, i.e., the phase damping channel and the random unitary channel to show the sensitivity of the proposed measure. By investigation, we find that the conditions of detecting the non-Markovianity for the phase damping channel are consistent with the results of existing measures for non-Markovianity, i.e., information flow, divisibility and quantum mutual information. However, for the random unitary channel non-Markovian conditions are same to that of the information flow, but is different from that of the divisibility and quantum mutual information. Supported by the National Natural Science Foundation of China under Grant No. 61505053, the Natural Science Foundation of Hunan Province under Grant No. 2015JJ3092, the Research Foundation of Education Bureau of Hunan Province, China under Grant No. 16B177, the School Foundation from the Hunan University of Arts and Science under Grant No. 14ZD01

Effectiveness and safety of wheelchair skills training program in improving the wheelchair skills capacity: a systematic review.

PubMed

Tu, Chun-Jing; Liu, Lin; Wang, Wei; Du, He-Ping; Wang, Yu-Ming; Xu, Yan-Bing; Li, Ping

2017-12-01

To comprehensively assess the effectiveness and safety of wheelchair skills training program in improving wheelchair skills capacity. PubMed, OVID, EBSCO, ScienceDirect, Web of Science, CINAHL, Cochrane Library, Google Scholar, and China Knowledge Resource Integrated Database were searched up to March 2017. Controlled clinical trials that compared a wheelchair skills training program with a control group that received other interventions and used the wheelchair skills test scores to evaluate wheelchair skills capacity were included. Two authors independently screened articles, extracted data, and assessed the methodological quality using the Cochrane risk-of-bias tool in randomized controlled trial (RCT) and methodological index for non-randomized studies. The data results of wheelchair skills test scores were extracted. Data from 455 individuals in 10 RCTs and from 140 participants in seven non-randomized studies were included for meta-analysis using Stata version 12.0 (Stata Corporation, College Station, TX, USA). In the short term (immediately to one week) post-intervention, relative to a control group, manual wheelchair skills training could increase the total wheelchair skills test scores by 13.26% in RCTs (95% confidence interval (CI), 6.19%-20.34%; P < 0.001) and by 23.44% in non-randomized studies (95% CI, 13.98%-32.90%; P < 0.001). Few adverse events occurred during training; however, compared with a control group, evidence was insufficient to support the effectiveness of powered wheelchair skills training and the long-term (3-12 months) advantage of manual wheelchair skills training ( P = 0.755). The limited evidence suggests that wheelchair skills training program is beneficial in the short term, but its long-term effects remain unclear.

The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda.

PubMed

Nakimuli-Mpungu, Etheldreda; Okello, James; Kinyanda, Eugene; Alderman, Stephen; Nakku, Juliet; Alderman, Jeffrey S; Pavia, Alison; Adaku, Alex; Allden, Kathleen; Musisi, Seggane

2013-10-01

The effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa. To assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda. 631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants. In comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=-1.84, 95%CI (-3.38 to -0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=-2.14, 95%CI (-4.21 to -0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61-6.40), p=0.018] than participants who attended only one session. Selection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences. The group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial. © 2013 Elsevier B.V. All rights reserved.

Robust PRNG based on homogeneously distributed chaotic dynamics

NASA Astrophysics Data System (ADS)

Garasym, Oleg; Lozi, René; Taralova, Ina

2016-02-01

This paper is devoted to the design of new chaotic Pseudo Random Number Generator (CPRNG). Exploring several topologies of network of 1-D coupled chaotic mapping, we focus first on two dimensional networks. Two topologically coupled maps are studied: TTL rc non-alternate, and TTL SC alternate. The primary idea of the novel maps has been based on an original coupling of the tent and logistic maps to achieve excellent random properties and homogeneous /uniform/ density in the phase plane, thus guaranteeing maximum security when used for chaos base cryptography. In this aim two new nonlinear CPRNG: MTTL 2 sc and NTTL 2 are proposed. The maps successfully passed numerous statistical, graphical and numerical tests, due to proposed ring coupling and injection mechanisms.

Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study

PubMed Central

Avis, Jillian LS; Cave, Andrew L; Donaldson, Stephanie; Ellendt, Carol; Holt, Nicholas L; Jelinski, Susan; Martz, Patricia; Maximova, Katerina; Padwal, Raj; Wild, T Cameron

2015-01-01

Background Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents’ motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents’ concern for, and motivation to, support children’s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children—boys and girls, 5 to 17 years old—will be recruited from a primary care pediatric clinic while they await their children’s clinical appointment. Parents will be randomly assigned to one of five groups—four intervention groups and one control group—as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children’s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or “nudge” individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr). PMID:25831265

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

PubMed

Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England.

PubMed

Boyd, Matthew; Waring, Justin; Barber, Nick; Mehta, Rajnikant; Chuter, Antony; Avery, Anthony J; Salema, Nde-Eshimuni; Davies, James; Latif, Asam; Tanajewski, Lukasz; Elliott, Rachel A

2013-12-01

Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. parallel group patient-level pragmatic randomized controlled trial. patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. impact of NMS on: patients' understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice.Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice. 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate. At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken. Current controlled trials: ISRCTN23560818. Clinical Trials US (clinicaltrials.gov): NCT01635361.

Dementia care initiative in primary practice – study protocol of a cluster randomized trial on dementia management in a general practice setting

PubMed Central

Holle, Rolf; Gräßel, Elmar; Ruckdäschel, Stefan; Wunder, Sonja; Mehlig, Hilmar; Marx, Peter; Pirk, Olaf; Butzlaff, Martin; Kunz, Simone; Lauterberg, Jörg

2009-01-01

Background Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent as possible and to reduce the burden of caregivers. The objective of the study is to compare a complex intervention including caregiver support groups and counselling against usual care in terms of time to nursing home placement. In this paper the study protocol is described. Methods/Design The IDA (Initiative Demenzversorgung in der Allgemeinmedizin) project is designed as a three armed cluster-randomized trial where dementia patients and their informal caregivers are recruited by general practitioners. Patients in the study region of Middle Franconia, Germany, are included if they have mild or moderate dementia, are at least 65 years old, and are members of the German AOK (Allgemeine Ortskrankenkasse) sickness fund. In the control group patients receive regular treatment, whereas in the two intervention groups general practitioners participate in a training course in evidence based dementia treatment, recommend support groups and offer counseling to the family caregivers either beginning at baseline or after the 1-year follow-up. The study recruitment and follow-up took place from July 2005 to January 2009. 303 general practitioners were randomized of which 129 recruited a total of 390 patients. Time to nursing home admission within the two year intervention and follow-up period is the primary endpoint. Secondary endpoints are cognitive status, activities of daily living, burden of care giving as well as healthcare costs. For an economic analysis from the societal perspective, data are collected from caregivers as well as by the use of routine data from statutory health insurance and long-term care insurance. Discussion From a public health perspective, the IDA trial is expected to lead to evidence based results on the community effectiveness of non-pharmaceutical support measures for dementia patients and their caregivers in the primary care sector. For health policy makers it is necessary to make their decisions about financing new services based on strong knowledge about the acceptance of measures in the population and their cost-effectiveness. Trial registration ISRCTN68329593 PMID:19500383

A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the 'HYPOTENS' study design and rationale.

PubMed

Eberhart, Leopold; Geldner, Götz; Huljic, Susanne; Marggraf, Kerstin; Keller, Thomas; Koch, Tilo; Kranke, Peter

2018-06-01

To compare the effectiveness of 20:1 cafedrine/theodrenaline approved for use in Germany to ephedrine in the restoration of arterial blood pressure and on post-operative outcomes in patients with intra-operative arterial hypotension of any origin under standard clinical practice conditions. 'HYPOTENS' is a national, multi-center, prospective, open-label, two-armed, non-interventional study. Effectiveness and post-operative outcome following cafedrine/theodrenaline or ephedrine therapy will be evaluated in two cohorts of hypotensive patients. Cohort A includes patients aged ≥50 years with ASA-classification 2-4 undergoing non-emergency surgical procedures under general anesthesia. Cohort B comprises patients undergoing Cesarean section under spinal anesthesia. Participating surgical departments will be assigned to a treatment arm by routinely used anti-hypotensive agent. To minimize bias, matched department pairs will be compared in a stratified selection process. The composite primary end-point is the lower absolute deviation from individually determined target blood pressure (IDTBP) and the incidence of heart rate ≥100 beats/min in the first 15 min. Secondary end-points include incidence and degree of early post-operative delirium (cohort A), severity of fetal acidosis in the newborn (cohort B), upper absolute deviation from IDTBP, percentage increase in systolic blood pressure, and time to IDTBP. This open-label, non-interventional study design mirrors daily practice in the treatment of patients with intra-operative hypotension and ensures full treatment decision autonomy with respect to each patient's individual condition. Selection of participating sites by a randomization process addresses bias without interfering with the non-interventional nature of the study. First results are expected in 2018. ClinicalTrials.gov identifier: NCT02893241; DRKS identifier: DRKS00010740.

A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial

PubMed Central

Imam, Bita; Finlayson, Heather C; Eng, Janice J; Payne, Michael WC; Jarus, Tal; Goldsmith, Charles H; Mitchell, Ian M

2014-01-01

Background The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed “Wii.n.Walk”, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants’ homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks’ duration. The primary outcome measure will be the “Two-Minute Walk Test” to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). PMID:25533902

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

LEGO therapy and the social use of language programme: an evaluation of two social skills interventions for children with high functioning autism and Asperger Syndrome.

PubMed

Owens, Gina; Granader, Yael; Humphrey, Ayla; Baron-Cohen, Simon

2008-11-01

LEGO therapy and the Social Use of Language Programme (SULP) were evaluated as social skills interventions for 6-11 year olds with high functioning autism and Asperger Syndrome. Children were matched on CA, IQ, and autistic symptoms before being randomly assigned to LEGO or SULP. Therapy occurred for 1 h/week over 18 weeks. A no-intervention control group was also assessed. Results showed that the LEGO therapy group improved more than the other groups on autism-specific social interaction scores (Gilliam Autism Rating Scale). Maladaptive behaviour decreased significantly more in the LEGO and SULP groups compared to the control group. There was a non-significant trend for SULP and LEGO groups to improve more than the no-intervention group in communication and socialisation skills.

Study Protocol of MINI SALTEN: a technology-based multi-component intervention in the school environment targeting healthy habits of first grade children and their parents.

PubMed

Kovalskys, Irina; Rausch Herscovici, Cecile; Indart Rougier, Paula; De Gregorio, María José; Zonis, Luciana; Orellana, Liliana

2017-05-06

MINI SALTEN is a program developed to increase moderate to vigorous physical activity (PA) and improve eating habits at home and school in first grade children. It aims to assess the effects of a technology family-based and PA school-based intervention. The purpose of this manuscript is to describe the protocol design and the MINISALTEN intervention. This is cluster-randomized controlled trial designed to run from July 2015 to November 2016 in 12 public schools of the city of Buenos Aires, matched for socio-demographic characteristics. The intervention is based on two main components: (a) "active breaks" (AB): implemented during school breaks by a PA instructor; (b) "virtual" (V): web-based contents delivered to the families via a multiplatform application. Using a computer generated random sequence participants are allocated to one of four intervention conditions: (AB), (V), (AB + V), and control (C). Outcomes are measured at baseline and 12 months post intervention, and will include data collected from the child and her/his mother/father or guardian. Primary outcome measures are: PA and sedentary behaviour (measured with accelerometers). Secondary outcome measures related are: percentage of kilocalories (kcal) from added sugars, and from total and saturated fats; grams of fruits and vegetables; and number of snacks and kcal coming from their added sugars and total and saturated fats. Family socio-economic level, home environment, and school environment will also be assessed. Statistical analysis is on an intention-to-treat principle. Baseline characteristics are described using summary measures and mixed models (with school as random effect). The effect of the two interventions will be estimated using a generalized mixed linear model with link and distribution selected according to the type of outcome. Included random effects are: child (or mother/father or guardian) accounting for repeated measures; school accounting for cluster induced by school. The most parsimonious model for each outcome will be reported. The False Discovery Rate criterion will be used to correct for multiple testing in non-planned analyses. It is a pioneer assessment of the impact of a technology-based virtual intervention and a school-based PA program, designed to prevent obesity, and involving the parents at public schools of Buenos Aires. Current Controlled Trials ISRCTN58093412 . Registered March 14th, 2016 (retrospectively registered).

Increased Classroom Consumption of Home-Provided Fruits and Vegetables for Normal and Overweight Children: Results of the Food Dudes Program in Italy.

PubMed

Presti, Giovambattista; Cau, Silvia; Oppo, Annalisa; Moderato, Paolo

2015-01-01

To increase classroom consumption of home-provided fruits (F) and vegetables (V) in obese, overweight, and normal weight children. Consumption evaluated within and across the baseline phase and the end of the intervention and maintenance phases. Three Italian primary schools. The study involved 672 children (321 male and 329 female) aged 5-11 years. Body mass index measures were available for 461 children. Intervention schools received the Food Dudes (FD) program: 16 days of repeated taste exposure (40 g of F and 40 g of V), video modeling, and rewards-based techniques. The comparison school was only repeatedly exposed to FV. Grams of FV brought from home and eaten. Chi-square, independent t test, repeated-measures ANOVA, and generalized estimating equation model. Intervention schools show a significant increase in home-provided F (P < .001) and V (P < .001) consumption both in overweight and non-overweight children. Approximately half of children in the intervention schools ate at least 1 portion of FV at the end of the intervention and maintenance phases. The increase in home-provided FV intake was similar in overweight and non-overweight children in the FD intervention schools compared with the comparison school. The effect of the FD program was higher at the end of the intervention phase than the end of the maintenance phase. Copyright © 2015 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Behavioral interventions for improving dual-method contraceptive use.

PubMed

Lopez, Laureen M; Stockton, Laurie L; Chen, Mario; Steiner, Markus J; Gallo, Maria F

2014-03-30

Dual-method contraception refers to using condoms as well as another modern method of contraception. The latter (usually non-barrier) method is commonly hormonal (e.g., oral contraceptives) or a non-hormonal intrauterine device. Use of two methods can better prevent pregnancy and the transmission of HIV and other sexually transmitted infections (STIs) compared to single-method use. Unprotected sex increases risk for disease, disability, and mortality in many areas due to the prevalence and incidence of HIV/STI. Millions of women, especially in lower-resource areas, also have an unmet need for protection against unintended pregnancy. We examined comparative studies of behavioral interventions for improving use of dual methods of contraception. Dual-method use refers to using condoms as well as another modern contraceptive method. Our intent was to identify effective interventions for preventing pregnancy as well as HIV/STI transmission. Through January 2014, we searched MEDLINE, CENTRAL, POPLINE, EMBASE, COPAC, and Open Grey. In addition, we searched ClinicalTrials.gov and ICTRP for current trials and trials with relevant data or reports. We examined reference lists of pertinent papers, including review articles, for additional reports. Studies could be either randomized or non-randomized. They examined a behavioral intervention with an educational or counseling component to encourage or improve the use of dual methods, i.e., condoms and another modern contraceptive. The intervention had to address preventing pregnancy as well as the transmission of HIV/STI. The program or service could be targeted to individuals, couples, or communities. The comparison condition could be another behavioral intervention to improve contraceptive use, usual care, other health education, or no intervention.Studies had to report use of dual methods, i.e., condoms plus another modern contraceptive method. We focused on the investigator's assessment of consistent dual-method use or use at last sex. Outcomes had to be measured at least three months after the behavioral intervention began. Two authors evaluated abstracts for eligibility and extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Where studies used adjusted analysis, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures. We identified four studies that met the inclusion criteria: three randomized controlled trials and a pilot study for one of the included trials. The interventions differed markedly: computer-delivered, individually tailored sessions; phone counseling added to clinic counseling; and case management plus a peer-leadership program. The latter study, which addressed multiple risks, showed an effect on contraceptive use. Compared to the control group, the intervention group was more likely to report consistent dual-method use, i.e., oral contraceptives and condoms. The reported relative risk was 1.58 at 12 months (95% CI 1.03 to 2.43) and 1.36 at 24 months (95% CI 1.01 to 1.85). The related pilot study showed more reporting of consistent dual-method use for the intervention group compared to the control group (reported P value = 0.06); the investigators used a higher alpha (P < 0.10) for this pilot study. The other two trials did not show any significant difference between the study groups in reported dual-method use or in test results for pregnancy or STIs at 12 or 24 months. We found few behavioral interventions for improving dual-method contraceptive use and little evidence of effectiveness. A multifaceted program showed some effect but only had self-reported outcomes. Two trials were more applicable to clinical settings and had objective outcomes measures, but neither showed any effect. The included studies had adequate information on intervention fidelity and sufficient follow-up periods for change to occur. However, the overall quality of evidence was considered low. Two trials had design limitations and two had high losses to follow up, as often occurs in contraceptive trials. Good quality studies are still needed of carefully designed and implemented programs or services.

Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

PubMed

Lhakhang, Pempa; Lippke, Sonia; Knoll, Nina; Schwarzer, Ralf

2015-02-04

Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.

PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol.

PubMed

Lindbäck, Yvonne; Tropp, Hans; Enthoven, Paul; Abbott, Allan; Öberg, Birgitta

2016-07-11

Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes. This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary outcome measure is Oswestry Disability Index. Secondary outcome measures are the visual analogue scale for back and leg pain, pain drawing, health related quality of life, Hospital anxiety and depression scale, Fear avoidance beliefs questionnaire, Self-efficacy scale and Work Ability Index. The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery. ClinicalTrials.gov reference: NCT02454400 (Trial registration date: August 31st 2015) and has been registered on ClinicalTrials.gov, identifier: NCT02454400 .

Feasibility of mobile health game "Fume" in supporting tobacco-related health literacy among early adolescents: A three-armed cluster randomized design.

PubMed

Parisod, Heidi; Pakarinen, Anni; Axelin, Anna; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

2018-05-01

New interventions supporting health literacy and a tobacco-free lifestyle in adolescence are needed to narrow the widening gap in existing health inequalities. Health games offer potential and could be utilized for example in school healthcare, but more research is needed to increase the understanding of the effects of game elements in health interventions. The aim of this feasibility study is to determine the short-term effectiveness of the tobacco-related mobile health game Fume and a non-gamified website in comparison with a no-intervention control group, regarding tobacco-related health literacy among 10-13-year-old early adolescents. In addition, we compare the demand for and acceptability of Fume to that of the website. In total, 151 early adolescents participated in this single-blinded, three-armed cluster randomized trial. The participants from three municipalities in southwest Finland were randomly allocated between a group with access to the health game Fume (n = 61), a group with access to the website (n = 47), and a group with no intervention (n = 43). The intervention groups first participated in a 20-min training session with Fume/the website, and then had two weeks to use Fume/the website based on their own interest. Short-term effectiveness was measured by primary (anti-smoking self-efficacy) and secondary (smoking outcome expectations, attitudes towards tobacco use, tobacco-use motives, motivation to decline tobacco use in the future, and knowledge about tobacco) outcomes derived from the theory-based determinants of tobacco-related health literacy and evaluated with self-assessment questionnaires at baseline and post-intervention (after a two-week follow-up). For evaluating the demand, the actual use of Fume/the website was tracked during the two-week period. Regarding acceptability, the raised interest towards Fume/the website and opinions about the interventions were evaluated post-intervention. Differences were tested with the McNemar, Fisher exact, and non-parametric tests. Statistically significant favorable changes during the study period were found for positive (P = 0.002) and negative (P = 0.02) smoking outcome expectations and attitudes towards cigarette smoking (P = 0.01) within the group using Fume. No statistically significant changes were detected within the website or control groups. Statistically significant differences were not found for the change in outcome variables among the three groups. The number of visits (P < 0.001), number of separate visit days (P < 0.001) and total duration of use (P < 0.001) were larger for the group using Fume than for that using the website. Fume sparked more interest in early adolescents than the website did (P <  0.001). There were no statistically significant differences in opinions about Fume and those regarding the website. The intervention with embedded game elements, the health game Fume, was found to be more feasible as a tobacco-related health education intervention than the non-gamified website among early adolescents in light of demand and acceptability (raised interest). Even though no change in anti-smoking self-efficacy was found, the results of this feasibility study demonstrated favorable short-term changes with Fume in some other theory-based determinants of tobacco-related health literacy. Copyright © 2018 Elsevier B.V. All rights reserved.

Spike phase synchronization in multiplex cortical neural networks

NASA Astrophysics Data System (ADS)

Jalili, Mahdi

2017-01-01

In this paper we study synchronizability of two multiplex cortical networks: whole-cortex of hermaphrodite C. elegans and posterior cortex in male C. elegans. These networks are composed of two connection layers: network of chemical synapses and the one formed by gap junctions. This work studies the contribution of each layer on the phase synchronization of non-identical spiking Hindmarsh-Rose neurons. The network of male C. elegans shows higher phase synchronization than its randomized version, while it is not the case for hermaphrodite type. The random networks in each layer are constructed such that the nodes have the same degree as the original network, thus providing an unbiased comparison. In male C. elegans, although the gap junction network is sparser than the chemical network, it shows higher contribution in the synchronization phenomenon. This is not the case in hermaphrodite type, which is mainly due to significant less density of gap junction layer (0.013) as compared to chemical layer (0.028). Also, the gap junction network in this type has stronger community structure than the chemical network, and this is another driving factor for its weaker synchronizability.

Clinical feasibility of interactive motion-controlled games for stroke rehabilitation.

PubMed

Bower, Kelly J; Louie, Julie; Landesrocha, Yoseph; Seedy, Paul; Gorelik, Alexandra; Bernhardt, Julie

2015-08-02

Active gaming technologies, including the Nintendo Wii and Xbox Kinect, have become increasingly popular for use in stroke rehabilitation. However, these systems are not specifically designed for this purpose and have limitations. The aim of this study was to investigate the feasibility of using a suite of motion-controlled games in individuals with stroke undergoing rehabilitation. Four games, which utilised a depth-sensing camera (PrimeSense), were developed and tested. The games could be played in a seated or standing position. Three games were controlled by movement of the torso and one by upper limb movement. Phase 1 involved consecutive recruitment of 40 individuals with stroke who were able to sit unsupported. Participants were randomly assigned to trial one game during a single session. Sixteen individuals from Phase 1 were recruited to Phase 2. These participants were randomly assigned to an intervention or control group. Intervention participants performed an additional eight sessions over four weeks using all four game activities. Feasibility was assessed by examining recruitment, adherence, acceptability and safety in both phases of the study. Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and improvements over time were seen in several functional outcome measures. There were no serious adverse safety events reported in either phase of the study; however, a number of participants reported minor increases in pain. A post-stroke intervention using interactive motion-controlled games shows promise as a feasible and potentially effective treatment approach. This paper presents important recommendations for future game development and research to further explore long-term adherence, acceptability, safety and efficacy. Australian and New Zealand Clinical Trials Registry ( ACTRN12613000220763 ).

Tailored interventions for screening mammography among a sample of initially non-adherent women: when is a booster dose important?

PubMed

Skinner, Celette Sugg; Kobrin, Sarah C; Monahan, Patrick O; Daggy, Joanne; Menon, Usha; Todora, Helen Smith; Champion, Victoria L

2007-01-01

To assess added value of a booster dose of a tailored mammography intervention. Participants, non-adherent at baseline, were randomly assigned to usual care or one of three tailored interventions. Intervention group members (n=657) were further randomly assigned to receive/not receive a booster intervention dose. Electronic record mammography data were collected following initial intervention and at 6 and 15 months post-booster. Booster had no effect among women not screened after first intervention dose (n=337). Among women screened after initial dose (n=320), booster predicted re-screening at 6 but not 15 months. A boosterxrace interaction showed a booster effect at 6 months for African Americans (OR=4.66, p=.0005) but not Caucasians (OR=0.74, p=.44). Findings suggest if a first-dose intervention does not facilitate screening, neither will a booster dose. However, among women for whom a first dose is effective, boosters can facilitate timely repeat adherence, especially among African Americans. At 6 months booster recipients were less likely to be off-schedule but, by 15 months, the groups were similar. Boosters may effect when, but not whether, women continue screening.

Comparing the Effects of Aromatherapy With Rose Oils and Warm Foot Bath on Anxiety in the First Stage of Labor in Nulliparous Women

PubMed Central

Kheirkhah, Massomeh; Vali Pour, Nassimeh Setayesh; Nisani, Leila; Haghani, Hamid

2014-01-01

Background: Anxiety is the most common emotional response in women during delivery, which can be accompanied with adverse effects on fetus and mother. Objectives: This study was conducted to compare the effects of aromatherapy with rose oil and warm foot bath on anxiety in the active phase of labor in nulliparous women in Tehran, Iran. Patients and Methods: This clinical trial study was performed after obtaining informed written consent on 120 primigravida women randomly assigned into three groups. The experimental group 1 received a 10-minute inhalation and footbath with oil rose. The experimental group 2 received a 10-minute warm water footbath. Both interventions were applied at the onset of active and transitional phases. Control group, received routine care in labor. Anxiety was assessed using visual analogous scale (VASA) at onset of active and transitional phases before and after the intervention. Statistical comparison was performed using SPSS software version 16 and P < 0.05 was considered significant. Results: Anxiety scores in the intervention groups in active phase after intervention were significantly lower than the control group (P < 0.001). Anxiety scores before and after intervention in intervention groups in transitional phase was significantly lower than the control group (P < 0.001). Conclusions: Using aromatherapy and footbath reduces anxiety in active phase in nulliparous women. PMID:25593713

Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity?

PubMed

Bührer, Christoph; Bassler, Dirk

2015-01-01

Oral propranolol has improved the treatment of infantile hemangiomas, and a pediatric oral solution of propranolol has recently been licensed in the USA and Europe. In very preterm infants, infantile hemangiomas are associated with the occurrence of retinopathy of prematurity (ROP), and both diseases share a peculiar time course, featuring a lag phase after birth followed by rapid growth and then gradual regression. To identify clinical studies evaluating the use of oral propranolol in preterm infants with ROP. Two small bicentric, pilot, randomized controlled trials found a nonsignificant reduction of ROP requiring intervention by laser treatment or bevacizumab injection of similar magnitude. Together, 6 of 35 (17%) infants who had been receiving oral propranolol underwent ROP intervention, as opposed to 14 of 36 (39%) controls (relative risk 0.42, 95% CI: 0.15-1.16). Randomized controlled trials are ongoing that investigate early preventive oral propranolol starting at 1 week of age and propranolol eye drops in preterm infants with stage 2 ROP. Further, large interventional studies are required to determine the clinical benefit-risk ratio of oral propranolol to prevent vision-threatening ROP in very preterm infants. © 2015 S. Karger AG, Basel.

The immediate effect of neuromuscular joint facilitation on the rotation of the tibia during walking.

PubMed

Li, Desheng; Huang, Qiuchen; Huo, Ming; Hiiragi, Yukinobu; Maruyama, Hitoshi

2017-01-01

[Purpose] The aim of this study was to investigate the change in tibial rotation during walking among young adults after neuromuscular joint facilitation therapy. [Subjects and Methods] The subjects were twelve healthy young people (6 males, 6 females). A neuromuscular joint facilitation intervention and nonintervention were performed. The interventions were performed one after the other, separated by a 1-week interval. The order of the interventions was completely randomized. The rotation of the tibia during walking was evaluated before and after treatment. [Results] The neuromuscular joint facilitation group demonstrated increased lateral rotation of the tibia in the overall gait cycle and stance phase, and decreased medial rotation of the tibia in the overall gait cycle, stance phase, and swing phase after the neuromuscular joint facilitation intervention. In the control group, there were no significant differences. [Conclusion] These results suggest neuromuscular joint facilitation intervention has an immediate effect on the rotational function of the knee.

Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial.

PubMed

Greblo Jurakic, Zrinka; Krizanic, Valerija; Sarabon, Nejc; Markovic, Goran

2017-12-01

There is limited research about beneficial effects of physical activity in older adults suffering from mild cognitive impairment (MCI). The aim of the study was to provide preliminary evidence on the effects of two types of non-aerobic training on cognitive functions in older women suffering from MCI. Twenty-eight participants aged 66-78 years with MCI were randomly assigned to a combined balance and core resistance training group (n = 14) or to a Pilates group (n = 14). Following completion of the 8-week exercise programme, both groups showed significant improvements in global and specific cognitive domains. Findings suggest that non-aerobic training should be further explored as a beneficial intervention for older adults suffering from MCI.

Comparison of the Effects of Two Auditory Methods by Mother and Fetus on the Results of Non-Stress Test (Baseline Fetal Heart Rate and Number of Accelerations) in Pregnant Women: A Randomized Controlled Trial

PubMed Central

Khoshkholgh, Roghaie; Keshavarz, Tahereh; Moshfeghy, Zeinab; Akbarzadeh, Marzieh; Asadi, Nasrin; Zare, Najaf

2016-01-01

Objective: To compare the effects of two auditory methods by mother and fetus on the results of NST in 2011-2012. Materials and methods: In this single-blind clinical trial, 213 pregnant women with gestational age of 37-41 weeks who had no pregnancy complications were randomly divided into 3 groups (auditory intervention for mother, auditory intervention for fetus, and control) each containing 71 subjects. In the intervention groups, music was played through the second 10 minutes of NST. The three groups were compared regarding baseline fetal heart rate and number of accelerations in the first and second 10 minutes of NST. The data were analyzed using one-way ANOVA, Kruskal-Wallis, and paired T-test. Results: The results showed no significant difference among the three groups regarding baseline fetal heart rate in the first (p = 0.945) and second (p = 0.763) 10 minutes. However, a significant difference was found among the three groups concerning the number of accelerations in the second 10 minutes. Also, a significant difference was observed in the number of accelerations in the auditory intervention for mother (p = 0.013) and auditory intervention for fetus groups (p < 0.001). The difference between the number of accelerations in the first and second 10 minutes was also statistically significant (p = 0.002). Conclusion: Music intervention was effective in the number of accelerations which is the indicator of fetal health. Yet, further studies are required to be conducted on the issue. PMID:27385971

Comparison of the Effects of Two Auditory Methods by Mother and Fetus on the Results of Non-Stress Test (Baseline Fetal Heart Rate and Number of Accelerations) in Pregnant Women: A Randomized Controlled Trial.

PubMed

Khoshkholgh, Roghaie; Keshavarz, Tahereh; Moshfeghy, Zeinab; Akbarzadeh, Marzieh; Asadi, Nasrin; Zare, Najaf

2016-03-01

To compare the effects of two auditory methods by mother and fetus on the results of NST in 2011-2012. In this single-blind clinical trial, 213 pregnant women with gestational age of 37-41 weeks who had no pregnancy complications were randomly divided into 3 groups (auditory intervention for mother, auditory intervention for fetus, and control) each containing 71 subjects. In the intervention groups, music was played through the second 10 minutes of NST. The three groups were compared regarding baseline fetal heart rate and number of accelerations in the first and second 10 minutes of NST. The data were analyzed using one-way ANOVA, Kruskal-Wallis, and paired T-test. The results showed no significant difference among the three groups regarding baseline fetal heart rate in the first (p = 0.945) and second (p = 0.763) 10 minutes. However, a significant difference was found among the three groups concerning the number of accelerations in the second 10 minutes. Also, a significant difference was observed in the number of accelerations in the auditory intervention for mother (p = 0.013) and auditory intervention for fetus groups (p < 0.001). The difference between the number of accelerations in the first and second 10 minutes was also statistically significant (p = 0.002). Music intervention was effective in the number of accelerations which is the indicator of fetal health. Yet, further studies are required to be conducted on the issue.

Depression Treatment by Non-Mental-Health Providers: Incremental Evidence for the Effectiveness of Listening Visits

PubMed Central

O’Hara, Michael W.; Segre, Lisa S.

2017-01-01

Maternal depression is a prevalent public health problem, particularly for low-income mothers of young children. Intervention development efforts, which often focus on surmounting instrumental barriers to care, have not successfully engaged and retained women in treatment. Task-sharing approaches like Listening Visits (LV) could overcome key instrumental and psychological barriers by leveraging the access of trusted, community caregivers to deliver treatment. A recent randomized controlled trial (RCT) demonstrated the efficacy of LV delivered by non-mental-health providers as compared to usual care. The present report presents results from a follow-up phase of that RCT during which participants who had completed LV were followed for an additional 8 weeks and completed measures of depression and quality of life. In addition, participants who were initially randomized to the wait-list control group received LV and were assessed. Treatment gains previously observed in participants completing LV were enhanced during the 8-week follow-up period. Participants receiving LV during the follow-up period experienced significant improvement in depressive symptoms. Results demonstrate the sustainability of LV delivered by non-mental-health providers, and provide preliminary evidence for the replicability of this approach in a sample of predominately low-income pregnant women and mothers of young children. PMID:28349604

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

PubMed

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

PubMed Central

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

The Effects of PECS Teaching to Phase III on the Communicative Interactions between Children with Autism and Their Teachers

ERIC Educational Resources Information Center

Carr, Deborah; Felce, Janet

2007-01-01

The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h…

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A 12-Week Physical and Cognitive Exercise Program Can Improve Cognitive Function and Neural Efficiency in Community-Dwelling Older Adults: A Randomized Controlled Trial.

PubMed

Nishiguchi, Shu; Yamada, Minoru; Tanigawa, Takanori; Sekiyama, Kaoru; Kawagoe, Toshikazu; Suzuki, Maki; Yoshikawa, Sakiko; Abe, Nobuhito; Otsuka, Yuki; Nakai, Ryusuke; Aoyama, Tomoki; Tsuboyama, Tadao

2015-07-01

To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults. Randomized controlled trial. Kyoto, Japan. Community-dwelling older adults (N = 48) were randomized into an exercise group (n = 24) and a control group (n = 24). Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase. Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase. The outcome measures were global cognitive function, memory function, executive function, and brain activation (measured using functional magnetic resonance imaging) associated with visual short-term memory. Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group (P < .05). In addition, after the intervention, less activation was found in several brain regions associated with visual short-term memory, including the prefrontal cortex, in the exercise group (P < .001, uncorrected). A 12-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults, which is associated with improvements in memory and executive function. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions.

PubMed

Finigan-Carr, Nadine M; Copeland-Linder, Nikeea; Haynie, Denise L; Cheng, Tina L

2014-01-01

Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11-13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families ( N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation.

Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions

PubMed Central

Finigan-Carr, Nadine M.; Copeland-Linder, Nikeea; Haynie, Denise L.; Cheng, Tina L.

2016-01-01

Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11–13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families (N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation. PMID:27122960

Randomized trial of anaesthetic interventions in external cephalic version for breech presentation.

PubMed

Khaw, K S; Lee, S W Y; Ngan Kee, W D; Law, L W; Lau, T K; Ng, F F; Leung, T Y

2015-06-01

Successful external cephalic version (ECV) for breech presenting fetus reduces the need for Caesarean section (CS). We aimed to compare the success rate of ECV with either spinal anaesthesia (SA) or i.v. analgesia using remifentanil. In a double-phased, stratified randomized blinded controlled study we compared the success rates of ECV, performed under spinal anaesthesia (SA), i.v. analgesia (IVA) using remifentanil or no anaesthetic interventions. In phase I, 189 patients were stratified by parity before randomization to ECV, performed by blinded operators, under SA using either hyperbaric bupivacaine 9 mg with fentanyl 15 µg, i.v. remifentanil infusion 0.1 µg kg min(-1), or Control (no anaesthetic intervention). Operators performing ECV were blinded to the treatment allocation. In phase 2, patients in the Control group in whom the initial ECV failed were further randomized to receive either SA (n=9) or IVA (n=9) for a re-attempt. The primary outcome was the incidence of successful ECV. The success rate in Phase 1 was greatest using SA [52/63 (83%)], compared with IVA [40/63 (64%)] and Control [40/63 (64%)], (P=0.027). Median [IQR] pain scores on a visual analogue scale (range 0-100), were 0 [0-0] with SA, 35 [0-60] with IVA and 50 [30-75] in the Control group (P<0.001). Median [IQR] VAS sedation scores were highest with IVA [75 (50-80)], followed by SA, [0 (0-50)] and Control [0 (0-0)]. In phase 2, 7/9 (78%) of ECV re-attempts were successful with SA, whereas all re-attempts using IVA failed (P=0.0007). The incidence of fetal bradycardia necessitating emergency CS within 30 min, was similar among groups; 1.6% (1/63) in the SA and IVA groups and 3.2% (2/63) in the Control group. SA increased the success rate and reduced pain for both primary and re-attempts of ECV, whereas IVA using remifentanil infusion only reduced the pain. There was no significant increase in the incidence of fetal bradycardia or emergency CS, with ECV performed under anaesthetic interventions. Relaxation of the abdominal muscles from SA appears to underlie the improved outcomes for ECV. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial.

PubMed

van de Rest, Ondine; van der Zwaluw, Nikita L; Tieland, Michael; Adam, Jos J; Hiddink, Gert Jan; van Loon, Luc J C; de Groot, Lisette C P G M

2014-01-01

Physical activity has been proposed as one of the most effective strategies to prevent cognitive decline. Protein supplementation may exert an additive effect. The effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly people was assessed in a secondary analysis. Two 24-week, double-blind, randomized, placebo-controlled intervention studies were carried out in parallel. Subjects performed a resistance-type exercise program of two sessions per week (n=62) or no exercise program (n=65). In both studies, subjects were randomly allocated to either a protein (2×15 g daily) or a placebo drink. Cognitive functioning was assessed with a neuropsychological test battery focusing on the cognitive domains episodic memory, attention and working memory, information processing speed, and executive functioning. In frail and pre-frail elderly, resistance-type exercise training in combination with protein supplementation improved information processing speed (changes in domain score 0.08±0.51 versus -0.23±0.19 in the non-exercise group, p=0.04). Exercise training without protein supplementation was beneficial for attention and working memory (changes in domain scores 0.35±0.70 versus -0.12±0.69 in the non-exercise group, p=0.02). There were no significant differences among the intervention groups on the other cognitive tests or domain scores. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Prone positioning reduces severe pushing behavior: three case studies.

PubMed

Fujino, Yuji; Amimoto, Kazu; Sugimoto, Satoshi; Fukata, Kazuhiro; Inoue, Masahide; Takahashi, Hidetoshi; Makita, Shigeru

2016-09-01

[Purpose] Pushing behavior is classically described as a disorder of body orientation in the coronal plane. Most interventions for pushing behavior have focused on correcting the deviation in vertical perception. However, pushing behavior seems to involve erroneous movements associated with excessive motor output by the non-paretic limbs and trunk. The present study aimed to inhibit muscular hyper-activity by placing the non-paretic limbs and trunk in the prone position. [Subjects and Methods] The subjects of the present study were 3 acute stroke patients with severe pushing behavior. The study consisted of the following 3 phases: baseline, intervention, and follow-up. In addition to conventional therapy, patients received relaxation therapy in the prone position for 10 minutes a day over 2 days. The severity of pushing behavior was assessed using the scale for contraversive pushing, and truncal balance was evaluated using the trunk control test. These assessments were performed before and after the baseline phase, and after the intervention and follow-up phases. [Results] At the baseline phase, both scores were poor. Both scores improved after the intervention and follow-up phases, and all the patients could sit independently. [Conclusion] Relaxation therapy in the prone position might ameliorate pushing behavior and impaired truncal balance.

The effects of fantastical pretend-play on the development of executive functions: An intervention study.

PubMed

Thibodeau, Rachel B; Gilpin, Ansley T; Brown, Melissa M; Meyer, Brooke A

2016-05-01

Although recent correlational studies have found a relationship between fantasy orientation (FO; i.e., a child's propensity to play in a fantastical realm) and higher order cognitive skills called executive functions (EFs), no work has addressed the causality and directionality of this relationship. The current study experimentally examined the directionality of the observed relationship between FO and EF development in preschool-aged children through an innovative play intervention employing a randomized controlled design. A sample of 110 children between the ages of 3 and 5years were randomly assigned to one of three conditions: fantastical pretend-play intervention, non-imaginative play intervention, or business-as-usual control. Results revealed that children who participated in a 5-week fantastical pretend-play intervention showed improvements in EFs, whereas children in the other two conditions did not. Within the fantastical pretend-play condition, children who were highly engaged in the play and those who were highly fantastical demonstrated the greatest gains in EFs. These data provide evidence for the equifinal relationship between fantasy-oriented play and EF development, such that engaging in fantasy-oriented play may be one of many ways to directly enhance EF development. Copyright © 2016 Elsevier Inc. All rights reserved.

Adolescent depressive disorders and family based interventions in the Family Options multicenter evaluation: study protocol for a randomized controlled trial.

PubMed

Lewis, Andrew J; Bertino, Melanie D; Skewes, Joanna; Shand, Lyndel; Borojevic, Nina; Knight, Tess; Lubman, Dan I; Toumbourou, John W

2013-11-13

There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention. Australia and New Zealand Clinical Trials Registry Title: engaging youth with high prevalence mental health problems using family based interventions; number 12612000398808. Prospectively registered on 10 April 2012.

Efficacy of Group Cognitive-behavioral Therapy in Maintenance Treatment and Relapse Prevention for Bipolar Adolescents.

PubMed

Arman, Soroor; Golmohammadi, Farnaz; Maracy, Mohammadreza; Molaeinezhad, Mitra

2018-01-01

Despite conducting wide-ranging of pharmacotherapy for bipolar adolescents, many of them are showing a deficit in functioning with high relapse rate. The aim of the current study was to develop a manual and investigate the efficacy of group cognitive-behavioral therapy (G-CBT) for female bipolar adolescents. During the first qualitative phase of a mixed-methods study, a manual of G-CBT was developed. Then, 32 female bipolar adolescents aged 12-19 years old, receiving usual maintenance medications (UMM), were selected. Participants were randomized to the control (UMM) and intervention group (5, 2 h weekly sessions based on G-CBT manual with UMM). The parents in intervention group participated in three parallel sessions. All participants filled the following questionnaires before 1, 3, and 6 months after the initiation of the study: Young Mania Rating Scale, Children Depression Inventory and Global Assessment of Functioning. The results were analyzed using SPSS 21 software. The concurrent qualitative phase was analyzed through thematic analysis. The results showed no significant differences in all questionnaires' scores through intervention and follow-up sessions ( P > 0.05). However, using cutoff point of CDI, G-CBT was effective for intervention group (relapse rate: 25% vs. 44.4%). Two themes were extracted from the second qualitative phase: emotion recognition and emotion regulation, especially in anger control. The results showed that the addition of G-CBT to UMM leads to decrease in the depressive scores but has no effect on manic symptoms and relapse rate.

Telephone cognitive-behavioral therapy for adolescents with obsessive-compulsive disorder: a randomized controlled non-inferiority trial.

PubMed

Turner, Cynthia M; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

2014-12-01

Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information-Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

PubMed Central

Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

2014-01-01

Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

A systematic review of non-pharmacological interventions to improve nighttime sleep among residents of long-term care settings.

PubMed

Capezuti, Elizabeth; Sagha Zadeh, Rana; Pain, Kevin; Basara, Aleksa; Jiang, Nancy Ziyan; Krieger, Ana C

2018-06-18

Disturbances in sleep and circadian rhythms are common among residents of long-term care facilities. In this systematic review, we aim to identify and evaluate the literature documenting the outcomes associated with non-pharmacological interventions to improve nighttime sleep among long-term care residents. The Preferred Reporting Items for Systematic Reviews guided searches of five databases (MEDLINE, Embase, CINAHL, Scopus, and Cochrane Library) for articles reporting results of experimental or quasi-experimental studies conducted in long-term care settings (nursing homes, assisted-living facilities, or group homes) in which nighttime sleep was subjectively or objectively measured as a primary outcome. We categorized each intervention by its intended use and how it was administered. Of the 54 included studies evaluating the effects of 25 different non-pharmacological interventions, more than half employed a randomized controlled trial design (n = 30); the others used a pre-post design with (n = 11) or without (n = 13) a comparison group. The majority of randomized controlled trials were at low risk for most types of bias, and most other studies met the standard quality criteria. The interventions were categorized as environmental interventions (n = 14), complementary health practices (n = 12), social/physical stimulation (n = 11), clinical care practices (n = 3), or mind-body practices (n = 3). Although there was no clear pattern of positive findings, three interventions had the most promising results: increased daytime light exposure, nighttime use of melatonin, and acupressure. Non-pharmacological interventions have the potential to improve sleep for residents of long-term care facilities. Further research is needed to better standardize such interventions and provide clear implementation guidelines using cost-effective practices.

Predictors of long-term weight loss in adults with modest initial weight loss, by sex and race.

PubMed

Svetkey, Laura P; Ard, Jamy D; Stevens, Victor J; Loria, Catherine M; Young, Deb Y; Hollis, Jack F; Appel, Lawrence J; Brantley, Phillip J; Kennedy, Betty M; Kumanyika, Shiriki K; Batch, Bryan C; Corsino, Leonor; Lien, Lillian F; Vollmer, William M

2012-09-01

Effective weight management interventions could reduce race-sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race-sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25-45 kg/m(2)) adults who lost ≥4 kg in a 6-month behavioral weight loss intervention (phase I) were randomized into one of three 30-month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36-month study ranged from -2.3% (95% confidence interval = -3.1 to -1.5%) in BW to -4.5% (95% confidence interval = -5.7 to -4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race-sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36-month weight loss in all race-sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race-sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long-term maintenance after a modest weight loss.

Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial

PubMed Central

Unkovic, Cait; Sen, Maya; Quinn, Kevin M.

2016-01-01

Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women’s conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that “low dose” interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial.

PubMed

Anderson, Cheryl A M; Cobb, Laura K; Miller, Edgar R; Woodward, Mark; Hottenstein, Annette; Chang, Alex R; Mongraw-Chaffin, Morgana; White, Karen; Charleston, Jeanne; Tanaka, Toshiko; Thomas, Letitia; Appel, Lawrence J

2015-09-01

For decades, dietary sodium intake in the United States has remained high, and few studies have examined strategies for maintaining recommended intakes. We examined the effects of a behavioral intervention, which emphasized spices and herbs, on the maintenance of sodium intake at the recommended intake of 1500 mg/d in individuals to whom the US Dietary Guidelines for Americans apply. We conducted a 2-phase study that included adults ≥18 y of age for whom Dietary Guidelines for Americans recommends 1500 mg Na/d. The study was conducted in Baltimore, Maryland, from 2012 to 2014. In phase 1, 55 individuals consumed a low-sodium diet for 4 wk. Participants were provided all foods, snacks, and calorie-containing drinks. In phase 2, 40 participants from phase 1 were randomly assigned to either a behavioral intervention to reduce sodium intake (n = 20) or a self-directed control group (n = 20) for 20 wk. The primary study outcome was the change in mean 24-h urinary sodium excretion during phase 2. Linear regression analyses were used to determine intervention effects on urinary sodium excretion. Participant characteristics were as follows: women: 65%; African American: 88%; hypertension: 63%; diabetes: 18%; mean age: 61 y; and mean body mass index (in kg/m(2)): 30. At the end of phase 2, mean 24-h sodium excretion was lower in the behavioral intervention than in the self-directed group (mean difference: -956.8 mg/d; 95% CI: -1538.7, -374.9 mg/d) after sodium intake at screening was controlled for (P = 0.002). These findings persisted in sensitivity analyses that excluded potentially incomplete urine collections [Mage's equation mean difference: -1090 mg/d (P = 0.001); Joosens' equation mean difference: -796 mg/d (P = 0.04)]. A multifactorial behavioral intervention emphasizing spices and herbs significantly reduced sodium intake. Because of the ubiquity of sodium in the US food supply, multilevel strategies addressing individual behaviors and the food supply are needed to improve adherence to recommendations. This trial was registered at clinicaltrials.gov as NCT01615159. © 2015 American Society for Nutrition.

A culturally tailored Internet cancer support group for Asian American breast cancer survivors: A randomized controlled pilot intervention study.

PubMed

Chee, Wonshik; Lee, Yaelim; Im, Eun-Ok; Chee, Eunice; Tsai, Hsiu-Min; Nishigaki, Masakazu; Yeo, Seon Ae; Schapira, Marilyn M; Mao, Jun James

2017-07-01

Introduction The necessity of culturally competent Internet Cancer Support Groups (ICSGs) for ethnic minorities has recently been highlighted in order to increase its attractiveness and usage. The purpose of this study was to determine the preliminary efficacy of a culturally tailored registered-nurse-moderated ICSG for Asian American breast cancer survivors in enhancing the women's breast cancer survivorship experience. Methods The study included two phases: (a) a usability test and an expert review; and (b) a randomized controlled pilot intervention study. The usability test was conducted among five Asian American breast cancer survivors using a one-month online forum, and the expert review was conducted among five experts using the Cognitive Walkthrough method. The randomized controlled pilot intervention study (a pre-test and post-test design) was conducted among 65 Asian American breast cancer survivors. The data were analysed using content analysis and descriptive and inferential statistics including the repeated ANOVA. Results All users and experts positively evaluated the program and provided their suggestions for the display, educational contents, and user-friendly structure. There were significant positive changes in the support care needs and physical and psychological symptoms ( p < 0.05) of the control group. There were significant negative changes in the uncertainty level of the intervention group ( p < 0.10). Controlling for background and disease factors, the intervention group showed significantly greater improvements than the control group in physical and psychological symptoms and quality of life ( p < 0.10). Discussion The findings supported the positive effects of ICSGs on support care needs, psychological and physical symptoms, and quality of life.

Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

PubMed

Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

2017-08-08

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa.

PubMed

Pallitto, Christina; García-Moreno, Claudia; Stöeckl, Heidi; Hatcher, Abigail; MacPhail, Catherine; Mokoatle, Keneoue; Woollett, Nataly

2016-11-05

Intimate partner violence (IPV) during or before pregnancy is associated with many adverse health outcomes. Pregnancy-related complications or poor infant health outcomes can arise from direct trauma as well as physiological effects of stress, both of which impact maternal health and fetal growth and development. Antenatal care can be a key entry point within the health system for many women, particularly in low-resource settings. Interventions to identify violence during pregnancy and offer women support and counselling may reduce the occurrence of violence and mitigate its consequences. Following a formative research phase, a randomized controlled trial will be conducted to test a nurse-led empowerment counselling intervention, originally developed for high-income settings and adapted for urban South Africa. The primary outcome is reduction of partner violence, and secondary outcomes include improvement in women's mental health, safety and self-efficacy. The study aims to recruit 504 pregnant women from three antenatal clinics in Johannesburg who will be randomized to the nurse-led empowerment arm (two 30-min counselling sessions) or enhanced control condition (a referral list) to determine whether participants in the intervention arm have better outcomes as compared to the those in the control arm. This research will provide much needed evidence on whether a short counselling intervention delivered by nurses is efficacious and feasible in low resource settings that have high prevalence of IPV and HIV. The study was registered in the South African Clinical Trials Registry (DOH-27-0414-4720) on 11 August 2014 and in the ISRCTN Registry ( ISRCTN35969343 ) on 23 May 2016).

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

PubMed Central

2012-01-01

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

Implementation of an evidence-based intervention to promote colorectal cancer screening in community organizations: a cluster randomized trial.

PubMed

Maxwell, Annette E; Danao, Leda L; Cayetano, Reggie T; Crespi, Catherine M; Bastani, Roshan

2016-06-01

The implementation of evidence-based strategies to promote colorectal cancer (CRC) screening remains challenging. The aim of this study is to evaluate two strategies to implement an evidence-based intervention to promote CRC screening in Filipino American community organizations. Twenty-two community organizations were randomized to either a basic or enhanced implementation strategy. In both arms, community health advisors recruited participants non-adherent to CRC screening guidelines, conducted educational sessions, distributed print materials and free fecal occult blood test kits, reminded participants to get screened, and mailed letters to participants' providers. In the enhanced arm, leaders of the organizations participated in implementation efforts. While the effectiveness was similar in both arms of the study (screening rate at 6-month follow-up was 53 % in the enhanced arm, 49 % in the basic arm), 223 participants were screened in the enhanced arm versus 122 in the basic arm. The enhanced implementation strategy reached 83 % more participants and achieved a higher public health impact. NCT01351220 (ClinicalTrials.gov).

Predictors of prevention failure in college students participating in two indicated depression prevention programs.

PubMed

Blanco, Vanessa; Rohde, Paul; Vázquez, Fernando L; Otero, Patricia

2014-04-04

The purpose of this study was to identify subgroups of university students with the highest likelihood of remaining at elevated levels of depressive symptoms six months following the receipt of a depressive prevention intervention on the basis of known risk factors and participation in one of two depression prevention programs. Data from a randomized controlled trial evaluating depression prevention among 133 college students with elevated depressive symptoms were analyzed. Participants were randomized to a cognitive-behavioral or relaxation training group preventive intervention. Classification tree analysis showed that older age was the strongest risk factor for persistently elevated depression. Additional risk factors were: (1) for younger students, fewer daily pleasant activities; (2) for those with higher level of pleasant activities, higher level of stressful events; and (3) for those with higher level of stressful events, lower assertiveness. Results offer directions for prevention foci, identify specific subgroups of college students to target for depression prevention efforts, and suggest that research aim to help older, non-traditional students or graduating students manage the transition from college to the work force.

Predictors of Prevention Failure in College Students Participating in Two Indicated Depression Prevention Programs

PubMed Central

Blanco, Vanessa; Rohde, Paul; Vázquez, Fernando L.; Otero, Patricia

2014-01-01

The purpose of this study was to identify subgroups of university students with the highest likelihood of remaining at elevated levels of depressive symptoms six months following the receipt of a depressive prevention intervention on the basis of known risk factors and participation in one of two depression prevention programs. Data from a randomized controlled trial evaluating depression prevention among 133 college students with elevated depressive symptoms were analyzed. Participants were randomized to a cognitive-behavioral or relaxation training group preventive intervention. Classification tree analysis showed that older age was the strongest risk factor for persistently elevated depression. Additional risk factors were: (1) for younger students, fewer daily pleasant activities; (2) for those with higher level of pleasant activities, higher level of stressful events; and (3) for those with higher level of stressful events, lower assertiveness. Results offer directions for prevention foci, identify specific subgroups of college students to target for depression prevention efforts, and suggest that research aim to help older, non-traditional students or graduating students manage the transition from college to the work force. PMID:24714056

Reduction of hypoglycaemic events with a behavioural intervention: a randomized clinical trial for paediatric patients with Type 1 diabetes mellitus.

PubMed

Gee, B T; Nansel, T R; Liu, A

2017-03-01

To determine if a low-intensity, clinic-integrated behavioural intervention reduced the incidence of hypoglycaemic events in children with Type 1 diabetes. A total of 390 families with children with Type 1 diabetes were enrolled in a 2-year, randomized clinical trial of a behavioural intervention. The intervention was designed to improve diabetes management practices by targeting the family's diabetes problem-solving skills. Hypoglycaemic events were categorized in two groups: those treated by oral ingestion and those treated by parenteral therapy. Events were self-reported by participants at each clinic visit, which occurred approximately every 3-4 months. Analyses included two-sample t-tests, the mean cumulative function test, and the Cox proportional hazards model for recurrent events to compare the incidence between groups. Across the entire 2-year study period, the incidence of hypoglycaemic events treated by oral ingestion of glucose-rich foods and events requiring parenteral therapy did not significantly differ between study conditions; however, during the second year of participant enrolment, the incidence of events treated by oral ingestion in the intervention group was 13.6 per 100 person-years compared with 27.3 per 100 patient-years in the control group (P = 0.02). The hazard ratio of these events during the second year was 0.49 (95% CI 0.27-0.90; P = 0.02). Our findings suggest the need for a long-term (> 1 year) focus on the implementation of interventions targeting diabetes management in young people. Behavioural interventions targeting problem-solving skills could be considered as practical, non-pharmacological strategies to reduce hypoglycaemia in adolescents with Type 1 diabetes. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Effectiveness of psychological interventions delivered by non-psychologists on low back pain and disability: a qualitative systematic review.

PubMed

Bostick, Geoff P

2017-11-01

Psychological treatments delivered by non-psychologists have been proposed as a way to increase access to care to address important psychological barriers to recovery in people with low back pain (LBP). This review aimed to synthesize randomized controlled trials (RCTs) that assess the effectiveness of psychological interventions delivered by non-psychologists in reducing pain intensity and disability in adults with LBP, compared with usual care. A systematic review without meta-analysis was carried out. Randomized controlled trials including adult patients with all types of musculoskeletal LBP were eligible. Interventions included those based on psychological principles and delivered by non-psychologists. The primary outcomes of interest were self-reported pain intensity and disability. Information sources included Medline, EMBASE, and the Cochrane Central Registrar for Controlled Trials. The Cochrane Collaboration's tool for assessing risk of bias was used for the evaluation of internal validity. There were 1,101 records identified, 159 were assessed for eligibility, 16 were critically appraised, and 11 studies were included. Mild to moderate risk of bias was present in the included studies, with personnel and patient blinding, treatment fidelity, and attrition being the most common sources of bias. Considerable heterogeneity existed for patient population, intervention components, and comparison groups. Although most studies demonstrated statistical and clinical improvements in pain and disability, few were statistically superior to the comparison group. Consistent with the broader psychological literature, psychological interventions delivered by non-psychologists have modest effects on low back pain and disability. Additional high quality research is needed to understand what patients are likely to respond to psychological interventions, the appropriate dose to achieve the desired outcome, the amount of training required to implement psychological interventions, and the optimal procedures to ensure treatment fidelity. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of the effect of two sugar-substituted chewing gums on different caries- and gingivitis-related variables: a double-blind, randomized, controlled clinical trial.

PubMed

Martínez-Pabón, María C; Duque-Agudelo, Lucas; Díaz-Gil, Juan D; Isaza-Guzmán, Diana M; Tobón-Arroyave, Sergio I

2014-01-01

The aim of this study was to compare the effect of two sugar-substituted chewing gums besides toothbrushing on different clinical, microbiological, and biochemical caries- and gingivitis-related variables. The study was designed as a double-blind, randomized, controlled trial with three parallel arms. A total of 130 dental students, who volunteered after signing an informed consent, were randomly allocated to receive one of the following interventions: hexitol-sweetened gum containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), pentitol-sweetened gum containing no CPP-ACP, and control group with no gum. Subjects within the experimental groups chewed two gum pellets for 20 min three times a day after meals. The daily consumption level of both polyols was 6.0 g. Clinical examinations and salivary samplings were conducted at baseline and after 30 days of gum use. Pre- and post-intervention stimulated whole saliva samples were quantified for calcium/phosphate ionic concentration, total facultative bacterial load, Streptococcus mutans/Lactobacillus spp. counts, and Gram-negative percentage. A statistically significant reduction in visible plaque score was displayed in the hexitol/CPP-ACP gum group after the intervention when compared with baseline, but the order of the effect was in the same order as the differences between the groups at baseline. A similar tendency was seen in both the pentitol/non-CPP-ACP gum and control groups regarding total salivary facultative bacterial load and S. mutans count, but median values of these parameters were more significantly reduced in the pentitol/non-CPP-ACP gum group in comparison with those of the control group. Alterations of salivary Lactobacillus spp. were demonstrated only in the pentitol/non-CPP-ACP gum group. Although these findings might indicate that a 30-day protocol of daily chewing of pentitol-sweetened gum containing no CPP-ACP might have some a reducing effect on the salivary levels of facultative bacteria, S. mutans and Lactobacillus spp., there was only a marginal, if any, benefit from the chewing gums under study on some microbiological caries- and gingivitis-related variables. Taking into account that for transferring results into clinically relevant conclusions the findings need to be strong and consistent, adhering to single significant differences appears not appropriate. Hence, the clinical significance of chewing gums as an adjunctive tool for daily oral care remained questionable.

Water-based vs. non-water-based physiotherapy for rehabilitation of postural deformities in Parkinson's disease: a randomized controlled pilot study.

PubMed

Volpe, Daniele; Giantin, Maria Giulia; Manuela, Pilleri; Filippetto, Consuelo; Pelosin, Elisa; Abbruzzese, Giovanni; Antonini, Angelo

2017-08-01

To compare the efficacy of two physiotherapy protocols (water-based vs. non-water-based) on postural deformities of patients with Parkinson's disease. A single blind, randomized controlled pilot study. Inpatient (Rehabilitative Department). A total of 30 patients with idiopathic Parkinson's disease. Participants were randomly assigned to one of two eight-week treatment groups: Water-based ( n = 15) or non-water-based physiotherapy exercises ( n = 15). Changes in the degree of cervical and dorsal flexion and in the angle of lateral inclination of the trunk (evaluated by means of a posturographic system) were used as primary outcomes. Unified Parkinson Disease Rating Scale section III, Time Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale and the Parkinson's disease quality of life questionnaire (39 items) were the secondary outcomes. All outcomes were assessed at baseline, at the end of training and eight weeks after treatment. Patients were always tested at the time of their optimal antiparkinsonian medication ('on' phase). After the treatment, only Parkinson's disease subjects randomized to water-based treatment showed a significant improvement of trunk posture with a significant reduction of cervical flexion (water-based group: -65.2°; non-water-based group: +1.7°) and dorsal flexion (water-based group: -22.5°; non-water-based group: -6.5°) and lateral inclination of the trunk (water-based group: -2.3°; non-water-based group: +0.3°). Both groups presented significant improvements in the secondary clinical outcomes without between-group differences. Our results show that water-based physiotherapy was effective for improving postural deformities in patients with Parkinson's disease.

Optimizing the Scientific Yield from a Randomized Controlled Trial (RCT): Evaluating Two Behavioral Interventions and Assessment Reactivity with a Single Trial

PubMed Central

Carey, Michael P.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.; Vanable, Peter A.; Carey, Kate B.

2013-01-01

Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites.

PubMed

Salinardi, Taylor C; Batra, Payal; Roberts, Susan B; Urban, Lorien E; Robinson, Lisa M; Pittas, Anastassios G; Lichtenstein, Alice H; Deckersbach, Thilo; Saltzman, Edward; Das, Sai Krupa

2013-04-01

Worksites are potentially effective locations for obesity control because they provide opportunities for group intervention and social support. Studies are needed to identify effective interventions in these settings. We examined the effects of a multicomponent lifestyle intervention on weight loss and prevention of regain in 4 worksites (2 intervention and 2 control sites). Overweight and obese employees (n = 133) enrolled in this pilot worksite-randomized controlled trial with a 0-6-mo weight-loss phase and a 6-12-mo structured weight-maintenance phase. The intervention combined recommendations to consume a reduced-energy, low-glycemic load, high-fiber diet with behavioral change education. Outcome measurements included changes in body weight and cardiometabolic risk factors. The mean ± SEM weight loss was substantial in intervention participants, whereas control subjects gained weight (-8.0 ± 0.7 compared with +0.9 ± 0.5 kg, respectively; P < 0.001), and 89% of participants completed the weight-loss phase. Intervention effects were not significant at the 0.05 level but would have been at the 0.10 level (P = 0.08) in a mixed model in which the worksite nested within group was a random factor. There were also significant improvements in cardiometabolic risk factors in intervention compared with control subjects regarding fasting total cholesterol, glucose, systolic blood pressure, and diastolic blood pressure (P ≤ 0.02 for each). No significant weight regain was observed in participants who enrolled in the structured weight-maintenance program (0.5 ± 0.7 kg; P = 0.65), and overweight and obese employees in intervention worksites who were not enrolled in the weight-loss program lost weight compared with subjects in control worksites (-1.3 ± 0.5 compared with +0.7 ± 0.2 kg, respectively; P = 0.02). Worksites can be effective for achieving clinically important reductions in body weight and improved cardiometabolic risk factors. This trial was registered at clinicaltrials.gov as NCT01470222.

Entomological efficacy of durable wall lining with reduced wall surface coverage for strengthening visceral leishmaniasis vector control in Bangladesh, India and Nepal.

PubMed

Huda, M Mamun; Kumar, Vijay; Das, Murari Lal; Ghosh, Debashis; Priyanka, Jyoti; Das, Pradeep; Alim, Abdul; Matlashewski, Greg; Kroeger, Axel; Alfonso-Sierra, Eduardo; Mondal, Dinesh

2016-10-06

New methods for controlling sand fly are highly desired by the Visceral Leishmaniasis (VL) elimination program of Bangladesh, India and Nepal for its consolidation and maintenance phases. To support the program we investigated safety, efficacy and cost of Durable Wall Lining to control sand fly. This multicentre randomized controlled study in Bangladesh, India and Nepal included randomized two intervention clusters and one control cluster. Each cluster had 50 households except full wall surface coverage (DWL-FWSC) cluster in Nepal which had 46 households. Ten of 50 households were randomly selected for entomological activities except India where it was 6 households. Interventions were DWL-FWSC and reduced wall surface coverage (DWL-RWSC) with DWL which covers 1.8 m and 1.5 m height from floor respectively. Efficacy was measured by reduction in sand fly density by intervention and sand fly mortality assessment by the WHO cone bioassay test at 1 month after intervention. Trained field research assistants interviewed household heads for socio-demographic information, knowledge and practice about VL, vector control, and for their experience following the intervention. Cost data was collected using cost data collection tool which was designed for this study. Statistical analysis included difference-in-differences estimate, bivariate analysis, Poisson regression model and incremental cost-efficacy ratio calculation. Mean sand fly density reduction by DWL-FWSC and DWL-RWSC was respectively -4.96 (95 % CI, -4.54, -5.38) and -5.38 (95 % CI, -4.89, -5.88). The sand fly density reduction attributed by both the interventions were statistically significant after adjusting for covariates (IRR = 0.277, p < 0.001 for DWL-RWSC and IRR = 0.371, p < 0.001 for DWL-FWSC). The efficacy of DWL-RWSC and DWL-FWSC on sand fly density reduction was statistically comparable (p = 0.214). The acceptability of both interventions was high. Transient burning sensations, flash on face and itching were most common adverse events and were observed mostly in Indian site. There was no serious adverse event. DWL-RWSC is cost-saving compared to DWL-FWSC. The incremental cost-efficacy ratio was -6.36, where DWL-RWSC dominates DWL-FWSC. DWL-RWSC intervention is safe, efficacious, cost-saving and cost-effective in reducing indoor sand fly density. The VL elimination program in the Indian sub-continent may consider DWL-RWSC for sand fly control for its consolidation and maintenance phases.

Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial

PubMed Central

Gong, Jie; Chen, Xinguang; Li, Sijian

2015-01-01

Objective To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP). Design Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention. Setting Community-based and patient-centered self-care for behavioral intervention in urban settings of China. Participants A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients) or the standard care only (6 centers and 218 patients). Intervention KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke. Outcome Measures Heart attack and stroke (clinically diagnosed, primary outcome), blood pressure (measured, secondary outcome), and physical activity (self-report, tertiary outcome) were assessed at the individual level during the baseline, 3- and 6-month post-intervention. Results Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05) and stroke (5.11% vs. 9.90%, p<0.05), and moderate reduction in blood pressure (-3.72mmHg in DBP and -2.92 mmHg in DBP) at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85) and 6-month (d = 0.45, 95% CI: 0.04, 0.85) post-intervention, respectively. Conclusion The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti-hypertensive medication. Findings of this study provide solid data supporting a formal phase-III trial to establish the effectiveness of KM2H2 for use in community settings for prevention. Trial Registration ISRCTN Register ISRCTN12608966 PMID:26426421

Patient Engagement Programs for Recognition and Initial Treatment of Depression in Primary Care: A Randomized Trial

PubMed Central

Kravitz, Richard L.; Franks, Peter; Feldman, Mitchell D.; Tancredi, Daniel J.; Slee, Christina A.; Epstein, Ronald M.; Duberstein, Paul R.; Bell, Robert A.; Jackson-Triche, Maga; Paterniti, Debora A.; Cipri, Camille; Iosif, Ana-Maria; Olson, Sarah; Kelly-Reif, Steven; Hudnut, Andrew; Dvorak, Simon; Turner, Charles; Jerant, Anthony

2015-01-01

Importance Interventions encouraging primary care patients’ engagement with their clinicians to address depression could improve outcomes but foster unnecessary treatment. Objective Determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care without increasing unnecessary anti-depressant prescribing. Design Randomized controlled trial comparing three interventions (DEV, IMCP, and control) conducted in two patients groups (depressed, defined by a Patient Health Questionnaire [PHQ]-9 score ≥5, and non-depressed [PHQ-9<5]) conducted between June 2010 and March 2012. Setting Primary care offices at 7 sites in 2 cities. Participants Depressed (N=559) and non-depressed (N=308) adult patients of 135 primary care clinicians. Intervention(s) DEV targeted to gender and income; IMCP tailored to individual patient characteristics; a sleep hygiene video (control). Main Outcome Measure(s) Depressed patients: composite measure of antidepressant recommendation and/or mental health referral (primary outcome); 12-week mental health, measured by the PHQ-8 (secondary outcome). Non- depressed patients: clinician-reported prescribing and patient-reported antidepressant recommendation (primary outcomes, pre-specified 3.5% non-inferiority margins). Results Depressed patients: composite care outcome rates were 18%, 26%, and 16% respectively in the DEV, IMCP, and control groups (cluster-adjusted DEV-control difference = 1.1% [95% CI −6.7 to 8.9, P=.79]; IMCP-control = 9.9% [95% CI 1.6 to 18.2, P=.02]). Twelve-week PHQ-8 effects were not significant: DEV- control = −0.2 points (95% CI −1.2 to 0.8); IMCP – control = 0.9 (95% CI −0.1 to 1.9). Non-depressed patients: clinician-reported antidepressant prescribing in the DEV and IMCP groups was non-inferior to control (DEV-control = −2.2%, 90% CI −8.0 to 3.498, non-inferiority (NI) P=.0499; IMCP-control = −3.3%, 90% CI −9.1 to 2.4, NI P=.02); patient-reported antidepressant recommendation did not achieve non-inferiority: DEV-control = 0.9% (90% CI −4.9 to 6.7; NI P=.23); IMCP-control = 0.3% (90% CI −5.1 to 5.7; NI P=.16). Conclusions and Relevance A tailored IMCP increased antidepressant recommendation and/or mental health referral among depressed patients but had no effect on 12-week mental health. The possibility that the IMCP and DEV increased patient-reported antidepressant recommendations among non-depressed patients could not be excluded. Further research is needed on the benefits and harms of these interventions. PMID:24193079

Randomized controlled trial of Gastrografin in adhesive small bowel obstruction.

PubMed

Burge, Jonathan; Abbas, Saleh M; Roadley, Graeme; Donald, Jennifer; Connolly, Andrew; Bissett, Ian P; Hill, Andrew G

2005-08-01

Several previous studies have shown that Gastrografin can be utilized to triage patients with adhesive small bowel obstruction (ASBO) to an operative or a non-operative course. Previous studies assessing the therapeutic effect of Gastrografin have been confounded by post-administration radiology alerting the physician to the treatment group of the patient. Therefore the aim of the present paper was to test the hypothesis that Gastrografin hastens the non-operative resolution of (ASBO). Patients, diagnosed with ASBO on clinical and radiological grounds, were randomized to receive Gastrografin or placebo in a double-blinded fashion. Patients did not undergo further radiological investigation. If the patient required subsequent radiological intervention or surgical intervention they were excluded from the study. End-points were passage of time to resolution of ASBO (flatus and bowel motion), length of hospital stay and complications. Forty-five patients with ASBO were randomized to receive either Gastrografin or placebo. Two patients were excluded due to protocol violations. Four patients in each group required surgery. Eighteen of the remaining patients received Gastrografin and 17 received placebo. Patients who received Gastrografin had complete resolution of their ASBO significantly earlier than placebo patients (12 vs 21 h, P = 0.009) and this translated into a median of a 1-day saving in time in hospital (3 vs 4 days, P = 0.03). Gastrografin accelerates resolution of ASBO by a specific therapeutic effect.

Effect of Royal Jelly on premenstrual syndrome among Iranian medical sciences students: a randomized, triple-blind, placebo-controlled study.

PubMed

Taavoni, Simin; Barkhordari, Fatemeh; Goushegir, Ashrafeddin; Haghani, Hamid

2014-08-01

Premenstrual syndrome (PMS) may have negative effects on women's health and sometimes need therapeutic non-pharmacological management. To determine the effect of oral consumption of 1000 mg Royal Jelly capsule on premenstrual syndrome. This is a randomized, triple-blind, placebo-controlled clinical trial, which was conducted in Tehran University of Medical Sciences female dormitories between December 2011 and October 2012. The study population comprised 110 medical sciences student with PMS, whom were randomly assigned to an intervention or a control group. Each participant in the intervention group took one Royal jelly capsule orally per day, starting on the first day of menstruation and continued the same treatment daily throughout two consecutive menstrual cycles, while participants in the intervention group took placebo capsules as same method. The outcome measure in this study was PMS score as obtained through the Premenstrual Profile 2005. The mean of personal characteristics and baseline level of the premenstrual score before intervention did not differ between groups. After two consecutive months consumption of Royal Jelly, PMS score had decreased from 23.17 ± 17.43 to 11.42 ± 14.58 (mean change: 11.75; 95% confidence interval [CI]: 8.31-15.19) and in Placebo, PMS score changed from 21.48 ± 16.39 to 20.27 ± 15.76 (mean change: 1.20; 95% CI: -1.69 to 4.10). Also difference between mean changes was significant (mean difference: 10.54; 95% CI: 6.10-14.98). The results of the study have demonstrated that 2 months consumption of Royal Jelly was effective in reducing PMS. Copyright © 2014. Published by Elsevier Ltd.

Study of the Effect of an Oral Formulation of Fig and Olive on Rheumatoid Arthritis (RA) Remission Indicators: A Randomized Clinical Trial.

PubMed

Bahadori, Shahnaz; Salamzadeh, Jamshid; Kamalinejad, Mohammad; Shams Ardekani, Mohammad Reza; Keshavarz, Mansoor; Ahmadzadeh, Arman

2016-01-01

This study was designed to explore the complementary effects of a combination formulation of olive oil, olive and fig fruits on RA remission indicators. A randomized controlled clinical trial was designed. Adult RA patients were randomly divided into two groups receiving routine Disease-modifying antirheumatic drugs (DMARDs) regimen (control group) and routine DMARDs regimen plus the herbal supplementary formulation of olive oil, fig and olive fruits (intervention group). Patients were followed every 4 weeks for total study period of 16 weeks. In addition to demographic and medical history of the patients, the Disease Activity Score with 28-joint counts based on Erythrocyte Sedimentation Rate (DAS28_ESR) were recorded. SPSS (version 22.0) software was used to analyze data, assuming p<0.05 as significance level. 56 patients (control = 27 and intervention = 29), with mean ± sd age of 50.91 ± 12.26 years completed the study. Repeated measures analysis revealed that differences between remission indicators in the two study groups were not statistically significant, however, there was a p = 0.03 for the within-subjects contrast test of the Patient Global Assessment (PtGA), approving a nonlinear change for PtGA with respect to time. No between groups differences in adjunct drug therapy pattern for disease flares were seen. In conclusion, although, non-significant changes in the study variable of DAS28_ESR is in agreement with few previous reports, nevertheless, trends in its reduction in the intervention group along with the significant delayed PtGA score improvements occurred in the intervention group convince us to suggest further investigations on the supplementary olive and fig products, with a longer follow up periods.

Effectiveness of differing levels of support for family meals on obesity prevention among head start preschoolers: the simply dinner study.

PubMed

Brophy-Herb, Holly E; Horodynski, Mildred; Contreras, Dawn; Kerver, Jean; Kaciroti, Niko; Stein, Mara; Lee, Hannah Jong; Motz, Brittany; Hebert, Sheilah; Prine, Erika; Gardiner, Candace; Van Egeren, Laurie A; Lumeng, Julie C

2017-02-10

Despite slight decreases in obesity prevalence in children, nearly 25% of preschool-aged children are overweight or obese. Most interventions focused on promoting family meals as an obesity-prevention strategy target meal planning skills, knowledge and modeling of healthy eating without addressing the practical resources that enable implementation of family meals. There is a striking lack of evidence about what level of resources low-income parents need to implement family meals. This study will identify resources most effective in promoting family meals and, subsequently, test associations among the frequency of family meals, dietary quality and children's adiposity indices among children enrolled in Head Start. The Multiphase Optimization Strategy, employed in this study, is a cutting-edge approach to maximizing resources in behavioral interventions by identifying the most effective intervention components. We are currently testing the main, additive and interactive effects of 6 intervention components, thought to support family meals, on family meal frequency and dietary quality (Primary Outcomes) as compared to Usual Head Start Exposure in a Screening Phase (N = 512 low-income families). Components yielding the most robust effects will be bundled and evaluated in a two-group randomized controlled trial (intervention and Usual Head Start Exposure) in the Confirming Phase (N = 250), testing the effects of the bundled intervention on children's adiposity indices (Primary Outcomes; body mass index and skinfolds). The current intervention components include: (1) home delivery of pre-made healthy family meals; (2) home delivery of healthy meal ingredients; (3) community kitchens in which parents make healthy meals to cook at home; (4) healthy eating classes; (5) cooking demonstrations; and (6) cookware/flatware delivery. Secondary outcomes include cooking self-efficacy and family mealtime barriers. Moderators of the intervention include family functioning and food security. Process evaluation data includes fidelity, attendance/use of supports, and satisfaction. Results will advance fundamental science and translational research by generating new knowledge of effective intervention components more rapidly and efficiently than the standard randomized controlled trial approach evaluating a bundled intervention alone. Study results will have implications for funding decisions within public programs to implement and disseminate effective interventions to prevent obesity in children. Clincaltrials.gov Identifier NCT02487251 ; Registered June 26, 2015.

Effectiveness of lifestyle interventions to reduce binge eating symptoms in African American and Hispanic women

PubMed Central

Mama, Scherezade K.; Schembre, Susan M.; O’Connor, Daniel P.; Kaplan, Charles D.; Bode, Sharon; Lee, Rebecca E.

2015-01-01

Objective Lifestyle interventions that promote physical activity and healthy dietary habits may reduce binge eating symptoms and be more feasible and sustainable among ethnic minority women, who are less likely to seek clinical treatment for eating disorders. The purpose of this study was to investigate (1) whether participating in a lifestyle intervention is a feasible way to decrease binge eating symptoms (BES) and (2) whether changes in BES differed by intervention (physical activity vs. dietary habits) and binge eating status at baseline (binger eater vs. non-binge eater) in African American and Hispanic women. Method Health Is Power (HIP) was a longitudinal randomized controlled trial to promote physical activity and improve dietary habits. Women (N=180) who completed anthropometric measures and questionnaires assessing fruit and vegetable and dietary fat intake, BES and demographics at baseline and post-intervention six months later were included in the current study. Results Over one-fourth (27.8%) of participants were categorized as binge-eaters. Repeated measures ANCOVA analyses ANOVA demonstrated significant two- and three-way interactions. Decreases in BES over time were greater in binge eaters than in non-binge eaters (F(1,164)=33.253, p<.001), and women classified as binge eaters who participated in the physical activity intervention reported greater decreases in BES than non-binge eaters in the dietary habits intervention (F(1,157)=5.170, p=.024). Discussion Findings suggest behavioral interventions to increase physical activity may lead to reductions in BES among ethnic minority women and ultimately reduce the prevalence of binge eating disorder and health disparities in this population. PMID:26188275

Effectiveness of lifestyle interventions to reduce binge eating symptoms in African American and Hispanic women.

PubMed

Mama, Scherezade K; Schembre, Susan M; O'Connor, Daniel P; Kaplan, Charles D; Bode, Sharon; Lee, Rebecca E

2015-12-01

Lifestyle interventions that promote physical activity and healthy dietary habits may reduce binge eating symptoms and be more feasible and sustainable among ethnic minority women, who are less likely to seek clinical treatment for eating disorders. The purpose of this study was to investigate (1) whether participating in a lifestyle intervention is a feasible way to decrease binge eating symptoms (BES) and (2) whether changes in BES differed by intervention (physical activity vs. dietary habits) and binge eating status at baseline (binger eater vs. non-binge eater) in African American and Hispanic women. Health Is Power (HIP) was a longitudinal randomized controlled trial to promote physical activity and improve dietary habits. Women (N = 180) who completed anthropometric measures and questionnaires assessing fruit and vegetable and dietary fat intake, BES and demographics at baseline and post-intervention six months later were included in the current study. Over one-fourth (27.8%) of participants were categorized as binge-eaters. Repeated measures ANOVA demonstrated significant two- and three-way interactions. Decreases in BES over time were greater in binge eaters than in non-binge eaters (F(1,164) = 33.253, p < .001), and women classified as binge eaters who participated in the physical activity intervention reported greater decreases in BES than non-binge eaters in the dietary habits intervention (F(1,157) = 5.170, p = .024). Findings suggest behavioral interventions to increase physical activity may lead to reductions in BES among ethnic minority women and ultimately reduce the prevalence of binge eating disorder and health disparities in this population. Copyright © 2015 Elsevier Ltd. All rights reserved.

Encouraging physician appropriate prescribing of non-steroidal anti-inflammatory therapies: protocol of a randomized controlled trial [ISRCTN43532635

PubMed Central

Doupe, Malcolm; Katz, Alan; Kvern, Brent; Manness, Lori-Jean; Metge, Colleen; Thomson, Glen TD; Morrison, Laura; Rother, Kat

2004-01-01

Background Traditional non-steroidal anti-inflammatory drugs (NSAIDs) are a widely used class of therapy in the treatment of chronic pain and inflammation. The drugs are effective and can be relatively inexpensive thanks to available generic versions. Unfortunately the traditional NSAIDs are associated with gastrointestinal complications in a small proportion of patients, requiring costly co-therapy with gastro-protective agents. Recently, a new class of non-steroidal anti-inflammatory agents known as coxibs has become available, fashioned to be safer than the traditional NSAIDs but priced considerably higher than the traditional generics. To help physicians choose appropriately and cost-effectively from the expanded number of anti-inflammatory therapies, scientific bodies have issued clinical practice guidelines and third party payers have published restricted reimbursement policies. The objective of this study is to determine whether an educational intervention can prompt physicians to adjust their prescribing in accordance with these expert recommendations. Methods This is an ongoing, randomized controlled trial. All primary care physicians in Manitoba, Canada have been randomly assigned to a control group or an intervention study group. The educational intervention being evaluated consists of an audit and feedback mechanism combined with optional participation in a Continuing Medical Education interactive workshop. The primary outcome of the study is the change, from pre-to post-intervention, in physicians' appropriate prescribing of non-steroidal anti-inflammatory therapies for patients requiring chronic treatment. Three classes of non-steroidal anti-inflammatory therapies have been identified: coxib therapy, traditional NSAID monotherapy, and traditional NSAID therapy combined with gastro-protective agents. Appropriate prescribing is defined based on international clinical practice guidelines and the provincial drug reimbursement policy in Manitoba. PMID:15327694

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.

PubMed

Pasha, Omrana; McClure, Elizabeth M; Wright, Linda L; Saleem, Sarah; Goudar, Shivaprasad S; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A; Derman, Richard J; Hibberd, Patricia L; Liechty, Edward K; Krebs, Nancy; Hambidge, K Michael; Buekens, Pierre; Moore, Janet; Jobe, Alan H; Koso-Thomas, Marion; Wallace, Dennis D; Stalls, Suzanne; Goldenberg, Robert L

2013-10-03

Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be. ClinicalTrials.gov NCT01073488.

One session of high-intensity interval training (HIIT) every 5 days, improves muscle power but not static balance in lifelong sedentary ageing men: A randomized controlled trial.

PubMed

Sculthorpe, Nicholas F; Herbert, Peter; Grace, Fergal

2017-02-01

Declining muscle power during advancing age predicts falls and loss of independence. High-intensity interval training (HIIT) may improve muscle power, but remains largely unstudied in ageing participants. This randomized controlled trial (RCT) investigated the efficacy of a low-frequency HIIT (LfHIIT) intervention on peak muscle power (peak power output [PPO]), body composition, and balance in lifelong sedentary but otherwise healthy males. Thirty-three lifelong sedentary ageing men were randomly assigned to either intervention (INT; n = 22, age 62.3 ± 4.1 years) or control (n = 11, age 61.6 ± 5.0 years) who were both assessed at 3 distinct measurement points (phase A), after 6 weeks of conditioning exercise (phase B), and after 6 weeks of HIIT once every 5 days in INT (phase C), where control remained inactive throughout the study. Static balance remained unaffected, and both absolute and relative PPO were not different between groups at phases A or B, but increased significantly in INT after LfHIIT (P < 0.01). Lean body mass displayed a significant interaction (P < 0.01) due to an increase in INT between phases B and C (P < 0.05). 6 weeks of LfHIIT exercise feasible and effective method to induce clinically relevant improvements in absolute and relative PPO, but does not improve static balance in sedentary ageing men.

Effects of an Early Numeracy Intervention on Struggling Kindergarteners' Mathematics Performance

ERIC Educational Resources Information Center

Bryant, Brian R.; Bryant, Diane Pedrotty; Roberts, Greg; Fall, Anna-Maria

2016-01-01

The purpose of this study was to investigate the effects of an early numeracy intervention delivered by kindergarten teachers to students identified as having mathematics difficulties. A multigroup growth-modeling-with-random-assignment-to-intervention-condition design was employed. Thirty-two teachers were randomly assigned to the treatment or…

Effects of Supplementation of the Synbiotic Ecologic® 825/FOS P6 on Intestinal Barrier Function in Healthy Humans: A Randomized Controlled Trial.

PubMed

Wilms, E; Gerritsen, J; Smidt, H; Besseling-van der Vaart, I; Rijkers, G T; Garcia Fuentes, A R; Masclee, A A M; Troost, F J

2016-01-01

Probiotics, prebiotics and synbiotics have been suggested as dietary strategies to improve intestinal barrier function. This study aimed to assess the effect of two weeks synbiotic supplementation on intestinal permeability under basal and stressed conditions. Secondary aims were the assessment of two weeks synbiotic supplementation on systemic immune function and gastrointestinal symptoms including defecation pattern. Twenty healthy adults completed a double-blind, controlled, randomized, parallel design study. Groups either received synbiotic (1.5 × 1010 CFU Ecologic® 825 + 10 g fructo-oligosaccharides (FOS P6) per day) or control supplements for two weeks. Intestinal segment specific permeability was assessed non-invasively by oral administration of multiple sugar probes and, subsequently, assessing the excretion of these probes in urine. This test was conducted at baseline and at the end of intervention, in the absence and in the presence of an indomethacin challenge. Indomethacin was applied to induce a compromised gut state. Plasma zonulin, cytokines and chemokines were measured at baseline and at the end of intervention. Gastrointestinal symptoms and stool frequency were recorded at baseline and daily during intervention. Significantly more male subjects were in the synbiotic group compared to the control group (P = 0.025). Indomethacin significantly increased urinary lactulose/rhamnose ratio versus without indomethacin, both in the control group (P = 0.005) and in the synbiotic group (P = 0.017). Urinary sugar recoveries and ratios, plasma levels of zonulin, cytokines and chemokines, and gastrointestinal symptom scores were not significantly different after control or synbiotic intervention. Stool frequency within the synbiotic group was significantly increased during synbiotic intervention compared to baseline (P = 0.039) and higher compared to control intervention (P = 0.045). Two weeks Ecologic® 825/FOS P6 supplementation increased stool frequency, but did not affect intestinal permeability neither under basal nor under indomethacin-induced stressed conditions, immune function or gastrointestinal symptoms in healthy adults.

Greater energy reduction in 6-n-propylthiouracil (PROP) super-tasters as compared to non-tasters during a lifestyle intervention.

PubMed

Coletta, Adriana; Bachman, Jessica; Tepper, Beverly J; Raynor, Hollie A

2013-04-01

Little is known as to how 6-n-propylthiouracil (PROP) taster status may influence changes in dietary intake in adults participating in a lifestyle intervention to assist with reducing weight. This secondary data analysis examined changes in energy, percent energy from macronutrients, and food group intake; physical activity; and body mass index (BMI) in super-tasters and non-tasters participating in two randomized controlled trials implementing a lifestyle obesity intervention. One trial focused on lowering energy density of the diet and the other trial focused on changing eating frequency. Overweight and obese participants (n = 57) who completed measures of dietary intake, physical activity, and anthropometrics at 0 and 3 months were included in the analyses. Taster status was determined at baseline: 46 non-tasters and 11 super-tasters. After controlling for condition assignment and baseline values, results indicated that a significantly greater reduction in energy intake occurred for super-tasters as compared to non-tasters (-1149 ± 561 kcal/day vs. -902 ± 660 kcal/day, p < 0.05). No other significant differences in changes in dietary intake, physical activity, or BMI were found. These results suggest that in situations of reducing energy intake, overweight and obese super-tasters may be more successful than overweight and obese non-tasters. More research is needed to understand the influence of taster-status on dietary change during a lifestyle intervention and how this may impact weight loss. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Long-Term Intensive Lifestyle Intervention and Physical Function: the Look AHEAD Movement and Memory Study

PubMed Central

Houston, Denise K.; Leng, Xiaoyan; Bray, George A.; Hergenroeder, Andrea L.; Hill, James O.; Jakicic, John M.; Johnson, Karen C.; Neiberg, Rebecca H.; Marsh, Anthony P.; Rejeski, W. Jack; Kritchevsky, Stephen B.

2014-01-01

OBJECTIVE To assess the long-term effects of an intensive lifestyle intervention on physical function using a randomized post-test design in the Look AHEAD trial. METHODS Overweight and obese (BMI ≥25 kg/m2) middle-aged and older adults (aged 45–76 years at enrollment) with type 2 diabetes (n=964) at four clinics in Look AHEAD, a trial evaluating an intensive lifestyle intervention (ILI) designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including an expanded short physical performance battery (SPPBexp), 20-m and 400-m walk, and grip and knee extensor strength 8 years post-randomization, during the trial’s weight maintenance phase. RESULTS Eight years post-randomization, individuals randomized to ILI had better SPPBexp scores (adjusted mean (SE) difference: 0.055 (0.022), p=0.01) and faster 20-m and 400-m walk speeds (0.032 (0.012) m/sec, p=0.01, and 0.025 (0.011) m/sec, p=0.02, respectively) compared to those randomized to DSE. Achieved weight loss greatly attenuated the group differences in physical function and the intervention effect was no longer significant. CONCLUSIONS An intensive lifestyle intervention has long-term benefits for mobility function in overweight and obese middle-aged and older individuals with type 2 diabetes. PMID:25452229

Evaluation of a Socio-Cultural Intervention to Reduce Unprotected Sex for HIV Among African American/Black Women

PubMed Central

Boekeloo, B; Geiger, T; Wang, M; Ishman, N; Quinton, S; Allen, G; Ali, B; Snow, D

2015-01-01

African American/Black (Black) women suffer disproportionately to other women from HIV. An HIV prevention intervention combining two previous evidenced-based HIV intervention programs; “Coping with Work and Family Stress” and “Hip Hop 2 Prevent Substance Abuse and HIV”, was evaluated in a diverse sample of Black women (n=205). Study participants at 10 recruitment sites were assigned non-randomly to either the intervention or comparison group and then surveyed at baseline, immediate posttest, and 6-month follow-up. General Estimating Equation modeling revealed that participants in the comparison group reported less unprotected sex at immediate post-test and the intervention group less unprotected sex at 6-month follow-up. Despite the initial drop in reported unprotected sex in the comparison group, this study suggests that an HIV risk reduction intervention tailored to address Black women’s socio-cultural stress and enhance their coping may reduce their unprotected sex at 6-months. PMID:25645327

Development of a tobacco cessation intervention for Alaska Native youth

PubMed Central

Patten, Christi A.; Fadahunsi, Oluwole; Hanza, Marcelo; Smith, Christina M.; Hughes, Christine A.; Brockman, Tabetha A.; Boyer, Rahnia; Decker, Paul A.; Luger, Elizabeth; Sinicrope, Pamela S.; Offord, Kenneth P.

2013-01-01

Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and acceptability of a targeted cessation intervention developed for AN youth. Intervention components were informed by prior focus groups assessing treatment preferences among AN youth, a social cognitive theoretical framework and feedback obtained from a teen advisory group. The intervention consisted of a weekend program where youth traveled by small airplane from their villages to stay overnight with other adolescents who quit tobacco use together. The program included recreational activities, talking circles, personal stories from elders and teen advisors, and cognitive behavioral counseling. Two intervention pilots were conducted from October 2010 to January 2011 using a non-randomized, uncontrolled study design with assessments at baseline and six-week follow-up. One village in Western Alaska was selected for each pilot with a targeted enrollment of 10 adolescents each. Participants were recruited for each pilot within five days, but recruitment challenges and ‘‘lessons learned’’ are described. The first pilot enrolled nine adolescents (all female) aged 13–16 years; all nine attended the intervention program and 78% (7/9) completed follow-up. The second pilot enrolled 12 adolescents (eight females, four males) aged 12–17 years, of which seven attended the intervention program. Six of these seven participants (86%) completed follow-up. In both pilots, participants rated the intervention as highly acceptable. A targeted cessation intervention was feasible and acceptable to AN youth. The intervention will be tested for efficacy in a subsequent randomized controlled trial. PMID:24058327

Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

ERIC Educational Resources Information Center

Dowling, S.; Hubert, J.; White, S.; Hollins, S.

2006-01-01

Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

Testing the Efficacy of a Kindergarten Mathematics Intervention by Small Group Size

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Kosty, Derek; Kurtz Nelson, Evangeline; Smolkowski, Keith; Fien, Hank; Turtura, Jessica

2017-01-01

This study used a randomized controlled trial design to investigate the ROOTS curriculum, a 50-lesson kindergarten mathematics intervention. Ten ROOTS-eligible students per classroom (n = 60) were randomly assigned to one of three conditions: a ROOTS five-student group, a ROOTS two-student group, and a no-treatment control group. Two primary…

How effective are weight-loss interventions for improving fertility in women and men who are overweight or obese? A systematic review and meta-analysis of the evidence.

PubMed

Best, Damian; Avenell, Alison; Bhattacharya, Siladitya

2017-11-01

The prevalence of obesity is increasing worldwide, with a corresponding increase in overweight and obese patients referred with infertility. This systematic review aimed to determine whether non-surgical weight reduction strategies result in an improvement in reproductive parameters affected by obesity, e.g. delayed time to pregnancy, oligozoospermia and azoospermia. No prior reviews have examined this within the general fertility population, or in both sexes. Our objective was to answer the question: 'In overweight and obese women, men and couples seeking fertility treatment, what non-surgical weight-loss interventions have been used, and how effective are they at weight loss and improving reproductive outcomes?' An electronic search of MEDLINE, EMBASE and the Cochrane Library was performed for studies between January 1966 and March 2016. Text word and MESH search terms used related to infertility, weight and barriers to weight loss. Inclusion criteria were an intervention to change lifestyle evaluated in any study design in participants of either gender with an unfulfilled desire to conceive. Studies were excluded if they included participants not attempting pregnancy, with illnesses that might cause weight fluctuations, or studies evaluating bariatric surgery. Two reviewers performed data extraction and quality assessment using the Cochrane Risk of Bias Tool for randomized trials, and a ratified checklist (ReBIP) for non-randomized studies. A total of 40 studies were included, of which 14 were randomised control trials. Primary outcomes were pregnancy, live birth rate and weight change. In women, reduced calorie diets and exercise interventions were more likely than control interventions to result in pregnancy [risk ratio 1.59, 95% CI (1.01, 2.50)], and interventions resulted in weight loss and ovulation improvement, where reported. Miscarriage rates were not reduced by any intervention. Overweight and obese persons seeking fertility should be educated on the detrimental effects of fatness and the benefits of weight reduction, including improvement in pregnancy rates. A combination of a reduced calorie diet, by reducing fat and refined carbohydrate intake, and increased aerobic exercise should form the basis of programmes designed for such individuals. A lack of randomized studies in men and couples, and studies evaluating barriers to undertaking weight loss in infertile populations is evident, and future research should examine these issues further. © 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 email: journals.permissions@oup.com

Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials.

PubMed

Qaderdan, Khalid; Vos, Gerrit-Jan A; McAndrew, Thomas; Steg, Philippe Gabriel; Hamm, Christian W; Van't Hof, Arnoud; Mehran, Roxana; Deliargyris, Efthymios N; Bernstein, Debra; Stone, Gregg W; Ten Berg, Jurriën M

2017-12-01

Since older age is a strong predictor of not only bleeding but also of ischemic events, understanding the risk:benefit profile of bivalirudin in the elderly undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation (STEMI) is important. For this, we aim to compare elderly with young patients, who all underwent pPCI for STEMI and randomly received either bivalirudin or heparin. We performed a patient-level pooled analysis (n=5800) of two large randomized trials. A total of 2149 (37.1%) elderly patients (>65 years of age) with STEMI were enrolled and randomly assigned to either bivalirudin or heparin with or without a GPI (control group) before pPCI. Clinical outcomes at 30 days were analyzed. In elderly patients, bivalirudin significantly reduced non-CABG major bleeding (7.1% vs 10.4%; P<.01), subacute ST (0.4% vs 1.5%; P<.01), and net adverse clinical events (NACE; composite of all-cause mortality, reinfarction, IDR, stroke or protocol-defined non-CABG major bleeding [13.7% vs 17.2%; P=.03]) with comparable rates of stroke, MI, acute ST, or all-cause death, when compared with heparin with or without GPI. In a large group of elderly patients enrolled in the EUROMAX and HORIZONS-AMI trials, bivalirudin was associated with lower 30-day rates of non-CABG major bleeding, subacute ST and NACE, with similar 30-day rates of acute ST and mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

The impact of an alcohol harm reduction intervention on interpersonal violence and engagement in sex work among female sex workers in Mombasa, Kenya: Results from a randomized controlled trial.

PubMed

Parcesepe, Angela M; L Engle, Kelly L; Martin, Sandra L; Green, Sherri; Sinkele, William; Suchindran, Chirayath; Speizer, Ilene S; Mwarogo, Peter; Kingola, Nzioki

2016-04-01

To evaluate whether an alcohol harm reduction intervention was associated with reduced interpersonal violence or engagement in sex work among female sex workers (FSWs) in Mombasa, Kenya. Randomized controlled trial. HIV prevention drop-in centers in Mombasa, Kenya. 818 women 18 or older in Mombasa who visited HIV prevention drop-in centers, were moderate-risk drinkers and engaged in transactional sex in past six months (410 and 408 in intervention and control arms, respectively). 6 session alcohol harm reduction intervention. 6 session non-alcohol related nutrition intervention. In-person interviews were conducted at enrollment, immediately post-intervention and 6-months post-intervention. General linear mixed models examined associations between intervention assignment and recent violence (physical violence, verbal abuse, and being robbed in the past 30 days) from paying and non-paying sex partners and engagement in sex work in the past 30 days. The alcohol intervention was associated with statistically significant decreases in physical violence from paying partners at 6 months post-intervention and verbal abuse from paying partners immediately post-intervention and 6-months post-intervention. Those assigned to the alcohol intervention had significantly reduced odds of engaging in sex work immediately post-intervention and 6-months post-intervention. The alcohol intervention was associated with reductions in some forms of violence and with reductions in engagement in sex work among FSWs in Mombasa, Kenya. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2016-07-11

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

The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis.

PubMed

Aksamit, Timothy; Bandel, Tiemo-Joerg; Criollo, Margarita; De Soyza, Anthony; Elborn, J Stuart; Operschall, Elisabeth; Polverino, Eva; Roth, Katrin; Winthrop, Kevin L; Wilson, Robert

2017-07-01

The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis (NCFB) are to reduce the number of exacerbations, and improve quality of life. However, currently no therapies are licensed for this. Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients. The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design. Adult patients with idiopathic or post-infectious NCFB, a history of ≥2 exacerbations in the previous 12months, and positive sputum culture for one of seven pre-specified pathogens, undergo stratified randomization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5mg or placebo using a pocket-sized inhaler in one of two regimens: 28days on/off treatment or 14days on/off treatment. The treatment period is 48weeks plus an 8-week follow-up after the last dose. The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation. Secondary endpoints, including frequency of events using different exacerbation definitions, microbiology, quality of life and lung function will also be evaluated. The RESPIRE trials will determine the efficacy and safety of Ciprofloxacin DPI. The strict entry criteria and stratified randomization, the inclusion of two treatment regimens and a stringent definition of exacerbation should clarify the patient population best positioned to benefit from long-term inhaled antibiotic therapy. Additionally RESPIRE will increase understanding of NCFB treatment and could lead to an important new therapy for sufferers. The RESPIRE trials are registered in ClinicalTrials.gov, ID number NCT01764841 (RESPIRE 1; date of registration January 8, 2013) and NCT02106832 (RESPIRE 2; date of registration April 4, 2014). Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.

PubMed

Levin, Frances R; Mariani, John J; Pavlicova, Martina; Brooks, Daniel; Glass, Andrew; Mahony, Amy; Nunes, Edward V; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M; Sullivan, Maria A; Choi, Jean C

2016-02-01

Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence. One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method. There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9% for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time. Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder. Published by Elsevier Ireland Ltd.

Dronabinol and Lofexidine for Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial*

PubMed Central

Levin, Frances R.; Mariani, John J.; Pavlicova, Martina; Brooks, Daniel; Glass, Andrew; Mahony, Amy; Nunes, Edward V.; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M.; Sullivan, Maria A.; Choi, Jean C.

2016-01-01

Background Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence. Objective The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence. Methods One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20 mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method. Results There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9 % for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time. Conclusions Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder. PMID:26711160

The effect of a healthy lifestyle programme on 8-9 year olds from social disadvantage.

PubMed

Breslin, Gavin; Brennan, Deirdre; Rafferty, Ruth; Gallagher, Alison M; Hanna, Donncha

2012-07-01

This study assessed the efficacy of a school-based healthy lifestyle intervention (Sport for LIFE) for increasing physical activity, decreasing sedentary behaviour, reducing screen time behaviour, encouraging healthy attitudes and behaviour to nutrition, and reducing body mass index (BMI) in 8-9-year-old primary school children from lower socioeconomic backgrounds in Northern Ireland. A non-randomised controlled trial of 416 children from 24 schools took part. Schools were randomly assigned to one of two groups, an intervention or control group with 12 schools in each group. The intervention group received a 12-week school-based programme based on social cognitive theory. At baseline and follow-up, groups completed questionnaires assessing physical activity, screen time behaviour and dietary patterns. On each occasion anthropometric assessments of height and weight were taken. Physical activity and sedentary behaviour were measured by accelerometry. Significant effects were observed for vigorous, moderate and light activity for the intervention group at follow-up. Sedentary behaviour was significantly reduced for the intervention group but not for the control group. No significant effects of the intervention on BMI, screen time behaviour or attitudes to nutrition, with the exception of non-core foods, were shown. The programme was effective in increasing physical activity and reducing sedentary behaviour, however no significant changes in screen time behaviour and attitude to nutrition, with the exception of non-core foods, were observed. Future research ideas are offered for tackling low levels of physical activity in children.

The effect of aromatherapy with lavender essence on severity of labor pain and duration of labor in primiparous women.

PubMed

Yazdkhasti, Mansoreh; Pirak, Arezoo

2016-11-01

The aim of this study was to investigate the effect of Lavender essence inhalation on severity of labor pain and duration of labor. This single-blind, randomized clinical trial was conducted on 120 pregnant women in two groups. The experimental group received 2 drops of Lavender essence inhaled at three stages (4-5, 6-7, 8-9 cm cervical dilation) and severity of the labor pain and duration of labor was measured before and after intervention. The control group was treated with distilled water as a placebo in the similar ways, too. The results showed that difference in the labor pain before and after intervention in two groups was significant (P = 0/001). But there was no difference in mean duration of the active phase and the second stage of labor between the two groups. Lavender essence aromatherapy may be an effective therapeutic option for pain management for women in labor. Published by Elsevier Ltd.

Keeping a Step Ahead: formative phase of a workplace intervention trial to prevent obesity.

PubMed

Zapka, Jane; Lemon, Stephenie C; Estabrook, Barbara B; Jolicoeur, Denise G

2007-11-01

Ecological interventions hold promise for promoting overweight and obesity prevention in worksites. Given the paucity of evaluative research in the hospital worksite setting, considerable formative work is required for successful implementation and evaluation. This paper describes the formative phases of Step Ahead, a site-randomized controlled trial of a multilevel intervention that promotes physical activity and healthy eating in six hospitals in central Massachusetts. The purpose of the formative research phase was to increase the feasibility, effectiveness, and likelihood of sustainability of the intervention. The Step Ahead ecological intervention approach targets change at the organization, interpersonal work environment, and individual levels. The intervention was developed using fundamental steps of intervention mapping and important tenets of participatory research. Formative research methods were used to engage leadership support and assistance and to develop an intervention plan that is both theoretically and practically grounded. This report uses observational data, program minutes and reports, and process tracking data. Leadership involvement (key informant interviews and advisory boards), employee focus groups and advisory boards, and quantitative environmental assessments cultivated participation and support. Determining multiple foci of change and designing measurable objectives and generic assessment tools to document progress are complex challenges encountered in planning phases. Multilevel trials in diverse organizations require flexibility and balance of theory application and practice-based perspectives to affect impact and outcome objectives. Formative research is an essential component.

Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial.

PubMed

Martínez-Vizcaíno, Vicente; Sánchez-López, Mairena; Notario-Pacheco, Blanca; Salcedo-Aguilar, Fernando; Solera-Martínez, Montserrat; Franquelo-Morales, Pablo; López-Martínez, Sara; García-Prieto, Jorge C; Arias-Palencia, Natalia; Torrijos-Niño, Coral; Mora-Rodríguez, Ricardo; Rodríguez-Artalejo, Fernando

2014-12-10

Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results. The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren. Cluster randomized trial study of 712 schoolchildren, 8-10 years, from 20 public schools in the Province of Cuenca, Spain. The intervention (MOVI-2) consisted of play-based and non-competitive activities. MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011. We measured changes in adiposity (overweight/obesity prevalence, body mass index [BMI], triceps skinfold thickness [TST], body fat %, fat-free mass, waist circumference) and other cardiometabolic risk factors (LDL-cholesterol, triglycerides/HDL-cholesterol ratio, insulin, C-reactive protein and blood pressure). The analyses used mixed regression models to adjust for baseline covariates under cluster randomization. Among girls, we found a reduction of adiposity in intervention versus control schools, with a decrease in TST (-1.1 mm; 95% confidence interval [CI] -2.3 to -0.7), body fat % (-0.9%; 95% CI -1.3 to -0.4), waist circumference (-2.7 cm; 95% CI -4.5 to -0.9), and an increase in fat-free mass (0.3 kg; 95% CI 0.01 to 0.6). The intervention also led to lower serum LDL-cholesterol and insulin levels. Among boys, a reduction in waist circumference (-1.4 cm; 95% CI -2.6 to -0.1; P = 0.03), and an increase in fat-free mass (0.5 kg; 95% CI 0.2 to 0.9; P = 0.003) was associated with the intervention versus control schools. The prevalence of overweight/obesity or underweight, BMI, and other cardiometabolic risk factors was not modified by the intervention. No important adverse events were registered. An extracurricular intervention of non-competitive physical activity during an academic year, targeting all schoolchildren regardless of body weight, is a safe and effective measure to reduce adiposity in both genders and to improve cardiometabolic risk profile in girls. Clinical trials NCT01277224.

Influence of phase connectivity on the relationship among capillary pressure, fluid saturation, and interfacial area in two-fluid-phase porous medium systems

DOE PAGES

McClure, James E.; Berrill, Mark A.; Gray, William G.; ...

2016-09-02

Here, multiphase flow in porous medium systems is typically modeled using continuum mechanical representations at the macroscale in terms of averaged quantities. These models require closure relations to produce solvable forms. One of these required closure relations is an expression relating fluid pressures, fluid saturations, and, in some cases, the interfacial area between the fluid phases, and the Euler characteristic. An unresolved question is whether the inclusion of these additional morphological and topological measures can lead to a non-hysteretic closure relation compared to the hysteretic forms that are used in traditional models, which typically do not include interfacial areas, ormore » the Euler characteristic. We develop a lattice-Boltzmann (LB) simulation approach to investigate the equilibrium states of a two-fluid-phase porous medium system, which include disconnected now- wetting phase features. The proposed approach is applied to a synthetic medium consisting of 1,964 spheres arranged in a random, non-overlapping, close-packed manner, yielding a total of 42,908 different equilibrium points. This information is evaluated using a generalized additive modeling approach to determine if a unique function from this family exists, which can explain the data. The variance of various model estimates is computed, and we conclude that, except for the limiting behavior close to a single fluid regime, capillary pressure can be expressed as a deterministic and non-hysteretic function of fluid saturation, interfacial area between the fluid phases, and the Euler characteristic. This work is unique in the methods employed, the size of the data set, the resolution in space and time, the true equilibrium nature of the data, the parameterizations investigated, and the broad set of functions examined. The conclusion of essentially non-hysteretic behavior provides support for an evolving class of two-fluid-phase flow in porous medium systems models.« less

Influence of phase connectivity on the relationship among capillary pressure, fluid saturation, and interfacial area in two-fluid-phase porous medium systems

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

McClure, James E.; Berrill, Mark A.; Gray, William G.

Here, multiphase flow in porous medium systems is typically modeled using continuum mechanical representations at the macroscale in terms of averaged quantities. These models require closure relations to produce solvable forms. One of these required closure relations is an expression relating fluid pressures, fluid saturations, and, in some cases, the interfacial area between the fluid phases, and the Euler characteristic. An unresolved question is whether the inclusion of these additional morphological and topological measures can lead to a non-hysteretic closure relation compared to the hysteretic forms that are used in traditional models, which typically do not include interfacial areas, ormore » the Euler characteristic. We develop a lattice-Boltzmann (LB) simulation approach to investigate the equilibrium states of a two-fluid-phase porous medium system, which include disconnected now- wetting phase features. The proposed approach is applied to a synthetic medium consisting of 1,964 spheres arranged in a random, non-overlapping, close-packed manner, yielding a total of 42,908 different equilibrium points. This information is evaluated using a generalized additive modeling approach to determine if a unique function from this family exists, which can explain the data. The variance of various model estimates is computed, and we conclude that, except for the limiting behavior close to a single fluid regime, capillary pressure can be expressed as a deterministic and non-hysteretic function of fluid saturation, interfacial area between the fluid phases, and the Euler characteristic. This work is unique in the methods employed, the size of the data set, the resolution in space and time, the true equilibrium nature of the data, the parameterizations investigated, and the broad set of functions examined. The conclusion of essentially non-hysteretic behavior provides support for an evolving class of two-fluid-phase flow in porous medium systems models.« less

The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

PubMed Central

Marzouk, Tyseer M. F.; El-Nemer, Amina M. R.; Baraka, Hany N.

2013-01-01

Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 (n = 48) received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil). Group 2 (n = 47) received the same intervention but with placebo oil (almond oil). In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding. PMID:23662151

The efficacy of Sustained Natural Apophyseal Glides with and without Isometric Exercise Training in Non-specific Neck Pain.

PubMed

Ali, Abid; Shakil-Ur-Rehman, Syed; Sibtain, Fozia

2014-07-01

To determine the efficacy of Sustained Natural Apophyseal Glides (SNAGs) with and without Isometric Exercise Training Program (IETP) in Non-specific Neck Pain (NSNP) Methods: This randomized control trial of one year duration was conducted at out-patient department of Physiotherapy and Rehabilitation, Khyber Teaching Hospital (KTH) Peshawar, Pakistan from July 2012 to June 2013. The sample of 102 patients of NSNP were randomly selected through simple random sampling technique, and placed into two groups. The SNAGs manual physical therapy technique with IETP was applied on 51 patients in group A and SNAGs manual physical therapy techniques was applied alone on 51 patients in group B. The duration of intervention was 6 weeks, at 4 times per week. The Neck Disability Index (NDI) and Visual Analog Scale (VAS) for neck pain were assessment tools used for all patients before and after 6 weeks of physical therapy intervention. All the patients were assessed through NDI and VAS before intervention and at the completion of 6 weeks program. The data of all 102 was analyzed by SPSS-20 and statistical test was applied at 95% level of significance determine the efficacy of both the treatments interventions and compare with each other. The patients in group A, treated with SNAGs and followed by IETP for 6 weeks, demonstrated more improvement in pain and physical activity as assessed by VAS (p=0.013) and NDI (p=0.003), as compared to the patients treated with SNAGS alone, as pain and function assessed by VAS (p=0.047) and NDI (p=0.164). In group A the NDI score improved from 40 to 15 and VAS from 7 to 4, while in group B the NDI score improved from 42 to 30 and VAS from 7 to 4. Patients with non-specific neck pain treated with SNAGs manual physical therapy techniques and followed by IETP was more effective in reduction of pain and enhancement of function, as compared to those patients treated with SNAGs manual physical therapy techniques alone.

Prevention of problematic gambling behavior among adolescents: testing the efficacy of an integrative intervention.

PubMed

Donati, Maria Anna; Primi, Caterina; Chiesi, Francesca

2014-12-01

This study aimed at testing the efficacy of an integrative intervention to prevent adolescent problem gambling acting on a multidimensional set of factors including gambling related knowledge and misconceptions, economic perception of gambling, and superstitious thinking. A pre- and post-test design was performed with 181 Italian adolescents (64% boys; Mean age = 15.95) randomly assigned to two groups (Training and No Training). Results revealed that the intervention was effective in improving correct knowledge about gambling and reducing misconceptions, perception of gambling's profitability, and superstitious thinking. Except for misconceptions, these effects were obtained both in participants who were classified as Non-problem and At-Risk/Problem gamblers at the beginning of the intervention. Findings attested also that the training effects were stable over time, and that some changes in gambling behavior were produced. Findings were discussed referring to indications for future research aiming at confirming and extending the present results.

Usage, adherence and attrition: how new mothers engage with a nurse-moderated web-based intervention to support maternal and infant health. A 9-month observational study

PubMed Central

Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Peters, Jacqueline D; Mpundu-Kaambwa, Christine; Clark, Jennifer J; McDonald, Denise; Mittinty, Murthy N; Lynch, John W

2016-01-01

Objectives To identify factors predicting use, adherence and attrition with a nurse-moderated web-based group intervention designed to support mothers of infants aged 0–6 months. Design 9-Month observational study. Setting Community maternal and child health service. Participants 240 mothers attending initial postnatal health checks at community clinics who were randomly assigned to the intervention arm of a pragmatic preference randomised trial (total randomised controlled trial, n=819; response rate=45%). Intervention In the first week (phase I), mothers were assisted with their first website login by a research assistant. In weeks 2–7 (phase II), mothers participated in the web-based intervention with an expectation of weekly logins. The web-based intervention was comparable to traditional face-to-face new mothers’ groups. During weeks 8–26 (phase III), mothers participated in an extended programme at a frequency of their choosing. Primary outcome measures Number of logins and posted messages. Standard self-report measures assessed maternal demographic and psychosocial characteristics. Results In phase II, the median number of logins was 9 logins (IQR=1–25), and in phase III, it was 10 logins (IQR=0–39). Incident risk ratios from multivariable analyses indicated that compared to mothers with the lowest third of logins in phase I, those with the highest third had 6.43 times as many logins in phase II and 7.14 times in phase III. Fifty per cent of mothers logged-in at least once every 30 days for 147 days after phase I and 44% logged-in at least once in the last 30 days of the intervention. Frequency of logins during phase I was a stronger predictor of mothers’ level of engagement with the intervention than their demographic and psychosocial characteristics. Conclusions Mothers’ early use of web-based interventions could be employed to customise engagement protocols to the circumstances of individual mothers with the aim of improving adherence and reducing attrition with web-based interventions. Trial registration number ACTRN12613000204741; Results. PMID:27496227

Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial.

PubMed

Ramalingam, Suresh S; Jänne, Pasi A; Mok, Tony; O'Byrne, Kenneth; Boyer, Michael J; Von Pawel, Joachim; Pluzanski, Adam; Shtivelband, Mikhail; Docampo, Lara Iglesias; Bennouna, Jaafar; Zhang, Hui; Liang, Jane Q; Doherty, Jim P; Taylor, Ian; Mather, Cecile B; Goldberg, Zelanna; O'Connell, Joseph; Paz-Ares, Luis

2014-11-01

Dacomitinib is an irreversible pan-EGFR family tyrosine kinase inhibitor. Findings from a phase 2 study in non-small cell lung cancer showed favourable efficacy for dacomitinib compared with erlotinib. We aimed to compare dacomitinib with erlotinib in a phase 3 study. In a randomised, multicentre, double-blind phase 3 trial in 134 centres in 23 countries, we enrolled patients who had locally advanced or metastatic non-small-cell lung cancer, progression after one or two previous regimens of chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and presence of measurable disease. We randomly assigned patients in a 1:1 ratio to dacomitinib (45 mg/day) or erlotinib (150 mg/day) with matching placebo. Treatment allocation was masked to the investigator, patient, and study funder. Randomisation was stratified by histology (adenocarcinoma vs non-adenocarcinoma), ethnic origin (Asian vs non-Asian and Indian sub-continent), performance status (0-1 vs 2), and smoking status (never-smoker vs ever-smoker). The coprimary endpoints were progression-free survival per independent review for all randomly assigned patients, and for all randomly assigned patients with KRAS wild-type tumours. The study has completed accrual and is registered with ClinicalTrials.gov, number NCT01360554. Between June 22, 2011, and March 12, 2013, we enrolled 878 patients and randomly assigned 439 to dacomitinib (256 KRAS wild type) and 439 (263 KRAS wild type) to erlotinib. Median progression-free survival was 2·6 months (95% CI 1·9-2·8) in both the dacomitinib group and the erlotinib group (stratified hazard ratio [HR] 0·941, 95% CI 0·802-1·104, one-sided log-rank p=0·229). For patients with wild-type KRAS, median progression-free survival was 2·6 months for dacomitinib (95% CI 1·9-2·9) and erlotinib (95% CI 1·9-3·0; stratified HR 1·022, 95% CI 0·834-1·253, one-sided p=0·587). In patients who received at least one dose of study drug, the most frequent grade 3-4 adverse events were diarrhoea (47 [11%] patients in the dacomitinib group vs ten [2%] patients in the erlotinib group), rash (29 [7%] vs 12 [3%]), and stomatitis (15 [3%] vs two [<1%]). Serious adverse events were reported in 52 (12%) patients receiving dacomitinib and 40 (9%) patients receiving erlotinib. Irreversible EGFR inhibition with dacomitinib was not superior to erlotinib in an unselected patient population with advanced non-small-cell lung cancer or in patients with KRAS wild-type tumours. Further study of irreversible EGFR inhibitors should be restricted to patients with activating EGFR mutations. Pfizer. Copyright © 2014 Elsevier Ltd. All rights reserved.

The effect of self-selected soothing music on fistula puncture-related pain in hemodialysis patients.

PubMed

Shabandokht-Zarmi, Hosniyeh; Bagheri-Nesami, Masoumeh; Shorofi, Seyed Afshin; Mousavinasab, Seyed Nouraddin

2017-11-01

This study was intended to examine the effect of selective soothing music on fistula puncture-related pain in hemodialysis patients. This is a randomized clinical trial in which 114 participants were selected from two hemodialysis units by means of a non-random, convenience sampling method. The participants were then allocated in three groups of music (N = 38), headphone (N = 38), and control (N = 38). The fistula puncture-related pain was measured 1 min after venipuncture procedure in all three groups. The music group listened to their self-selected and preferred music 6 min before needle insertion into a fistula until the end of procedure. The headphone group wore a headphone alone without listening to music 6 min before needle insertion into a fistula until the end of procedure. The control group did not receive any intervention from the research team during needle insertion into a fistula. The pain intensity was measured immediately after the intervention in all three groups. This study showed a significant difference between the music and control groups, and the music and headphone groups in terms of the mean pain score after the intervention. However, the analysis did not indicate any significant difference between the headphone and control groups with regard to the mean pain score after the intervention. It is concluded that music can be used effectively for pain related to needle insertion into a fistula in hemodialysis patients. Future research should investigate the comparative effects of pharmacological and non-pharmacological interventions on fistula puncture-related pain. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

Sun protection at elementary schools: a cluster randomized trial.

PubMed

Hunter, Seft; Love-Jackson, Kymia; Abdulla, Rania; Zhu, Weiwei; Lee, Ji-Hyun; Wells, Kristen J; Roetzheim, Richard

2010-04-07

Elementary schools represent both a source of childhood sun exposure and a setting for educational interventions. Sun Protection of Florida's Children was a cluster randomized trial promoting hat use at (primary outcome) and outside of schools among fourth-grade students during August 8, 2006, through May 22, 2007. Twenty-two schools were randomly assigned to the intervention (1115 students) or control group (1376 students). Intervention schools received classroom sessions targeting sun protection attitudes and social norms. Each student attending an intervention school received two free wide-brimmed hats. Hat use at school was measured by direct observation and hat use outside of school was measured by self-report. A subgroup of 378 students (178 in the intervention group and 200 in the control group) underwent serial measurements of skin pigmentation to explore potential physiological effects of the intervention. Generalized linear mixed models were used to evaluate the intervention effect by accounting for the cluster randomized trial design. All P values were two-sided and were claimed as statistically significant at a level of .05. The percentage of students observed wearing hats at control schools remained essentially unchanged during the school year (baseline = 2%, fall = 0%, and spring = 1%) but increased statistically significantly at intervention schools (baseline = 2%, fall = 30%, and spring = 41%) (P < .001 for intervention effect comparing the change in rate of hat use over time at intervention vs control schools). Self-reported use of hats outside of school did not change statistically significantly during the study (control: baseline = 14%, fall = 14%, and spring = 11%; intervention: baseline = 24%, fall = 24%, and spring = 23%) nor did measures of skin pigmentation. The intervention increased use of hats among fourth-grade students at school but had no effect on self-reported wide-brimmed hat use outside of school or on measures of skin pigmentation.

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

PubMed

Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

2013-08-19

Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the intervention on both patients receiving drug treatment and their family members. ISRCTN22608399. ISRCTN22608399 registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Effect of Oral Valproic Acid vs Placebo for Vision Loss in Patients With Autosomal Dominant Retinitis Pigmentosa: A Randomized Phase 2 Multicenter Placebo-Controlled Clinical Trial.

PubMed

Birch, David G; Bernstein, Paul S; Iannacone, Alessandro; Pennesi, Mark E; Lam, Byron L; Heckenlively, John; Csaky, Karl; Hartnett, Mary Elizabeth; Winthrop, Kevin L; Jayasundera, Thiran; Hughbanks-Wheaton, Dianna K; Warner, Judith; Yang, Paul; Fish, Gary Edd; Teske, Michael P; Sklaver, Neal L; Erker, Laura; Chegarnov, Elvira; Smith, Travis; Wahle, Aimee; VanVeldhuisen, Paul C; McCormack, Jennifer; Lindblad, Robert; Bramer, Steven; Rose, Stephen; Zilliox, Patricia; Francis, Peter J; Weleber, Richard G

2018-06-07

There are no approved drug treatments for autosomal dominant retinitis pigmentosa, a relentlessly progressive cause of adult and childhood blindness. To evaluate the potential efficacy and assess the safety of orally administered valproic acid (VPA) in the treatment of autosomal dominant retinitis pigmentosa. Multicenter, phase 2, prospective, interventional, placebo-controlled, double-masked randomized clinical trial. The study took place in 6 US academic retinal degeneration centers. Individuals with genetically characterized autosomal dominant retinitis pigmentosa were randomly assigned to receive treatment or placebo for 12 months. Analyses were intention-to-treat. Oral VPA 500 mg to 1000 mg daily for 12 months or placebo. The primary outcome measure was determined prior to study initiation as the change in visual field area (assessed by the III4e isopter, semiautomated kinetic perimetry) between baseline and month 12. The mean (SD) age of the 90 participants was 50.4 (11.6) years. Forty-four (48.9%) were women, 87 (96.7%) were white, and 79 (87.8%) were non-Hispanic. Seventy-nine participants (87.8%) completed the study (42 [95.5%] received placebo and 37 [80.4%] received VPA). Forty-two (46.7%) had a rhodopsin mutation. Most adverse events were mild, although 7 serious adverse events unrelated to VPA were reported. The difference between the VPA and placebo arms for mean change in the primary outcome was -150.43 degree2 (95% CI, -290.5 to -10.03; P = .035). This negative value indicates that the VPA arm had worse outcomes than the placebo group. This study brings to light the key methodological considerations that should be applied to the rigorous evaluation of treatments for these conditions. This study does not provide support for the use of VPA in the treatment of autosomal dominant retinitis pigmentosa. ClinicalTrials.gov Identifier: NCT01233609.

Randomized Controlled Trial of a Paraprofessional-Delivered In-Home Intervention for Young Reservation-Based American Indian Mothers

ERIC Educational Resources Information Center

Walkup, John T.; Mullany, Britta C.; Pan, William; Goklish, Novalene; Hasting, Ranelda; Cowboy, Brandii; Fields, Pauline; Baker, Elena Varipatis; Speakman, Kristen; Ginsburg, Golda; Reid, Raymond

2009-01-01

The efficacy of the paraprofessional-delivered Family Spirit home-visiting intervention for young American Indian mothers on maternal knowledge and infant behavior outcomes is supported. Participating mothers showed greater knowledge gains compared to non-participating mothers.

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

PubMed

Pitchford, Nicola J

2015-01-01

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